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Insights on Improving Global Drug Development from Bench to Commercialization

Pharmaceutical development is expensive, time consuming, and risky. Together, we can overcome these obstacles with clear goals, proactive planning and precision delivery to advance predictability and shorten timelines. 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.

Throughout the series, you’ll gain unique insights on expanding your drugs into new markets:

  • Solutions to mitigate overall development risk
  • Value of the target product profile and developing a sound regulatory strategy
  • Integration of safety and efficacy data through translational medicine
  • Five ways to reach your proof-of-concept milestones and maximize molecule value
  • Importance of companion diagnostics in clinical trial design

Who should attend? Chief Medical Officers, Chief Scientific Officers, Research & Development, Preclinical or Clinical Outsourcing, Medical/Regulatory Affairs and Business Development

May 14, 2014 (archived): Integrated Approach for Successful Drug Development

June 27, 2014 (archived): Starting with the End in Mind: Regulatory Strategy from the Beginning

September 17, 2014 (archived): Transitioning from Bench into Clinical Phase

November 4, 2014 (archived): Strategies and Operations for Early Clinical Development

December 3, 2014 (archived): Accelerating Drug Development through Companion Diagnostic Co-Development

For information about the archives for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

WEBINAR #1

Integrated Approach for Successful Drug Development

Modern pharmaceutical development is expensive, time consuming, risky and has a very high attrition rate. However, historically, governmental regulation used to be far more lax.

The presentation will discuss the unique aspects of pharmaceutical development while emphasizing that it is critical at all development stages to keep the end goal in mind. The development process itself is rarely linear. Factors that may increase the overall risk of a program will be discussed with examples from successful and unsuccessful programs that have dealt with these issues. Finally, the modalities by which a CRO can offer support to de-risk the overall development program will be discussed.

Date:
May 13, 2014

Speaker:
Eric Lang, MD, VP, Molecule Development Group, Covance

WEBINAR #2

Starting with the End in Mind: Regulatory Strategy from the Beginning

Although R&D spending on new drugs is high and the number of new INDs for small molecules and biologics continues to increase each year, the number of NDAs/BLAs submitted and approved by FDA has remained on average steady over the last 10 years. This is not limited to the US and speaks to the complexity of drug development and navigating the global regulatory environment. Successful drug development requires a clear plan that starts with the end in mind. A well developed regulatory strategy that takes into account what the global business objectives are and factors in the regulatory needs to achieve those goals compliments a clinical development plan.

The presentation will discuss the importance of having a regulatory strategy, the specific elements that are considered when developing a regulatory strategy and will explore in more detail the value of a Target Product Profile, importance of conducting Agency meetings and the challenges of a global patient database on drug approvals.

Date:
June 26, 2014

Speaker:
William Hanlon, PhD, VP, Head of Global Regulatory Affairs, Covance

WEBINAR #3

Transitioning from Bench into Clinical Phase

In over the decade, the pharmaceutical industry is continuing to face a number of challenges – high attrition rate, low productivity, patent expiry, rising costs of research and development, high regulatory hurdles, increasing concern about adverse side effects. It has also become clear that the traditional business model of pharmaceutical companies is no longer sustainable. The pharmaceutical companies are now seeking to find better ways to reduce operational costs, increase output of new drugs through innovation within research and development. Drug research and development is a dynamic process, requiring integration of activities across a number of preclinical scientific disciplines for successful progression of therapeutic candidates.

The presentation will review the deep analysis data of what are the critical challenges in pharmaceutical R&D and highlight how innovative approaches can help to overcome these challenges. Dr. Yan will also share some cases to illustrate how Covance applied its “Seamless and Strategic Approach” to help its partners to bring the miracles of medicine to market sooner.

Date: September 17, 2014

Speaker:
James Yan, PhD, MD, DABT, Executive Director, Early Development, Covance

WEBINAR #4

Strategies and Operations for Early Clinical Development

Demonstrating your compound's proof-of-concept is an important developmental milestone. If you can show compelling, valid data supporting the safety, efficacy and commercial potential of your molecule at this stage, you can:

  • Optimize the market value of your compound
  • Enhance your ability to meet your drug development goals
  • Meet the demands of regulators, providers and patients

As R&D expenditures in Asia-Pac continue to increase, Dr. Gries’ presentation will examine the five ways to maximize molecule value. He will provide practical advice on reaching your proof-of-concept milestones.

  • Medicalization of early phase clinical development
  • Biomarkers and pharmacogenomics
  • Risk-based drug development
  • Commercial valuation
  • Working with external partners

Date: November 4, 2014

Speaker:
Jean-Michel Gries, PharmD PhD MBA FCP, VP & GM, Early Clinical Development, Covance

WEBINAR #5

Accelerating Drug Development through Companion Diagnostic Co-Development

The past decade has seen a transition from the traditional model of drug development to a more targeted, personalized approach to drug development and clinical trial design. The use of a companion diagnostic strategy is increasingly an essential component of the drug development process where it facilitates optimal patient stratification and outcome management. Parallel development of the drug and its companion diagnostic assay affords simplified logistics, economies of scale and the potential to accelerate the drug development process through optimal patient selection. The application of the companion diagnostic within the corresponding drug trial also provides valuable insight into the use of the companion diagnostic in a clinical setting and produces valuable data to support the regulatory filing of both the drug and the companion diagnostic.

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.

Date: December 3, 2014 

Speaker:
Mark Roberts, PhD, Director, Diagnostics Development, Covance

ABOUT THE SPEAKERS

Eric Lang, MD, VP, Molecule Development Group, Covance

Dr. Eric Lang is Vice President with the Molecule Development Group (MDG), a dedicated globally-focused drug development group that can work with clients through the various stages of drug development. MDG is focused on molecules entering into or already in the clinical phases of drug development and creates value by providing strategy and navigating to achieve drug development milestones.

Dr. Lang has more than 17 years of experience in drug development in the pharmaceutical industry in both large and small pharma. His experience includes leading drug development teams that have successfully filed NDAs, directing clinical operations, clinical development, pharmaceutical business development, and designing, planning, and directing regulatory strategies. Dr. Lang has negotiated with the FDA regarding clinical and regulatory development programs for drug and device approvals.

Prior to working at Covance, Dr. Lang was Vice President, Head of Clinical Development for Grünenthal USA Inc. Before that he was Vice President of Clinical Research at Javelin Pharmaceuticals and also held positions of Head of Clinical Research and Development at Novartis Consumer Health, Pain and Executive Director of Licensing and New Business Development at Johnson and Johnson.

Dr. Lang received his M.D. from Ben Gurion University of the Negev in Beer Sheba, Israel. He completed a fellowship in Clinical Research and in Acute and Chronic Pain at Emory University Medical School in Atlanta, Georgia. He is a board certified Anesthesiologist and Pain Management Specialist and has been published in many peer-reviewing research papers as well as book chapters and review articles.

William Hanlon, PhD, VP, Head of Global Regulatory Affairs, Covance

Dr. Bill Hanlon is Vice President and Head of the Global Regulatory Affairs organization which includes the, Regulatory Strategy, Regulatory Submissions and Medical/Regulatory Writing & Publishing groups. Global Regulatory Affairs at Covance provides clients with a broad array of regulatory services to support the planning, development, reviewing, publishing and submission of regulatory documents to Health Authorities to support clinical trials, agency interactions and marketing applications globally. He and his group are also responsible for advising clients on global, regional or local regulatory strategy associated with pre-clinical or clinical study design, regulatory agency interactions, as well as for complete drug development programs. Bill and his team work with and advise internal cross-functional molecule development teams as well as external clients.

Prior to joining Covance, Dr. Hanlon was Vice President and Head of Global Regulatory Affairs at Archimedes Pharma in Bedminster, NJ where he led a team of regulatory professionals in the US and EU providing complete regulatory support for their flagship pain product, product lifecycle management, and molecules in their development pipeline. Prior to joining Archimedes Pharma, Dr. Hanlon spent more than 23 years at Merck Research Laboratories in Rahway, NJ. The first 14 years were in discovery research working on novel immunological and inflammatory targets, and the remainder of his time was in World-wide Regulatory Affairs developing regulatory strategy and leading Regulatory Authority interactions globally for internal drug development programs. Dr. Hanlon s final position at Merck was as the regulatory Therapeutic Area Co-Leader for the Cardiovascular/Atherosclerosis Franchise developing products for treatment of hypercholesterolemia, hypertension, atrial fibrillation, thrombosis and heart failure. During his tenure at Merck, Dr. Hanlon also led a late stage CV/Athero drug development team advancing double and triple combination products through the drug development process.

Dr. Hanlon received his PhD in biochemistry and cell biology jointly conferred from the University of Medicine and Dentistry of New Jersey (UMDNJ) and Rutgers Graduate School in Piscataway, NJ. He completed his post doctoral training at Merck Research Laboratories in Rahway, NJ.

James Yan, PhD, MD, DABT, Executive Director, Early Development, Covance

Dr. James Yan is Site Lead and Executive Director of Covance Early Development (ED) Shanghai Site and Covance Pharmaceutical R&D (Shanghai) Co., Ltd. James is responsible for all activities of Covance ED business in Shanghai.

James has over 20 years of research experience in academics and the pharmaceutical industry with extensive training in the fields of Pharmacology, Toxicology, Molecular Biology, and Oncology. He started his career in industry with Pharmacia and was responsible for the development of a variety of new technologies for drug safety evaluation and non-clinical safety assessments. Then he worked in Pfizer and Hospira, where he headed toxicology group and focused on toxicology programs supporting drug development and regulatory submissions. James has over 12 years working experiences in non-clinical safety assessment of both small molecules and biologics in drug research and development. He is well versed in multiple industry regulations such as FDA, EMEA, CFDA, OECD, ICH as well as other international guidelines for drug development. In 2009, James moved back to China and serviced as the head of Drug Safety Evaluation in Hutchison MediPharma. Over the course of his career, he was involved in IND and NDA filings for multiple drug candidates and gained substantial experience working with global regulatory agencies, including the US FDA, EMA and China FDA (CFDA).

James received his PhD degree from Peking Union Medical University in China and did his post-doctoral training at the Ben-May Institute for Cancer Research, University of Chicago in the United States. He is a Diplomate of the American Board of Toxicology (DABT).

Jean-Michel Gries, PharmD PhD MBA FCP, VP & GM, Early Clinical Development, Covance

Dr. Jean-Michel Gries is Vice President and GM of Early Clinical Development, an organization dedicated to help companies achieve their major clinical and investment decision through efficient Proof-of-Concept and early in-patient studies.

Prior to joining Covance, Dr. Gries was the Head of R&D for pharmaceutical products at Alcon (a Novartis Company), in which capacity he led the transformation of the organization to support more innovative mechanism of actions for the treatment of ocular diseases. Prior to Alcon, Dr. Gries was the US Head of Clinical Pharmacology for Hoffmann-La Roche. Dr. Gries started his career as a director of clinical pharmacology at Aventis (and predecessor companies), in Bridgewater, NJ. Dr. Gries has lead compound development across both early stage (with over 300 INDs) and late stage (13 NDAs, 7 ANDAs) and across a broad set of disease areas including Oncology, Inflammation and Pain, CNS, Metabolism, Cardio-Renal, Anti-Infectives (including HIV and HCV), Dermatology, Ophthalmology, Genito-Urinary and GastroEnterology.

As a business executive, Dr, Gries helped create 9 companies (2 of which are now public) via 26 assets acquisition and led them early on, in a Venture Capital company specialized in the creation and incubation of Biotechnology startups. He has extensive licensing experience from both Roche (member of the licensing committee) and Aventis (Oncology and CNS licensing committee) and Alcon (Board level). Dr. Gries also served on private companies and Not For Profits Boards of Directors.

Dr. Gries is the author of more than 30 papers and communications. He has been a fellow of the American College of Clinical Pharmacology since 2001, served on its Finance Committee and on its Board of Regents, and is a reviewer for JCP. He is also a member of ASCPT, ASCO, and AAO.

Dr. Gries received his PhD in Pharmacokinetics and applied mathematics, and his PharmD from the University Rene Descartes (Paris V) in France, his PhD in Analytical chemistry and his Master in Statistics, Computer sciences and Epidemiology from University Paris XI, and his MBA from the Wharton School at the University of Pennsylvania.He completed his post doctoral training at the University of California, San Francisco.

Mark Roberts, PhD, Director, Diagnostics Development, Covance

Dr Roberts received his PhD in Pharmaceutical Sciences from the University of Nottingham (UK) and has worked in the clinical diagnostics arena for over 20 years holding senior positions in both the in vitro diagnostic and reference laboratory industries. He joined Covance at the end of 2012 to spearhead the company's companion diagnostics program which is designed to assist pharmaceutical and diagnostic companies in drug / companion diagnostic co-development.

ABOUT COVANCE

Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 12,000 employees in more than 60 countries. Covance has the people, processes, client service, and global resource capabilities to respond to biotechnology and pharmaceutical clients' toughest drug development challenges.

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