Our Team

Dr. Melissa Badding, PhD, DABT is the Director of Biologics Consulting’s clinical, toxicology and nonclinical team.  Dr. Badding is a board-certified toxicologist with expertise in human health risk assessment, nonclinical regulatory testing, and product safety evaluations. Prior to joining Biologics, Dr. Badding was a toxicology consultant at Exponent, Inc. where she specialized in nonclinical testing and biocompatibility/safety evaluations for medical devices and drug/device combination products. In that role, she assisted clients with regulatory strategies for product testing, nonclinical study monitoring, data gap analyses, and toxicological risk assessments of extractables and leachables. She has extensive experience interfacing with both testing laboratories and FDA reviewers to support clients in their regulatory meetings and ensure reviewer feedback is incorporated into the safety testing for successful regulatory submission outcomes.

Prior to her consulting career, Dr. Badding performed laboratory research for over a decade with a focus in the areas of particulate toxicity during her postdoctoral fellowship at CDC/NIOSH and in non-viral gene therapy during her doctoral thesis work.

Education:

Ph.D., Toxicology, University of Rochester School of Medicine and Dentistry, Rochester, NY (2012)

M.S., Toxicology, University of Rochester School of Medicine and Dentistry, Rochester, NY (2009)

B.S., Biotechnology, Rochester Institute of Technology, Rochester, NY (2007)

DABT, American Board of Toxicology, Diplomate (2016-present)