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. 

Wednesday, September 29th – Genomics

12:30 pm	Welcome and Opening Remarks Norman Sharpless, MD, National Cancer Institute, and Jeffrey Shuren, MD, JD, U.S. Food and Drug Administration
12:45 pm	Goals of the Workshop Lyndsay Harris, MD, National Cancer Institute
12:55 pm	Keynote Presentation NCI Research Data Commons Anthony Kerlavage, Ph.D., National Cancer Institute
1:25 pm	10-minute Break
1:35 pm     1:55 pm	Genomics Plenary Session Reference Samples to Compare Next Generation Sequencing Test Performance: The Sustainable Predictive Oncology Therapeutics and Diagnostics (SPOT/Dx) Diagnostic Quality Assurance Pilot John Pfeifer, MD, PhD, Washington UniversityAccelerating Genomics into the Clinic  Euan Ashley, MD, PhD, Stanford University
2:15 pm	Medical Device Innovation Consortium (MDIC) Somatic Reference Sample Project Carolyn Hiller, MBA, Medical Device Innovation Consortium, and Justin Zook, PhD, National Institute of Standards and Technology
2:35 pm	Summary of Genomics RFI Comments and Charge to Break-Out Group Kristofor Langlais, Ph.D., U.S. Food and Drug Administration
2:50 pm	Genomics Break-Out Group Session Facilitated by Birgit Funke, PhD, PACMG, Sema4
3:50 pm	10-minute Break
4:00 pm	Genomics Break-Out Group Report Out Birgit Funke, PhD, PACMG, Sema4