ABOUt

Dr Jason Cooke

Merlin Pharma Consulting Ltd is run by Dr Jason Cooke who has more than 26 years experience in pharmaceutical research and development at one of the world’s leading pharma companies.

 

Now independent, he is available to guide your molecule through the next phase of development. Let’s talk about what you need to advance your small molecule candidate drug with speed, quality and confidence.

 

Jason led the GSK chemistry team responsible for the development and manufacture of the HIV attachment inhibitor fostemsavir tromethamine. Marketing authorisations were recently submitted to both the FDA and EMA to allow commercialisation of fostemsavir. During this project the team successfully transferred more than a decade of development history from BMS (the originators of the molecule) to GSK and developed a new supply chain for the commercial manufacture of the drug substance. Jason was heavily involved in evaluating potential suppliers (CDMOs) and transferring the chemistry process to the technical teams at the selected suppliers.

 

Jason wrote major sections of the NDA regulatory submission for fostemsavir while supervising the GMP manufacture of the site specific registration stability batches. In addition he reviewed validation protocols and reports to ensure successful validation of the registered stages of chemistry at several CDMOs. This was followed up by visits to all sites to prepare for pre-approval inspection by regulatory authorities. For this work Jason was awarded a Gold employee recognition award.

 

Prior to this Jason worked on a large number of clinical and pre-clinical development compounds developing new routes and processes using a range of technologies including flow chemistry and Quality by Design (QbD) approaches. Jason has extensive experience of working with teams in the UK, Europe, US, India and China.

 

In addition to a first class degree in chemistry and doctorate in synthetic organic chemistry – both from the University of Oxford – Jason also holds an MBA with merit from Warwick Business School.

Jason formal portrait Dec 2019