Dispute resolution
Latham & Watkins LLP’s client base ranges from globally recognized life sciences businesses to biopharma and biotech start-ups. The busy practice is active across a range of life sciences industry sectors, from pharmaceuticals and biotechnology to cosmeceuticals and food tech. The team’s key areas of activity include complex corporate transactions such as M&A, with experts including Julie Scallen. Also on the transactional side, Shayne Kennedy focuses on capital markets along with Matthew Bush and Nathan Ajiashvili, while Cheston Larson advises on financing. Through its development of licensing structures and facilitation of commercial transactions, the team has been active in the funding of drug development and commercialization. The firm also handles litigation matters such as IP disputes, counting on experts such as Arlene Chow, as well as regulatory and legislative strategies; Ben Haas is a key figure in the latter. Among the practice’s key figures are also John Manthei and Elizabeth M. Richards, both experts in FDA regulatory matters, and Terra Reynolds, in white-collar defense and investigations. In 2024, litigation and regulatory specialists Jennifer L. Bragg and William McConagha joined the practice from Skadden, Arps, Slate, Meagher & Flom LLP, and in April 2025, Kate Hillier joined from Cooley LLP.
Legal 500 Editorial commentary
Mentions
Profile
Position
Bill McConagha, a former Associate Chief Counsel and Assistant Commissioner at the US Food and Drug Administration (FDA), is a nationally recognized life sciences attorney who advises clients on a range of complex issues spanning the FDA-regulated product life cycle, from premarket development and clinical trials, through product launch, post-market safety reporting, and manufacturing requirements, including cGMP.
Bill draws on extensive federal government experience to represent companies across the FDA’s regulatory spectrum, including companies that manufacture or market pharmaceuticals, medical devices, biologics, foods, tobacco, and cosmetics. He helps clients navigate:
-
- FDA compliance, including preparing for and managing FDA inspections, responding to FDA 483s and warning letters, and complying with post-market safety requirements
- FDA regulatory issues, including pre- and post-market requirements and related commercial activities such as product importation and supply chain oversight
- FDA-related diligence and regulatory counsel, including negotiating representations and warranties, in corporate transactions
- Internal investigations involving clinical trial oversight, post-market safety reporting, and risk management
A recognized industry leader, he worked at FDA for 17 years in various high-level roles and served as a Health Policy Advisor on the Senate Committee on Health, Education, Labor, and Pensions (HELP).
During his tenure in public service, he received the following awards: Secretary’s Award for Distinguished Service, Department of Health and Human Services; Excellence in Legal Services, Office of the General Counsel, Department of Health and Human Services; Commissioner’s Special Recognition Award, FDA; Commissioner’s Special Citation, FDA; and the Director’s Award for Outstanding Service, FDA’s Office of Criminal Investigations.
Content supplied by Latham & Watkins LLP
Testimonials
Collated independently by Legal 500 research team.
‘Very strong knowledge in technology-driven life sciences, including unique aspects of such a regulated industry (FDA, etc.). Particularly strong knowledge and experience in public securities offerings in the life sciences.’
‘After my 35 years in the medical device industry and 3 IPOs, I believe Shayne Kennedy has more relevant experience than any other lawyer at any firm.’
Key clients
- 4D Molecular Therapeutics AbbVie Actelion Aiolos Bio Alkermes Arcutis Biotherapeutics Artelon Ascendis Pharma Avidity Biosciences BioXcel Therapeutics BridgeBio Boston Scientific Boundless Bio CARGO Therapeutics Centerview Partners Cerevel Therapeutics CeriBell CG Oncology Erasca Fractyl Health Fulgent Genetics GRAIL Gossamer Bio Homology Medicines Icosavax IDEAYA Biosciences Janssen Biotech Jnana Therapeutics Johnson & Johnson Laminar Metsera Mineralys Therapeutics Mirador Therapeutics Owlet PACS Group Phathom Pharmaceuticals Pharmacyclics Regeneron Revolution Medicines Rhythm Pharmaceuticals Sanofi Seres Therapeutics Sobi Tavo Biotherapeutics Tyra Biosciences Verona Pharma Zevra Therapeutics
Work highlights
Advised CARGO Therapeutics in its IPO of 18,750,000 Shares of Common Stock listed on Nasdaq.
Advised CG Oncology in its IPO of 20,000,000 Shares of Common Stock listed on Nasdaq.
Advised Cerevel Therapeutics, a biotechnology and pharmaceuticals company focused on the development of novel therapies for mental and neurological illnesses, in its acquisition by AbbVie Inc. for US$8.7 billion, including an FTC Second Request clearance.