VENUE ONE:
March 1-2, 2004, Westin Hotel, Princeton, NJ

7:15    Registration & Morning Coffee

8:15    Welcome & Moderator's Opening Remarks

Sam Holtzman, Ph.D., Chief Executive Officer, Rosa Pharmaceuticals

8:30    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

9:15    Implications of Pharmacogenomics for R&D Organization and Efficiency

• Which pharmacogeomics activities promise the greatest, and least, return on investment?
• How are pharma R&D organizational structures changing in response to pharmacogenomics?
• What impact will pharmacogenomics have on efforts to improve R&D efficiency?
• How do expections differ between researchers and management?

Andrew F. Branca, Vice President and Senior Analyst, Cambridge Healthtech Advisors

10:00  The Impact of Diagnostics on both Drugs in Development & Products On the Market

• Pharmaceutical market opportunities and threats arising from the personalization of therapies
• Determining the value of diagnostic products that stratify pharmaceutical therapeutics
• Proactive and reactive strategies in view of new stratified markets
• The effect of an aging population on market fragmentation
• Therapeutic categories where diagnostics define markets

Cavan M. Redmond, Executive Vice President & General Manager, BioPharma Business Unit, Wyeth Pharmaceuticals

10:45  Networking Coffee Break

11:15  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

11:45  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

12:15  Luncheon

1:45 How do Pharmaceutical Companies Improve Profitability in Fragmented Markets? Moderator: Andrew F. Branca, Vice President and Senior Analyst, Cambridge Healthtech Advisors Panelists: Stan Bernard, MD, MBA, President, Bernard Associates and Senior Fellow - Health Care Systems Department, The Wharton School of Business Thomas A. Metcalfe, Senior Vice President, Business Development/Operational Excellence, Roche Molecular Diagnostics, Kim Slocum, Director, Strategic Planning & Business Development, AstraZeneca Pharmaceuticals Michael T. Stocum, M.S., Director, Business Development & Alliance Management, Human Biomarker Centers, GlaxoSmithKline R&D

3:15    Afternoon Refreshment Break

3:30    The Future of Stratified Pharmaceutical Therapeutics
• Can the pharmaceutical industry's mental model of market success be changed?
• What will be the challenges in convincing consumers of the value of these products?
• What are the likely barriers to physician adoption of this new modality?
• How are payors thinking about the role of new diagnostics in redefining appropriate utilization
   and reimbursement of focused pharmaceuticals?

Kim Slocum, Director, Strategic Planning & Business Development, AstraZeneca Pharmaceuticals

4:15    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

5:00    Close of Day One

 

Tuesday, March 2, 2004

7:30    Morning Coffee

8:00    Chairpersons Review of Day One
Sam Holtzman, Ph.D.

8:15    MORNING PANEL: Future Reimbursement and Regulation of New Therapeutics & Diagnostics Moderator: Sam Holtzman, Ph.D. Panelists: Patricia Deverka, Vice President, Scientific Affairs, Medco Health Robert A. Freeman, Ph.D., Executive Director, Public Policy, AstraZeneca Pharmaceuticals Luis Gutierrez, General Manager, Covance Health Economics and Outcome Services Dolly Judge, Senior Director, Federal Regulations, Pfizer

9:45    Networking Coffee Break

10:15  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

11:00  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

11:45  FDA PERSPECTIVE: The Role of Diagnostics in Drug Discovery and Pharmacogenomics

Joseph L. Hackett, Ph.D., Special Programs Director, Office of In Vitro Diagnostic Device, Evaluation and Safety, CDRH,  Food & Drug Administration

12:30  Close of Executive Round Table 

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