Advisory Board Member

Dr Jenny Sims

Jenny has been with NDA since 2012, she is a leading expert in non-clinical safety strategies for chemical, biological & advanced therapies, mechanistic safety, juvenile animal study design and interpretation. 

She provides non-clinical, translational and immunogenicity expertise to clients that are developing exciting and novel technologies and who are facing issues during discovery and candidate selection, early development to First-in-Human studies, and beyond.

Area of Expertise
  • Nonclinical strategy and regulatory requirements to support European Clinical Trial Applications (CTA), US INDs and Marketing Authorisations Applications (MAA)
  • Preclinical development plan scientific strategy and design including:
    • Non-clinical pharmacology, translational PK-PD and safety assessment for new medicinal products, biopharmaceuticals (including gene and cellular therapies), biosimilars
  • Immunogenicity risk assessment
  • Due-diligence evaluation
Before joining the NDA Advisory Board

Jenny worked at the MHRA as an assessor of non-clinical pharmacology, pharmacokinetics and toxicology for new drugs, biopharmaceuticals (including gene and cellular therapies), clinical trial applications and has also been the UK delegate to CHMP Safety Working Party. Upon leaving the MHRA, Jenny has worked for more than 13 years in industry with AstraZeneca/MedImmune and Novartis, where she was Head of Biologics Translational Sciences and Safety. 

Jenny holds a BSc in Biochemistry and a PhD in Pharmacokinetics and Toxicology

Dr Jenny Sims


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