7:50 am Chair’s Opening Remarks

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

8:00 am The Role of Philanthropy in Delivering Breakthroughs for Cancer Patients

Synopsis

  • Discussing critical barriers for delivering treatments that are optimal for each individual cancer patient, namely gaps in the discovery
    and development of platforms for early detection and intervention, forecasting resistance to therapies, tracking patient trajectories,
    and diagnosing recurrence
  • Highlighting obstacles in translating data and platforms to practical clinical applications as well as in increasing uptake among end-users
  • Showcasing our collaboration with the cancer research community to identify critical unmet needs and mechanisms to support highly
    innovative solutions
  • Rapidly establishing a robust portfolio of funded projects poised for near-term patient benefit and centered on novel technologydriven insights difficult to achieve with conventional strategies

8:30 am Cradle to Grave – CDx Development Lifecycle Case Studies

Synopsis

  • 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 Advancements in Immuno-Oncology Patient Selection Through the Use of Multi-Diagnostic Approaches Designed to Interrogate the Tumor Microenvironment

  • Cindy Spittle Vice President, Development & Scientific Affairs, Molecular MD

Synopsis

  • Advances in clinical research underscore the importance of new markers to assess immune infiltration and abnormal activity in cellular
    pathways, including DNA damage repair and DNA replication
  • Precise molecular tests which can pinpoint the right biomarkers to predict patient response are crucial to the clinical success of an
    immune-oncology candidate.
  • Data presentation on the potential utility and performance of tumor mutation burden (TMB), microsatellite instability (MSI), and gene
    expression for tumor infiltration (TILs)

9:30 am Morning Refreshments & Networking

10:00 am How Can We Use Data More Intelligently to Improve Companion Diagnostic Commercialization?

Synopsis

  • 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

10:30 am Multiplexed Analysis for Complete Liquid Biopsy Solutions

Synopsis

  • 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

11:00 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

Moderated by: Robert McCormack, Independent

Achieving Regulatory Success for Diagnostic-
Enabled Precision Medicines

Moderated by: Naveen Babbar, Global Precision
Medicine Leader, Oncology Precision Medicine, Novartis

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

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
Jaya Goyal, Vice President, Bioanalytical, Pharmacology
& 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
Jeffrey Miller, CSO & CEO, Invivoscribe Technologies

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 & CEO, 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

14.00 Advancing RNA-ISH Detection in
Companion 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
Keith Wharton, Senior Medical Director, Leica Biosystems

14.00 Democratizing Precision Medicine
Targeted Companion Diagnostics today are too
complicated, too slow and too expensive
• HDPCR translates sequencing discovery into low cost
precision medicine diagnostics using highly multiplexed
digital PCR
• HDPCR enables broad access to oncology and genetic
screening
Aditya Rajagopal, Chief Technical Officer, ChromaCode

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
Vishal Sikri, US General Manager, 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 Characterizing Targeted Cancer Therapies via a Structural Alteration Database
• What is the best way to understand the
pathophysiology of a pathway or disease?
• How do you identify gene fusion partners to facilitate
the development of targeted drugs?
• Why is it 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

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 Accurate Plasma Biomarker Detection for
Clinical Trials & Clinical Practice: Why Sensitivity Matters

Advantages of plasma mutation testing for patient
stratification and response monitoring
• OncoBEAM and SafeSEQ technologies: Overcoming
the technical challenges of low frequency mutation
detection
• Advantages of focused biomarker detection

Speaker confirming, Sysmex Inostics

15.20 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 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

15.10 Leveraging AI to Drive Advances in
Precision Medicine, Diagnostic Development &
Real-World Impact

How can we harness advances in predictive analytics
and algorithmic development to elucidate actionable
biomarkers from complex biology
• How can real-world data be harnessed to create more
clinically meaningful biomarkers?
• How are we creating new opportunities in the
identification of new therapies using machine learning
and other predictive tools?

Speaker confirming shortly

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

3:50 pm End of Day Two & Close 10th Clinical Biomarkers & World CDx Boston 2019