Job title: Senior Investigator
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.
Deep Dive: Evaluating Immunogenicity in the Eye: Best Approaches & Practices 2:30 pm
There has been much debate over the relative ‘immunoprivilege’ of the eye compared to other organs being targeted by gene therapy. It’s clear from a regulatory perspective that immune response triggered by administration of gene therapies is a key consideration, and so working to better predict, monitor and mitigate immune response in the eye will…Read more
day: Day Two