Immunotherapy Biomarkers 2016: Overcoming the Barriers

When:  Apr 1, 2016 from 08:00 to 17:00 (ET)

Cosponsored with the National Cancer Institute
 

Friday, April 1, 2016 • 8 a.m. – 5 p.m.
Masur Auditorium, National Institutes of Health Clinical Center
Bethesda, Maryland

Organized by the SITC Immune Biomarkers Task Force in collaboration with the Center for Cancer Research, National Cancer Institute (NCI/CCR), of the National Institutes of Health, U.S. Department of Health & Human Services

Program Purpose

NCI/CCR and SITC co-sponsored a 2016 Biomarkers meeting to review the state of the art, discuss current hurdles to further success, and consider recommendations to move the field forward. The main goals were to provide updated information to a wide audience and solicit stakeholder participation in promoting successful immune biomarker research. This one-day event was divided into four didactic sessions representing the four working groups of the SITC 2015-2016 Immune Biomarkers Task Force. Each session included presentations by members of one working group followed by a 30-minute panel discussion designed to engage workshop participants in productive conversation and debate.

Intended Audience

The target audience for these programs included a broad representation from academia, biotech, pharma, government, researchers and early career individuals who wished to review the biomarkers state of the art, discuss current hurdles to further success, and consider recommendations to move the field forward.

Educational Objectives

Upon the completion of this program, participants will be able to:

  • Describe the most promising companion diagnostics by evaluating proficiency panels of assays
  • Discuss new technologies and their application to clinical trials of immunotherapeutic agents and implement best practices for sample handling and data analysis
  • Discuss the state of the art high throughput technologies for identifying signatures of immune function, immune response, and clinical outcomes in cancer patients
  • Understand how examination of blood, genetic, transcriptomic and immune infiltrate assessments work to identify patients suitable for different treatment approaches

Planning Committee

Lisa H. Butterfield, PhD – University of Pittsburgh
Mary L. Disis, MD – University of Washington
Bernard A. Fox, PhD – Earle A. Chiles Research Institute, Providence Cancer Center
Sacha Gnjatic, PhD – Icahn School of Medicine at Mount Sinai
James L. Gulley, MD, PhD, FACP – National Cancer Institutes, National Institutes of Health
Samir N. Khleif, MD – Georgia Regents University Cancer Center
Francesco M. Marincola, MD – Sidra Medical and Research Center
Giuseppe V. Masucci, MD, PhD – Karolinska University Hospital at Solna
David F. Stroncek, MD – National Cancer Institute, National Institutes of Health
Magdalena Thurin, PhD – National Cancer Institute, National Institutes of Health
Jianda Yuan, MD, PhD – Memorial Sloan Kettering Cancer Center


Session I: Immunologic Monitoring Assay Standardization and Validation
Co-Chairs:
Magdalena Thurin, PhD – National Cancer Institute, National Institutes of Health
Giuseppe V. Masucci, MD, PhD – Karolinska Institutet
8:10 a.m. – 8:15 a.m. Session  I Introduction
Magdalena Thurin, PhD – National Cancer Institute, National Institutes of Health
8:15 a.m. – 8:30 a.m. Pre-Clinical Validation & Validation Process    
Alessandra Cesano, MD, PhD – NanoString Inc.
8:30 a.m. – 8:45 a.m. TCR Sequencing Technology Platform    
Ilan Kirsch, MD – Adaptive Biotechnologies Corporation
8:45 a.m. – 9 a.m. Blood Assays in Pre-Analytical Validation (Proficiency Panels & Harmonization)    
Sylvia Janetzki, MD – ZellNet Consulting, Inc.
9 a.m. – 9:15 a.m. Regulatory Considerations for Diagnostic Devices in Cancer Immunotherapy
Shyam Kalavar, MPH, CT(ASCP) – U.S. Food and Drug Administration
9:15 a.m. – 9:45 a.m.
Panel Questions and Answers
9:45 a.m. – 10 a.m.
Break
Session II: New Developments in Biomarker Assays and New Technologies
Chair: Jianda Yuan, MD, PhD – Merck & Co., Inc.
10 a.m. – 10:05 a.m. Session II Introduction
Jianda Yuan, MD, PhD – Merck & Co., Inc.
10:05 a.m. – 10:20 a.m. Multispectral Imaging
Bernard A. Fox, PhD – Earle A. Chiles Research Institute, Providence Cancer Center
10:20 a.m. – 10:35 a.m. Mutational Landscapes and Immunotherapy Efficacy    
Jianda Yuan, MD, PhD – Merck & Co., Inc.
10:35 a.m. – 10:50 a.m. Defining New Metrics of Immune Competence by CyTOF    
Holden Maecker, PhD – Stanford University Medical Center
10:50 a.m. – 11:05 a.m. Multifaceted Immunomonitoring to Identify Predictive Biomarkers for the
Clinical Outcome of Immunotherapy-treated Melanoma Patients    
Cristina Maccalli, PhD – Sidra Medical and Research Center
11:05 a.m. – 11:35 a.m. Panel Questions and Answers
11:35 a.m. – 12:35 p.m. Break
Session III: Assessment of Immune Regulation and Modulation Systematically (High Throughput Approaches)
Chair: David F. Stroncek, MD – National Cancer Institute, National Institutes of Health
12:35 p.m. – 12:40 p.m. Session III Introduction
David F. Stroncek, MD – National Cancer Institute, National Institutes of Health
12:40 p.m. – 12:55 p.m. Tumor Microenvironment    
Peter P. Lee, MD – City of Hope
12:55 p.m. – 1:10 p.m. Monitoring Adoptive Cellular Therapies    
David F. Stroncek, MD – National Cancer Institute, National Institutes of Health
1:10 p.m. – 1:25 p.m. Monitoring of Studies
Barbara Seliger, MD, PhD – Martin Luther University Halle-Wittenberg
1:25 p.m. – 1:40 p.m. Analysis of the Systemic Host Response    
Janet Siebert, MS – CytoAnalytics
1:40 p.m. – 2:10 p.m. Panel Questions and Answers
2:10 p.m. – 2:25 p.m. Break
Session IV: Prediction of Clinical Outcome Based on Baseline Measures
Chair: Sacha Gnjatic, PhD – Icahn School of Medicine at Mount Sinai
2:25 p.m. – 2:30 p.m. Session IV Introduction
Sacha Gnjatic, PhD – Icahn School of Medicine at Mount Sinai
2:30 p.m. – 2:45 p.m. Tumor Microenvironment at a Genetic Level     
Samir N. Khleif, MD – Georgia Cancer Center
2:45 p.m. – 3 p.m. Multiplex IHC    
Vaios Karanikas, PhD – Roche Innovation Center Zurich
3 p.m. – 3:15 p.m. Multiplex/Blood Profiles    
Marcus O. Butler, MD – Princess Margaret Hospital/Ontario Cancer Institute
3:15 p.m. – 3:30 p.m. Serology and IHC at the Tumor Site
Sacha Gnjatic, PhD – Icahn School of Medicine at Mount Sinai
3:30 p.m. – 4 p.m. Panel Questions and Answers
Session V: National Cancer Institute Perspectives on Biomarkers
Chair: James Gulley, MD, PhD, FACP – National Cancer Institute, National Institutes of Health
4 p.m. – 4:15 p.m. Lessons Learned from the Peripheral Immunoscore
Jeffrey Schlom, PhD – National Cancer Institute, National Institutes of Health
4:15 p.m. – 4:30 p.m. Extracellular Vesicles as Biomarkers of Immune Responses and Tumor Responses in
Cancer Immunotherapy
Jay A. Berzofsky, MD, PhD – National Cancer Institute, National Institutes of Health
4:30 p.m. – 4:45 p.m. Panel Questions and Answers
4:45 p.m. – 5 p.m. Closing Remarks
James Gulley, MD, PhD, FACP – National Cancer Institute, National Institutes of Health

 

Immunotherapy Biomarkers 2016: Overcoming the Barriers is supported in part by grants from AstraZeneca; Bristol-Myers Squibb; Genentech; and Merck & Co., Inc.

Location

Masur Auditorium, National Institutes of Health Clinical Center
Bethesda, MD