ACDRS 2025 Session 1 - The Medical Product Development Enterprise: Past, Present, and Future Perspectives

Date: 
Wednesday, January 29, 2025 - 8:00 am to Friday, January 31, 2025 - 4:00 pm
Location: 
University of California Washington Center (UCDC), 1st floor meeting room

Full map

1608 Rhode Island Ave NW, Washington DC

This is Session 1 of 6. Must register for the entire 2025 Course and not per session.

Session Co-chairpersons:
Charlie T. Gombar, PhD, ACDRS Director
Daniela Drago, PhD RAC FRAPS FTOPRA, Expert Consultant, NDA Partners
Michael Dyszel, Project Excellence Lead, CSL Behring

Lecturers

Daniela Drago, PhD RAC FRAPS FTOPRA Expert Consultant, NDA Partners
Michael Dyszel R&D Project Excellence Lead, CSL Behring
Fortunato (Fred) Senatore, MD PhD FACC Medical Officer, Division of Cardiovascular and Renal Products, Office of New Drugs (OND), Center for Drugs and Evaluation Research (CDER), US Food and Drug Administration (FDA)
Christine Garnett, PharmD Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, Division of Cardiovascular and Renal Products, OND, CDER, US FDA
Charlie T. Gombar, PhD ACDRS Director

Kenneth Kaitin, PhD

 Professor and Senior Fellow, Tufts Center for the Study of Drug Development, Tufts University
Annie Kennedy Chief of Policy, Advocacy & Patient Engagement, EveryLife Foundation for Rare Diseases
David Morris, MD Vice Chancellor, Business Development, Partnerships, and Entrepreneurship, University of California, San Francisco
David S. Reasner, PhD

Division Director, Division of Clinical Outcome Assessment, ODE, OND, CDER, US FDA
Vanitha Sekar, MS PhD

Director, Division of Biomedical Informatics, Research & Biomarker Development, Office of Drug Evaluation Sciences, OND, CDER, US FDA (to be confirmed)
Brad Stolshek, PharmD Principal, Innopiphany
Olivia D. Uitto, JD Partner, Goodwin Procter
Sepideh Farivar Varon, PhD MPH Vice President, Head of Evidence Generation, Novartis

Additional faculty - case study proctors

to be confirmed  

Topics

  • History of the pharmaceutical enterprise
  • Development timelines
  • Principles of contemporary drug development and regulatory science
  • Patient perspectives in medical product development
  • Artificial intelligence disruption and impact on medical product development
  • US FDA Drug Development Tool (DDT) Qualification Programs
  • Pharmacoeconomics, health technology assessment, and methods for comparison of economic value for different products
  • Overview of drug pricing
  • 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