Area of Expertise:
Dana Minnick, PhD, DABT, RAC-US
Dana is a board-certified toxicologist and general regulatory affairs professional with over 20 years’ in the pharmaceutical/biotech industry. She provides strategic nonclinical and regulatory consulting services to the healthcare industry and has broad regulatory and scientific expertise across different therapies including small molecules, peptides, proteins, monoclonal therapies, gene and cell therapies. She identifies gaps in drug development programs, defines and prosecute strategies to address gaps, and leads programs from concept through NDA and postmarketing or to milestone decisions or exit. Dana has successfully led and been a key contributor of many drug development programs through the entire life cycle from IND-enabling through marketing authorization/licensure and postmarketing. She has broad therapeutic expertise including analgesia, neurology, 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. 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).