Pre-Conference Symposia | Day 1 | Day 2 | Download Brochure
GAINING REGULATORY APPROVAL FOR MOLECULAR DIAGNOSTIC TESTS
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Ensuring the Safety and Validity of Molecular Diagnostic Tests
Alberto Gutierrez, Ph.D., Deputy Director, OIVD, Office of in Vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration
Bringing Point-of-Care HIV Diagnostics to Market: FDA Perspectives
Elliot Cowan, Ph.D., Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, FDA/CBER/OBRR
Featuring Sessions on:
HEALTH ECONOMICS AND ADOPTION
ESTABLISHING CLINICAL UTILITY
REIMBURSEMENT TRENDS
STANDARDS DEVELOPMENT TO IMPROVE PERFORMANCE OF TESTS
Distinguished Faculty
Michael D. Amos, Ph.D., Biosciences Advisor, Director’s Office, Chemical Science and Technology Laboratory, National Institute of Standards and Technology
Mara G. Aspinall, Senior Advisor, Genzyme Genetics
Bin Chen, Ph.D., Health Scientist, Division of Laboratory Systems, National Center for Preparedness, Detection, and Control of Infectious Diseases, CDC
Bill Cook, MBA, Vice President Molecular Diagnostics, Affymetrix Inc.
Jeffrey Cossman, Ph.D., Chief Scientific Officer, C-Path Institute
Robert S. Epstein, M.D., M.S., Senior Vice President, Medical & Analytical Affairs & Chief Medical Officer, Medco Health Solutions, Inc.
Matthew P. Goetz, M.D., Assistant Professor, Oncology, Assistant Professor, Pharmacology,
Mayo Clinic
Valerie Ng, Ph.D., M.D., President, ACMC Medical Staff; Chairman, Pathology, Director, Clinical Laboratory, Alameda County Medical Center/Highland General Hospital
Jared N. Schwartz, M.D., Ph.D., FCAP, President, College of American Pathologists
Robert Wells, Partner, Co-Founder, HealthFutures LLC
Judith A. Yost, M.A., M.T. (ASCP), Director, Division of Laboratory Services, Centers for Medicare & Medicaid Services
Pre-conference Symposia
(SC1) CIRCULATING TUMOR CELLS AS SURROGATE ENDPOINTS IN CLINICAL TRIALS
(SC2) REALITY CHECK ON COMPANION DIAGNOSTICS
Scientific Advisory Board
Valerie Ng, Ph.D., M.D., President-Elect, ACMC Medical Staff; Chairman, Pathology; Director, Clinical Laboratory, Alameda County Medical Center/Highland General Hospital
Myla Lai-Goldman, M.D., Managing Partner, Personalized Science, LLC
Clinical adoption of molecular diagnostic by the medical community is vital to the success of novel tests. The process by which new testing protocols become accepted and get incorporated will be explored. Experts from the medical and regulatory community will be speaking on a diverse range of issues. Find out what factors influence the adoption and acceptance of your diagnostic test, and how to navigate the changing regulatory requirements.
Tuesday, August 11
11:00am - 12:00pm Registration
12:00pm Keynote Introduction and Opening Remarks
Thomas F. Soriano, President & Chief Executive Officer, DOCRO, Inc.
12:10 Ensuring the Safety and Validity of Molecular Diagnostic Tests
Alberto Gutierrez, Ph.D., Deputy Director, OIVD, Office of in Vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration
12:35 Q&A
12:45 Bringing Point-of-Care HIV Diagnostics to Market: FDA Perspectives
Elliot Cowan, Ph.D., Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, FDA/CBER/OBRR
Point-of-care diagnostics for human immunodeficiency virus are playing an important role in helping individuals know their HIV status. FDA is responsible for assuring that these products are safe and effective. This talk will address FDA’s expectations for the approval of rapid HIV tests, pitfalls in the process, and challenges posed by home use HIV test kits.
1:10 Q&A
1:20 Luncheon Presentation (Opportunity Available) or Lunch on Your Own
2:30 Chairperson’s Remarks
2:40 Tamoxifen and CYP2D6: Using Pharmacogenetics to Individualize Breast Cancer Hormonal Therapy
Matthew P. Goetz, M.D., Assistant Professor, Oncology, Assistant Professor, Pharmacology, Mayo Clinic
Tamoxifen has been the most important drug world-wide for the prevention and treatment of estrogen receptor positive breast cancer. Cytochrome P450 (CYP) 2D6 is the hepatic enzyme necessary for the metabolic activation of tamoxifen to endoxifen, a substantially more potent metabolite which differs from 4-OH tamoxifen in regard to its effect on ERα degradation. Multiple independent studies in the adjuvant setting (nine) have demonstrated that patients with decreased CYP2D6 metabolism have a higher risk of recurrence compared to CYP2D6 extensive metabolizers. Given that there is no difference between tamoxifen and aromatase inhibitors in terms of breast cancer mortality, CYP2D6 pharmacogenetics appears to be a tool to individualize adjuvant hormonal therapy.
3:25 Industry and the Reasons for Advancing Standards in New Diagnostics
Jared N. Schwartz, M.D., Ph.D., FCAP, President, College of American Pathologists
This presentation will focus on the critical role industry must play to advance the introduction of new diagnostics in the era of Personalized or Precision Medicine. We will cover the state-of-the-art and illustrate how the significant improvement in standards will facilitate adoption.
4:10 Networking Refreshment Break, Exhibit and Poster Viewing
4:45 A New President, A New Congress and the Path to Personalized Medicine
Robert Wells, Partner, Co-Founder, HealthFutures LLC
The Obama Administration and the leadership of the 111th Congress have both identified the need for dramatic reforms in health care. But can the country afford them amid the most severe financial crisis since the Great Depression? And how will the new administration and Congress incorporate genomics and the personalization of medicine into those plans?
5:25 Close of Day
Pre-Conference Symposia | Day 1 | Day 2 | Download Brochure