Dr. Mielach has over 35 years of scientific and regulatory experience in the pharmaceutical industry, healthcare industries, and United States Food and Drug Administration (US FDA).
Prior to joining Brighton Biotech, Inc., Dr. Mielach spent 5 years as a reviewer and supervisor in the US FDA Center for Drug Evaluation and Research (CDER) Division of Anti-Viral Drug Products, where she was responsible for the evaluation and approval of final reviews for Investigational New Drug Applications (INDs) and New Drug Application (NDAs). During her FDA tenure, Dr. Mielach contributed to the formation of the FDA’s first formal pre-IND program, participated in the development and writing of several “Points to Consider”, guidance, and policy documents, was an approved FDA speaker, and earned a peer-reviewed promotion to CDER Center Expert in Immunotoxicology. During this time, Dr. Mielach founded the Regulatory and Safety Evaluation Specialty Section of the Society of Toxicology.
After leaving the FDA in 1993, Dr. Mielach founded Aspen Biomedical Consulting, Ltd., to assist clients with strategic regulatory, scientific, legal, due diligence, and safety aspects of drug and biologics development. She has extensive expertise with 505(b)(2) drug development and regulatory applications, and SBIR grant applications for drug development programs.
Dr. Mielach holds a B.S. degree in Pharmacy from University of Utah College of Pharmacy, and a Ph.D. degree in Toxicology from the Joint Graduate Program in Toxicology between Rutgers University of Medicine and Dentistry of New Jersey and Rutgers University. Dr. Mielach is a registered pharmacist, a Diplomate of the American Board of Toxicology, and a qualified FDA drug regulatory expert for litigation.