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Dr. Frances Mielach, Principal and Owner, has extensive U.S. and international drug development and drug safety experience in government, industry, and private consulting. Her areas of expertise include strategic regulatory, scientific, safety, due diligence, and legal aspects of drug and drug/device development, 505(b)(2) drug development, orphan drug development, and Small Business Innovation Research (SBIR) grant applications.
During her five year tenure as a Pharmacology/Toxicology reviewer and supervisor in the FDA’s Division of Antiviral Drug Products, Dr. Mielach helped create FDA's first formal Pre-IND program, was the CDER Center Expert in Immunotoxicology, worked on several committees that produced FDA and ICH guidances and policies, and received FDA recognition awards for her work and contributions to HIV and AIDS drug development and approval.
During 25 years since leaving the FDA, Dr. Mielach has been a private consultant to pharmaceutical and drug/device companies, venture capital firms, technology transfer companies, and law firms. She has been a scientific peer reviewer of SBIR grants and served as Vice President, Regulatory and Scientific Affairs at Myriad Pharmaceuticals.
Dr. Mielach earned her Ph.D. in Toxicology from the University of Medicine and Dentistry and 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 is a Registered Pharmacist in Utah and California. Dr. Mielach is Principal and Owner of Wise Choice Wellness.
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