TUESDAY, AUGUST 21, 7:30 – 8:30 AM
Table 1: Molecular Diagnostics and Detection of Rare Mutant Alleles at the Point of Care
Haim H. Bau, PhD, Professor, Mechanical Engineering and Applied Mechanics, University of Pennsylvania
- Molecular diagnostics at the point of care
- Detection of mutant alleles at the point of care
Table 2: Evidence Review and Development for Advanced Diagnostics
Joseph Chin, MD, Deputy Director, Coverage & Analysis Group, US Dept of Health & Human Services, Centers for Medicare & Medicaid Services
- Framework for evidence review
- Translation and implementation science
- Clinical study networks to develop evidence
Table 3: Challenges for Point-of-Care Blood Collection: Managing Quality in the Real-World
James H. Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry and POCT, Vanderbilt University School of Medicine
- Describe current challenges with phlebotomy and transfer of blood to POCT devices
- Recognize inconsistencies in transfer of blood to POCT devices
- Identify problems processing pediatric specimens on modern laboratory automation
Table 4: Getting POC NAAT Tests into the Home
Paul Yager, PhD, Professor, Bioengineering, University of Washington
- Ongoing changes in US domestic healthcare
- POC NAAT Testing
- New opportunities for home testing
Circulating Tumor Cells
Table 5: Liquid Biopsy to Advanced Personalized Care
Moderator: Massimo Cristofanilli, MD, FACP, Professor, Medicine; Associate Director, Translational Research and Precision Medicine; Director, OncoSET Precision Medicine Program, Medicine-Hematology and Oncology, Robert H Lurie Comprehensive Cancer Center, Feinberg School of Medicine
- CTCs and ctDNA are both important?
- CTCs commercial and technical challenges to clinical applications
- What is necessary in liquid biopsy field to become standard of care
Tale 6: CTC Capture, Interrogation, and Culture
Moderator: Richard J. Cote, MD, FRCPath, FCAP, Professor, Joseph R. Coulter Jr. Chair, Pathology & Laboratory Medicine; Professor, Biochemistry and Molecular Biology; Chief of Pathology, Jackson Memorial Hospital
- Live CTC capture
- CTC and circulating tumor micro environment cells (cCAF)
- Novel image capture and analysis of CTC/cCAF
- Conditions for expansion and propagation of CTC
- Biomimetic Systems for CTC propagation
Biomarkers for Cancer Immunotherapy and Combinations
Table 7: Cell-Based Biomarkers
Moderator: Katie Streicher, PhD, Associate Director, Translational Medicine, Medimmune
- Integrating cell-based biomarkers with TMB and other genomic analyses
- Value of cell-based biomarkers in characterizing mechanisms of resistance
- Challenges in identifying markers that represent diversity of the tumor micro-environment
Table 8: Challenges to Companion Diagnostic Development in Multiplex Biomarkers
Moderator: Deepti Aurora-Garg, PhD, Director, Companion Diagnostics, Translational Medicine, Merck & Co.
- Regulatory hurdles
- High cost of test. Reimbursement issues
- Challenges of incorporating into prospective clinical trials
Clinical NGS Assays: Interpretation and Clinical Utility
Table 9: How Can We Develop Reference Materials for Clinical NGS Tests?
Lisa Kalman, PhD, Senior Advisor for Repository Science, Division of Laboratory Systems, Centers for Disease Control and Prevention
- How do laboratories validate the ability of their tests to detect a variety of variant types throughout the genome?
- What reference materials are available for these validation activities? What materials are needed?
- How can needed reference materials be developed?
Table 10: NGS Tests in Clinical Settings; Challenges and Future Directions
Arezou Ghazani, PhD, FACMG; Senior Scientist and Medical Geneticist; Dana Farber Cancer Institute & Harvard Medical School
- Moving from panel to whole genome; what are current clinical and diagnostic challenges
- Overcoming clinical inertia; how to address and improve health professional preparedness for different genetic tests and incidental findings
- Usefulness of genetics data; what are innovative methods to mine for clinically actionable targets in the genome
Companion Diagnostics: Strategy and Partnerships
Table 11: Companion Diagnostics Outside Oncology
Moderators: Mark Curran, PhD, Vice President, Companion Diagnostics, Janssen R&D
Jorge Villacian, MD, CMO, Janssen Diagnostics
Brad Nohe, MBA, Head of Lupus, Global Product and Portfolio Strategy, AstraZeneca
- It’s been 20 years!! Why so little success for a great idea (right drug, right patient, right time)? What are we doing wrong?
- Are health care providers outside of Oncology actually ready to implement Personalized Medicine?
- Where is the value for Co-Dx outside of oncology? Prediction of R? Prediction of NR? Prognosis?
- How good would a Co-Dx need to be to change care paradigms from requiring patients to fail “cheaper” drugs first? Is there a robust value proposition?
- Changing clinical practice is very hard –potential synergies between stakeholders (Pharma, Dx co’s, payors, providers)?
- Future utility of AI/ML in biomarker discovery – areas of low lying fruit?
- What does it take to change clinical practice in order to implement precision medicine?
- Are there examples outside oncology where precision medicine is currently being practiced?
- What has led to the success of these approaches and can it be extrapolated to other disease areas?
- Is the concept of precision medicine well understood across the board?
- How will personalized medicine in other therapeutic areas be different than in oncology?
- How attractive is personalized medicine to non-oncology patients?
Table 12: Solutions for Supporting Companion Diagnostic Commercialization
Moderator: Gary Gustavsen, Partner, Health Advances
- Typical barriers to CDx adoption
- Split of roles and responsibilities across partners
- Marketing, reimbursement, logistics support, and field force strategies
THURSDAY, AUGUST 23, 7:30 – 8:25 AM
Molecular Diagnostics for Infectious Disease
Table 13: Comparison of Reference Standards and Technologies for Clinical Next-Generation Sequencing in Infectious Diseases
Moderator: Charles Chiu, M.D., Ph.D., Associate Professor, Laboratory Medicine and Medicine/Infectious Diseases, Director, UCSF-Abbott Viral Diagnostics and Discovery Center, Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine
- What are the advantages and disadvantages of various NGS platforms for infectious disease applications?
- When should NGS approaches be used, and when are faster and streamlined approaches (e.g. multiplex PCR, most appropriate)?
- What controls and standards need to be included?
- What bioinformatics programs and computational approaches be included?
Table 14: Developing an Implementation Toolkit for Clinical Roll-Out of a New Diagnostic Test
Moderator: Kevin Messacar, MD, Assistant Professor of Pediatrics, University of Colorado/Children’s Hospital Colorado, Section of Infectious Diseases
- What strategies have been successful to help health care facilities implement new diagnostic technologies?
- How can you target a high-impact patient population for testing?
- What electronic medical record strategies have been successful for ordering and reporting?
- Who are key stakeholders to include in implementation?
- What are successful strategies to integrate new diagnostic technologies with antimicrobial stewardship teams and efforts?
Clinical Application of Cell-Free DNA
Table 15: Clinical Implications of Clonal Hematopoiesis
Kelly Bolton, MD, Hematology-Oncology Fellow, Department of Medicine, Memorial Sloan Kettering
Table 16: Complementarity of NGS and Optimized dPCR Approaches in Cancer Research
Valerie Taly, PhD, CNRS Research Director (Dr2), Group Leader, Co-Director Ediag Platform, UFR Des Sciences Fondamentales Et Biomedicales, France
- Pro and cons of both technics including recent optimizations
- Example of strategy using either approaches or combination of both
- How to choose the appropriate strategy for a given project?
Companion and Complementary Diagnostics in Immuno-Oncology
Table 17: Emerging Biomarkers for Immuno-Oncology
Moderator: Jonathan Baden, Director, Pharmacodiagnostics, Translational Medicine, BMS
- Current Biomarker Landscape of Immuno-Oncology (I-O)
- Tumor mutation burden (TMB) as a potential predictive biomarker for I-O therapy
- Next-generation sequencing (NGS) testing approaches and challenges for assessing TMB
Table 18: Partnering to Advance Personalized Immuno-Oncology
Moderators: Janaki Veeraraghavan, PhD, Senior Staff Fellow, FDA
Theresa LaVallee, PhD, Head of Translational Medicine, The Parker Institute for Cancer Immunotherapy
- IO personalized medicine will most likely require a set of tests using different technologies – an immunoscore – and will need an algorithm to determine likelihood to benefit – is the field ready for this?
- Would a treatment based biomarker be the most informative to determine who to continue to treat? If so, what are the key attributes?
- How much of a benefit is enough for a test to have utility in clinical practice?
- Do biomarkers- such as TMB represent the same biology in different cancer indications?
- Pathways to rationalize the definition and measurement of an emerging biomarker
- Validation elements diagnostic test for personalized I/O therapy.
Sample Prep, Assay Development and Validation
Table 19: AI for Image Analysis
Moderator: Orly Ardon, MSc MBA PhD, R&D Program Manager, ARUP Laboratories/University of Utah
- Major developments in artificial intelligence and digital imaging in healthcare
- Incorporation of machine learning tools into classic diagnostics lab practices
- Partnerships between labs and machine learning start ups
Table 20: Tissue Printing for Biomarker Studies and Beyond
Moderator: Sandra Gaston, PhD, Director, Molecular Biomarkers Research Laboratory, Pathology and Laboratory Medicine, Tufts Medical Center
- Key considerations when designing biomarker studies that utilize human tissue biospecimens
- Emerging new applications of tissue print technologies
- Using tissue prints to analyze molecular biomarkers in biopsies and other limited high-value tissue specimens
Commercialization of Molecular Diagnostics
Table 21: Recent FDA Feedback, Tips and Trends for IVDs
Gail Radcliffe, President, Consulting, Radcliffe Consulting, Inc.
- De Novo submissions: timing and benefit/risk
- Next-Gen Testing: regulation snafu
- CLIA Waiver: simple and low risk of erroneous result
- IHC, ISH, Digital Pathology: study designs
Table 22: Patient Engagement in Healthcare
Larry K. Wray, PhD, Wray IVD Consulting
- What do me mean by "patient engagement in healthcare"?
- What changes are taking place and/or anticipated?
- How is this changing the healthcare system, e.g. manufacturers, providers, payers, etc.
- What new products and services are or will be entering the marketplace?
- What are the major obstacles to overcome to reach the desired end result?