BIO is a key co-sponsor for a key meeting on genomics policy being held by the FDA and the Drug Information Association (DIA).
The meeting is entitled: 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making
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
This will be a great workshop for members of BIO to attend as well as other industry companies!