12:00 Registration

1:00    Welcome & Moderator's Opening Remarks
Sam Holtzman, Ph.D., Chief Executive Officer, Rosa Pharmaceuticals

1:15    How the Pharmaceutical Business Model is Evolving

• How is the pharmaceutical business changing?
• The challenge of developing valuable products less expensively
• What forward steps are pharmaceutical companies taking?
• What beyond a compound does a pharmaceutical company need to provide?

Bo Saxberg, M.D., Ph.D., President, DDO Strategic Services and former Vice President, Corporate Staff, Advanced Communications for Johnson & Johnson

2:00    Stratified Pharmaceutical Therapeutics Does Not Mean "Death to the Blockbuster"

• Scenario I: opportunity to “rescue” clinical compounds
• Scenario II: opportunity to “salvage” marketed compounds
• Scenario III: opportunity to increase market share in competitive markets

Stan Bernard, M.D., M.B.A., President, Bernard Associates and Senior Fellow - Health Care Systems Department, The Wharton School of Business

2:45    Networking Coffee Break

3:15    New Business Opportunities at the Intersection of Pharmaceuticals and Diagnostics: A Roche Case Study

• How pharmaceutical companies will reorganize in response to new diagnostics
• What pharmaceutical companies are doing to better understand their markets
• Lessons learned from mergers, acquisitions, and licensing of diagnostic technologies
• Using diagnostics as an integral part of clinical trials

Thomas A. Metcalfe, Senior Vice President, Business Development/Operational Excellence, Roche Molecular Diagnostics

3:45    Delivering on the Promise of Companion Diagnostics
With recent perspectives and/or guidelines from both the FDA and EU DIA regulatory bodies on Pharmacogenomics, the emerging field of Personalized Medicine (involving companion diagnostics) is rapidly gaining momentum. As the world's largest Diagnostics provider, Roche Diagnostics has taken a dedicated interest in this field and is applying its expertise to address the expressed needs of the Pharma industry. The key questions surrounding companion diagnostics will be discussed, including:

• The recent regulatory trends, both in the US and EU
• The current clinical environment and readiness to embrace this concept
• Some basic research into Pharma industry issues and interest vis-a-vis companion diagnostics
• The current Diagnostic readiness (infrastructure and scientific) to deliver on this promise
• New models for enabling an optimized outcome for all parties
• Practical means for implementing a diagnostic with a therapeutic, despite past hurdles for effective realization of Pharmacogenomics

Angus Hastie, Director, Marketing and Business Development, Roche Molecular Diagnostics

4:15    Pharmacogenomic Selection: A Method to Improve Benefit/Risk Ratios
Fragmentation of a market can be very positive. Although it may not be intuitively obvious, the ability to increase the benefit/risk of an expensive drug may not only encourage payor support, but also permit registration in markets that are otherwise closed. Pharmacogenomic profiling of diseases and drugs holds promise to allow the parallel development of diagnostics that will allow prescribers to select appropriate patients for each drug. Examples will be given for oncology as well as anti-inflammatory drugs.

John L. Ryan, M.D., Ph.D., Senior Vice President, Experimental Medicine, Wyeth Pharmaceuticals

5:15    Networking Reception Sponsored by

6:15     Close of Day One

Friday, April 23, 2004

7:45    Morning Coffee

8:15    Chairpersons Review of Day One
Sam Holtzman, Ph.D.

8:30 How do Pharmaceutical Companies Improve Profitability in Fragmented Markets? Moderator: Andrew F. Branca, Vice President and Senior Analysts, Cambridge Healthtech Advisors Panelists: Thomas A. Metcalfe, Senior Vice President, Business Development/Operational Excellence, Roche Molecular Diagnostics Amrit Ray, MD, MBA., Director, Strategic Management Group, Pfizer, Inc. Jeffrey S. Ross, M.D., Scientific Fellow Oncology Molecular Medicine, Millennium Pharmaceuticals, Inc.; Chairman Department of Pathology and Laboratory Medicine, Albany Medical College John L. Ryan, M.D., Ph.D., Senior Vice President, Experimental Medicine, Wyeth Pharmaceuticals Michael T. Stocum, M.S., Director, Business Development & Alliance Management, Human Biomarker Centers, GlaxoSmithKline R&D

9:15    Personalized Medicine: An Economic Dilemma?

• What are the goals of personalized medicine?
• What are the economic impacts from a payer and industry point of view?
• What are the implications and how to leverage these?

Peter Lauper, Ph.D., Worldwide Vice President for Health Economics, Pricing and Market Research, Johnson & Johnson, Raritan NJ

10:00  Networking Coffee Break

10:30  How will Pharmacy Benefit Managers Assess Pharmacogentic Testing?

• How will diagnostics affect coverage decisions, co-pays, formulary decisions and practice
   guidelines?
• What are the unique scientific and ethical hurdles that will need to be overcome before
   diagnostic tests are widely used?
• Will diagnostic testing be cost-effective and will the addition of PGx testing help to reduce
   annual increases in drug trend?
• How will HIPPA and privacy requirements affect this evolution?

Patricia Deverka, M.D., M.S., Vice President, Scientific Affairs, Medco Health

11:15  The Economic Ramifications of Stratified Pharmaceutical Therapeutics (SPT)?

• How will indemnity and managed-care models use diagnostics to structure formularies?
• What will be the balance between cost/adoption/utilization of diagnostics and
   pharmaceuticals?
• What outcomes metrics will be used to measure quality impact of diagnostic stratification for
   prescriptions?

David Parker, Ph.D, Vice President, Covance Health Economics and Outcome Services

12:00  Luncheon

1:00 Future Reimbursement and Regulation of New Therapeutics & Diagnostics Moderator:  Sam Holtzman, Ph.D., Chief Executive Officer, Rosa Pharmaceuticals Panelists:  Patricia Deverka, Vice President, Scientific Affairs, Medco Health Robert A. Freeman, Ph.D., Executive Director, Public Policy, AstraZeneca Pharmaceuticals LP Luis Gutierrez, General Manager, Covance Health Economics and Outcome Services Dolly Judge, Senior Director, Federal Regulations, Pfizer

2:30    Afternoon Refreshment Break

2:45    FDA PERSPECTIVE: Future Regulation of Pharmacogenomics -A Guidance for the Industry

David Feigal, M.D., Director, CDRH, Food & Drug Administration

3:30    CMS PERSPECTIVE: Medicare's Coverage Process in the Era of Pharmacogenomics

Sharad Mansukani, M.D., M.B.A., Medical Officer/Special Assistant, Centers for Medicare & Medicaid Services, Department of Health & Human Services (invited)