Breakout Discussions

WEDNESDAY, AUGUST 21 | 7:30-8:25AM

Enabling Point-of-Care Diagnostics

Independence B-E and Foyer

Challenges and Potential Solutions to POC Implementation of Sequencing Technologies

Moderator: Charles Chiu, MD, PhD, Professor, Departments of Laboratory Medicine and Medicine, Division of Infectious Diseases; Director, UCSF-Abbott Viral Diagnostics and Discovery Center; Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine

• Challenges to routine implementation of sequencing technologies in POC settings?
• Cost, validation, and regulatory issues and potential markets
• Crowd-sourcing versus physician/scientist-driven initiatives
• Viral, bacterial, versus pan-pathogen targeting for POC infectious disease diagnostics

Informatics in POC Testing

Moderator: Bill Marquardt, C(ASCP), MBA, CSSBB, Vice President, Lab Intelligence, McKesson Laboratory Solutions

• Connectivity challenges and future of POC to D/EMR interfacing
• POC connectivity from home devices
• Artificial intelligence and autoverification of POC test results
• How more complex testing can become CLIA-Waived using more advanced informatics tools
• Using machine learning and predictive analytics within the POC laboratory

Strategies for Home and Field Deployable POCT

Moderator: Nam Tran, PhD, Associate Clinical Professor, Clinical Chemistry, Special Chemistry, Toxicology, POCT and SARC Sections, Department of Pathology and Laboratory Medicine, University of California, Davis

• Preparing for the worst: Strategies for the next disaster with field deployable POCT
• Educating home users on POCT environmental limitations
• Future of field-robust POCT devices

Enabling Technologies for Circulating Biomarkers

Independence B-E and Foyer

Analytical Considerations for Liquid Biopsy RNA-seq

Moderator: Ryan M. Spengler, PhD, Postdoctoral Fellow, Muneesh Tewari Laboratory, Hematology/Oncology, University of Michigan

• Quality control measures and sample assessment
• Mapping and quantification: dealing with contaminates and ambiguous alignments.
• Pitfalls of expression analysis: sequencing bias, normalization and differential expression

Challenges for Early Cancer Detection

Moderator: Michael J. Heller, PhD, Distinguished Scientist, Knight Cancer Institute at Oregon Health & Science University (OHSU), Center for Cancer Early Detection and Research (CEDAR); Professor Emeritus, Bioengineering and Nanoengineering, University of California San Diego

• Which biomarkers?
• Problem of extremely low biomarker levels in blood
• Viable technology to meet these challenges

Emerging Technologies and Biomarkers for Cancer Immunotherapy

Independence B-E and Foyer

Non-Genomic Biomarkers in Immuno-Oncology

Moderator: Ana I. Robles, PhD, Program Director, Office of Cancer Clinical Proteomics Research, Center for Strategic Scientific Initiatives, National Cancer Institute, National Institutes of Health

• What are the performance characteristics of currently available genomic and non-genomic biomarkers for Immuno-Oncology?
• What are the clinical needs that have not been (properly) addressed by existing biomarkers?
• Which non-genomic biomarkers are at early stages of development and how do we best prioritize and move them forward?

Novel Genomic Biomarkers in Oncology

Moderator: Matthew Marton, PhD, Director, Companion Diagnostics and Genomics, Merck & Co., Inc.

• What can Dx companies do to decrease the cost and increase the rate of NGS tumor testing?
• Will plasma-based cancer Dx testing supplant tumor-based Dx testing in oncology?
• What will be the dominant setting for future plasma-based Dx testing? Cancer detection or metastatic treatment decision-making?
• How broadly applicable will the tumor-agnostic Dx approach be?
• How do you think FDA is handling the regulation of novel genomic biomarker tests? What should they do differently?

Multiplexed IHC Advances in Immuno-Oncology

NEW: Moderator: Michael Surace, PhD, Scientist II, AstraZeneca

• Validation of Multiplex IHC methods for clinical specimens
• The role of multiplex IHC for biomarkers discovery and validation
• Potential application of Multiplex IHC in the clinical laboratory and for patient selection in clinical trials

Coverage and Reimbursement for Advanced Diagnostics

Independence B-E and Foyer

Pocket Change: Does Patient Contribution Impact Uptake of Screening Testing?

NEW: Moderator: Jennifer R. Leib, ScM, CGC, Founder, Innovation Policy Solutions, LLC

• Should patients have any out-of-pocket contribution for screening testing?
• What role should guidelines regarding screening and surveillance play in determining health insurance coverage and reimbursement?
• Do you see a difference between preventative versus disease-managing assays in the way that out-of-pocket payment should be managed?

Working with Laboratory Benefit Managers

Moderator: Mitchell Burken, MD, Associate Medical Director, Genetics, eviCore

• What should be the key goal of diagnostic companies when working with Laboratory Benefit Managers (LBMs)?
• What is the most important piece of advice diagnostic professionals should keep in mind when working with LBMs?
• What is additional advice or suggestions for companies who are in the early stages of working with LBMs?

Companion Diagnostics: Strategy & Partnerships

Independence B-E and Foyer

Disruptive Technologies for Companion Diagnostics: Challenges and Solutions

Moderator: Jonathan Beer, MBA, Director, Disruptive Technologies, Oncology Precision Medicine, Novartis

• Why is TMB not yet a validated IO CDx biomarker?
• Which technology class is most likely to become an approved CDx?
• What factors are preventing approval of more liquid biopsy CDx assays?

Companion and Complementary Diagnostics in Immuno-Oncology: The FDA Perspective

Moderators: Pamela Gallagher, PhD, Scientific Reviewer, FDA

Anand Pathak, MD, PhD, MPH, Medical Officer, FDA

• What are some common challenges to validating I-O CDx and complementary diagnostic devices?
• What are some clinical trial design considerations for validating I-O biomarkers?
• Why is it important to have well-defined I-O biomarkers?
• What is the best approach to harmonize I-O biomarker definitions among device sponsors?
• Are there any emerging I-O biomarkers on the horizon?

Applications of Digital Pathology

Independence B-E and Foyer

Impact of Digitization on the Practice Pathology

Moderator: Juan Antonio Retamero, MD, Staff Pathologist, Department of Anatomical Pathology, Hospital Campus de la Salud

• Impact of digitization on the practice of the profession
• The future of pathology: Digital and computational tools
• Clearing roadblocks on the adoption of digital pathology

Image Analysis Challenges of Digital Pathology: What do Pathologists Need?

Moderator: Hamid Tizhoosh, PhD, Professor, Computer Science; Director, Kimia Lab, Faculty Affiliate, Vector Institute, University of Waterloo, Canada

• Image segregation
• Image classification
• Image search
• Tissue recognition
• Survivability prediction

THURSDAY, AUGUST 22 | 7:30-8:25AM

Emerging Technologies at the Point-of-Care

Independence B-E and Foyer

Technologies to Enable Point-Of-Care… Anywhere?

Moderators: Dionysios Christodouleas, PhD, Assistant Professor, Department of Chemistry, University of Massachusetts Lowell

Shawn Mulvaney, PhD, Section Head, Surface Nanoscience and Sensor Technology Section, Chemistry, US Naval Research Laboratory

• In the future, POCT will be common at the home, in the battle field, etc. How can we start planning now?
• So your sensor works, but what about the sample prep? Does that strategy work at home? In a field?
• Do you have the "Tricorder"? How sophisticated does POCT medicine get before my backpack gets too full?

Multiplex at the POC

Moderator: Mehdi Javanmard, PhD, Assistant Professor, Department of Electrical and Computer Engineering, Rutgers University

• How to balance increasing technological complexity with the need for low cost?
• Integrating new biomarkers, ex. miRNA, protein, etc
• How to tackle sample prep, integration on chips/assays?
• Translating from the bench to a cartridge

The Next Big Step Forward in Microfluidics; Microstructured Films Combined with Polymer or Glass Parts
Moderators: Maria Bauer, PhD, CEO, Myropartners, Salzburg, Austria
Violeta Tacheva, MSc, Project Engineer, Stratec Consumables, Cambridge MA, USA

• What are microstructured films and foils
• Advantages of the roll to toll process
• Industrial partnership with the Kurz Group
• Applications of microstructured foils in POC and IVD applications
  

Molecular Diagnostics for Infectious Disease

Independence B-E and Foyer

Strengths and Limitations of AI and Machine Learning for Healthcare Applications

Moderators: Hooman H. Rashidi, MD, FASCP, Professor and Vice Chair, GME, Director of Residency Program; Director, Flow Cytometry & Immunology, Department of Pathology and Laboratory Medicine, University of California, Davis School of Medicine

Nam Tran, PhD, Associate Clinical Professor, Clinical Chemistry, Special Chemistry, Toxicology, Point-of-Care Testing, SARC Sections, Pathology and Laboratory Medicine, University of California, Davis

• Data collection challenges
• Data processing limitations
• Highlights and limitations of various machine learning algorithms
• Regulatory considerations and barriers
• Generalizability of laboratory data for AI/ML applications

Overcoming the Challenges of Point-of-Care Diagnostics for Better Antibiotic Stewardship

Moderator: Kfir Oved, PhD, Co-founder, CTO, Chairman, MeMed Dx

• What are the major roadblocks preventing POC diagnostics from impacting antibiotic misuse?
• Can POC diagnostics propagate from hospitals and EDs to serve the wider continuum of care including the outpatient setting? How?
• Syndrome testing versus host response-based diagnostics - pros and cons. 
• How can value-based reimbursement models be developed to support novel POC diagnostics?

Clinical Application of Circulating Biomarkers

Independence B-E and Foyer

Current Status of ctDNA in Disease Monitoring

Moderator: Christine Parseghian, MD, Assistant Professor, Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center

• Current status of ctDNA in disease monitoring
• Potential of ctDNA monitoring in clinical management of advanced cancers
• Potential of ctDNA monitoring in clinical trials for advanced cancers

Companion Diagnostics and Clinical Biomarkers in Immuno-Oncology

Independence B-E and Foyer

Clinical Biomarkers in the Era of Combination Cancer Therapy

Moderator: Jamie Shaw, Principal Scientist, Clinical Biomarkers and Diagnostics, EMD Serono, Inc.

• How can clinical sample testing be prioritized to be most informative when tissue is limited?
• What are the challenges of assessing pretreatment markers vs. resistance markers acquired upon progression?
• Which design parameters are essential for robust evaluation of multiple markers within a clinical study?
• What strategic considerations need to be taken when there are multiple CDx assays commercially available?

Next Generation Oncology Biomarkers: Value Demonstration and Role of Real-World Data

Moderators: Shuvayu S. Sen, PhD, Executive Director, CORE Oncology, Merck & Co., Inc.

Kaushal Desai, PhD, Director, Informatics & Outcomes Research, Merck & Co., Inc.

• What are the critical questions drug developers face in showing the value of such markers for approval and utilization?
• What are the methodological and data challenges do we face in conducting value assessment of biomarkers and relevant drugs?
• What are the perspectives of diagnostic labs and data integrators in terms of linking data of different part of the health care system including biomarkers?

Commercialization of Diagnostic Tests

Independence B-E and Foyer

IVD Regulatory Paths: What is FDA Looking for?

Moderator: Gail Radcliffe, PhD, President, Radcliffe Consulting, Inc.

• De Novo submissions: timing and benefit/risk
• Companion Diagnostics: broad claims
• IHC, ISH, Digital Pathology: study designs
• Next-Gen Testing: intended use claims
• CLIA Waiver & Point of Care Devices

Changing Oncology Workflows to Adopt New Technologies

Moderator: Bill Getty, Vice President, Marketing, Guardant Health

• ASCO, CAP, and NCCN guidelines and recommendations
• Physician education and peer influence
• Pathways and EMR integration
• Nurse and nurse-navigator education