Next Generation Dx Summit

 

Clinical Adoption of Next Generation Diagnostics

Pre-Conference Symposia | Day 1 | Day 2 | Download Brochure 


 

GAINING REGULATORY APPROVAL FOR MOLECULAR DIAGNOSTIC TESTS

AlbertoGutierrezEnsuring 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

 

 

 

 

ElliotCowanBringing 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

Plenary Keynote Session

GAINING REGULATORY APPROVAL FOR MOLECULAR
DIAGNOSTIC TESTS

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

AlbertoGutierrezAlberto 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

ElliotCowanElliot 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 Tamoxifen and CYP2D6: Using Pharmacogenetics to Individualize Breast Cancer Hormonal Therapy

Matthew GoetzMatthew 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 SchwartzJared 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 WellsRobert 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

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