May 24, 2010 / West Coast Clinical Trials (WCCT, www.wcct.com) successfully hosted an educational symposium Tuesday, May 18, 2010 entitled, “Accelerating Early Clinical Development” in San Mateo, CA. The purpose of this symposium was to provide insight to leaders interested in expediting completion early phase pharmaceutical development. Due to the unexpected volume of attendees, the venue was filled beyond capacity; however, accommodations were made to address the issue. Industry leaders from biotechnology, pharmaceutical and venture capital companies were in attendance to gain unique perspectives from innovators with direct experience in pharmaceutical development. The presenters provided in depth analysis of industry trends and insight into advantageous methods for accelerating clinical research.
Paul Frohna, MD, PhD, PharmD, ProFibrix presented “Laying the Groundwork for a Successful Early Development Program”. Dr. Frohna discussed the applicability of recent FDA guidance’s, like the Critical Path Initiative and Exploratory INDs, for your program also need to be considered before designing the most efficient and effective early development program for your company.
Richard Shames, MD, Merck & Co. presented “Fast and Smart Drug Development”. Dr. Shames discussed that many drugs fail in late stage development because of insufficient proof of concept and inadequate dose finding in early stage development and provided strategies to utilize adaptive design and characterize the full dose range of activity can help to reduce risk and maximize the probability of accelerating the “winners” and eliminating the “losers”.
Richard Lowenthal presented “Integrating Japan and Asia into Global Development”. Lowenthal discussed focusing on approaches into integrating Japan and Korea into the global development process and accelerating time to market in Asia. He also discussed streamlining the approach to bridging drug development across regions for global development.
Anthony Fossa, PhD presented “Advanced ECG Analyses in Early Clinical Development”. Dr. Fossa discussed the benefits highly automated ECG analysis technologies that have recently been validated in studies with the FDA. His experience has shown that these technologies can help differentiate QT interval effects to the ICH E14 standard and improve decision making at earlier stages in development where fewer subjects are needed.
For those who are interested in receiving copies of the symposium, requests may be sent to firstname.lastname@example.org.
West Coast Clinical Trials (WCCT, wcct.com) is a privately held 120-bed clinic located in Southern California that specializes in early clinical drug development. WCCT partners with companies to help design their drug development strategy, draft protocols, and execute their phase I and phase IIa proof of concept programs. WCCT has a unique focus on ethnobridging studies along with extensive experience with healthy volunteer and specialty trials (allergy, asthma, infectious disease, pediatric, renal and vaccines).