Grant Williams, MD is an oncology and regulatory consultant. He received his medical and oncology training at the University of Alabama in Birmingham prior to joining FDA in 1989. For 16 years, from 1989 to 2005, he worked in the Division of Oncology Drug Products at FDA evaluating cancer drug applications, 8 years as a medical reviewer, 5 years as a medical team leader and 3 years as Deputy Director. During his tenure at FDA he contributed to 3 guidance documents, including the Cancer Endpoints Guidance. He subsequently spent three and half years working in oncology clinical development with Novartis and GSK. In September 2008 he became an independent based in Wayne, PA. Over the past 9 years he has worked as a consultant exclusively in oncology regulatory strategy.
Ramachandra (Ram) G. Naik, M.D.
Biostatistics
Regulatory Science & Innovation; Biomedical Advanced R&D
EU Regulatory
Clinical Operations/Project Management
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Health Policy Development
CMC, Formulation/Process Development & Sourcing
Medical Device
Eric Kolb
Melissa Thompson
QA/QC
Medical Writing/Electronic Submissions
Kristi Hultberg, B.S.
Botanicals
Government Relations and Public Affairs
Defense & National Security Practice
Commercialization and Business & Corporate Strategy
Kinexum Associates
Elijah Abass