Lauren M. Mihalcik received a BSE in Chemical Engineering from Princeton University and a Ph.D. in Pharmacology from the University of Virginia. She is a diplomate of the American Board of Toxicology. She is currently is a Senior Consultant for Aclairo Pharmaceutical Development Group, where she has a broad practice encompassing cell and gene therapies, oligonucleotides, and large and small molecule therapeutics across mostly non-oncology indications. Before joining 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). Lauren was the pharmacology/toxicology reviewer at the FDA for more than ninety 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 Amgen’s oligonucleotide platform’s nonclinical safety strategy, mentored junior toxicologists, and represented Amgen in the EFPIA Oligonucleotide Working Group and the Oligonucleotide Safety Working Group. Lauren is active in professional organizations, including the American Society of Gene & Cell Therapy, the Society of Toxicology, the Oligonucleotide Therapeutics Society, and the American College of Toxicology. She is also a member of the organizing committee for the Applied Pharmaceutical Toxicology meeting. Lauren has extensive industry and government experience and has authored or co-authored numerous peer reviewed publications and book chapters.