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2023 PRIM&R Annual Conference

Pharma/Biotech Perspectives

Flexibility and Innovation in Research Oversight Processes

H17 - [IN-PERSON/RECORDED] Balancing the Pressure of Getting New Therapies to Clinical Trial: Ensuring Robust Study Design, Nonhuman Animal Welfare, and Human Subjects Protections

Wednesday, December 6, 2023
1:45 PM – 2:45 PM ET
Location: Room 154 AB
Live Session Recorded Crossover Deep Dive Series
This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

This session will address the challenges of balancing the pressures associated with advancing new therapies to clinical trials while ensuring robust study design, optimal nonhuman animal welfare, and human subjects protections. It will explore the critical role of the IACUC and IRB in facilitating agile review processes and study start times while maintaining high-quality research. This session will highlight the potential risks of rushing or delaying pre-clinical studies and offer strategies to support the appropriate transition to clinical trials while upholding ethical standards.

Learning Objectives:

  • Explore case studies that exemplify the potential consequences when pre-clinical studies are rushed or delayed, impacting both nonhuman animal welfare and human subjects
  • Consider how the increased pressure of getting new therapies to market has led sponsors to explore the use of commercial IRBs verse local IRBs
  • Learn what both IACUC and IRB committees can do to facilitate the transition from the pre-clinical stage to clinical trials, and how to balance agile yet comprehensive review of pre-clinical data