Dr Michael Gamlen has had an extensive career spanning over 40 years in scientific research and tablet development in a range of contexts including Development, Clinical Trials Manufacturing and Production. Formally the Head of Tablet Development at the Wellcome Foundation Ltd for 15 years. Author of pharmaceutical contributions to at least 20 successful INDs and CTXs and at least 6 successful NDAs/MAAs. Experienced and successful in FDA interactions with reviewers and inspectors. Organised and fronted two successful PreApproval Inspections by FDA. Dr Gamlen has developed hundreds of successful tablet formulations at all scales from gram to Production. He has worked with many of the world’s leading pharma companies including GSK, J and J, Pfizer, Teva and Astellas.