Melanie Hartsough

Independent Consultant

About

Dr. Hartsough has been in the drug development field for over 20 years with experience as a regulator in the U.S. FDA and as a nonclinical consultant. In 2017, Dr. Hartsough founded Hartsough Nonclinical Consulting to provide scientific, regulatory and strategic advice associated with nonclinical pharmacology and toxicology development of biologic products, small molecules and combination products. Dr. Hartsough has experience developing nonclinical programs for cell and gene therapies, prophylactic and therapeutic vaccines, recombinant therapeutic proteins, monoclonal antibodies (including antibody-drug conjugates (ADC)), peptides, siRNAs and small molecules for many types of clinical indications intended for the U.S. market.

Country

United States

City

Derwood

Industry

Biotechnology

Skill

Biopharmaceuticals, Regulatory Affairs, Lifesciences, Clinical Development, FDA, Regulatory Submissions, Biotechnology, Pharmaceutical Industry, Drug Discovery, R&D, Drug Development, GLP, IND, Pharmaceutics, Vaccines, Toxicology, Clinical Trials, Pharmacology, CRO, Oncology

Experience

Independent Consultant

Hartsough Nonclinical Consulting

2017-1 - Present · 9 yrs 9 mos

Derwood, MD

Provide advice on the overall nonclinical strategy and development of drug products (toxicology, pharmacokinetic and pharmacology programs), including relevant species, tissue cross-reactivity, comparability, immunogenicity and “Animal Rule” issues, as well as aid in solving problems that may arise during performance of the programs. Provide strategic, regulatory and technical assistance on nonclinical and clinical immunogenicity assays and performs immunogenicity risk assessments. Perform reviews of nonclinical development programs to determine appropriateness to support the intended clinical stage of development (due diligence/ gap analysis) and provide aid in the design and completion of toxicology studies and programs. Aid clients in the preparation of regulatory submissions (INTERACT, preIND, IND, BLA, NDA, response to hold, etc) and participate in FDA meetings.

Senior Consultant

Biologics Consulting

2007-2 - 2016-12 · 9 yrs 11 mos

Assisted clients with nonclinical development of biologics, small molecules, biotechnology and combination products.

Consultant

Aclairo Pharmaceutical Development Group, Inc.

2006-10 - 2007-2 · 5 mos

Provided preclinical advice on scientific and regulatory issues, due diligence, and strategic planning for biologic and small molecule drug development.

Pharmacologist

FDA

2004-6 - 2006-10 · 2 yrs 5 mos

CDER, Office of Oncology Drug Products, Division of Biologic Oncology Products

Responsible for the review and maintenance of Pharmacology/Toxicology sections of Investigational New Drug (IND) submissions and original Biological License Applications (BLA) and supplements for biotechnology-derived products, including cytokines, growth factors, enzymes, toxins and monoclonal antibody products. Regulated biologic products for all clinical indications for approximately 1 ½ years. Regulation of biologic products specific for oncology indications started with the establishment of OODP in October 2005. Designed toxicology studies for all stages of clinical development and provide collaborative reviews and consults for Office of Blood Research and Review (OBRR) and Office of Vaccine Research and Review (OVRR).

Product Reviewer

Food and Drug Administration (FDA)

2001 - 2004-6 · 3 yrs

CBER/CDER Division of Therapeutic Proteins

Responsible for the review and maintenance of Chemistry, Manufacturing and Controls (CMC) of IND submissions and original BLA and supplements for all indications for biotechnology products (recombinant proteins).