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Thursday, March 27

8:25am Chairperson's Remarks
Linda McAllister M.D., Ph.D., Vice President of Diagnostics, Arbor Vita Corporation

8:30 Regulation of Diagnostic Tests  Steven I. Gutman, M.D., Director, Office of In Vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration - Speaker Biography With the convergence of many scientific and technology breakthroughs, the pace of medical device innovation is accelerating, inspiring hope for better health outcomes with less invasive procedures and shorter recovery times. Cutting edge medical devices, including device-drug and device-biologic combination products, are increasingly incorporating cutting edge technologies that hold great promise for advancing patient care by making treatments safer, more effective, more convenient, or more comfortable. CDRH is expanding efforts to promote scientific innovation in product development, focusing device research on cutting edge science, modernizing the review of innovative devices, facilitating a least burdensome approach to clinical trials, and working to transform and strengthen the way it currently monitors the safety of medical devices. Effective and on-going communication among CDRH, industry, patients and clinicians is essential for fostering device innovation. Dr. Gutman will address CDRH's accomplishments, expectations and opportunities for the coming year.

9:00 Personalized Health Care at Roche: Development of Tests for Response Prediction in Oncology 
Gerd Maass, Ph.D., Head of Research & Development, Roche Applied Science 
Our understanding of which compounds and indications will benefit from the application of predictive response test has increased significantly. The major challenge is gaining early access to a test which allows sufficiently accurate prediction of response and can be integrated practically and economically into clinical practice. Roche begins the search for potential response markers very early in the lifecycle of a new compound. In many cases, parallel assessment of multiple markers is required. To cope with this increasing complexity, Roche has invested in a comprehensive portfolio of cutting-edge technologies. A case study will be presented.

9:30 Disseminated Clinical Molecular Diagnostics 
John L. Bishop, Chief Executive Officer, Cepheid 
A number of factors are driving increasing clinical interest in utilizing molecular diagnostics including the emergence of drug resistant and virulent organisms, and the recognized need for test results in less time. There is a growing interest in expanding clinical molecular diagnostics testing capability outside of the traditional central lab setting to the emergency department, intensive care units, and the doctors office. The dissemination of clinical molecular diagnostics capability through the use of multiple system platforms will lead to a growing problem with correlation of test results with the Central Lab.

10:00 Technology Spotlight

Sponsored by

10:15 Technology Spotlight (Sponsorship Available)

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

11:30 Clinical Translation of Personalized Medicines: Opportunities and Challenges 
Munir Pirmohamed, Ph.D., Professor, Clinical Pharmacology, University of Liverpool 
The ultimate aim of pharmacogenomic research is to improve the use of medicines to maximise benefits and minimize harms. The uptake of pharmacogenomics into healthcare however has been very slow and erratic. There are many reasons for the lack of clinical translation, the most important of which has been the lack of a robust evidence base that has allowed us to demonstrate clinical validity and clinical utility. The challenges and opportunities in this exciting field of healthcare will be discussed in the presentation using case studies where genetic tests have either succeeded or failed in improving drug therapy.

12:00pm Development and Commercialization of a PharmacoGenetic Companion Diagnostic to Predict Response to the Beta-blocker Bucindolol 
David M. Johnston, Ph.D., Vice President LabCorp, and Chief Scientific Officer, Esoterix Clinical Trials Services 
Bucindolol is a beta blocker indicated for the treatment of moderate to severe chronic heart failure. Sustained cardiac adrenergic stimulation has been implicated in the development and progression of heart failure. Release of norepinephrine is controlled by negative feedback from pre-synaptic adrenergic receptors, and the targets of the released norepinephrine on myocytes are adrenergic receptors. In transfected cells, a variant of the a2C adrenergic receptor (ADRA2C; a2C Del322-325) has decreased function, while the Arg389 variant of the adrenergic receptor b1 (ADRB1) has increased function. Studies indicate that this combination of receptor variants results in increased synaptic norepinephrine release and enhanced receptor function at the myocyte, predisposing such patients to heart failure. Clinical trial data demonstrates an association between the b1 and a2C adrenergic receptor genotypes and response to treatment with Bucindolol. This session will describe the validation of the pharmacogenetic biomarker, the development of a companion diagnostic for Bucindolol, and the unique partnership and business model created to commercialize the test with lower costs and faster timelines than traditional models.

12:30 Presentation I: Optimizing Microarray-Based Diagnostic Assays for FFPE Specimens Sponsored by Thomas Goralski, Ph.D., Vice President of Operations Expression Analysis Raji Pillai, Ph.D., Associate Director, Clinical Programs, Pathwork Diagnostics RNA isolated from formalin-fi xed, paraffi n-embedded (FFPE) tissues is often degraded and not amenable to mi-croarray techniques. Expression Analysis has successfully adapted its Affymetrix GeneChipｮ procedures for FFPE-derived specimens using NuGEN痴 RiboSPIA・technology. This sample type also shows promise with mi-croarray-based molecular diagnostics, including the Pathwork・Tissue of Origin Test. 1:00 Presentation II (Sponsorship Available)

1:30 Break

1:45 Expert Panel:
ASSESSING AND CAPTURING VALUE IN COMPANION DIAGNOSTICS 
(Shared session with Molecular Diagnostics)
Moderator: Jorge A. Le�n, Ph.D., President, Leomics Consulting

• What component drives the process, the drug or the diagnostic? Where does the ownership lie?

• When a diagnostic is linked to a targeted therapeutic, how is each component valued by the diagnostic? By the pharma?

• How is the value measured by the payer? How they conduct a cost-economics study, to see how populations with or without molecular diagnostics compare?

William J. Welch, Senior Vice President and Chief Commercial Offi cer, Monogram
Biosciences, Inc.
Joseph V. Ferrara, Executive Vice President, Boston Healthcare Associates, Inc.
Kathryn A. Phillips, Ph.D., Professor of Health Economics & Health Services Research,
School of Pharmacy, Institute for Health Policy Studies, and UCSF Comprehensive
Cancer Center (tentative)
Hakan Sakul, Ph.D., Senior Director and Global Head of Diagnostics, Translational and Molecular Medicine Group, Worldwide Development, Pfizer Global R&D

2:30 Expert Panel:
PUTTING PERSONALIZED MEDICINE INTO CLINICAL 
PRACTICE: Perspectives From The Stakeholders 
(Shared session with Molecular Diagnostics)
Moderator: David S. Lester, Ph.D., Senior Vice President, Strategy & Corporate Development, Gene Express, Inc.
Panelists: 
Brian E. Ward, Ph.D., FACMG, Senior Vice President, Development, Genomic Health Inc. 
Deborah Kilpatrick, Ph.D., Vice President, Market Development, CardioDx, Inc. 
Robert A. Schueren, Ph.D., Head of Diagnostics, Genentech 

3:20 Plenary Keynote

4:00 Ice Cream Refreshment Break in the Exhibit Hall with BEST OF SHOW AWARDS

4:45 Expert Panel:
MEASURING DEVELOPING MARKETS 
(Shared session with Molecular Diagnostics)
Moderator: Deborah C. Burgess, Ph.D., Senior Program Officer, Global Health Technologies, Bill & Melinda Gates Foundation 

• How do they work?

• Who is the target population?

• How do you reach them? How do they get the diagnostics out into the market?

Panelists: 
Allen L. Hammond, Vice President for Innovation & Special Projects, World Resources Institute 
Giorgio Roscigno, M.D., Chief Executive Officer, FIND Diagnostics 
Tala V. de los Santos, M.S., M.B.A., Commercialization Officer, Commercialization and Corporate Partnerships, PATH 
Steven A. Harvey, Ph.D., Senior Quality Assurance Advisor, University Research Co., LLC 

5:00 End of Conference