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Name
Frances Mielach
Educational Degrees
PhD
Certifications
DABT - Diplomate American Board of Toxicology
Education
PhD, UNDNJ/Rutgers Joint Graduate Program in Toxicology
BS in Pharmacy, University of Utah College of Pharmacy
Expertise
Drug/Pharmaceutical Development, Litigation Support, Medical Devices, Medical/Clinical Toxicology, Product Safety Assessment, Regulatory Toxicology, Training and Training Courses
Specialties
Scientific and regulatory advice for drug and drug/device development, due diligence, 505(b)(2) drug development, SBIR grant applications, technology transfer, translational medicine
Experience
Dr. Frances Mielach 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 is Principal and Owner of Aspen Biomedical Consultants and Wise Choice Wellness.
City
Glen Ridge
State
NJ
Zip Code
07028
Country
USA