Grant Williams is a board certified medical oncologist with 16 years experience in Oncology Review at FDA and 3 years experience in oncology clinical development in the pharmaceutical industry.
FDA Oncology Drugs Reviewer (1989-1996)
- primary review of 15 NDAs or efficacy supplements
- review of INDs and protocols
- participated in industry meetings (preIND, end of phase II, and preNDA)
- presented to Oncology Drugs Advisory Committee (ODAC).
FDA Oncology Drugs Team Medical Team Leader: (1997-2001)
- led a team of five medical officers in review of INDs and NDAs
- led preparation for advisory committee presentations
- approved FDA team responses to meeting questions
FDA Oncology Drugs Deputy Director (2002-2005)
- attended most and chaired many meetings with industry (pre IND, EOPII, PreNDA)
- with the Division Director developed the Cancer Endpoints Project (an ongoing project to evaluate cancer endpoints used in drug approval)
- led the writing process for a draft guidance on oncology endpoints in 2005 (Final version subsequently published in May, 2007)
PhRMA Oncology Clinical Development at Novartis and GSK (2005-2008)
- chaired the oncology protocol committees for Novartis (05-06) and GSK (06-08)
- worked on clinical development team for a MTOR inhibitor and a VEGR TKI
- developed drug approval programs for neuroendocrine cancers, breast cancer, and ovarian cancer
- Discussed trial designs with FDA and EMEA
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