Melanie Hartsough has been in the drug development field for over 25 years, with experience both as a regulator in the U.S. FDA and as a consultant. In 2017, Dr. Hartsough founded Hartsough Nonclinical Consulting, LLC to provide scientific, regulatory and strategic advice associated with nonclinical pharmacology, pharmacokinetic and toxicology development of biologics, biopharmaceuticals, small molecules and combination products. Dr. Hartsough has experience developing nonclinical programs for therapeutic proteins (such as cytokines, growth factors, enzymes, toxins and fusion proteins), monoclonal antibodies (including antibody-drug conjugates (ADC)), cell and gene therapies, oncolytic virus therapies, prophylactic and therapeutic vaccines, peptides, oligonucleotide (RNA and DNA) therapies and small molecules for many types of clinical indications and routes of administration intended for the U.S. market.

Melanie received her Ph.D. in Pharmacology from the Pennsylvania State University. After a postdoctoral fellowship at NIH, Melanie joined FDA’s Center for Biologic Evaluation and Research (CBER) as a full-time product reviewer, where she conducted chemistry, manufacturing and controls and immunogenicity reviews for biopharmaceuticals. Melanie transferred to the Oncology Products, Center for Drug Evaluation and Research (CDER), as a pharmacology/ toxicology reviewer. She was responsible for reviewing the nonclinical pharmacology and toxicology data submitted by sponsors to support the safety of clinical trials and, ultimately, the approval of new biological therapeutics (i.e., therapeutic proteins, monoclonal antibodies and derivations thereof). During this time, she also performed consult reviews for the Office of Vaccines Research and Review and Office of Blood Research and Review, CBER. In 2006, she left the FDA and became a consultant, first with Aclairo Pharmaceutical Development Group, Inc and then with the Biologics Consulting Group, Inc prior to becoming an independent consultant.