Session 1: September 10-13, 2007
The Pharmaceutical Development Enterprise: Current and Future Perspectives
Session Co-Leaders: Fritz Buhler, MD, University of Basel; Thaddeus Grasela, PharmD, PhD, Cognigen Corporation; and Sean Tunis, MD, MSc, Center for Medical Technology Policy
Session Chairs: Fritz Buhler, MD, University of Basel; Bruce Burlington, MD, Independent Consultant; Thaddeus Grasela, PharmD, PhD, Cognigen Corporation; Robert O'Neill, PhD, Food and Drug Administration; and Sean Tunis, MD, MSc, Center for Medical Technology Policy
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.
Frontiers in Drug Development and Regulatory Science Series: Impact of the IOM Safety Report, FDA Critical Path Initiative and PDUFA IV upon the Drug Development and Regulatory Review Processes on September 13.
- Introduction to the Principles of Contemporary Drug Development and Regulatory Science
- Overview of the Global Drug Development Enterprise
- Development Time Lines Today and Tomorrow
- The Drug Development Deficits
- The Value of Target Product Profiles in Discovery and Development
- How to Balance an R&D Portfolio
- The Economics and Probabilities of Drug Development
- Impact of Health Technology Assessment on Drug Development and Commercialization
- How are drugs and biologics paid for by public and private payers in the US?
- Global Trends in Healthcare Delivery and Financing
- Comparative Effectiveness Research as the Basis for Drug Plan Formulary Development
- Overview of the Biopharmaceutical Industry
- Introduction to Model-based Development
- Virtualization of the Drug Development Process
- Overview of the Global Regulatory Environment: What Do the Regulators Review and Approve?
- Management Science: Portfolio, Program and Project Teams
- Keynote Address: What Will 2012 Look Like?
- The FDA Critical Path and Opportunities List
- The EMEA Roadmap 2010 Initiative
- The IOM Safety Report and the Current Safety Environment
- FDA Response to IOM Report
- Impact of the IOM Report and Emerging Safety Tools
- Understanding Drug Safety through Active Surveillance
- How We Need to Understand Drug Benefits and Balance Risks
- PDUFA IV, US Good Review Management Practices, Regulatory Interactions and Submissions over the Next Five Years
Frontiers Workshop
Teaching Faculty
Christopher Adams, PhD, Federal Trade Commission
Steve Arlington, PhD, PricewaterhouseCoopers
Alasdair Breckenridge, FRSE, FMedSci, Medicines and Healthcare Products Regulatory Agency
Jeffrey Brown, PhD, Harvard Medical School / Harvard Pilgrim Health Care
ShaAvhrée Buckman, MD, PhD, FAAP, Food and Drug Administration
Fritz Bühler, MD, University of Basel
D. Bruce Burlington, MD, Wyeth
Jon Court, PhD, Fulcrum Pharma Plc.
Susan Cummins, MD, Food and Drug Administration
Gerald Dal Pan, MD, Food and Drug Administration
Patricia Evans, PhD, Consultant
Ellen Feigal, MD, University of California, San Francisco
Charles Gombar, PhD, Wyeth
Thaddeus Grasela, PhD, Cognigen Corporation
Charles Grudzinskas, PhD, NDA Partners LLC
Fred Hassan, MBA, Schering-Plough
John Jenkins, MD, FCCP. FDA
Kenneth Kaitin, PhD, Tufts University
Argeris Karabelas, PhD, Care Capital
David Korn, MD, Association of American Medical Colleges
Newell McElwee, PharmD, MSPH, Pfizer
Robert O’Neill, PhD, Food and Drug Administration
Carl Peck, MD, University of California, San Francisco
Sebastian Schneeweiss, MD, ScD, Harvard Medical School and Harvard School of Public Health
Jayson Slotnik, Hogan & Hartson LLP
Thomas Szucs, MBA, MPH, LLM, University of Basel
Sean Tunis, MD, MSc, CMTP, Center for Medical Technology Policy
Janet Woodcock, MD, Food and Drug Administration
