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Genomics at FDA
Presentations

2008

"Warfarin Pharmacogenetic Testing is now ready for Prime Time", invited presentation at the "Warfarin Pharmacogenetics Debate" PDF Huang, Shiew-Mei, Ph.D., AACC Annual Meeting, Washington D.C. July 28, 2008

Pharmacogenomic Research Meets Clinical Practice: Examples of incorporating pharmacogenomic principles into clinical practice PDF Burckart, J Gilbert, Pharm.D., American College of Clinical Pharmacy Meeting, Phoenix, A.Z. April 2008

Personalized Medicine: Regulatory Perspective PDF Lawrence J. Lesko, Ph.D., FCP, Washington, D.C. January 8, 2008

2007

Warfarin Pharmacogenomics: Translation Into Clinical Practice, PDF Lawence J. Lesko Ph.D., FCP, Silver Spring, MD, October 17, 2007

Challenges for Co-Development of New Medical Products: A regulatory perspective, PDF Felix W. Frueh, Ph.D., CDER, Bethesda, October 19, 2007

Personalized Medicine - Quo Vadis? PDF Felix W. Frueh, Ph.D., CDER, Cambridge, MA, October 11, 2007

Principles of Risk-Based Regulatory Decision Making, PDF Lawence J. Lesko Ph.D., FCP, Pittsburgh, PA, October 23, 2007

New Paradigms for Drug Development: A Regulatory Perspective, PDF Felix W. Frueh, Ph.D., CDER, Baltimore, MD, July 31, 2007

The Future of Technology and Regulation: Opportunities in Drug Development, Regulatory Review and Clinical Practice, Shiew-Mei Huang, Ph.D., 10th Annual FDA - Orange County Regulatory Affairs Educational Conference, Irvine, CA, June 11, 2007

Regulatory Perspecive on Warfarin: Relabeling with Genetic Information, Lawrence J. Lesko, Ph.D., FCP, CDER, Ninth Annual Conference of Anticoagulation Therapy, May, 2007

The Transition from Pre-Clinical to Clinical Application of Safety Related Related Genomics, Felix W. Frueh, Ph.D., CDER, IOM/FDA Emerging Safety Science Workshop, April 23, 2007

Update on the Critical Path and Personalized Medicine Initiative Implementation, Felix W. Frueh, Ph.D., CDER, R&D Leaders Forum Spring 2007, March 5, 2007

Clarifying the Current Regulatory Position on the Validation and Standardization of Biomarkers for Approval and Ongoing Patient Care, Felix W. Frueh, Ph.D., CDER, R&D Leaders Forum Spring 2007, March 5, 2007

2006

Pharmacogenetics –Pharmacogenomics in Early Drug Development: Regulatory Expectations, Shiew-Mei Huang, Ph.D., AAPS Annual Meeting, November 2, 2006

The VGDS Process at the US FDA: Lessons Learned and Future Directions, Michael S. Orr, Ph.D., DABT, CDER, American College of Toxicology 27th Annual Meeting, November 6, 2006

Celebrating the Two-Year Milestone and Planning for the Future of Voluntary Genomic Data Submissions (VGDS) to the FDA, Federico Goodsaid, Ph.D., and Felix Frueh, Ph.D., CDER, DIA Webinar, September 28, 2006

Challenges in Biomarker and Drug Co-Development and Regulation: The regulatory view for drugs, Felix W. Frueh, Ph.D., CDER, AACC 2006 Annual Meeting, Chicago, IL, July 24, 2006

Personalized Medicine – Today!, Felix W. Frueh, Ph.D., CDER, Clinical Ligand Assay Society, Louisville, KY, May 22, 2006

Can Pharmacogenomics Help in Psychiatric Drug Development?
Shiew-Mei Huang, Ph.D., CDER
NCDEU 46th Annual Meeting, Boca Raton, Florida, June 15, 2006

Pharmacogenomics: Patient Selection for Clinical Trial Participation and Enrichment Strategies
Felix W. Frueh, Ph.D., CDER
Accelerating Anticancer Agent Development and Validation Workshop, May 17, 2006

Co-Development of Drug and Test – Is It a Special Challenge with PGx?
Felix W. Frueh, Ph.D., CDER
Annual DIA EuroMeeting, March 8, 2006

Qualification of Genomic Biomarkers for Regulatory Decision Making
Felix W. Frueh, Ph.D., CDER
Annual DIA EuroMeeting, March 7, 2006

Voluntary Genomic Data Submissions: Review and Analysis of Toxicogenomic Data in Preclinical Drug Safety Assessment
Felix W. Frueh, Ph.D., CDER
Pharmacogenomics Grand Rounds, January 31, 2006

2005

Creating a Network to Study the Effect of Genomics on Clinical Outcomes: The View from FDA
Felix W. Frueh, Ph.D., CDER
Group Health Cooperative – CDC Meeting, December 14-15, 2005

Voluntary Genomic Data Submissions at the U.S. FDA
Felix W. Frueh, Ph.D., CDER
International Conference on Harmonization, November 9-10, 2005

Presentations from FDA, DIA, PhRMA, BIO, & PWG Workshop on  “Applications and Validation of Genomic Biomarkers for Use in Drug Development and Regulatory Decision Making” Bethesda, MD, October 6 – 7, 2005.  Download zip file of all presentations (6.71 MB). Individual presentations.

Voluntary Genomic Data Submissions: One Year Later
Felix W. Frueh, Ph.D., CDER
41st Annual DIA Meeting

Pharmacogenomics and Biomarkers: Current role in drug development
Felix W. Frueh, Ph.D., CDER
Accelerating Anticancer Agent Development and Validation, June 2, 2005

Personalized Medicine: What Is It? How Will It Affect Health Care?
Felix W. Frueh, Ph.D., CDER
11th Annual FDA Science Forum, April, 2005

Translation of Pharmacogenomics and Pharmacogenetics: A Regulatory Perspective
Lawrence J. Lesko, Ph.D., FCP
11th Annual FDA Science Forum, April, 2005

Pharmacogenomics, Personalized Medicine and the Role of FDA
Lawrence J. Lesko, Ph.D., FCP
Bio-IT World Conference, May 18, 2005

[Rat Mixed Tissue RNA Reference Material (MTRRM) for Microarrays]
Application of a Cross-Platform RNA Standard for Assessing Microarray Data Comparability
P. Scott Pine, CDER
Karol Thompson, Ph.D.
11th Annual FDA Science Forum, April, 2005

Pharmacogenomics: Experience with Voluntary Submissions and Regulatory Development
Felix W. Frueh, Ph.D., CDER
International Conference on Drug Development, February 15, 2005

Toxicogenomic Data Submissions: Regulatory Considerations
Felix W. Frueh, Ph.D., CDER
The Toxicology Forum: February 1, 2005

2004

Pharmacogenomic Data Submissions: Review of Guidances and Goals
Felix W. Frueh, Ph.D., CDER
Pharmacogenomics Working Group, December 14, 2004

Education in Pharmacogenomics: Closing the Gap between Possibility and Reality]
Felix W. Frueh, Ph.D., CDER
Drug Metabolizing Enzymes and Pharmacogenomic Testing Workshop September 13-14, 2004

Regulatory Perspective on Integrating Pharmacogenomics into Drug Development and Regulatory Decision Making
Lawrence J. Lesko, Ph.D., F.C., CDER, May 18, 2004

2003

Regulatory Issues in Genotyping Metabolizing Enzymes-CDER Perspective
Shiew-Mei Huang, Ph.D., CDER
FDA/Johns Hopkins University/PhRMA Educational Workshop, September 13-14, 2003, Rockville, MD

Effect of Pharmacogenetics and Drug-Drug Interactions on Exposure-Response: What Needs to be Done?
Shiew-Mei Huang, Ph.D. CDER
American College of Clinical Pharmacology Exposure-Response (E-R) Relationships, September 21, 2003, Tampa, FL,

2002

2002 Workshop on Pharamacogenetics/Pharmacogenomics in Drug Development and Regulatory Decision-Making
Lawrence J. Lesko, Ph.D., CDER
May 16-17, 2002, University of Maryland

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Date created: March 22, 2005, updated August 8, 2008

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