Lincoln Tsang

Information about the specialist

Lincoln.Tsang@ropesgray.com

Practice Areas

Dr. Lincoln Tsang, partner and head of Ropes & Gray’s European Life Sciences Practice, qualified as a lawyer and a pharmacist with post-graduate training in toxicology and cancer pharmacology, concentrates his practice on UK, EU and cross-border regulatory compliance and enforcement, including litigation, internal investigations and public policy matters affecting the life sciences industry. Lincoln advises clients on research and development strategies, product life cycle management, product acquisition, and risk and crisis management. He also regularly represents clients before various regulatory bodies on a wide range of matters, including clinical trials, product approval, advertising and promotion, manufacturing, safety vigilance, and health technology appraisal relevant to pricing and reimbursement decision-making for medicines and medical devices. He has also appeared before various legislatures as an independent expert on product approval and market access of medical products. He is the first lawyer outside the United States to testify in a congressional hearing before the United States Senate as an expert on matters concerning access to treatments for rare diseases.

Before entering private practice, Lincoln was head of biologicals/biotechnology and a senior official at the UK Medicines and Healthcare Products Regulatory Authority, where he developed a number of UK and European policies governing medicines regulation, including advanced therapies, biologicals and drug/device combinations. He represented the EU and the UK on a number of international regulatory cooperative initiatives. He chaired the Gene Therapy Expert Group and the Transmissible Spongiform Encephalopathy Expert Group of the European Medicines Agency and served as an advisor to the European Commission, the European Directorate for the Quality of Medicines, the Council of Europe, the British Pharmacopoeia Commission, and the World Health Organization, among others. He was appointed by UK Ministers to serve as a non-executive board member of a number of governmental organizations. A thought leader in his field, Lincoln has authored numerous articles and speaks frequently at industry events.