Bruce S. Manheim, Jr.

Partner at Wilmer Cutler Pickering Hale and Dorr LLP

Bruce S. Manheim, Jr.

Bruce S. Manheim, Jr.

Partner at Wilmer Cutler Pickering Hale and Dorr LLP

Biography

Bruce 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.

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Partner at Wilmer Cutler Pickering Hale and Dorr LLP

Relationship likelihood: Strong

Partner at Wilmer Cutler Pickering Hale and Dorr LLP

Relationship likelihood: Strong

Partner at Wilmer Cutler Pickering Hale and Dorr LLP

Relationship likelihood: Strong

Partner at Wilmer Cutler Pickering Hale and Dorr LLP

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Partner at Wilmer Cutler Pickering Hale and Dorr LLP

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Partner at Wilmer Cutler Pickering Hale and Dorr LLP

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Attorney at Wilmer Cutler Pickering Hale and Dorr LLP

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Co-Chair, Capital Markets Group at Wilmer Cutler Pickering Hale and Dorr LLP

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Partner at Wilmer Cutler Pickering Hale and Dorr LLP

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Partner Vice Chair, Transactional Department at Wilmer Cutler Pickering Hale and Dorr LLP

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Bruce S. Manheim, Jr.
Partner at Wilmer Cutler Pickering Hale and Dorr LLP
Career History
Attorney
Prior

Ropes & Gray LLP is a global law firm with 11 offices located in the United States, Asia, and Europe. The firm has over 1,100 lawyers, and professionals worldwide, and its clients include corporations and financial institutions, government agencies, universities, and health care organizations. It was founded in 1865 in Boston, Massachusetts by John Codman Ropes and John Chipman Gray

Partner
2013 - Current

Wilmer Cutler Pickering Hale and Dorr has expertise in areas including trial, appellate, Supreme Court, securities, regulatory, intellectual property, corporate transactions, bankruptcy, environmental, labor and employment, private client, real estate, and tax matters.

Transactions
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Stealth BioTherapeutics Corp. issued USD American Depository Shares

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Xeris Pharmaceuticals, Inc. issued USD Common Stock

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Entasis Therapeutics Holdings, Inc. issued USD Common Stock

Other Affiliations

Bruce S. Manheim, Jr. is affiliated with Ropes & Gray LLP, Wilmer Cutler Pickering Hale and Dorr LLP

This web site is not endorsed by, directly affiliated with, maintained, authorized, or sponsored by Bruce S. Manheim, Jr.. The use of any trade name or trademark is for identification and reference purposes only and does not imply any association with the trademark holder. The Presence of Bruce S. Manheim, Jr.'s profile does not indicate a business or promotional relationship of any kind between RelSci and Bruce S. Manheim, Jr..