DMPK professional with 13+ years of experience working with biotherapeutics (monoclonal antibodies, ADCs, antibody fragments) and small molecules. Represented DMPK on multi-disciplinary teams to provide ADME input and strategy to drug discovery and development programs, proposing and implementing paradigms for addressing project needs with respect to ADME, pharmacology and safety in CNS, pain, ophthalmic and oncology areas.
Extensive experience in preparing regulatory documents (IND sections 2.6.4 & 2.6.5, IB, BD and support NDA and BLA filings) for biologics and small molecules. Additional experience with preclinical PK/PD analysis, defining therapeutic window, and prediction of human pharmacokinetics. Designing and implementing strategy for assessing ADME issues and addressing those using conventional and novel technologies. Adept at mentoring and developing junior staff, managing contractors and CROs. Lead efforts to innovate within DMPK, and developed partnerships with multiple disciplines to hunt for leads.