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Wednesday, February 22

 

REGULATION OF LDTS: THREE POINTS OF VIEW

7:55 am Chairperson’s Remarks

Harry Glorikian, Managing Partner, Scientia Advisors

8:00 FDA Oversight of Laboratory Developed Tests (LDTs): Where Are We? Where Are We Going?

Elizabeth Mansfield, Ph.D., Director, Personalized Medicine, Office of in vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH)

This presentation will provide an update regarding FDA oversight of Laboratory Developed Tests (LDTs), discuss publication of a draft guidance document related to Investigational Use/Research Use products, and discuss regulatory issues associated with next-generation sequencing technologies.

8:30 Is There, and Should There Be, a Role for RUO and IUO Labeled Products in LDTs?

Stephen P. Day, Ph.D., Director, Medical Affairs, Hologic, Inc.

Laboratory Developed Tests (LDTs) have often used commercially manufactured “Research Use Only” and “Investigational Use Only” products as components of the test or as complete tests.  This presentation will provide an overview of what recently released draft guidance on RUO and IUO products may mean to clinical laboratories and manufacturers and how it may impact LDTs.

9:00 Regulation of LDTs: The Laboratory’s Perspective

Peter M. Kazon, General Counsel, American Clinical Laboratory Association

This presentation will look at the past actions of FDA with regard to Laboratory Developed Tests, and will focus on particular  concerns that FDA regulation could pose for laboratories, from both a legal and practical standpoint.   It will also focus on the other regulatory scheme that affects laboratories, namely CLIA, and will discuss the differences and overlap between the two regulatory frameworks.  It will then discuss if CLIA  could also be useful in addressing the potential gaps that exist in oversight. 

9:30 Rigorous Design and Validation of a Molecular Laboratory Developed TestCarol Berry, Sr. Vice President, Services Division, Asuragen Inc.This presentation will feature a case study on the design, development, and validation of a molecular LDT, including steps necessary to achieve medical adoption.
 

10:00 Transition to Plenary Keynote

11:00 Refreshment Break in the Exhibit Hall with Poster Viewing

 

GLOBAL OPPORTUNITIES FOR MOLECULAR DIAGNOSTICS

11:55 Chairperson’s Remarks

Kenneth Bahk, Ph.D., Lurie Investments

12:00 pm Non-Instrumented and Fully Integrated Molecular Diagnostic Solutions for the Developing World

Timothy T. Stenzel, M.D., Ph.D., CSO, Quidel

At least two of Quidel’s molecular programs have Developing World applications. Quidel is collaborating with BioHelix to develop isothermal amplification tests utilizing lateral flow for detection (NALF). And in collaboration with Northwestern University, Quidel is developing a low-cost fully integrated molecular diagnostics platform using the novel Immiscible Phase Nucleic Acid Purification technology.

12:20 China: Market Opportunity and Characteristics

Min Cui, Ph.D., Principal, Bay City Capital

12:40 Applying Molecular Diagnostic Tests in High Burden Developing Countries (HBDC)

Russel K. Enns, Ph.D., Senior Vice President, Chief Regulatory Officer, Cepheid

A simple to operate, totally automated molecular diagnostic test platform being used for detection of Mycobacterium tuberculosis and multi-drug resistant tuberculosis in HBDC will be described. Insights and experiences with this testing platform and the challenges of this environment will be discussed, including an overview of the associated regulatory requirements.

1:00 Luncheon Presentation Proving Value as a Companion Diagnostics Partner

Mya Thomae, CEO, Myraqa, Inc.

What does it take to show a therapeutics firm that you’re ready for a companion diagnostics partnership? We’ll look at pharma needs and expectations with an eye toward helping MDx firms demostrate readiness for a CoDx regulatory application.

1:30 Changing the Management of Global Infectious Diseases Using Novel Molecular Diagnostic Tools

Jeremy Bridge-Cook, Sr. VP of Assay Research and Development, Luminex Corporation

The recent expansion of molecular diagnostics testing is beginning to change how global infectious disease epidemics and outbreaks are detected and tracked. In the advent of an increasingly globalized world, Luminex will discuss how ID assays developed for "modern healthcare" systems are being ported to the developing world and how this may be one sustainable model that will see innovative molecular testing solutions reaching those in highest need.  Additionally a different perspective on 'personalized medicine' will be discussed when multiplexed molecular testing identify infectious agents that would normally go undetected.

2:00 Ice Cream Refreshment Break in the Exhibit Hall with Poster Viewing

3:50 Refreshment Break & Poster Awards in the Exhibit Hall

THE SUPPORT OF COMPANION DIAGNOSTICS THROUGH CENTRAL LABORATORY TESTING

4:25 Chairperson’s Remarks

Brian T. Edmonds, Ph.D., Research Advisor, Global External Research & Development, Lilly Corporate Center

4:30 Key Considerations: Biomarkers as Potential Companion Diagnostics

Terry Robins, Ph.D, Director of Biomarker R&D, Quest Diagnostics Clinical Trials

This will cover, gaining insight in developing an optimal biomarker strategy for a drug development program, understanding key issues and considerations in developing a biomarker strategy that can bridge to potential companion diagnostics development and understanding the strategic partnerships needed to enable biomarker to companion diagnostic development.

5:00 The Use of Molecular Diagnostics to Guide Drug Development and Patient Tailoring

Andrew Schade, M.D., Ph.D., Senior Director, Clinical Diagnostics Laboratory, Eli Lilly & Co.

The increasing interest in targeting specific molecular pathophysiology (e.g., BRAF, EML4-ALK, etc.) is changing the way therapeutic agents are being developed.  Targeting smaller populations of patients requires new "companion" diagnostics to support appropriate therapeutic use.  This talk will provide perspective of patient tailoring/companion diagnostics from the drug development standpoint.

5:30 PANEL DISCUSSION: Are Complex Genetic Tests Fulfilling Their Promise? 

This session will review and discuss the status of genetic testing’s ability to inform and improve clinical care in the present and in the future from multiple perspectives, including academia, industry, and clinical care.

Moderator: 

Edward Abrahams, President, Personalized Medicine

Panelists: 

Iris Schrijver, M.D., Director, Molecular Pathology Laboratory Stanford University Medical Center, Lucile Packard Children’s Hospital; Associate Professor of Pathology and (by courtesy) Pediatrics, Stanford University School of Medicine; and President, American Association of Molecular Pathology

John J. Sninsky, Ph.D., Vice President, Discovery Research,
Celera Diagnostics

Kathy Behrens Wilsey, Ph.D., Board Member, KEW Group

6:30 Close of Day

The Personalized Medicine Coalition invites you to attend a cocktail reception on Wednesday, February 22, 2012 from 6:30 – 8:30 p.m. At the Intercontinental San Francisco. The reception will feature Sue Siegel, General Partner, Mohr Davidow, a leading personalized medicine investor and advocate. Registration is free for employees of PMC member institutions, government employees and the press; all other members of the personalized medicine community are welcome to attend for $100 and may pay by credit card. To register, please visit http://conta.cc/xBwLOJ.

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