Dana Minnick, PhD, DABT, RAC-US
Senior Advisor
Dana Minnick is a board-certified toxicologist and general regulatory affairs professional with more than 25 years’ experience in the pharmaceutical industry. Dana has broad regulatory and scientific expertise across different therapeutic modalities including small molecules, peptides, proteins, monoclonal therapies, oncolytic viruses, and gene and cell therapies. Her strengths include an ability to identify gaps in drug development programs, define and prosecute strategies to address gaps, and lead programs from concept through new drug application (NDA) and post-marketing or to milestone decisions or exit. In her former roles as consultant and Sponsor, Dana has successfully led and been a key contributor of dozens of programs through investigational new drug application (IND) as well as several marketing authorizations. She has broad therapeutic expertise including immunology, neurology, pain, psychiatry, gastroenterology, hematology, infectious diseases, metabolic diseases, and oncology. In addition, Dana has substantial experience developing products for orphan indications and for serious and life-threatening diseases including design of accelerated clinical and nonclinical programs, where appropriate, orphan drug designations, breakthrough therapy designations, and regenerative medicines disease therapy designations. She has substantial experience in the preparation for and participation in regulatory authority meetings including roles as both moderator and nonclinical representative. Dana has a PhD and an MS in Environmental Health Sciences/Toxicology from Case Western Reserve University. She maintains Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society (RAPS), and she is a certified Diplomate of the American Board of Toxicology (DABT).
