The University of Iowa Human Subjects Office is hosting a PRIM&R Regional Connections conference: Pathways to Compliance: AI, Devices, and Drug Oversight Conference 2025 on Wednesday, April 9, 2025, 8:00 am-4:30 pm. We hope you can join us!
Wednesday, April 9, 2025, from 8:00 am – 4:30 pm (Registration begins at 7:30 am)
This conference brings together regional Human Subject Research Protection Programs (HRPPs) to discuss and address current issues related to FDA regulations, focusing on their application to drugs, devices, and emerging technologies like AI/software. Participants will explore best practices to ensure compliance and learn how HRPPs can effectively support researchers throughout the regulatory process.
Guest Speakers
Kindra Cooper is a regulatory and life sciences attorney. She currently serves as the Director of IRBMED at the University of Michigan, and as regulatory faculty for the Radiological Society of North America’s Annual Clinical Trials Workshop. Kindra previously served as IRB Director for Creighton University, Chairperson for Advarra, and Senior Regulatory Counsel for Quorum Review IRB. Kindra holds advanced degrees in law, bioethics and health policy, and public administration. She is a published author and invited speaker on topics including IRB review, FDA drug and device regulations, eConsent, sIRB, mobile medical devices, and the use of remote technology in clinical trials. Kindra currently resides in Omaha, Nebraska with the love of her life – a 64-pound pit bull mix named Annie.
Brenna Loufek is the Director of Regulatory & Quality in the Center for Digital Health at Mayo Clinic. Brenna partners with user-innovators to create regulatory strategies that offer the least burdensome pathway to market for digital health technologies developed internally. Her subject matter expertise is in the nuanced application of US FDA regulatory policies for AI-enabled software functionalities.
Brenna brings extensive experience guiding teams through domestic and international regulations and standards. With previous roles at Medtronic and Philips, Brenna has managed complex regulatory submissions and advised on studies for digital health products including AI/ML-based technologies, telehealth platforms, and in-clinic management tools. In addition to program support, Brenna is an instructor for various courses that provide training for and interpretation of FDA regulations.
Brenna has a master’s degree in Patient Safety & Healthcare Quality from Johns Hopkins. She is a PhD candidate at the University of Oxford with a research focus on patient harms that can result from use of AI-enabled clinical decision support software in healthcare institutions.
Panelists
Dr. Sean Fain is professor and vice chair of research in the Department of Radiology at University of Iowa. He previously served as professor of Medical Physics, Radiology and Biomedical Engineering at the University of Wisconsin – Madison. He now directs the Functional Lung Imaging Laboratory in the Iowa Institute for Biomedical Imaging. His research develops quantitative imaging methods using magnetic resonance imaging (MRI) and CT. His research is highly translational, including leadership roles in multi-center imaging studies of asthma (Severe Asthma Research Program; The Great Lakes PrecISE Partnership), and industry collaborations (GE Healthcare, Xemed LLC, Polarean, Imbio LLC) to improve quantitative measures of lung disease. He is the physics chair of the of the CT Lung Density Biomarker Committee of the Quantitative Image Biomarkers Alliance (QIBA) and is working with the COPD Foundation on quantitative CT imaging biomarkers of airway remodeling and parenchymal density to improve phenotyping of obstructive lung disease.
Dr. Diana Jalal is a tenured professor of medicine at the University of Iowa and the director of clinical research in the renal division. In addition she serves as the associate director of the Center for Access and Delivery Research and evaluation. She graduated from the University of Jordan and completed her internal medicine residency training at the University of Iowa. She then moved with her husband to Houston TX where she completed her clinical nephrology training at Baylor College of Medicine. Subsequently she pursued research training at the University of Texas in Houston and was hired as a faculty member there until she moved to the University of Colorado in 2008. She has served in several clinical leadership positions including as clinical director of renal at the University of Colorado Hospital and deputy chief of specialty medicine at the Iowa City VA HCS. Her research is focused on identifying novel pathways and therapies that may reduce the risk of cardiovascular disease and kidney disease progression in individuals with chronic kidney disease. She has received funding from NIH, VHA, and the American Heart Association.
Debra O’Connell-Moore is the Clinical Trials Regulatory Core Manager at the University of Iowa’s Institute for Clinical and Translational Science (ICTS). Ms. O’Connell-Moore, and her staff, provide oversight of regulatory submissions as well as interfacing with government and other external entities (e.g., FDA Investigational New Drug [IND], Investigational Device Exemption [IDE] and clinicaltrials.gov). She also serves as a content expert on the NCATS QA/QC team assisting investigators with submission of pilot and KL2 human subject prior approvals. In addition to these roles, Ms. O’Connell-Moore also develops training for research staff throughout the University of Iowa and has served as a member of the general research implementation team for the enterprise-wide expansion of the Advarra CTMS system.
Agenda
Registration:
The conference is free and open to all. Registration is capped at 150 attendees.
The registration deadline is 5 pm on Friday, March 21, 2025. Follow the links below to register:
Financial support provided in part by Public
Responsibility in Medicine and Research (PRIM&R)
QUESTIONS?
Let us know if you have questions or need any assistance.
Phone: 319-335-6564
Email: irb-outreach@uiowa.edu
Individuals with disabilities are encouraged to attend all University of Iowa-sponsored events. If you are a person with a disability who requires a reasonable accommodation in order to participate in this program, please contact the University of Iowa's Human Subjects Office in advance at 319/335-6564 or irb-outreach.uiowa.edu.
LOCATION:
Iowa Memorial Union, Richey Ballroom, 360 IMU, 125 N. Madison Street, Iowa City, IA 52242
PARKING AND DRIVING DIRECTIONS:
- Driving Directions
- Iowa Memorial Union Parking Ramp, on North Madison Street across the street from the Iowa Memorial Union.
- North Campus Ramp, at the North end of Madison Street, by North Hall.
HOTEL ACCOMODATIONS:
There are many hotels in the Iowa City/Coralville area. The ones closest to the conference site include:
ADDITIONAL INFORMATION FOR VISITORS: