CBER Collaborative Scientific Training Program

The Center for Biologics Evaluation and Research (CBER) has a long tradition of improving regulatory pathways and facilitating the availability of safe, effective and high quality biological products. This is accomplished through research conducted by CBER intramural scientists on vaccines; blood and blood products; cell, tissue and gene therapies; and allergenics (http://www.fda.gov/cber/research.htm).

CBER established the Collaborative Scientific Training Program (CSTP) to facilitate research and training partnerships that engage scientific partners in pursuing the goals of the Critical Path Initiative (http://www.fda.gov/oc/initiatives/criticalpath/) of the U.S. Food and Drug Administration (FDA). The FDA Critical Path seeks scientific solutions to the challenges of modernizing existing product evaluation pathways and developing approaches for the evaluation of new products. Attaining these goals will move biomedical discoveries and innovations to the marketplace as safe and effective products providing preventative, therapeutic and diagnostic benefits to the people who need them. CSTP Partnerships will provide opportunities to bring national and international scientific institutions, experts and trainees together to synergize CBER's unique scientific and regulatory expertise with the complimentary scientific knowledge and skills of Collaborators.

Direct CSTP inquiries to Dano B. Murphy, J.D., Telephone: 301 827 0801; email: dano.murphy@fda.hhs.gov. or Wayne Wray, Ph.D., Telephone 301-827-0372; email wayne.wray@fda.hhs.gov.

A memorandum of understanding (MOU) or similar documentation of intent creates a CSTP Partnership between CBER and a Collaborator Institution. Under the CSTP umbrella, projects or activities can be tailored to address the specific scientific needs and goals of CBER and the Collaborator Institution.

Potential Collaborating Institutions include:

  • Academic institutions
  • International regulatory authorities
  • Other US government agencies
  • Non-profit organizations.

Collaborative projects and activities may include:

  • Scientific research or training
  • Participation in co-sponsored meetings, conferences, workshops and symposia
  • Piloting new methods and standards.

Participating personnel may include:

  • Established scientists and clinicians
  • Postdoctoral fellows
  • Research trainees
  • Pre or post baccalaureate student interns.

CBER scientists, primarily located on the NIH Campus, engage in a broad spectrum of mission-relevant research and their training and expertise span many scientific fields that are critical to the development, characterization, and production of biological products. CSTP collaborations utilize the research tools and specialized technology routinely employed by CBER investigators, which include:

  • Proteomics / Mass Spectrometry Facility
  • Genomics / DNA Microarray Facility
  • Nuclear Magnetic Resonance Facility
  • Bio-containment facilities
  • Molecular biology laboratories
  • Infectious agent laboratories
  • Cell Biology laboratories
  • Immunology Laboratories
  • Biomedical Science Core Facility
    1. Oligonucleotide Synthesis
    2. DNA Sequencing
    3. Peptide Synthesis
    4. Amino Acid Analysis
    5. Amino Acid Sequence Analysis
    6. Mass Spectrometry Analysis
    7. DNA Synthesis
    8. TAQMAN Probe Synthesis
    9. Capillary Electrophoresis
    10. High Performance Liquid Chromatography

For more information on specific CBER research programs and scientists: http://www.fda.gov/cber/research.htm

Use this search form to find research programs at CBER. You can search by name of the investigator or by research topic. Enter your search terms below.


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Updated: January 29, 2007