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Biologics Consulting Group, Inc. offers a full range of pharmacology-toxicology
services including planning of pharmacology/toxicology programs
to support clinical product development from IND through marketing
application, writing of the pharm/tox section of INDs, BLAs
and NDAs, review and interpretation of toxicology study data
with respect to potential risk, participation in due diligence
programs for perspective new products, GLP audits, development
of comparability protocols, writing of labeling, recommendation
and interface with Toxicology CROs, participation in FDA meetings
and others as required.
Dr.
Jessop, Director, Pharmacology-Toxicology, has 20 years
of experience with the FDA (both CBER and CDER), two years
with private industry and almost four years with our consulting
firm for a total of over 25 years experience in biological
product and drug development. 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.
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.
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.
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Updated:
April 6, 2007
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