15 October 2015
5:30-8:30 pm
GlaxoSmithKline Upper Merion West Campus
King of Prussia, PA
Join your regulatory colleagues from across the Philadelphia area for an evening of networking and “Regulatory Strategic Considerations-Multiple Marker Diagnostic Approach in Drug Development,” an expert presentation with Jennifer Dudinak, PharmD.”
The speed of evolution of scientific knowledge to identify molecularly-targeted agents and advancements in technology (such as multiple-marker diagnostics) offers great promise in identifying subsets of patients who will likely benefit (or experience minimal/detrimental effect) from novel therapies. Multiple marker diagnostics (multiplex) or next-generation sequencing (NGS) platforms offer the ability to test for a wide array of biomarkers and mutations at once. These platforms can be instrumental in fostering efficient health care utilization, maximizing sampling for tissue/specimen/biopsy and advancing innovations in molecularly-targeted therapeutic development and registration across a variety of therapy areas.
There are several regulatory and development strategic considerations when employing a multiple-marker diagnostic approach in a therapeutic development program. This session will explore challenges and opportunities of utilizing a multiple-marker approach, including how stakeholders can partner together to advance the regulatory framework. Pertinent highlights from recent FDA workshops on NGS and precision medicine will also be discussed.
A light meal will be available. Attendees may claim two RAC recertification credits.
This meeting is sponsored by the RAPS Philadelphia Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals.
Please bring a photo ID for admission onto the campus.