Daniel McLain, PhD, CNS, DABFE

Daniel McLain is cofounder and president of Walker Downey & Associates Inc., an evidence-based product safety and development consulting firm located in the heart of the third coast scientific and biotechnology community—Madison, WI. He received his PhD in nutritional toxicology and preventive medicine from Cornell University (Ithaca, NY). McLain has more than 25 years of experience in toxicology, drug and device development, vaccine development, statistics, and risk assessment. He has specific expertise in medical device material biocompatibility, immunotoxicology, and developmental and reproductive toxicity (DART). He is the current AAMI US Chair for TC194/WG7 and convener of ISO 10993—Biological Evaluation of Medical Devices—Part 11 (2006): Systemic Toxicity Evaluation. He has contributed to and has meaningful personal experience with IND, BLA, 510(k), GTAC, and CTD preparation. He is experienced with the design, conduct, analysis, and reporting of preclinical safety and pharmacokinetic studies for drugs, devices, biologics, and combination products, as well as with the international regulatory submissions associated with them. McLain is a Diplomate and Fellow of the American College of Forensic Examiners (DABFE, Toxicology) and the American College of Nutrition (FACN), and is a board-certified nutrition specialist (CNS). Additionally, he is an active and contributing member of the Society of Toxicology (25-years), the Regulatory Affairs Professional Society (16-years), ISO/AAMI (13-years), and the American Society for Quality (13-years). He served on MD&DI’s Editorial Advisory Board from 1995 to 2002 and rejoined the board in 2009.