Frances Mielach, PhD, RpH

Dr. Frances Mielach has over 30 years of U.S. and international drug development and drug safety experience in government, the pharmaceutical industry, and as an independent consultant.

Dr. Mielach served as reviewer, Team Leader and Supervisor, focused on Pharmacology and Toxicology, with the Division of Antiviral Drug Products (DAVDP), CDER, at the FDA, reviewing and evaluating safety in IND and NDA submissions, including those of DDI, Mepron, D4T, and AZT.  During her DAVDP tenure, she participated in creating FDA’s first formal Pre-IND program, and, as the CDER Center Expert in Immunotoxicology, chaired the committee that crafted the first CDER guidance document on immunotoxicology considerations in new drug development.  She was also a member of the CDER committee whose work formed the basis for the 1993 CDER policy change that allowed 9 month (instead of 12 month) non-rodent studies to be adequate to support an NDA (this work decreased development time and coordinated with ICH initiatives).

In addition to assisting private clients for over 25 years in her independent consulting practice, she served as an NIH SBIR grant scientific peer reviewer.  She also served as Vice President, Regulatory and Scientific Affairs for Myriad Pharmaceuticals, establishing a state-of-the-art regulatory function and leading the preparation and filing of pre-IND and IND submissions.

Dr. Mielach provides individualized, specific assistance and solutions for optimal translational research and development of all classes of drugs and drug/device combination products, from pre-IND through post-NDA.  For early drug development, she provides high level, strategic, integrated planning and solutions to optimize overall development and operations timelines, and achieve “bench to man” as soon as possible.  She has:

  • Been involved in the submission of over 100 IND applications
  • Supported over 50 NDAs in therapeutic areas including anxiety/depression, AIDS, cancer, endocrine/metabolic, cardiovascular, radioimaging and drug/device combinations
  • Provided expert scientific and regulatory support for more than 50 505(b)(2) applications
  • Supported the startup of over 100 small pharmaceutical companies and new drug development programs that achieved approval for first in man studies, some in less than 1 year from initiation of supporting toxicology studies
  • Prepared drug development plans for multiple millions in grants, including SBIR grants
  • Designed and supported multimillion dollar nonclinical drug development programs

Dr. Mielach has served as lead regulatory expert witness in litigations, conducted regulatory and scientific due diligence, negotiated resolutions of clinical holds and waivers for carcinogenicity studies with the FDA, served on scientific and policy committees in industry and government, and co-authored numerous scientific and policy documents.

Dr. Mielach earned her Ph.D. in Toxicology from the University of Medicine and Dentistry of New Jersey (UMDNJ)/Rutgers University Joint Graduate Program in Toxicology and is a Diplomate of the American Board of Toxicology.  She earned her B.S. in Pharmacy from the University of Utah College of Pharmacy, and maintains active Registered Pharmacist licenses in Utah, California, and New Jersey.  She is a practicing Integrative Health Coach, trained at Duke Integrative Medicine.