7:50 am Chair’s Opening Remarks

  • Anthony Sireci Senior Medical Director, Medical Affairs, Loxo Oncology

Plenary Address: Showcasing Cutting Edge Innovation in Precision Medicine & the Impact on Patient Care

8:00 am Accelerating Functional Analysis of Patient Tumor Cells to Reduce Metastasis

  • Stuart Martin Professor, Physiology, Marlene and Stewart Greenebaum NCI Comprehensive Cancer Center, University of Maryland School of Medicine


  • How the limitations of clinical imaging affect cancer detection and patient monitoring for therapeutic responses
  • Technologies for propagating patient tumor cells to enable functional studies
  • Improving the understanding of tumor cell responses in the free-floating environments of metastasis (bloodstream, lymphatics)
  • Bioengineering solutions to accelerate functional phenotyping of patient tumor cells for metastatic behaviors and drug responses

8:30 am Launching a Companion Diagnostic in the Clinical Laboratory


  • Evaluating the key considerations for being day one ready – a focus on PD-L1
  • PIK3CA cast study – discussing the full spectrum of CDx development from bench to bedside
  • Perspectives on lessons learned and future paradigms for diagnostic development

9:00 am Comprehensive Biomarker Strategies to Accelerate Adoptive Cell Therapy Development


  • Adoptive Cell Therapies (ACTs) harness the immune system to target cancer cells. Recent successes include two FDA-approved CAR-T immunotherapies
  • The potential for ACTs appears limitless, from the exploration of new indications and combination therapies to novel cancer antigens
  • Consequently, the complexity of immunotherapy clinical trials increases rapidly. Key challenges include regulatory and operational risks that limit approvals and commercialization
  • This talk will focus on biomarker-driven strategies to overcome the unique barriers confronted during ACT development


9:30 am Comfort Break & Networking

9:45 am How Can We Use Data More Intelligently to Improve Companion Diagnostic Commercialization?


  • Discussing data requirements to commercialize CDx
  • What gaps exist in the data?
  • How can we fill in those gaps to ensure seamless test integration?
  • Showcasing most effective uses for available testing data
  • Leveraging data to drive ROI & improve patient care

10:15 am Multiplexed Analysis for Complete Liquid Biopsy Solutions


  • Discussing highly sensitive techniques for small samples and harvested rare cells
  • Harnessing clinically useful CTC liquid biopsy tests for treatment and patient outcomes
  • Future trends for CTC liquid biopsies as powerful precision medicine tool

10:45 am Morning Refreshments & Networking

11:30 am

Biomarker Discovery & Translation

Clinical Biomarker Development

Drug-Dx Commercialization

Improving the Validation & Standardization of Biomarker Assays to Advance Development & Adoption

Chair: Robert McCormack, Independent

Achieving Regulatory Success for Diagnostic-
Enabled Precision Medicines

Chair: Naveen Babbar, Global Precision Medicine Leader, Oncology Precision Medicine, Novartis

Clinician & Patient Perspectives on the
Advancement of Precision Medicine &
Diagnostic Testing

Chair: Leslie Hoyt, Chief Commercial Officer, Olaris

11.30 Standardization & Validation: The Challenges Associated with Establishing Accuracy of Liquid Biopsy Assays

• Discussing BloodPAC’s efforts to develop standards to improve the reliability and reproducibility of liquid biopsy testing
• Understanding how to best safeguard result reproducibility across geographies to avoid false readings
• Exploring the pre-competitive development of standard materials to create gold standards for certain biomarkers and indications
Lauren Leiman, Executive Director, BloodPAC

11.30 Translating New Technologies into Personalized Medicine & Diagnostic Sphere
• Introducing the promise of precision medicine in molecular target therapeutics against diseases such as Huntington’s disease (HD)
• Evaluating allele-specific targeting of the mHTT transcript as a personalized approach to HD treatment
• Discussing bioanalytical and bioinformatic methods, approaches and strategies used for the development, validation and implementation of a long-range sequencing assay to prescreen subjects for enrollment into clinical studies
Rama Boyanapalli, Director, Bioanalytical & Biomarker Development, Wave Life Sciences

11.30 Molecular Medicine in a Community Practice
• Molecular Tumor Boards are an effective means of allowing end users to more effectively incorporate molecular results into clinical decision making
• Clinical trials designs are now meeting community practices desire to match patients to treatments based on molecular subtype rather than tissue of origin
• While most patients are treated in community settings, molecular tests are often not built with community practices in mind as they typically originate from academic medical centers
Timothy Cannon, Medical Oncologist & Clinical Director, Inova Schar Cancer Institute Molecular Tumor Board, Inova Health System

12.00 Development of a Blood-Based Clinical Dx for a ssPMA
• Evaluate key challenges with bringing a liquid biopsy from concept to commercialization
• Understand the developmental timelines and execution to achieve clinical readiness
• Discuss PMA/510k and distribution readiness for liquid biopsy assays
Gary Pestano, Chief Development Officer, Biodesix

12.00 Streamlined CDx™: A Pipeline that Accelerates Drug Approvals
• Reducing the complexity and risk of CDx development
• Invivoscribe’s Streamlined CDx™ program has been shown to collapse the development timelines of biomarker assays, improve and accelerate selection of more consistent patient cohorts
• Establishing earlier international submissions and accelerated FDA, EMA and PMDA approvals of new targeted therapies
Michael Vishnevetsky, Head, Global Business Development, Invivoscribe

12.00 Companion Diagnostics in Immuno-Oncology: Global Commercial & Partnership Considerations
• The testing paradigm in immuno-oncology is growing increasingly complex, moving beyond PD-L1, to include mismatch repair, microsatellite instability, tumor mutational burden, and others
• Key commercialization considerations for drug and test innovators, including balancing test access and quality, and embedding CDx global commercial considerations in pharma and diagnostic company partnerships will be highlighted
Joseph Ferrara, President & Chief Executive Officer, Boston Healthcare

12.30 From Big Pharma to Innovative Start-up-Challenges for Precision Medicine
• Resources – is there enough money and how long will it last?
• Personnel – how can we get the help we need?
• Outsourcing – who to trust; cost; so many contracts and capabilities presentations
• Partnering – identifying the right partners and forming strategic alliances
• The right balance between basic research and development activities
• Educating the organization
• And here come the Investors!
Julie Engel, Head, Molecular Diagnostics, Cyteir Therapeutics

12.30 IVDR: Where Are We? The Notified Body Perspective
• Implementing the IVDR: The view from a notified body
• The role of notified bodies on approvals under new regulation
• Discussing the effect of a decrease in accredited notified bodies and how you can make preparatory steps now to avoid last minute bottlenecks
• Evaluating your regulatory options for Dx approval, from IVD to LDT
Andreas Stange, Vice President, Global IVD, TÜV SÜD

12.30 Informing Patient Treatment Decisions: The Clearity Foundation Experience
• Overview of ovarian cancer histotypes, genomics, targeted therapy, and CDx
• Clearity provides patients with individualized treatment information based on their clinical situation and tumor characteristics
• Phone consults and online tools help patients understand results from biomarker testing and identify standard of care and clinical trial options to discuss with their medical team
• Examples illustrate how patient education engagement can positively impact outcomes
Deborah Zajchowski, Scientific Director, The Clearity Foundation

1:00 pm Lunch & Networking

Chair: Brian Tunquist, Associate Director of Companion Diagnostics & Translational Medicine, Array BioPharma

14.00 Increasing Complexity in Tissue Based Diagnostics

• Advantages and applications of in situ RNA detection
• Collaboration of key stakeholders for co-development of a drug and RNA-ISH diagnostic device
• Regulatory and commercial considerations for new innovative technologies
Bill Powell, Senior Director, Companion Diagnostic Product Development, Leica Biosystems

Chair: Dennis Merkle, Head of Market Enabling Technologies & Companion Diagnostics, Merck KGaA, Darmstadt, Germany

14.00 Democratizing Testing Through Data Science: Leveraging Mathematics to Make Diagnostics Affordable

• Liquid biopsy is a minimally-invasive and convenient way of physically sampling the body for clues on pathology

• Current liquid biopsy solutions leave a gap between diagnosis needs and capability: sequencing is a sensitive, but expensive technology and dPCR is scalable, but limited

• The ChromaCode technology bridges this gap by enabling highly multiplexed, scalable liquid biopsy diagnostics for any dPCR platform

Aditya Rajagopal, Chief Technical Officer, ChromaCode

Chair: Leslie Hoyt, Chief Commercial Officer, Olaris

14.00 Maximizing Patient Access to Unlock the Potential of Precision Medicine
• Discussing considerations and choice of CDx strategy for novel precision medicines
• Evaluating and deciding upon the variety of diagnostic technologies
• Deciding between solutions for centralized versus decentralized testing
• Discussing the development of a fully automated, highly accurate MDx platform
• Demonstrating the value of such a platform to the advancement of patient access to ensure the right treatment at the right time
Erik Vossenaar, Vice President, Business Development, Biocartis

14.30 Impact of Digital & Computational Pathology on Precision Medicine
• Introducing digital pathology and its potential applications for precision medicine
• Barriers being to overcome to drive global adoption
• Efficiency implications for future clinical trials
Bill Keating, Head, Pharma Business Development, Philips Digital and Computational Pathology

14.30 Immunoassays in Personalized Medicine: Is It Time for Circulating Proteins to Join the Party?
• Proteomics research has led to the discovery of new therapeutic targets and circulating protein biomarkers for disease detection, prognosis and therapy response
• Circulating protein biomarkers gives the immunoassay a new role in personalized medicine, and can provide clinicians with more diagnostic tools to detect, select for treatment, and monitor disease
Dawn McHugh, Vice President, Business Development, Personalized Diagnostics, Corgenix

14.30 Optimizing Clinical Trial Design with Comprehensive Genomic Landscapes
• The best way to understand the pathophysiology of a pathway or disease
• How to identify gene fusion partners to facilitate the development of targeted drugs
• Why it is important to understand the genomic landscape of a pathway or disease prior to selecting patient cohorts for clinical trials
Mark Kiel, Co-Founder & Chief Scientific Officer, Genomenon

Discovering & Developing Novel Biomarkers in New Areas of Precision Medicine

14.40 Standardization of NGS for Oncology Trials & Practice: The PGDx elio Model
• Discussing the role of NGS testing in informing clinical decisions and enrolling clinical trials, including biomarkers like MSI and Tumor Mutational Burden (TMB) for immune therapies
• Developing IVD NGS assays optimized for complex and comprehensive tumor profiling applications
• Evaluating ctDNA and tissue assays designed to empower local laboratories, bringing NGS technologies into standard of care for patients worldwide
John Simmons, Vice President, Translation Medicine, PGDx

14.50 Adding Value to Traditional In Vitro Diagnostics (IVDs)
• Computational image analysis can improve precision and accuracy for tissue-based IVDs
• Image analysis can quantify important cell types and interactions in the tissue in the absence of biomarker staining, such as tumor-infiltrating lymphocytes (TILs)
• Using a multi-omic analysis approach to integrate other data with the IVD output generates richer patient sample analyses
Kelsey Weigel, Scientist II, Flagship Biosciences

15.00 Accurate Plasma Biomarker Detection for Clinical Trials & Clinical Practice: Why Sensitivity Matters
• Sensitivity matters in liquid biopsies for accurate biomarker detection and patient classification in clinical trials
• Sysmex Inostics’ OncoBEAM™ and SafeSEQ Platforms deliver unparalleled sensitivity for ctDNA detection: a review of clinical data
• Highly accurate ctDNA detection accelerates biopharmaceutical clinical development programs

Dan Edelstein, Vice President, Commercial Operations, Sysmex Inostics

15.30 STEAP4 ISH Diagnostics for Tarloxotinib Activation in EGFR/HER2 Mutant Cancers

• Discussing best practice for optimizing and validating an ISH assay
• Correlating STEAP4 mRNA as a biomarker for Tarloxotinib patient stratification and clinical enrolment

Vijaya Tirunagaru, Vice President & Head, Biology & Non-Clinical Development, Rain Therapeutics

15.00 Close of Track

Addressing Rx-Dx Business Models & Partnership Allignment to Further Precision Medicine Collaboration

14.40 Roundtable Discussion

• How will advancements in platform technology and cost impact the diagnostic business model?
• Stayin’ Aligned: Developing deeper, non-transactional relationships between Rx and Dx to better align codevelopment
• Discussing innovation in revenue models, novel revenue streams and how deal structures will evolve over time. What does great look like?
• How do we “deal” with the issues of exclusivity? What should be the industry standard moving forward?
• Addressing the risk:value scale for precision medicine stakeholders
• Non-traditional partnerships - How do you partner outside of your formal CDx provider to gain access to testing?

Moderated By: Christina Bender, Exploratory Biomarker Lead, WW Oncology Commercialization, Bristol-Myers Squibb

Moderated By: Bill Pignato, Independent

4:00 pm End of Day Two & Close 10th Clinical Biomarkers & World CDx Boston 2019