ACDRS 2022 Session 1 - The Medical Product Development Enterprise: Past, Present, and Future Perspectives

Date: 
Monday, January 24, 2022 - 10:00 am to Friday, January 28, 2022 - 3:00 pm
Location: 
virtual/online

This is Session 1 of 6. Must register for the entire course and not per session.

Session Co-chairpersons:
Charlie T. Gombar, PhD, ACDRS Director
Carl C. Peck, MD, Adjunct Professor, University of California, San Francisco

Lecturers

Daniela Drago, PhD RAC Senior Director, Global Safety & Regulatory Sciences, Biogen
Michael Dyszel Senior Director, Global Program Head, TA POE & CSR, Bayer US LLC
Ellen G. Feigal, MD Partner, NDA Partners LLC
Christine Garnett, PharmD Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, Division of Cardiovascular and Renal Products, Center for Drugs and Evaluation Research (CDER), US Food and Drug Administration
Charlie T. Gombar, PhD ACDRS Director
Brett Giroir, MD Former Assistant Secretary for Health and Admiral, US Public Health Service Commissioned Corps

Kenneth Kaitin, PhD

 Professor and Senior Fellow, Tufts Center for the Study of Drug Development, Tufts University
David Macarios, MBA Head, Health Economics and Outcomes Research and Payer Engagement, EMD Serono

Bernard Munos

 Senior Fellow, FasterCures
Sally Okun, RN MMHS Executive Director, Clinical Trials Transformation Initiative, Duke University
Fred Senatore, MD PhD FACC Medical Officer, Division of Cardiovascular and Renal Products, CDER, US Food and Drug Administration
Brian Tseng, PhD MD Vice President, Clinical Development Neurology, Vertex Cell & Gene Therapy
Theo Vos, MD PhD Professor of Global Health, Institute for Health Metrics and Evaluation, University of Washington
Janet White, MBA MA Portfolio & Platform Lead - Pneumonia, HPV and Neglected Tropical Diseases, Bill & Melinda Gates Foundation

Additional faculty - case study proctors

Breena Berte, MSS MEd Deputy Joint Lead, Joint Assisted Acquisition, US Department of Defense (JPEO-CBRND)
Bryan McGill, MD PhD Translational Medicine Expert, Neuroscience, Novartis Institutes of Biomedical Research
Kofi A. Mensah, MD PhD Director, Early Clinical Development, Bristol Myers Squibb
Jorge Safi Jr., MD PhD Head, Patient Safety - Ophthalmology, Medical Safety/Global Drug Development, Novartis
Gary Skiles, PhD Independent Consultant
Alice Wang MD Director, Translational Development Clinical Pharmacology, Bristol Myers Squibb

Topics

  • History of the pharmaceutical enterprise
  • Development timelines
  • Principles of contemporary drug development and regulatory science
  • Patient perspectives in medical product development
  • Pharmacoeconomics, health technology assessment, and methods for comparison of economic value for different products
  • Global health trends, disease management, and their effect on health outcomes
  • Regulatory pathways for drugs and biologics
  • Regulatory landscape and development challenges in pediatric, cell and gene therapies, and novel treatment modalities
  • Special topics based on cutting edge science, changing regulations, controversies, etc.
  • Decision points in development of small and large molecules
  • Management science: Portfolio, projects, and teams
  • Target product profile: A key strategic tool in product development