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Clinical Trials Webinars - Archived

Clinical trials are a group of biomedical or behavioral efficacy and safety studies, completed in humans, that are usually broken down in to four phases. Phase I clinical trials test a treatment's safety, dosage range and side effects in a small group of healthy people to determine if a treatment can be checked for efficacy. Phase II is initiated with a therapeutic dose to determine the treatment's effectiveness and further safety. Phase III clinical trials are administered to a larger group of people to finally verify efficacy and safety. Phase IV studies, or post-marketing studies are completed after the treatment has been brought to market to determine the effect of long-term use in a wide-range of patient populations. There are a wide range of topics covered in our clinical trial webinars - from tips on clinical trial start-up and adaptive trials to risk-based monitoring and best practices for clinical trial enrollment. If clinical trials is to broad a term, don’t forget, you can search our webinar catalog using the search bar, or, if you’re looking for something different, browse through our other topics.

  Synopsis Webinar Title Date

LifeScience - During this webinar, the speaker will describe Evotec’s medicinal chemistry and drug discovery philosophy
Speaker: Dr. Craig Johnstone, EVP, Global Head of Chemistry and Directeur General, Evotec France
Medicinal Chemistry Excellence – Efficient and Innovative Solutions for Superior Preclinical Candidates Jun 20, 2017

LifeScience - This webinar will provide an overview of the use of endpoints based on tumor measurements in cancer clinical trials
Speakers: Tomasz Burzykowski, PhD, VP Research, International Drug Development Institute (IDDI)
Everardo Saad, MD, Medical Director, International Drug Development Institute (IDDI)
Tumor-Size-Based Measurements as Endpoints in Cancer Clinical Trials Jun 15, 2017

LifeScience - This webinar will examine the use of targeted clinical strategies are as a critical step towards improving success rates
Speakers: Dr. Richard K. Harrison, Chief Scientific Officer, Clarivate Analytics
Gavin Coney, Head of Clinical Products, Clarivate Analytics
Dr. Lee Lancashire, Principal Research Scientist, Clarivate Analytics
The Evolving Utilization of Specific Biomarker Roles Within Trial Design Jun 15, 2017

LifeScience - See how drug safety teams can use dynamic visual analytics to uncover safety issues earlier
Speakers: Masha Hoffey, Director of Clinical Analytics, PerkinElmer Informatics
James (Jamie) Powers, Director of Real World Evidence and Data Science, PerkinElmer Informatics
Uncover Pharmacovigilance Insights with Data Discovery and Active Surveillance Jun 12, 2017

LifeSciences - Coming from a both a CRO and clinical pharmacology unit perspective, WCCT Global offers insight into the five qualities that are most indicative of a high-performing, optimized Phase 1 clinical pharmacology unit
Speaker: Jon Rojas, CEO, WCCT Global
5 Qualities to Consider When Selecting Clinical Pharmacology Units for Early Drug Development Jun 6, 2017

LifeSciences - Join this webinar as Covance highlights proven solutions for overcoming the enormous challenge of study planning and patient recruitment and learn more about how the Covance informatics platform solves patient recruitment challenges by using strategic, evidence-based methodologies
Speakers: Pamela Atwell, Senior Director, Strategy and Planning, Oncology, Covance
Michelle Jones, Senior Director, Clinical Informatics, Clinical Business Informatics & Solutions, Covance
Evidence-Based Approaches for Accelerating Patient Enrollment in Oncology May 24, 2017

LifeSciences - This webinar will cover how life sciences research and development teams can enable compliant and secure data lifecycle management across multiple use cases including early discovery phase, clinical trials, and the building of biotech therapies as example
Speakers: Gary Palgon, Vice President, Healthcare and Life Sciences Solutions, Liaison Technologies
Gopal Sharma, Chief Data Architect EU, Liaison Technologies
Enabling Patient-Centric Digital Transformation in Pharma and Biotech May 19, 2017

LifeSciences - This presentation will discuss a few diagnostic and theranostic agents currently under development and in use from the lifecycle management perspective, discuss challenges, and the solutions to overcome them
Speakers: Prithul Bom, MBA, RAC, ASQ-CSQE, Senior Director of Scientific Affairs and Therapeutic Area Lead for Medical Devices & Diagnostics, Chiltern
Lisa Moore, RN, PhD, Executive Director, Medical Devices & Diagnostics Development, Chiltern
Jeffrey Joseph, Executive Director, Statistics, Chiltern
Imaging Diagnostics and Theranostics: Meeting Clinical Development Challenges May 17, 2017

LifeSciences - This webinar will discuss the role and relevance of cognitive endpoints in clinical trials to accelerate our understanding of cognitive dysfunction related to cancer and cancer treatments
Speaker: Jeffrey S. Wefel, PhD, ABPP, Section Chief and Associate Professor, Section of Neuropsychology, Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center
The ABCs of Assessing Cognition in Oncology Clinical Trials: Applications, Benefits, and Considerations May 16, 2017

LifeSciences - In this live webinar, the speakers will outline both the importance of a coherent endpoint strategy as well as the importance of leveraging scientific leadership early-on in trial design
Speakers: Professor Christine Jenkins, Scientific Leader – Respiratory, George Clinical
Dr. Marisa Petersen, Associate Director, CEO, George Clinical
Respiratory Endpoints, Scientific Leadership and the Asia-Pacific Region May 16, 2017

LifeSciences - Through quantitative analysis of IHC images, effective biomarkers can be predictors of disease prognosis and immune response of various immunotherapies.
Speaker: Belma Dogdas, PhD, Associate Principal Scientist, Merck, Inc.
Quantitative Immunohistochemistry for Development of Predictive Biomarkers in Oncology Clinical Trials May 10, 2017

LifeSciences - This webinar will focus on some of the challenges faced in executing a complex global oncology trial
Speakers: Amy Franke, Senior Director, Strategy and Planning, Covance
Bridget (Fitzsimmons) Weeks, Director, Project Management (Oncology), Covance
Montessa Lizaso, RN, Senior Data Analyst, Strategy and Planning (Oncology), Covance
Implementing Basket/Bucket and Umbrella Designs: What You Need to Know for Global Oncology Trials May 8, 2017

LifeSciences - This webinar will focus on emerging IRT system functionality that expedites go-live timeline, provides more sponsor control, and full visibility into the whole project lifecycle.
Speaker: Grant Dietrich, Vice President, Strategic Partnerships, YPrime
The New Gold Standards of IRT Delivery for Clinical Trials May 3, 2017

LifeSciences -  Understand factors the presenters believe medical device sponsors should consider when developing or using embloic protection devices in clinical trials
Speakers: Alan B. Lumsden, MD, ChB, RVT, FACS, Medical Director, Medical Metrics
Zsolt Garami, MD, Director of Vascular Imaging, Medical Metrics
Richelle Massey Senior Director, Project Management, Medical Device & Diagnostic Division, Novella Clinical
Clinical Trial Considerations in Cerebral Protection for TAVR Patients Apr 26, 2017

LifeSciences - The webinar will focus on specific analytical test solutions for Type II Diabetes that enable the creation of high quality laboratory data sets which in turn enable an accurate and efficient assessment of the test compound
Speakers: Andrew Roche, Ph.D., Scientific Director, Global Validation, Scientific Affairs, ICON
Martin Benson, Ph.D., Senior Director and Global Lead, Cardiometabolic Drug Development Services
Addressing the Challenges of Type II Diabetes Global Clinical Trials via Use of High Quality Laboratory Solutions Apr 26, 2017

LifeSciences -  The webinar will discuss the implications of the results and highlight key insights for sponsors and CROs to optimize their investigative site management practices
Speakers: Ken Getz, Director of Sponsored Research Programs & Associate Professor, Tufts CSDD
Beth Harper, President, Clinical Performance Partners
Patricia Smith, Business Architect, goBalto
New Tufts CSDD Study on End-to-End Site Identification Through Startup Apr 25, 2017

LifeSciences - Whether your organization is just starting to consider eConsent or looking to expand adoption company-wide, learn about what others in the industry are currently thinking about the informed consent process
Speakers: Sam Sather, Quality and Regulatory, TrialConsent, CRF Health
Naor Chazan, Director of Marketing, CRF Health
Electronic Informed Consent: 2017 Industry Survey Results Apr 20, 2017

LifeSciences -  This webinar will cover the broad scope of developing a biological safety evaluations and how to assess the biocompatibility of device and process changes
Speaker: Audrey Turley, B.S., RM (NCRM), CBA (ASQ), Research Scientist, Nelson Labs
Developing a Biological Safety Evaluation Apr 18, 2017

LifeSciences -  This webinar will discuss noninvasive ways to assess NASH using imaging, including proton density fat fraction (PDFF), T1 relaxometry, Magnetic resonance elastography (MRE) and the latest advances in MRE and how they can be used to assess inflammation.
Speakers: Richard L. Ehman, M.D., Professor of Radiology, Blanche R. & Richard J. Erlanger Professor of Medical Research, Mayo Clinic; President and CEO, Resoundant, Inc.
Jonathan Riek, Vice President, Ph.D., Musculoskeletal and Metabolic Imaging, BioTelemetry Research (Cardiocore & VirtualScopics)
Assessing NASH: Discover the Non-invasive Techniques Apr 13, 2017

LifeSciences -  This webinar provides a timely update on new industry expectations of eCOA technologies
Speaker: Mike Hughes, Senior Director, eCOA Solutions, YPrime
The Modernization of eCOA Technology for Clinical Trials Apr 13, 2017

LifeSciences - This webinar will take an in-depth look at CRO oversight and risk management best practice, delving into the gaps in oversight processes, the causes of these gaps and how to successfully address them
Speakers: Julie Peacock, Client Services, Comprehend
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
Critical CRO Oversight Metrics: How to Establish the Right Metrics and Monitor them in Real-time Apr 12, 2017

LifeSciences -  In this webinar, the speakers will discuss their experience with the regulatory and product development processes for combination products to show you how to navigate regulatory complexities
Speakers: Diane Beatty, PhD, Managing Director, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences
Jean Dehdashti, MSc, RAC, Scientist III, Regulatory Affairs & Product Development, Cardinal Health Regulatory Sciences
Combination Product Regulatory Requirement Complexities and the Impact of the 21st Century Cures Act Apr 5, 2017

LifeSciences - This webinar will review some of the key components to consider when developing your strategy to minimize risk, manage cost, and ultimately deliver a product to market
Speakers: Kristen Franklin, Client Services Manager, Cell Therapy, Fisher BioServices
Amy Hendricks, Project Manager, Fisher BioServices
Cell Therapy – Achieving Achieving Success on the Road to Commercialization Apr 5, 2017

LifeSciences -  This series explores proven ways to develop go/no-go insights faster so clinical development teams can get submission-ready faster, reduce the risk of a rejected submission or potential market withdrawal, and optimize data provisioning, aggregation and review
Speaker: Masha Hoffey, Director of Clinical Analytics, PerkinElmer Informatics
Predict and Act on Site Risks With Data-Driven Insights
Part 2 of Series "Four Steps to Shorten Your Clinical Trials with Informatics"
Apr 4, 2017

LifeSciences -  Key elements of this webinar will include the importance of natural history information in rare disease research, the difference between registry and natural history studies, and how to design and conduct a registry or natural history study
Speakers: Angi Robinson, Executive Director, Pediatrics & Rare Disease, Premier Research
Juliet Moritz, Executive Director, Rare Disease & General Medicine, Premier Research
Natural History vs. Registry Studies in Rare Disease Apr 4, 2017

LifeSciences - The purpose of this webinar is to evaluate and discuss the methodological approaches outlined in the guidance and highlight several key areas that may warrant further consideration when designing and planning for such studies
Speakers: Dr. Jack E. Henningfield, PhD, Vice President, Research, Health Policy, Abuse Liability, PinneyAssociates
Dr. David J. Heal, PhD, DSc, FRSC, FBPhS, Executive Director, RenaSci Ltd.
Dr. Beatrice Setnik, PhD, Vice President, Scientific Affairs, INC Research, Early Phase
The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review Mar 30, 2017

LifeSciences - This webinar will examine the clinical and pathogenetic aspects of the disease and the characteristics of clinical trials that seek to address this genetic condition
Speakers: Howard Welgus, Executive Medical Director, Dermatology, Premier Research
Ted Trafford, Managing Director, Probity Medical Research
Treatment of Psoriasis: Improvements Through Clinical Trials Mar 29, 2017

LifeSciences -  Can technology really streamline processes, make the research team more efficient, improve patient safety, and get to the end result of the research faster?
Speakers: Graham Belgrave, Chief Operations Officer, Cmed
Sammie Rivera, Senior Client Services Manager, Cmed
Jon Carter, Product Manager, Cmed
David Holloway, Global Head of Commercial Operations, Cmed
How to Improve the Speed and Efficiency of Your Clinical Trials Mar 28, 2017

LifeSciences - This presentation will explore how exponential growth in the variety of real world data sources and their quick adoption across functional business units is necessitating the need for the standardization of real world data and analytics platforms
Speakers: Robert Collins, Senior Life Sciences Industry Consultant, SAS
Ari Yacobi, Chief Data Scientist, Knowledgent
Institutionalizing Real-World Evidence Across Your Organization Mar 22, 2017

LifeSciences - While PD-L1 by immunohistochemistry has been successfully employed as a companion diagnostic for several therapies across a handful of indications, PD-L1 is only one potential biomarker for showing a predictive response. As more combination therapies are examined, more informative markers will need to guide when and how a treatment or combinations of treatment should be considered.
Speaker: Gina Wallar, PhD, MPH, Division Vice President for Pharma Services Sales, NeoGenomics, Inc.
Evaluation of the Tumor Microenvironment Using Image Analysis for Clinical Trials Mar 21, 2017

LifeSciences - This webinar follows a previous session from December 2016 on preparing for ICH-GCP E6(R2) at investigator sites by addressing questions practitioners now have as they prepare for future GCP audits and inspections conducted in accordance with these revised guidelines
Speakers: Andrew Mitchell, Director of Life Sciences, Intralinks
Dan Sfera, The Clinical Trials Guru
Gunnar Danielsson, DGD Consulting
ICH-GCP E6(R2) – Live Q&A with GCP Inspector and Investigator Site Perspectives Mar 15, 2017

LifeSciences - This talk will focus on various aspects of designing and conducting clinical trials for submission to the FDA, as well as, communicating with FDA during the pre-submission and submission process
Speaker: Richard Kotz, Senior Medical Research Scientist, Biostatistics, NAMSA
Designing an Effective Clinical Trial Mar 7, 2017

LifeSciences - In this presentation, the speaker will discuss a case study of how a global external quality assessment (EQA) organization is using these reference materials to ensure the accuracy and consistency of one such clinical genomics application in the area of non-invasive prenatal testing (NIPT)
Speaker: Sandi Deans, Consultant Clinical Scientist, Director of UK National External Quality Assessment Service (UK NEQAS) for Molecular Genetics
Enabling Clinical Genomics with Highly Multiplexed and Patient-like Reference Materials Mar 1, 2017

LifeSciences - This webinar will help viewers comprehend regulatory requirements, understand the steps in preparing a successful Integrated Summaries project from a timelines and cost perspective and have a better idea of the deliverables they should expect from their CRO
Speakers: Mark Paul, Senior VP North America, CROS NT
Caroline Terrill, Director of Statistical Programming, CROS NT
Gail Head, Senior Medical Writer, CROS NT
Integrated Summaries – Tips for Meeting the Challenges Faced by Sponsors Feb 28, 2017

LifeSciences - New regulatory pathways and processes are expediting the translation of novel therapies to the bedside, and understanding these options helps ensure availability of more new treatments while minimizing delays
Speakers: Peter Larson, Senior Medical Director, Hematology-Oncology, Premier Research
Colin Hayward, Chief Medical Officer, Premier Research
From Laboratory to Bedside: Expediting Development of Novel Rare Cancer Treatments Feb 28, 2017

LifeSciences - Learn how technological advances are helping to best support the mid-study change process
Speaker: Rich Davies, Executive Director of Business Solutions, OmniComm Systems
Mid-Study Changes: Keeping Your Clinical Trial on Track with EDC Feb 23, 2017

LifeSciences -  This webinar will provide an overview of the current use and potential of HTA as a component of clinical trials aimed at regulatory approval of novel agents in various medical fields, including the general concept of HTA and cost-effectiveness in healthcare
Speakers: Everardo Saad, MD, Senior Medical Expert, IDDI
Oriana Ciani, PhD, Postdoctoral Research Fellow, University of Exeter Medical School; Research and Teaching Fellow, Centre for Research on Health and Social Care Management (CeRGAS), Bocconi University, Milan
Rod Taylor, MSc, PhD, Professor of Health Services Research, University of Exeter Medical School; Director, Exeter Clinical Trials Unit; Senior Investigator, National Institute for Health Research (NIHR), UK
Incorporating Health Technology Assessment (HTA) in Clinical Trials Feb 22, 2017

LifeSciences - This webinar will explore the development process, the changing regulatory environment, and the device approval pathways to help sponsors optimize the likelihood of regulatory and commercial success
Speakers: Joanne Emmett, Vice President, Medical Device & Diagnostics, Premier Research
Lisa Pitt, Vice President, Global Regulatory Affairs, Premier Research
Medical Device Regulation: Finding Your Path to Success Feb 14, 2017

LifeSciences - In this webinar, the presenter will consider issues associated with the application of cognitive tests to guide decision making about the safety and efficacy of drugs in both the chronic and acute stages of schizophrenia
Speaker: Paul Maruff, Chief Science Officer, Cogstate
Increasing the Precision of Cognitive Endpoints in Schizophrenia Clinical Trials Feb 9, 2017

LifeSciences - In this webinar, the speaker will examine the requirements listed in MEDDEV 2.7/1 revision. 4, discuss notable changes from MEDDEV 2.7/1 revision 3, while focusing on the global benefits of the Clinical Evaluation Report for your product’s path to market
Speaker: Vincent Legay, Manager Europe, Consulting Services, NAMSA
Clinical Evaluation Reports (CERS): Global Benefits & The Impact of MEDDEV Updates to Manufacturers Feb 8, 2017

LifeSciences - This webcast discusses how medical monitors can leverage guided visual analytics to find and act on the right issues quickly without sifting through mounds of clinical data
Speaker: Masha Hoffey, Director of Clinical Analytics, PerkinElmer Informatics
Propel Medical Review with Guided Analytics
Part 1 of Series "Four Steps to Shorten Your Clinical Trials with Informatics"
Feb 7, 2017

LifeSciences -  The speaker will discuss the importance of scientific leadership in the trial design process and throughout trial delivery, and examine the challenges of trial design in the Asia-Pacific along with the region's many opportunities for all phases of clinical studies
Speaker: Professor Vlado Perkovic, MBBS PhD FRACP FASN, Director, George Clinical, Executive Director, The George Institute, Australia
Trial Design and Scientific Leadership: How to Boost Patient Recruitment in Asia and Around the World Jan 31, 2017

LifeSciences - As cancer treatments become more focused on personalized care for the patient, understanding the intricacies of immuno-oncology becomes increasingly important. Join our speakers who will outline how to manage the complexity of these studies and ways to maintain a successful partnership with your CRO.
Speakers: Megan Liles, Director, Project Management, Chiltern
Lynn Donald, Project Director, Chiltern
Operational Excellence in Immuno-Oncology Clinical Trials Jan 26, 2017

LifeSciences -  This webinar will focus on data integration, which brings to life risks that are not apparent when examining data from one source alone
Speakers: Andy Lawton, Advisor, Risk Based Approach Ltd.
Pankaj Manon, CTO, ThoughtSphere
Bridging the Clinical Data Structure Gap for Holistic RBM: How Fully Integrated Data Empowers Risk Management Jan 19, 2017

LifeSciences - This session provides insight into managing and operationalizing various aspects of clinical trials as well as identifying challenges and the technology based solutions needed to overcome them.
Speaker: Kelly Knowles, PMP, Director, Client Services, Bracket
The Future of IRT is in Your Hands – Leveraging Mobile Technology to Bring Clinical IRT into the 21st Century Jan 18, 2017

LifeSciences - This webinar will focus on how Investigator Sites are preparing for ICH-GCP E6(R2) and its impact on remote monitoring
Speakers: Andrew Mitchell, Senior Life Sciences Executive, Intralinks
Dan Sfera The Clinical Trials Guru
Remote Monitoring and Preparing for ICH-GCP E6(R2) at Investigator Sites Dec 13, 2016

LifeSciences -  This webinar will address emerging trends in clinical trial methodology for orphan disease drug development
Speakers from Worldwide Clinical Trials:
Michael Murphy, MD, PhD, Chief Medical and Scientific Officer
Josie Measures, Vice President Biostatistical Operations
Lorna Graham, BSc, MSc, Associate Director, Project Management, Evidence
Barbara Zupancic, Director, Global Patient Recruitment and Retention
Necessity is the Mother of Invention: The Impetus for Observational Research in Orphan Drug Development Dec 7, 2016

LifeSciences -  This webinar will discuss the findings from a commissioned study conducted by Forrester Consulting on behalf of Attivio surveying 112 life sciences experts involved with data analytics and visualization regarding current challenges such as too many data sets, unstandardized formats, multiple data sources (many outside the firewall), and lack of business-friendly analytics
Speakers: Rowan Curran, Analyst, Application Development & Delivery Professionals
Brendon Kellner, Presales Consultant, PerkinElmer
Four Reasons You’re Not Harnessing Big Data for R&D Dec 6, 2016

LifeSciences - The speakes will discuss how to prepare your organization for excellence related to the increased requirements in vendor management, operational data collection and reporting, and risk-based monitoring
Speakers: Julie Peacock, Clinical Intelligence Expert, Comprehend
Chris Panteli, Principal and Managing Consultant, Chaucer Life Sciences
ICH E6 (R2): Best Practice Implementation and Technology Solutions for Pending Updates to Global GCP Guidelines Dec 1, 2016

LifeSciences -  Discussion topics include risk factors for disease progression, the detection, assessment and monitoring of DILI in NASH patients, and the strategic framework of applying a seamless adaptive design in a NASH development program
Speakers: Arun Sanyal, MD, Professor of Medicine and Chairman of Gastroenterology Division, Virginia Commonwealth University School of Medicine
Claudia Filozof, MD, PhD Executive, Medical Director in CVM/ER Therapeutic Area, Covance
Arie Regev, MD, Head of the Safety Advisory Hub, Eli Lilly and Company
Tammy McIver, MSc, CStat, Senior Manager, Biostatistics and Statistical Programming, Covance
Hot Topics in Non-Alcoholic Steatohepatitis (NASH) Nov 29, 2016

LifeSciences -  Viewers will learn how implementation, evolution and change management are critical for a successful remote monitoring program. But how does a remote monitoring program harmonize with current SDV practices?
Speaker: Dr. Gavin H.R Boodoo, Remote Clinical Data Monitoring (RCDM) Manager, Quanticate
Implementation, Evolution and Change Management Required for Remote Source Data Verification (rSDV) Nov 29, 2016

LifeSciences -  The spaeker will outline many of the opportunities that exist when conducting clinical trials, such as the SAVE trial (one of the largest obstructive sleep apnea medical device trials ever undertaken), in Asia and debunk a lot of the misconceptions that exist for sponsors who have operated in the traditional clinical trial markets of the USA and Europe
Speakers: Professor Craig Anderson, Executive Director, The George Institute, China, and Senior Director, Neurological & Mental Health Division
Emma Field, Project Manager, George Clinical, A division of The George Institute for Global Health
The Scientific Leadership Model: An Innovative Approach to Clinical Trial Leadership, Design and Delivery Nov 28, 2016

LifeSciences -  The speakers will demonstrate the functionality of by encapsia™ and how "Smart Monitoring" improves the quality, speed and cost of clinical trials
Speakers: Graham Belgrave, Chief Operations Officer, Cmed
Jon Carter, Product Manager, Cmed
Risk-Based Monitoring, Remote Monitoring and eSource: The Unattainable Trilogy of Monitoring? Nov 22, 2016

LifeSciences - In this webinar, the speakers will provide an overview of the current status of surrogates for overall survival in oncology
Speakers: Marc Buyse, ScD, Chief Scientific Officer, International Drug Development Institute (IDDI)
Dr. Everardo Saad, Senior Medical Expert, IDDI
Current Status of Surrogates for Survival in Cancer Trials Nov 17, 2016

LifeSciences -  The speakers will we will discuss considerations for multi-sponsor registries from a variety of stakeholder perspectives: manufacturer/sponsor, CRO, patients/healthcare providers
Speakers: Bill Row, MBA, MSm, Vice President, INC Research
Dr. Jessica Albano, PhD, MPH, Senior Director, Epidemiology, INC Research
Dr. Susan Sinclair, PhD, MPH, Associate Professor, UNCW College of Health and Human Services, and Sr. Advisor, INC Research
Navigating Multi-Sponsor Registries: The Journey to Success Nov 17, 2016

LifeSciences - This webinar will focus on the methodology for developing and validating Clinician-Reported Outcomes (ClinROs) for implementation in clinical trials and to support labeling claims
Speakers: Magdi Vanya, Lead Outcomes Researcher, ICON
Olga Moshkovich, Outcomes Researcher, ICON
Katy Benjamin, Principal, ICON
Development and Validation of Clinician-Reported Outcomes Measures (ClinROs): Review of Best Practices and Lessons Learned Nov 16, 2016

LifeSciences -  This webinar will privide a wide-ranging examination of strategies that can help ensure a successful trial
Speakers: Anne-Marie Nagy, Ph.D., Executive Director, Strategic Development, Neuroscience, Premier Research
Carol M. Gaines, M.D., Senior Medical Director, Premier Research
Todd Leathers, MBA, Executive Director, Strategic Development, Neuroscience, Premier Research
Neurodegenerative Disease Research: Steps to a Successful Clinical Trial Nov 15, 2016

LifeSciences - In this webinar, the speakers will share recent data and discuss recommendations for how the industry will move forward to overcome the obstacles in the path of acceptance of PRO as an appropriate measure of the patient’s voice in cancer care
Speakers:
David Thompson, PhD, Senior Vice President, Real-World Evidence, inVentiv Health
Joseph O’Connell, MD, Vice President, Medical & Scientific Affairs, Hematology & Oncology, inVentiv Health
Heather Gartman, Managing Director, Patient Engagement Practice Lead, inVentiv Health
Kelly E. White, Director, Managed Markets Research, inVentiv Health
Patient Centered Strategies for Clinical Trials & Treatment: Reactions to Payer Perspectives on Patient Reported Outcomes Nov 10, 2016

LifeSciences -  Hear how Bioclinica’s Optimizer tool can help optimize logistics strategy, forecast and plan a study
Speaker: Casey Ferrier, Director of Supply Chain Management, eHealth Solutions, Bioclinica
What Value Does Forecasting and Demand Planning Technology Bring to the Management of the End-to-end Clinical Supply Chain? Nov 3, 2016

LifeSciences - This webinar will examine what it takes to manage multi-protocol programs and deliver consistent results
Speaker: Svetlana Kolchinsky, Director, Project Operations, BioTelemetry Research (Cardiocore & VirtualScopics)
Managing Multi-Protocol Programs & Building Efficient Partnerships Nov 3, 2016

LifeSciences - Learn how clinical supplies professionals are working behind the scenes to bring these complex devices through clinical development
Speakers: Shawn Regits, Process Engineering Manager, Fisher Clinical Services
Guido Hunkeler, Director Engineering & Automation, Fisher Clinical Services
Key Tips to Sharpen Your Clinical Trial Packaging Strategy for Prefilled Syringes Nov 3, 2016

LifeSciences -  The webinar will offer practical advice on employing the right mobile strategies to increase patient engagement and support smarter decisions based on larger, better data streams
Speakers: Matt Kibby, President, BBK Worldwide
Lewis Millen, Operational Intelligence Leader, Roche Products Limited
Harnessing the Power of mHealth for New, Better Data and Improved Patient Engagement Oct 28, 2016

LifeSciences -  Topics include scientific and clinical research insights on the principles of BOLD fMRI and its application as a clinical tool and drug development biomarker, design of an fMRI study, and an overview of the challenges and limitations of performing fMRI evaluation under an Investigational New Drug Application for drug development
Speakers: Maria Laura Blefari, PhD, Biomedical Engineer, WorldCare Clinical
Mykol Larvie, MD, PhD, Physician, Department of Radiology, Director of Molecular Neuroimaging, Massachusetts General Hospital
Functional Brain Imaging Using MRI: An Emerging Tool for Drug Development and Clinical Trials Oct 28, 2016

LifeSciences -  This webinar will showcase the results of Comprehend’s 2016 ClinOps ICH E6(R2) survey and its impact on the CRO/Sponsor relationship
Speakers: Bruno Gagnon, B Pharm, MSc, Clinical Intelligence Expert
Matt McKinney, Clinical Intelligence Expert, Comprehend Systems
ICH E6(R2) Benchmark Survey: Essential Elements of Compliant CRO Oversight Oct 27, 2016

LifeSciences -  Data visualization and analytics is only the beginning of a holistic RBM program. The speaker will show how PerkinElmer puts the principles of actionable and adaptive RBM to work in an enhanced RBM offering.
Speaker: George H. Johnson IV, SCPM, Senior Consultant Clinical, Services Lead for Risk Based Monitoring and Data Provisioning, PerkinElmer Informatics
Actionable & Adaptive RBM: PerkinElmer’s Comprehensive Approach to Risk-Based Monitoring Oct 26, 2016

LifeSciences - This webinar will examine transformative applications in observational studies and pragmatic clinical trials
Speakers: Jim Carroll, Vice President, Real World Evidence, ICON
Rob Sambrook, Divisional Principal, Epidemiology, ICON
Meeting Evidentiary Needs with Electronic Health Records Oct 25, 2016

LifeSciences -  The webinar includes case studies and discussion of the advantages of continuous processing in general, shortcomings associated with the current batch manufacturing processes and limitations observed in continuous processors today
Speakers: Dr. Babu Padmanabhan, Managing Director and Chief Knowledge Officer, STEERLife
Mr. Indu Bhushan, Chief Technical Officer, STEERLife
Novel Continuous Activated Granulation Oct 21, 2016

LifeSciences - Comprehensive analysis of target expression and key proteins of cancer pathways as well as their modifications (e.g., phosphorylation) can provide a much more detailed (and more predictive) picture of the individual tumor biology.
Speaker: Prof. Dr. med. Hartmut Juhl, Founder and CEO, Indivumed GmbH and IndivuTest GmbH (Hamburg)
Tissue Collection Standards Determine the Future of Precision Medicine Oct 18, 2016

LifeSciences - Hear from industry experts how to implement an automated process for EDC to PV via E2B
Speakers: Rich Davies, Executive Director of Business Solutions, OmniComm Systems, Inc.
Dr. Marc Zittartz, Chief Quality Officer, pharmasol
What You Need to Know About Electronic Data Capture, Serious Adverse Events, E2B and Pharmacovigilance Systems Oct 13, 2016

LifeSciences - This webinar will help organizations evaluate how their structure and processes will be affected with the pending adoption of revisions the ICH Guideline for Good Clinical Practice (E6 R2) that primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting
Speaker: Kristin Mauri, MBA, Senior Director, Global Consulting, eHealth Solutions, Bioclinica
What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management? Oct 5, 2016

LifeSciences - This webinar will present a streamlined enrichment method based on Molecular Inversion Probes and will elaborate on how its fast workflow and other refinements can simplify the variant discovery and validation process
Speaker: Michael Brockman, PhD, Manager of Research Informatics, Roche Sequencing
Rapid and Accurate Variant Detection with the HEAT-Seq Target Enrichment System, a New Method Using Advanced Molecular Inversion Probes Sep 30, 2016

LifeSciences - Overcoming the challenges in the NAFLD/NASH race to the market will not only benefit the pharmaceutical and biotech industry to bring new therapies to market, but will ensure that the millions of NAFLD/NASH patients are treated or cured of this chronic liver disease
Speakers: Sabina Paglialunga, PhD, Metabolic and Pharmacodynamic Specialist, Celerion
Rafiq Islam, MS, Senior Director, Bioanalytical Services, Celerion
NAFLD/NASH – Race to the Market: Strategies and Tactics to Address Unmet Needs Sep 28, 2016

LifeSciences - The webinar will focus on study startup and discuss best practices for the identification and mitigation of potential risks before they occur
Speakers: Rob Wynden, VP Technology and Engineering, goBalto
Linda Sullivan, Co-Founder and President, Metrics Champion Consortium
Andrea Sim, VP Product, goBalto
Refocusing on Risk Mitigation in Starting Clinical Trials Sep 27, 2016

LifeSciences - The webinar will present conceptual and logistical challenges of both qualitative and quantitative studies to assess the content validity and measurement properties of these PerfO assessments in these patient groups, and the results from these studies
Speakers: Elizabeth (Nicki) Bush, Research Scientist, Eli Lilly and Company
Rachel Ballinger, Lead Outcomes Researcher, ICON
Helen Doll, Senior Principal, Clinical Outcomes Assessments, ICON
Validating Select Physical Performance Outcome (PerfO) Assessments to Support Labelling Claims in the US: Methods and Lessons Learned Sep 21, 2016

LifeSciences - The webinar will examine factors that produce a therapeutic effect which erodes the efficacy signal of a potential treatment, with particular focus on study design considerations, site factors, subject selection and eligibility, and data surveillance
Speakers: Krista Armstrong, PhD, Vice President, Strategic Development, Premier Research
Susan Kozauer, MD, Senior Medical Director, Psychiatry, Premier Research
Conclusive Results: Strategies for Collecting Quality Data in Psychiatric Clinical Trials Sep 20, 2016

LifeSciences - This webinar will give an overview of endpoint assessment as it relates to RECIST, irRC, and clinical benefit in the setting of cancer immunotherapy
Speakers: Klaus Noever, MD, Senior Director of Medical Affairs, WorldCare Clinical, LLC
Ryan J. Sullivan, MD, Assistant in Medicine, MGH Cancer Center, Massachusetts General Hospital, and Assistant Professor, Medicine, Harvard Medical School
Tumor Burden and Clinical Benefit Assessment in Immunotherapy Clinical Trials Sep 19, 2016

LifeSciences - The speaker will takes us along a journey with lessons learnt from both an organizational and personal perspective
Speaker: Ed Tucker, Senior Vice President for Medical Safety, Quality and Compliance, Acerta (a majority owned company of AstraZeneca)
Drug Safety in a Startup Biotech Sep 15, 2016

LifeSciences -  The webinar will discuss challenges faced in setting up a shipper reuse program, the various reuse models that can be adopted, and the benefits of a successful program to the various parties involved.
Speaker: Royce Heap, Global Cold Chain Technology Lead, Fisher Clinical Services
Shipper Return & Reuse – Making It Work For Clinical Trials Sep 15, 2016

LifeSciences - This webinar reviews the history of patient advocacy groups in advancing clinical research and examines the evolution of their role in light of recent and pending legislative and regulatory changes in the United States and European Union
Speakers: Juliet M. Moritz, Executive Director, Strategic Development, Rare Diseases, Premier Research
Susan Stein, MPH, CEO & President, Connexion Healthcare, and Board Member, Global Genes
The Powerful and Evolving Role of Patient Advocacy Groups in Orphan Drug Development Sep 14, 2016

LifeSciences - This session details best practices for onboarding RBM that have been gained through implementation involving smaller and larger BioPharma sponsors and CROs
Speakers: Francois Torche, Chief Executive Officer, CluePoints
Craig Serra, Senior Director, Data Management BPO, Clinical Sciences and Operations, Pfizer
Removing the “Risk” in Risk-Based Monitoring
What We Have Learnt in the Last 4 Years from the Practical Implementation of RBM
Sep 12, 2016

LifeSciences -  The presentation will include a brief history of the microbiome in research, a discussion of health standards and host interaction with the gut flora, care and use of gnotobiotic and germ-free models and a review of current studies involving the microbiome
Speaker: Jennifer Phelan, Product Manager, Taconic Biosciences
Intro to the Microbiome Aug 25, 2016

LifeSciences -  The speakers will discuss the growing range of imaging modalities and analysis methods that are available for use in your clinical trials during oncology drug development
Speakers: Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research (Cardiocore & VirtualScopics)
Edward Ashton, Ph.D, Vice President, Oncology Imaging, BioTelemetry Research (Cardiocore & VirtualScopics)
Advanced Imaging in Oncology Aug 24, 2016

LifeSciences -  Flexible multiplex testing platforms can provide both targeted and broad respiratory testing
Speakers:
Marilyn Mitchell, MT(ASCP)MS, Supervisor, Microbiology Laboratory, Community Regional Medical Center
Robin Chamberland, Ph.D., Assistant Professor, Department of Pathology, Director of Microbiology Laboratory, Medical Director of Molecular Microbiology, Saint Louis University Hospital
Flexible Testing for Respiratory Pathogens: Cost-Effectiveness and Impact on Clinician Ordering Patterns Aug 23, 2016

LifeSciences - Learn how Quintiles uses TrialOne® to eliminate unnecessary duplication of data, reduce the opportunity for transcription errors, promote real-time entry of electronic source data during subject visits and ensure the accuracy and completeness of data
Speakers: Roman Laddach, Director of Early Phase Consulting, OmniComm Systems, Inc.
Sara Rothermich, Clinical Lead Manager, Quintiles
Early Phase Clinic’s Real World Experience with Clinic Automation Aug 18, 2016

LifeSciences -  Topics include how a modern application platform can deliver automation, control, data accuracy and on-demand operational transparency in critical initial trial phases
Speakers: Michael Calluori, Sr. Business Analyst BPM, Sanofi
Pramod Sachdeva, Managing Director and Founder, Princeton Blue
Evi Cohen, Global Practice Leader, Life Sciences, Appian
Avoid Patent Eclipse – Accelerate Your Study Start Up and Tracking Aug 17, 2016

LifeSciences -  Join the webinar to learn more about the consequences of poor forecasting, the difficulties of reforecasting with manual systems, the complexities that make forecasting so challenging, and how technology that is purpose-built for clinical trials can help CROs and Sponsors forecast more effectively and accurately
Speakers: Jay Trepanier, Senior VP and General Manager, Bioclinica Financial Lifecycle Solutions
James Sacchetta, Manager, Technical Operations, Premier Research
Clinical Trial Forecasting: Managing the Challenges and Avoiding the Fines Aug 3, 2016

LifeSciences - In this webinar, the speakers will discuss in detail the digital health market and the tremendous positive impact it can have for clinical research right now and in the coming years
Speakers: Ken Light, EVP of Transformation and Professional Services, OmniComm Systems
Jennifer Plumer, Pharma/CRO Lead, Validic
Digital Health and the Emerging Vital Role of EDC Jul 28, 2016

LifeSciences - This session will focus on the keys to finding a good sponsor/CRO match for your clinical research
Speakers: Cassie Jacobson, Clinical Research Strategy Director, 3M, Critical & Chronic Care Solutions Division
Katie Schaaf, Director, Strategic Partnerships, NAMSA
Ensuring a Successful Collaboration between Sponsors and CROs Jul 27, 2016

LifeSciences -  This webinar will explain and provide examples to illustrate the importance of cultural adaptation and the steps in the linguistic validation process
Speakers: Adelina Lear, BA, Strategic Account Executive, ICON Language Services
Diane Wild, MSc, Consultant
Linguistic Validation – When Google Translate Just Isn’t Enough Jul 26, 2016

LifeSciences - End-to-end safety solutions need to encompass the required service, product and technology components in order to stand up to the challenges
Speaker: Francois Audibert, Vice President, Global Consulting Practice, Bioclinica, Inc.
Finding the Right End-to-End Safety Solution for Your Needs Jul 21, 2016

LifeSciences -  Viewers will learn about the PACC component tests, challenges to implementation and possible solutions, plus possible alternative component measures
Speakers: Paul Maruff, Chief Science Officer, Cogstate
Edward Bartolic, Senior Science Director, Cogstate
The Preclinical Alzheimer Cognitive Composite (PACC): From Theory to Practical Application in Global Clinical Trials Jul 20, 2016

LifeSciences -  In this webinar, te speakers will discuss examples of identified data quality concerns coming from CNS clinical trials and the impact of their presence on study outcomes
Speakers: Alan Kott, MUDr, Clinical Vice President and Practice Lead, Data Analytics, Bracket
David G. Daniel, MD, Senior Vice President and Chief Medical Officer, Bracket, and Professor of Psychiatry, George Washington University
Disruptive Innovations in Data Analytics in CNS Clinical Trials Jul 20, 2016

LifeSciences - While post-approval research is evolving rapidly, and these studies are becoming far more complex, our knowledge in implementing and conducting such studies has not evolved with the same pace
Speaker: Kirsten Colling, Senior Director Global Operations, Bioclinica Post-Approval Research
Conducting Post-Approval Research Requires a Unique Mindset and Specialized Infrastructure. Do You Have What it Takes? Jul 14, 2016

LifeSciencesPart 1: Robust Assay Development for Multiplex qPCR and SNP Genotyping in Miniaturized Volumes on a High-Throughput Instrument, Presented by Luke Linz, Ph.D. Laboratory Operations Manager, LGC Douglas Scientific
Part 2: Digital PCR as a Tool to Support the Molecular Diagnosis of Infectious Diseases, Presented by Jim Huggett, Ph.D. Principal Scientist, Nucleic Acid Research, LGC, and Senior Lecturer, Analytical Microbiology, University of Surrey
Pushing the Limits of PCR: Considerations for Assay Development in High-Throughput qPCR and Digital PCR Platforms Jul 13, 2016

LifeSciences - During this webinar, the speakers will describe how Enabled-First-in-Human® programs integrate real-time GMP drug product manufacturing with healthy volunteer and patient clinical testing into a seamless early development plan
Speakers: Alyson Connor, Executive Director, Exploratory Clinical Pharmacology, Quotient Clinical
Ofir Moreno, Vice President of R&D, MEI Pharma, Inc.
First-in-Human to Proof-Of-Concept: Addressing Development Challenges and Accelerating Timelines Jul 12, 2016

LifeSciences - While this webinar will focus primarily on important laboratory issues when developing clinical trials involving multiple myeloma, many of the issues to be discussed are also relevant to the other plasma cell dyscrasias
Speakers: Marc Golightly, PhD, SI (ASCP), Professor of Pathology, Stony Brook University, and Consultant, ICON Laboratory Services
Domenica Gandini, MD PhD, Medical Director, ICON Clinical Research
Learn about Laboratory Considerations when Developing Multiple Myeloma Trials Jun 30, 2016

LifeSciences - In this webinar, the speakers will challenge the view that the expected benefits from new drugs are generally sufficient to forgo randomization to a standard-of-care arm
Speakers: Marc Buyse, ScD, Chief Scientific Officer, International Drug Development Institute (IDDI)
Everardo Saad, Senior Medical Expert, IDDI
Personalized Cancer Medicine Needs Randomized Trials Jun 24, 2016

LifeSciences - This webinar will introduce the concept of diet-induced obesity models, including preferred mouse strains as well as resistant strains and compare to other models of diabetes and metabolic syndrome
Speaker: Jennifer Phelan, Product Manager, Taconic Biosciences
DIO 101: Diet-induced Obesity in Mice Jun 23, 2016

LifeSciences - In Using a case study approach, webinar participants will learn more about developing Observer-Reported Outcomes Measures and implementing them in clinical studies
Speakers: Beverly Romero, MA, Senior Outcomes Researcher, ICON Clinical Outcomes Assessment
Emuella Flood, Senior Principal, ICON Clinical Outcomes Assessment
Developing an Observer-Reported Outcomes Measure (ObsRO): Best Practices, Challenges, and Solutions Jun 22, 2016

LifeSciences - From patient identification to submission, what would be a "game changer" for flexibiilty, accuracy, speed and cost efficiency?
Speakers: Graham Belgrave, Chief Operations Officer, Cmed
Jon Carter, Product Manager, Cmed
In Pursuit of the Holy Grail: A New Generation Clinical Data Suite Jun 21, 2016

LifeSciences - Topics include a review of the benefits and considerations related to pursuing accelerated approval, advice on how to access the applicable expedited program, and effectively interact with the Agency, following the regulatory pathway most expeditiously
Speakers:
Robert Millham, MS, MSc, PharmMed, Senior Vice President & General Manager, Hematology & Oncology, inVentiv Health
Carolyn Finkle, MSc, Senior Vice President, Regulatory Affairs, inVentiv Health
Joseph O’Connell, MD, Vice President, Medical & Scientific Affairs, Hematology & Oncology, inVentiv Health
Pursuing Accelerated Approval in Oncology Indications: Is your Asset the Right Candidate? Jun 16, 2016

LifeSciences - This webinar will guide you through BioTelemetry Research’s exclusive offering, EvriBeat, an advanced method for assessing cardiac safety in early human trials
Speaker: Daniel B. Goodman, MD, Vice President and Medical Director, BioTelemetry Research
EvriBeat – Dynamic Electrocardiography Jun 15, 2016

LifeSciences - Join us for this webinar to learn how to deal with the above mentioned challenges in R&D procurement and employ a strategic buying approach
Speakers: Gurdeep S. Rooprai, Global Client Partner, Life Sciences Practice, Infosys Limited
Shubham Tripathi, Client Parter (Americas) - Source to Pay, EdgeVerve Systems (Infosys Limited)
Reduce R&D Costs by Simplifying Procurement: Enhance Efficiency, Increase Compliance and Save Costs Jun 8, 2016

LifeSciences - Will remote monitoring create an additional and unnecessary burden of responsibility at the site level, or will it make for a more efficient and profitable workflow dynamic?
Speakers: Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks
Dan Sfera, The Clinical Trials Guru
Reinventing Remote Monitoring: The Implications of Innovation June 7, 2016

LifeSciences - The clinical data review solution speeds up the process, automatically combining data to allow clinical development team members to interactively explore information and discover new relationships
Speaker: Donald Sullivan, PhD, Principal Solutions Consultant, PerkinElmer Informatics
Next Generation Clinical Data Review with TIBCO Spotfire® June 7, 2016

LifeSciences - Understanding existing resources, financial aid, and incentives is important for any orphan product developer. This webinar will describe support offerings available through global regulatory agencies and examine pending initiatives affecting orphan drug clinical development.
Speakers: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research
Lisa Pitt, Vice President, Global Regulatory Affairs, Premier Research
Juliet M. Moritz, Executive Director, Strategic Development, Rare Diseases, Premier Research<
No Opportunity Unturned: Optimizing Orphan Drug Development June 1, 2016

LifeSciences - This case study details how one successful Clinical Operations team automated their next generation risk and centralized monitoring program
Speakers: Ken Wu, ClinOps Consultant and Expert
Matt McKinney, Continuous Quality Solution Expert, Comprehend Systems
How One Clinical Operations Team Returned 100% of Studies to Within Risk Threshold: A Next Generation Monitoring Case Study May 26, 2016

LifeSciences - Learn about what you need to know to make the best decisions for your clinic and intended parents when planning an operational strategy for both storage and shipping of reproductive materials, domestically and internationally
Speakers: Tamie Joeckel, Senior Vice President of Client Services, Cryoport
Shannon Curiel, Director of Sales, Reproductive Medicine, Cryoport
Optimize Your IVF Clinic Operations: Facilitating Growth Through Cold Chain Management May 25, 2016

LifeSciences - This presentation will discuss what level of Validation is required at the different stages of the pharmaceutical product development lifecycle
Speaker: Troy Fugate, Vice President, Compliance Insight, Inc.
When Does Validation Start? May 20, 2016

LifeSciences - The webinar aims to help sponsors conducting oncology trials in Asia navigate the maze of trial logistics, local regulatory requirements and cultural differences to ensure success
Speakers: Dr. John Moller, Chief Operating Officer - Asia, Novotech
Andrea Jeffrey, Senior Project Manager, Novotech
Chin Wee Tan, Clinical Operations Manager - Singapore, Novotech
Navigating Oncology Trials in Asia: How a Regional CRO can Deliver on a Global Project May 19, 2016

LifeSciences - The presenters will discuss the opportunities and challenges and provide tips on how to achieve success in running biosimilar clinical trials
Speakers: Dan Ramos, North America Customer Liason, Fisher Clinical Services
Khaled ElGendy, Associate Director – Head Comparator, Fisher Clinical Services
Biosimilars in Clinical Trials: Smart Reference Drug Sourcing and Advanced Blinding Techniques May 17, 2016

LifeSciences - This webinar will showcase studies and metrics from two experts in drug delivery and drug product optimisation, illustrating the applications and benefits for a range of drug formulations
Speakers: John McDermott, Executive Director, Drug Product Optimisation, Quotient Clinical
Kieran Crowley, Senior Scientific Director, Quotient Clinical
How to Reduce the Time and Cost for Optimizing Drug Product Formulations with RapidFACT® (Rapid formulation Development And Clinical Testing) May 16, 2016

LifeSciences - Join this webinar and consider the potential of collaborative partnerships between academicians, clinical investigators and contract research organizations in delivering new therapies for patients with diabetic nephropathy
Speakers: George L. Bakris , MD, Hon. DSc, F.A.S.H, F.A.S.N., F.A.H.A., Professor of Medicine, Director, ASH Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL
Michael D. Cressman, D.O., Senior Medical Director, Covance
Jennifer Ennis, MD, Medical Director, Litholink Corporation, A LabCorp Company
Applying Advanced Informatics to Accelerate Drug Development in Diabetic Nephropathy May 6, 2016

LifeSciences - In this webinar, buyers and users of clinical trial software will learn how to assess current technology options with the goal of streamlining the management of data for clinical trials
Speaker: Patrick Smith, Product Manager, DATATRAK
A Buyer and Users Guide to Clinical Trial Software May 5, 2016

LifeSciences - This webinar explores challenges smaller companies should consider when embarking on immunotherapy studies
Speakers: Andrew Zupnick, Ph.D., Vice President, Oncology Strategy, Novella Clinical
Julia Lawrence, D.O., Senior Medical Director, Novella Clinical
Mastering Oncology Immunotherapy Clinical Trials: The Smaller Biopharmaceutical Perspective May 5, 2016

LifeSciences - The presentation includes a discussion of known or suspected mechanisms that mediate protection elicited by very different licensed vaccines: MMRV (anti-Measles, -Mumps, -Rubella and -Varicella), Pertussis (anti-whooping cough), and the recently introduced anti-serogroup B meningococcal vaccines
Speaker: Rolando Pajon, PhD , Vaccine Validation Scientist, Vaccine and Novel Immunotherapeutic Laboratory Solutions, Covance
Immunological Mechanisms of Vaccine-elicited Protection: Licensed Vaccines Apr 28, 2016

LifeSciences - The speakers will discuss how current state-of-the-art cognitive assessment technology can be incorporated into the clinical development process to facilitate early decision making, evaluate cognitive efficacy, profile safety and tolerability and satisfy regulatory requirements in an increasingly challenging and competitive pharmaceutical landscape
Speakers: Pradeep Nathan, MA, PhD, MRACI, CChem, FCP, Vice President Neuroscience Scientific Strategy Lead and Head, Neuroscience Center of Innovation, inVentiv Health
Kenton H. Zavitz, PhD, Director of Clinical Affairs , Cambridge Cognition, Ltd.
Assessing Cognitive Safety of Drugs in Clinical Development Apr 28, 2016

LifeSciences - This webinar looks to highlight some of the major challenges of PV in early phase clinical trials and what can be done to overcome them
Speaker: Tom Nichols, Senior Director, Pharmacovigilance, Quanticate
The Challenges of Pharmacovigilance in Early Phase Clinical Trials

Apr 27, 2016

LifeSciences - Tufts CSDD presents the findings of a new study assessing practices and inefficiencies associated with site selection, study startup, and site activation in starting clinical trials
Speakers: Ken Getz, Director of Sponsored Research Programs & Associate Professor, Tufts Center for the Study of Drug Development
Judy Luk-Smit, Director of Product Management, goBalto
Tufts Report & Removing the Blinders in Site Selection Apr 26, 2016

LifeSciences - Learn about how the largest molecular diagnostic clinical laboratory in the world can help identify molecular characteristics linked to complex disease states and drug response phenotypes to improve drug development and help deliver the promise of precision medicine
Speaker: Patrick M. Burke, Ph.D., Executive Vice President, Emerging Products, Myriad Genetics
Enabling Precision Medicine with Complex Companion Diagnostic Tools Apr 25, 2016

LifeSciences - This webinar will examine past design issues, current techniques to raise standards and new technology which will aid future understanding
Speaker: Philip Lake, PhD, Executive Director of Scientific Affairs, Respiratory, Chiltern
Jan De Backer, PhD, CEO, Fluidda
An Illustration of Challenges in Respiratory Drug Development Apr 19, 2016

LifeSciences - This free webinar examines the nuances of successfully conducting hematological oncology clinical trials
Speakers: Chris Smyth, PhD, MBA, Managing Director, European & Asian Operations, Novella Clinical
Richard Gams, MD, Chief Scientific Officer, Novella Clinical
Achieving Effective Haematological Oncology Clinical Trials Apr 14, 2016

LifeSciences - Discussion topics include how hematological patient-derived xenograft (PDX) models are established, why hematological PDX models are more translational than cell line-derived models, and can be employed in drug discovery and development
Speakers:Julia Schueler, Department Head, In Vivo Tumor Biology, Oncotest GmbH
Megan MacBride , Associate Director, Product Management, Taconic Biosciences
Patient-derived Xenografts of Hematological Malignancies: Model Systems for Drug Development and Tumor Biology Research Apr 14, 2016

LifeSciences - This webinar will review the recent article in Pain by Cooper et al that summarizes the findings of a meeting convened by IMMPACT, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials
Speaker: Michael Kuss, Vice President, Analgesia, Premier Research
Research Design Considerations for Single-Dose Analgesic Clinical Trials in Acute Pain Apr 12, 2016

LifeSciences - There are two major categories of safety monitoring: “Clinical” which refers to safety monitoring of clinical trials and “Post-marketing”, safety monitoring of situations following approval and marketing, other than directly associated with clinical trials
Speaker: Margaret McCulloch, M.D. , Medical Doctor, Ashfield Pharmacovigilance
The Differences Between Clinical and Post Market Medical Reviews Mar 30, 2016

LifeSciences - The speaker will describe the Clinical Laboratory Standards Institute’s Quality System Model, define the path of workflow and the points of variability/error that occur at each stage in spirometry testing, and help viewers understand mechanisms to reduce variability in lung function testing
Speaker: Carl D. Mottram, RRT, RPFT, FAARC, Director, Mayo Clinic Pulmonary Function Laboratories and Pulmonary Rehabilitation Program
Reducing Variability in Spirometry Testing for Clinical Trials Mar 29, 2016

LifeSciences - This webinar will highlight some of the challenges in designing and conducting trials for rare cancers and explore positions adopted by various authors and research consortia on how to best design and conduct these trials, including a review of pending legislation — the 21st Century Cures Act — and how it might affect rare oncology research if passed
Speakers: Sachin Kulkarni, Executive Director, Strategic Development, Oncology & General Medicine, Premier Research
Juliet M. Moritz, Executive Director, Strategic Development, Rare Diseases, Premier Research
Rare Oncology Research in the 21st Century Mar 29, 2016

LifeSciences - To seek explanation for the variability of opioid response is one of many important facets in easing the burden of chronic pain upon our society, as is understanding the heritability of pain
Speaker: Dr. Lynn Webster, MD, Vice President, Scientific Affairs, PRA Health Sciences, and Past President, American Academy of Pain Medicine
Personalized Medicine: Genetic Testing for Predicting Opioid Response Mar 22, 2016

LifeSciences - This webinar describes and explains pragmatic studies and discusses why key Late Stage stakeholders are increasingly interested in pragmatic studies – and why, nevertheless, pragmatic approaches are still relatively rare in the area of RWE
Speakers: Stuart McCully, PhD,,Vice President, Late Stage Support Services, inVentiv Health
Florian Eichmann, PhD, Principal, Scientific Affairs and Real World Evidence, Late Stage, inVentiv Health
Pragmatic Studies for Real World Evidence – Lifting the Veils Mar 17, 2016

LifeSciences - This webinar outlines the key issues behind pediatric enrollment failures and focuses on the requisite steps to successful design and planning
Speakers: Karen Rosenzweig, Senior Director, US Operations, Clariness
Pediatric Clinical Trials: Best Practices in Recruitment Feasibility Mar 8, 2016

LifeSciences - The speaker will examine the requirements listed in MEDDEV 2.7.1 rev. 3 while focusing on the global benefits of the Clinical Evaluation report for an individual's product’s path to market
Speaker: Sandra Welch, Director of Clinical Research Services, NAMSA
The Global Value for Clinical Evaluation Reports in Medical Device Studies Feb 29, 2016

LifeSciences - This webinar will highlight the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process
Speakers: Paul Hallenbeck, Executive Director, Drug Development Strategy, Oncology, Premier Research
Luke Gill, Executive Director Clinical Development Planning, Premier Research
Early-Stage Considerations for Maximizing Success in Initial Oncology Clinical Trials Feb 24, 2016

LifeSciences - The speakers will discuss the best practices for justification, validation, and implementation of the Verigene Respiratory Pathogens Flex Test, Verigene Gram-Positive and Gram-Negative Blood Culture Tests, and Verigene Enteric Pathogens Test.
Speakers:
Kevin McNabb, Ph.D., MT(ASCP), Director of Microbiology, Immunology and Molecular Testing, Department of Pathology and Laboratory Services, New Hanover Regional Medical Center
Susan Sable, MT (ASCP), Manager, Microbiology and Molecular Department, Meridian Health at Jersey Shore University Medical Center
Kevin Alby, Ph.D., Assistant Professor of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania
Justification, Validation, and Implementation: Best Practices for Multiplex Molecular Infectious Disease Tests Feb 24, 2016

LifeSciences - The presentation will help clinical operations teams navigate through two new 2016 regulatory imperatives, including clinical supply specific rules in the European Union and a new inspection strategy from the U.S. Food and Drug Administration
Speakers: Harry Berlanga, Lead Qualified Person (QP), Fisher Clinical Services
Maria Matos, DEA and Licenses Manager, Fisher Clinical Services
Asiya Imam, Director of Quality Assurance, Fisher Clinical Services
Regulatory Readiness for Clinical Trial Supplies Feb 23, 2016

LifeSciences - This webinar will review the principles, opportunities, complexities, and risks of data sharing, and discuss future perspectives, including full access to all data, including biomarker and –omic data, access to analysis code for reproducible research, involvement of principal investigators in the research process, and access to data from academic trials
Speakers: Marc Buyse, ScD, Chief Scientific Officer, International Drug Development Institute (IDDI)
Frank Rockhold, PhD, Senior Vice President, Safety and Pharmacovigilance, GlaxoSmithKline
Patient-Level Data Sharing in Clinical Research Feb 16, 2016

LifeSciences - This webinar will outline some of the 2015 Avoca Quality Consortium research around sponsor and CRO perceptions of quality in protocol design, effectiveness in identifying concerns from the patient perspective, and share some key factors identified that impede quality in protocols
Speakers: Jennifer Byrne, CEO, PMG Research, Inc.
JoAnn Muir, Head of Clinical QA Vendor Oversight, Novartis Pharmaceutical
Kenneth Getz, Director and Associate Professor, Tufts CSDD
Tomasz Sablinski, M.D., Ph.D., Founder, Transparency Life Sciences
Jeremy Gilbert, VP, Life Science Ventures, Patients Like Me
Moderator: Denise Calaprice-Whitty, Ph.D., Senior Consultant, The Avoca Group, Inc.
Protocol Quality: Challenges and Opportunities for Patient Centricity in Protocol Design and Execution Feb 11, 2016

LifeSciences - This webinar discusses Data Sciences Analytics and the new Analytics Paradigm from an overall industry perspective along with a discussion of the MaxisIT Common Services Analytics Framework and Data Sciences Analytics Workbench functionality and how the it is used to oversee the presentation and availability of data that will support and drive Data Sciences initiatives across the Health Care & Life Sciences industries, including Predictive Analytics
Speakers: Patrick Zbyszewski, Executive Director of Project and Data Management, Onconova Therapeutics
Vipul Kashyap, Ph.D., Head, Product Strategy and Management, MaxisIT
Data Sciences – The New Analytics Paradigm Feb 10, 2016

LifeSciences - A ClinOps team goes beyond simple CRA monitoring by implementing new generation Portfolio Monitoring to increase speed, lower study cost and risk. Their solution: A single system with powerful data aggregation, monitoring, collaboration and analytic capabilities to actively manage enrollment funnels, patient compliance, and site productivity across systems and studies.
Speakers: Ken Wu, former Clinical Operations Executive at Scios
Jud Gardner, CTO and Co-Founder, Comprehend Systems
Next Generation Centralized and Risk Monitoring Jan 28, 2016

LifeSciences - As the globalization of clinical research gathers pace, the Asian region will continue to grow, making it the most exciting frontier for biopharma companies conducting clinical research
Speakers: Dr. John Moller, Chief Operating Officer - Asia, Novotech
Kim Wong, Head of Regulatory Affairs, Novotech
Chayanontchaimongkol Boonchaliew, Clinical Operations Manager - Thailand, Novotech
Clinical Trial Planning in Asia: A Roadmap for Biotech Sponsors Jan 22, 2016

LifeSciences - Learn from two market leaders about an optimal way to get actionable results from the comprehensive analysis of clinical and operational data
Speakers: James Streeter, Senior Director of Life Sciences Product Strategy, Oracle Health Sciences
Francois Torche, CEO and Chief Information Officer, CluePoints
The Complete Integrated Risk-Based Monitoring (RBM) Solution:
Harnessing the Power of Multiple Technology Systems to Drive RBM and Overall Data Quality Oversight
Jan 21, 2016

LifeSciences - This webinar will highlight the challenges of emerging and re-emerging infectious diseases such as MTB, HIV, MRSA, and Ebola
Speakers: Stephen Mortlock, DSc, Global Infectious Diseases and Microbiology Liaison, Heston, UK, Q2 Solutions, a Quintiles Quest Joint Venture
Ayaskant Pany, MD, Director, Medical Laboratory, Central Laboratories South Africa, Q2 Solutions, a Quintiles Quest Joint Venture
Sorika van Niekerk, MSc Medical Microbiology, UP, SA, Senior Director / General Manager, Central Laboratories South Africa, Q2 Solutions, a Quintiles Quest Joint Venture
Combating Emerging and Re-emerging Infectious Diseases in Clinical Trials by Harnessing Innovative Technologies Jan 20, 2016

LifeSciences - This webinar will examine the opportunities for improvement introduced by RBM invite evaluation of a new pattern of interaction between clinical development teams and ERBs, and provide recommendations to industry, ERBs and other stakeholders
Speakers: Andy Lawton, Global Head, Biometrics and Data Management, Boehringer Ingelheim Ltd.
Ellen Kelso, Executive Director Strategic Development, Chesapeake IRB
Risk-Based Monitoring and The IRB: Convergence and Opportunities Dec 17, 2015

LifeSciences - Opening sites in countries where clinical trials are uncommon requires detailed knowledge of the host countries and the complex regulations they may impose, along with thorough site training in protocol and good clinical practices
Speakers: Alison Sampson, Senior Project Director, Premier Research
Hanna Wide, MSc, Project Manager, Premier Research
Rare Disease Research: Conducting Clinical Trials Where the Patients Are Dec 15, 2015

LifeSciences - This webinar will explore important areas of early preparation in vaccine studies
Speakers: Lynlee Burton, Director of Project Delivery, Vaccines, PRA Health Sciences
Jeff Rosen, Medical Director and Founder, Clinical Research of South Florida (CRSF)
Vaccine Studies – Operationalize before you Finalize Dec 11, 2015

LifeSciences - The webinar will focus on how these frameworks are currently perceived through sharing of comprehensive survey data from oncologists and payers
Speakers: Doug Neely, CMPE, MHA, Senior Director, Xcenda
Lisa Bloudek, PharmD, MS, Assistant Director, Xcenda
Oncology in the Era of Value Frameworks: Perspectives from Payers and Oncologists & Implications for Product Planning Dec 10, 2015

LifeSciences - The purpose of this webinar is to simplify the regulatory submission process, which is a source of difficulty largely unmitigated by available technologies today
Speaker: Patrick Smith, Technical Marketing Writer, DATATRAK
Simplifying the Clinical Trial Regulatory Submission Process Dec 9, 2015

LifeSciences - This webinar will provide a unique insight into human abuse potential studies and their diverse challenges, notably from the perspective of the study subject.
Speakers: Dr. Beatrice Setnik, Vice President, Clinical Pharmacology, Early Phase, INC Research
Dr. Pierre Geoffroy, Vice President, Early Phase, INC Research
Clinical Challenges in the Abuse Potential Assessment of CNS-Active Drugs: Investigator Perspectives with a Special Commentary from a Study Volunteer Dec 9, 2015

LifeSciences - This webinar will demonstrate how, through the adoption of innovative best practice and a continuous quality SAAS solution, the team was able to succeed with limited resources
Speaker: Jay Podence, Continuous Quality Solution Expert, Comprehend
Bruno Gagnon, Faculty Member, SF State University, Clinical Trial & Management Certification Program (former VP of ClinOps at BioMarin)
3 Adjustments Every Clinical Operations Executive Needs to Make to Increase Clinical Site Productivity Dec 3, 2015

LifeSciences - This webinar help viewers understand the surprising ways on how local sourcing can offer unique benefits to your clinical program
Speaker: Jason Nolte, Comparator Key Account Manager, Fisher Clinical Services
Local Sourcing for Clinical Trials – Overview and Challenges Dec 3, 2015

LifeSciences - This webinar will present a bird’s eye view highlighting a Phase I study with mid-level complexities and showcase lessons learned from the speakers' experiences, highlighting how building the database structure utilizing CDASH standards minimizes the gap with SDTM format
Speakers: Jonathan Zimmerman, Senior Clinical Data Manager, FMD K&L Inc.
Yuguang Zhao, MS, Vice President, Statistical Programming, FMD K&L Inc.
Utilizing a Collaborative Approach to Create Efficiencies with CDISC – CDASH Standards Nov 19, 2015

LifeSciences - In adaptive design trials, the importance of careful design, meticulous planning, and rigorous ethical review cannot be overemphasized
Speakers: Thomas Laage, MD, MPH, Director, Product Development Consulting and Regulatory Medical Writing Support, Premier Research
Jennifer Nezzer, Director of Biostatistics, Premier Research
Ethical Considerations in Adaptive Design Clinical Trials Nov 19, 2015

LifeSciences - This webinar will discuss the challenges and the importance of NAb assays and a well thought out immunogenicity strategy in drug development to assess and mitigate risk
Speaker: Paul W. Rhyne, Ph.D., Scientific Director, Q2 Solutions, a Quintiles Quest Joint Venture
Strategies for Effective Neutralizing Cell Based Assays in Early Immunogenicity Risk Assessment Nov 18, 2015

LifeSciences - With the practical application of advanced data management capabilities and processes, meaningful analytics are now possible in the new world of converged health and life sciences
Speakers: Dan Soceanu, Senior Data Management Solution Architect, SAS
Bill Shimp, Healthcare Data Management Account Executive, SAS
Tame Your Health Data and Build Meaningful Analytics Nov 16, 2015

LifeSciences - Industry leaders are now adopting ‘best of breed’ applications in the eClinical stack to speed the development of needed therapies to patients
Speakers: Vittoria Sparacio, Head of Clinical Documentation, GSK Pharmaceuticals
Scott McCulloch, Principal Consultant, SMClinical Limited
Barry Milton, Director of Client Engagement, goBalto
Ready to Start Your Clinical Trial? Think Again. Nov 16, 2015

LifeSciences - Learn about optimal clinical trial patient recruitment planning and execution
Speaker: Dr. Ute Simon, Head, Clinical Research, Novartis Pharma GmbH
Dr. Nils Drews, Chief Medical Officer, Clariness
Optimizing Clinical Trial Patient Recruitment from Lessons Learned: From the Burning House to Strategic Collaboration Nov 12, 2015

LifeSciences - Dr.Harder will present the Tissue Phenomics methodology to discover new tissue-based diagnostics using image and clinical data from prostate cancer patients with similar pathologies and known clinical outcome
Speaker: Nathalie Harder, PhD, Research Scientist, Definiens AG
How to Discover Powerful Tissue-Based Prognostic Biomarkers for the Benefit of Individual Patients Nov 11, 2015

LifeSciences - Wipro and OmniComm Systems have developed an integrated system that connects EHR and the research systems to ease and simplify EDC data capture process supporting clinical research to enable faster completion of study, reduce the cost of development
Speakers: Rao Teki, PhD, Global Head, Pharma R&D Innovation Solutions Group, Wipro
Ken Light, EVP of Transformation and Professional Services, OmniComm Systems, Inc.
NexGen eSource: EHR-EDC Integration - Clinical Data as a Service - The Game Changer Nov 10, 2015

LifeSciences - Premier Research has developed a proprietary Pediatric Certificate Training Program to train our employees on core competencies and considerations in the development and conduct of pediatric studies
Speakers: Alison Sampson, Senior Project Director, Premier Research
Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research
Pediatric Trial Certification: A Platform for Success Nov 9, 2015

LifeSciences - This webinar will provide an overview of the independent endpoint adjudication process with a focus on understanding what is necessary to operationalize an endpoint committee
Speakers: Richard Walovitch, PhD, President, WorldCare Clinical
Glenn Bubley, MD, Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center
An Overview and Guide to Clinical Trial Endpoint Adjudication Nov 9, 2015

LifeSciences - In order to generate reliable immune monitoring data that will help us determine the safety and efficacy of the therapeutic intervention approach from a global study, highly standardized methods to collect, process and prepare patient samples need to be implemented
Speaker: Sinnathamby Gomathinayagam, PhD, Senior Scientist, Translational Biomarkers Solutions, Covance
Recent Advances in Immune Monitoring Nov 5, 2015

LifeSciences - This webinar summarizes key aspects of evaluating safety and efficacy in studies of immune checkpoint inhibitors and describes operational strategies that support successful trial execution and regulatory approval
Speakers: Thomas Moehler, MD, PhD, Vice President, Medical & Scientific Affairs, Hematology/Oncology, inVentiv Health
Cheryl Askew, PhD, Senior Director, Program Delivery, Hematology/Oncology, inVentiv Health
Jessica Lee, PhD, Senior Engagement Manager, Campbell Alliance (an inVentiv Health Company
Immuno-Oncology Clinical Trials: Best Practices for Clinical Development of Immunotherapies Nov 4, 2015

LifeSciences - This webinar will review the ISPOR guidance in relation to changes over the past 10 years in the COA environment and describe some of the current issues, methodological challenges and solutions in this ever changing field
Speakers: Helen Anderson, DPhil, Manager, ICON Language Services
Diane Wild, MSc, Consultant
Linguistic Validation of Clinical Outcomes Assessments (COAs) and Electronic Clinical Outcomes Assessments (eCOA) Nov 3, 2015

LifeSciences - This free webinar examines the nuances of successfully conducting hematological oncology clinical trials
Speakers: Ray Reilly, Senior Director, Oncology Division, Novella Clinical
Richard Gams, MD, Chief Scientific Officer, Novella Clinical
Achieving Effective Hematological Oncology Clinical Trials Nov 3, 2015

LifeSciences - This webinar will discuss the assessment of cognitive function throughout the development of drugs for both CNS and non-CNS indications
Speaker: Kenton Zavitz, PhD, Director of Clinical Affairs, Cambridge Cognition
Leveraging Cognitive Measures in Clinical Trials Oct 30, 2015

LifeSciences - Dr. Lappalainen will present an overview of what medications have been developed for addictive disorder, what study end-points were used, and what operational challenges companies may face when developing medications for addictive disorders
Speaker: Jaakko Lappalainen, MD, PhD, Executive Director, Global Drug Development, Neuroscience at Premier Research
Challenges in Medication Development for Addictions Oct 28, 2015

LifeSciences - The speakers will discuss a menu of genomic tests developed to supplement many endpoints for complex clinical trials, including a Comprehensive Cancer Panel (Q2 Solutions CCP), HLA typing, exome sequencing and pan-cancer immune-profiling, to set the stage for more precise and individualized therapeutics, also known as precision medicine
Speakers: Patrice Hugo, Ph.D., Chief Scientific Officer, Q2 Solutions, a Quintiles Quest Joint Venture
Victor Weigman, Ph.D., Associate Director, Translational Genomics, Q2 Solutions, a Quintiles Quest Joint Venture
Precision Medicine: Shifting from One Drug for All Trials to Targeted Therapy Trials Oct 28, 2015

LifeSciences - This webinar will reveal some of the concerns that clinical study sites have regarding risk-based monitoring, including impacts to workload, budgets and monitoring support
Speaker: Bob Bois, Director, Clinical Innovation, INC Research
Risk-Based Monitoring: What Does it Mean for Clinical Study Sites? Oct 22, 2015

LifeSciences - The speakers will present an approach to forecasting enrollment in oncology trials, sharing a case study with predicted vs. actual results
Speakers: Robert Millham, MS, MSc, PharmMed, Senior Vice President & General Manager, Hematology & Oncology, inVentiv Health
JB Flinders, MPH, MBA, Director, Feasibility & Clinical Informatics, InVentiv Health
Taking the Guesswork Out of Feasibility Assessment in Oncology Clinical Trials Oct 22, 2015

LifeSciences - This webinar will cover new technologies and study management strategies for both viral and bacteriological infectious disease trials.
Speakers: Chris Petropoulos, Ph.D., CSO of Monogram Biosciences and Vice President, Laboratory Corporation of America
Pritty Patel, M.S, MBA, Global Director of Microbiology, Vaccines and Novel Immunotherapies, Covance Laboratories
The Prescription for an Efficient Infectious Disease Clinical Trial: Rich Science & Seamless Operations Oct 21, 2015

LifeSciences - Learn from industry experts as they delve into the journey from CDASH to SDTM and beyond...
Speakers: Neil Vivian, Senior Director of Business Solutions, OmniComm Systems
Ed Chappell, Consultancy Team Lead, Formedix
The Journey to Study Data Tabulation Model and Beyond Oct 21, 2015

LifeSciences - This webinar will focus on the analytical validation of in-vitro diagnostic devices, the process through which one gains assurance that the data delivered by in-vitro diagnostic devices are ‘reliably correct’, the prerequisite for in-vitro diagnostic devices' clinical use
Speakers: Elisabeth (Els) Coart, PhD, Senior Research Biostatistician, IDDI
Hugo Vanderstichele, PhD, Co-Founder and Director Assay Development, ADx NeuroSciences
From Biomarker to In-Vitro (Companion) Diagnostic Device:
How to Design and Conduct Efficient Analytical Validation Studies in Accordance with CLSI Guidelines
Oct 19, 2015

LifeSciences - Demographics trends and present examples, case studies and recommendations on leveraging private social networking technology to maintain oversight to will provided
Speakers: James Denmark, Founder and CEO, myClin Clinical Research
John Silowsky, Clinical Operations, Nektar Therapeutics
I'm the Millennial That Is Running Your Clinical Trial Oct 16, 2015

LifeSciences - The speakers will present the design and results of an early development program focused on a new molecule CORT125134, which is in development for the treatment of Cushing’s syndrome and certain cancers, as well as further cases studies illustrating the applications and benefits of Enabled-FIH
Speakers: Alyson Connor, Executive Director, Exploratory Clinical Pharmacology, Quotient Clinical
Hazel Hunt, VP of Research, Corcept Therapeutics
Accelerating Timelines from Candidate Selection to Proof-Of-Concept with Enabled-FIH® Programs Oct 14, 2015

LifeSciences - As the evolution to a new approach in assessment of repolarization liability of new chemical entities continues, it is necessary to expand the usefulness of early human-phase testing to systematically confirm the preclinical assessments and to allow the exploration findings uniquely available from human subjects
Speakers: Anthony A. Fossa, PhD, Consultant
Daniel B. Goodman, MD, Vice President and Medical Director, BioTelemetry Research
Dynamic Repolarization Analysis: A New Phase I Cardiac Safety Paradigm Oct 14, 2015

LifeSciences - With an increasing number of biomarkers and, often, limited availability of biopsy material, there is a growing need for multiplexed assays for both research and clinical purposes
Speaker: Matthew R. Silver, Ph.D, Principal Scientist, Translational Assays, Cell Signaling Technology
Analysis of Immune Checkpoint Control Protein Co-expression in Breast and Ovarian Cancer Using Novel Rabbit Monoclonal Antibodies and Multiplex IHC Oct 7, 2015

LifeSciences - Learn through case studies how to effectively address the challenges across a product's lifecycle, despite the increasing demand for Real World Evidence (RWE) generation
Speaker: Alex Exuzides, PhD, Director, Health Economics & Epidemiology, ICON Commercialisation & Outcomes
Building the Evidence Generation Roadmap: The Role of Real World Data in Drug Development Oct 7, 2015

LifeSciences - This webinar explores the pragmatic solution of accessing clinical research talent and creating an avenue for developing CRAs through a comprehensive training program
Speakers: John Avender, Associate Director, Clinical Performance, inVentiv Health Clinical
Michael L. Jimmink, Vice President, Strategic Resourcing, inVentiv Health Clinical
Joe Mills, Senior Director - Global Recruitment Center, inVentiv Health Clinical
Talent Management Solutions to the CRA Shortage: Investing in a Global Talent Pool Oct 1, 2015

LifeSciences - This webinar discusses metadata from an overall industry perspective along with a discussion of the MaxisIT In-Stream Metadata Repository which has been implemented and can support Semantic Search, Syntactical Metadata, and Full Versioning as an integral component of the process as associated with data harmonization, standardization, transformation, analytics & reporting, including more recent adaptations of metadata concepts such as Translational Medicine and Adaptive Trials
Speakers: Patrick Zbyszewski, Executive Director of Project and Data Management, Onconova Therapeutics
Jonathan Taylor, VP Global Product Strategy, MaxisIT
New Metadata Role for Life Sciences & Healthcare Sept 30, 2015

LifeSciences - This program will provide an important overview of the impacts and issues involved in leveraging the IoT within healthcare and clinical research in particular
Speakers: Eric Meslin, PhD, Director of the Indiana University Center for Bioethics, Dean for Bioethics, Indiana University School of Medicine
Jennifer Covich Bordenick, Co-Chair of the Federal HIT Policy Committee’s Strategy and Innovation Workgroup, CEO of eHealth Initiative
Marvin Slepian, MD, Co-Founder and Chief Scientific Officer of SynCardia Systems Inc., Founder and Director of The Arizona Center for Accelerated Biomedical Innovation
Megan Doerr, MS, CGC, Principal Scientist, Governance Team, Sage Bionetworks
Ellen Kelso, Executive Director Strategic Development, ChesapeakeIRB
The "Internet of Things" and Clinical Research: Privacy, Security, and Ethical Aspects Sept 28, 2015

LifeSciences - This webinar will focus on two important aspects of Data Monitoring Committees: Set-up and communications
Speakers: Angela McPartlane, Associate Director of the DMC Unit, PRA Health Sciences
Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks
Data Monitoring Committees: Simple Solutions for Critical Issues Sept 25, 2015

LifeSciences - This webinar will show how Tissue Phenomics® can be utilized to identify previously undiscovered prognostic and predictive image-based features or combinations of features for patient stratification
Speaker: Peter Caie, PhD, Senior Research Fellow in Quantitative and Systems Pathology, University of St Andrews
Applying Tissue Phenomics® to Clinical Questions for Patient Stratification Sept 23, 2015

 

LifeSciences - In this session, specific case study examples will be used to explore all these key topics. Learn best practices for site selection, including the possible need to over recruit sites for Phase IV trials
Speaker: Alexandra Adams, Ph.D Dip.Clin.Sci. Hon FICR, Director, Late Phase, Chiltern
Best Practice Approaches in Executing Post Approval Programs Sept 17, 2015

 

LifeSciences - The speaker will share her perspective and suggest best practice initiatives on how to achieve success in clinical research in this region
Speaker: Mathilde (Tilly) Niessen, Distribution Project Manager, Fisher Clinical Services
Clinical Trials – Russia & Ukraine – Opportunities and Challenges Sept 15, 2015

 

LifeSciences - In this case study, the speakers will show the power of using a novel combination of machine learning algorithms with a systems biology based approach for identifying genes and the subsequent exonic regions driving prognosis for patients with lung squamous cell carcinoma (SQCC)
Speakers: Scott Marshall, Ph.D., Managing Director, Analytics, Precision for Medicine
Jared Kohler, Ph.D., Managing Director, Analytics, Precision for Medicine
Tobias Guennel, Ph.D., Principal, Analytics, Precision for Medicine
Applying Systems Biology and Predictive Genomic Analytics on Patients with Lung Squamous Cell Carcinoma and RNA-Seq Gene Expression Sept 14, 2015

LifeSciences - This webinar provides a framework to assist pharmaceutical, biotechnology and/or medical device companies in the development of a risk based monitoring plan that will define the various risks and steps needed to implement a risk-based monitoring strategy
Speakers: Dr. Bill Gluck, Vice President Clinical Knowledge, DATATRAK
Tim Lyons, Vice President, Product Development and Operations, DATATRAK
Rob Nichols, Chief Commercial Officer, Algorics
Risk Based Monitoring Adoption Simplified Sept 10, 2015

LifeSciences - Demographics trends and present examples, case studies and recommendations on leveraging private social networking technology to maintain oversight to will provided
Speakers: James Denmark, Founder and CEO, myClin Clinical Research
John Silowsky, Clinical Operations, Nektar Therapeutics
I'm the Millennial That Is Running Your Clinical Trial Aug 27, 2015

 

LifeSciences - This presentation on the new EU clinical trials regulation will identify what’s happening with the regulation that governs clinical trials in Europe
Speaker: Dr. Martine Dehlinger-Kremer, Global VP, Medical and Regulatory Affairs, SynteractHCR
The New EU Clinical Trials Regulation: What You Need to Know Before 2016 Jul 23, 2015

LifeSciences - During the webinar, the presenters will describe a targeted sequencing workflow that combines Roche NimbleGen’s SeqCap EZ enrichment technology with Pacific Biosciences’ SMRT Sequencing to provide a more comprehensive view of variants and haplotype information over multi-kilobase, contiguous region.
Speakers: Dr. Lawrence Hon, Senior Manager, Bioinformatics, Pacific Biosciences
Dr. Denise Raterman, R&D Scientist, Sequence Capture, Roche NimbleGen
Long Genomic DNA Fragment Capture and SMRT Sequencing Enables Accurate Phasing of Cancer and HLA Loci Jun 30, 2015

LifeSciences - In this webinar, the successful development and commercialization of companion diagnostics (CDx) will be discussed by experts from Covance and LabCorp.
Speakers: Mark Roberts, Ph.D., Director of Diagnostics Development, Covance
Alan Wookey, Associate Vice President and Executive Director of Companion Diagnostics, Covance
Pathway Considerations to CDx Development and Commercialization Jun 30, 2015

LifeSciences - This free webinar features topics such as considerations of trial design, site/patient selection, data collection and endpoint evaluation as well as best practices to help guide cardiovascular device developers down the path to approval.
Speakers: Eric Distad, Director of Project Management, Medical Device & Diagnostics Division, Novella Clinical
Ori Ben-Yehuda, MD, FACC, Executive Director, Cardiovascular Research Foundation (CRF) Clinical Trials Center
Interventional Cardiovascular Device Development: Considerations in Clinical Trial Implementation Jun 25, 2015

 

LifeSciences - This free webinar aims to describe novel medical imaging approaches and methodologies to help sponsors maximize clinical trial efficiency along the development pathway.
Speakers: Sandra Chica, MD, VP of Medical Imaging, BioTelemetry Inc.
Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research
Medical Imaging: Maximizing Efficacy and Safety in Oncology Clinical Trials Jun 24, 2015

 

LifeSciences - In this free webinar, the speakers will explore what we believe are the driving factors of change toward that future, hoping that it will be suitable to a broad audience of stakeholders in cancer clinical trials.
Speakers: Dr. Jay Herson, Senior Associate, Biostatistics, Johns Hopkins University Baltimore, Maryland USA
Dr. Everardo Saad, Senior Medical Expert, IDDI
What is the Future of Cancer Clinical Trials? Jun 22, 2015

 

LifeSciences - This webinar aims to help attendees understand the epidemiology and health burden of Non-Alcoholic Steatohepatitis and present contemporary information on new preclinical models that can support drug development for NASH.
Speakers: Claudia Filozof, MD, PhD, Senior Medical Director, Cardiovascular/Metabolic, Covance
Arun Sanyal, MD, Executive Director, Education Core, Center for Clinical and Translational Research, Virginia Commonwealth University
Richard Williams, PhD, JD, Senior Director, Global Regulatory Strategy, Covance
Non-Alcoholic Steatohepatitis (NASH): Preclinical and Clinical Development and Progress Toward Regulatory Approval Pathways Jun 17, 2015
LifeSciences - This webinar will discuss how risk based monitoring can be used to leverage common clinical data sources, advanced statistical methodologies and cutting-edge visualizations for your central nervous system clinical trials.
Speakers: Michael Phillips, Director, Product Innovation, ICON plc
Gerard Conway, Director, Data Analytics, PerkinElmer Informatics
Risk Based Monitoring for Central Nervous System (CNS) Clinical Trials Jun 11, 2015
LifeSciences - This webinar will highlight the fundamentals of effective patient recruitment and discuss the new standards for success in today’s complex clinical trials
Speakers: Cynthia Pan, Senior Manager, Clinical Program Operations Manager, Amgen, Inc.
Michael Stadler, CEO, Clariness
The Tipping Point for Clinical Trial Success – New Standards for Patient Recruitment and Retention Jun 10, 2015
LifeSciences - The speaker will discuss clinical supply strategies for Investigator Initiated Trials, including an extensive analysis of the study protocols
Speaker: Helen Underwood, Director of Strategic Customer Relationships, Fisher Clinical Services
How Clinical Supply Teams can Respond to the Growth in Investigator Initiated Trials Jun 9, 2015
LifeSciences - Several key factors have conspired against RBM progress, however the speakers, both industry and RBM experts, will share their insights on RBM keys to success
Speakers: Steve Young, Senior Director of Transformation Services, OmniComm Systems, Inc.
Andy Lawton, Global Head of Clinical Data Management, Boehringer Ingelheim
Ensuring RBM Success – Keep it Simple! Jun 5, 2015
LifeSciences Viewers will learn how to reduce cycle times and late stage attrition rates while managing the ethical considerations that are at the heart of everything
Speakers: Cheng Gang Greg Wei, Ph.D., Research Fellow, SynteractHCR
Zoran Antonijevic, Senior Director, Strategic Consulting, Cytel, Chair of the Adaptive Design Scientific Working Group at DIA
Adaptive Trial Design in Clinical Trials: What You Need to Know June 4, 2015
LifeSciences - The speakers will discuss replacing manual paper-based procedures and implementing secure offsite document access and management
Speakers: Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks
Kathie Clark, Vice President of Product Management, Wingspan Technology
Closing the Loop: eTMF and eISF Reduce Paper and Support Remote Monitoring May 21, 2015
LifeSciences - This webinar will discuss the specific techniques used in order to accelerate subject recruitment
Speakers: Barry Simms, Senior Executive Director, Clinical Monitoring, Chiltern
Amanda Wright, Senior Director of Client Services, PMG Research
Enrollment Is Open, But We Have No Drug! Making Lemons into Lemonade May 14, 2015
LifeSciences - This webinar will go into detail on how to devise a method of quantitative IHC assay design that overcomes the inherent challenges of traditional IHC assays
Speaker: Sharon Moulis, PhD, Director, Tissue Diagnostics Alliances, Definiens
How to Develop Fit-for-Purpose Quantitative IHC Assays to Enable Clinical Trial Patient Stratification May 13, 2015
LifeSciences - During this webinar, the speakers will explore the challenges, business justification, and approach to EDC Rescue Studies and Clinical Data Migration
Speakers: Ken Light, EVP of Transformation and Professional Services, OmniComm Systems, Inc.
Rob Mangold, Sr. Director of Client Services, OmniComm Systems, Inc.
EDC Rescue Studies & Clinical Data Migrations – Challenges, Business Justification, and Approach May 12, 2015
Life Sciences - This webinar will deliver key considerations and imperative questions you must ask of any cloud services provider to ensure the offering can satisfy key requirements of 21 CFR Part 11, as well as cover essential questions to ask during the vendor audit of a cloud provider
Speaker: Matt Walz, B.S., M.B.A., Chief Strategy Officer, NextDocs Corporation
FDA Compliant Systems in the Cloud: Five Requirements You Must Satisfy! May 7, 2015
Life Sciences - This webinar will give you the inside track on what you need to know about managing specimen logistics for global clinical trials
Speaker: Richard Cunningham, Director, Global Logistics, ACM Global Central Laboratory
Implementing a Sound Logistical Strategy to Mitigate Risk and Streamline Clinical Testing Across Global Clinical Trials – A Central Laboratory Perspective May 7, 2015
Life Sciences - Learn from industry experts how a unique combination of data analytics and Electronic Data Capture is being harnessed by large, medium and smaller Pharma to de-risk clinical studies and drive Risk-Based Monitoring
Speakers: James Streeter, Senior Director of Life Sciences Product Strategy, Oracle Health Sciences
Francois Torche, CEO and Chief Information Officer, CluePoints
De-risking It All – A Systematic and Proven Approach to RBM and Data Quality Oversight Apr 29, 2015
Life Sciences - The speakers will discuss trends in continuous ecg monitoring and the implications for clinical trials of both medical device and therapies for cardiovascular, hematologic, metabolic and cns diseases, with an emphasis on atrial fibrillation and other arrhythmias
Speakers: Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research
Wayne M. Derkac, MD, Vice President of Medical Affairs, BioTelemetry Inc.
Evaluation of Atrial Fibrillation and Other Arrhythmias within Clinical Trials and Clinical Practice Apr 28, 2015
Life Sciences - This learn how OmniComm and Mortara use the bi-directional communication between Mortara ECG devices and the TrialOne® eSource system to automatically transmit information between the two, and how the implementation of direct data capture is able to improve clinical trial data quality and availability
Speakers: Mark Mentzer, Vice President of Strategic Partnerships, Mortara Instrument
Michelle King, Director, Early Phase Consulting, OmniComm Systems, Inc.
Improving ECG Data Quality and Availability: Automatic Transmission of Data from Devices into eSource Systems Apr 21, 2015
This webinar will discuss glucose clamping as a method for quantifying insulin resistance and secretion, outlining methods used, including algorithm controlled clamping, and all its inherent benefits
Speakers: Dariush Elahi, PhD, Director of Metabolic Research, Early Phase Services, ICON plc
Dennis Ruff, MD, Vice President, Medical Director, Early Phase Services, ICON plc
Glucose Clamping in Humans: Establishing Early Proof-of-Concept in the Development of Diabetes Interventions Apr 9, 2015
While the technology is advancing at a rapid rate, users are hampered by the lack of official regulatory guidance documents regarding the validation of flow cytometric instruments and methods
Speakers: Virginia M. Litwin, PhD, Principal Scientist in Hematology/Flow Cytometry, Covance
Lisa Green, MS, Manager of Flow Cytometry, Covance
Linsen Du, PhD, Lead Scientist, Flow Cytometry/Hematology, Covance
Evolution of Flow Cytometry Guidelines for Drug Development and Clinical Testing Apr 8, 2015
This webinar is intended to help Oncology drug developers explore Biomarkers in the design of clinical trials
Speakers: Kamala Maddali, DVM, PhD, Director of Scientific Development, Quest Diagnostics Clinical Trials
Arturo Anguiano, MD, FFACMG, International Medical Director – Medical Affairs, Quest Diagnostics
Frederick K. Racke, M.D.,Ph.D., Medical Director, Hematopathology and Coagulation, Quest Diagnostics Nichols Institute
Emerging Role of Biomarkers in Improving the Success Rate of Early Oncology Drug Development Mar 31, 2015
Understand key lessons learned through years of experience using RBM procedures and processes to get to a global, scalable approach, proven to deliver higher efficiencies with improved data quality and patient safety
Speakers: Yvonne Barnes, Senior Director, Clinical Operations, Quintiles
Rajneesh Patil, Director, Clinical Development Productivity and Quality, Quintiles
Risk-based Monitoring Requires Changes to Leverage Data Insights Mar 31, 2015
Quintiles experts will discuss practices that will help emerging biopharma companies design smarter trials to put their products on a more predictable path to success
Speakers: Seth Berry, PharmD, Director, Clinical Pharmacokinetic / Pharmacodynamic Modeling & Simulation, Quintiles
Laura Marquis, Vice President and Global Head, Emerging Biopharma, Quintiles
Cara Willoughby, Senior Director, Infosario Design Delivery Lead, Quintiles
Emerging Biopharma: Designing Smarter, More Predictable Clinical Trials Mar 25, 2015
This webinar offers risk mitigation strategies for clinical supply professionals and those in key functional adjacencies
Speaker: Susan Diehl, Project Manager, Fisher Clinical Services
How to Avoid Breaking the Blind in Clinical Trials Mar 18, 2015
The speaker will present a new approach: MethylC-Capture Sequencing (MCC-Seq), for customizable and cost-effective sequencing of disease or tissue-targeted functional methylomes that simultaneously provides information on genetic variation
Speaker: Dr. Elin Grundberg, Assistant Professor of Human Genetics, McGill University
Characterization of Functional Methylomes by Next-Generation Capture Sequencing Identifies Novel Disease Associated Variants Mar 13, 2015
This webinar will focus primarily on rare disease programs, as well as ultra rare disease programs
Speakers: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research
Patricia Nowowieski, Head, Global Clinical Operations, Cambridge, Alexion Pharmaceuticals
Mallory Bissett, Associate Director, Global Clinical Operations, Alexion Pharmaceuticals
Rare Disease Studies: How to Run Successful Programs Mar 11, 2015
This webinar will discuss how rapid molecular stool pathogen diagnostic testing may minimize the burden of diarrheal illness throughout the entire hospital and to healthcare providers worldwide
Speakers: David Peaper, MD, PhD, Assistant Professor of Laboratory Medicine, Yale School of Medicine; Director of Clinical Microbiology Laboratory, Yale-New Haven Hospital; and Director of Virology Reference Laboratory, VA Connecticut Healthcare System
Marilyn Mitchell, MT(ASCP)MS, Microbiology Supervisor, Community Regional Medical Center, Fresno, California
Molecular Testing for GI Pathogens: Cost-Effectiveness, Clinical Impact and Lab Implementation Feb 18, 2015
In this scientific webinar, Caprion and Medicago will describe how the production of Virus-Like Particle (VLP)-based vaccines using plant-based transient expression technology has particular advantages for accelerating both the development of new vaccines and the scaling-up of production for deployment in affected areas
Speakers: Jean-Francois Poulin, PhD, MBA, Senior Principal Scientist and Business Development Liaison, Caprion/IMMUNECARTA Services
Stéphane Pillet, PhD, , Scientifique immunologie / Scientist Immunology, Medicago Inc.
Multiparametric Flow Cytometry Analysis of Cell-mediated Immunity in Clinical Trials: A Case-study Using Plant-derived Virus-like Particles (VLP) in Influenza Vaccines Feb 17, 2015
This interactive webinar will look at changing the conversation from one of engagement to collaboration with both patients and patient influencers
Speakers: Amy Parke, VP Integrated Marketing Communications, Ashfield Healthcare Communications
Nareda Mills BScN, RN, AE-C, VP, Nursing Services, Ashfield Healthcare
Navigating the Optimal Patient Journey to Treatment Success Feb 5, 2015
Viewers will take away vital new perspectives and tools that can be used to achieve the levels of accelerated clinical and commercial development and cooperation that are critical to success in today’s environment
Speakers: Jeff Trotter, President, Continuum Clinical
Neil Weisman, Executive Vice President, Patient Recruitment, Continuum Clinical
Jeff Kent, Senior Vice President, Medical Affairs and Health Outcomes, Horizon Pharma
Elaine Ferguson, Executive Vice President, Medical Communications, Continuum Clinical
Optimizing Late-Stage Clinical and Commercial Development: The Benefits and Challenges of Bridging the Gap Feb 3, 2015
The speakers will discuss proven approaches to address these challenges through patient and caregiver engagement with the help of qualified oncology nurse educators, MSL’s and even specialized pharmaceutical reps engaging providers
Speakers: Susie Newton, RN, MS, AOCN, AOCNS, Senior Director, Health Management Solutions, Quintiles
Cheryl Fowler, BN, RN, National Director, Hematology Clinical Nurse Educators
Nicole Korak, MSN, FNP, National Director, Oncology Clinical Nurse Educators
Oral Oncology Therapies: Meeting New Patient Adherence Challenges Jan 27, 2015
This webinar will provide insight into these questions by reviewing the methods involved in collecting abuse potential data during CNS drug development and current regulatory thinking on NMEs and ADFs
Speaker: Kerri A. Schoedel, PhD, Director and Co-founder, Altreos Research Partners, Inc.
Understanding the Clinical Assessment of Abuse Potential during CNS Drug Development Jan 14, 2015
Join the webinar to discover future trends, assess available options, and implement an eClinical system that works best for your organization's particular business requirements
Speakers: Eldin Rammell, Managing Director and Principal Consultant, Rammell Consulting
Rob Wynden, VP of Technology and Engineering, goBalto
Best Practices for Leveraging eClinical Systems for Study Startup Dec 17/14
The speakers will present the various types of clinical networks that are available (Europe and the US) and the functions that they are able to provide
Speakers: Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research
Charles A. Thompson, MD, FAPP, Global Lead, Pediatric Center of Excellence, Pfizer
Pediatric Clinical Networks, Pharma and CROs Working Together for Success in Pediatric Clinical Trials Dec 16/14
The challenge of and need for developing more sensitive clinical outcomes, and ensuring that they are administered and scored properly will be presented
Speakers: Veronika Logovinsky, M.D., Ph.D., Executive Director, Eisai Inc., Neuroscience & General Medicine
David Miller, M.D., Clinical Vice President, Bracket
Enhancing Confidence in Alzheimer's Disease Clinical Trial Outcomes: Composite Measures and In-Study Quality Programs Dec 11/14
This presentation discusses the translation process, needs, requirements, review cycles, and regulations surrounding the use of eCOA in clinical studies and the need for linguistic validation
Speakers: Colleen Chulis, Global Director of Linguistic Validation, TransPerfect
Brielle Sydor, Account Executive of Linguistic Validation, TransPerfect
Jane Carter, Program Director, CRF Health
Translation of eCOA in Global Studies – Challenges & Solutions Dec 10/14
This webinar will explore data monitoring committees (DMC) best practices that have emerged over the past 25 years
Speaker: Dr. Jay Herson, Senior Associate, Biostatistics, Johns Hopkins University Baltimore, Maryland USA
Data Monitoring Committees for Today and Tomorrow Dec 8/14
LifeSciences - Recent Standardization and harmonization of methodologies across multicenter allergy and respiratory trials with induced sputum biomarkers as a primary outcome
Speakers: Graham Clarke, PhD, Senior Director and Head of Respiratory & Inflammation, Quintiles Early Clinical Development
Neil Alexis, Professor, Department of Pediatrics, Division of Immunology and Infectious Disease, University of North Carolina at Chapel Hill
Improving the Quality of Allergy and Respiratory Clinical Research Using Induced Sputum Biomarkers Dec 2/14
Hear TransCelerate and Medidata discuss the results of a data-driven analysis on the relative effectiveness of SDV—which will be published in the November 2014 issue of Therapeutic Innovation & Regulatory Science (TIRS), the official journal of DIA—as well as learn how to turn the findings into real-world practice
Speakers: Stephen Young, Principal Engagement Consultant, Medidata
Andy Lawton, Global Head of Clinical Data Management, Boehringer Ingelheim
Mark Travers, Vice President, Head of Clinical Study Units, Sanofi
TransCelerate and Medidata Discuss SDV ​Findings and Application to Risk-Based Monitoring Nov 17/14
Hear industry experts offering key insights which will help you gain a better understanding of the opportunities and challenges when conducting vaccines studies within Latin America
Speakers: Valeria Staffolani, Associate Medical Director, Quintiles Pediatric Center of Excellence
Mauro Martinelli, DEmerging Markets Specialist, Quintiles
Vaccine Trials in Latin America – Insight and Opportunities Nov 13/14
The presenters will discuss ways to improve site engagement and cost management by leveraging the industry’s latest developments and technologies
Speakers: Frank J. Cattie, Vice President, Trial Planning Solutions (TPS), Medidata
Marcus Thornton,Senior Director, CTMS, Medidata
Streamlining the Site Budgeting and Payment Process Nov 11/14
Learn how optimized study design dramatically decreases excessive cost, waste and subject burden, the positive effect of streamlined protocols on downstream operational execution, and the benefits of a facilitated design and review process
Speaker: Jason Attanucci, Global Director, Study and Protocol Design, Medidata
Focusing Resources on the Science of Study Design Nov 6/14
The presenter will examine the growth of pre-filled syringes, the factors contributing to this growth, and the key role technological advances in syringe assembly and labeling are playing in this expanding area
Speaker: Pamela Osborne, Senior Clinical Supply Chain Manager, Fisher Clinical Services
Pre-Filled Syringes in Clinical Trials Nov 6/14
As R&D expenditures in Asia-Pac continue to increase, Dr. Gries’ presentation will examine the five ways to maximize molecule value and will provide practical advice on reaching your proof-of-concept milestones
Speaker: Jean-Michel Gries, PharmD PhD MBA FCP, VP & GM, Early Clinical Development, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 4: Strategies and Operations for Early Clinical Development
Nov 4/14
qPCR experts describe their experience overcoming challenges to assay design for diverse applications. The BHQplus® probe format presents a compact oligo design offering enhanced specificity for the detection of challenging target sequences and discrimination of sequence variations.
Speakers: James C. Willey George Isaac Professor for Cancer Research, University of Toledo Health Sciences Campus, Consultant for Accugenomics, Inc.
Cassie Keppel Laboratory Operations Manager, Douglas Scientific
Probe-based qPCR Approaches for Detection of SNPs and Validation of Molecular Diagnostics Oct 30/14
This webinar will examine three key benefits of electronic clinical outcome assessments: reduced data variance, increased patient compliance and reduced site monitoring costs
Speakers: Elisabeth Kurkimilis, Senior Manager of Clinical Operations, Celgene Corporation
Valdo Arnera, MD, General Manager Europe, PHT Corporation
Benefits and ROI of eCOA Data Collection in Clinical Trials Oct 30/14
The speakers will present data and lessons drawn from risk based monitoring of 12 global schizophrenia trials involving over 80000 visits
Speakers: Alan Kott, MUDr, Senior Manager Data Analytics, Bracket
David G. Daniel, M.D., Senior Vice President and Chief Medical Officer, Bracket
Risk-Based Monitoring in Global Schizophrenia Trials: A 360 Degree View Oct 28/14
There is great excitement in the pharmaceutical and oncology fields as drugs targeting immune checkpoint proteins promise to truly restore immune anti-tumor activity to broad patient populations across many indications
Speakers: Chris Learn PhD, PMP, Senior Clinical Project Manager , Quintiles
Brad Smith, PhD, VP of Translational Medicine, Quintiles
Eric Groves, MD, PhD, VP, Center for Integrated Drug Development, Quintiles
Seizing the Future in Oncology: Improving the Clinical Development of Immunotherapies Oct 23/14
Presentation will include a case study where a sponsor found sites in a highly competitive therapeutic area, with a number of competing ongoing studies, and successfully rescued their study
Speakers: William Turnbull, Local Study Leader, AstraZeneca
Kirsty Kwiatkowski, Director, Feasibility and Site Identification, DrugDev
Jim DiCesare, Vice President, Contract & Regulatory Services, DrugDev
S.O.S. – Best Practices for Finding, Engaging and Activating Investigators on a Rescue Study Oct 21/14
The presenters will explore and showcase how Cambrex can manage your API life cycle through innovation, process and cost improvements, to meet you API development needs and help you move your products quickly to market
Speakers: Jonathan Knight, VP of New Product Development, Cambrex
Margus Eek, Head of R&D, Cambrex Tallinn
Lars Eklund, Technical Lead, Cambrex
Managing the API Life Cycle: Cambrex Innovation, Process and Cost Improvement Oct 16/14
Knowledge created from holistic clinical trial insights are improving efficiency in clinical development through timely, integrated data, enabling the identification of potential issues faster than previously possible – but changes are required in how we integrate processes and change roles
Speakers: Crona O’Conallain, Director, Global Data and Safety Monitoring, Quintiles
Rajneesh Patil, Director, Clinical Development Productivity and Quality, Quintiles
The Evolving Role of Data Management in Risk-Based Monitoring Oct 16/14
The session will include a hands-on workshop using a simple ITC tool requiring no technical experience
Speaker: Marie Maxime Hubert, M.Sc., Health Economics and Outcomes Research Manager, JSS Medical Research
Indirect Treatment Comparisons and Network Meta-analyses for Managers and Directors: Concept & Application Using a Non-technical, User-friendly Tool Oct 14/14
Topics include clinical data challenges when outsourcing trials to CROs, capturing data from EDC, CTMS, Electronic patient reported outcomes, Electronic health records, and actionable analytics that are possible once the data is captured and aggregated
Speakers: Greg Caressi, Senior Vice President, Healthcare & Life Sciences, Frost & Sullivan
Hunter Walker, Chief Technology Officer, Atlantic Research Group
Ben McGraw, Senior Vice President, Strategy & Marketing, Comprehend Systems
Partnering with the Right CRO to Complement Clinical Data Analytics Oct 10/14
This interactive webinar will review how to manage various working relationships while being aware of the challenges with co employment
Speakers: Wendy Wolf, Senior VP, Commercial & Clinical Operations, Ashfield Healthcare
Vicki Alston, Director, Human Resources, Ashfield Healthcare
Co-employment: Get the Best of a Flexible Partnership with the Strategic Benefits of Outsourcing Oct 7/14
This webinar will focus on newer patient recruitment techniques that can be implemented much earlier in the process
Speakers: Chris Frega, Sr. Director & Head of Global Feasibility and Patient Recruitment, Quintiles
Julie Parmelee, Director, Patient Recruitment, Quintiles
Bernadette Tosti, Director Business Development, Health Engagement and Communications, Quintiles
The Right Start: Optimizing Trial Recruitment Through Earlier Planning and Patient Identification Oct 2/14
In today’s monitoring environment which has been enabled by recent guidance and reflection papers by regulators on clinical risk-based approaches to monitoring clinical study quality, monitoring activities should now be designed to track two types of risks identified in the clinical risk assessment
Speakers: Michael Macri, Director, Strategic Services, inVentiv Health Clinical
Jeffrey Fetterman, President, ParagonRx, an inVentiv Health company
Using a Clinical Quality Risk Management (QRM) Process to Implement Risk-Based Monitoring: Concepts and Case Study Oct 1/14
Discussion of the current clinical trial regulatory scenario in India and the many aspects involved in conducting clinical trials in this region
Speaker: Dr. Renu Razdan, Chief Operating Officer, Max Neeman International
Clinical Trials in India: Approval Process Sep 26/14
Using real-world examples, the presenter will provide an overview of Tissue Phenomics™ and how the platform supports improved biomarker discovery on through to clinical diagnostic assay commercialization
Speakers: Thomas Nifong, MD, Executive Vice President, Diagnostic Tests, Definiens
Tissue Phenomics™: From Biomarker Discovery to Clinical Diagnostic Assay Commercialization Sep 23/14
The presenters will discuss ways to improve site engagement and cost management by leveraging the industry’s latest developments and technologies
Speakers: Frank J. Cattie, Vice President, Trial Planning Solutions (TPS), Medidata Solutions
Marcus Thornton, Senior Director, CTMS, Medidata Solutions
Streamlining the Site Budgeting and Payment Process Sep 23/14
This webinar will provide best practice approaches fo decision making regarding the identification and mitigation of operational risk, and optimization of positive opportunities
Speakers: Coleen Glessner, Vice President, Clinical Trials Process & Quality Pfizer Inc.
Brian W. Hagen, Ph.D., Managing Director, Decision Empowerment Institute
Ann Meeker O'Connell, Senior Director, Clinical Strategy Strategic Development QA, Janssen Research & Development LLC
Steve Whitaker, Executive Director, The Avoca Quality Consortium The Avoca Group
Clinical Trial Risk Management Using Decision Analytics Sep 23/14
Join experts from Covance in a five-part webinar series that explores critical aspects of pharmaceutical development to help you accelerate your drug development success
Speaker: James Yan, PhD, MD, DABT, Executive Director, Early Development, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 3: Transitioning from Bench into Clinical Phase
Sep 17/14
This webinar will delve into patient self-reporting, examining the use of paper and ePRO by phase and therapeutic area, and examining the projected use of patient-direct data
Speaker: Anne Zielinski, Global Lead for the Patient Engagement, Medidata Solutions
The Voice of the Patient in Clinical Trials: Hearing It, Understanding It Sep 10/14
This webinar will explore the benefits, challenges and methodologies for using POD and Protocol Pooling philosophies
Speaker: Joseph G. Iacobucci,Vice-President, Clinical Supplies, Xcelience
Protocol Pooling & Point of Distribution (POD) Clinical Labeling Sep 3/14
Gain an understanding of ways to make the most of your early clinical trial development -- from efficiently conducting studies to providing dependable model predictions to optimize the overall process
Speakers: N. Seth Berry, PharmD, Director, Clinical PK/PD Modeling & Simulation, & Center for Statistics in Drug Development, Quintiles
Professor Tim Mant, FRCP FFPM, Vice President, Medical Research and Principal Investigator, Quintiles
Best Practices for Optimizing Dose Escalation in First in Human Studies Aug 6/14
The presenters will share examples of delivering effective programs that achieved greater resource efficiencies and improved data quality nearly twofold better than industry benchmarks
Speakers: Teresa Lamantia, Vice President, Strategic Operations Quintiles
Alexandra Massoud, Director of Clinical Operations, Quintiles
Implementing Risk-based Monitoring, Using Oncology Examples Jul 31/14
The presenters will discuss time response modeling for Rheumatoid Arthritis (RA) and similar indications based on a number of biologic agents that they have studied
Speakers: Russell Reeve, PhD, Senior Biostatistics Director, Center for Statistics in Drug Development, Quintiles
Niti Goel, MD, Senior Medical Director & Global Head, Rheumatology Center of Excellence, Quintiles
Time Response Modeling in Rheumatoid Arthritis and Other Autoimmune Indications Jul 23/14
The increase in adoption of rapid sepsis diagnostic tests has been driven, in large part, by clinical trial studies that have captured the clinical and economic impact of these tests. This webinar will look at a few of these studies and discuss the design, execution and clinical and/or economic outcomes achieved in each.
Speakers: Michael Saubolle, Ph.D., D(ABMM), F(AAM), F(IDSA), Medical Director, Infectious Diseases Division Laboratory Sciences of Arizona/Banner Health, Clinical Associate Professor of Medicine, University of Arizona College of Medicine
Bert Lopansri, M.D, Associate Professor of Medicine, Division of Infectious Diseases , Intermountain Medical Center
Each Hour Counts: The Clinical and Economic Case for Rapid Sepsis Diagnostics Jul 17/14
This webinar will examine strategies, processes, and technology to help maximize productivity and reduce cycle times
Speakers: Wendy Stewart, Vice President, Integrated Site Start Up, Quintiles
Sam Searcy, Associate Contracts Services Director, Global Regulatory Start Up, Quintiles
Accelerated Start-Up: The Right Start to Trial Success July 10/14
This webinar will describe the Translational Pharmaceutics™ platform and present Enabled-First-in-Human case studies to illustrate how it has been applied in early stage drug development programs
Speakers: Alyson Connor, Director, Exploratory Clinical Pharmacology, Quotient Clinical
Phil Collis, VP, Clinical Development, Biocryst Pharmaceuticals
Enabled-First-in-Human™ – Accelerating Your Programs into Clinic and Through to Proof of Concept (PoC) July 9/14
During this presentation, you will discover how the Target Product Profile (TPP) process can provide your company with a clear advantage in early clinical trial development, leading to the greatest possibility of approval and successful product launch
Speaker: Kimberly Hunsicker, MSN, CRNP, MBA, Vice President, Medical Device and Diagnostics, Premier Research
Target Product Profile Guiding Cross-functional Strategies for Medical Device and Diagnostic Organizations Jun 26/14
During this presentation, you will discover how the Target Product Profile (TPP) process can provide your company with a clear advantage in early clinical development, leading to the greatest possibility of approval and successful product launch
Speaker: Kimberly Hunsicker, MSN, CRNP, MBA, Vice President, Medical Device and Diagnostics, Premier Research
Target Product Profile Guiding Cross-functional Strategies for Medical Device and Diagnostic Organizations Jun 26/14
This webinar focuses on the relationship between Infinity Pharmaceuticals and INC Research as a case study in how Pharma and CROs can successfully make this transition
Speakers: Maria Makarovskaya, Clinical Outsourcing Lead, Infinity Pharmaceuticals
David Burnham, Vice President, Strategic Alliances INC Research
Innovation in Strategic Alliances: Moving from Transactional Outsourcing to a Partnership Jun 25/14
Life Sciences - This 6-part series Webinar presentations showcase best practices and case studies across various stakeholder perspectives, identifying barriers to improving the patient experience, and highlighting the latest strategies for optimizing patient participation
Moderator: Sarah E. Kucharski, Award-winning Writer and Editor, Smoky Mountain Living; Patient Advocate and ePatient Advisory Board Member, Medicine X, Stanford University School of Medicine; CEO/Chairman and Founder, FMD Chat
Speakers: Joseph Kim, MBA, Director Clinical Operations, Patient Engagement and Recruitment, Shire Pharmaceuticals
Jerry Matczak, Community Manager, Lilly Clinical Open Innovation, Eli Lilly and Company
Paulo Moreira, VP - GCO, Head of External Innovation, EMD Serono
Optimizing Patient Participation in Clinical Trials: Attract. Engage. Retain.

Part 6: Optimizing Patient Participation in Clinical Trials: Challenges & Opportunities Going Forward
Jun 25/14
This webinar will focus on translating current business drivers and challenges within the global drug product labeling domain into a set of opportunities and next-generation operating models that support scale, efficiency, quality and compliance
Speakers: Bindu Narang, Director of Scientific Writing and Regulatory Affairs, Sciformix
Boris Jankowski, Director of Solutions Architecture, Sciformix
Craig Trautman, CEO, Intagras
Trends & Best Practices in Global Drug Product Labeling Management: Taking Control of the End-to-End Labeling Process June 24/14
This webinar will describe the applications and benefits of Translational Pharmaceutics and RapidFACT™, illustrated by case studies and metrics from industry experts and users of RapidFACT™
Speakers: John McDermott, Director, Drug Product Optimization, Quotient Clinical
Magnus Ronn, VP, CMC, Tetraphase Pharmaceuticals
Rapid Formulation Development and Clinical Testing (RapidFACT™) – Expediting Development of Optimal Drug Products June 24/14
Life Sciences - This 6-part series Webinar presentations showcase best practices and case studies across various stakeholder perspectives, identifying barriers to improving the patient experience, and highlighting the latest strategies for optimizing patient participation
Speakers: Zachary Hallinan, Director of Patient Communication and Engagement Programs, CISCRP
Joseph Kim, MBA, Director Clinical Operations, Patient Engagement and Recruitment, Shire Pharmaceuticals
Optimizing Patient Participation in Clinical Trials: Attract. Engage. Retain.

Part 5: Communicating Clinical Trial Results to Study Volunteers: The Critical Role of Post-trial Communication in Engaging Patients as Partners in Clinical Research
Jun 23/14
This webinar will explore the impact of clinical trial labels design and execution on the patient and site experience
Speaker: Kevin Shea, Label Program Director, Clintrak Clinical Labeling LLC., Part of Thermo Fisher Scientific
Clinical Labels: Keeping the Patient & Site in Mind Jun 17/14
The presentation will provide a discussion of operational challenges that are of key importance in adaptive trials with illlustrations using an actual phase I trial in oncology
Speakers: Marc Buyse, Sc.D., Founder and Chairman, IDDI
Linda Danielson, Chief Operating Officer, IDDI
Implementing Adaptive Trials: Operational Considerations June 12/14
Viewers will learn Industry-wide monitoring trends from the annual monitorforhire.com survey, how monitors spend their time on-site to support activities like recruitment and training, and a methodology for triggered monitoring visit schedules
Speakers: Scott Freedman, President, Founder, monitorforhire.com
Mauro Citterio, Director of R&D and Industrialization, Plastiape S.p.A.
The Role of the Monitor in a Risk-Based Monitoring Program June 12/14
Learn how OmniComm’s enterprise class cloud technology, when combined with an innovative electronic data capture application, can create the platform for an integrated and optimized clinical enterprise
Speaker: Keith Howells, SVP Development, OmniComm Systems, Inc.
Ken Light, EVP Transformation and Professional Services, OmniComm Systems, Inc.
Kuno van der Post, Ph.D, SVP Business Development, OmniComm Systems, Inc.
Integrating the Clinical Enterprise with Innovative Cloud Technology June 11/14
Life Sciences - This 6-part series Webinar presentations showcase best practices and case studies across various stakeholder perspectives, identifying barriers to improving the patient experience, and highlighting the latest strategies for optimizing patient participation
Speaker: Christine Pierre, President, Society for Clinical Research Sites
Optimizing Patient Participation in Clinical Trials: Attract. Engage. Retain.

Part 4: The Site’s Realities and Its Impact on Barriers to Patient Recruitment and Retention
Jun 11/14
Topics address include the neuropsychiatric tests required for demonstrating safety and tolerability in neuropsychiatric clinical trials, cognitive and functional endpoints that are relevant clinically and for regulatory purposes, and options that are available and affordable in the marketplace
Speakers: Thomas Laage, MD, MPH, Director, Product Development Consulting and Regulatory Medical Writing Support, Premier Research
Matthew T. Healy, Senior Manager, Clinical Management, Premier Research
Measuring How Well Subjects Know and Do in Neuropsychiatric Clinical Trials Jun 10/14
Life Sciences - This 6-part series Webinar presentations showcase best practices and case studies across various stakeholder perspectives, identifying barriers to improving the patient experience, and highlighting the latest strategies for optimizing patient participation
Speakers: Peter Coë, Executive Director and Co-Founder, Tudor Reilly Health
Paulo Moreira, VP - GCO, Head of External Innovation, EMD Serono
Optimizing Patient Participation in Clinical Trials: Attract. Engage. Retain.

Part 3: The Impact of the ePatient on Clinical Development
Jun 9/14
Life Sciences - This 6-part series Webinar presentations showcase best practices and case studies across various stakeholder perspectives, identifying barriers to improving the patient experience, and highlighting the latest strategies for optimizing patient participation
Speaker: Ronald Heslegrave, Ph.D., Corporate Chief of Research, William Osler Health System
Optimizing Patient Participation in Clinical Trials: Attract. Engage. Retain.

Part 2: Patient Protection, Engagement & Informed Consent: A Global Perspective
Jun 5/14
Life Sciences - This 6-part series showcases best practices and case studies across various stakeholder perspectives, identifying barriers to improving the patient experience, and highlighting the latest strategies for optimizing patient participation
Speaker: Kenneth A. Getz, MBA, Internationally recognized R&D expert, Director of Sponsored Research Programs & Associate Professor, Center for the Study of Drug Development, Tufts University School of Medicine, and Founder, The Center for Information and Study on Clinical Research Participation (CISCRP)
Optimizing Patient Participation in Clinical Trials: Attract. Engage. Retain.

Part 1: Reinventing Drug Development through Patient Centricity
Jun 2/14
Life Sciences - This 3-part series examines the global pharmacovigilance and drug safety landscape and outlook for future years
Speaker: Marie-Ange Noue, Local Medical Information Officer & Deputy Local Drug Safety Officer, EMD Serono
Pharmacovigilance Global Landscape, 2014
Part 3: Medical Information Then and Now: Leveraging Technology to Enhance Customer Experience
May 29/14
Hear from Sanofi Aventis how intelligent Central Statistical Monitoring techniques have been harnessed to improve data quality and oversight
Speakers: Eric Genevois-Marlin, Vice-President of Biostatistics and Programming, Sanofi
Francois Torche, CEO, CluePoints
Karen FANOUILLERE, Biostatistics Project Leader, Sanofi - Biostatistics & Programming
Risk-Based Monitoring – What we’ve learnt in a year, a Large Pharma Perspective from Sanofi May 28/14
This talk will focus on lessons learned and applied to the standardization of global clinical trials and reducing variability in Anatomic Pathology and Histology (APH) services supporting global clinical trials
Speakers: Paul Kirchgraber, MD, MBA, FCAP, Vice President, Global Testing Services, Medical & Technical Affairs, General Manager of the Americas, Covance Central Laboratory
Steven G. Brodie, PhD, FACMG, Director of Molecular Genetics and Cytogenetics, NeoGenomics Laboratories
Harmonization of Anatomic Pathology and Histology services in Support of Global Oncology Clinical Trials May 21/14
Life Sciences - This 3-part series examines the global pharmacovigilance and drug safety landscape and outlook for future years
Speaker: Fernando Pereira, Pharmacovigilance Manager, Merck Sharp & Dohme
Pharmacovigilance Global Landscape, 2014
Part 2: Pharmacovigilance and Best Practices in Latin America: An Overview on Safety Reporting, ADR Management & Scope of ANVISA
May 21/14
Life Sciences - This 3-part series examines the global pharmacovigilance and drug safety landscape and outlook for future years
Speaker: Marcin Marciniak, Director Drug Safety & Pharmacovigilance / Deputy EU QPPV, PregLem SA
Pharmacovigilance Global Landscape, 2014
Part 1: ADR Management and Reporting to EudraVigilance
May 14/14
Viewers Join experts from Covance in a five-part webinar series that explores critical aspects of pharmaceutical development to help you accelerate your drug development success
Speaker: Eric Lang, MD, VP, Molecule Development Group, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 1: Integrated Approach for Successful Drug Development
May 13/14
Viewers will learn about the advantages of continuous glucose monitoring and the new possibilities DSI’s solution enables for diabetes and metabolic disease research
Speaker: Bob Brockway, Director of Advanced Market Research, Data Science International (DSI)
Continuous Glucose Monitoring Applications in Rodents May 13/14
This session includes a regulatory overview of rare diseases and orphan drug status as well as practical considerations for varying stages of the development process
Speaker: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research
Rare Disease Trials: The Beginning, the Middle and the End May 12/14
In this presentation the challenge of timely reporting of SUSARs to Investigators in global and large-scale clinical trials with a high number of SUSARs will be addressed
Speaker: Dr. Max Horneck, CEO, maxclinical GmbH Germany
Informing the Investigator: Implementation of an Automated SUSAR System
This webinar will include a discussion of the current missing data landscape, how missing data can be prevented, the framework for handling missing data known as multiple imputation, and examples of how multiple imputation can provide reasonable approaches to analysing missing data
Speakers: Michael O’Kelly, Ph.D, Senior Director, Centre for Statistics in Drug Development (CSDD), Innovation, Quintiles
Jessica Cooper, Clinical Project Manager, Quintiles
Ilya Lipkovich, Ph.D., Senior Director, Center for Statistics in Drug Development (CSDD), Innovation, Quintiles
Handling & Preventing Missing Data: Improving Clinical Trial Data Credibility May 2/14
The key to successful implementation starts with identifying what type of strategy your study needs
Speaker: Donna Hanson, Director, Global Feasibility and Patient Recruitment, Advanced Clinical
How to Determine and Build an Effective Patient Recruitment and Retention Strategy Apr 30/14
This webinar will explore the current state of eCOA and the future offered by BYOD, while highlighting some of the issues that need to be addressed to move the industry forward
Speaker: Paul O’Donohoe, Director of Health Outcomes, CRF Health
What's Next in eCOA? Psychometric Validation and BYOD Apr 17/14
The presentation will discuss when a HAL study will likely be required and how a HAL study is conducted
Speaker: Dr. Lynn Webster, Vice President of Scientific Affairs, PRA, and President, American Academy of Pain Medicine

Human Abuse Liability Role in NDAs
Apr 15/14
Learn about the complexities and challenges in producing SDTM datasets, as well as groundbreaking new technology that allows SDTM datasets to be generated directly from an EDC system
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Albert Chau, CStat CSci, Senior Director, Data Science, SCRI Development Innovations
Automating the Production of SDTM Datasets Apr 2/14
Through case examples the speakers will discuss ways to accelerate enrollment across the continuum of protocol development to activation
Speakers: Martin Lee, M.D., Vice President, Investigator Relations, PRA
Gretchen Goller, MSW , Sr. Director, Patient Access and Retention Services, PRA

A Comprehensive Approach to Accelerating Clinical Trial Enrollment
Mar 26/14
This webinar will provide a regulatory perspective on what is expected from an independent and objective assessment of clinical trial data
Speakers: Marc Buyse, Founder, IDDI and CluePoints
Francois Torche, CEO, CluePoints

Risk-Based Monitoring & Central Statistical Monitoring
Mar 25/14
The aim of this webinar will be to convey the importance of considering differing ages/ stages of development of children when designing and conducting clinical trials, and how doing so can contribute to successful well-designed pediatric studies
Speakers: Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research
Susanne Schmidt, MD, PhD, Director Medical Affairs, Premier Research

The Aspects of Clinical Development Related to the ICH E11 Categories of Children: Preterm Neonates, Term Neonates, Infants and Toddlers, Children and Adolescents
Mar 24/14
Speaking from years of experience, the presenters will share insights they have gained through years of deploying risk-based monitoring principals and procedures from a variety of therapeutic studies on a global scale
Speakers: Martin Giblin, Vice President, Clinical Data Management, Quintiles
Teresa Lamantia, Vice President, Strategic Operations, Quintiles
Risk-based Monitoring: Using Centralized Data Surveillance to Evolve Data Review and Site Engagement Mar 20/14
Dr. Moulis will discuss how Merrimack Pharmaceutical has devised a method of IHC assay design that increases the chance of finding the optimal cutpoint of biomarker expression and maximizing the chance of success for companion diagnostic use
Speaker: Sharon Moulis, Ph.D., Principal Scientist and Director of the Human Tissues Laboratory, Merrimack Pharmaceuticals
IHC Assays for Companion Diagnostic Use: Standardization Methods that Maximize Success Mar 18/14
This webinar will focus on EMA and FDA regulatory perspectives on nonclinical and clinical trial safety assessment in biosimilars
Speaker: Joerg Bluemel, Director Toxicology within Biologics Safety Assessment / Translational Sciences, MedImmune, Gaithersburg MD

Nonclinical and Clinical Safety Assessment of Biosimilars
Part 2 : Regulatory Perspective

Feb 20/13

During this webinar, the speakers discuss preclinical and clinical perspectives on how to use increasingly intricate and sophisticated procedures for intravenous injection or infusion, and new ideas on attending to animal welfare
Speakers: Stéphane Milano, Chief Scientific Officer, WIL Research – Europe
Edward Marsden, Associate Director, WIL Research – Europe
Tim Vanderveen, Vice President, Center for Safety and Clinical Excellence
Intravenous Infusion: From Preclinical Challenge to Clinical Reality Feb 5/14
This webinar will discuss adaptive designs for phase I, phase II and phase III clinical trials in oncology
Speakers: Marc Buyse, Sc.D, Founder and Chairman, IDDI
Tomasz Burzykowski, PhD, VP of Research, IDDI
Everardo Saad, MD, Scientific Director and Chairman, Dendrix, Senior Oncology Consultant, IDDI
Pros and Cons of Adaptive Designs: A Leisurely Conversation Between a Clinician and Two Statisticians Jan 14/14
During this webinar, the presenters will explore how mHealth technology can be used to reduce overall clinical trial development cost, while increasing subject and investigator satisfaction, retention, and engagement
Speakers: Andy Lee, Deputy Head of Clinical Sciences and Operations, Sanofi
Glen De Vries, President, Medidata Solutions
Randy Spaulding, Founder and President, Spaulding Clinical Research, LLC
Patient-Centric Technology for Better Trial Outcomes Dec 13/13
In this webinar, you will learn how Metamark Genetics developed a new prognostic test using image analysis for early stage prostate cancer based on tissue samples: ProMark
Speakers: Thomas Nifong, M.D., Senior Vice President of Clinical Labs, Metamark Genetics
Thomas Colarusso, Vice President, Business Development Tissue Diagnostics, Definiens
ProMark: Lessons Learned in Launching a Prognostic Test Based on Tissue Image Analysis Dec 10/13
Learn about the details of the candidate identification, assay development, testing and results, beginning with the derivation of the initial list of candidates, to the identification of the five blood-based proteins, which together constitute the biomarker panel used in the commercial protein expression test, developed by Caprion Proteomics in collaboration with Integrated Diagnostics (InDi)
Speaker: Daniel Chelsky, Chief Scientific Officer, Caprion Proteomics
A Blood-Based Proteomic Classifier for the Molecular Characterization of Pulmonary Nodules:
A Case Study in the Discovery and Validation of a Molecular Diagnostic Using Caprion’s Technology Platform
Dec 9/13
The presenters will examine MCIDs and different types of PROs that are available for respiratory diseases and review case studies of successful demonstrations of product value in respiratory programs
Speakers: Dr. Chad Gwaltney , Senior Director, Consulting Services, ERT
Dr. Kai-Michael Beeh , Founder and Medical Director, insaf Respiratory Research Institute Wiesbaden
Respiratory Update: Interpreting Minimal Clinically Important Differences in COPD and Demonstrating Product Value with Patient-Reported Outcomes (PROs) Dec 4/13
This webinar will discuss the latest advances in AD research and explain how central laboratories can contribute to the progress in the battle against this disease by supporting clinical trials through quality testing
Speaker: Tatiana Souslova, M.Sc., Ph.D., Principal Scientist, ACM Global Central Laboratory
Past, Present and Future: The Role of Central Laboratories in Alzheimer’s Disease Research Nov 21/13
This webinar will highlight a solutions-based approach to filling large panels for complex trials, while incorporating special populations in a high volume environment
Speakers: Ingrid Holmes, Senior Director, Clinical Operations, Algorithme Pharma
Petra Hillebrand, Vice President, Integrated Services, Altasciences
Early Stage Recruitment Strategies for Complex Trials & Special Populations: How to Deliver Full Panels On-Time Nov 21/13
This third webinar of the series will focus on the data analysis questions related to clinical trial outcome assessment in multinational clinical trials
Speaker: Antoine Regnault, PhD, MSc, MA , Research Director, Mapi HEOR & Strategic Market Access - France
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 3: Quantitative Approaches for Clinical Outcome Assessment in a Cross-cultural Context
Nov 20/13
An open dialog explaining the changes occurring now, and what the future looks like, for clinical product development
Speaker: Dan White, Vice President, Global Operations, Quintiles
The Next-Generation of Risk-based Monitoring Nov 15/13
This program will present a systematic approach to the risk assessment of clinical trials, using methodologies that have been accepted by regulatory authorities as the basis for approvals in other healthcare categories and in other industries
Speakers: Michael Macri, Director, Strategic Services, inVentiv Health Clinical
Jeffrey Fetterman, President, ParagonRx International, an inVentiv Health Business
Risk Assessment: Laying the Foundation for RBM Nov 14/13
Learn about the importance of early and careful planning of all activities related to the generation and submission of DSURs, which includes resource planning
Speaker: Sabine Richter, PhD, M.Sc, Vice President Safety and Risk Management PRA
Challenges with Planning and Generation of Development Safety Update Reports (DSURs) and How to Overcome Them Nov 13/13
This webinar will address in more detail the advantages of globalization as well as the best practices for overcoming the challenges
Speakers: Garth Tierney, Executive Vice President, Asia/Pacific, INC Research
Silvia Zieher, President, Clinical Development and Latin America Operations, INC Research
Globalizing Clinical Trials to Include Emerging Markets Nov 12/13

In this webinar, an overview of the market environment along with the key operational, logistical, and regulatory aspects of conducting clinical trials in China and other Asian countries will be discussed
Speakers: Li Yan, MD, PhD, Executive Director of Clinical Development for Infectious Diseases, Oncology, Respiratory & Immunology, and Vaccines in Emerging Markets, Merck
Patrice Hugo, PhD, Chief Scientist, LabCorp Clinical Trials

Current Trends for Conducting Clinical Trials in China Nov 12/13
This webinar will discuss factors critical to success in the design and execution of pediatric clinical trials
Speaker: Alison Sampson, Senior Project Director, Premier Research
Successful Pediatric Studies: Key Study Design and Operational Considerations Nov 11/13
This webinar focuses on Covance's experience with in vitro assays to demonstrate pharmacological similarity between biologics and biosimilars
Speaker: Sinnathamby Gomathinayagam, PhD, Senior Scientist, Biomarker Center of Excellence, Covance
Biomarker Challenges in Biosimilar Drug Development Nov 6/13
Join our speakers for an in-depth look at challenges and proven strategies to develop and implement post-approval risk management procedures
Speakers: Mazhar Thakur, MD, MBA, MAMM, Senior Director, Safety and Risk Management, PRA
Agnes Rivaille, Scientific Affairs Director, Late Phase Services, PRA
Risk Minimization/Mitigation in the Post-Marketing Arena: Regulatory Landscape, Strategy and Effectiveness Nov 4/13
This webinar will focus on Covance's experience in standardization of methods for microparticle isolation from preclinical and clinical trial samples, as well as recent findings from microparticle analyses in disease models of Oncology and Cardiovascular/Metabolic Disease
Speaker: Katherine T. Landschulz , PhD, Manager, Biomarker Center of Excellence, Covance
Microparticles and Applications in Assays and Endpoints Oct 29/13
In this presentation the challenge of timely reporting of SUSARs to Investigators in global and large-scale clinical trials with a high number of SUSARs will be addressed
Speaker: Dr. Max Horneck, CEO, maxclinical GmbH Germany
Informing the Investigator: Implementing an Automated SUSAR Reporting System Oct 24/13
This webinar will cover the concepts involved in using metadata to improve the efficiency of data transformation programming. We will also see a case study of a large portfolio of work that has implemented these concepts to great success
Speaker: Keith Hibbetts, Manager, Statistical Programming, inVentiv Health Clinical
Using Metadata for Data Transformation: How Your Specifications Can Serve You Oct 24/13
This diabetes webinar will provide an overview of advanced data mining and software applications that can be used to understand the implications of various protocol entrance criteria
Speakers: Claudia de Oliveira, MD, PhD, MPH, Associate Medical Director, Cardiovascular and Metabolic Therapeutic Delivery Unit , Quintiles
Denise Messer, MA, Senior Project Manager, Clinical Analytics and Simulations, Quintiles
Erica Caveney, MD, MD, Senior Medical Director & Therapeutic Strategy Head, Diabetes, Cardiovascular & Metabolic Therapeutic Delivery Unit, Quintiles
Bruce Basson, MS, Associate Director, Clinical Planning & Design, Quintiles
Improve Protocol Designs for Diabetes Trials Using Predictive Techniques Oct 23/13
The need for leaner, faster and cost effective clinical trials demands more attention on where to target enrollment and Latin America can  play a key role this regard
Speakers: Mauro Martinelli, Emerging Markets Specialist, Quintiles
Jose Emilio, Associate Director, Clinical Operations, Quintiles
The Clinical Research Landscape in Latin America Oct 21/13
Learn how RFID enabled smart rooms can eliminate shrinkage, automate reordering processes, simplify inventory reconciliation and financial accounting, and eliminate manual inventory checkouts to return researchers and lab tech’s back to their bench more quickly
Speaker: Keith Hoffman, Director of Marketing, Terso Solutions, Inc.
Improving Efficiency in Research and Clinical Labs with RFID Smart Rooms Oct 18/13
The webinar will examine the automation of NGS library preparation using different chemistries and its applications
Speakers: Dr. Oleg V Evgrafov, Associate Professor, University of Southern California
Susan Lee, Senior Application Specialist, Hamilton Robotics
Automation Solutions for NGS Sample Preparation Oct 16/13
During the past two decades, the number and complexity of clinical trials have grown dramatically. These changes create new challenges to clinical trial oversight, particularly increased variability in clinical investigator experience, site infrastructure, treatment choices, and standards of health care.
Speaker: Mark Travers, VP, Head of Clinical Study Units, Sanofi-Aventis

Risk-Based Monitoring

Oct 10/13

The speaker will discuss the emerging field of companion diagnostics with focus on its importance in clinical trial design and how drug / companion diagnostic co-development is rapidly changing the drug development process
Speaker: Mark Roberts, PhD, Director, Diagnostics Development, Covance
Accelerating Drug Development through Drug & Companion Diagnostic Co-Development Oct 9/13
A discussion of the issues from Health Canada’s perspective as the regulatory agency with the most recent and perhaps progressive guidance in the world on the inclusion of women in clinical trials, plus insights into the practical barriers to overcome, and some strategies that can be successfully employed by sponsors and sites to encourage better engagement and improved recruitment and retention of women in clinical trials, a legal, moral and pragmatic imperative
Speaker: Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada
Mr. Zach Halinan, Director of Patient Communication and Engagement Programs, Center for Information and Study on Clinical Research Participation
Gender Issues in Clinical Trials: Ethical, Regulatory and Practical Considerations Oct 7/13
This presentation will discuss how the LCMS Biomarkers and Biologics Services business at Quintiles has partnered with a sponsor to develop methods that compare the surrogate matrix and surrogate analyte approaches for the analysis of five amino acids in human plasma: alanine, valine, methionine, leucine and isoleucine
Speaker: Barry R. Jones, Ph.D., Assistant Research Investigator, LCMS Biomarkers and Biologics, Quintiles Bioanalytical and ADME Labs
Better Methods for Novel Biomarkers Series:
LC/MS Biomarker Assay Validation Strategies Using Surrogate Matrix and Surrogate Analyte Approaches
Oct 3/13
In this webinar, the speakers will focus on the use and quality of COA translations, the importance of linguistic validation and how to assess the reliability of its process
Speakers: Axelle Nadjar, Key Account Director – Linguistic Validation, Mapi
Caroline Anfray, Business Development Director – Linguistic Validation, Mapi
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 2: Maximizing Cross-cultural Equivalence of PRO Measures: The Linguistic Validation Methodology
Oct 3/13
During this webinar, Cubist Pharmaceuticals and CluePoints will explore how sponsors are harnessing the power of Central Statistical Monitoring (CSM) to improve data quality and de-risk their studies
Speakers: Marc Buyse, Sc.D, Founder, CluePoints
Kostia Franklin, Senior Manager, Clinical Data Management, Cubist Pharmaceuticals
Risk-Based Monitoring Improves Data Quality – It’s A Fact! Sep 25/13
The implementation of innovative technology tools that make INC Researcg's SDM approach a viable option for improving efficiency in clinical trials will be discussed, as well as how life science companies can use technology to implement a strategic monitoring program
Speakers: Jill Collins, Senior Director, Clinical Innovation, INC Research
Stephen Young, Senior Product Director, Medidata Solutions
Reduce Site Monitoring Costs with a Strategic Approach Sep 25/13
The case-reports presented will include a discussion of the tools used to comprehensively monitor antigen-specific T cells and evaluation of the immunostimulatory and suppressive compartments
Speaker: Yoav Peretz, Ph.D, Senior Principal Scientist, Caprion/IMMUNECARTA Services
Revealing Relationships Between the Clinical and Immunological Response in Vaccination Trials Sep 24/13
This webinar will demonstrate how selecting the right EDC can help ensure project success and return on investment
Speaker: Toby Odenheim, MBA, Director, Clinical Technology Services, SynteractHCR, United States
Selecting the Right Electronic Data Capture (EDC) Platform Sep 23/13
In vitro pharmacological profiling, testing compounds in select panels of assays like SafetyScreen, play an increasingly important role in reducing drug related safety attrition
Speaker: Gonzalo Castillo, Ph.D., Technical Director, Eurofins Panlabs
In Vitro Safety Screening for Clinical Liabilities Sep 17/13
This webinar and panel discussion focuses on new ways to design biomarker driven trials and access the right patients, as well as demonstrate the power of the Total Cancer Care data warehouse, featuring participation from Millennium Pharmaceuticals
Speakers: Kyle Kuvalanka, MBA, VP, Strategy and Business Development, Millennium Pharmaceuticals
William (Bill) Trepicchio, PhD, Senior Director, Translational Medicine, Millennium Pharmaceuticals
William Dalton, PhD, MD, CEO, M2Gen and Director, Personalized Medicine Institute at Moffitt Cancer Center
Frank Makosiej, PharmD, Executive Director, Operations, Strategy and Planning, Covance
Enhanced Strategies for Design and Execution of Biomarker-driven Oncology Trials Sep 12/13
A discussion of platforms, platform selection and migration, optimising tests for FFPE tissue, clinical delivery for trial enrichment, and development routes for companion diagnostics
Speaker: Dr. Austin Tanney, Scientific Liaison Manager, Almac
Optimizing Assays from FFPE for Biomarker Strategies Sep 4/13
Learn how technology can assist VAMC’s & Hospital’s to not only meet regulatory requirements, but also provide savings and patient safety
Speakers: Alan J. Brander, RN BSN BSW MBA CHE HACP, Vice President of National Sales & Clinical Services, LPIT Solutions
Alisa Riebe, Terso Solutions, Inc.
Using RFID Technology to Compliantly Track Tissue and Implants Aug 22/13
Improving Development of antibacterial and antifungal agents remains an important priority in the pharmaceutical research industry
Speaker: Lynn Miesel, Ph. D., Global Technical Director, Infectious Disease and Microbiology, Eurofins Panlabs
Anti-Infective Services for Drug Discovery and Development Aug 15/13
Improving management of CRE’s and other antibiotic-resistant BSI’s with rapid molecular diagnostics
Speakers: Karen C. Carroll, M.D., Professor of Pathology and Medicine, Johns Hopkins University School of Medicine
Blake W. Buchan, PhD, Assistant Professor of Pathology, Medical College of Wisconsin, Associate Director, Clinical Microbiology Dynacare Laboratory
Debra A. Goff, PharmD, FFCP, Clinical Associate Professor, The Ohio State University College of Pharmacy, Infectious Diseases Specialist, The Ohio State Medical Center
Each Hour Counts: Improving Management of CRE’s and Other Antibiotic-Resistant BSI’s with Rapid Molecular Diagnostics Aug 14/13
An overview of clinically relevant assays for ultrasensitive endocrine clinical trial testing services will be discussed
Speakers: Walt Chandler, PhD, Executive Director of Endocrine Sciences, LabCorp
Patrice Hugo, PhD, Chief Scientist, LabCorp Clinical Trials
Advancements in Endocrine Testing – Case Studies and Solutions for Clinical Trials Aug 7/13
This webinar will explain the similarities and differences that exist for device and drug studies in the US and EU and the nuances of study conduct
Speakers: Kimberly D. Hunsicker, MSN, CRNP, MBA, Vice President, Global Medical Devices & Diagnostics, Premier Research
Victoria Cavendish, BSc(Hons), MPhil, PhD, PGDipPH, MICR, CSci, Senior Director, Devices, Premier Research
Medical Device and Drug Research: Similarities and Differences Jul 30/13
This webinar will focus on the regulatory requirements and expectancies for the conduct of studies to support the scheduling of new chemical entities
Speaker: Mary Jeanne Kallman, Ph.D., Director of Nonclinical Neuroscience, Covance
Addressing Scientific and Regulatory Challenges for Abuse Liability Studies Jul 26/13
The webinar will review the current regulatory landscape and guidance for nonclinical and clinical trial development of biosimilars with a focus on safety-related aspects and discuss the current challenges and future perspectives in this area
Speaker: Joerg Bluemel, Director Toxicology within Biologics Safety Assessment / Translational Sciences, MedImmune, Gaithersburg MD

Nonclinical and Clinical Safety Assessment of Biosimilars: Status and Perspective

Jul 25/13

The best practices for applying quantitative and qualitative information to develop study strategies, from feasibility through patient recruitment will be discussed
Speakers: Michelle Archibald, Senor Director, Site & Patient Strategies, Quintiles
Nicole Turner, Associate Director, Global Feasibility, Quintiles
Julie Parmelee, Director, Patient Recruitment, Quintiles
Mark Brown, Vice President of Strategic Site Intelligence and Feasibility, Quintiles
DOs and DON’Ts of Study Start-Up: Best Practices to Improve Efficiency and Meet/Exceed Timelines Jul 23/13
The panel will explain how safety and therapeutic medics, biostatisticians, data management experts and operations gurus apply risk-based thinking before a trial begins
Speakers: Rick Sax, M.D., Senior Vice President, Integrated Clinical Services, Quintiles
Dan White, Vice President, Global Operations, Quintiles
Risk-based Thinking: The Success of Risk-based Monitoring Begins with Risk-based Thinking Jul 19/13
This webinar will explore the roles of DSMBs and IRBs in particular and examine how they are involved in ensuring patient safety in pediatric trials, the unique considerations in developing DSMBs for pediatric populations, how regulatory guidance is driving change for DSMBs and IRBs and how to best work with each other and sponsors to ensure the highest degree of safety for patients and the best quality of research and data
Speakers: Jeffrey Cooper: Vice President Global Consulting at WIRB Copernicus Group IRB
Amy Professor Philip Walson, MD Board Certified in Paediatrics, Clinical Pharmacology and Medical Toxicology; Visiting Professor, Department of Laboratory Medicine at Georg-August-University Medical School, Germany
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Pediatric Safety Monitoring: Role of IRBs and DSMBs Jul 18/13
Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical trial and regulatory challenges on the path to successful orphan drug development
Speakers: Angi Robinson, Executive Director, Scientific Account Leader, Premier Research
Charlene Sanders, Vice President, Global Regulatory Affairs & Pediatric Strategic Consulting, Premier Research
Strategies for Rare Disease Studies and Orphan Drug Development in the US Jul 16/13
This webinar will feature a case study on Heparin-induced thrombocytopenia (HIT) antibodies developed in response to heparin, and its low molecular weight analogues using the SQI Diagnostics’ platform
Speakers: Jaymie R. Sawyer, Ph.D., Vice-President, Research and Development, SQI Diagnostics
Robert Massé, Ph.D., Vice-President, Large Molecule Bioanalysis, Algorithme Pharma
A Multiplexed Approach for Immunogenicity Assessment Using the New SQiDlite™ System: Case Study Analysis Jul 11/13
This webinar will cover mapping SDTM specifications during study design, describe the benefits of having an SDTM database available during study conduct and the final datasets within 24 hours of database lock, and provide a brief overview of the technology that provides these capabilities
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Prashanthi Vunnava, Senior SAS Programmer, Alkermes, Plc.
SDTM in Real Time – A Case Study: Initial Datasets by First Patient In; Final Datasets Within 24 Hours of Study Lock Jul 11/13
This webinar will encompass the three key steps that maximize cross-cultural equivalence of scales assessing patient benefit and safety in international research
Speakers: Benoit Arnould, PhD, Senior Director, Mapi
Nicola Germain, MA, Senior Research Associate, Mapi
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 1: Cross-cultural Qualitative Research for Simultaneous Scale Development
Jul 2/13
This presentation will examine recent changes in Indian clinical trial regulations, iImmediate and long term impacts, an foreseeable opportunities
Speaker: Dr. Josemund Menezes, MBBS, Regional Director, Clinical Development (Asia-Pacific), Sanofi Pasteur

Adhering Navigating the Dynamic Indian Clinical Trial Landscape

Jun 28/13

This presentation will discuss how the LCMS Biomarkers and Biologics Services business at Quintiles has partnered with our sponsors to develop quantitative methods for biomarkers and biotherapeutics by adapting the immunoprecipitation methodologies of ELISA with the specificity and robustness of LCMS to achieve sensitivity that is comparable to ELISA but with the specificity of LCMS
Speaker: Gary Schultz Ph.D., Director, LCMS Biomarkers and Biologics, Quintiles Bioanalytical and ADME Labs
Quantitative Analysis of Biomarkers with the Specificity and Robustness of Liquid Chromatography/Mass Spectrometry (LC/MS) and the Sensitivity of ELISA Jun 27/13
This presentation will explore optimization and validation strategies for flow cytometry assays, as well as highlight assays used at MPI Research on GLP toxicology and drug discovery studies
Speaker: Brandon Zeigler, PhD, research scientist, MPI Research
Practical Uses for Flow Cytometry in Toxicology Studies Within a GLP Environment Jun 25/13
This webinar will provide an overview of clinical trial outsourcing in the MENA (Middle East and North Africa) and APAC (Asia-Pacific) regions and will provide considerations for programs of development
Speaker: Larry Ajuwon, (former) Senior Outsourcing Manager, Genzyme Europe, the Netherlands

Clinical Development, Contracts and Outsourcing in MENA & APAC

Jun 19/13

This webinar will explore the direction clinical research is headed and the role innovation plays in its new course
Speakers: Jamie Macdonald, Chief Executive Officer, INC Research
Amy Kissam, Executive Director, Integrated Clinical Processes, INC Research
John Whitaker, Ph.D., Senior Vice President, Clinical Innovation, INC Research
Clinical Process Innovation: Driving Predictability in Clinical Development through Innovation Jun 18/13
In this webinar the issue of adherence to asthma medication in both clinical trials and the real world will be explored, including measurement of adherence, data interpretation, regulatory implications, and the challenges of generalizing study data to routine clinical practice
Speakers: Liam Heaney, Clinical Professor and Consultant, Queen's University. Belfast, UK
Peter Summerfield, VP, Global TAH Respiratory, Global Product Development, PPD
Rav Seeruthun, MRCGP, MFPM, Senior Director, Global Late Stage Research, PPD
Adherence in Asthma: Comparing Clinical Trials to the "Real-World" Jun 14/13
This webinar will discuss the new European Union (EU) Pharmacovigilance legislation to ensure compliance and evaluate the optimal risk management plan (RMP) and Risk Evaluation and Risk Evaluation and Mitigation Strategies (REMS) for EU and US submissions
Speaker: Amy Sun MD, Ph.D., FACP, Director of Clinical Risk Management, Merck

Drug Safety & Risk Management

Jun 14/13

This webinar will discuss the benefits of partnering with an academic medical center and will feature case studies for successful biomarker discovery, biomarker development and companion diagnostics co-development
Speakers: Steve Groshong, MD, PhD, Pathology Division Chief, National Jewish Health
Preveen Ramamoorthy, PhD, Molecular Diagnostics Laboratory Director, National Jewish Health
Leveraging an Academic-Industry Partnership for Commercial Success Jun 13/13
A discussion of the core principles, best practices and steps that must be taken in order to optimize the selection of the diagnostic testing to support the trial protocol
Speaker panel from ACM Global Central Laboratory: Mark Engelhart, Chief Commercial Officer
Kathleen Murray, Executive Director, Scientific Affairs
Suzanne Dale, PhD, D(ABMM), Director of Microbiology and Molecular Diagnostics
Endpoint Based Protocol Development: A Central Laboratory Perspective + Microbiology Case Study Jun 12/13
This session will give an in-depth examination of Central Statistical Monitoring (CSM)
Speakers: Marc Buyse, Sc.D, Founder, CluePoints
Brian Nugent, Associate Director, Clinical Operations, Gilead Sciences, Inc.
Removing the Risk in Risk-Based Monitoring – A Practical and Proven Approach to Implementing Central Statistical Monitoring Jun 10/13
This webinar will explore how biopharma can use information technology to bring drugs to market faster, better, and cheaper
Speaker: Thomas Grundstrom, Vice President & Global Head, Integrated Processes and Technologies, Quintiles Infosario
Mark Gorton, Senior Director of Information Technology, Quintiles
Accelerating Drug Development by Harnessing Technology Jun 7/13
The webinar will examine the objectives of PMOS and Phase IV studies, possible designs, benefits, disadvantages and challenges
Speaker: John S. Sampalis, B.Sc., B.A. (Hon.), M.Sc., Ph.D., F.A.C.E., Founder, CEO and Chief Scientific Officer, JSS Medical Research Inc.
Post-Marketing Observation Studies (PMOS) and Phase IV Studies Jun 5/13
Understand the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) and additional regulations for the conduction of clinical trials
Speaker: Jeremy Lim, Pharm.D., Fellow, Clinical Development, Novartis Pharmaceuticals Corporation

Adhering to Good Clinical Practice: An Overview of Clinical Trials

May 31/13

LifeSciences This talk will discuss the use of computational biology tools to ensure high-quality genomics when used as part of the QC process
Speaker: Sergey Stepaniants, Ph.D., Head of Computational Biology, Genomics Laboratory, Covance
Impacting Clinical and Preclinical Decisions: Computational Analysis of Complex Genomics Data Sets May 29/13
LifeSciences In this webinar the presenter will discuss best practices for optimizing design to improve success rates and deliver more cost effective and timely clinical trial programs
Speaker: Dan Frederic L. Sax, M.D., Global Head, Center for Integrated Drug Development, Quintiles
Optimizing Trial Outcomes through Computer Assisted Design May 28/13
LifeSciences This webinar focuses on OncoPanelTM,, a collection of 240 genomically and histologically diverse cancer cell lines, that providesmultiplexed high-content imaging analysis of therapeutics in oncology
Speakers: O. Jameel Shah, Ph.D, Principal Scientist and Group Leader, Oncology, Eurofins Panlabs
Jonathan Crane, Ph.D., Senior Scientist, Oncology and Cell Biology, Eurofins Panlabs
Predictive Biomarker Discovery for Oncology Small-Molecules and Biologics May 22/13
LifeSciences Learn how Caprion applies its label-free mass spectrometry-based proteomics platform to successfully identify tissue-specific protein biomarkers that can be used to follow disease progression in human blood
Speaker: Eustache Paramithiotis, Ph.D., Senior Director, Molecular and Cell Biology, Caprion
Discovery of Circulating Protein Biomarkers by Analysis of the Tissue Secretome May 21/13
LifeSciences An in-depth look at the challenges and solutions in conducting biosimilar trials
Speaker: Rodeina Challand B.Sc., Executive Director, Biosimilars Development, Scientific Affairs, PRA
Challenges and Solutions in Conducting Biosimilar Trials May 15/13
LifeSciences Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical trial and regulatory challenges on the path to successful orphan drug development
Speakers: Susan Tansey, MD, Medical Director, Paediatrics, Premier Research
Susan Bhatti, PhD, Executive Director European Regulatory Affairs and Medical Writing, Premier Research
Strategies for Rare Disease Studies and Orphan Drug Development in Europe May 14/13
LifeSciences Translating the Preclinical Pharmacology of the Select TLR8 Agonist VTX-2337, into Clinical Activity using the Myriad RBM MAP Inflammation Panel
Speaker: Dr. Gregory N Dietsch, Ph.D., DABT, Vice President of Research, VentiRx Pharmaceuticals
Translating Preclinical Pharmacology to Clinical Activity May 2/13
LifeSciences In this webinar, Quintiles will share recent research insights and real experiences using a modernized approach to risk-based monitoring
Speakers: Dan White, Quintiles, Vice President, Global Operations, Quintiles
Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles
Risk-based Approach to Monitoring: Deployment Insights and Lessons Learned Apr 30/13
LifeSciences An in-depth look at strategies to implement risk minimization procedures in Clinical Pharmacology Units at PRA
Speaker: Thijs van Iersel, M.D., Senior Director of Scientific Affairs, PRA, Early Development Services, The Netherlands
Risk Assessment and Risk Mitigation in Phase I Trials in High Risk Compounds: A Continuously Developing Process Apr 25/13
LifeSciences This webinar will break down the issues related to the implementation and tracking of a risk-based monitoring program through the utilization of site quality management as well as the process and organizational challenges of adopting site quality management and centralized monitoring
Speakers: Steve Young, Senior Product Director, Medidata Solutions
Laurie Halloran, President, Halloran Consulting Group
Site Quality Management to Optimize Risk-Based and Centralized Monitoring Apr 23/13
LifeSciences This webinar will provide insight into current approaches and issues in co-developing novel oncology therapeutics and diagnostics
Speakers: Brad Smith, Ph.D., Vice President, Translational Medicine, Center for Integrated Drug Development, Quintiles
Eric Faulkner, MPH, Director, Global Market Access – Diagnostics / Personalized Medicine, Quintiles
Drug-Diagnostic Co-Development Strategies for Oncology: Critical Aspects of Development and Launching an Oncology Companion Diagnostic Apr 19/13
The speaker will examine the move in the pharma/biotech industry to the adoption and implementation of Lean Six Sigma
Speaker: Rodrigo Crispim, Hub Unit Manager, Regional Clinical Operations Office, Bristol-Myers Squibb

Serialization Best Practices for Lean Six Sigma in Clinical Development and R&D

Apr 17/13

LifeSciences This webinar will focus on lead optimization pharmacology and toxicology and a fail fast strategy that many companies are using
Speaker: Shawn Heidel, D.V.M., Ph.D., Executive Director, Global Discovery Pharmacology & Toxicology, Covance
A “Fail Fast” Strategy for Lead Optimization Pharmacology and Toxicology Apr 16/13
LifeSciences This fourth webinar in our series will focus on the regulatory aspects of conducting clinical trials in Russia
Speakers: Yuri Afonchikov, MD, PhD, Vice President, Regulatory Affairs, Synergy Research Group
Igor Stefanov, Director, General Manager, Synergy Research Group
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 4 - Regulatory Affairs: The Key to Russia
Apr 10/13
LifeSciences The speakers will evaluate the quality of clinical trials being conducted in Russia / Ukraine compared to Western Europe, Eastern Europe and other Emerging Markets based on the results of recent FDA inspections conducted at clinical trial sites in these regions
Speakers: David Passov, MBA Senior Vice President, Eastern Europe, ClinStar, A PRA Company
Stanislav Gneushev, MD, MRQA, Director, Quality Assurance, ClinStar, A PRA Company
An Evaluation of Clinical Trial Quality in Russia / Ukraine Compared to Western Europe, Eastern Europe and Other Emerging Markets Mar 22/13
LifeSciences Viewers will learn how organizations, such the ONC sponsored Colorado Beacon Consortium (CBC), are using IndiGO, a clinical trial decision support tool, to optimize the cost and quality objectives in their population-based programs
Speakers: David Eddy, MD, PhD, Founder and CMO Emeritus, Archimedes Inc.
Patrick Gordon MPA, Associate Vice President , Rocky Mountain Health Plans
David Kendrick, MD, MPH, CEO , MyHealth Access Network
Succeed in a World of Shared Savings and Capitation Mar 21/13
LifeSciences During this presentation, you will learn current strategies and best practices for comparator product testing
Speakers: Nathan T. Whitford, M.B.A., Manager, Chemistry and Site Operations, Eurofins Lancaster Laboratories, Inc.
Jutta Wagner, Head of Project Management Manufacturing, Fisher Clinical Services
Chrissy Leslie, Manager, Pharmaceutical Product Testing, Eurofins Lancaster Laboratories, Inc.
Effective Strategies for Managing Comparator Product Testing Mar 20/13
LifeSciences The speaker will present an overview of LabCorp's HCV capabilities, and discuss ongoing and future HCV assay development activities, such as the implementation of next generation sequencing platforms for minor variant detection
Speaker: Christos Petropoulos, PhD, Chief Scientific Officer, Monogram Biosciences, a LabCorp Company
Comprehensive Global Testing Solutions for HCV Novel Therapeutics in Clinical Development Mar 13/13
LifeSciences This webinar will examine highlights of the draft guidance issued in late 2011 by the FDA entitled: “A Risk-based Approach to Monitoring” and will provide examples of potential cost savings and increased efficiencies gained by implementing a risk-based monitoring approach
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Becky (Causey) Carpenter, VP of Operations, ResearchPoint Global
Challenges and Opportunities in Risk-based Approach to Monitoring Mar 12/13
LifeSciences This webinar will provide an overview of the basics of model based drug development and its practical applications in selecting the right dose and population, optimizing trial, program, and portfolio design, and quantitative decision making through computer modeling and simulation
Speakers: N. Seth Berry, PharmD, Director, Clinical PK/PD and Modeling & Simulation, Quintiles
Russell Reeve, PhD, Senior Strategic Biostatistics Director, Quintiles
Model-Based Drug Development (MBDD) 101: A Primer on MBDD and Its Benefits Feb 28/13
LifeSciences This third webinar in our series will focus on how conducting clinical trials in Russia can help cut the cost of clinical trial research
Speakers: Sergei Varshavsky, MD, PhD, Sr. VP, Global Strategy, Synergy Research Group
Igor Stefanov, Director, General Manager, Synergy Research Group
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 3 - Cutting the Cost of Clinical Research: The Solution Comes from Russia
Feb 25/13
In this webinar, Dr. Speers will describe the AAHRPP accreditation process, the value of accreditation and why sites and IRBs should seek accreditation, and demonstrate that research protection and quality are responsibilities of those at the highest level at the site
Speaker: Marjorie A. Speers, Ph.D., President and CEO, AAHRPP

Human Research Protection and Understanding the Landscape of AAHRPP Accreditation

Feb 20/13

LifeSciences In this webinar, our expert shares a case study for a biological drug product that required re-development of both the bioassay method for potency, as well as an improved process for extracting the drug product from a carrier so that the potency of the final drug product could be reproducibly measured
Speaker: Peter Wunderli, Ph.D., associate director, biopharmaceutical services, PPD, cGMP laboratory
Developing Robust Potency Assays for Validation: A Case Study Feb 19/13
LifeSciences In this webinar we will discuss best practices for using data to objectively assess the best fit countries and associated sites for particular trials
Speakers: Chris Frega, Sr. Director and Head of Global Feasibility, Quintiles
Tom Larrichio, Senior Director, Strategic Site Intelligence, Quintiles
Country and Site Selection: Optimizing Protocol Planning Decisions by Leveraging Data Through Custom Algorithms Feb 13/13
LifeSciences A strategy to achieve a better assessment of QT liability early in the drug development cycle, at lower cost, will be discussed by the experts in this webinar
Speakers: Dr. Jay Mason, Chief Medical Officer, Spaulding Clinical Research
Dr. Charles Benson, Eli Lilly and Company and E14 Implementation Working Group Member
Moderator: Daniel Selness, Sr. VP and GM of Clinical Research, Spaulding Clinical Research
Farewell to TQT Studies? Feb 7/13
In this presentation, a detailed description of the requirements for registration and post-marketing, as well as a Pharmacovigilance plan will be discussed
Speaker: Vijay Tammara, VP Global Regulatory Affairs, Nuron Biotech, AAPS Member

Biosimilar Regulatory Guidelines in Emerging Markets – India

Jan 24/13

LifeSciences Dr. Klein will discuss Health Canada’s approach and stringent infectious disease requirements for Phase 1 clincal trials. Dr. Larouche will discuss the practical dimensions of the problem, and what must be done at the clinic level, over and above regulatory requirements.
Speakers: Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada
Dr. Richard Larouche, BPharm, MD, Director, Medical Affairs, Early Stage Development, Pharmanet/i3
Protection of Phase 1 Research Volunteers in an Age of Pandemics and Re-emergence of Contagious Diseases Long Thought Conquered Jan 18/13
LifeSciences This webinar will address the various clinical, regulatory (US & EU) and commercialization strategies that may be implemented in the development of products to treat rare diseases and orphan indications
Speaker: William C. Maier, PhD, Chief Scientific Officer, REGISTRAT-MAPI
Clinical, Regulatory and Commercialization Strategies for Rare Diseases Jan 15/13
LifeSciences Learn how to dramatically enhance the value derived from outsourcing, without additional expense
Speakers: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Thomas J. Wilson, Vice President of Quality, Synta Pharmaceuticals Corp.
Best Practices for Outsourcing Drug Development: The Human Elements of a Successful Relationship Jan 14/13
LifeSciences This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies
Speaker: Clark Williard, Executive Director, Mass Spectrometry Operations, PharmaNet/i3
Application of GC/MS/MS in Monitoring Steriods as a Pharmacokinetic and Pharmacological Biomarker Dec 17/12
LifeSciences This webinar will provide insight into some of the current issues in progressing oncology compounds from the pre-clinical arena through early clinical development in humans, with specific focus on three areas of early oncology research that can make or break these critical first-in-man studies
Speakers: Philip Breitfeld, MD, Vice President, Therapeutic Strategy, Oncology Therapeutic Area, Quintiles
Eric Groves, MD, PhD, Vice President, Center for Integrated Drug Development, Quintiles
Chris Learn, PhD, PMP, Senior Clinical Project Manager, Quintiles
Maximizing Quality and Efficiency of Go/No Go Decisions in Early Oncology Development Dec 14/12
LifeSciences Understand the role of Next Generation Sequencing in personalized medicine, how to identify various genomic alterations in rapid time, and how Next Generation Sequencing can help stratify patient populations
Speaker: Anup Madan, Ph.D., Director of Sequencing, Covance
Personalized Medicine Through Integrated Next Generation Sequencing Dec 12/12
LifeSciences In this webinar we will discuss how evidence generated for regulatory purposes can be useful for CER
Speakers: Jeroen Jansen, PhD, Vice President, Health Economics & Outcomes Research, MAPI Consultancy
Carl de Moor, PhD, Vice President Epidemiology, REGISTRAT-MAPI, North America
Comparative Effectiveness Research – The Role of Evidence Synthesis and Non-randomized Real World Studies Dec 11/12
LifeSciences During this session we will explore ways to minimize the variability in pain studies and methods for increasing the chances of showing a therapeutic effect for the study medication being tested
Speaker: Michael Kuss, Vice President, Analgesia, Premier Research
Managing Variability in Pain Studies Dec 10/12
LifeSciences This presentation will review the potential clinical trial applications of Vectra DA in the management of RA, with a specific focus on findings from recent studies presented at the Annual Rheumatology Meeting held in DC
Speaker: Eric Sasso, MD, Vice President Medical and Scientific Affairs Crescendo Bioscience
Clinical Applications of Vectra™ DA: Review of Recent Study Findings Dec 4/12
LifeSciences This webinar will explore the current regulatory and scientific challenges facing industry engaged in developing biosimilars with emphasis on EU and US regulatory framework.
Speakers: Carolyn Finkle, Vice President, Global Regulatory Consulting, Catalent Pharma Solutions
Vincy Abraham, Senior Manager, Bioanalytics Catalent Pharma Solutions
Biosimilars: Creating Workable Solutions to Global Regulatory and Analytical Challenges Nov 30/12
LifeSciences The purpose of this webinar is to discuss recent changes in regulatory requirements and their impact on the clinical supply chain, including the QP release process, considerations when using comparators, and cold chain/temperature sensitive materials
Speaker: Ronnie Constable, Director of Quality, Fisher Clinical Services
The Changing Role of the QP and Regulatory Challenges That Impact the Clinical Supply Chain Nov 14/12
LifeSciences This webinar discusses evolution and the current landscape of pediatric clinical research networks, selecting and engaging with the right network for your pediatric trial, and enhancing your pediatric clinical research process while fostering high-quality, ethical research on medicines for use in children
Speakers: Brian Smith, MD, MPH, MHS, Associate Professor of Pediatrics, Duke University Medical Center, Duke Clinical Research Institute
Peter Clayton, BSc, MB, ChB, MD, MRCP, FRCPCH, Professor of Child Health, Director NIHR Greater Manchester, Lancashire & South Cumbria (GMLC) Medicines for Children Local Research Network, Associate Director, Greater Manchester Comprehensive Local Research Network
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
The Role of Research Networks in Pediatric Clinical Trials Nov 13/12
LifeSciences Post Ap­proval Clinical and Epidemio­logical Studies (PACES) that in­clude Phase IV and Post Mar­keting Observational Studies (PMOS) have evolved into an integral and essential phase of the drug develop­ment life cycle with implications that have comparable weight to that of the Phase II and III registrational studies. Join Dr. John Sampalis for a live discussion.
Speaker: John S. Sampalis, B.Sc., B.A. (Hon.), M.Sc., Ph.D., F.A.C.E., Founder, CEO and Chief Scientific Officer, JSS Medical Research Inc.
Post Approval Clinical Epidemiological Studies (PACES) Nov 12/12
LifeSciences In this final webinar of our series, we will look at (i) when we should start preparing for database lock, (ii) what can/will go wrong, (iii) how we can minimize/correct issues and (iv) what checklists everyone should have in their repertoire to ensure success.
Speakers: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.
Advanced EDC Trials: The Homestretch – Don’t Let the Timelines Slip Nov 9/12
LifeSciences Our speaker will discuss the enormous value and practical considerations of including Russia in your global clinical study planning from the outset, and at a minimum, in your risk management and contingency planning
Speakers: Richard Koenig, Vice President of Operations, ClinStar,
Alina Tatarenko, MD, Senior Project Manager, ClinStar
Including Russia and Ukraine in Your Risk Management and Rescue Study Plans Nov 8/12
LifeSciences This webinar will focus on the key aspects of monitoring for the development of renal toxicities and the issues in conducting clinical trials in patients with both recognized and unrecognized kidney disease
Speaker: Lynda Szczech, MD, MSCE, FASN, FNKF, Medical Director, Pharmacovigilance, PPD, LLC
Kidney Safety in Clinical Trial Design: Recognizing the Complexities and Avoiding the Pitfalls Nov 2/12
LifeSciences This webinar will discuss a number of methodologies to facilitate the assessment of potential development risks including safety and immunogenicity, stability, aggregation and low productivity
Speaker: Noel Smith, Ph.D., Senior Scientist, Lonza Applied Protein Services, Lonza Biologics plc
Developability: Reducing the Risk of Failure of Biotherapeutic Candidates Oct 23/12
LifeSciences This webinar will provide insight into the various regulations which direct pediatric diabetes drug development for registration globally
Speakers: Cynthia Jackson, DO, Leader, Pediatric Center of Excellence, Quintiles
Paul Strumph, MD, Leader, Diabetes Center of Excellence, Quintiles
Robin Huff, PhD, Sr. Director, Global Pediatric Regulatory Strategy Lead, Quintiles
Moderator: Rick Turner, PhD, Sr. Scientific Director, Corporate Communications, Quintiles
DIABETES DRUG DEVELOPMENT: A Perspective on Pediatric Indication Planning Oct 19/12
LifeSciences This webinar presents an overview of some of the key components involved in developing products related to the application of biomarkers earlier in the drug development pipeline
Speakers: Tim Davison , B. Math, Ph.D., VP, Bioinformatics and Biostatistics, Almac Diagnostics
Susan Farragher, Operations Manager, Almac Diagnostics
Developing and Applying Biomarkers in Early Phase Clinical Trials

Oct 18/12

LifeSciences The speakers will provide a definition of RBM, insight into the regulatory landscape, and a perspective on executing RBM leveraging the three elements of people, process and technology
Speakers: Thomas Grundstrom, Vice President, Integrated Processes and Technologies and Global Head, Quintiles Infosario®
Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles
Risk-based Approach to Monitoring: The Future Roles of People, Process & Technology Oct 15/12
LifeSciences This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies
Speaker: Brigitte Pellerin, Senior Bioanalytical Project Manager, PharmaNet/i3
Reduce Filing Time - Fast Turnaround of Innovator and BE First-to-File Analysis Oct 15/12
LifeSciences This second webinar in the series will examine the the advantages and disadvantages of conducting clinical trials in Russia and Kazakhstan, and the upcoming trends in this market
Speakers: Igor Stefanov, Director, General Manager, Synergy Research Group
Anna Ravdel, Director of Business Development, Synergy Research Group
Evgeny (Eugene) Rogov, MD, PhD, JD, Deputy Head of Clinical Trials State Control Department (ROSZDRAVNADZOR)
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 2 - Conducting Cinical Trials in Russia and Kazakhstan
Oct 12/12
LifeSciences This webinar will present rationale for a dedicated study start-up process which lends to a decrease in cycle times, higher quality pre-study site assessments, and improved study start up metrics
Speakers: Brett Barber, Senior Director, Strategic Sourcing, PharmaNet/i3
Nicole Baker, Director, Strategic Resourcing, PharmaNet/i3
Lisa Rhiner, Clinical Study Lead, PharmaNet/i3
Innovative Solutions Designed to Improve Operational Capacity, Efficiency, and Effectiveness in Clinical Monitoring Oct 4/12
LifeSciences An examination of why Asia-Pac excels as a region for strategic clinical data management / medical writing base in which to achieve savings in cost and time investment
Speakers: Koteshwar Govind, Head of Data Management, Max Neeman International
Donald Swankie, MBA, Vice President, USA, Max Neeman International
Global Data Management & Medical Writing: The Asia-Pac Advantage

Sep 26/12

LifeSciences This presentation addresses the challenges of analytical method development that is required for physicochemical characterization
Speakers: Robert J. Duff, Ph.D., manager, Biopharmaceutical Services, Lancaster Laboratories
Lieza M. Danan-Leon, Ph.D., principal scientist, Biochemistry, Lancaster Laboratories
Critical Aspects of Antibody-Drug Conjugates: Structural Characterization and Analysis Sep 25/12
LifeSciences This webinar will provide best practice insights into dose selection for First in Human (FIH) dose escalation studies to mitigate risk and optimize the value of your early clinical data
Speaker Panel from Quintiles: Eleanor A. Lisbon MD, MPH, CPI, Senior Medical Research Director, Early Clinical Development
Professor Tim Mant, Vice President, Medical Research and Principal Investigator
Steve Lowes, PhD, Vice President, Scientific, Advion Bioanalytical Labs
N. Seth Berry, PharmD, Director, Clinical PK/PD and Modeling & Simulation
EARLY CLINICAL INSIGHTS: Best Practices for Optimizing Dose Escalation in FIH Studies Sep 24/12
LifeSciences In this webinar, case studies will be presented to demonstrate how advanced immune monitoring tools have been used to gain insight on the proportion of major lymphocyte subsets, their response to various stimuli and their activation versus exhaustion status.
Speaker: Yoav Peretz Ph.D., Principal Scientist, Caprion/IMMUNECARTA Services
PD-1 and the Immune Exhaustion Paradigm: Immune Profiling tools for Drug Discovery and Clinical Monitoring Sep 20/12
LifeSciences The presentation give an overview of the advantages of conducting clinical trials in emerging markets, an analysis of the importance of start-up timelines in the decision-making process when selecting geographies for a global clinical trial, and a review of the regulatory challenges that can be anticipated when starting up a trial in Russia
Speakers: Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics
Richard Koenig, Vice President of Operations, ClinStar
Study Start-up: A Comparison Across Emerging Markets Sep 13/12
LifeSciences A discussion of the  fundamental principles of preclinical modeling in cancer and the specific roles that imaging can play in improving the predictive power for clinical success, formulating a new standard for drug development, with particular reference to gliomas as case studies
Speakers: Jim Dougherty, MD, General Partner, Arcus Ventures, and former Deputy Physician-in Chief for Clinical Affairs a Memorial Sloan-Kettering Cancer Center (MSKCC)
Dick Leopold, PhD, VP, R&D, Molecular Imaging Inc.
John L. Chunta, PhD, Senior Imaging Scientist, Molecular Imaging Inc.
Driving Translational Imaging to a Drug Industry Standard: Case Studies in Glioblastoma and Other Clinically Predictive Cancer Models Sep 12/12
LifeSciences In this 3rd of 4 webinars, we look at the impact of one or more protocol amendment(s) on the study database and the EDC team and how changes can be implemented smoothly and with minimal effect on the ongoing study
Speaker: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Advanced EDC Trials: The Team is Working Together, Now Get Ready for Change Sep 10/12
LifeSciences Although the Guidance remains in draft form, it is clear that the key elements of the Final Guidance will likely be retained. Some sponsors and CROs have already begun to adopt a risk-based approach, but the key questions around operationalizing the Guidance and its implications to all drug development stakeholders remain. The discussion will include perceptions from the legal and regulatory perspective, recent initiatives at the highest levels to integrate a risk-based approach to clinical trial monitoring, and practical implementation aspects of risk based monitoring.
Speakers: - Mr. Gary Yingling, BS, MS, JD, Partner, K&L Gates, Washington DC
- Nicholas Alp, PhD, BM BCh, FRCP, DM, Vice President, Scientific Council, ICON plc, and Hon. Consultant Cardiologist, Oxford University Hospitals NHS Trust
- Anick Duchesne, BSc, DSA, Senior Director, CRA Management - North America, ICON plc
A Risk-Based Approach to Monitoring - Implications for Sponsors, CROs, Investigators and IRBs — AN UPDATE Sep 6/12
LifeSciences Learn about a new transformative proteomic biomarker discovery technology that measures over 1129 human proteins in small sample volumes with a sensitive, specific and semi-automated assay
Speakers: Steve Williams, M.D., Chief Medical Officer, SomaLogic
Nick Saccomano, Ph.D., Chief Technology Officer, SomaLogic
Unlocking Protein Biomarker Discovery for Pharma, Biotech and Academia Aug 23/12
LifeSciences This webinar will review models available for assessing anti-inflammatory activity in vivo then focus on imaging technologies, for discovery screening and for translatable biomarkers as applied in inflammation models
Speakers: James Mobley, Ph.D., Founder and CSO, Sunapten Therapeutics, Inc.
Patrick McConville, Ph.D., COO, CSO and Co-founder, Molecular Imaging Inc.
Advances in Inflammation Models and Associated Drug Evaluation: Improved Assessment Using Imaging Biomarkers Jun 26/12
LifeSciences In this 2nd of 4 webinars, the speakers highlight the typical problems associated with the initial stage and present several tips and solutions to addressing them at the start, while showing how technology can play an integral part in coordination, control and communication
Speakers: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.
Advanced EDC Trials: Bringing the Team Together Jun 8/12
LifeSciences This webinar will discuss compounding at the clinic’s pharmacy as a means to accelerate development and minimize CMC development resources
Speakers: William Schachtner, associate director, small molecule and inhalation product testing services, cGMP laboratory, PPD
Eugene McNally, Ph.D., executive director, global CM&C, global regulatory affairs, PPD
Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 4: Accelerating to Phase I Clinical Trials for All Dosage Forms
Jun 7/12
LifeSciences Learn how Caprion accelerates validation of biomarkers, diagnostics, and toxicology profiles using MRM technology. A variety of sample types and applications will be covered, including plasma proteins, immune response, toxicology, and tissue-specific panels
Speaker: Daniel Chelsky, Chief Scientific Officer, Caprion Proteomics
New Solutions for Highly Multiplexed Protein Assays via MRM Jun 4/12
LifeSciences In this 1st of 4 webinars, the speakers will provide insight into the unique needs of Biotech/Biopharma companies from both the Sponsor and Technology/Services providers (CROs) perspectives. Subsequent webinars will focus on case studies, specific challenges and solutions.
Speakers: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.
Advanced EDC Trials: The Unique Needs of Biotech/Biopharma May 30/12
LifeSciences This presentation will discuss a unique system called Isolation Liquid Chromatography with Mass Spectrometry (Iso-LCMS), a two-dimensional HPLC system coupled to MS that allows for one-step mass analysis of peaks in MS-incompatible mobile phases
Speaker: David J. Sherlock, Senior Research Scientist, cGMP Laboratory, PPD
Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 3: Impurity Identification Using Two Dimensional LCMS
May 24/12
LifeSciences This webinar will further explore the challenges that we face in the industry today due to the globalization of clinical trials and the increased penetration of less developed countries
Speaker: Rognvald Lamb, Distribution & Logistics, Fisher Clinical Services
Evaluating Challenges with Clinical Trial Supply Logistics in the Less Developed World May 22/12
LifeSciences The speakers will discuss the benefits of conducting clinical trials in Russia and parts of Eastern Europe compared to other emerging markets, address many of the questions and concerns Sponsors have about logistics, and introduce five keys to successfully managing clinical trial logistics in this region
Speakers: David Passov, CEO, ClinStar
Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics
5 Keys to Successful Clinical Trial Logistics in Russia, Ukraine and Belarus May 17/12
LifeSciences This presentation will include a brief background on the development & validation of Vectra DA delivered by Dr. David Chernoff, followed by a patient case study discussion led by Dr. Alvin Wells highlighting the application of Vectra DA in clinical practice
Speakers: Alvin Wells, MD, PhD, Director, Rheumatology and Immunotherapy Center
David Chernoff, MD, Chief Medical Officer, Crescendo Bioscience®, Inc.
Clinical Applications of Vectra™ DA, a Multi-Biomarker Blood Test for Rheumatoid Arthritis Disease Activity May 15/12
BusinessStrategy This program will analyze the basis of India’s Regulatory environment, the regulations [both current and future] of clinical trials in India, and the challenges faced in the present scenario
Speakers from Max Neeman International: Renu Razdan, PhD, Chief Operating Officer
Vandana Pandey, Manager Regulatory Affairs
Clinical Research in India – Regulatory Environment May 9/12
LifeSciences This webinar will address advances in the development of drugs to treat respiratory diseases with a focus on new technologies that enrich data collected early in clinical research
Speakers: J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion
Professor J. Stuart Elborn, MD, FRCP, Professor of Respiratory Medicine, Queen's University of Belfast
Stephen Smith, MB BCh BAO, MRCGP, Diploma Pharmaceutical Medicine, Principal Investigator, Celerion
Discerning Early Clinical Signals of Efficacy for Treating Respiratory Diseases Apr 24/12
LifeSciences This webinar will provide an overview of simulation modeling and how it can be used to improve clinical development efforts, including enhancing choice of target population, powering, and operational feasibility, as well as understanding performance in real-world settings
Speaker: Badri Rengarajan, MD, Medical Director, Archimedes Inc.
Simulation Modeling for Optimizing Design of Clinical Trials and Registries Mar 20/12
LifeSciences This webinar will address the key elements of early biosimilar development that provide the bridge between the manufactured product and the larger clinical studies needed to prove comparable efficacy and safety
Speakers: J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion
Raymond Farmen, PhD, Vice President, Global Bioanalytical Services, Celerion
Michael E. Placke, PhD, DABT, Senior Vice President and General Manager, Ricerca Biosciences

Challenges in Early Comparability Assessment of Biosimilars
Mar 20/12
LifeSciences This first webinar in the series will examine the the advantages and disadvantages of conducting clinical trials in Russia, the clinical studies cycle, regulatory environment, and impact of the new Drug Law in Russia on the clinical trials
Speakers: Igor Stefanov, Director, General Manager, Synergy Research Group
Anna Ravdel, Director of Business Development, Synergy Research Group
Evgeny (Eugene) Rogov, MD, PhD, JD, Deputy Head of Clinical Trials State Control Department (ROSZDRAVNADZOR)
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 1 - Russia: Understanding the Regulatory Environment, Challenges & Benefits
Mar 13/12
LifeSciences Our speakers will discuss interventional observational studies, including different types of data that can be collected, different country regulations and approval processes, and setting up and running international real-world observational studies
Speakers: Dr. William Maier, Chief Scientific Offier & VP Epidemiology, Drug Safety and Risk Management, Registrat-Mapi
Dr. Carl de Moor, Vice President Epidemiology, North America, Registrat-Mapi
Sarah Rosen, Global Project Director, Registrat-Mapi
International Real World Post-marketing Studies that Involve Patient Intervention Mar 12/12
LifeSciences The speaker panel will discuss key elements for clinical research in pediatric patients from the point of view of the research site and the investigator
Speakers: Ginger Steinhilber RN.MS. CCRC, Clinical Research Manager, Children’s Hospital of Michigan and Wayne State University
John van den Anker, MD, Vice Chair of Pediatrics for Experimental Therapeutics and Director of Pediatric Clinical Pharmacology at Children’s National Medical Center (Washington, DC)
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Perspectives on Pediatric Trials from Investigative Sites Feb 14/12
LifeSciences Topics include a discussion of different models available to commercialisation, IVD and Regulated Laboratory Developed Test (LDT), scalable commercialization pathways, and strategies to reduce CDx development timelines by up to 12 months. Recent case studies with FDA submissions will also be cited to demonstrate a different approach.
Speaker: Alan Wookey, Executive Director, Companion Diagnostics, LabCorp
Companion Diagnostics (CDx): Accelerating the Path to Commercialization Feb 1/12
LifeSciences This webinar will explore the challenges in clinical supply chain strategy and discuss how to develop the appropriate risk profile
Speaker: Jim Benkendorf, General Manager, Fisher Clinical Services
Optimizing Clinical Supplies When Facing Drug and Resource Constraints Jan 30/12
LifeSciences Learn how to effectively navigate the challenges of conducting clinical trials in Russia and parts of Eastern Europe (EE) and successfully include these emerging markets in rescue trials and as an integral part of your initial study plans
Speaker: David Passov, CEO, ClinStar
Include Russia and Eastern Europe for Successful Clinical Trials Jan 24/12
LifeSciences An examination of the complex process of translating biomarkers into clinically applicable tests and their use in clinical trials
Speakers: Dr. Peter Kerr, Product Development Team Manager, Almac
Dr. Stephen Moore, Product Development Team Manager, Almac
Translating Pre-clinical Markers to Validated Assays and Their Application to Clinical Trials for the Pharma Industry Jan 19/12
LifeSciences This presentation will, through the use of actual illustrations, demonstrate some of the pitfalls encountered in early phase pediatric clinical pharmacology studies and by doing so, provide direction on how they might be avoided in the design and conduct of future studies
Speakers: Gregory L. Kearns, PharmD, PhD, Marion Merrell Dow/ Missouri Chair in Pediatric Medial Research
Dr. Alexander Cvetkovich Muntañola, Senior Director Clinical Development, INC Research
Pediatric Clinical Trials - Lessons Learned the Hard Way Dec 13/11
LifeSciences This webinar will consider recent proposed changes to the regulatory and legislative environment and efforts to better define the roles of the IRB and the investigator in effectively carrying out their responsibilities
Speakers: Greg Koski, PhD, MD, Senior Scientist, James Mongan Institute for Health Policy, Associate Professor of Anesthesia, Harvard Medical School, Associate Editor, Journal for Empirical Research on Human Research Ethics
Jack Corman, B.Sc, B.Ed, President and Founder, Institutional Review Board Services
Human Research Subject Protection: A Time of Reflection, Renewal and Reform? No--It's Time to Redesign! Dec 12/11
LifeSciences Topics include evaluating CTCs as prognostic and predictive tools, obtaining extensive biomarker data without invasive procedures, and personalized therapy based upon CTC molecular pathology
Speaker: Ken Pennline, PhD, Vice President and Global Head, Cytometry Services, Esoterix Clinical Trials Services, a Division of LabCorp
Circulating Tumor Cells as a Biomarker Approach in Oncology Nov 9/11
LifeSciences The goals of this presentation are to provide clarity on the rationale for this proposed change to the federal regulations; to discuss the potential impact on sponsors, CROs, and academic institutions; to dispel some of the myths regarding the independent review board model and to provide a case study of the collaborative relationship between the Duke University and Copernicus Group IRB in the review and conduct of clinical trials
Speakers: Barry Mangum, Pharm.D., FCP, Director Clinical Pharmacology, Duke Clinical Research Unit
Yvonne Higgins, A.B., CIP, Director Quality Management, Copernicus Group IRB
Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A Case Study Oct 18/11
LifeSciences This webinar will address scientific and practical aspects of formulation selection and process design relative to early- and late-stage pharmaceutical development
Speakers: Dana Settell, Director of Engineering, Late Stage Programs, Bend Research Inc.
Corey Bloom, Director, Formulation Science, Bend Research Inc.
Spray Dried Dispersions: Robust Formulation and Science of Scale from Preclinical to Launch Sep 29/11
LifeSciences This program will provide an overview and key lessons in leveraging India as a strategic venue for research as well as post market approval in a country of 1.3 Billion
Speaker panel from Max Neeman International: Ajoy Kumar, MD, CEO, Renu Razdan, COO, and Donald Swankie, MBA, VP, USA
Clinical Research in India – Potential & Challenges Jun 15/11
LifeSciences This webinar will review the requirements and practical considerations around preparation and parametric release of drug in a pharmacy clean room to be administered intravenously. In addition, the regulatory requirements around validation and quality control of AMS assays will be reviewed.
Speakers: Staci McDonald, PharmD, Senior Director, Scientific Clinical Operations, Celerion
Stuart Best, PhD, Senior Director of Operations, Xceleron
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Microtracer Studies Jun 8/11
LifeSciences During this webinar, the speaker will introduce a unique web-based solution for gaining rapid insight into temperature-sensitive shipments in clinical trials
Speaker: Shirley Attryde, Product Manager, STEMS, Almac
Improving Insight and Increasing Control of Temperature-Sensitive Supplies in Clinical Trial Jun 1/11
Healthcare In this webinar David Eddy, MD. PhD. will demonstrate ARCHeS Innovator, a software as a service (SaaS) that enables researchers and decision makers to use many of the capabilities of the Archimedes Model over the web
Speaker: David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
DEMO: ARCHeS Innovator May 31/11
LifeSciences Celerion's clinical pharmacology scientists will describe recent trends in adaptive designs, highlight areas where innovative approaches resulted in more robust clinical study results and discuss the challenges sometimes faced with these designs
Speakers: Michelle L. Combs, PhD, Vice President, Clinical Pharmacology Sciences
Elliot Offman, BSc Pharm, MSc, Director, Clinical Pharmacology Sciences
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Adaptive Study Design May 17/11
LifeSciences Reduce the reporting burden on sites, sponsors, CROs and review boards while raising the bar on providing real protection of the subjects participating in clinical trials
Speaker: Glenn Veit, JD, CIP, Chairperson, Copernicus Group IRB
Safety Reporting to the Institutional Review Board (IRB): Understanding Recent Guidance May 4/11
LifeSciences Panel discussion with Celerion’s experienced physicians describing their approaches and experience in making the early assessments of safety and tolerability of new drug candidates. Through brief case studies, the audience will learn about changing tools, approaches and considerations for identifying hepatic, renal, pulmonary, neuropsychiatric, ophthalmologic and cardiovascular adverse effects as well as assessing risk for ocular toxicity in humans.
Key Presenter: William Wheeler, M.D., Therapeutic Area Lead-Cardiovascular (Chair)
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Value of Early Safety Assessments Apr 28/11
LifeSciences This webinar will discuss using amorphous dispersions as a platform technology to rapidly formulate compounds as respirable dry powders for preclinical evaluation
Speakers: Dan Dobry, Vice President Engineering, Bend Research Inc.
Dr. David T. Vodak, Vice President Chemistry, Bend Research Inc.
Dana M. Settell, Director of Business Development, Bend Research Inc.
Dextran-Based Amorphous Dispersions as a Platform Technology in Preclinical Screening for Inhaled Dry Powders Apr 27/11
LifeSciences The role of the Clinical Logistics Leader will be explained as well as the contributions to study performance that such a role can provide
Speakers: Rico Berger, Ph.D., Manager Central Laboratory Services, PAREXEL International
Alain Eudaric, Director Clinical Logistics, North America and Asia Pacific, PAREXEL International
Leveraging Your Clinical Supply Chain Talent For A Well-Run Global Clinical Trial Apr 21/11
LifeSciences This webinar will address strategies for expediting small molecule oral dosage formulations to Phase I studies, strategies to overcome challenges associated with poorly soluble compounds, technical considerations for liquid in capsule formulations, and controlled release formulations
Speaker: Paul F. Skultety, PhD, Director, Pharmaceutical Development Services, Xcelience, LLC
Formulation Development Strategies for Expediting Small Molecule Oral Dosage Formulations to Phase I Studies Mar 23/11
LifeSciences In this webinar, Celerion partners with Xceleron to discuss how Accelerator Mass Spectrometry (AMS), through measurement of ultra low levels of drug-associated radioactivity, can enrich the information gathered from early clinical studies
Speakers:  J. Fred Pritchard, Ph.D.,Vice President, Drug Development Services, Celerion
Jeremy Hague, BSc, Senior Director, Strategic Development, Xceleron Ltd.
The Need for Speed: Enriching Early Clinical Studies for Better Data, Faster Oct 7/10
LifeSciences Our speaker panel from Almac will utilise their experience in the industry to explore the various mechanisms and techniques currently available in the marketplace to promote successful clinical trial supply capsule manufacture and over-encapsulation. They will also discuss key GMP challenges that need to be overcome in order to ensure product quality and study result integrity.
Speakers: Dr. Colin Lorimer, Senior Formulation Scientist
James Hurst, Analytical Support Manager
Michael Rainey, Production Manager
Richard Shannon, Head of Business Development (Europe)
Evaluating Capsule Manufacturing & Comparator Blinding Techniques for Clinical Trials Sept 24/10
LifeSciences A discussion of the potential of biopharmaceutical products including differentiating the risk associated with internal attributes of the drug from the risk derived from external factors, a guideline to selecting the best methods to analyze and characterize antibodies, and recommendations on a risk-based sampling strategy and representative clinical case studies describing the importance of immunogenicity testing not only during clinical trials but also after the drug is commercialized
Speaker: Ana T. Menendez, Ph.D., Senior Director of Biotechnology, Catalent Pharma Solutions
Strategic Considerations For A Successful Immunogenicity Program Sept 17/10
LifeSciences This webinar will explore what clinical delivery alliances are and the value alliance partnership models bring to the drug development process from both the sponsor and CRO perspective
Speakers: Tim Dietlin, Vice President of Alliance Development, INC Research
David Gillogly, Global Head, Clinical Contracting and Category Management, Novartis
The Value of Strategic Alliances vs. Transactional CRO-Sponsor Relationships Sept 15/10
LifeSciences The role of the Clinical Logistics Leader will be explained as well as the contributions to study performance that such a role can provide
Speakers: Rico Berger, Ph.D., Manager Central Laboratory Services, PAREXEL International
Alain Eudaric, Director Clinical Logistics, North America and Asia Pacific, PAREXEL International
Leveraging Your Clinical Supply Chain Talent For A Well-Run Global Clinical Trial Sept 9/10
LifeSciences This webinar will introduce the utility of SharePoint for clinical trial operations and will present the application of SharePoint to two specific areas: clinical trial management and investigator portals. Viewers will learn how they can use technology to manage their clinical operational data to collect more timely information and to make more informed decisions.
Speakers: Les Jordan, CTO, Life Sciences Industry Unit, Microsoft
Bob Webber, President & CEO, TranSenda
Greg Cohee, Director, eClinical Services, Pharmica Consulting
Perspectives on Utilizing Microsoft SharePoint to Improve Clinical Trial Operations Mar 4/10
Healthcare In this webinar Dr Eddy will explain how the Archimedes Model is formulated, how physiology is modeled, how patient behavior is modeled, sources and methods for deriving equations, how utilization and costs are calculated, and how the Model is validated
Speaker:David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
Healthcare Modeling Part 4: How the Archimedes Model Works and is Validated Feb 11/10
LifeSciences This webinar will address considerations for prototype formulation development, formulation options for phase I studies, a prototype formulation approach, strategies to overcome poorly soluble compounds, liquid in capsule, and controlled release formulations
Speaker: Paul F. Skultety, PhD, Director, Pharmaceutical Development Services, Xcelience, LLC
Formulation Development Options for Speed to Phase I Studies Jan 21/10
LifeSciences An in-depth look at the most effective strategies for planning and implementing this new breed of trials.
Speaker: Judith Quinlan, Vice President, Adaptive Trials, Cytel Inc.
Real-time Clinical Trial Decision Making: Reaching the correct decisions - at the earliest time point - in the most efficient way Nov 18/09
LifeSciences Join our webcast as we discuss paperless clinical trials, covering the initiatives, the progress and what we have learned along the way
Speakers: Gail M. Farfel, Ph.D., President, Pharmaceutical & Regulatory Strategy, GM Group Consulting
Alison Shurell, Vice President, Life Sciences Product Marketing, IntraLinks
The Journey Toward Paperless Clinical Trials Nov 5/09
LifeSciences Learn about how drug development strategies are changing to keep pace with these discoveries
Speakers: Jeffrey Settleman, Ph.D., Laurel Schwartz Professor of Oncology, Scientific Director, Massachusetts General Hospital Cancer Center
Christine O’Day, Ph.D., Technical Director, In Vitro Pharmacology, MDS Pharma Services
Dan Rhodes, Ph.D., CEO, Compendia Bioscience
Advances in Oncology Drug Development: Linking Drug Response Phenotypes to Multiplex Molecular Signatures June 18/09
LifeSciences This web-based training class is geared to clinical program managers, clinical trial managers and directors of clinical trials to expand their understanding and to learn the intricacies involved in managing the Central Lab component of clinical trials through the APOLLO:RDA™
Speaker: Jennifer Trudel, Training Manager, MDS Pharma Services
Quality On Time™ results with APOLLO:RDA™ (Remote Data Access) Apr 23/09
LifeSciences Through case studies this webinar will introduce integrated approaches for data management, PK/PD analysis, reporting technology and automation to optimize drug development
Speakers: JF Marier, Ph.D., FCP, Vice President and Lead Scientist, Reporting and Analysis Services, Pharsight Corporation
Mark LJ Reimer, Ph.D., Senior Director, Reporting and Analysis Services, Pharsight Corporation
Combining Technology and PK/PD Expertise to Optimize Drug Development: A New Era for Collaborative Environments in Translational Medicine Apr 22/09
LifeSciences This webinar will feature an examination of the current status of the hemagglutination inhibition assay (HAI) as a surrogate test for evaluating serological status to influenza, both vaccines and natural infection
Speaker: Keith A. Gottlieb, PhD, Principal Scientist, Clinical Trials Department, Focus Diagnostics, Inc.
Influenza Options: HAI and Beyond Apr 14/09
LifeSciences A panel discussion of a flexible, cost effective approach for today's R&D and clinical supply leaders that accounts for the complexity of the global distribution of the clinical trial supplies
Speakers: Dr. Michael N. Eakins, Principal Consultant, Eakins & Associates
Martin Page, General Manager, Catalent Pharma Solutions
Andrew Willis, VP of Regulatory Affairs, Catalent Pharma Solutions
Phil Wilson, Director of Global Trade Operations, Supply Chain and Corp. Security, Catalent Pharma Solutions
Meeting the Challenges of Global Clinical Supply Chain Management Jan 27/09
Healthcare Healthcare Modeling is explained using the Archimedes Model, including its importance in defining inclusion and exclusion criteria to lower the risk of failure in clinical trials
Speaker: Peter Alperin, M.D., Medical Director, Archimedes
Healthcare Modeling Part 2: Simulation Modeling in Clinical Trial Design Jan 21/09
LifeSciences This presentation will address the recent regulatory initiatives in the U.S. and Europe and how safety registries can effectively be used as part of a risk management, riskMAP, or REMS program strategy
Speaker: Richard Gliklich, MD, President, Outcome
From Registries to REMS, Measuring Safety, Minimizing Risk, and Meeting New Regulatory Requirements Nov 6/08
LifeSciences Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis
Speakers: William Wheeler, MD, FACC, Global Medical Director, Centralized Cardiac Services, MDS Pharma Services
Michelle L. Combs, PhD, Vice President, Global Clinical Pharmacology, MDS Pharma Services
Nathan S. Teuscher, PhD, Director, PK/PD, MDS Pharma Services
Joy Olbertz, PharmD, PhD, Director, Cardiac Safety Services, MDS Pharma Services
Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis Nov 5/08
LifeSciences Find out in an exclusive webcast that brings together CROs and investigative sites to share their experiences managing study start-ups online
Speakers: Lee Ferrell, Director, Site Start Up, Quintiles, Inc.
Adam McFarland, ECMP, Business Systems Specialist, Copernicus Group IRB
Dave Espenshade, Vice President of Life Sciences, IntraLinks, Inc.
Site Activation: How to Reduce Costs and Shorten Study Start-up Time Oct 29/08
LifeSciences Learn about science-driven strategies for a successful First-in-Human trial
Speakers: Todd Johnson, MD, Senior Vice President, Early Stage Development, MDS Pharma Services
Robert F. Butz, PhD, Vice President, Medical & Scientific Affairs, Biovail
Michelle L. Combs, PhD, Vice President, Global Clinical Pharmacology, MDS Pharma Services
Gaetano Morelli, MD, Senior Director, Global Medical Affairs, MDS Pharma Services
First- In-Human Studies: Science-Driven Strategies Oct 23/08
LifeSciences Benefits of the Clinical Investigator Management Process System (CIMPS)
Speaker panel from CTMG, Inc. led by Anton Usala, M.D., CEO & Medical Director
CIMPS—A GMP Approach to Physician Site Management Enabling Clinical Trial Success (Regardless of PI Experience) Sep 19/07
LifeSciences This Adaptive Dose-Ranging Studies: an Evaluation with Recommendations from the PhRMA Working Group
Speaker: Dr. Jose Pinheiro, Director Biostatistics, Senior Modeler, Pharmacology Modeling and Simulation, Novartis Pharmaceutical
Adaptive Clinical Trials: Improving the Efficacy of Dose Finding Trials June 28/07
LifeSciences This The team from CRG will present three simple solutions to accelerating trial completion
Speakers: Lynn. S. Bachrach, President and CEO, CRG
Harry Bachrach, Principal and CFO, CRG
Vicky Rochford, Senior Vice President, CRG
Three Simple Solutions to Accelerating Trial Completion June 19/07
LifeSciences An examination of Electronic Data Capture (EDC), including the differences between EDC and eClinical, why the industry is shifting from EDC to eClinical, and the key benefits of implementing an eClinical platform
Speaker:David J. Laky, Vice-President & General Manager Clinical Data Applications, eResearchTechnology, Inc.
eClinical Delivers Solutions June 14/07
LifeSciences A case study that will include a discussion of site selection and recruitment strategies, the importance of patient advocacy support, regional differences and participant expectations, acknowledge and address barriers to participation & moral concerns, and retention strategies
Speakers: Lisa A. Ward, MPH Clinical Research Manager, Genzyme Corporation
Gail Adinamis, President, CEO, Clinical Resource Network, Inc.
Patient Retention in Orphan Drug Studies June 8/07
LifeSciences Current insights into the differences between Phase I versus Phases II-III and Phase IV cardiac safety testing. Discussion will also include common ECG collection practices at sites versus best practices, the impact of the TQT on Phase III programs, ECG data considerations beyond QTc, and how implementation of best practices ensures data quality and consistency and reduces data evaluation time.
Speaker: Jeffrey S. Litwin, M.D., F.A.C.C., Executive Vice -President, Chief Medical Officer, eResearchTechnology, Inc
Best Practices in Cardiac Safety Data Collection Before and After the Thorough QT Trial June 7/07
LifeSciences The collaboration of pharmaceutical, medical devices, and diagnostic testing companies in order to create innovative ways to administer drugs and increase patent lengths
Speaker: Wesley Wheeler, President, Valeant Pharmaceuticals
Alternative Methods of Drug Delivery June 4/07
LifeSciences Current insights into the ICH guidance and practical implications for implementation of the TQT
Speaker: Joel Morganroth, M.D., F.A.C.C., Chairman, Chief Scientist, eResearchTechnology, Inc.
ICH-E14 Two Years Later - Trends in Design & Conduct of a Thorough ECG Trial (TET) May 31/07
LifeSciences Strategies for accelerating patient recruitment
Speaker: Jim Kremidas, Global Enrollment Optimization, Eli Lilly
Peter DiBiaso, MHA, Director, Worldwide Development Operations, Pfizer Global Research & Development
Kenneth J. Tomaszewski, PhD, MS, SVP, Healthcare Research, Harris Interactive
Gail Adinamis, President, CEO, Clinical Resource Network, Inc.
Taking Clinical Trials and Patient Recruitment Global Nov 14/06

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