Dr. Williams is a board-certified medical oncologist with 16 years of experience in oncology review at FDA followed by 3 years in the industry as an oncology protocol review chairman for two leading pharmaceutical companies, GlaxoSmithKline and Novartis. He was the Deputy Director for the Division of Oncology Drug Products at FDA, for 3 years.
During his tenure at FDA, he has attended and chaired many meetings with industry, developed the Cancer Endpoints Project with the Division Director, and led the writing process for draft guidance on Oncology Endpoints in 2005. He led preparation for advisory committee presentations and was involved in the primary review of more than 20 NDAs or efficacy supplements, approval of FDA team responses to sponsor meeting questions and, review of several INDs and protocols.
Dr. Williams received his medical degree and completed his fellowship in pathology, internal medicine, haematology, and oncology, at the University of Alabama at Birmingham. As a consultant, he provides a unique blend of experience in oncology clinical trial design and oncology drug regulation.
Areas of special expertise:
- Protocol design for regulatory success
- Novel oncology endpoints
- Novel trial designs
- Resolution of oncology regulatory issues
- Oncology regulatory strategy
- In-depth understanding of FDA regulations and guidances in oncology drug approval
- Possibilities of special oncology regulations to speed drug approval
- Preparation for regulatory meetings
- Evaluation of oncology pre-IND, End of Phase 2 (EOP2), pre-NDA meetings and NDA submission documents
- Advice, review, and feedback on industry presentations and briefing documents from the perspective of reviewer, medical team leader, and deputy division director
- Valuable participant in a “mock ODAC” meeting
- Scientific review of protocols
- Scientific critique of protocols, with emphasis on safety in phase I and efficacy in phase III
- Regulatory considerations of phase I, phase II, and phase III trials including pharmacokinetics, biomarkers, and operational considerations
- Independent Data Monitoring Committee (IDMC)
- Extensive experience in evaluating oncology data, considering the interim nature of the data, the safety of the patient, whether findings are definitive, and the potential impact of the IDMC decision on the drug’s development
- Valuable member of an IDMC
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