Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Steven Kunder, Ph.D., DABT., joined Biologics Consulting Group, Inc. as a Senior Consultant in June, 2008. Dr. Kunder is an toxicologist (Ph.D., Medical College of Pennsylvania, Philadelphia, PA) who brings 12 years of experience with the U.S. Food and Drug Administration (FDA) in both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).  He is a Diplomat of the American Board of Toxicology (DABT, 2005).

In 2006, Dr. Kunder became a regulatory toxicologist in the CBER Division of Vaccines and Related Product Applications. As a preclinical pharmacology/toxicology reviewer he provided preIND advice to sponsors and reviewed INDs and BLAs for vaccines and adjuvants. Dr. Kunder represented the FDA as an invited speaker for these products at scientific and regulatory meetings.

In 1997 he joined the newly created Division of Special Pathogen and Immunologic Drug Products, as a pharmacology/toxicology reviewer of preINDs, INDs and NDAs of drugs and biologic products for organ transplantation and infectious disease.  He made numerous FDA presentations for immunotoxicology and models for organ transplantation. He also served on and co-chaired the CDER Immunotoxicology Committee, where he was a co-author of “Guidance for Industry-Immunotoxicology Evaluation of Investigational New Drugs” and served as a member of the CDER Starting Dose Committee was a co-author of “Guidance for Industry-Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers”.

In 1995, he became a regulatory toxicologist in CDER.  Dr. Kunder initially served as a pharmacology/toxicology reviewer in the Division of Antiviral Drug Products, reviewing INDs and NDAs for anti-HIV drugs.
Prior to serving as a reviewer in the FDA, Dr. Kunder was a research fellow in the CDER Antiviral Research Laboratory.  His research focused on developing HIV-infected SCID-Hu mice and murine retrovirus models for antiviral drug development using proprietary drug products and immunomodulators.

His training, research and regulatory experience with vaccines and adjuvants, immunosuppressants for organ transplantation and antiviral drugs provides an excellent understanding of these products acting by stimulation or suppression of the immune system.

As a Senior Consultant with Biologics Consulting Group, Inc. Dr. Kunder will utilize his expertise in drugs, biologics and vaccines to assist clients in the following aspects of development:

• Preclinical development planning
• Preparation and review of preIND, IND, NDA and BLA submissions
• Design of pharmacology and toxicology studies
• Interpretation of pharmacology and toxicology data
• Monitoring for immunotoxicology issues
• Preparation and participation in FDA meetings

View Dr. Kunder's Curriculum Vitae...

Page Updated June 12, 2008