ACDRS 2024 Session 1 - The Medical Product Development Enterprise: Past, Present, and Future Perspectives

Wednesday, January 17, 2024 - 8:00 am to Friday, January 19, 2024 - 4:00 pm
University of California Washington Center (UCDC), 1st floor meeting room

1608 Rhode Island Ave NW, Washington DC

This is Session 1 of 6. Must register for the entire 2024 Course and not per session.

Session Co-chairpersons:
Charlie T. Gombar, PhD, ACDRS Director
Daniela Drago, PhD RAC FRAPS FTOPRA, Expert Consultant, NDA Partners


Daniela Drago, PhD RAC FRAPS FTOPRA Expert Consultant, NDA Partners
Michael Dyszel R&D Project Excellence Lead, CSL Bering
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 (FDA)
Jeremy Goldberg, MBA Operating Partner, Arsenal Capital Partners
Charlie T. Gombar, PhD ACDRS Director

Kenneth Kaitin, PhD

Professor and Senior Fellow, Tufts Center for the Study of Drug Development, Tufts University
David Macarios, MBA Vice President, Global Health Economics and Outcomes Research and RWE, Becton Dickinson

K. Kimberly McCleary

Founder and Chief Executive Officer, The Kith Collective, LLC
Hansjorg Sauer, PhD JD Deputy General Counsel and Vice President, Intellectual Property, Biotechnology Industry Organization
Fortunato (Fred) Senatore, MD PhD FACC Medical Officer, Division of Cardiovascular and Renal Products, CDER, US FDA
Mary T. Thanh Hai, MD Deputy Director, Clinical, Office of New Drugs, CDER, US FDA (virtual) (to be confirmed)
Liane Ong, MD PhD Lead Research Scientist, Institute for Health Metrics and Evaluation, University of Washington

Additional faculty - case study proctors

John Kelly, MD PhD FAAD Director, Discovery Medicine, Dermatology, GSK
Kofi Mensah, MD PhD Director, Early Clinical Development, BMS
Shira Perl, MD Executive Medical Director, AstraZeneca
Jorge Safi Jr., MD PhD Head, Patient Safety, Novartis
Islam Younis, PhD MS Senior Director, Cardiovascular and Metabolism TA Lead, Quantitative Pharmacology & Pharmacometrics, Merck


  • 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
  • Overview of drug pricing
  • Global health trends, disease management, and their effect on health outcomes
  • Regulatory pathways for drugs and biologics
  • Intellectual Property in Drug Discovery and Development
  • 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
  • Substantial evidence
  • International Council on Harmonization of Technical Requirements for Pharmaceutical for Human Use