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Clinical Adoption of Next Generation Diagnostics

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Wednesday, August 12, 2009

8:00am Morning Coffee

ESTABLISHING CLINICAL UTILITY

8:30 Chairperson’s Remarks

Valerie NgValerie Ng, Ph.D., M.D., President, ACMC Medical Staff, Chairman, Pathology, Director, Clinical Laboratory, Alameda County Medical Center/Highland General Hospital

 

 

 

 

 

8:40 Establishing Clinical Utility of Assays

Valerie Ng, Ph.D., M.D., President, ACMC Medical Staff; Chairman, Pathology, Director, Clinical Laboratory, Alameda County Medical Center/Highland General Hospital

Getting an assay into clinical use is a long and arduous process. First, a clinically relevant analyte has to be identified. Then an assay must be developed that can accurately measure this analyte. Well designed statistically valid clinical trials must then demonstrate assay reliability when used by the intended user in the appropriate clinical setting. Finally, implementation of the assay into a clinical setting is dependent on individual healthcare setting unique issues (e.g., desired turnaround time, staffing, personnel training and expertise, cost, environment/facility issues, etc.). This talk will highlight the decision making process occurring at the clinical end of this process. It will include examples of how and why a particular manufacturer’s assay, from an array of commercial assays for the single analyte under consideration, is ultimately chosen by a clinical site for patient care.

9:10 Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions

Bin ChengBin Chen, Ph.D., Health Scientist, Division of Laboratory Systems, National Center for Preparedness, Detection, and Control of Infectious Diseases, CDC

As molecular genetic testing is increasingly used in healthcare, concerns have been raised regarding the adequacy of regulatory oversight and quality assurance measures in this area of laboratory testing. Since 1997, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services have been working with other stakeholder groups and organizations to promote the quality of genetic testing and improve the appropriate use of genetic tests in healthcare. This presentation will discuss the recommended good laboratory practices for molecular genetic testing for heritable diseases and conditions in a CDC Morbidity and Mortality Weekly Report (MMWR) document published in spring 2009. The MMWR document, developed based on the recommendations of the Clinical Laboratory Improvement Advisory Committee (CLIAC), addresses good laboratory practices in the total testing process, responsibilities of laboratories for authorized persons, confidentiality of patient information and test results, personnel competency, issues to consider before introducing molecular genetic testing or offering new molecular genetic tests, and the potential benefits of the quality management system approach in molecular genetic testing. These recommendations are intended to serve as a guide for considering and implementing good laboratory practices to improve the quality and healthcare outcomes of molecular genetic testing for heritable diseases and conditions.

9:40 From R&D to Commercial Launch: Roadmap for MDx

William Cook

Bill Cook, M.B.A., Consultant, Strategy and Business Development Clinical Diagnostics, WECA

This talk will review a case study for a new molecular diagnostic as it makes its way from biomarker discovery through to a commercial launch, emphasizing the identification of critical hurdles such as reimbursement, physician education, KOL (Key Opinion Development), etc. It will also address strategies on how to address critical parts of the roadmap to success.

 

10:10 Networking Coffee Break

10:45 So, You Think that You Have the Next PSA - The Sequel  
Sponsored by DOCRO
Thomas Soriano Thomas F. Soriano, President & Chief Executive Officer, DOCRO, Inc.
This session will provide the participant with an overview of the issues, concerns, and important hurdles facing the clinical adoption of any new in vitro diagnostic test. Past and current experience with well-know tests (e.g., PSA) will be used to frame changes that will influence how new tests become considered to be "standard of care." A brief Question and Answer period will be available at the end of this session.


Each participant will understand:  
- Examples of how new IVD tests (e.g., PSA) have become standard of care
- Issues, concerns, and stumbling blocks for the wide spread use of any promising new IVD test
- Regulatory and reimbursement matters which impact clinical adoption of new tests
- Gossip and prognostications of the future

11:15 Sponsored Presentations (Opportunity Available)

11:45 Luncheon Presentations (Opportunity Available) or Lunch on Your Own


ON THE PATH FOR PERSONALIZED DIAGNOSIS

1:00pm Personalized Medicine on Deck - Home Run or Strike Out Ahead?

Mara AspinalMara G. Aspinall, President and Chief Executive Officer, VivirHealth

The good news is that the scientific power to diagnose, monitor and personalize patient treatment is greater today than ever before. The bad news is that physician adoption of these advances is frequently uneven and slow. Ms. Aspinall will discuss her current view of personalized medicine: opportunities, challenges and what we must do before its full promise can be achieved.

1:30 Experience with Adoption of Pharmacogenomics Testing on a National Scale

Robert EpsteinRobert S. Epstein, M.D., M.S., Senior Vice President, Medical & Analytical Affairs & Chief Medical Officer, Medco Health Solutions, Inc.

Pharmacogenomics was a scientific curiosity until very recently, when large organizations stepped up and adopted various pathways for coverage. This talk will describe the experiences by Medco, a company covering approximately 70 million Americans, in advocating coverage and encouraging adoption by patients and physicians for the commonly used breast cancer adjuvant drug tamoxifen. Data will be shared on the accelerators and decelerators of adoption, and future directions will be shared.

 

2:00 Break-out Sessions: Influencing Adoption to Bring a New Diagnostic to Market

 

Gaining Approval for Molecular Diagnostic Tests
Moderator: Thomas R. Soriano, President & Chief Executive Officer, DOCRO, Inc.

  • Do new technology platforms change the regulatory pathway?
  • Impact of new guidance for IVDMIA on commercialization plans
  • Will Laboratory Developed Tests ("Home Brews") offered only via a CLIA lab still be a viable route to commercialization?
  • Impact of Direct to Consumer Tests and SAGHS on regulatory oversight of molecular tests

Using Pharmacogenetics to Individualize Therapy
Moderator: Matthew P. Goetz, M.D., Associate Professor of Oncology, Assistant Professor of Pharmacology, Mayo Clinic

Learning How Standards Facilitate Adoption
Moderator: Michael D. Amos, Ph.D., Biosciences Advisor, Director's Office, Chemical Science and Technology Laboratory, National Institute of Standards and Technology

Getting a Diagnostic Assay into Clinical Use
Moderator: Valerie Ng, Ph.D., M.D., President, ACMC Medical Staff, Chairman, Pathology; Director, Clinical Laboratory, Alameda County Medical Center/Highland General Hospital

3:00 Networking Refreshment Break


STANDARDS DEVELOPMENT TO IMPROVE PERFORMANCE OF TESTS

3:30 Chairperson’s Remarks

Jared N. Schwartz, M.D., Ph.D., FCAP, President, College of American Pathologists

3:40 Validation and Standardization of Predictive Diagnostics: Promises and Pitfalls

Timothy J. O’Leary, M.D., Director Biomedical Laboratory and Clinical Science Research and Development, Department of Veterans Affairs  

4:10 Standards for Multiplex Technologies: What they are and Why they are Important for Next Generation Laboratory Medicine

Michael AmosMichael D. Amos, Ph.D., Biosciences Advisor, Director’s Office, Chemical Science and Technology Laboratory, National Institute of Standards and Technology

New measurement technologies can play an important role in expanding the current vision of personalized medicine from mostly encompassing pharmacogenomics and electronic health records to one involving early detection and prevention of the chronic diseases (cancer, diabetes, cardiovascular and other diseases) that cause massive pain and suffering and represent more than 80% of U.S. health care spending. New multiplex measurement tools are making it possible to, for the first time, analyze the complex biomolecular network systems and gain a better understanding of the molecular pathology of diseased cells. DNA microarray, IVD-MIA products are reaching market and the signatures they can discern appear to possess greater diagnostic and prognostic value than single measurements alone. The same will probably be true for multiplex proteome analysis. However, because these technologies are considerably more complex, their utility in the clinic will require entirely new and innovative approaches to standards to enable their further development and deployment.

4:40 Close of Clinical Adoption of Next Generation Diagnostics Conference

 

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