Problem Solving Breakout Discussions

WEDNESDAY, AUGUST 26 | 10:40-11:10AM

BREAKOUT 1: Extracellular Vesicles (EV) are Heterogenous, but Would Single EV Analysis be Helpful for Making Clinical Decisions?

Lydia Sohn, PhD, Chancellor’s Professor, Mechanical Engineering; Faculty Assistant to the Vice Chancellor for Research, UC Berkeley

BREAKOUT 2: Risk Management for Point-of-Care Testing

James Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine

  • Recognize common sources of error at the point-of-care
  • Identify CLSI EP23 guideline as a resource for risk management
  • Describe some novel control processes developed by manufacturers to address specific errors

BREAKOUT 3: Work Smarter, Not Harder: Tips to Make Your POCT Life Easier 

Joe Wiencek, PhD, Assistant Professor, Department of Pathology; Medical Director, Point-of-Care Testing; Associate Medical Director, Clinical Chemistry; Co-Director, Clinical Chemistry Fellowship, University of Virginia School of Medicine

  • Standardization
  • Middleware
  • Lean/A3

BREAKOUT 4: Reimbursement Issues with COVID-19 Testing

Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories
Jim Almas, MD, Vice President and National Medical Director, Clinical Effectiveness, LabCorp

BREAKOUT 5: Working with CMS Contractors

Gabriel Bien-Willner, MD, PhD, Medical Director, MolDx, Palmetto GBA

BREAKOUT 6: Disruptive Technologies and Approaches for Companion Diagnostics and Clinical Biomarkers

Neeraj Adya, PhD, Head, Diagnostics, Genmab

THURSDAY, AUGUST 27 | 10:15-10:45AM

BREAKOUT 8: Clinical Metagenomic Sequencing

Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin

BREAKOUT 9: Getting a Foot in the SBIR Grant Rat Race

Robert Duncan, PhD, Principal Investigator, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), FDA

  • What defines Small Business Innovation Research?
  • What is the importance of interaction with the NIH Project Managers?
  • What is the Phase I Grant? Visualize proof of concept research.
  • What is the Phase II Grant? Visualize larger scale funding for research that leads to a commercialization plan?

BREAKOUT 10: How AI-Based Devices can Better Inform Clinical Decision-Making

Sharief Taraman, MD, CMO, Cognoa; Division Chief, CHOC Children’s Hospital

  • Digital technologies can address healthcare disparities for more equitable outcomes and become first-line-of care, solving the access challenge
  • Digital devices have safety/low-risk advantages over drugs and can enable combination therapies that are more effective

BREAKOUT 11: Blood-Based Biomarkers in Oncology

Jonathan Baden, MS, Senior Director, Pharmacodiagnostic, Bristol-Myers Squibb
Katie Streicher, PhD, Associate Director, Translational Medicine, Research and Early Development, Oncology R&D, AstraZeneca

BREAKOUT 12: Comprehensive Approach to Early Detection of Disease

John Sninsky, PhD, Independent Consultant, Translational Medicine and Science

BREAKOUT 13: Genomic Biomarkers in Oncology: Today and Tomorrow

Carl Morrison, Senior Vice President, Pathology, Roswell Park Cancer Institute

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