CIRB Education Days (Agenda)

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
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
11:00 a.m. - 1 p.m. Workshop: Artificial Intelligence
Moderator: Jenny Morris, MS, CIP; Dir. Central Operations, CIRB Operations Office
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
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
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)
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)
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
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
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
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
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
12:00 p.m. - 12:30 p.m. Presentations by Boards (7-8 min. each)

12:00-12:07: EPE
12:07-12:14: LPE
12:14-12:22: CPC
12:22-12:30: Peds

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
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
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
3:55 p.m. - 4:00 p.m. Meeting Synthesis and Next Steps
Jenny Morris, MS, CIP; Dir. Central Operations, CIRB Operations Office