Jenny Sims

Jenny Sims, Ph.D., has a degree in Biochemistry and a Ph.D. in Pharmacokinetics and Toxicology. She has more than 30 years of experience in non-clinical drug development, with a focus on biotechnology products (monoclonal antibodies, antibody-drug conjugates, protein-drug conjugates, therapeutic proteins, novel scaffolds, DNA vaccines, and cell & gene therapies).

Jenny worked for 12 years as an Expert Preclinical Assessor in the Clinical Trials Unit and Biotechnology Group at the MHRA and was a member of many CHMP Rapporteur/Co-Rapporteur assessment teams for biopharmaceuticals and scientific advice procedures. She then became Head of Project Safety Assessment, Preclinical Safety at Novartis Pharma AG. Jenny then Headed up the BioPharma Safety Assessment Group at Medlmmune before returning to Novartis to take on the role of Head of Translational Sciences and Safety, in the Novartis Biologics group.

In 2012, Jenny established Integrated Biologix GmbH, to provide independent non-clinical development consultancy for biopharmaceuticals and advanced therapy products, working with early start-ups and small/large companies at all stages of the drug-development cycle. Jenny has been involved in many successful clinical trials and BLA/CTD approvals and has experience supporting projects at Health Authority Scientific Advice meetings, FDA advisory committees, and CHMP oral hearings. She is a regular member of company Scientific Advisory Board meetings.