BIO Co-Sponsors February FDA/DIA Workshop

BIO is a key co-sponsor for a key meeting on genomics policy being held by the FDA [2] and the Drug Information Association (DIA). [3]

The meeting is entitled: 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making [4]

It will be held February 2, 2010 8:00AM – February 4, 2010 3:00 pm at the Marriott Bethesda North Hotel.

Some of the featured topics of interest include:

• When PGx 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 PGx
• Translation of genomic information to labels that are useful to prescribers and patients
• Challenges with sample collection for PGx 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

We think this will be a great workshop for members of BIO [5] to attend as well as other industry companies!