1.00 Registration

1.45 Workshop I: Improving Partnering to Ensure Optimal Drivers and Financial Benchmarks of Personalized Medicine

A personalized or targeted therapy is not the same as a one-size-fits-all therapy, often requiring different drivers and financial metrics to ensure successful launch and adoption. Furthermore, fully integrated coordination between the two primary stakeholders involved in development of such therapies is imperative to effectively achieve these goals.

This workshop will address the drivers necessary to ensure the successful launch of a personalized or targeted therapy, how to optimize resources behind those drivers and how to ensure that the optimal partnership model is put into place between the pharmaceutical and diagnostic partner to meet those goals.

The workshop will begin by looking at a suggested model of drivers necessary to ensure optimal net present value of a personalized medicine is achieved. This discussion will lay the foundation for consideration of resource requirements necessary to power those drivers to guarantee achievement of the targeted therapies goals for return on investment without loss of resource. The workshop will then consider how these goals are best effectuated and allocated within the Rx/Dx partnership and means to provide incentives to ensure therapy targets are met.

Workshop Leader: Diaceutics

About Diaceutics
Diaceutics is an international change management and consulting firm specializing in personalized medicine with a mission to build bridges between pharmaceutical and diagnostic players. Diaceutics provides pharmaceutical industry leaders with the foundation and operational structure needed to effectively develop and commercialize targeted therapies to better meet patients' needs and to improve overall return on investment.

3.45 Workshop II: Patent Protection - A Key to Commercializing Personalized Medicine

This workshop will consider the role of intellectual property in personalized medicine.  In particular, the program will provide an overview of the patenting process and present strategies for securing global patent protection.  We also will discuss the impact of recent court cases on theranostic patents and propose tactics for navigating the minefield.

Workshop Leader: Brian McCaslin, Senior Counsel, Foley & Lardner LLP

About Brian McCaslin
Mr. McCaslin counsels life-science companies and funds on the strategic acquisition and use of intellectual property. He is experienced in drafting and prosecuting U.S. and foreign patent applications, and in writing validity and infringement opinions. Mr. McCaslin also is experienced in negotiating and preparing licenses and performing due diligence analyses for asset valuations and transfers. He has conducted interferences before the U.S.P.T.O. and has argued numerous appeals before the Board of Patent Appeals and Interferences. Mr. McCaslin's practice also includes patent litigation.

Prior to joining Foley in 1998, Mr. McCaslin worked for Chiron Corporation as a molecular biologist. There he led a team to develop a quantitative HIV assay for clinical reference laboratories. Before working at Chiron, Mr. McCaslin worked as a molecular biologist for Becton Dickinson Microbiology Systems. There he designed molecular diagnostic systems useful for discriminating respiratory infections in immune-compromised patients. Mr. McCaslin also worked as a research assistant for Hoechst Celanese Corporation.

Mr. McCaslin is the author of "Are Patent Offices Ready for Personalized Medicine?" Bio-IT World, (March/April 2009).

Mr. McCaslin graduated from Wake Forest University (B.S., biology, minor in chemistry, 1991), East Carolina University (M.S., molecular biology and biotechnology) and the National Law Center at George Washington University (J.D., with honors). Mr. McCaslin is admitted to practice in the states of Maryland and Massachusetts, the District of Columbia and before the United States Patent and Trademark Office.

5.30 - 6.30 Early Registration and Cocktail Reception

Day Two - February 23, 2010

7.30 Registration

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8.00 Chairperson's Opening Remarks

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8.10 Companion Diagnostics: Poised to Take Center Stage in the Era of Personalized Medicine

8.45 Panel Session: Partnering Models in Personalized Medicine

William Welch
Former Sr Vice President, Chief Commercial Officer
Monogram Biosciences (LabCorp)

Bryan Dechairo, Ph.D.
Senior Director, Development Head Personalized Medicine
Medco

Joseph Ferrara
President
Boston Healthcare Associates

Mohan S. Iyer
Chief Business Officer
Tethys Bioscience

9.15 Trends in the International Market for Advanced Personalized Diagnostics

9.45 Best practices for Pharmaceutical and Diagnostics/lab Companies in Partnering to Co-Develop Clinical Trials Biomarker and Commercial Companion Diagnostic Tests

10.15 Morning Break/Networking/Exhibit Viewing

10.35 Alternative Partnering Models for Personalized Medicine

11.05 Foundations for Personalized Medicine: Business Models in Action

Keith Batchelder, MD
Chief Executive Officer and Founder
Genomic Healthcare Strategies

Peter Miller
Chief Operating Officer
Genomic Healthcare Strategies

Keynote Presentation

11.35 Presentation TBA

Stafford O'Kelly
President
Abbott Molecular

12.05 Lunch

Diagnostic Company Presentations

1.00 Presentation TBA

Mara G. Aspinall
President and CEO
On-Q-ity
Vice Chairman
Personalized Medicine Coalition
former President
Genzyme Genetics

1.30 Integrated Technologies for Supporting Personalized Rx Discovery and Dx Development

Manohar Furtado, Ph.D.
Distinguished Scientific Fellow
Life Technologies (Applied Biosystems)

2.00 Market Perspective and Learnings from a Global IVD Player

Iain D. Miller, Ph.D.
Senior Director, Oncology Strategy and Theranostics
bioMérieux

2.30 The Plying, the Pitch and the DNA Probe: How to do Companion Diagnostic Deals with Pharma

Dr. Stephen Little
Vice President Personalized Healthcare
Qiagen Manchester (DxS Diagnostic Innovations)

3.00 Refreshment Break/Exhibit Viewing

3.20 Presentation TBA

Charles Raffin
VP Commercial Assessment, Worldwide Franchise Development
Ortho Clinical Diagnostics (Johnson & Johnson)

3.50 Presentation TBA

Jason Coloma, Ph.D.
Head of Strategic Partnering
Roche Molecular Diagnostics

Pharmaceutical Company Presentations

4.20 Merck’s Licensing Strategy – Oncology Partnerships and Personalized Medicine

Linda Egger, Ph.D.
Director, Scientific Liaison
Merck & Co.

4.50 Strengthening Big Pharma's Personalized Medicine Pipeline via Partnerships with Diagnostics Companies

Cecilia Schott, PharmD., MBA
Business Development Director, Personalized Healthcare, Strategic Planning and Business Development
AstraZeneca

5.20 Presentation TBA

One to One Partnering Meetings

Day Three - February 24, 2010

7.30 Registration

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8.00 Chairperson's Opening Remarks

8.10 Establishing Clinical Utility and Cost Effectiveness for Personalized Medicine Diagnostics: A PBM and Dx Partnership

Bryan Dechairo, Ph.D.
Senior Director, Development Head Personalized Medicine
Medco

8.40 A Molecular Diagnostic (MDx) Perspective: Partnering MDx’s with Therapeutics (Rx’s) in Drug Development and Commercial Rx/MDx Launches

9.10 Bridging the Gap to Personalized Medicine: An FDA-Reform Managerial and Scientific Look at Regulations, Partnerships, Tools and Implications

John A. Norris, JD, MBA
Former Chief Operating Officer
FDA
Chairman and Chief Executive Officer
Norris Capital, Inc.
Chief Operating Officer
Health Discovery Corporation

Stephen Barnhill, MD
Chairman and Chief Executive Officer
Health Discovery Corporation

10.10 Morning Break/Networking/Exhibit Viewing

10.30 FDA's Experience with Personalized Medicine Clearances & Approvals

11.00 Getting Personalized Medicine Financed in Troubled Economic Times

11.30 Partnering to Integrate Genomic Medicine into Clinical Care

12.00 Lunch

12.55 The Integration of Biomedical Technologies as a Requirement to Deliver Personalized Medicine

1.25 Presentation TBA

1.55 Panel Session: What Does the Future Hold for Personalized Medicine

Panelists TBA