Biological Resources Branch (BRB)

BRB supports preclinical and early (e.g. Phase I and II) clinical studies of biological response modifiers (BRMs) research in the biomedical community using grant and contract mechanisms. These studies assess the effects of novel biological and immunomodulatory agents and explore relationships of biological and immunological responses with antitumor activity.

BRM Development through the Biopharmaceutical Development Program

BRB Program Staff provide oversight of the Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research (FNLCR) Advanced Technologies and Research Facility (ATRF) in Frederick, MD. The BDP produces a variety of biopharmaceuticals under current Good Manufacturing Practices (cGMP) for Phase I/II human clinical trials or advanced preclinical animal testing, including monoclonal antibodies, recombinant proteins and virus-like particles, viral and DNA vaccines, peptides, gene therapy products, and cell-based products such as engineered T cells. The BDP functions under contract by Leidos Biomedical Research, Inc., which provides operations and technical support. The BDP supports extramural and intramural NIH innovators. The program is uniquely situated to address first-in-class and novel technologies, orphan markets, and complex regulatory challenges associated with these unique agents. BDP capabilities include:

• cGMP manufacturing, filing, testing, and release
• Process development and feasibility studies
• Process Analytics/QC testing
• Quality Assurance oversight
• Regulatory Affairs support
• Technology Transfer
• Training on Good Manufacturing Practice regulations (21 CFR 210, 211)

BRB Preclinical Biologics Repository

The preclinical repository stores cytokines, monoclonal antibodies, and other biologic reagents under carefully controlled conditions. The repository provides a limited supply of high-quality reagents to qualified research investigators at academic and non-profit institutions at no charge. For more information on available reagents and ordering instructions click here.

BRB Grants Portfolio

The BRB manages a grant portfolio consisting of approximately 130 funded grants, totaling ~$30,000,000 per year. The subject matter of the funded grants in the BRB is in the area of biological agents and animal models for cancer treatment. Examples include monoclonal antibodies (conjugated and unconjugated), cytokines, gene therapy using a variety of vectors, delivery of biological agents, antisense and siRNA therapy, specific animal models, and combination therapies. Although most of the grants are preclinical, some early Phase I pilot trials are also included in the BRB portfolio.

BRB Staff

Name	Title	Email
Jason Yovandich, PhD, RAC	Branch Chief / COR III	yovandij@mail.nih.gov
Dawn Edwards	Program Specialist	albaughda@mail.nih.gov
Robin Barnett	Extramural Support Assistant	Robin.barnett@nih.gov
Jackie Smith	Repository Coordinator	Jacqueline.smith@nih.gov
Kasia Bourcier, PhD	Program Director	katarzyna.bourcier@nih.gov
Jayne Christen, PhD, PMP	Program Director / COR II	Jayne.christen@nih.gov
Ray Harris, PhD	Program Director / COR III	raymond.harris@nih.gov
Rachelle Salomon, PhD	Program Director / COR III	rachelle.salomon@nih.gov