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April 22, 2009
Combining Technology and PK/PD Expertise to Optimize Drug Development: A New Era for Collaborative Environments in Translational Medicine
Speakers for this event:
  • JF Marier, Ph.D., FCP, Vice President and Lead Scientist, Reporting and Analysis Services, Pharsight Corporation Learn More
  • Mark LJ Reimer, Ph.D., Senior Director, Reporting and Analysis Services, Pharsight Corporation  Learn More

Combining Technology and PK/PD Expertise to Optimize Drug Development:
A New Era for Collaborative Environments in Translational Medicine

Developing a new drug remains a costly and risky endeavor.  In today’s challenging economic climate, at a time when development costs and timelines continue to skyrocket, effective use of technology, collaborative environments with multiple vendors and scientific expertise can help sponsors save money and shorten the overall development process for new drug approval.

 

This webinar will introduce integrated approaches for data management, PK/PD analysis, reporting technology and automation to optimize drug development. Collaborative platforms for efficient translational medicine activities will also be presented.

 

Through a series of case studies, this webinar will provide an overview of approaches and tools used by Pharsight in the drug development process for:

  • Preclinical analysis and modeling to support first-in-human dose selection
  • Phase I/II study analysis and reporting to support efficient protocol design
  • Population PK/PD modeling to support program decision-making
  • Regulatory submissions, CDISC and data transfer

The case studies will be supplemented with data and insights from drug development organizations on challenges and opportunities for efficient clinical study design, execution and analysis.

THIS PROGRAM IS INTENDED FOR:

  • Directors/VPs of Research & Development

  • Directors/VPs of Clinical Operations

  • Directors/VPs of Clinical Development or Clinical Research

  • Outsourcing Directors/Managers

  • Chief Medical Officers / Medical Directors

  • Chief Scientific Officers

  • Directors of Clinical Pharmacology

  • Directors of Drug Development

  • Directors of Clinical Pharmacokinetics/Pharmacodynamics

  • Directors of Preclinical/ADME/Tox

  • Executives involved in Translational Medicine

  • Presidents and CEOs

For Biotech and Pharmaceutical companies

ABOUT OUR SPEAKERS:

JF Marier, Ph.D., FCP, Vice President and Lead Scientist, Reporting and Analysis Services Pharsight Corporation 

Dr. Marier has been involved in hundreds of studies in early clinical research. He directs PK/PD analyses and reporting of results using noncompartmental and population approaches of drugs in various phases of development and in specific populations (pediatric/geriatric, renal/liver impaired). His expertise includes scientific and regulatory consultation on drug development programs for small and large molecules, particularly in the therapeutics areas of oncology, inflammation, immunosuppressants, cardiovascular, infection and metabolic diseases. Dr. Marier has authored or co-authored more than 30 manuscripts and book chapters in the field of pharmacokinetics, and has leveraged PK/PD modeling and simulation to build and optimize development programs for dozens of industry sponsors.

Mark LJ Reimer, Ph.D., Senior Director, Reporting and Analysis Services,  Pharsight Corporation  

Dr. Reimer is an experienced leader in the development of new drug therapies with

20 years of scientific, managerial and executive responsibilities in the field of preclinical drug research, including ADME-Tox and bioanalysis. His experience includes the design, execution and interpretation of a wide variety of preclinical services used in the pharmaceutical and biotechnology industries to bring new molecular entities through the drug development process. He has led preclinical research efforts at a major Canadian biopharm company, and was responsible for the inception, build-out, and consistent profitability of the drug metabolism unit at one of the world’s top-five contract research organizations.

ABOUT OUR SPONSORING PARTNER:

Pharsight® software products and scientific consulting services facilitate improved productivity and strategic decision making in drug development. Pharsight’s Reporting and Analysis Services (RAS) group is a highly skilled team of pharmaceutical scientists, biostatisticians, and technical experts committed to providing high-quality, regulatory-compliant PK/PD analysis, biostatistics, and reporting for new drug approval.

 

RAS scientists make use of Pharsight’s industry-leading software tools to provide analyses, data management and report writing for preclinical and clinical studies to support sponsor's new drug approval submissions. RAS serves all major drug development geographies, with business representatives in the United States, Europe, and Japan. RAS scientists bring experience to Pharsight representing more than 400 client engagements in the past several years. All RAS work is executed to the highest professional standards, in minimum time, at competitive rates.

 

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

 
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