Advisory Board Member

Grant Williams

Grant joined NDA as a medical advisor in 2015. He is a board-certified oncologist and regulatory consultant with 25 years of experience focused on oncology drug development trail design and regulatory strategy with special emphasis on US FDA requirements.

He successfully advises & supports clients throughout all stages of development.

Key Areas Of Expertise
  • In-depth knowledge of medical oncology
  • Detailed knowledge of the FDA approval system from Division of Oncology Drug Products point of view including:
    • Requirements for US Accelerated Approval.
    • Advice on design of pivotal trials in oncology to obtain Marketing Authorisation in the US
    • Participation in Pre IND, End-of-Phase-2, and Pre NDA meetings
  • Clinical documentation requirements to support Investigational New Drug (IND) and New Drug Application (NDA) applications including:
    • Scientific and strategic design aspects of clinical development plans
    • Review of IND and NDA submissions on a large portfolio of cancer drugs including phase 1, phase 2, and phase 3 trials
  • Clinical development plan scientific strategy and design
  • Pharmacogenomics, biomarkers and personalised medicine
  • Author of FDA Guidance Documents, e.g.: Cancer Guidance on Clinical Data in Marketing Applications (Draft), IND Exemptions for Lawfully Marketed Cancer Drugs, Oncology General End Points Guidance
  • Member of the FDA Pharmacogenomics Working Group and Interdisciplinary Pharmacogenomics Working Group (IPRG)
Before Joining The NDA Advisory Board

Grant was a Drug Reviewer, Team Leader and subsequently Deputy Director, Division of Oncology Drug Products at the FDA. During his tenure, he drafted guidance documents that are now central to the design and interpretation of pivotal studies for cancer drug approval. This included the Cancer Endpoints Guidance which outlines FDA positions on analysis of PFS, a key endpoint in cancer drug approval.

After leaving the FDA he went on to be the Chair of oncology product committee at Novartis and later GSK. He was a member of the PhRMA statistical subgroup on PFS and co-authored papers on this topic.

Grant Williams

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