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

Kevin Bugin, PhD MS Head of Global Regulatory Policy and Intelligence, Amgen
Daniela Drago, PhD RAC FRAPS FTOPRA Expert Consultant, NDA Partners
Michael Dyszel R&D Project Excellence Lead, CSL Behring
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
Murray (Mac) Lumpkin, MD MSc

Lead for Global Regulatory Systems Initiatives, Regulatory Affairs, Global Health | Integrated Development, Gates Foundation
David Morris, MD Vice Chancellor, Business Development, Partnerships, and Entrepreneurship, University of California, San Francisco (UCSF)
Carl C Peck, MD Adjunct Professor, Bioengineering and Therapeutic Sciences, School of Pharmacy, UCSF
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

Kofi Mensah, MD PhD Director, Early Clinical Development, BMS
Ki Lee Milligan, MD Executive Director, Pediatric Center of Excellence, Global Drug Development, Novartis
Jorge Safi Jr., MD PhD Head, Patient Safety, Novartis
Liudmila Schafer, MD FACP Associate Director of Clinical Development, MacroGenics
Sule Yavuz, MD   Global Program Clinical Lead, Immunology, AstraZeneca

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