Dr. Kathleen Hanley provides strategic regulatory advice, program and project management services, expertise in manufacturing process development and analytical method development. Dr. Hanley’s scientific expertise is biochemistry, molecular biology and analytical chemistry, including mass spectrometry.

Prior to consulting, Dr. Hanley was at Large Scale Biology Corporation for 13 years. At LSBC she was involved with all aspects of preclinical and clinical development of biopharmaceuticals using a plant viral-vector based recombinant expression system. She was Director of Analytical R&D from 2000-2005. In that capacity, Dr. Hanley led a team of scientists involved with development of analytical methods, SOP writing, release and stability testing, technology transfers, and preparation of regulatory filings for a number of human and animal health therapeutics. Dr. Hanley also initiated a core mass spectrometry lab at LSBC used in analytical method development.

Dr. Hanley obtained her BS degree from Cornell University. She received her M.S. and Ph.D. degrees from the University of Massachusetts Amherst with a specialization in plant physiology and biochemistry. Dr. Hanley did her postdoctoral research at the University of Kentucky on the regulation of the isoprenoid pathway. She was invited to numerous pharmaceutical companies and Universities to discuss her work on the regulation of sterol biosynthesis.

As a Senior Consultant at CBR International, Dr. Hanley has expanded the company's expertise in the areas of scientific review, project management, and analytical chemistry.

Consistent, thorough and up-to-date analysis of your evolving needs is just the beginning of our commitment to your program. For a comprehensive assessment of your program requirements, please contact us by calling (720) 746-1190 or by email at info@cbrintl.com.

For a comprehensive assessment of your program requirements, please contact us by calling (720) 746-1190 or by email at info@cbrintl.com.