CBER’s Research Scientists
CBER currently has about 450 research scientists, most of whom are organized into laboratory groups led by Principal Investigators (PIs) with associated staff scientists, research fellows, and technicians. The majority of CBER’s research staff are researcher-reviewers who both conduct research and perform regulatory review. Listings below describe the work of individual CBER PIs by research area. Organizationally, PI-led groups are part of units known as Labs or Branches; Labs/Branches comprise Divisions, and Divisions are assembled into Offices. Each Office is organized around the products that its scientists regulate. Laboratory research activities are included in CBER’s three product Offices that manage review of 1) vaccines, allergenics, and live biotherapeutic products; 2) blood products and related diagnostics; and 3) cell, gene, and tissue-based biological therapeutics. Research is also conducted by scientists in the Office of Biostatistics and Pharmacovigilance, which provides statistical review across all types of products. Laboratory work in the Office of Compliance and Biologics Quality focuses on testing products being released for use in the U.S. market.
CBER Biological Research Projects
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Regulatory Science Research Offices
The Office of Biostatistics and Pharmacovigilance (OBPV) evaluates the safety and efficacy of the spectrum of CBER products throughout their entire lifecycle, from preclinical to post-marketing. OBPV comprises three Divisions, and each division’s work includes research.
The Division of Biostatistics conducts research that investigates statistical methodology and applications related to CBER-regulated products. This includes research related to clinical trial design, study analysis methodologies, methodologies for evaluating diagnostic device performance, meta-analyses of the safety and effectiveness of biological products, and non-clinical statistical applications including quality control methodologies.
The Division of Pharmacovigilance (DPV) conducts research dealing with passive surveillance post-marketing safety data related to CBER-regulated products. This research may describe trends in adverse event reporting or provide descriptive information about the clinical features of adverse reactions to various CBER related products. DPV often collaborates with the CDC Immunization Safety Office to conduct research related to the safety of vaccines and data reported to the Vaccine Adverse Event Reporting System.
The Division of Analytics and Benefit-Risk Assessment conducts research to support CBER’s mission in areas related to real world evidence, benefit-risk assessment, bioinformatics, model-informed drug development, and biological systems modeling.
- Division of Biostatistics
- Division of Pharmacovigilance
- Division of Analytics and Benefit-Risk Assessment
Research in Office of Blood Research and Review (OBRR) supports the safety and effectiveness of transfusion products and related devices and technologies. These include donor screening tests for transfusion-transmitted infectious diseases (TTID), supplemental tests, and retroviral diagnostics. To enhance review of these products, OBRR maintains an active mission-related laboratory program that studies blood; blood components; plasma for fractionation; medical devices; related drugs such as anticoagulants and additive solutions for collecting and manufacturing blood components; and retroviral diagnostic tests. As part of assuring blood safety from infectious agents, the Office also studies novel technologies for blood-borne pathogen detection and inactivation.
- Division of Emerging & Transfusion Transmitted Diseases
- Division of Blood Components and Devices
The Office of Compliance and Biologics Quality (OCBQ) has many responsibilities including ensuring the quality of CBER regulated products throughout their life cycle. In addition to regulatory responsibilities that comprise inspections, surveillance, regulatory review, policy, and compliance and enforcement actions, the office has a significant laboratory component. Laboratory work in OCBQ is conducted by the Division of Biological Standards and Quality Control (DBSQC) where tests are performed in compliance with ISO 17025 standards. Biological, chemical and microbiological testing is performed in support of product licensure as well as to confirm that licensed product lots are compliant with release specifications. DBSQC is also responsible for the preparation, calibration and distribution of reference materials. Antitoxin standards and influenza potency reference antigens as well as panels used to determine the suitability of blood donor screening kits and influenza diagnostic tests are prepared in compliance with ISO 17034 standards. The preparation of reference material for seasonal and pandemic influenza vaccines is performed as a WHO Essential Regulatory Laboratory of the Global Influenza Surveillance and Response System, ensuring international uniformity of these standards and global product consistency.
- Division of Biological Standards and Quality Control
Research in the Office of Therapeutic Products (OTP) applies state-of-the-art technologies to advance understanding of biological factors that can affect the safety, quality, and efficacy of a diverse group of therapeutics. These include blood-derived proteins; gene and cellular therapies; cancer vaccines; immunotherapies; and human tissue products. OTP’s regulatory portfolio includes medicines based on some of the most cutting-edge emerging biomedical science and technologies available today. The Office’s goal is to advance these medical discoveries while ensuring that the products are truly safe and effective. Research in OTP includes understanding the product and patient factors that affect clinical outcomes, as well as development of new methods and standards to assess product quality. To do so, the Office applies translational cellular and animal models, innovative ‘omics methods, and advanced artificial intelligence and machine learning tools.
- Office of Gene Therapy CMC/Division of Gene Therapy 2
- Office of Cellular Therapy & Human Tissue CMC/Division of Cell Therapy 1&2
- Office of Plasma Protein Therapeutics CMC/Division of Hemostasis & Division of Plasma Derivatives
Office of Vaccines Research and Review (OVRR) researchers study the biology of bacterial, viral, and parasitic pathogens and the mechanisms by which these pathogens cause disease. They investigate the immunological responses to bacterial, viral, and parasitic infections, the role of microbiota in preventing or ameliorating disease, the use of bacteriophage as therapeutics, and the outcomes of exposures to allergens. The goal of this work is to advance the development and introduction of new vaccines and biological therapeutics, as well as new approaches for vaccine and therapeutic manufacturing. OVRR research develops tools, assays, and reagents to study host responses to vaccines and therapeutic intervention and to evaluate steps in the manufacturing process to ensure the safety, potency and effectiveness of licensed vaccines and biological therapeutics.
The OVRR research program contributes to regulation of vaccines and related products by addressing scientific aspects of critical regulatory issues. The research develops and maintains a base of scientific expertise for establishing methods and standards designed to ensure the continued safety, purity, potency and effectiveness of vaccines and related products. To conduct research, we recruit and retain highly trained scientists who possess the expertise necessary for the review of regulatory submissions and for the development of regulatory policies.
- Division of Viral Products
- Division of Bacterial, Parasitic, and Allergenic Products
CBER Research by the Numbers
Work With Us!
Scientists may join CBER’s research program in several ways. Postdoctoral and postbaccalaureate fellows may be appointed via fellowships supported by CBER through the Oak Ridge Institute of Science and Education (ORISE). These positions are advertised on CBER’s web site and on scientific and general web sites, and applications are entered via the ORISE Research Opportunities section. ORISE fellowships are available to those within 5 years of their most recent academic degree and can be renewed for up to 5 years. Other specialized fellowship opportunities include CBER’s Regenerative Medicine Fellowship, the Interagency Oncology Task Force Fellowship (a collaboration with the National Cancer Institute at NIH), and the Translational Science Interagency Fellowship (a collaboration with the National Center for Translational Science of NIH). Scientists of any level may be appointed via short-term contracts or selected for open federal positions, which may be temporary (staff fellows or visiting associates) or permanent (staff scientists or visiting scientists). Permanent federal positions are advertised on CBER’s web site as well as scientific and general web sites, and applications are entered via the USAJobs web site. Students may join paid fellowship programs or volunteer for short term internships using the Student Volunteer Service Program. Individual PIs may be contacted for information about current laboratory openings.
All positions require that candidates are either U.S. citizens, or that the candidate has lived in the United States for 3 of the last 5 years and is eligible for an applicable work visa.