Bob Clay established his own regulatory consultancy practice through Highbury Regulatory Science. Prior to this, he was a VP global regulatory affairs at AstraZeneca with responsibility for oncology, infection and personalised healthcare. Bob is the chief regulatory officer at Kinapse and a member of the board of TOPRA (The Organisation of Professional Regulatory
Affairs). He is a member of the Expert Scientific Advisory Committee for Medicines for Malaria Venture (MMV) and several working groups at CPTR (Critical Path to TB Regimens). Bob is a pharmacist with more than 30 years’
experience in drug development; leading the global regulatory approval of many products across a range of therapy areas including metabolic diseases, neuroscience, cancer and infection. Bob has held significant leadership roles
in regulatory affairs in regional and global functions at several companies including AstraZeneca and Pfizer. Bob has had a long-standing interest in the regulatory aspects of adaptive trial designs, including membership of the PhRMA working group.