Jenny has a degree in Biochemistry and a PhD in Pharmacokinetics and Toxicology.
Jenny 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. She then became Head of Project Safety Assessment Group, Preclinical Safety at Novartis Pharma AG in Basel, Switzerland. Jenny then Headed up the BioPharma Safety Assessment Group at MedImmune 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 trial and BLA/CTD approvals and has experience of 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.
Jenny was the MHRA/UK delegate to the CHMP Safety Working Party and MHRA observer on the UK Gene Therapy Advisory Committee (GTAC). She was a member of the Expert Working Groups for ICHS6/ICHS6R(1), ICHS8, ICHM4(S) and was part of the UK industry review team post-Tegenero which recommended greater consideration of the pharmacological active dose (PAD) and MABEL approach for First in Human trials.
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