Early Stage Development Team

Louis Mylecraine, M.S., PhD

Toxicologist

A graduate of Lebanon Valley College (BS, 1971), Louis Mylecraine has advanced degrees in Human Physiology (Fairleigh Dickinson University) and Zoology (Rutgers University). Dr. Mylecraine worked for 40 years in multinational pharmaceutical companies in the US and in Germany. He is experienced in the design and conduct of regulatory toxicology studies, strategic testing program design and execution, authorship and expert review of regulatory dossiers, and in interactions with regulatory agencies. Dr. Mylecraine is a diplomate of the American Board of Toxicology (1987-2022) and is a member of several professional toxicology and professional societies. He served on the Board of the New Jersey Association of Biomedical Research from 1989 to 2011. Prior to establishing his own toxicology consulting company, Dr. Mylecraine was Sr. Director, Nonclinical Drug Safety - US, for Bayer Healthcare in the United States. He supported Bayer in in sponsor meetings with FDA and EMA scientific consultation, including 3 FDA public Advisory Committee Meetings. Dr. Mylecraine has participated in the nonclinical development of small (NCE) and large (NBE) molecules for women’s health care, diagnostic and molecular imaging, inhalation drug delivery, cardiovascular drug products, radiopharmaceuticals, dermatologic drug products, fixed-drug combinations, and oncology drug products. Dr. Mylecraine composed, edited, or peer reviewed nonclinical dossiers for approximately 30 INDs, leading to submittal of 15 NDAs, most of which resulted in first cycle approval.. (Triskelion Toxicology LLC is an independent single-member LLC providing comprehensive regulatory pharmacology and toxicology services to the pharmaceutical industry. It is not affiliated with any CRO)