Michael A. Insko, M.S.
Drug development and translational science leader with nearly 30 years of experience spanning discovery research, nonclinical development, toxicology, pharmacokinetics, and laboratory operations across biotechnology and pharmaceutical organizations. Proven track record advancing small-molecule therapeutics from early discovery through IND-enabling studies and clinical development, with expertise in exploratory pharmacology, GLP toxicology, safety assessment, ADME/PK, bioanalytical sciences, and CRO management. Experienced in designing and executing complex in vivo disease models, including cardiovascular, critical care, ischemia-reperfusion injury, cachexia, oncology, inflammatory and metabolic disorders, while providing strategic scientific contributions on regulatory submissions with FDA, EMA, MHRA, including IB’s, IND’s, NDA’s, and DSUR updates.
Recognized for building and managing laboratory, vivarium, and EH&S operations, leading cross-functional development programs, and translating preclinical findings into clinical advancement. Career contributions include supporting the development of multiple therapeutics from discovery through commercialization, including tucatinib (TUKYSA®), and pioneering technologies that remain widely used in kinase drug discovery and translational pharmacology today such as KinomeScan™.
In addition to my scientific and drug development experience, I have led pre-commercialization and HCP engagement initiatives supporting cardiovascular and oncology programs. Developed scientific communication platforms, publication strategies, congress plans, speaker programs, and disease-state education campaigns designed to increase awareness, and support future product adoption.
My experience spans the full continuum from early-stage research through commercialization readiness, enabling me to effectively bridge scientific, clinical, and business objectives to advance innovative therapies and improve patient outcomes.
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