Jonathan Sisson

Jon is an experienced pharmaceutical physician with extensive knowledge of medicines development and regulation across the product lifecycle.

Since joining tranScrip in January 2022, Jon has led and supported multiple projects across many therapy areas, including regulatory submissions at all stages of clinical development. These have ranged from high level due diligence/gap analysis/regulatory strategy work to detailed data review and document writing.   

Whilst at tranScrip, Jon has been subcontracted by a national regulatory agency, and to date has assessed over 80 hybrid/generic/well-established use applications for Marketing Authorisation. 

Before moving to tranScrip, Jon was a senior medical assessor at the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in several positions across 22 years.  Initially, Jon worked in the post-licensing division across all therapeutic areas, with a focus on license variations (including new therapeutic indications) safety reviews, pro-active therapeutic reviews, and pre-vetting of industry advertising.  

After 10 years in post-licensing, he moved to MHRA licensing division, to assess new license applications (new chemical entities and generics) and provide scientific advice to companies. This mainly covered products for cardiovascular conditions and diabetes, but Jon gained cumulative experience in a wider range of therapy areas as a UK representative on the Committee for Medicinal Products for Human Use (CHMP) Scientific Advice Working Party.    

Previously, following clinical training in internal medicine, Jon worked in industry for around 5 years, for Hoechst Marrion Roussel and then GlaxoWellcome.  This was mainly in phase I and phase II, including as Principal Investigator in first-in-man studies.    

Jon is a fellow of the UK Faculty of Pharmaceutical Medicine and sits on the examination board for their Certificate and Diploma in Pharmaceutical Medicine.