Agenda
September 18-19, 2023 | Virtual Meeting via WebEx
(Please note, the following times are approximate and all times are ET)
| DAY 1: September 18, 2023 | ||
| 10:00 a.m. - 10:15 a.m. | Board Members Meet-and-Greet | |
| 10:15 a.m. - 10:25 a.m. | Welcome, Meeting Objectives, Review of Agenda, and CIRB Update Jenny Morris, MBA, MS, CIP; Director. Central Operations, CIRB Operations Office Vanessa Loyola, MHRM; CIRB Membership Administrator Linda K. Parreco, RN, MS; CIRB Liaison, NCI, Division of Cancer Prevention (DCP) Josh Lorenzo |
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| 10:25 a.m. - 10:30 a.m. | Introductions | |
| 10:30 a.m. - 11:00 a.m. | NCI Welcome Meg Mooney, MD, MBA; Chief, Clinical Investigations Branch (CIB), CTEP, DCTD, NCI |
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| 11:00 a.m. - 1 p.m. | Workshop: Artificial Intelligence Moderator: Jenny Morris, MS, CIP; Dir. Central Operations, CIRB Operations Office |
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| 11:00 a.m. - 11:45 p.m. | Keynote Speaker: An Overview of Artificial Intelligence and Where It May Lead In The Future Eric Perakslis, PhD, Chief Science and Digital Officer, Duke Clinical Research Institute |
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| 11:45 a.m. - 12:00 p.m. | Q & A/Open Discussion | |
| 12:00 p.m. - 12:45 p.m. | Ethical Challenges in AI Research & Practical Tools For Regulatory Review Challace Pahlevan, MBE, CIP, Director, Regulatory Affairs, Institute of Health System Science Feinstein Institutes for Medical Research, Northwell Health |
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| 12:45 p.m. - 1:00 p.m. | Q & A/Open Discussion | |
| 1:00 p.m. - 2:30 p.m. | 90-minute Break | |
| 2:30 p.m. - 4 p.m. | Workshop: Multi-cancer early detection (MCED) tests: A View From the NCI Moderator: Linda K. Parreco, RN, MS; CIRB Liaison, NCI, Div. of Cancer Prevention (DCP) |
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| 2:30 p.m. - 2:35 p.m. | Introductions | |
| 2:35 p.m. - 3:05 p.m. | MCED Tests: Opportunities In Early Cancer Detection Elyse LeeVan, M.D.; Early Detection, NCI (Backup: Paul Pinsky) |
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| 3:05 p.m. - 3:15 p.m. | Q & A/Open Discussion | |
| 3:15 p.m. - 3:45 p.m. | Use of Liquid Biopsy Assays (ctDNA) for the Purpose of Detecting Early Recurrence of Disease Lyndsay Harris, M.D.; Associate Director, Division of Cancer Treatment & Diagnosis (DCTD), NCI |
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| 3:45 p.m. - 3:55 p.m. | Q & A/Open Discussion | |
| 3:55 p.m. - 4:00 p.m. | Wrap Up | |
| DAY 2: September 19, 2023 | ||
| 10:00 a.m. - 12:00 p.m. | Devices and IDE Determinations Moderator: Jenny Morris, MS, CIP; Dir. Central Operations, CIRB Operations Office |
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| 10:00 a.m. - 10:05 a.m. | Overview for the Day & Introductions | |
| 10:05 a.m. - 10:35 a.m. | Devices and IDE Determinations - FDA Regulations Wendy Rubinstein, M.D., Ph.D., Senior Scientific Officer, Division of Cancer Prevention, NCI |
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| 10:35 a.m. - 10:40 a.m. | Q & A/Open Discussion | |
| 10:40 a.m. - 11:10 a.m. | Devices and IDE Determinations - CIRB Operations CIRB Ops Teams |
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| 11:10 a.m. - 11:15 a.m. | Q & A/Open Discussion | |
| 11:15 a.m. - 12:00 p.m. | Break Out Session by Board Lessons Learned/Action Items |
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| 12:00 p.m. - 12:30 p.m. | Presentations by Boards (7-8 min. each)
12:00-12:07: EPE |
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| 12:30 p.m. - 2:00 p.m. | 90-minute Break | |
| 2:00 p.m. - 2:35 p.m. | Impact of COVID on NCI's trials, the NCI's 2030 Vision for Clinical Trials, and the NCI's efforts to streamline clinical trials James Doroshow, M.D.; Director, Division of Cancer Treatment and Diagnosis, NCI |
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| 2:35 p.m. - 2:45 p.m. | Q & A/Open Discussion | |
| 2:45p.m. - 3:20p.m. | NCI Process Defined - Key Players and How They Fit Together Martha Kruhm, MS, RAC; Associate Branch Chief for Operations in the Clinical Trials and Informatics Branch |
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| 3:20 p.m. - 3:30 p.m. | Q & A/Open Discussion | |
| 3:30 p.m. - 3:55 p.m. | Feedback on Ed Days - Survey will be sent Q & A/Open Discussion |
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| 3:55 p.m. - 4:00 p.m. | Meeting Synthesis and Next Steps Jenny Morris, MS, CIP; Dir. Central Operations, CIRB Operations Office |
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