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Meet Our Consultants
Mai H. Le, MD
Mai is the founding partner of H2RnD Consulting, LLC and has over 16 years of drug development experience across a variety of indications, including oncology (solid tumors and hematologic malignancies), autoimmune/autoinflammatory diseases, and neurodegenerative/neuroinflammatory diseases.
Mai has been a critical member of clinical teams for multiple successful FDA filings, including numerous IND and 3 NDA/indication expansion applications. She has contributed to programs in all stages of development, from pre-candidate selection-to-Phase 4 post-marketing studies, although the majority of her experience and her passion is in the early clinical development (pre-IND-through-Phase 2) space. Mai has a proven track record of successful IND & NDA strategy and execution, clinical trial design & implementation, and companion diagnostics strategy.
She has extensive experience across multiple therapeutic modalities, including small molecules, gene therapy, bi-specific antibodies, antibody drug conjugates (ADCs), cell therapy (CAR-Ts and CAR-NK) and logic-gated biologics. Prior to launching H2RnD Consulting, LLC, Mai was Chief Medical Officer at Oncosec Medical, Inc., where she led the clinical development strategy and execution for Tavokinogene telseplasmid, a gene therapy utilizing electroporation for a variety of solid tumor indications. Mai was also previously Medical Director at Calithera Biosciences, Inc. and Plexxikon, Inc., and Associate Medical Director at Onyx Pharmaceuticals and Proteolix, Inc.
Mai received her B.A. from Cornell University and M.D. from the University of Rochester School of Medicine. Mai completed her residency training in Laboratory Medicine/Clinical Pathology at University of California, San Francisco. In addition to her role as Principal with H2RnD Consulting, LLC, Mai currently directs and supports clinical programs at Tempus AI, Inc. as Vice President of Clinical Research.
Robert H. Pierce, MD
Robert H. Pierce is an anatomic pathologist who brings more than two decades of scientific leadership and experience managing large teams dedicated to translational medicine, immunology and immune-oncology drug development in both academia and industry.
His research has focused on the mechanisms of tumor-induced immune tolerance and he has longstanding expertise in the development of biomarkers to predict responses to immuno-oncology treatments. While at Merck, Dr. Pierce led a team focused on the development of tissue-based biomarker approaches for Merck’s anti-PD1 therapeutic antibody (pembrolizumab; KEYTRUDA®) to define response and non-response phenotypes to anti-PD1 blockade, including the 22C3 PD-L1 companion diagnostic IHC assay.
He was also the medical lead responsible for the early clinical development of pembrolizumab in Merkel cell carcinoma and cutaneous T cell lymphoma. Dr. Pierce previously served as the CMO and, later, CSO of OncoSec Medical, Director of Immunopathology at the Fred Hutchinson Cancer Research Center and Chief R&D Officer at Sensei Biotherapeutics. He is currently serving as Consulting CSO of Attivare Therapeutics and Eterna Therapeutics as well as Consulting CMO of T Nano-Bio Therapeutics and Sendero Biotechnology. Additional ongoing consulting activities leverage Dr. Pierce’s expertise in immunology and pathology to help clients build effective translational programs.
Dr. Pierce has a B.A. from Yale University, was awarded a Fulbright scholarship to study philosophy at the Albert-Ludgwig University in Freiburg, Germany and the went on to receive an M.D. from Brown University School of Medicine, where he currently serves as an adjunct professor. Following graduation from medical school, he completed a residency program in Anatomic Pathology and a post-doctoral research fellowship at the University of Washington in Seattle.