Full PRIMR25 Schedule

7:00 AM - 8:30 AM ET

PRIMR25 Morning Beverage Service

Location: Exhibit Hall

7:00 AM - 5:00 PM ET

Registration Open

Location: Pratt Street Lobby

7:00 AM - 5:00 PM ET

IACUC Lounge

Location: Room 330

7:15 AM - 8:15 AM ET

Federal Agency/Accrediting Body Office Hours

Location: Exhibit Hall

7:15 AM - 8:15 AM ET

Info Session: Everything You Wanted to Know About the CPIA Credential

Location: Hall F&G - Industry Theater

Speaker: – Brigham and Women's Hospital

ACU/IACUC Program Management and Administration

7:15 AM - 8:15 AM ET

N02 - First Time Attendee Morning Coffee

Location: Exhibit Hall

8:30 AM - 10:00 AM ET

PRIMR25 Welcome Remarks and Opening Keynote Presentation by Vardit Ravitsky, PhD

Session is being held in person and will be recorded for on-demand viewing.

Session will be livestreamed in real time and captured for on-demand viewing.

Location: Ballroom III-IV

Opening Remarks: – UC Berkeley

Opening Remarks: – Novartis Pharmaceuticals

Opening Remarks: – PRIM&R

Moderator: – Independent Professional

Keynote Speaker: – The Hastings Center

10:00 AM - 10:30 AM ET

Beverage Break in the Exhibit Hall

Location: Exhibit Hall

Sponsored By

10:30 AM - 11:45 AM ET

A01 - PLENARY: Navigating the IRB's Role Beyond Regulatory Compliance

Location: Ballroom III-IV

Moderator: – North Star Review Board

Panelist: – Perelman School of Medicine, University of Pennsylvania

Panelist: – Loyola University Chicago Stritch School of Medicine

Foundations of Research Ethics and OversightIRB Operations and ManagementNavigating Ethical ChallengesRegulatory Frameworks and Compliance

10:30 AM - 11:45 AM ET

A02 - Collaborative Project on Artificial Intelligence (AI) Regulatory and Ethical Review: Insights, Challenges, and Practical Tools

Location: Ballroom II

Speaker: – Center for AI & Digital Policy (CAIDP)

Speaker: – Multi-Regional Clinical Trials Center

Speaker: – WCG

Speaker: – Multi-Regional Clinical Trials Center

Speaker:

Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance

10:30 AM - 11:45 AM ET

A03 - The Ethics of Placebo Controls in Vaccine Clinical Trials

Location: Room 345-346

Speaker: – The Johns Hopkins University

Speaker: – Johns Hopkins Bloomberg School of Public Health

Speaker:

Regulatory Frameworks and ComplianceEmerging Challenges and Innovations in ResearchNavigating Ethical Challenges

10:30 AM - 11:45 AM ET

A04 - Local Context Review: Why It’s Essential and How to Do It Well

Location: Room 324-326

Speaker: – AAHRPP

Speaker: – Johns Hopkins University School of Medicine

IRB Operations and ManagementRegulatory Frameworks and Compliance

10:30 AM - 11:45 AM ET

A05 - PLENARY: Planning for the Unknown: Organizational Strategies to Protect Animal Care and Use Programs from Emerging External Challenges

Location: Room 314-317

Moderator: – AAALAC International

Panelist: – MIT

Panelist: – Americans for Medical Progress

Panelist: – Novartis Pharmaceuticals

Emerging Research Challenges and Breaking IssuesAnimal Well-Being and the 3Rs

10:30 AM - 11:45 AM ET

A06 - Meeting the Challenges of IACUC Administration: Case Studies in Handling Complex Protocol Issues/Situations

Location: Room 343-344

Speaker: – Washington University in St. Louis

ACU/IACUC Program Management and AdministrationIACUC ReviewIACUC Fundamentals

10:30 AM - 11:45 AM ET

A07 - Setting New Faculty Up for Success: Onboarding Faculty Who Conduct Animal Research

Location: Room 339-342

Speaker: – St Jude Children's Research Hospital

Speaker: – Novartis

Speaker: – University of Connecticut and UConn Health

Education, Qualifications, and TrainingACU/IACUC Program Management and AdministrationEnhancing Collaboration and Inclusion in IACUC/ACU Programs

10:30 AM - 11:45 AM ET

A08 - Proactive Strategies for Emerging Trends and Crisis Management

Location: Room 318-320

Speaker: – The University of Texas at Austin

Speaker: – Advarra, Inc.

Research Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesEmerging Research Challenges and Breaking Issues

10:30 AM - 11:45 AM ET

A09 - PLENARY: AI Policy for Institutional Leaders

Location: Ballroom I

Panelist: – Ropes & Gray LLP

Panelist: – University of Michigan

Panelist: – University of Arizona

Research Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesEmerging Challenges and Innovations in Research

10:30 AM - 11:45 AM ET

A10 - Demystifying Sponsored Programs: A Compliance-Focused Introduction to Grants & Contracts

Location: Room 349-350

Speaker: – Univ of CA San Diego

Speaker: – University of New Hampshire

Education, Qualifications, and TrainingShared Research Oversight Challenges

11:45 AM - 1:30 PM ET

Lunch Service - Kiosks Open in Exhibit Hall

Location: Exhibit Hall

12:30 PM - 1:30 PM ET

Federal Agency/Accrediting Body Office Hours

Location: Exhibit Hall

12:30 PM - 1:30 PM ET

Meet and Greet With the Supporters and Exhibitors

Location: Exhibit Hall

12:30 PM - 1:30 PM ET

View the PRIMR25 Poster Abstracts

Location: Exhibit Hall

12:30 PM - 1:30 PM ET

N03 - Lunch with Leaders: Conversations for Institutional Officials

Location: Room 345-346

Speaker: – The Texas A&M University System

Speaker: – Novartis Pharmaceuticals

Research Oversight Leaders and Institutional OfficialsEmerging Research Challenges and Breaking Issues

12:30 PM - 1:30 PM ET

N04 - Advancing Earlier Pediatric Inclusion in Clinical Trials: Aligning IRBs, FDA, Industry, and Patient Advocates

Location: Room 314-317

Speaker:

12:30 PM - 1:30 PM ET

N05 - Future of Regulatory Oversight of Research in the US

Location: Room 324-326

Speaker: – Americans for Medical Progress

Emerging Research Challenges and Breaking IssuesACU/IACUC Program Management and Administration

12:30 PM - 1:30 PM ET

N06 - An Update from AAHRPP, Inc.

Location: Room 343-344

Speaker: – AAHRPP, Inc.

Emerging Research Challenges and Breaking IssuesACU/IACUC Program Management and Administration

12:30 PM - 1:30 PM ET

N07 - Round Table: Insights from Industry: Research Participant Compensation

Location: Room 339-342

Speaker: – WCG

Speaker: – Johnson & Johnson

Speaker: – Equipoise Consulting, LLC

Emerging Challenges and Innovations in ResearchRegulatory Frameworks and ComplianceNavigating Ethical Challenges

12:30 PM - 1:30 PM ET

N08 - Family and Household Record Linkage: Demonstration and Feedback on Human Subjects Review Guidance

Location: Room 349-350

Speaker: – University of Colorado School of Medicine

Speaker: – CCTSI (Colorado Clinical and Translational Sciences Institute) University of Colorado Anschutz Medical Campus

12:30 PM - 1:30 PM ET

N09 - Create & Connect: A Mindful Networking Session

Location: Room 321

12:30 PM - 12:50 PM ET

PRIMR25 Poster Presentation—Enhancing Post-Approval Monitoring: A Gap Analysis Approach to Foster Collaboration Among Regulatory Research Stakeholders

Location: Room 318-320

Poster Session Moderator: – Advarra

Poster Presenter: – University of Texas Rio Grande Valley

12:30 PM - 12:50 PM ET

PRIMR25 Poster Presentation—Reducing Barriers for People with Disabilities in Human Research: Potential Actions for Human Subjects Research Protections

Location: Hall F&G - Industry Theater

Poster Session Moderator: – Indiana University

Poster Presenter: – Kennedy Krieger Insitution

1:00 PM - 1:20 PM ET

PRIMR25 Poster Presentation—Engaging the Research Community through outreach to Promote Animal Welfare and Compliance

Pillars of PRIM&R Outstanding Poster Award

Location: Room 318-320

Poster Session Moderator: – North Carolina Central University

Poster Presenter: – UConn Health

1:00 PM - 1:20 PM ET

PRIMR25 Poster Presentation—Where Empathy Meets Ethics: A Peer-Led Model for IRB Readiness

Location: Hall F&G - Industry Theater

Poster Session Moderator: – Seattle Children's Research Institute

Poster Presenter: – Saybrook University

1:45 PM - 3:00 PM ET

B01 - PLENARY: Ethical and Regulatory Considerations for Cutting-Edge Neurotechnology Research

Location: Ballroom III-IV

Panelist: – Mass General Brigham

Panelist: – Johns Hopkins University

Emerging Challenges and Innovations in ResearchIRB Operations and ManagementRegulatory Frameworks and ComplianceNavigating Ethical Challenges

1:45 PM - 3:00 PM ET

B02 - Navigating the New Frontier: IRB Challenges with Complex Innovative Trial Designs

Location: Room 324-326

Speaker: – Klote Medical Research Advisors, LLC

Speaker: – WCG

Navigating Ethical ChallengesEmerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance

1:45 PM - 3:00 PM ET

B03 - Navigating Ethical and Regulatory Complexities in Research with Children

Location: Room 339-342

Speaker: – Research Foundation for Mental Health

Speaker: – University of South Florida

Speaker: – Teachers College, Columbia University

Foundations of Research Ethics and OversightRegulatory Frameworks and Compliance

1:45 PM - 3:00 PM ET

B04 - Building a Positive Post-Approval Program—Even with Limited Resources

Location: Room 345-346

Speaker: – Medical University of South Carolina

Speaker: – KBR

Speaker: – Connecticut Children's

IRB Operations and ManagementRegulatory Frameworks and Compliance

1:45 PM - 3:00 PM ET

B05 - PLENARY: Future of Animal Bioethics for IACUCs, Research, and Society

Location: Ballroom I

Moderator: – Novartis Biomedical Research

Panelist: – Landi Animal Research and Bioethics

Panelist: – Novartis Pharmaceuticals

Panelist:

Animal Well-Being and the 3RsEmerging Research Challenges and Breaking IssuesACU/IACUC Program Management and AdministrationNavigating Ethical Challenges

1:45 PM - 3:00 PM ET

B06 - Strengthening the IACUC: Recruiting, Training, and Supporting a Diverse Committee

Location: Room 343-344

Speaker: – UC Berkeley

Speaker: – Cincinnati Children's Hospital Medical Center

Education, Qualifications, and TrainingEnhancing Collaboration and Inclusion in IACUC/ACU ProgramsIACUC Fundamentals

1:45 PM - 3:00 PM ET

B07 - Adverse Event and Noncompliance Investigations: How to Get the Relevant Information You Need Without Burning Bridges

Location: Ballroom II

Speaker: – Labcorp Bedford, LLC

Speaker: – Emory University

Speaker: – WMU Homer Stryker MD School of Medicine

Enhancing Collaboration and Inclusion in IACUC/ACU ProgramsQA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration

1:45 PM - 3:00 PM ET

B08 - Emergency Preparedness for Institutional Leadership: You need a plan!

Location: Room 318-320

Speaker: – Loma Linda University Health

Speaker: – Ochsner Clinic Foundation

Emerging Research Challenges and Breaking IssuesResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

1:45 PM - 3:00 PM ET

B09 - Institutional Models for Managing Conflicts of Interest in Research

Location: Room 349-350

Speaker: – The University of Texas at Austin

Speaker: – Johns Hopkins University

Shared Research Oversight ChallengesACU/IACUC Program Management and AdministrationIACUC FundamentalsIRB Operations and ManagementFoundations of Research Ethics and Oversight

1:45 PM - 3:00 PM ET

B10 - Cultivating a Strong Research Culture

Location: Room 314-317

Speaker: – University of New England

Speaker: – AAHRPP

Shared Research Oversight ChallengesACU/IACUC Program Management and AdministrationResearch Oversight Leaders and Institutional OfficialsEnhancing Collaboration and Inclusion in IACUC/ACU ProgramsIRB Operations and Management

3:00 PM - 3:30 PM ET

Beverage Break in the Exhibit Hall

Location: Exhibit Hall

3:30 PM - 4:45 PM ET

C01 - PLENARY: Ethical Considerations for Discontinued Clinical Trials and Programs

Location: Ballroom II

Moderator: – Johnson & Johnson

Panelist: – Takeda Pharmaceuticals

Panelist: – Equipoise Consulting, LLC

Panelist: – Sanofi

Emerging Challenges and Innovations in ResearchNavigating Ethical ChallengesRegulatory Frameworks and Compliance

3:30 PM - 4:45 PM ET

C02 - FDA Oversight Made Simple: Key Concepts and Application to Research

Location: Room 343-344

Speaker: – The University of North Carolina at Chapel Hill

Speaker: – The Children's Mercy Hospital | Children’s Mercy Research Institute

Speaker: – Sanford

Foundations of Research Ethics and OversightRegulatory Frameworks and ComplianceIRB Operations and Management

3:30 PM - 4:45 PM ET

C03 - Spotlight on Post-Approval Monitoring & Single IRB: What’s Working Now?

Location: Ballroom I

Speaker: – University of Iowa Human Subjects Office

Speaker: – Indiana University

Speaker: – Northwestern University

IRB Operations and ManagementRegulatory Frameworks and Compliance

3:30 PM - 4:45 PM ET

C04 - Leveraging AI and Emerging Digital Technologies in Risk Management for Human Health Research

Location: Ballroom III-IV

Speaker: – Pontificia Universidad Javeriana

Speaker: – Hospital Universitario San Ignacio, Pontificia Universidad Javeriana

Speaker: – Center for AI & Digital Policy (CAIDP)

Emerging Challenges and Innovations in ResearchRegulatory Frameworks and ComplianceIRB Operations and Management

3:30 PM - 4:45 PM ET

C05 - Wildlife Animal Welfare 201: A Foundational Overview for Navigating the World of Oversight and Compliance With Free-Range Species

Location: Room 314-317

Speaker: – American Society of Mammalogists

Speaker: – USDA Forest Service

Oversight of Non-Typical Animals and SituationsIACUC Review

3:30 PM - 4:45 PM ET

C06 - Measuring Success: The IACUC’s Role in Evaluating the effectiveness of Training Programs for Animal Users

Location: Room 339-342

Speaker: – Novartis

Speaker: – Brigham and Women's Hospital

Education, Qualifications, and TrainingQA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration

3:30 PM - 4:45 PM ET

C07 - Innovative and Alternative Strategies for Developing the AAALAC Program Description

Location: Room 349-350

Speaker: – Hackensack Meridian Health

Speaker: – AAALAC International

ACU/IACUC Program Management and AdministrationEnhancing Collaboration and Inclusion in IACUC/ACU Programs

3:30 PM - 4:45 PM ET

C08 - Living Through Lean Times: Managing on Constricted F&A

Location: Room 318-320

Speaker: – Ropes & Gray Law Firm

Speaker: – University of Cincinnati

Speaker: – Emory University

Research Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

3:30 PM - 4:45 PM ET

C09 - Developing Leaders Within Research Compliance

Location: Room 324-326

Speaker: – University of Texas Health Science Center at Houston

Speaker: – HRP Consulting Group

Research Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesCareer Development

3:30 PM - 4:45 PM ET

C10 - Shared Risks, Local Responsibility: Empowering IRB and IACUC Professionals in Research Security

Location: Room 345-346

Speaker: – Rutgers University

Speaker: – Northeastern University

ACU/IACUC Program Management and AdministrationResearch Oversight Leaders and Institutional OfficialsIRB Operations and ManagementEmerging Challenges and Innovations in ResearchFoundations of Research Ethics and Oversight

4:45 PM - 6:00 PM ET

Federal Agency/Accrediting Body Office Hours

Location: Exhibit Hall

4:45 PM - 6:00 PM ET

Meet and Greet With the Supporters and Exhibitors

Location: Exhibit Hall

4:45 PM - 6:00 PM ET

View the PRIMR25 Poster Abstracts

Location: Exhibit Hall

4:45 PM - 6:00 PM ET

Welcome Reception in the Exhibit Hall

Location: Exhibit Hall

5:30 PM - 6:30 PM ET

Special Event: Human Subjects Research Trivia!

Location: Room 345-346

Co-Presenter: – The Ohio State University

Co-Presenter: – Sanford

Co-Presenter: – Virginia Tech

Co-Presenter: – Independent Professional

Co-Presenter: – University of Nevada, Las Vegas

Co-Presenter: – AAHRPP