NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Agnes Westelinck, PharmD

Practice Area Focus

  • Development Strategy
  • US and EU Regulatory Strategy
  • Oncology Products
  • Pharmaceuticals
  • Immunotherapies
  • Monoclonal Antibodies
  • Cell Therapies
  • Portfolio Assessment

Biography

Dr. Westelinck is a Premier Expert consultant with significant experience in regulatory strategy and operations in the US, EU and Asia and in engaging proactively with FDA, EMA and major national Agencies. She is former Executive Director and Global Head of Regulatory Affairs, Oncology, for GlaxoSmithKline; Director of Regulatory Affairs at Hoffman-La Roche; Visiting Scientist/Executive at the US Food & Drug Administration (FDA), Office of Drug Evaluation, Division of Oncology (CDER); and faculty member at the Pharmaceutical Education and Research Institute (PERI), teaching courses such as "Drug Development for Pharmaceutical Physicians and Scientists", "Global Drug Development" and "Advanced Course in Oncology Drug Development." Dr. Westelinck has co-authored a number of FDA/NIH and across-industry publications on drug development.

In addition to global regulatory strategy, Dr. Westelinck's expertise includes innovative approaches in drug development (targeted therapies, immunotherapy, breakthrough therapies, novel-novel combinations, companion diagnostics, and innovative study designs) and emerging technologies (cell therapies, therapeutic RNA). She also provides strategic input for portfolio and licensing/deal-making decisions, and guidance for IND and NDA submissions, rare diseases, biomarkers, pediatric exclusivity, and accelerated approvals.