Dileep Kumar
Translational Drug Development Leader | IND Strategy, Biomarkers & Multi-Omics | Driving Small Molecules, Biologics & RNA/DNA Therapeutics to Clinic
- Role
- Principal Scientist Product Development at Avstera Therapeutics Corp
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
Experience
Principal Scientist Product Development
Aug 2022 — Present · Malvern, PA, US
Secured FDA IND clearance for AVS100 (HDAC6 inhibitor + PD-1), enabling Phase I initiation in advanced solid tumors.Directed cross-functional IND-enabling strategy (ADME, GLP tox, PK/PD, CMC) across global CRO/CDMO partners.Authored IND modules (2–4), ensuring clearance with no major objections.Guided translational biomarker & clinical trial strategy, aligning preclinical findings with trial design.Advanced oncology pipeline, publishing in Science Advances (2024) on HDAC6 inhibitor synergy with immunotherapy.Initiated mRNA cancer vaccine program, leading construct design, LNP formulation, and preclinical evaluation.Advanced obesity/weight-loss program in DIO models, identifying biomarkers of efficacy and safety.Developed physiologically relevant primary adipocyte models from human adipose-derived stem cells and diabetic patient samples to investigate metabolic dysfunction and therapeutic mechanisms.
Education
Jawaharlal Nehru University
Master of Science (M.Sc.), Biotechnology
2003 — 2005
Institute of genomics and integrative biology (CSIR)
Doctor of Philosophy - PhD, Biochemistry
2009 — 2012
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