Amrith Bennet

A patient-centered, collaborative drug-developer with a passion for improving patient health through scientific and strategic innovation. A strong scientific, strategic and people leader, passionate about developing safe and effective therapeutics for improving patient health, with 20 years of expertise in drug development as a program team leader, nonclinical development leader, toxicologist, veterinary pathologist, Pathology lab leader, and safety issue resolution team leader in small and large global matrixed organizations. Experience with a wide range of modalities/platforms (small molecules, monoclonal antibodies, vaccines, therapeutic proteins and peptides, biosimilars, siRNA, and viral vector based gene therapy), in several therapeutic areas (oncology, cardiovascular/metabolic, neuroscience, infectious diseases, endocrine, hematology/immunology, rare diseases, women’s health), end to end spanning various stages from target identification through registration and post-marketing, in numerous countries around the world. Experience with global regulatory guidances, regulatory interactions and regulatory document authoring (IND, CTA, IMPD, NDA, responses to regulatory questions, pre-IND/CTA, End of Ph-1, Ph-2 discussions, Pre-NDA, CAC package, scientific advice applications). Successful track record in effectively leading multidisciplinary due diligence teams for in-licensing, out-licensing, and integration. Strong program management skills and knowledge of the drug development process and regulatory requirements, including experience as a drug development program team leader, research leader, seasoned organizational leader in governance bodies and safety boards, and an effective mentor for scientists across functions (toxicology, pathology, pharmacology, bioanalytical, DMPK, discovery) on their scientific and professional development. Proven ability to create and execute successful business models, building/growing high performing teams, leading pharmacology, bioanalytical, PK, Pathology, and toxicology professionals to achieve corporate goals and advance drug development. Science-driven leader, problem solver and strategist who transforms plans into workable solutions. Successful track record of enabling high quality data-driven decision-making, using stage-appropriate innovative strategies for risk: benefit analysis, to advance preclinical and clinical stage candidates through a regulatory framework. Effective communicator, patient-centered and collaborative leader with a passion for mentoring. 25 years of experience in veterinary medicine.