Leonard Both | ATMP assessor
Swissmedic

Leo has served at both the UK’s and Swiss health authorities: MHRA and Swissmedic. During his tenure, he has contributed to expert groups for WHO, EDQM (Council of Europe) and EMA. His work spans assessment of marketing authorisations, regulatory advice, compliance, health policy, and public speaking engagements across Europe, the USA, and China, particularly for biological products including vaccines.

Leo was the MHRA Licensing Lead for the ACCESS Consortium, an alliance of five international medicines regulators. In this role, he organized and coordinated the licensing activities between MHRA and the ACCESS partner agencies for several years. He has also led project work on international collaboration and international recognition procedures, using this experience in regulatory submissions, document review, project management and pre-empting regulatory challenges.

Leo was a former board member of the Control Program Board (CPB) at the National Institute for Biological Standards and Control (NIBSC) and a Team Leader in the MHRA Biologicals & Biotechnology Unit prior to his move to Switzerland.

During the COVID-19 pandemic, Leo played a pivotal role in MHRA’s ‘Vaccine Acceleration and Licensing’ workstream, acted as assessment lead for multiple COVID-19 vaccines and therapeutics, served as Principal Assessor to the Vaccines Expert Working Group (EWG) and was a member of the MHRA’s Covid Inquiry Evidence and Analysis Group which completed its written witness statements for the UK Covid-19 Inquiry. He also led vaccine assessment work related to monkeypox and polio virus outbreaks.

Leo has also delivered structured training on antibodies and passive immunity at the University of London and University of Surrey, and has trained Chinese FDA (NMPA) colleagues. He is a published thought leader with articles in Lancet Infectious Diseases and other leading journals on topics such as access to antitoxins. He authored an EMA article on antibiotics and co-authored an MHRA position paper on biosimilar licensing without the requirement for confirmatory clinical studies.

Leo holds scientific degrees from universities in Germany and the UK as well as a Postgraduate Diploma in Law (PgDip Law, with Merit) and a Master of Laws (LLM, with Merit). His main interests are in international collaboration and regulatory convergence.