Bruce S. Manheim Jr.
1875 Pennsylvania Avenue, NW Washington, District of Columbia 20006
Firm:
Wilmer Cutler Pickering Hale and Dorr LLP
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Overview
Bruce Manheim is a partner in the Litigation/Controversy and Regulatory and Government Affairs Departments, and a member of the Investigations and Criminal Litigation, Government and Regulatory Litigation, Life Sciences and Strategic Response Groups. He joined the firm in 2013.
Mr. 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 ten 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.
Mr. 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 ten 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.
What legal services does this lawyer offer?
Awards
- National Law Journal 2011 “Champion Award” for Upholding the Legal Profession’s Core Values Through Public Service, Pro Bono Efforts and Advocacy for Civil Liberties
- Recognized in the 2012, 2013 and 2014 editions of Chambers USA: America's Leading Lawyers for Business for Healthcare: Pharmaceutical/Medical Products Regulatory
Education
Graduated
Pomona College, BA
Vermont Law School, MSL
Claremont Graduate University, MA
Contact Details and Office Locations
Office: (202) 663-6000
1875 Pennsylvania Avenue, NW
Washington, District of Columbia 20006
Washington, District of Columbia 20006
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