Dr. Kate Darwin leads Quotient Sciences’ clinical and CMC regulatory teams, and is responsible for obtaining regulatory approval of our clinical trials and providing strategic regulatory advice to our clients.  She has over 25 years’ experience in early-phase contract research organisations, where she has held a variety of roles, including regulatory affairs, quality assurance, medical writing, and management of scientific and technical services.  She has expertise in a wide range of phase 1 trials, including first-in-human trials and trials with complex and flexible designs.  Kate authored the chapters ‘Conduct of Clinical trials: Good Clinical Practice’ in the Textbook of Pharmaceutical Medicine and ‘From Bench to Bedside: The First Studies of a New Molecule in Man’ in Pharmacology for Chemists:  Drug Discovery in Context.

Kate holds a DPhil in microbial pathogenesis and a BA in biochemistry, both from Oxford University.