San Mateo, California, United States
Physician scientist with 8+ years experience in clinical trials and operations with successful submissions and approvals from health authorities. Experienced in: * Clinical science, clinical practice, clinical operations. * Product development from early first-in-man trials to PhIII PMA trials. * Medical writing * Oncology, cardiovascular disease, molecular biology, cell biology.
* Led, as medical monitor, a phase 1, first-in-human, dose escalation and expansion clinical trial of a hematopoietic progenitor kinase 1 (HPK1) inhibitor in patients with advanced solid tumors, which demonstrated tolerability of this molecule and established an expansion dose for further evaluation in patients with head and neck squamous cell carcinoma and clear cell renal cell carcinomas. Results were presented at 2023 Society for Immunotherapy Annual Conference * Led, as medical monitor, a phase 1, dose escalation and expansion clinical trial of a threonine tyrosine kinase (TTK) inhibitor in patients with advanced solid tumors, which demonstrated tolerability of this molecule and established an expansion dose for further evaluation in patients with hormone receptor positive and Her2 negative breast cancers. Results were presented at 2023 San Antonio Breast Cancer Symposium Annual Meeting.
* Led, as medical monitor, a phase 2 clinical trial of zanubrutinib, a 2nd generation BTK inhibitor (BTKi), in patients with B-cell malignancies who became intolerant to prior BTKi treatments due to toxicities, which demonstrated a low reoccurrence of toxicities from prior BTKi treatment. Results were presented at 2021 European Hematology Association Annual Meeting. * Led investigator and clinical trial steering committee meetings, consisting of clinical trial investigators and key opinion leaders (KOL), to review study’s clinical trial data and to collect insight on trial progress and suggestions on trial conduct. * Supported a phase 3 head-to-head clinical trial of zanubrutinib vs ibrutinib in patients with Waldenstrom Macroglobulinemia (WM), which demonstrated clinical efficacy and safety, by reviewing and verifying the efficacy and safety data collected from clinical sites. * Supported meetings of KOLs to evaluate company’s clinical development plan for zanubrutinib in B-cell malignancies.
• Led, as medical monitor, a phase 2 clinical trial of acalabrutinib, a 2nd generation BTK inhibitor, in patients with Waldenstrom Macroglobulinemia, which demonstrated clinical efficacy and safety. Results presented in 2018 American Society of Clinical Oncology Annual Meeting. • Led, as medical monitor, a phase 1 clinical trial of acalabrutinib in patients with relapse refractory and treatment naïve chronic lymphocytic leukemia, which demonstrated long term clinical efficacy and safety. Results from treatment naïve cohort presented in 2018 American Society of Hematology Annual Meeting. • Led, as medical monitor, a Phase 1/2 clinical trial of acalabrutinib plus pembrolizumab in patients with B-cell malignancies including diffuse large B-cell lymphoma. Results presented at 2018 American Society of Hematology Annual Meeting. • Supported successful NDA filing for acalabrutinib in Mantle Cell Lymphoma by preparing abbreviated clinical study report and safety narrative of a phase 2 clinical trial of acalabrutinib in Waldenstrom Macroglobulinemia.