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Thursday, February 4

HEALTH IT: WHY IS IT SO HARD?

8:25 AM Chairperson’s Remarks

Wayne A. Rosenkrans, Jr., Ph.D., Distinguished Fellow, MIT Center for Biomedical Innovation; Program in Ethics and Systems Medicine, Georgetown University; Chairman, Personalized Medicine Coalition; VP, Strategic Consulting, Fuld & Co.; Chief Scientifc Advisor, Expertech Solutions; and Chief Applications Officer, SciTech Strategies

8:30 Keynote Presentation
Ensuring Responsible Testing through Real-Time Collaboration Between Providers, Payors and Labs

Matthew B. Zubiller, VP and General Manager, Advanced Diagnostics Management, McKesson Corp.

As molecular diagnostics proliferate, ensuring responsible testing becomes more complex. This is further complicated by changing reimbursement policies and health care IT reform. Ensuring your lab’s success requires technology-enabled collaboration with providers, payors and other labs. This keynote discusses business practices and strategies for labs to offer decision support and access to a broader array of tests to providers, to review payors’ reimbursement policies before tests are performed and to build effective lab networks to fulfill orders.

9:15 Keynote Presentation: HIT and PM: Conflict or Convergence

Wayne A. Rosenkrans, Jr., Ph.D., Distinguished Fellow, MIT Center for Biomedical Innovation; Program in Ethics and Systems Medicine, Georgetown University; Chairman, Personalized Medicine Coalition; VP, Strategic Consulting, Fuld & Co.; Chief Scientifc Advisor, Expertech Solutions; and Chief Applications Officer, SciTech Strategies

10:00 The Development of Multigene Prognostic and Predictive Tests in Cancer

Austin Tanney, Ph.D., Scientific Liaison Manager, Almac Diagnostics

The key to the delivery of personalized medicine is the development of molecular diagnostics to improve patient care, from better diagnostic and prognostic tests to companion diagnostics. The use of multigene signatures is increasingly of interest however there are many considerations in developing such signatures from study design to development of deliverable tests. Here we present out experience and perspective.

10:30 Poster Competition Refreshment Break & Raffles in the Exhibit Hall

12:30 PM Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:45 Ice Cream Refreshment Break in the Exhibit Hall

PLENARY KEYNOTE SESSION

2:15 Plenary Keynote Introduction

Plenary Keynote Presentation 

2:25 Chips, Clones and Living Beyond 100

Paul J.H. Schoemaker, Ph.D., M.B.A., Chairman and Chief Executive Officer, Decision Strategies International, Inc.; Research Director, Mack Center for Technological Innovation, The Wharton School; Adjunct Professor of Marketing, The Wharton School Adjunct Professor, Wharton School of Business

As information technologies and life sciences continue to converge, new business opportunities and challenges will arise for the field of diagnostics and beyond. This keynote reviews the deeper forces shaping the future of the biosciences, from social and economic to technological and political, including the stresses they will introduce for existing business models and healthcare. Not only will bioconvergence introduce new products, services and competitors, it may create entirely new industries on a scale larger than the computer revolution has to date. Several broad scenarios will be painted for the state of the biosciences in 2025 and the forces that might take us there, summarizing a multi-year strategy study conducted and supervised by the speaker at the Wharton school.

3:05 Refreshment Break in the Exhibit Hall

IP ISSUES ON GENE PATENTING:
WHAT IS THE SOLUTION?

3:45 Chairperson’s Remarks

Jorge A. León, Ph.D., President, Leomics Consulting

3:50 Gene Patents, Perspectives from the Clinical Laboratory

Karen P. Mann, M.D., Ph.D., Associate Professor and Director, Molecular Hematopathology, Department of Pathology and Laboratory Medicine, Emory University Hospital; President Elect, Association of Molecular Pathology

Gene patents are controversial, but are a reality in molecular diagnostics. As a laboratorian who co-directs an active clinical molecular diagnostics laboratory, I will describe how gene patents affect how I practice medicine including the effect of patents on test menus, turnaround times, choice of laboratories for referral testing, and laboratory finance.

4:20 Gene Patents in Molecular Diagnostics: Valuable Assets or Impediments?

Frances Toneguzzo, Ph.D., Director, Office of Corporate Sponsored Research and Licensing, Massachusetts General Hospital

Increasingly, genetic diagnostics are making use of panels of genes/gene fragments for accurate diagnosis of drug responses (toxicity and/or effectiveness and/or dosing) and disease stratification. In a number of situations, the patents covering these genes or their use are held by different owners, including companies, academic institutions and private individuals/foundations. While patents are generally considered valuable in that they provide a period of exclusivity when a company can exclude others from practicing the patented invention and thus protect the investment the company is making in commercializing the invention, this fragmentation of the intellectual property landscape in molecular diagnostics may impede the development of certain tests.

4:50 IP Fragmentation in Genetic Diagnostics

Jorge Goldstein, Director, Biotechnology & Chemical Group, Sterne Kessler Goldstein Fox PLLC

So called “patent thickets” have appeared when multiple patent owners each control one or a few genetic diagnostic correlation patents for one disease, where the multiple patents cover either alterations in one gene or several genes involved in the disease. Such thickets have already resulted in a failure to offer commercial tests for all possible gene alterations, or have generated test designs that are driven primarily by IP concerns. This talk will discuss possible solutions to the problem, including the use of patent pools driven by medical standards.

5:20 Expert Panel: Bioscience Patent Law 

5:50 Close of Day

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