Melanie T. Hartsough PhD

Dr. Hartsough is a Senior Consultant at Biologics Consulting Group, Inc. She utilizes her expertise in the strategy and development of drug products to assist clients with nonclinical development of biologics and small molecules. Dr. Hartsough received her PhD in Pharmacology from Pennsylvania State University, College of Medicine. After a postdoctoral fellowship at NIH, Melanie joined US FDA’s Center for Biologic Evaluation and Research (CBER), Division of Therapeutic Proteins, as a full-time product reviewer. During this time, she performed chemistry, manufacturing and controls (CMC) and immunogenicity reviews for biotechnology-derived products. In 2004, Melanie transferred to the Division of Biologic Oncology Products, Center for Drug Evaluation and Research (CDER), as a pharmacology/toxicology reviewer. 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 US FDA and joined Aclairo Pharmaceutical Development Group, Inc as a consultant. In 2007, Melanie left Aclairo and joined the Biologics Consulting Group, Inc.

Dr. Hartsough’s expertise focuses primarily on US FDA regulatory issues and strategies associated with nonclinical pharmacology and toxicology development of biologic (including cell and gene therapies, prophylactic and therapeutic vaccines, blood products and recombinant therapeutic proteins and monoclonal antibodies) and small molecule products. She is able to aid sponsors in the overall strategy and development of drug products, including relevant species, pharmacokinetic, tissue cross-reactivity, comparability and immunogenicity issues. For immunogenicity-related issues, her expertise encompasses both nonclinical and clinical disciplines. Melanie is able to provide general regulatory advice, perform reviews of the nonclinical development plan to determine regulatory gaps, design and interpret toxicology studies, interface with toxicology CROs, aid in the preparation of regulatory submissions (prepreIND, preIND, IND, BLA, NDA, response to hold, etc) and participate in US FDA meetings with the sponsor.