ACDRS 2023 Session 1 - The Medical Product Development Enterprise: Past, Present, and Future Perspectives

Date: 
Wednesday, January 25, 2023 - 8:00 am to Friday, January 27, 2023 - 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 course and not per session.

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

Lecturers

Daniela Drago, PhD RAC FRAPS FTOPRA  Expert Consultant, NDA Partners
Michael Dyszel  Vice President, Product Development Leader, Pyxis Oncology
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)
Charlie T. Gombar, PhD ACDRS Director
Dionna Green, MD FCP Director, Office of Pediatric Therapeutics, Office of Clinical Policy and Programs, Office of the Commissioner, US FDA

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

Bernard Munos

 Senior Fellow, FasterCures
Sally Okun, RN MMHS Executive Director, Clinical Trials Transformation Initiative, Duke University
Fortunato (Fred) Senatore, MD PhD FACC Medical Officer, Division of Cardiovascular and Renal Products, CDER, US FDA
Mirat Shah, MD Medical Oncologist and Clinical Reviewer, Office of Oncologic Diseases, CDER, US FDA
Mary T. Thanh Hai, MD Deputy Director, Clinical, Office of New Drugs, CDER, US FDA (virtual) (to be confirmed)
Theo Vos, MD PhD Professor of Global Health, Institute for Health Metrics and Evaluation, University of Washington

Additional faculty - case study proctors

Gideon Blumenthal, MD Vice President Oncology Global Regulatory Affairs, Merck
Maria Jison, MD Executive Director Clinical Development/Global Clinical Head - Fasenra, Astrazeneca
Kofi Mensah, MD PhD Director, Early Development, Bristol Myers Squibb
Ki Milligan, MD Director, Pediatric Center of Excellence, Global Drug Development, Novartis
Jorge Safi, MD PhD Senior Global Program Safety Lead, Novartis

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
  • 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
  • Special topics based on cutting edge science, changing regulations, controversies, etc.