ADVISORY BOARD

Dr. Bhardwaj Desai has been a hematologist and medical oncologist for 30 years and for the last 16 years has been a leader in oncology clinical development. Since 2008, Dr. Desai has led numerous global oncology and biologic/biosimilar drug development programs for leading pharmaceutical companies, including Astellas, Pfizer, Hospira, and Abbott/AbbVie. In the last 14 years, he has worked as a leader in global oncology drug development and was instrumental in bringing five new successful New Drug Applications (NDAs) in oncology. He has expertise in numerous investigational hematology and oncology agents including PARP inhibitors, cMet antibodies, LAG-3, PD-1, PI3K, CDK4/6, Claudin 18.2, EGFR, FLT3, among others.

Throughout his career he has led all phases of oncology drug development, including pre-clinical development, clinical trial management, designing of Phase 1 to Phase 3 clinical trials, post-launch marketing, post-approval studies and regulatory affairs. Dr. Desai has also worked closely with the FDA and other global regulatory authorities to expedite the review and approval of multiple compounds, including an oral presentation for a biosimilar Biologics License Application (BLA) submission to the European Medicines Agency (EMA), which led to the approval of the first biosimilar monoclonal antibody, and Health Canada as well as successful BPD type 2, 3 and 4 (pre-BLA) meeting for the initial biosimilar application to the FDA.

Dr. Desai is also Chief Strategic Medical and Clinical Development Consultant at Oncology Innovation, where he responsible for early go or no-go criteria-based proof of concept and proof of mechanism study design, and Phase 3, pivotal registration study for data quality. Additionally, he was accountable for Investigational New Drug (IND) and NDA filings in the U.S. as well as global submissions for Clinical Trial Applications (CTA) and NDAs.

Dr. Desai received his Bachelor of Medicine, Bachelor of Surgery (M.B.B.S.) in 1986 and his M.D. in 1989 from the Maharaja Sayajirao University of Baroda in Vadodara, India where he participated in the Internal Medicine Residency Program. Dr. Desai went on to complete his training at the American Society of Medical Oncology and the American Society of Hematology in 1992. Following his move to the U.S., Dr. Desai received his ECFMG certification with the U.S. Medical Licensing Exam step 3. Dr. Desai joined Penrose TherapeuTx in 2021.