Lauren Mihalcik, PhD, DABT

Lauren M. Mihalcik received a BSE in Chemical Engineering from Princeton University and a PhD in Pharmacology from the University of Virginia. She is a diplomate of the American Board of Toxicology. Currently, she is the Vice President (Toxicology) and Senior Consultant for Aclairo. Prior to her position with Aclairo, she was a Senior Scientist at Amgen and a Senior Toxicologist in the Division of Metabolism and Endocrinology Products in the Office of New Drugs at the Food and Drug Administration (FDA). At the FDA, Lauren was the pharmacology/toxicology reviewer for more than 90 programs and contributed to policy development for many drug classes. She was co-chair of the Information Technology Subcommittee and the primary FDA lead for the development of the Standard for Exchange of Nonclinical Data (SEND). At Amgen, Lauren was responsible for the nonclinical safety strategies for more than twenty programs across a wide range of indications, including large and small molecules, biosimilars, and oligonucleotides. She established the nonclinical safety strategy for the Amgen oligonucleotide platform, mentored junior toxicologists, and represented Amgen in the EFPIA Oligonucleotide Working Group and the Oligonucleotide Safety Working Group. She has been active in professional organizations, including the American Society of Cell and Gene Therapy, the American Society for Pharmacology and Experimental Therapeutics, the Society of Toxicology, the Oligonucleotide Therapeutics Society, and the American College of Toxicology, where she serves as an elected member of the Education Committee. Lauren has more than 20 years of experience in industry and government and has authored or co-authored numerous peer reviewed publications and book chapters.