The Drug Information Association (DIA) and US FDA, in collaboration with BIO, PhRMA, Industry Pharmacogenomics Working Group, will host the 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making from February 2-4, 2010 in Bethesda, MD.
This workshop will develop and advance approaches and ideas to improve the value of pharmacogenomics and other biomarker studies during clinical development and for regulatory decision making. Session topics will include:
- When pharmacogenomics data will be required during clinical development
- Defining parameters that allow retrospective/prospective analyses to be conducted for regulatory approval of compounds in biomarker defined cohorts
- Case studies in efficacy, safety, and dosing which have integrated Pharmacogenomics
- Translation of genomic information to labels that are useful to prescribers and patients
- Challenges with sample collection for Pharmacogenomics in global development programs and ways to overcome them
- Critical analyses and recommendations for drug-diagnostic co-development paradigms which are feasible in the competing hurdles to develop new medicines
- Discussion panel of stakeholders including regulators, industry, third party payers, medical researchers and practitioners
“The field of genetics and its applications continue to evolve rapidly with the publication of multiple genome-wide association studies, the availability of new DNA sequencing technologies, and examples of biomarkers that are being used to help define patient response in myriad diseases,” says Steering Committee Co-chair Issam Zineh, PharmD, MPH, Associate Director for Genomics, Office of Clinical Pharmacology, CDER/FDA. This fifth major workshop will provide stimulating learning and networking opportunities with colleagues from academia, regulatory authorities, industry, payors, and providors who work on personalized medicines.”
About the Drug Information Association (DIA)
A non-profit, neutral, multidisciplinary, global, member-driven association, DIA serves more than 30,000 professionals involved in the biopharmaceutical industry, academia, research organizations and governmental bodies worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of drug development and medical product lifecycle management. DIA is led by its volunteer Board of Directors and executive management team, has headquarters in Horsham, PA, USA, and offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China. For more information, visit www.diahome.org or call 215-442-6100.