Paul Hastings Adds Leading Life Sciences Regulatory Team from Band One Practice

WASHINGTON, D.C. – Paul Hastings LLP today announced the arrival of Lynn Mehler and Phil Katz to the firm’s full service, destination Life Sciences platform. The move adds a premier life sciences regulatory team from Hogan Lovells’ Chambers Band 1 practice to expand the firm’s expertise in guiding life sciences companies at every stage of their life cycle, from early development to launch and long-term growth.                                                     

Mehler was co-head of the Global Life Sciences and Health Care Industry Sector at Hogan Lovells and is joining as Chair, Life Sciences Regulatory at Paul Hastings. Katz is a luminary in life sciences regulatory, helping to build and lead Hogan Lovells’ Pharmaceuticals & Biotechnology Regulatory practice group for nearly two decades prior to Mehler leading the practice. The pair bring more than 60 years of combined experience guiding pharmaceutical and biotech clients through the U.S. Food & Drug Administration’s multifaceted regulatory process.

“The movement of a top-of-the market life sciences regulatory team is incredibly rare and we are grateful that Lynn and Phil share our vision for creating a premier full-service life sciences platform, from regulatory and compliance to IP litigation, investigations and antitrust to equity capital markets, ECVC and private and public M&A,” said firm Chair Frank Lopez. “With their extensive FDA regulatory experience and relationships, Lynn and Phil are the epitome of our focus on providing clients intellectual capital. Life sciences is a sector where the importance of premier regulatory talent provides a barrier to entry, and we believe that Lynn and Phil and the broader team immediately provide a destination regulatory practice and will be instrumental for us to take market share across many of our practices with premier life sciences clients.”

Mehler, ranked by Chambers for Healthcare: Pharmaceutical/Medical Products Regulatory, advises clients on a range of FDA and U.S. Drug Enforcement Agency regulatory matters. She has done considerable work on the approval processes for new drugs and biologics; safety issues, including Risk Evaluation and Mitigation Strategies, or REMS; and on post-market required studies. Mehler also has significant experience in controlled substances matters, including unique regulatory issues relating to the FDA approval of controlled substances and federal and state controlled substances compliance and administrative enforcement matters. Prior to entering private practice, Mehler worked for 12 years in the FDA’s Office of the Chief Counsel, including senior counsel to the Center for Drug Evaluation and Research, and received several top agency awards.

Also ranked by Chambers, Katz, for more than 30 years, has helped guide clients ranging from start-ups bringing their first products to market and navigating FDA to large public companies with extensive product portfolios needing compliance, regulatory issue-spotting, strategic planning and advocacy before government agencies and in court. He has deep expertise in lifecycle management, including regulatory exclusivities and orphan drugs.

Mehler and Katz have collaborated on numerous matters to support life sciences clients, from newly formed biotechnology startups to global public pharmaceuticals companies. They advise clients on navigating critical FDA and related regulatory and compliance issues integral to the development, manufacturing, marketing and distribution of drugs and biologics, including next-generation products, controlled substances and over-the-counter products. Additionally, they assist clients in responding to agency enforcement activities, counsel them on business transactions and successfully represent them before the courts.

“We look forward to continuing the momentum of Paul Hastings in life sciences with a destination regulatory practice,” said Mehler. “The energy and ambition at Paul Hastings is palpable and we are excited to collaboratively work with the impressive, broad and growing cross-practice life sciences team to provide a first-in-class full-service platform to best serve pharmaceutical and biotech clients.”

Paul Hastings’ full-service, destination life sciences platform has broadened in recent years to include several leading partners across practices integral to each key stage of a life sciences company’s development, including equity capital markets lawyer Seo Salimi, M&A lawyer Eric Schiele, technology transactions lawyer Sarah Gagan, ECVC partner James Huie and antitrust partner Joshua Soven, among others.

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