Paul Baldrick is Executive Director, Nonclinical Regulatory Strategy within the Product Development and Market Access Consulting group at Fortrea (formerly Labcorp and Covance); he has a BSc (1983) and PhD (1988) from Durham University, UK. Professor Baldrick is also Visiting Chair (Regulatory Toxicology) of the Lincoln School of Pharmacy, College of Science, University of Lincoln. His main responsibilities include providing regulatory strategy/nonclinical support for new product development and registration of small molecule pharmaceuticals, biotechnology products, gene and cell therapy products, vaccines and medical devices. Professor Baldrick has over 30 years of experience in nonclinical development (CRO, UK and Belgium industry) with knowledge of the development of many compound classes and regulatory issues/submissions; along with extensive regulatory agency interaction, he has written numerous peer-reviewed publications (over 75) and is a regular podium speaker/chairperson as well as a lecturer on training courses for a range of nonclinical and associated regulatory topics.