Biologics Consulting Group, Inc. (BCG) provides a full array of nonclinical pharmacology-toxicology consulting services that span the entire biologic/drug development process, from discovery through marketing application and approval.  At the early stages of biologic/drug development, BCG toxicologists review the product information and conduct a gap analysis, evaluating currently completed studies and considering the product class, proposed indication and mechanism of action and providing an appropriate nonclinical plan for development through marketing application.  Biologics and therapeutic biologics, and vaccines in particular, are generally designed to affect the immune system, and BCG offers toxicologists with knowledge of immunology that are especially equipped to understand the nonclinical requirements for this type of development program.  This nonclinical plan can be provided in the form of a Product Development Plan, including a detailed outline of the most effective and efficient nonclinical program for initiation of a Phase I clinical trial, and ultimately for submission of a BLA/NDA.

Dr. Jessop, Director, Pharmacology-Toxicology, has over 20 years of experience with the FDA (both CBER and CDER), two years with private industry, 9+ years with our consulting firm for a total of over 30 years experience in pharmacology-toxicology. He has extensive experience with the full array of FDA-regulated products, including vaccines, cytokines, recombinant proteins, enzymes, monoclonal antibodies, cellular and gene therapy products, blood products and drugs. His broad knowledge and experience is especially useful in light of the recent transfer of regulatory responsibility for many of the therapeutic products from CBER to CDER.

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Dr. Hartsough, Senior Consultant, was previously a consultant for Aclairo, Pharmaceutical Development Group, Inc. During her time at Aclairo, she aided drug sponsors with small molecule and biologic products with IND submissions (pharmacology/toxicology sections), provided product (CMC) review for biologic products and aided in the design and interpretation of toxicology studies. Before then, Dr. Hartsough Division of Therapeutic Biological Oncology Products (now Division of Biologic Oncology Products), CDER as a pharmacology/toxicology reviewer. She also served as a as a full-time product reviewer for FDA's Center for Biologic Evaluation and Research (CBER), Division of Therapeutic Proteins. Melanie will utilize her expertise in the strategy and development of biotechnology-derived products to assist clients in various aspects of drug development including IND and BLA submissions, design and interpretation of toxicology studies, including relevant species and immunogenicity issues and appropriate PK/TK studies, product review for biotechnology-derived products, planning and participating in FDA meetings, insights into the changes occurring with the review of nonclinical studies for biotechnology-derived products in CDER.

Dr. Kunder, Senior Consultant, was previously a regulatory toxicologist in the CBER Division of Vaccines and Related Product Applications and before that with CDER's Division of Antiviral Drug Products. As a preclinical pharmacology/toxicology reviewer he provided preIND advice to sponsors and reviewed INDs and BLAs for vaccines and adjuvants.

Dr. Pepperl, Senior Consultant, previously served as toxicologist and Manager of Preclinical Development at TherImmune where he drafted preclincial development strategies, authored nonclinical sections of regulatory submissions and managed preclinical development programs for clients. In this capacity, he designed and managed nonclinical pharmacology and toxicology studies, performed GLP and scientific audits and reviewed study data on behalf of clients. He also served as program manager, working closely with contract research facilities to assure timely completion of nonclinical development programs for small to mid size biopharmaceutical companies. He has authored position papers on comparability and development of biologic products and has participated in the development of pre-IND information packages and the nonclinical sections of INDs.