Bioanalysis Zone

AAPS Crystal City VI Workshop: Bioanalytical Methods Validation on Biomarkers

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September 28-29, 2015
Renaissance Baltimore Harborplace Hotel
Baltimore, Md.

The importance of biomarkers in drug development and approvals is growing at an increasing pace as their value in personalized and precision medicine is recognized. Early in drug development, biomarkers, be they small chemicals or proteins, may inform pharmaceutical/biotech companies about patient selection, target engagement, safety, or efficacy of drug candidates. Later on, demonstrated biomarkers become surrogate end-points, essential to establishing efficacy and upon which health authorities will base their approval of new therapeutics.

At the 2013 Crystal City V workshop, an initial framework was presented for future dialogues between the industry and FDA. Building on this foundation, this September the AAPS will hold a biomarker-specific workshop that will provide a more robust and in-depth discussion of the issues related to biomarkers measured by ligand binding assays (LBAs) and LC-MS assays that are of concern to FDA.

The full workshop program may be found on the AAPS website.

The format for the meeting will be similar to Crystal City V: Each of the three sessions will start with a short set of introductory presentations by industry and FDA subject matter experts. These will be followed by periods of extensive deliberation by the audience with a panel of FDA and industry experts to discuss the issues and answer questions. International regulators will also provide their perspective.

The workshop’s goal is similar to that of past Crystal City workshops: Through open discussion between the scientific community and the agency, establish best practice recommendations for LBAs and LC–MS assays to measure biomarkers that will be reported in a joint conference report.

The workshop will be held September 28-29, 2015, in Baltimore, Maryland, USA, at the Renaissance Baltimore Harborplace Hotel. Registration and hotel reservation details may be found on the workshop website. Registration discounts are available for registrations by 7-Sep-2015.

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