Gil David Fine, Ph.D.

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Dr. Gil Fine brings over 32 years of distinguished experience in the clinical development of medical products, specializing in biostatistics and regulatory submissions. Since earning his Ph.D. in Biostatistics from UCLA in 1991, he has played instrumental roles in numerous NDA, MAA, BLA, and IND submissions and approvals across diverse therapeutic areas.

Dr. Fine's expertise spans multiple critical therapeutic areas including oncology (solid tumors and hematologic malignancies), autoimmune disorders with emphasis on rheumatoid arthritis, acute and chronic pain management, and inflammatory conditions. His current research focuses on adaptive clinical trial designs, survival analysis in the presence of delayed treatment effects, and advanced statistical methodologies for complex clinical scenarios.

As a Statistical Consultant since 2012, Dr. Fine has provided strategic guidance to leading pharmaceutical and biotechnology companies including Genentech, Sorrento Therapeutics, Cullinan Oncology, and Humanetics Pharmaceuticals. His comprehensive approach encompasses study design, protocol development, statistical analysis planning, and database management for phase I through III clinical trials.

Previously, Dr. Fine held executive positions at Sumitomo Dainippon Pharma Oncology (Executive Director, Data Sciences, 2015-2022) and Astex Pharmaceuticals (Executive Director, Biometrics and Statistics, 2008-2012), where he successfully led global product development teams and managed regulatory submissions.

Dr. Fine has actively participated in numerous FDA meetings and served on Independent Data Safety Review Committees and Data Safety Management Boards. He is a SAS® Certified Professional with extensive experience in electronic data capture systems including Medidata Rave®, Oracle InForm®, and EDC Easy®—a platform he co-developed that complies with Title 21 CFR Part 11 on Electronic Records.

Dr. Fine has authored peer-reviewed statistical publications and contributed to abstracts, presentations, and posters for leading professional meetings including ASCO, ASH, and AACR. His teaching experience includes positions at De Anza College and UCLA's School of Public Health.

*Dr. Fine's unique combination of statistical expertise, regulatory knowledge, and hands-on clinical development experience provides an unparalleled perspective on study design, data analysis, and quality implementation in regulated environment.

At NexusBio Partners, we specialize in providing expert consulting services for drug development in the biotechnology sector. Our team of experienced professionals offers insights that can help streamline your research processes and enhance your product development timelines. We are committed to guiding you through the complexities of biotech with tailored strategies.