8:20 am Chair’s Opening Remarks

Keynote Address: A Candid Look at Value, Adoption & Patient-Centricity in Precision Medicine

8:30 am Keynote Address: Government, Policy & Socioeconomics – The Battle to Embed Precision Medicine at the Heart of Healthcare

Synopsis

  • Is precision medicine currently delivering on its promise to patients?
  • How do we better link the work we are doing in clinical development with the real world parameters for the best delivery of personalized healthcare?
  • Weighing up the cost of biomarkers and diagnostics. With the expense of a biomarker/Dx route vs. traditional drug development route, are all stakeholders seeing value in this investment and is this ultimately leading to a better standard of care for patients?

9:00 am Achieving Global Commercialization of Companion Diagnostics to Enable Precision Therapeutics

  • Mark Roberts Senior Director, Diagnostics Devlopment, Covance

Synopsis

  • Discussing the continuum of biomarker development and how to align development with the preparation for achieving a global footprint.
  • What does global commercialization mean and how do we build a strategy for this in the context of companion diagnostics

9:30 am Comprehensive Liquid Biopsy: Clinical & Commercial Use Cases

Synopsis

  • Emerging data on ctDNA in clinical trials
  • Using ctDNA for immunotherapy development
  • Maximizing patient access commercially

10:00 am Speed Networking

10:20 am Morning Refreshments

10:50 am Keynote Panel Discussion: Women In Precision Medicine

  • Shirin Khambata Ford Head, Precision Medicine, Clinical Biomarkers & Companion Diagnostics, Daiichi Sankyo
  • Kathryn Becker Global Marketing Director, Companion Diagnostics, Abbott Molecular
  • Robin Toft Chairman, Founder & CEO, Toft Group Executive Search

Synopsis

Coming soon. Uniting scientific and business leaders from all key stakeholders of the community, this keynote session will highlight the
importance of a diverse workforce and provide actionable takeaways for increased advocacy in individual workplaces. Stay tuned!

11:30 am Closing Gaps in Care with Population Health Analytics & Community-Based Implementation Programs

Synopsis

  • Analyzing the role of new technologies and advances in “big data” for generating insight for precision medicine
  • How best to blend scientific data (i.e omic data) with data on social, environmental and behavioural influences
  • Understanding how to utilize the wealth of data obtained from multiple stakeholders including pharma, labs, hospitals, community hospitals to accelerate utilization of precision medicine
  • Integrating genomic and other patient data into clinical care to overcome barriers to access

12:00 pm Adapting Clinical Trial Best Practices to a Complex Global CDx Landscape

  • Alan Wookey Scientific Advisor, Oncology & Companion Diagnostics, Q2 Solutions

Synopsis

  • Evaluating the central laboratory as a key component for developing, validating and executing companion diagnostics globally
  • Developing strong collaboration with pharmaceutical and IVD companies to streamline biomarker deployment in clinical trials and discussing the clinical validation of predictive biomarkers as CDx assays
  • Describing the role of the central laboratory and some of the key attributes required when using traditional and more complex
    technologies across the globe

12:30 pm Networking Lunch

Biomarker Discovery &
Translation

Clinical Biomarker Development

Drug-Dx Commercialization

Discovering the Next Generation of Robustly
Predictive Biomarkers

Advancing Clinical Validation of Predictive
Biomarkers

Overcoming Bottlenecks in Commercialization:
From Reimbursement to Market Access

13.30 NMR-Metabolite-Resonance Signature
Predicts HR+ Breast Cancer Patient Response to
CDK4/6 Inhibitors
• Correlating metabolite expression profiles to clinical
outcomes to identify a metabolic signature that could
differentiate CDK4/6 responders and resistant patients
with a predictive accuracy of > 90%
• Identifying independent signatures predictive of response
for individual CDK4/6 inhibitors palbociclib and ribociclib
• Discussing a paradigm shift in the administration of
CDK4/6 inhibitors wherein prior to treatment and during
treatment patient plasma is screened to determine
whether that individual patient is responsive or resistant
to a CDK4/6 inhibitor
Elizabeth O’Day, Founder & CEO, Olaris Therapeutics

13.30 Designing Biomarkers & Companion
Diagnostics for Antibody-Drug Conjugates
• Discussing predictive biomarker development for ADC
therapeutics
• How to best navigate the complex process of translating
biological data into a predictive biomarker utilized in
pivotal clinical trial
• Showcasing Seattle Genetics’ current companion
diagnostic projects
Matt Onsum, Head, Diagnostics, Bioanalytics &
Biomarkers, Seattle Genetics

Moderated by: Steven Rosen, Vice President, Business
Development & Strategy, Elucida Oncology
13.30 Key Market Access Challenges For
Drug-IVD Commercial Success
• Evaluating the pros and cons of commercial viability for
established vs cutting edge technology: what are the key
considerations for commercial success?
• Debating the current reimbursement paradigm for the
spectrum of IVD tests to assess viability of commercial
penetration
Omar Perez, Head, Precision Medicine & Diagnostics, GSK

14.00 The Increasing Adoption of RNA-Seq as
a Biomarker Discovery Tool & How to Solve the
Complex Data Challenge
• The opportunity of RNA-Seq as a biomarker discovery tool
• Challenges in analysing and interpreting large volumes
of complex RNA-Seq data
• How Almac Diagnostic Services’ claraT report solves this
challenge, simplifying the process whilst saving time & resource
• Detailed overview of the claraT reporting solution,
including cohort and sample report interpretation
• Case Study: In a real world RNA dataset utilising claraT
Katarina Wikstrom, Head, US Operations, Almac
Diagnostic Services

14.00 High Definition Multiplexing for Biomarker
Strategies & CDx Development
• Unravelling the complexity of biological samples
• Combining multiplexed detection with spatial resolution
to analyse heterogeneous cell populations and
colocalize multiple markers in scarce samples
• Discussing the impact of multiplexing on tissue integrity
and throughput
Philippe Mourere, Senior Vice President, Commercial
Operations, Ultivue

14.00 Democratization & Globalization of Next
Generation Sequencing for Companion Diagnostics
• Outlining the democratization of NGS in routine clinical testing
and as a commercially viable CDx for drug development
• Evaluating biomarker discovery and translational
research efforts driving the need for new solutions with
potential to become a predictive CDx in the future
• Showcasing a holistic approach to enable success
through the whole spectrum, from discovery through
development of companion diagnostics
Suzanne Graham, Associate Director, Business
Development for Diagnostic Partnering, Thermo Fisher
Scientific

14.30 Utilizing In Silico Approaches to Design
Translational Medicine Strategies

• Harnessing transcriptomic data sets for biomarker
identification in Asthma
• Showcasing an approach for data analysis to
understand and characterize subsets of Asthma
• Discussing the discovery of a biomarker of a subtype of
Asthama with high unmet need
Michael Burczynski, Senior Director & Head, Translational
Medicine, Teva Pharmaceuticals

14.30 PARPi Development in Prostate Cancer: Limitations & Opportunities for Companion Diagnostic Development

• PARP inhibitors have demonstrated clinical utility in treating metastatic prostate cancer due to enrichment of DNA repair deficiencies in a subset of these tumors • NGS testing of tumor tissue to identify patients with BRCA defects or other homologous recombination repair deficiencies has limited utility due to limited amount of tumor isolated from bone biopsies • Opportunities of developing liquid biopsy-based companion diagnostics for this disease will be discussed Mitch Raponi, Vice President, Biomarker Development & Translational Research, BeiGene

14.30 Payer Perspective: Demonstrating Value
of Next Generation Biomarkers & Diagnostics for
Precision Medicine
• Evaluating the impact of the CMS guidance on NGS
reimbursement: From IVD to LDT, is there now a path
forward for the commercial viability of these tests?
• What is the weighting of clinical evidence vs RWE
needed
• A guide to generating evidence either in conjunction
with or post trial to maximize the case for diagnostic
reimbursement
Payor presentation confirming

15.00 Details Shortly Confirming
Kathryn Becker, Global Marketing Director, Companion
Diagnostics, Abbott Molecular

15.00 Multiplex Immunohistochemistry for
Precision Medicine
• Discussing mIHC for the development of robust
biomarkers
• Evaluating the challenges with mIHC from an
implementation and clinical approval standpoint
• Showcasing the benefits to the user community and
what needs to be done to ensure market and regulatory
approval of these platforms
Courtney Nicholson, Director, Business Development,
Abcam

15.00 Commercialization of Precision Diagnostics
in Europe: Challenges & Opportunities
• Challenges exist when introducing new precision
diagnostic tests into the European market which
impact rate of test adoption
• To deliver an effective European wide test access
strategy, different approaches needs to be considered
on a market by market basis
• Opportunities for centralized vs de-centralized testing
approaches will be discussed with emphasis on access,
TAT and quality
Hans-Christian Pedersen, Director, Business
Development, Unilabs Denmark

3:30 pm Afternoon Refreshments & Networking

Accelerating the Translational from Exploratory
Signature to Clinical Biomarker Candidate

Executing Biomarker-Driven & DiagnosticEnabled Clinical Trials

Commercializing Diagnostics as Fit-For-Purpose
in the Real-World Healthcare Setting

16.00 Improving the Validation and Utility of
Multiplexed Assays
• Using predictive biomarkers to better understand
disease
• Complex biomarker profiles providing insights into
complex health states
• Development of a cardiac prognostic multiplex
biomarker assay
Sara Call, Business Development, Quansys Biosciences

16.00 DIKI Panel: Making Drug Development
Safer
• Discussing biomarker qualification and assay
development
• Technical and clinical assay validation
• Composite biomarker in the context of use
Claire Huguet, Head, Biomarker Services, Randox

16.00 Companion Diagnostic Co-Development
& the Value of Globally Distributed IVD Kits for
Market Adoption
• Discussing the complexity of companion diagnostic
development and how this process has changed with the
advent of NGS
• Highlighting kitted IVD globally distribution models to drive
future testing volume and patient identification. Where is
the market today and what does the future hold?
Josh Stahl, Chief Scientific Officer, Archer Dx

16.10 Strategizing Early Biomarker Decisions for
Future Precision Medicine Success
• Utilizing response rate and predictive biomarkers in early
strategy decision making
• From target engagement to surrogate endpoints
• Discussing Sanofi’s current thinking on the strategies for
biomarker-CDx co-development
• Less is more: How harnessing fewer, yet more informed
samples and biomarkers in large population sizes can be
more beneficial than using a multitude
Gerard Sanderink, Global Head, Biomarkers & Clinical
Bioanalyses, Sanof

16.10 A Guide to Biomarker-Driven Precision
Medicine Clinical Trials
• Discussing the landscape of biomarker use in clinical
trials
• Showcasing recent data from MDACC and GENIE re:
the percentage of patients with a potential biomarker
or without and what the field is doing in terms of next
steps for these patients
• Putting all of this into the context of precision oncology
decision support
Kenna Mills Shaw, Executive Director, Sheikh Khalifa
Bin Zayed Al Nahyan Institute for Personalized Cancer
Therapy, MD Anderson Cancer Center

16.10 From Turnaround Time to Distribution:
Addressing the Greatest Bottlenecks in
Diagnostic Testing in Healthcare
• Assessing the impact of platform cost and turn
around time on the potential commercialization of a
diagnostic-enabled therapeutic
• What impact does a centralized vs decentralized
approach have on adoption and penetration?
• Evaluating strategies to prepare for day one launch,
raise awareness, improve education and maximize
commercial success of diagnostic-enabled precision
medicines
Terri Ozegovich, Independent

16.40 Discussing the Immunogram for IO Precision Medcine
• Debating scoring systems and cut offs for immunooncology biomarkers
• Discussing the development of single and combined
immunotherapies and the context dependency upon
tumor immune microenvironment status
Corinne Danan, EVP, Partnerships BU, HalioDx

16.40 Successes & Challenges in Pre-Market
Registration & Approval of Companion
Diagnostic in Global Markets
• Agilent experiences and alignment with codevelopment guidance in obtaining premarket
approvals with original submissions as well as expansion
of indications
• CDx Regulatory considerations in global markets
• Challenges in assay development and registration to
meet pharma partners needs
Xiaolei Xu, Director, Global Regulatory Affairs, Companion
Diagnostics, Agilent Technologies

16.40 Multiplex IHC Development Updates & Impact on Commercialization
• Discussing next generation tissue assays and digital
pathology for multi-marker approaches
• Highlighting multiplexing as a tool to innovate medicines in
precision oncology
Lidija Pestic-Dragovich, Senior Director, CDx Pharma
Services & Pharma Alliance, Roche Tissue Diagnostics

17.10 Developing Biomarkers for an NTRK
Inhibitor in a Tissue Agnostic Indication
• From proof-of-concept to clinical: Showcasing the
development of biomarkers for TRK inhibitors
• How to best design and execute an exploratory
biomarker program to quickly inform a pivotal study
• Lessons learnt to develop rare biomarkers in tissue
agnostic manner
Emmanuelle di Tomaso, Head, Biomarkers Oncology,
Bayer

17.10 Integrating Predictive Biomarkers in Phase III Clinical Trial Designs
• Discussing the strengths and weaknesses of different
confirmatory phase III trial designs in the era of
precision medicine in oncology
• Presenting recommendations about when specific trial
designs are most appropriate
• Evaluating umbrella and basket trials that test
multiple therapies simultaneously and identify
biomarker-matched subgroups of patients who are
mostly likely to benefit from novel targeted treatments
Antje Hoering, President & CEO, Cancer Research And Biostatistics

 

17.10 Key Considerations for Accelerating the Integration of Diagnostic Testing
• Building commercial diagnostic considerations earlier
into clinical development Discussing infrastructure and
the operationalization of CDx testing internationally
• Delivering NGS diagnostics in oncology, the value
of panel based diagnostic testing, regulatory
considerations for NGS panel based test development
and approval
Maria Orr, Franchise Leader, Oncology Companion
Diagnostics, Precision Medicine & Genomics,
AstraZeneca

17.40 Panel Discussion: Multidimensional
Biomarkers & Machine Learning Based
Approaches for Precision Medicine
• Discussing the utility of multidimensional biomarkers in
the translational and clinical space
• Distilling down complex biological signals into
actionable biomarkers utilizing machine learning
• Evaluating the enhanced role of multiplexing in early
biomarker selection
Bonnie Anderson, Chairman & CEO, Veracyte
David Messina, Chief Operating Officer, Cofactor Genomics
Wendell Jones, Principal Bioinformaticist & Scientific
Advisor, Q2 Solutions
Gabriel Bien-Willner, Chief Medical Officer, Palmetto GBA

17.40 Panel Discussion: Executing Biomarker Driven & Diagnostic Enabled Clinical Trials
• Discussing the standard of care in precision immunotherapy
– how are the use of biomarkers and diagnostics evolving to
define response?
• How to best translate “continuum” biomarkers into robust
patient selectors
• Analyzing timings for submitting PMAs and 510ks for companion
diagnostics: When’s best to streamline clinical studies?
• How will precision medicine trials evolve given the hypercompetition for patient populations and sample biopsies?
• Is there a better way to manage studies and patient recruitment,
particularly where a biomarker/disease is being heavily
investigated, to get the maximum impact from every new trial?
• What Dx strategy do we use to support clinical drug
development in cases of accelerated approval?
• How do you best match the assay used in the clinical study
with the assay used in clinical practice?
Christina Bender, Exploratory Biomarker Lead, WW Oncology
Commercialization, Bristol-Myers Squibb
Shirin Khambata Ford, Head, Precision Medicine, Clinical
Biomarkers & Companion Diagnostics, Daiichi Sankyo
Gillian Livock, Vice President, Corporate Business
Development, Definiens
Alice Walsh, Head Analytics Innovation, Oncology
Translational Bioinformatics, Bristol-Myers Squibb

17.40 Panel Discussion: Commercializing
Diagnostics as Fit-For-Purpose in the Real-World Healthcare Setting
• Discussing International strategy for implementation of
diagnostics in healthcare to create a global footprint
• Debating targeted vs broad panels and their comparisons
for real-world application
• What are the respective roles and areas of improvement for
CLIA and FDA regulation to drive advances in testing?
• How do you channel clinical and post market evidence
generation to optimize access and uptake?
• Assessing the impact of platform cost pricing and TAT on the
potential global commercialisation of a diagnostic-enabled
therapeutic
• What impact does a centralized vs decentralized approach
have on adoption and penetration?
• Discussing the role of the lab and their impact on precision
medicine nearer patient care
Philina Lee, Vice President, Commercial Strategy &
Operations, Blueprint Medicines
Meggan Czapiga, Director, Companion Diagnostics,
Autolus
Speaker confirming, Agilent Technologies
Julie Ramage, National Account Director, Diagnostics,
Pfizer

6:25 pm End of Day One

6:30pm 10th Anniversary Clinical Biomarkers & World CDx Evening Reception