DR TONY WILLIAMS. MA, MB, BS, FRCP
Dr Williams is an experienced drug developer with experience of large pharma, smaller start-ups and consulting in due diligence for equity groups, in all areas of drug development in oncology. He has extensive experience in global pharmaceutical protocol and clinical development, including clinical, medical, and regulatory monitoring and operations. Expert in Phase 1-4 study development and oversight, regulatory affairs (NDAs, INDs, and SPAs), orphan and breakthrough drug applications, medicine innovation, strategic planning, and business development.
Clinical Development and Medical Affairs
He has managed medical, clinical, and regulatory operations and protocol development in the US/EU as well as for orphan and breakthrough drug applications. Medical monitoring and oversight of studies (preclinical and Phases 1-4); proof-of-concept studies; potential target review; PI relations including chairing medical advisory committee; management of SAWG, IMPD, NDAs, INDs, and SPAs; clinical program troubleshooting; and product commercialization and launch. Study site recruitment and acceleration. Strategic advice on developing novel breakthrough products and new dosage formats.
Executive Leadership
He has been chief medical officer in start-ups and established companies and has provided medical management; strategic advice on development of novel products; strategic planning for pivotal studies; creating and making presentations to venture capitalists and pharma partners as well as academic meetings; launch and CME activities; new business development, fundraising, and strategic alliances; competitor and market analyses; board presentations and investigator relations. Skilled at using clinical and executive expertise to increase productivity and success, gain funding, and boost stock prices.
Regulatory Affairs
He has overseen medical and clinical FDA/EMA regulatory process and interactions including advice on end-of-phase meetings, NDAs, INDs, and SPAs. Medical/regulatory expertise in protocol adherence and safety reporting, SAWG, IMPD, and study set-up in the EU and US. Expert in novel and orphan/breakthrough product designations. Advisor on FDA meetings regarding post-marketing commitments. Responsible for the clinical portion of a successful 505(b) (2) application for Rifate
Philosophy
Having read medical sciences at the University of Cambridge at a time of biological advances that have transfigured medicine and studying experimental pathology (immunology, bacteriology, and virology), he learnt of the importance of understanding and implementing translational medicine. Following qualification as a physician at University College Hospital (UCH), London, he worked in oncology (solid and haematogical) at Charing Cross Hospital and UCH London, and spent some years working in laboratory medicine, mostly infectious disease, gaining an appreciation of the need for a seamless integration of patient care and laboratory studies to ensure the best outcome for the patient.
Since pursuing a career in drug development, he has continued to integrate novel approaches to patient care (such as monoclonal antibodies) and innovative approaches to diagnostics, such as circulating tumor cell assays, NGS, and changes in the understanding of imaging data in a period where immune checkpoint inhibitors have given rise to the concept of pseudoprogression and using this to produce clinical data that satisfies current and likely future regulatory needs. He is also interested in patient-reported outcomes, which has become important in decisions involving dose escalation in early oncology clinical studies.
He is a Fellow of the Royal College of Physicians, London, based on his work in clinical pharmacology. Currently, he splits his time between the USA and London. He is slowly pursuing an MBA at UCL.