Sandra Silberman
CMO CNS Pharmaceuticals
Sandra L. Silberman, M.D., Ph.D. is the Chief Medical Officer of CNS Pharmaceuticals. Dr. Silberman is a Hematologist/Oncologist who earned her B.A., Sc.M. and Ph.D. from the Johns Hopkins University School of Arts and Sciences, School of Public Health and School of Medicine, respectively, and her M.D. from Cornell University Medical College, and then completed both a clinical fellowship in Hematology/Oncology as well as a research fellowship in tumor immunology at the Brigham & Women’s Hospital and the Dana Farber Cancer Institute in Boston, MA. Dr. Silberman has played key roles in the development of many drugs including Gleevec™, for which she led the global clinical development at Novartis. Dr. Silberman advanced several original, proprietary compounds into Phases I through III during her work with leading biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, Imclone and Roche.
Seminars
- A novel formulation of a taxane (abeotaxane) that effectively crosses the BBB
- Studied in over 350 patients to date, which include positive Phase 1 clinical trials in GBM
- Proposed Phase 2 trial for 2nd line GBM with an additional focus on the exploration of potential biomarkers
- Join this workshop to establish a future direction towards achieving a gold standard surrogate endpoint for GBM clinical trials
- Discussing innovative, non-invasive strategies for dose selection and defining a biologically effective dose in GBM trials such as using advanced imaging biomarkers and liquid biopsies from CSF to overcome the infeasibility of serial brain biopsies
- Exploring the challenges in gaining regulatory approval and validate advanced imaging biomarkers to build a strong scientific case for their use as reliable indicators of therapeutics response
- Diving into the limitations of using ‘Progression Free Survival’ as a surrogate endpoint for overall survival in GBM due to pseudo-progression and designing trials that can use complementary endpoints to accurately differentiate between treatment-based inflammation and true disease progression
- Addressing the FDA’s hesitation to accept PFS as a standalone surrogate for accelerated approval in GBM
- Exploring alternative or composite endpoints that could meet regulatory standards
