Thank you for attending PRIMR24! You have 90 days to access the session recordings and evaluations, which will be unavailable after February 28, 2025. PRIM&R members will have free access to the recordings starting November 17, 2026, one year after the conference. Contact registration@primr.org with questions.
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA03 - Why “It Depends”: General Considerations for IRBs and HRPPs When Reviewing Research Using FDA-Regulated ProductsLocation: Room 431-432
Speaker: – Office of the Chief Medical Officer, FDA
Speaker: – Office of Scientific Investigations/CDER/FDA
Speaker: – US Food and Drug Administration
Speaker: – USFDA
FDA Regulated ResearchIRB ReviewPharma/Biotech Perspectives
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA05 - The Ethical Conduct of Cell and Gene Therapy Research: Novel Challenges for Industry and the IRBLocation: Room 444
Speaker: – Takeda Pharmaceuticals
Speaker: – Boston Children's Hospital
Speaker: – Advarra
Pharma/Biotech PerspectivesResearch Involving Data and New Technologies
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA08 - What is the Role of Regret and Apology in Protecting the Human Participants of Clinical Trials?Location: Room 335
Speaker: – PIRE-Southwest
Speaker: – PRIM&R
Speaker: – Northwest Indian College
HRPP/IRB Management and AdministrationPharma/Biotech PerspectivesIRB Review
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB04 - Ethical Implications and Practical Application of Broad ConsentLocation: Room 343-344
Speaker: – Huron
Speaker: – University of Texas, MD Anderson Cancer Center
Speaker: – Indiana University Center for Bioethics
Pharma/Biotech PerspectivesInformed ConsentResearch Involving Data and New TechnologiesIRB Review
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB17 - Effectively Managing the Use of Controlled Substances in ResearchLocation: Room 445-446
Speaker: – Virginia Commonwealth University
Speaker: – University of Michigan
Speaker: – University of Michigan
Education, Qualifications, and TrainingHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsLegal Considerations in Research OversightPharma/Biotech Perspectives
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC10 - Updates to the Declaration of HelsinkiLocation: Room 336
Speaker: – National Institutes of Health
Speaker: – Office for Human Research Protections
Speaker: – American Medical Association
Speaker: – FDA
Pharma/Biotech Perspectives
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC14 - What Needs to Change in Nonhuman Primate (NHP) Housing and WhyLocation: Room 322
Speaker: – Labcorp
Speaker: – MAV Consulting
Pharma/Biotech PerspectivesAnimal Well-Being and the 3Rs
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC16 - PLENARY: Bridging Preclinical to Clinical Research With Artificial Intelligence (AI) and Digital Biomarkers: Current Landscape, Vision, and the Collaborative Path Toward Improved TranslationLocation: Room 333-334
Panelist: – Digital In Vivo Alliance
Panelist: – Pfizer, Inc.
Moderator: – TLR Ventures/ Digital In Vivo Alliance
Emerging Research Challenges and Breaking IssuesPharma/Biotech PerspectivesAnimal Well-Being and the 3RsResearch Involving Data and New Technologies
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF08 - Navigating Ethical and Institutional Considerations for Data and Biospecimen Sharing in the Era of Single (sIRB)Location: Room 345-346
Speaker: – AAHRPP
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Single IRBResearch Involving Data and New TechnologiesIRB ReviewPharma/Biotech Perspectives
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Wednesday, Nov 20th
7:30 AM – 8:30 AM PTOpening General Session: More Cure, Less Side Effects: A Potential Role for Preclinical StudiesLocation: Ballroom 1
Moderator: – Novartis Institutes for Biomedical Research
Panelist: – Novartis Biomedical Research
Panelist: – Digital In Vivo Alliance
Emerging Research Challenges and Breaking IssuesIACUC ReviewIRB ReviewPharma/Biotech Perspectives
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG04 - Expectations for the Use of Electronic Systems to Conduct Clinical Trial Activities and Considerations for IRBs: Perspectives From Regulators and Institutional Review BoardsLocation: Room 343-344
Speaker: – Clemson University
Speaker: – CDER/FDA/OC/OSI/DCCE
Speaker: – FDA/CDER/OC/OSI/DCCE
FDA Regulated ResearchHRPP/IRB Management and AdministrationPharma/Biotech PerspectivesQA/QI and Postapproval Monitoring
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG15 - Building Bridges: Towards an International Framework for Specimen Sharing (Part II)Location: Room 335
Speaker: – BIopreservation & Biobanking
Speaker: – Takeda
Speaker: – Center for Integrative Medical Sciences, RIKEN
Speaker: – ARC-Net and Department of Engineering for Innovative Medicine, University of Verona, Italy
Pharma/Biotech PerspectivesResearch Involving Data and New TechnologiesIRB Review
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH05 - Pharma Perspectives on the Use of Social Media and Social Media Influencers in Clinical ResearchLocation: Room 335
Speaker: – Takeda Pharmaceuticals
Speaker: – Johnson & Johnson
Speaker: – WCG
Pharma/Biotech PerspectivesEmerging Research Challenges and Breaking Issues
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH06 - What Are You Going To Do With My Specimens and Data? When Research Specimens and Data are Used for Commercial ProfitLocation: Signature Room
Speaker: – Huron Consulting Group
Speaker: – BIopreservation & Biobanking
Speaker: – Takeda
Speaker: – ARC-Net and Department of Engineering for Innovative Medicine, University of Verona, Italy
Research Involving Data and New TechnologiesLegal Considerations in Research OversightIRB ReviewPharma/Biotech Perspectives
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH12 - Adverse Events and Animal Welfare in Biotech and Academia Alike: Creating Efficiency, an Open Program, and Automated Functions of ReportingLocation: Room 345-346
Speaker: – UC Berkeley
Speaker: – Novartis Biomedical Research, Inc.
Pharma/Biotech PerspectivesQA/QI and Postapproval MonitoringIACUC ReviewACU/IACUC Program Management and Administration
