Session 1: October 20-23, 2008 (San Francisco, CA)

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; Bruce Burlington, MD, Independent Consultant; Thaddeus Grasela, PharmD, PhD, Cognigen Corporation; and Julian Gray, MD, PhD, MBA, Neuroglobe LLC

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: Meeting the Regulators on October 23.

Lectures

• Introduction to the Principles of Contemporary Drug Development and Regulatory Science
• The Drug Development Deficits
• Development Time Lines Today and Tomorrow
• The IOM Report on 'Drug Safety' and FDA Science Board Subcommittee on Science and Technology Report 'FDA Science and Mission at Risk': Where are We Now?
• The Value of Target Product Profiles in Discovery and Development
• Overview of the Major Decision Points in the Drug Discovery, Development and Regulatory Process
• What Will 2013 Look Like?
• Introduction to Model-based Development
• A Systems Biology View of Drug Development
• The Economics of New Drug Development
• Forward Perspective of Global Drug Development and the Pharma Enterprise
• Trends in Venture Capital
• What Will it Take to be Pharma Enterprise CEO of the Future?
• The Needs of Health Care Delivery Systems in the Future
• 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?
• Comparative Effectiveness Research as the Basis for Drug Plan Formulary Development
• Third-Generation Portfolio Management
• Management Science: Portfolio, Program and Project Teams


Frontiers Workshop
• FDA's Critical Path Initiative
• The European Medicines Agency (EMEA) Roadmap 2010 Initiative
• Stumbling Blocks in European Regulation
• Impact of the IOM Report, 2007 FDAAA Legislation and Emerging Safety Tools
• US Good Review Management Practices, Regulatory Interactions and Submissions over the Next Five Years
• Industry View on Today's Regulation
• How We Need to Understand Drug Benefits and Balance Risks

Case Studies

• Target Product Profile
• Value Driven Pricing and Reimbursement

Teaching Faculty
Christopher Adams, PhD, Federal Trade Commission
Steve Arlington, PhD, PricewaterhouseCoopers
Anthony Barrueta, JD, Kaiser Foundation Health Plan
Leslie Z. Benet, PhD, University of California, San Francisco
Alasdair Breckenridge, FRSE, FMedSci, Medicines and Healthcare Products Regulatory Agency
Fritz Bühler, MD, University of Basel
D. Bruce Burlington, MD, Wyeth
Patricia Evans, PhD, Consultant
Hans-Georg Eichler, MD, European Medicines Agency
David W. Feigal Jr, MD, MPH, Elan
Ellen Feigal, MD, University of California, San Francisco
Rodney Ferguson, PhD, Panorama Capital
Mikhail Gishizky, PhD, Entelos
Thaddeus Grasela, PhD, Cognigen Corporation
Charles Grudzinskas, PhD, NDA Partners LLC
Fred Hom, MD, Kaiser Permanente
Judith K. Jones, MD, PhD, The Degge Group
Malcolm Lloyd-Smith, MSc, Cadence
Theresa Musser, PhD, Rigel
Eleanor Perfetto, PhD, Pfizer
Jeffrey N. Siegel, MD, Food and Drug Administration
Carl Peck, MD, University of California, San Francisco
Jayson Slotnik, JD, Hogan & Hartson LLP
P. Roy Vagelos, MD, Retired Chairman and CEO, Merck & Co., Inc.
Raymond L. Woosley, MD, PhD, Critical Path Institute

The University of California, San Francisco, CA 94143, 415/476-9000
Copyright © 2009, The Regents of the University of California.