Grant Williams, MD: Offerings as a consultant
Grant Williams is a board certified medical oncologist with 16 years of oncology review experience at FDA and 3 years of experience in oncology clinical development in the pharmaceutical industry. As a consultant he provides a unique blend of experience in oncology clinical trial design and in oncology drug regulation.
Areas of special expertise:
The following paragraphs outline expertise in several areas:
- Protocol design for regulatory success
- Oncology regulatory strategy
- Preparing for regulatory meetings
- Scientific review of protocols
- Independent Data Monitoring Committee (IDMC) member
- Protocol design for regulatory success
Dr. Williams was involved in reviewing and designing protocols for approval of cancer drugs with FDA for 16 years as medical reviewer, team leader, and deputy director followed by 3 years in industry as oncology protocol review chairman for two leading oncology pharmaceutical companies. He has expertise in oncology endpoints, having authored the draft oncology endpoints guidance which was recently finalized by FDA. While at FDA he was a member of the FDA-PhRMA pharmacogenomics working group. He has experience with novel endpoints and has published his experience at FDA both in oncology journals and textbooks. He has explored the use of novel trial designs during experience in FDA and industry. He has also been a member of the PhRMA statistical subgroup working on PFS issues, such as difficulties with central radiologic review of the PFS endpoint. He has been an invited speaker to discuss PFS, novel trial design, and oncology regulatory issues.
- Oncology regulatory strategy
In order to develop a good clinical development plan, drug developers need to understand which clinical trial designs will provide substantial evidence of safety and efficacy, the FDA standard for drug approval. Dr. Williams has an in-depth understanding of FDA regulations in the area of oncology drug approval. He understands the possibilities of special oncology regulations to speed drug approval, such as the accelerated drug approval regulations (Subpart H). Over a number of years, he has witnessed the evolving application of these regulations to support drug approval. He has authored three final or draft guidances on oncology drug regulation.
- Preparing for regulatory meetings
During his 16 years at FDA, Dr. Williams evaluated oncology PreIND, End of Phase 2 (EOP2), PreNDA, and NDA submission documents and Industry presentations from the perspective of reviewer, medical team leader, and deputy division director. He has also helped prepare briefing documents for FDA and EMEA during his 3 years with PhRMA. Thus he is well qualified to provide advice, review documents, and critique presentations for FDA.
He would be a valuable participant in a “mock ODAC” meeting. As an FDA oncology reviewer, he personally prepared numerous FDA ODAC briefing documents and then presented his findings to ODAC. As a team leader and deputy directory he helped prepare many FDA teams for ODAC presentations, and sat at the ODAC table many times in his 16 years at FDA.
- Scientific review of protocols
In addition to providing an important regulatory perspective in protocol design, Dr. Williams can provide an important scientific critique of protocols. During his 16 years at FDA, his review of protocols emphasized safety in phase I and efficacy in phase III. At FDA he also learned important principals of statistics, pharmacokietics, pharmacodynamics, and toxicology working in a matrix setting with other FDA review staff. In his 3 years in PhRMA, as chairman of the oncology protocol review committee, his review of protocols has involved scientific and regulatory considerations of phase I, phase II, and phase III trials including pharmacokinetics, biomarkers, and operational considerations. Thus Dr. Williams can provide excellent feedback on the scientific and regulatory merit of phase I, phase II, or phase III protocols as part of a protocol review process.
- Independent Data Monitoring Committee (IDMC)
The use of IDMCs is often critical for assuring the safety of patients and the integrity of oncology clinical trials. Members of an IDMC should have extensive experience in evaluating oncology data. Their decisions need to take into account 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. Dr. Williams’ years of experience in making difficult judgments based on cancer trial data and his in-depth understanding of statistical and regulatory principles would make him a valuable member of an IDMC. During his 3 years in industry Dr. Williams helped write IDMC charters was involved in discussions with IDMCs. | 
