Interest Group Chairs:
Edward J. (Jim) Delikatny, PhD
University of Pennsylvania
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Summer Gibbs, PhD
Oregon Health and Science University
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Stephan Rogalla, MD PhD
Stanford University
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OSN WORKSHOP
Discovery to Clinical Acceptance: 3-Part Workshop
Tuesday, September 10th, 2024
10:00AM–11:30AM | 11:45AM–1:15PM | 2:15PM–3:45PM
Description
The Optical Surgical Navigation workshop will highlight experts from various institutions to discuss ongoing clinical trials and developments in the field of intraoperative molecular imaging. This workshop will focus on clinical trial design considerations and advancing regulatory guidance.
By the conclusion of the workshop sessions, participants will be updated on the progress of new research and the progress of clinical trials and will gain a deeper understanding of regulatory requirements, clinical trial design principles, and the critical role of FDA support in facilitating the development and commercialization of surgical navigation technologies. Armed with newfound insights and guidance, participants will be better equipped to navigate regulatory pathways and design robust clinical trials.
- David Holt, University of Pennsylvania, “Using Spontaneous Large Animal Models of Cancer to Test Near-Infrared Imaging Strategies”
- Michael Bouvet, UC San Diego, “Updates on Clinical Trials of the Nerve Imaging Agent ALM-488 in Patients Undergoing Head and Neck Surgery”
- Eric Henderson, Dartmouth College, “Necrotizing Fasciitis”
- Francoise Cailler, SurgiMab, “Industrial perspective on the clinical development of a tumor-specific marker for fluorescence-guided surgery: regulatory and market specificities”
- Alex Hofling, FDA: Introductory Remarks
- Colin Chen, FDA: Device Development and Evaluation Part 1
- Jessica Carr, FDA: Device Development and Evaluation
- Dhanalakshmi Kasi, FDA: Drug Product Quality
- Jonathan E. Cohen, Center for Drug Evaluation and Research, FDA: Nonclinical Assessments
- Nicole Toscano, FDA: Clinical Trial Design and Analysis: Clinical Considerations
- Sue Jane Wang, FDA: Clinical Trial Design and Analysis: Statistical Considerations
- Sunil Singhal, University of Pennsylvania: VGT-309 clinical trial work
- Alexander Vahrmeijer, Leiden University Medical Center (LUMC): FGS clinical trial work
- Graham Jang, Blaze Biosciences: BLZ-100
- Q&A/ Panel Discussion with the FDA
WMIC PUBCRAWL
Tuesday, September 10th, 2024
8PM – 10PM
Embark on a unique networking adventure at the annual WMIC Pubcrawl! Mingle with Interest Group leadership and attendees at a local pub, immersing yourself in Montreal’s vibrant culture. Start at the designated Old Town bar for your chosen Interest Group, then rotate through the city’s hotspots, meeting all 14 interest group chairs. Learn about getting involved with WMIS while savoring local flavors. This unforgettable evening blends professional connections with a taste of Montreal’s charm. Don’t miss this one-of-a-kind opportunity to network and explore!
OSN MEMBERSHIP
The Optical Surgical Navigation (OSN) Interest Group of The World Molecular Imaging Society is focused on advancing and supporting optical molecular imaging education, innovation, standardization, and translation to clinical use. They envision molecular optical imaging techniques being used during the majority of surgeries to visualize tissues, cells, and biochemical events in real time through improved instrumentation, markers, and expanding indications.
