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.
Read
Pharm/Tox article by Dr. Jessop>>
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. |