Science | Regulatory | Business
Over 30 years of perfectly integrated and successful projects.
- Designed the U.S. clinical development plan for a growth factor inhibitor sponsored by a Japanese pharmaceutical company and leading an expert panel to discuss the development plan.
- Assisted an ex-US company with preclinical testing and design of the Phase 1 clinical trial of a novel proteasome inhibitor.
- Assisted a Japanese pharmaceutical company in the Phase 1 design and medical oversight of a novel FLT3 inhibitor in acute myeloid leukemia
- Oversaw global medical management for an anti-coagulant in patients with malignancies for an international major pharmaceutical company (rivo for Janssen)
- Designed the Phase 1 study and served as medical monitor for a novel PRMT5 inhibitor.
- Assisted in the design of a Phase 2 program for a novel T-cell therapy.
- Performed clinical due diligence for a Japanese venture capital company for several potential assets
- Assisted a European pharmaceutical company with their pediatric investigational plan for the EMEA.
- Authored the Phase 1 protocol and the clinical portion of the IND and served as the clinical representative during the pre-IND meeting with the FDA for a novel monoclonal antibody targeting a growth factor receptor of a major international pharmaceutical company