Pharmaceuticals & Biotech

Our global team works with almost all of the largest multinational pharmaceutical and biotechnology companies and hundreds of innovative smaller companies, ranging from ultra orphan product developers, to venture-backed precommercial companies, to leaders in the gene and cell therapy spaces. We are intimately familiar with the nuances and challenges of the regulatory frameworks in the U.S., Europe, and China that govern discovery through development, commercialization, and lifecycle management of pharmaceuticals and biotechnology. Our extensive experience, coupled with our representation of major trade associations, gives us timely and unparalleled market-wide insights and benchmarking which we draw from when we work with clients. Our life sciences antitrust team is globally recognized in defensive and affirmative litigation related to U.S. and European competition law.

We are leaders in the field of market access and drug pricing counseling. Our team helps lawyers, compliance officers, and business leaders understand the latest legal, business, and policy challenges facing the industry’s approach to product pricing, reimbursement, and access. We have earned a reputation as “master strategists” for our ability to handle complex pharmaceutical and biotech regulatory issues, including product approval strategies; complex clinical trial arrangements; high-profile government and congressional investigations; product safety and quality matters inspections; and other administrative actions. Our litigators have a well-established track record resolving large-scale, high-stakes pharmaceutical and biotech disputes involving product liability and breach of contract matters. We are also adept at administrative litigation, and have been involved in consequential challenges to FDA, CMS, National Institute for Health and Care Excellence, and other agencies on behalf of individual companies or trade groups.

Additionally, we advise clients on complex licensing and M&A transactions that involve cutting-edge science and novel deal structures designed to achieve favorable outcomes in a dynamic business and scientific environment.