Session 1: September 30 - October 2, 2009 (Washington, DC)
The Pharmaceutical Development Enterprise: Current and Future Perspectives
Session Co-Leaders: Fritz Buhler, MD, University of Basel; and Thaddeus Grasela, PharmD, PhD, Cognigen Corporation
Session Chairs: Fritz Buhler, MD, University of Basel; Ellen G. Feigal, MD, University of California, San Francisco; and Thaddeus Grasela, PharmD, PhD, Cognigen Corporation
Principles and organization of global pharmaceutical research and label-driven product development. Future directions of global pharmaceutical and health economics and business environments, and their implications for drug selection, drug development, regulatory and business evaluations. Innovation in discovery and development as a response to medical and market needs. Health economics and disease management and their application in the changing health care environment. Patenting of new chemical and biological compounds.
- Introduction to the Principles of Contemporary Drug Development and Regulatory Science
- Forward Perspective of Global Drug Development and the Pharma Enterprise
- The Drug Development Deficit
- Development Time Lines Today and Tomorrow
- Emergence of Regulation in US, Europe and Asia
- Development of Drugs in the Safety Environment Post FDAAA
- The Obamacare to Come
- The Future of Drug Development in an Increasingly Evidence-based Environment
- What Will 2014 Look Like?
- Overview of the Major Decision Points in the Drug Discovery, Development and Regulatory Process
- Model-supported versus Model-based Development: Implications for Leading and Governing R&D Programs
- Trends in Venture Capital
- What Will it Take to be Pharma Enterprise CEO of the Future?
- The Quantitative Systems Pharmacology Journey: Seeing Drug Discovery and Development Through New Eyes
- The Value of Target Product Profiles in Discovery and Development
- Management Science: Portfolio, Program and Project Teams
- How are Drugs and Biologics Paid for by Public and Private Payers in the US?
- Comparative Effectiveness Research as the Basis for Drug Plan Formulary Development
- Impact of Health Technology Assessment on Drug Development and Commercialization
- Third-Generation Portfolio Management
Case Studies
- Target Product Profile
- Value Driven Pricing and Reimbursement
Teaching Faculty
Sandra RB Allerheiligen, PhD, Eli Lilly
Steve Arlington, PhD, PricewaterhouseCoopers
Fritz Bühler, MD, University of Basel
Patricia Evans, PhD, Consultant
David W. Feigal Jr, MD, MPH, Elan
Ellen Feigal, MD, University of California, San Francisco
Thaddeus Grasela, PhD, Cognigen Corporation
Charles Grudzinskas, PhD, NDA Partners LLC
John Jenkins, MD, FCCP, Food and Drug Administration
Argeris Karabelas, PhD, Care Capital
Carl C. Peck, MD, University of California, San Francisco
Sebastian Schneeweiss, MD, ScD, Harvard Medical School, Harvard School of Public Health and Brigham and Women's Hospital
Jayson Slotnik, JD, Hogan & Hartson LLP
Michael D. Tanner, Cato Institute
Jonothan C. Tierce, CPhil, IMS Consulting
P. Roy Vagelos, MD, Retired Chairman and CEO, Merck & Co., Inc.
Reginald D. Williams II, Avalere Health
