Bruce S. Manheim represents life science companies on a wide array of matters, including regulatory issues before the Food and Drug Administration and other agencies, life cycle management strategies for pharmaceuticals, GMP compliance matters, government and internal investigations, administrative agency litigation, valuation and diligence on life science transactions, and environmental compliance issues involving biotech products.
Mr. Manheim has also developed special knowledge on issues surrounding research, development and commercialization of products under the Biodiversity Convention and Nagoya Protocol.
Mr. Manheim holds graduate degrees in both science and law, and brings a multidisciplinary approach to the complex issues at the forefront of today’s life sciences industry. He also shares a special understanding of the manner in which in-house counsel grapple with issues confronting life science companies.
He spent almost a year on a secondment as acting general counsel of a major business unit of a large medical device company. Mr. Manheim frequently counsels life science clients based outside of the United States on FDA regulatory issues and related matters. Mr. Manheim has extensive experience representing clients on matters involving drugs, biologics, devices, cosmetics, supplements and other food products.
Mr. Manheim assists clients on biosimilars and Hatch-Waxman exclusivity issues, leads internal investigations and compliance assessments, and works closely with attorneys from the Litigation/Controversy Department on civil and criminal investigations. He has filed numerous petitions with FDA and served as lead counsel in litigation challenging FDA and other federal agency actions.
Mr. Manheim was formerly a partner in the Life Sciences Group at Ropes & Gray for more than 10 years. Before that, he served as counsel and partner at a boutique FDA law firm for a decade.
Prior to entering private practice, Mr. Manheim worked for many years as a senior attorney-scientist at the Environmental Defense Fund, where his practice focused on public health and environmental issues arising within both domestic and international legal frameworks.
Since entering private practice, Mr. Manheim has continued to pursue his interest in pro bono matters involving significant public policy issues. He successfully represented the Brady Campaign to Prevent Gun Violence in a lawsuit striking down a federal rule that would have allowed loaded and concealed guns in national parks and wildlife refuges.
He currently serves as co-lead counsel to the chapters of three national medical organizations in First Amendment litigation challenging a Florida law barring physicians from asking their patients about firearm safety.
Experience :
- Assisted a major biotechnology company with numerous legal and legislative issues surrounding the development and implementation of the biosimilars legislation.
- Submitted citizen petitions, and assisted in preparation for Advisory Committee meetings, on various issues involving approval of generic versions of complex products.
- Assisted in the defense of the chairman of a medical device company in a government enforcement investigation involving allegations of improper marketing of devices.
- Conducted diligence and prepare an evaluation of the value of a target company in connection with its acquisition by a large pharmaceutical firm.
- Assisted a major pharmaceutical company on compliance issues and access-benefit sharing agreements arising under the Biodiversity Convention.
EDUCATION :
- JD, Georgetown University Law Center, 1988
- MSL, Public Policy, Vermont Law School, 1981
- MS, Claremont Graduate University, 1978
- BA, Biology, Pomona College, 1977
ADMISSIONS : District of Columbia, California
Cost
Rate : $$$
