Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Michael Shumsky has become its newest Director. Mike joined HP&M in February 2019 after nearly 15 years at Kirkland & Ellis LLP, where he played a key role in developing that firm’s FDA and pharmaceutical practices.
As a Director at HP&M, Mike will continue to provide strategic advice and counseling to U.S. and global pharmaceutical companies pursuing FDA approval of NDAs, 505(b)(2) products, ANDAs, BLAs and biosimilar applications. In addition to helping clients develop successful regulatory strategies and perfect high-stakes regulatory submissions, Mike has litigated a number of significant Hatch-Waxman matters arising from the award or denial of 180-day exclusivity, 3-year and 5-year exclusivity, orphan drug exclusivity, 30-month stays, and REMS-related matters. Courts and commentators alike have praised Mike’s abilities as both a writer and oral advocate, and he repeatedly has been recognized as a “Rising Star” in both the Life Sciences and Appellate Litigation fields.
Mike graduated from Harvard College, where he was elected to Phi Beta Kappa, and Yale Law School, where he was an officer on the Yale Law Journal. After law school, Mike clerked for the Hon. Diarmuid F. O’Scannlain on the U.S. Court of Appeals for the Ninth Circuit. He currently serves as a Lecturer in Law at Columbia Law School, where he teaches a popular seminar on the U.S. Supreme Court.