Kofi
Owusu, MBBS, MRCP
Medical Director
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Kofi is a Medical Director and works as a member of the VCLS non-clinical and clinical team. He provides advice on projects involving the design of clinical development plans, clinical aspects of Scientific Advice Procedures and Marketing Authorisation Applications, clinical trial protocols, Health Technology Assessment submissions, Risk Management Plans, Paediatric Investigation Plans and Compassionate Use Programs.

Kofi has more than 20 years of experience working in clinical practice and pharmaceutical medicine, eight of which he spent working with the MHRA. During his time at MHRA Kofi led on various interactions with the CHMP, FDA and the Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) and frequently presented at MHRA, CHMP, EMA expert advisory group and joint FDA – EMA meetings.

He has extensive experience with centralised, mutual recognition and decentralised procedures and has led the clinical assessment of marketing authorisation, type II variation and line extension applications for a variety of medicinal products, as the lead assessor within CHMP Rapporteur assessment teams. Kofi has authored several CHMP and MHRA reports including product assessment, inspection, similarity and new active substance assessment reports. He has also negotiated with European regulators on content of key regulatory documents, including product information documents and European product assessment reports (EPAR).

Kofi has specific expertise in clinical development of biotechnology products including monoclonal antibodies, antibody-drug conjugates, ATMPs (stem cell, somatic cell and gene therapies), enzymes, hormones, blood products, growth and colony stimulating factors and their antagonists and ancillary medicinal substances. Through this focus he has developed expert knowledge in the treatment of chronic inflammatory diseases and in rheumatology, oncology and haematology therapy areas.

Prior to joining the MHRA Kofi worked as a Senior Medical Adviser on Immunology at Abbott UK; working on the company’s immunology research and development programs, providing clinical support for market access programs and coordinating advisory boards and KOL liaison initiatives. At Abbott he oversaw clinical activities for HTA submissions in the UK and represented the company at National Institute for Health and Care Excellence (NICE) HTA meetings.

As part of his clinical experience he worked as Senior House Officer and then as Registrar in Internal Medicine at St Thomas’ Hospital, London and Croydon University Hospital, where he managed teams of doctors in a number of sub-specialties in internal medicine.

Kofi earned a Medical Doctor Degree from the St. George’s Hospital Medical School, University of London and is a member of the Royal College of Physicians (MRCP, UK). Kofi is based in our London office.