Frank Sasinowski to Speak on Regulatory Issues at Orphan Drugs Conference, Feb. 20-21, 2014, SD, CA
Frank Sasinowski will speak about orphan drugs approved under the FDA's Subpart H at the second annual Orphan Drugs Research & Commercialization Conference, to be held February 20-21, 2014 in San Diego, CA.
- (1888PressRelease) November 28, 2013 - The presentation will provide an analysis of the 19 non-cancer, non-HIV drugs approved via the Subpart H pathway since the pathway's inception. The analysis was submitted on August 26, 2013 as a comment to FDA's July 2013 Draft Guidance on "Expedited Programs for Serious Conditions," and showed that FDA exercised a great deal of flexibility in its review of those drugs. Dr. Sasinowski will discuss the evidentiary foundation for FDA's determinations that a surrogate or clinical endpoint that was not validated was "reasonably likely to predict" patient benefit sufficient to meet statutory standard of substantial evidence of effectiveness.
Dr. Sasinowski is currently Director at Hyman, Phelps & McNamara, where he assists sponsors in developing new medicines and securing FDA approval for hundreds of new drugs that are often for serious and/or rare diseases. He was previously with the FDA, and was key in implementing the 1983 Orphan Drug Act. In May 2013, the National Organization for Rare Disorders (NORD) awarded Dr. Sasinowski with its first ever Lifetime Achievement Award. He was elected to NORD's Board of Directors in 2000, and remains on the Board today.
The Orphan Drugs Research & Commercialization Conference is a forum for various stakeholders in the community to gather and share complementary perspectives on the challenges in the field and paths forward. The meeting includes presentations on the latest scientific therapeutics, panel discussions on patient registries and advocacy, networking sessions, and much more.
For more information, please visit www.gtcbio.com/orphan.
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