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.

BCG Strengths

• Toxicologists with a unique combination of FDA (both CBER and CDER), industry and toxicology CRO experience, allowing for planning of optimal pharm/tox programs
• Extensive experience in preparation and/or review of pharmacology-toxicology sections of regulatory submissions including pre-IND meeting packages, INDs (paper and electronic), BLAs/NDAs, Master files, Orphan Drug Applications, etc.
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• Able to provide expert advice on a broad range of pharmacology-toxicology issues associated with U.S. and international approval of biopharmaceutical products; in depth knowledge and understanding of FDA as a regulatory agency
• Extensive experience with CRO screening, GLP auditing, and study monitoring
• Review and evaluation of nonclinical final study reports

Product Experience

• Vaccines
• Therapeutic Proteins
• Cytokines
• Monoclonal Antibodies
• Blood Products
• Gene Therapy Products
• Cell and Tissue Products
• Devices and Diagnostics Products
• Allergenic Products
• Drugs (Small Molecules)

BCG Provides Pharmacology-Toxicology Guidance Throughout the Drug Discovery, Development and Approval Process

Pre-IND/IND Support

• Review and gap analysis of currently existing pharmacology-toxicology programs
• Strategic advice on planning and implementation of pharmacology-toxicology programs (product development plan)
• Guidance on interactions with regulatory agencies
• Planning and conduct of pre-IND, end-of-Phase I and II and pre-BLA meetings as well as special meetings with FDA to discuss pharmacology-toxicology issues
• Preclinical assessment of pharmacology studies to determine when the client is ready for the pre-IND meeting
• Planning of safety pharmacology studies
• Design of product-specific pharmacology-toxicology programs to support all stages of development through marketing application
• Selection of appropriate toxicology CRO, management of the toxicology studies, GLP auditing, study monitoring and review and evaluation of final study reports
• Design of specific toxicology study protocols
• Analysis of pharmacokinetics data
• Development of the pharmacology-toxicology sections of all regulatory documents (pre-IND information package, IND, BLA/NDA, etc)
• Complete pharmacology-toxicology due diligence for potential product acquisitions
• Prepare/evaluate comparability protocols and consult on comparability issues
• Provide any level of consulting required for development from review of currently existing pharmacology-toxicology programs, study reports, IND sections, etc. to providing complete preclinical/nonclinical consulting services for development of a new product from the lab to marketing application
• GLP auditing

BCG Offers FDA-Specific Regulatory Guidance Related to Pharmacology-Toxicology

GLP Support

• GLP inspections
• GLP study monitoring
• SOP review and preparation

BLA/NDA Support

• Plan pharmacology-toxicology program for product development through marketing application
• Evaluation/preparation of the pharmacology-toxicology section of the BLA/NDA
• Assistance in planning/conducting pre-BLA meeting

Toxicology Staff

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.

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. 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.