PMLS Virtual Series – Precision Diagnostics

Unable to attend? On Demand Here

September 24-25, 2020


Welcome & Introduction

Nigel Russell, President and Founder, Precision Medicine Leaders’ Summits and The Journal of Precision Medicine

9:00 – 10:10

Diagnostics for Covid- How to Get What We Need

The pandemic has made everyone realize the importance of diagnostics in healthcare, but 8 months into the pandemic, we still lack the diagnostics we need to best manage Covid-19. How can we incentivize the development of the diagnostics we need to find disease, determine risk, and assess immunity? What are the regulatory barriers, and how can they be overcome? Who pays for these tests? What can we learn from Covid-19 for the next pandemic?

Moderator: Hannah Mamuszka, CEO and Founder, Alva10

Panelists: Parker Cassidy, MBA, Principal, Diagnostics and Tools, RA Capital Management LP;  Mark Hiatt, MD, MBA, MS, Vice President Medical Affairs, Guardant Health; Christiana Iyasere, MD, MBA, Physician and Director, Massachusetts General Hospital Department of Medicine Innovation Program; Eugean Jiwanmall, MBA, MPH Senior Research Analyst for Medical Policy & Technology Evaluation, Independence Blue Cross;  Andy Riemer, EdM, Associate, SidePorch

10:10 – 10:40

Fireside Chat

4D Path: Is it possible to obviate the need for NGS panels in oncology with a digital solution?

Imagine if instead of using hard slides stained with different antibodies in order to determine if a patient was HER2+, or running assays on PCR machines or even more expansive NGS machines to find an ALK fusion to prescribe Alectinib, there was a way to get all of that information and more instantaneously from a single whole slide H&E?

Satabhisa Mukhopadhyay PhD, MS, Chief Scientific Officer & Founder, 4D Path; Hannah Mamuszka, CEO and Founder, Alva10

10:40 – 11:35

Precision Medicine Outside Oncology: Where Are We?

Precision Medicine usually connotes use of diagnostics and other tools to optimize care in oncology, but really we should be considering development and use of these tools in every disease area. In this panel, we will discuss the challenges around development and commercialization of Precision Medicine diagnostics for use in stroke and autoimmune diseases.

Moderator: Hannah Mamuszka, Chief Executive Officer and Founder, Alva10

Panelists: Holly Bauzon, Vice President Commercial Development, Microba; Martyn Gross, MBA, Chief Business Officer, Mindera;  Jeff June, Chief Executive Officer & Founder, Ischemia Care

11:35- 12:15

How Can Software Enable Diagnostics To Impact Patient Care?

Diagnostic tests can be well validated, accepted in guidelines, and even reimbursed, yet they still don’t impact patient care. Why? Improper use, lack of physician understanding and support, lack of inclusion in coverage policies, inability to track all contribute to losing the potential impact of critical diagnostic tools. Software that highlights and streamlines decision making and provides information at the point of care allows for more efficient precision delivery of these tools.

Moderator: Hannah Mamuszka, Chief Executive Officer and Founder, Alva10

Panelists: Feyi Olopade Ayodele, MBA, Chief Executive Officer and Co-Founder, CancerIQ; Jerome Madison, Vice President Provider Relations, Trapelo Health; Robert Metcalf, MBA, Chief Executive Officer, Concert Genetics

12:20 – 12:45

ctDNA for Minimal Residual Disease Detection and Disease Monitoring in Solid Tumors

Asset-agnostic disease monitoring tools for solid tumor will help to identify earlier-stage patients at highest risk of relapse. A growing body of evidence across multiple tumor types suggests patients with detectable circulation tumor DNA (ctDNA) post- definitive treatment have increased risk of recurrence and worse outcomes. This presentation provide an introduction to ctDNA for minimal residual disease detection and disease monitoring in solid tumors. Highlight the technology challenge for utilizing ctDNA in clinical trials, and explore perspective clinical trials that need to demonstrate clinical validity and utility of ctDNA as a predictive biomarker.

Nancy Zhang, MD, Associate Director, Pharmacodiagnostics, Bristol Myers Squibb


Day One Wrap Up



Day One Recap

Nigel Russell, President and Founder, Precision Medicine Leaders’ Summits and The Journal of Precision Medicine

9:30 – 10:00

Blood Based Biomarkers of IO

Jonathan Baden, Senior Director, Pharmacodiagnostics, Bristol Myers Squibb

10:00 – 10:45

Keynote – How to be Precise in Managing Pandemics: 5 Critical Domains for Precision in Leadership Action

Dr. Lasalvia shares practical suggestions for hospital and national healthcare leaders on navigating the current pandemic with precision. 5 critical domains to be highlighted include testing, tracing, public health infrastructure, global collaboration, and addressing the most vulnerable populations.
As future pandemics are inevitable, the relevance of public health applies not only to the present COVID-19 situation, but also looking into the future. Today’s learning allows hospitals and healthcare systems to be much better prepared to manage them.

Luis Lasalvia, MD, Vice President & Global Medical Officer, Siemens Healthineers

10:45 – 11:30

Reimbursement Tied to Clinical Records: Impacts and Data Approaches to Improve Profitability

Diagnostic providers are the guardians of an enormous volume of healthcare data within their laboratory information system and revenue cycle management solutions. Yet, this data represents only a subset of the information often requested by payors. In the absence of the right data — and even in the possession of the right data — payors make reimbursement and coverage decisions that negatively impact the bottom line of labs, practices, molecular diagnostic providers, and remote patient monitoring organizations.

Attendees will learn:
• The impact of payor requests for additional information and medical necessity or experimental denials
• Payor behavior uncovered through detailed data analysis
• The importance of capturing clinical indicators, familial & patient history to prevent denials and improve appeals success
• Approaches and technology that enable the use of temporal data, analytics, and pattern recognition to identify anomalies that inform strategy, decisions, negotiations, and workflow
• Data curation best practices for real-world evidence development
• How well organized, centralized, and curated data sets can be leveraged to improve profitability

Moderator: Lori Anderson, Senior Product Manager, VisualStrata,  XIFIN, Inc.

Panelists: Patricia Goede, PhD, MS, Vice President, Clinical Informatics, XIFIN, Inc.; Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC


Closing Remarks

Nigel Russell