Dr Susan Jerian

Susan has been with NDA since 2017, a leading expert in drug and biologic development for hematology and oncology indications, combination product development including companion diagnostics, biosimilars, clinical trial design and regulatory strategy with special emphasis on US FDA requirements.

Providing regulatory and clinical development technical expertise to pharmaceutical and biotechnology companies worldwide.

Key Areas Of Expertise

• National Cancer Institute (NCI) trained oncologist
  • With over two decades of leadership and experience in the Pharmaceutical/Biotechnology Industry and the Food and Drug Administration (FDA)
  • a track record of product approvals (over 20) and successful clinical programs.
  • Strategic oncology product development including drugs, biologics (antibodies, therapeutic proteins, tumour vaccines, cellular and gene therapies), and therapeutic aspects of devices (stem cell selection devices and in vitro diagnostics)
  • Design and analysis of Phase 1, 2 and 3 human clinical studies
  • Regulatory expertise for all phases of development: pre-IND, IND, NDA, BLA, post-marketing commitments, safety, product labelling, and FDA advisory committee meetings
  • Expertise coordinating global initiatives for U.S. based teams, multinational teams and corporate partnership scenarios
  • Critical program analysis and solution implementation: Identification of program strengths and rate-limiting weaknesses with assistance in the development and implementation of solutions

• Extensive expertise in the inner workings of the US regulatory systems
  • Provided expertise for preparation for FDA meetings including briefing document preparation, coaching sponsor teams regarding FDA interactions and participation in FDA meetings. Typical meetings include pre-IND, Type A, B, and C, end of phase 1, end of phase 2, pre-NDA/BLA, a clinical hold, Breakthrough Designation request, Fast Track request, and public advisory meetings
• Clinical documentation requirements supporting US regulatory applications
  • Design and drafting of clinical protocols, informed consent documents, charters and other protocol-related documents, regulatory briefing documents, clinical study reports, and marketing authorization applications.

• Clinical development plan scientific strategy and design
  • Designed and authored clinical development and regulatory strategic plans
  • Designed and analysed complex or novel regulatory strategies
• Served on clinical trial oversight committees (e.g. safety oversight)
• Worked with academic institutions to establish novel product development programs including spinoff start-up companies.
• Conducted due diligence assessment of therapeutic products

Before Joining The NDA Advisory Board

Susan was the Visiting Faculty, Keck Graduate Institute of Applied Life Sciences.  The Director of Clinical Research, at Amgen, Inc., and Global Development Leader for two programs. Prior to that, she was the Medical Officer and Team Leader at the FDA’s Center for Biologics Evaluation and Research, Division of Clinical Trials Design and Analysis, Oncology Branch.

Susan is also the President and Founder of ONCORD, Inc. ONCORD has worked with over 200 pharmaceutical and biotechnology companies in the US, EU, Australia and Asia.