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Participants will be able to describe how FDA’s Office of New Drugs (OND) uses regulatory science research to address knowledge gaps that slow down or prevent new drug development. They will gain familiarity of research opportunities available to currently enrolled and recently graduated college students through the OND ORISE fellowship program. The learner will also become aware of two OND extramural research programs that have funding opportunities available for external collaborators.

TOPICS COVERED

• Overview of OND’s regulatory science research portfolio.
• Examples of how the Office uses funding to address knowledge gaps that prevent or slow down drug development.
• Overview of FDA’s Oak Ridge Institute for Science and Education (ORISE) Fellowship Program.
• Examples of opportunities, requirements for applicants, tips for how to find projects and apply for fellowships.
• Overview of OND’s Combatting Antibiotic-Resistant Bacteria (CARB) Program.
• Overview of OND’s 21st Century Cures Drug Development Tools Grant Program.
• Description of opportunities for collaborating, types of projects being solicited, and how to apply for funding.
• Location of websites where priority lists and funding opportunities are posted.

INTENDED AUDIENCE

• Science, mathematics, or engineering college students (currently enrolled in an accredited U.S. college or university) or post-graduates looking for opportunities to participate in research-based professional development opportunities at FDA.
• Professional development programs at accredited U.S. colleges or universities that award science, technology, engineering, and/or math degrees (example here).
• Biomedical researchers working on topics in the area of drug development tools (e.g., pre-clinical and clinical biomarkers, animal models, clinical outcomes assessments, patient reported outcomes).
• Academic program managers for regulatory science graduate degree or certificate awarding programs (e.g., U Maryland, Johns Hopkins, U Southern California, University of Arkansas for Medical Sciences, Northeastern University, Chapman U, Arizona State University, UC San Diego).
• Federal partners who conduct biomedical research as part of their mission (CDC, NIH/NCAATS, etc.).
• Non-Profit organizations who collaborate with FDA (e.g., Critical Path Institute, Foundation for the National Institutes for Health, Reagan-Udall Foundation).
• Scientific professional development groups who collaborate with FDA (e.g., American Association for the Advancement of Science).

FDA SPEAKERS

Overview of OND Research

Laura B. Jaeger, Ph.D.
Acting Associate Director, OND Research Program
Division of Biomedical Informatics, Research, and Biomarker Development (DBIRBD) | Office of Drug Evaluation Sciences (ODES) | Office of New Drugs (OND) | CDER | FDA

Research Fellowships at FDA

Michelle DeNamur
CDER Fellowship Liaison
Office of Translational Sciences | CDER | FDA

OND’s Congressionally Mandated Research Programs

Thushi Amini, Ph.D.
Associate Director for Research
Office of Infectious Diseases | OND | CDER | FDA

Christopher Leptak, M.D., Ph.D.
Director, CDER Biomarker Qualification Program
Office of New Drugs (OND) | CDER | FDA

LEARNING OBJECTIVES

• Provide examples of how regulatory science research is used by the Office of New Drugs to (OND) facilitate drug development or inform policy.
• Describe the types of candidates who are eligible for FDA’s Oak Ridge Institute for Science and Education (ORISE) Fellowship Program.
• Distinguish between FDA’s Broad Agency Announcement (BAA) and the Centers of Excellence in Regulatory Science and Innovation (CERSI) Programs.
• Locate websites where priority lists and funding opportunities are posted for OND’s Combatting Antibiotic-Resistant Bacteria (CARB) Program.
• Identify opportunities for collaborating with and applying for funding from OND’s 21st Century Cures Drug Development Tools Grant Program.

FDA RESOURCES

• CDER’s Regulatory Science Program Areas
• CDER Research Tools and Resources
• Specific Examples of CDER Regulatory Science Research
• FDA Center of Regulatory Science and Innovation (CERSI) Program
• Broad Agency Announcement (BAA) for the Advanced Research and Development of Regulatory Science - solicitation announcement is open and posted on SAM.GOV
• ORISE Fellowships

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

• has been pre-approved by RAPS as eligible for up to 4 credits towards a participant’s RAC recertification upon full completion.
• has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

QUESTIONS

Please contact info@sbiaevents.com for all technical questions.

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