C. Bradley Hager, PhD
Sr. Quality Scientist/Team Leader
Brad, a PhD biochemist, is an experienced executive/manager/scientist with over 35 years experience in the healthcare industry. From a research scientist at Oak Ridge National Laboratory he held increasingly challenging positions in major healthcare companies to Vice President of R&D before helping found and manage several start-up companies. He has established and managed clinical trials in China to meet FDA GCP regulations. He has been founder or cofounder of three new start-up companies and directed the R&D that led to 12 new FDA-approved diagnostic kits/systems as well as many first generation biotechnology reagents. He is also cofounder and ex-President of the Virginia Biotechnology Association and Scientific China Inc. and is recognized in the industry for his entrepreneurship, understanding of FDA regulations for both IVDs and pharmaceuticals, and biotechnology. Besides consulting, Dr. Hager is President of ClinServices, LLC – an online eTraining company dedicated to distance learning for healthcare professionals.
Brad’s consultantships include Novartis (China Breast Cancer Study), Quintiles (FDA Compliance Issues), Tetracore (Immunoassay Development), ARDAK (Defense Contractor), Environmental Test Systems (Strip Test Development), ATLIS (Government Contracts), American Association for the Advancement of Science (Speaker), and Virginia Center of Innovative Technology (Biotechnology).
EXPERIENCE:
- Consultantships include Novartis (China Breast Cancer Study), Quintiles (FDA Compliance Issues), Tetracore (Immunoassay Development), ARDAK (Defense Contractor), Environmental Test Systems (Strip Test Development), ATLIS (Government Contracts), American Association for the Advancement of Science (Speaker) and Virginia Center of Innovative Technology (Biotechnology).
- Developed QSR policies and design controls for both product-specific and common process validations.
- Conducted and reviewed Product Assessments using the Risk and Hazard Analysis Approach.
- Remediated products and processes out of compliance with FDA regulations
- Established the first GLP laboratory in China
- Established and conducted the first major clinical trial in China for a pivotal breast cancer drug obtaining early FDA approval.
- Expanding government and pharmaceutical contracts doubling sales/profits.
- Generating 12 new products in a company that had no new products in 3 years.
- Conducted training throughout the world in various areas of diagnostic medicine, FDA regulations and risk assessment.
POSITIONS HELD:
- Sr. Quality Systems Specialist Consulting
- President ClinServices, LLC
- President/Chief Scientific Officer Scientific China Inc.
- Director, Clinical Studies Institute American Medical Laboratories
- Director, Biotechnology Division Hazleton Laboratories (Corning)
- Vice President, R&D MicroMedic Systems (Rohm & Haas)
- Director, R&D, Quality Assurance Miles Research Products Div. (Bayer)
- Director, Technical & Customer Serv. Ames Company Div. Of Miles Laboratories
EDUCATION:
Ph.D. Biochemistry, WVU Medical Center (NCI Pre-doctoral Fellow)
M.S. Biochemistry, WVU Medical Center
B.S. Pre-Medicine
