David Bourke Email & Phone Number

David is a qualified organic chemist (PhD) specialising in management and CMC technical assistance in process development and manufacturing of drug substances and drug products for preclinical, clinical and commercial use (cGMP). He is experienced in preparation of development plans and subsequent contractor selection, contract negotiation and technical management of projects for Biotech and Pharma companies. . He has worked with numerous contractors in Asia, UK, Europe and the USA on development programs supporting IND and ANDA submission. Specific expertise also includes management of analytical method development and characterisation/control of API solid properties (salt and polymorph screens) to risk mitigate further development. He is experienced in formulation development for many routes of administration included solid oral/liquid, inhalation and intravenous infusion.David’s strong background in organic, medicinal and process chemistry enables him to critically review early stage programs and facilitate the transition from research into preclinical and onto clinical development. Similarly he has employed these skills to manage API sourcing for programs at late stages of development and heading into commercial launch.

Listed skills include Upstream, Sourcing, and Apis.