About this Class

This NIH-FDA sponsored workshop will bring together members of the scientific community to discuss the obstacles and opportunities associated with NGS and radiomics tool development, validation, and regulatory science. NCI presenters include NCI Director, Dr. Ned Sharpless, and CBIIT Director, Dr. Tony Kerlavage, who will be giving the keynote presentation on NCI’s Cancer Research Data Commons. The NIH-FDA Joint Leadership Council on Next-Generation Sequencing (NGS) and Radiomics Working Group is hosting a virtual workshop to engage the scientific community on ways to accelerate the clinical applications of NGS and radiomics. Namely, the group intends to address the following topics:

• Critical resource gaps, particularly as they relate to reference standards, which must be corrected to enable high-quality research, development, validation, and regulatory science in NGS and radiomics
• Opportunities that support NGS and radiomic tool development and validation (especially tools utilizing artificial intelligence and machine learning)
• Existing resources that might be leveraged to accelerate growth in NGS and radiomics

NCI presenters include NCI Director, Dr. Ned Sharpless; Associate Director, Cancer Diagnosis Program, Dr. Lyndsay Harris; and Clinical Trials Branch Chief, Cancer Imaging Program, Dr. Lalitha Shankar. CBIIT Director, Dr. Anthony Kerlavage, will provide the keynote presentation on the NCI Cancer Research Data Commons. Two Requests for Information (RFIs) related to the topics of this workshop have been published. (Responses received prior to the workshop date may be discussed at the event.) Visit the workshop webpage for additional details on the RFIs as well as the workshop agenda and presenter bios.

Agenda

All times are listed in Eastern Daylight Time. 

Thursday, September 30th – Radiomics

9:45 am	Day 2 Opening Remarks Lalitha Shankar, MD, PhD, National Cancer Institute
10:00 am     10:20 am	Radiomics Plenary Session Clinical Utility of AI Tools in Brain Tumors Brad Erickson, MD, PhD, Mayo ClinicResources needed to advance AI/ML in cancer imaging, COVID-19, and other diseases: data collection, annotations, harmonization, metrology, and sequestered datasets Maryellen Giger, PhD, University of Chicago
10:40 am	Summary of Radiomics RFI Comments and Charge to Break-Out Group Kristofor Langlais, Ph.D., U.S. Food and Drug Administration
10:55 am	Radiomics Break-Out Group Session Facilitated by Curtis Langlotz, MD, PhD, FACMI, Stanford University
11:55 am	10-minute Break
12:05 pm	Radiomics Break-Out Group Report Out Curtis Langlotz, MD, PhD, FACMI, Stanford University