Michael S. Email & Phone Number

Experienced non-clinical safety expert in drug discovery and development and preclinical development (PCD) therapeutic area leader to the business development and licensing group. Responsible for managing and conducting PCD reviews (including costing) of potential agreements (in-licensing, acquisitions, collaborations, etc.) in all therapeutic areas and stages of development, involving small molecules, biologics, vaccines, and devices, and including presentations to executive committees. Non-clinical drug safety discovery program leader in multiple therapeutic areas and development compound leader for marketed products with responsibility and experience in preparing annual updates and regulatory documents for submission to international and national regulatory agencies, including INDs, CTAs, BLAs, etc and regulatory responses. Experience in multiple modalities. translational research, biomarkers, GLPs, CROs, and regulatory affairs. Strong business development professional with a MS in Regulatory Science and PhD in Toxicology.