Breakout Discussions

TUESDAY, AUGUST 21, 7:30 – 8:30 AM

Independence F-I

Point-of-Care Diagnostics

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

Independence F-I

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?

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