The Medical Product Development Enterprise: Past, Present & Future
Co-chairs: Charlie Gombar, ACDRS Director & Mike Dyszel, CSL Behring
Details
- Type Event
- Date -
- Time -
- Location University of California Washington Center Multipurpose Room, 1st floor
About
Must be registered in advance to attend.
Topics
- History of the pharmaceutical enterprise
- Development timelines
- Balancing bioinnovation and affordable access
- Artificial intelligence: emerging trends and enhanced productivity
- Principles of contemporary drug development and regulatory science
- Substantial evidence
- Patient-centered medical product development
- Pharmacoeconomics, health technology assessment, and methods for comparison of economic value for different products
- Drug pricing
- Intellectual property in drug discovery and development
- Regulatory pathways for drugs and biologics
- US FDA Drug Development Tool (DDT) qualification programs
- 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
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Speakers
- Kevin Bugin, MS PhD RAC, Head of Global Regulatory Policy and Intelligence, Amgen
- Michael Dyszel, Global Product Lead - Immunoglobulins, CSL Behring
- 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 of Medicine and Senior Fellow, Tufts Center for the Study of Drug Development, Tufts University
- Antti Kourula, MD MSc, Vice President and Head of Global Market Access, CSL (virtual)
- Leila Lackey, DEnv, Director, Patient Preference Evidence Generation, Pfizer
- Chris Leptak, MD PhD, Principal, Drug & Biological Products, ELIQUENT
- Juan Pinelli, MMS, Director, Digital Innovation Strategist R&D, Digital Innovation and Alliances, Pfizer
- Fortunato (Fred) Senatore, MD PhD FACC, Lead Physician, Division of Cardiology and Nephrology, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), US FDA
- Olivia D. Uitto, JD, Partner, Goodwin Procter LLP
Additional case study proctors
- Kofi Mensah, MD PhD, Director, Early Development, BMS
- Julie Mund, MS PhD, Director, Global Regulatory Affairs - Regional Regulatory - Americas, Eli Lilly