Sarah Gould is a senior principle scientific advisor with extensive experience (20 + years) in biotech, pharma and as a consultant. She has a proven track record of delivering toxicology and safety pharmacology programs, individual studies and regulatory documents (IND, IMPD, CTD) for both small and large molecules (proteins, peptides, mAbs, virus vectors) along the development pipeline and has supported over 100 submissions. Sarah has interacted with various health authorities, including FDA, EMA, PMDA, as well as individual European authorities and emerging markets.
- Deep expertise in various therapeutic areas and modalities including vaccines/adjuvants, oncology including oncolytics and miRNA, diabetes including obesity, immunology, cardiovascular, neuroscience, anti-infectives and toxicology evaluations of chemicals
- Presented, organized and chaired toxicology meetings including at SOT, Eurotox, HESI, DIA and Biosafe
- Involved in international scientific collaborations: HESI (vice president- safety of adjuvants; concordance project) and IMI projects (EFPIA rep)
- Contributory author to regulatory guidelines documentation including safety assessment of process residues/contaminants in vaccines (EVM re: TTC, 2012); WHO vaccine guideline (2013)
- Published several scientific papers in peer reviewed journals and co-authored a book chapter titled “vaccine toxicology: nonclinical predictive strategies” and is also an ad hoc reviewer for peer reviewed journals