Dr. Bruce was trained in Internal Medicine with sub-specialization in Endocrinology at the National Institutes of Health. At the NIH, he received training and conducted human patient-oriented clinical research. For the past 17 years, he has held positions of increasing responsibility in both large pharmaceutical and small to medium sized biotech companies. He has broad experience across all phases of clinical development and has been responsible for clinical development strategy and execution from pre-IND to first-in-human and phase 1/2 proof-of-concept trials through Phase 3 planning, execution and filing. Specific programs DPP4 inhibitors, orphan drug development of metreleptin, NDA filing for Bydureon®, and phase 4 development and sNDA for combination metformin/glyburide. These programs covered small molecules, synthetic peptides and recombinant biologics.
He led clinical development of multiple compounds in the Metabolic and Diabetes therapeutic areas including DPP4 and SGLT2 inhibitors, GLP-1 agonists, leptin and prandial insulins among others. Most recently he served as Chief Medical Officer with Adocia Inc, working on an ultra-rapid insulin in collaboration with Eli Lilly.
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Ramachandra (Ram) G. Naik, M.D.
Biostatistics
Regulatory Science & Innovation; Biomedical Advanced R&D
EU Regulatory
Clinical Operations/Project Management
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Health Policy Development
CMC, Formulation/Process Development & Sourcing
Medical Device
Eric Kolb
Melissa Thompson
QA/QC
Medical Writing/Electronic Submissions
Kristi Hultberg, B.S.
Botanicals
Government Relations and Public Affairs
Defense & National Security Practice
Commercialization and Business & Corporate Strategy
Kinexum Associates
Elijah Abass