Pre-Conference | Day 1 | Day 2 

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

Plenary Session Session

GAINING REGULATORY APPROVAL FOR MOLECULAR
DIAGNOSTIC TESTS

12:00pm Session Introduction and Opening Remarks

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

HEALTH ECONOMICS AND ADOPTION

2:30 Chairperson’s Remarks

2:40 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?

3:25 Personalized Medicine on Deck - Home Run or Strike Out Ahead?

Mara G. Aspinall, Senior Advisor, Genzyme Genetics

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.

4:10 Networking Refreshment Break, Exhibit and Poster Viewing

4:45 The Good, Bad & the Ugly of POCT—Comes with 10 Easy Steps to High Quality

Judith A. Yost, M.A., M.T. (ASCP), Director, Division of Laboratory Services, Centers for Medicare & Medicaid Services

With the continuing emergence of accurate, robust and portable technologies for a multitude of tests, point-of-care testing (POCT) is expanding exponentially. POCT produces expedited test turnaround times and therefore, facilitates rapid patient care. However, it is critical for the patients for whom action is taken because of POCT, that the testing is of the same high quality as those performed in a traditional laboratory setting. This exciting phenomenon comes with unique issues and these must be addressed in order to ensure accurate and reliable testing.

5:25 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.

6:10 Close of Day

Pre-Conference | Day 1 | Day 2