October 17 – 19 2017 | Boston, MA

Hilton Boston/Woburn

Day One
Wednesday, October 18, 2017

Day Two
Thursday, October 19, 2017

07.00
Breakfast & Networking

08.05
Chairs’ Opening Remarks

Plenary Address: Dissecting the Progression from Predictive Biomarker Signature to Companion Diagnostic to Commercial Launch and Adoption

08.15
Collaborations and Technologies to Deliver Precision Medicine

  • Sarah Hersey Companion Diagnostics & Precision Medicine Head, Celgene

Synopsis

  • Evaluating pre-competitive collaborations: How do we ensure we are winning for our patients?
  • Discussing the evolution of diagnostic testing in the precision medicine field
  • Analyzing strategies for standardization of diagnostic testing

08.45
Key Trends in CDx Development for Precision Medicine Success

Synopsis

  • Why, when and how should you decide to translate your biomarker strategy into a high value CDx approach
  • Discussing how assay platforms can evolve to better inform patient selection to provide more meaningful insights into outcomes?
  • Evaluating the value of complementary diagnostics in validating “continuum” signatures to guide therapy
  • Discussing how assay platforms can evolve to better inform patient selection to provide more meaningful insights into outcomes?
  • Understanding how to build a companion diagnostic program into your therapeutic development without compromising timeline goals

09.15
Successful Development of an NGS-Based Companion Diagnostic Test to Support Multiple NSCLC Drug Therapies

  • Jim Godsey Vice President, R&D, Clinical Sequencing Division , Thermo Fisher Scientific

Synopsis

  • Challenging considerations
  • Lessons learned from the successes
  • Insight and an assessment into future directions

09.45
Mitigating Risk when Navigating the Journey from Clinical Trial Assay Validation to the Commercial Deployment of a Companion Diagnostic

  • Dan Snyder President & Chief Executive Officer, Molecular MD

Synopsis

  • Delivering insight into how to smooth the transition of assay development from proof of concept to registrational clinical trial to regulatory approval by identifying the true diagnostic need and developing an assay that is more suitable for each phase of the lifecycle that avoids multiple bridging studies
  • Developing a framework for commercial/market considerations to help pharma avoid making poor decisions which can delay uptake after launch
  • From CTA validation and IDE strategies to commercial CDx implementation, insights and examples will be provided on how to effectively manage a co-development project with ever compressing timelines

10.15
Taking a Well Measured Biomarker and Executing a Robust IVD Development Strategy for Your Targeted Therapy

  • Jay Foust Vice President , Companion Diagnostics & Business Development , Ventana Companion Diagnostics

Synopsis

  • How best can you measure and clinically validate your novel signature
  • Earlier may not always be better – when should you invest and how should to start your CDx development piece
  • What role should bridging studies play and how should how clinical trial design should have a strategic impact on targeted therapy development
  • Case studies of opportunities where this strategic impact is experienced when developing companion diagnostics and what that might mean for future commercialization best practice

10.45
Morning Refreshments & Networking

Advancing the Development & Clinical Utility of Liquid Biopsies

11.30 Proving the Clinical Utility of ctDNA

  • Advancing the practical applications of ctDNA for patient selection, monitoring and therapeutic recommendations
  • Validating the impact of ctDNA testing on the accuracy of clinical decision: What’s real, what’s technical, what’s just tumor heterogeneity?
  • Harnessing ctDNA to identify responder population by their tumour burden

 

Carl Barrett, Vice President, Translational Sciences, Oncology, Astrazeneca

12.00 The OncoBEAM™ Platform: The Use of a High Sensitive Technology for Liquid Biopsies in Clinical Practice

  • The OncoBEAM™ Platform has been validated across cancer types with sensitivity of around 0.02% MF
  • Sensitivity matters in liquid biopsies for accurate biomarker detection and patient classification
  • Sysmex Inostics OncoBEAM™ assays are available for CRO services and/or Patient testing globally

Dan Edelstein,  Senior Manager, Medical Scientific Affairs, Sysmex Inostics

12.30 Deep Sequencing QC: A Component Study of the FDA-led Sequencing Quality Control Project Phase 2 (SEQC2)

  • Comprehensive QC assessments of reproducibility and detection sensitivity are essential in translating deep targeted DNA sequencing from lab development to clinical application
  • A set of benchmarking samples is designed to empower a cross-lab evaluation of about a dozen pan-cancer panels and liquid biopsy kits
  • Quality metrics will be developed to inform the confidence of each mutation call

Joshua Xu, Principal Investigator, National Center for Toxicological Research (NCTR), FDA

13.00 The Celsee™ PREP platforms: Simplified Rare Single Cell Isolation, Analysis and Retrieval

  • Validated, label-free integrated platforms to isolate, characterize, and retrieve rare cells from whole blood or other heterogeneous cell suspensions
  • Simplified workflows can be used alone or in tandem to enrich either individual cells or cell populations
  • 85 to 95% capture efficiency and over 95% viability
  • Analysis options include immunochemistry, DNA and mRNA FISH, PCR, NGS, live cell imaging and culture

Kalyan Handique, Chief Executive Officer & President, Celsee Diagnostics

13.10 Improved Sensitivity for EGFR Mutation Profiles in Liquid Biopsies Using the VTX-1 Liquid Biopsy System

  • Discussing VTX-1, a simple, fully automated system that uses the physical properties of CTCs to isolate them directly from whole blood
  • Demonstrating a workflow for the collection and EGFR mutation analysis of both cfDNA and CTCs from a single blood tube using the VTX-1 platform, and will
  • Case study: Comparing the results to matched tumor samples for NSCLC patients

Elodie Sollier, Chief Scientific Officer, Vortex Biosciences

13.20 Networking Lunch

Investigating Future Disruptive Technologies Advancing Precision Medicine: The Microbiome, mHealth & Digital Biomarkers

14.20 Evaluating the Role of Microbiome Diagnostics in Precision Medicine

  • Overcoming wide variation in microbiome sequencing and analysis to establish standards and enhance the prospect of clinically useful microbiome based signatures
  • Evaluating standardization methods and bioinformatics approaches for interrogating microbiome based signatures
  • Understanding the impact of the microbiome on drug metabolism and sensitivity and the potential for harnessing the microbiota for personalized therapeutics

 

Rodolphe Clerval, Chief Business Officer & Vice President, US Operations, Enterome Bioscience

14.50 Beyond CDx, Beyond Oncology: How Biological and Digital Markers are Redefining Personalized Medicine

  • Harnessing digitally based biomarkers and wearable technology to create novel predictive markers
  • Evaluating the impact of digital technology on commercial success
  • Leveraging remote patient monitoring technologies to create novel surrogate markers: Case study from outside of oncology

Ron Kamienchick, Senior Director, Diagnostics & Personalized Medicine, Teva Pharmaceuticals

Bridging Validation to Real-World Application

11.30 Panel Discussion: The Real World Application and Adoption of Drug and Dx and the Impact on What Platform to Choose and Why

  • Selecting the right assay for your biomarker to promote physician adoption
  • Discussing different assay merits on cost, turn around time, assay sensitivity, labor resources on selecting the appropriate assay to maximize chance of adoption
  • With such rapid advancement in molecular diagnostics how do we ensure commercialized and adopted tests don’t become obsolete?
  • Debating IP, propriatary assays and the impact of platform standardization
  • How to improve the commercial launch of drug-dx products to gain early buy-in and adoption
  • Debating the prevalence of the biomarker and the transition from what is relevant in the clinical trial setting with what is viable in the real world
  • Discussing the health economics around CDx deployment and acceptance to improve adoption of the diagnostic test
  • A stark look at the post market real world: How is the diagnostic impact adoption and market penetration for my precision medicine?
  • Are we progressing the IVD vs LDT debate and how is the current situation impacting on the real world adoption of diagnostics?

Nicholas Dracopoli,  Vice President, Oncology Diagnostics, Janssen R&D

Ferran Prat, Vice President, Strategic Industry Ventures, MD Anderson Cancer Center

Sarah Hersey, Companion Diagnostics & Precision Medicine Head, Celgene

Ron Kamienchick, Senior Director, Diagnostics & Personalized Medicine, Teva Pharmaceuticals

12.40 Validation of NGS Workflows for Precision Medicine

  • Discussing best practice clinical guidelines for the validation of NGS pipelines in a personalised medicine context to support the increasing complexity of biomarkers in precision genomics, NGS-based patient stratification for therapy and/or clinical trials
  • Validating NGS pipeline depends upon processes for calibrating and implementing quality thresholds for NGS data files as well as for optimising accuracy by maximising sensitivity without losing specificity
  • Analyzing  the importance of NGS data validation together with data interpretation for actionable clinical outcome

Christophe Roos, Chief Scientific Officer, Euformatics, speaking on behalf of Horizon Discovery

13.10 Using Computational Tissue Analysis to Deliver Clinical Response Profiles for Diagnostic Approaches

  • Using image analysis of IHC stained tissues to create a response profile from clinical outcome data.
  • Determining what computational scores are relevant to the biological mechanism.
  • Delivering tissue image analysis based patient selection tools in a regulated clinical setting to support drug development and commercialization

Joseph Krueger, Chief Scientific Officer, Flagship Biosciences

13.20 Networking Lunch

Utilizing Downstream Analytics to Power Positive Clinical Trial Outcomes

14.20 Harnessing Statistical Analysis to Prove Clinical Validation and Relevance to Decision Making

  • Delineating statistical significance and biological significance: What is enough statistical significance to drive a meaningful change in a patient population?
  • Analytical strategies for robustly delineating beyond “biomarker positive” to enrich for “responder positive populations”
  • Realizing the power of translational bioinformatics and interpretive methods to optimize the transformation of data analysis into proactive measure of health outcomes

Matthew Onsum, Director & Head of Bioinformatics, Seattle Genetics

14.50 Building and Implementing Analytical Capabilities for Clinical Studies

  • Understanding how to build and integrate an analytical framework to implement advanced analytic strategies
  • Pre-selecting non-responsive patients to simultaneously better set up clinical trials for success and identify unmet medical need for new, innovation personalized treatment
  • Defining cut offs for patient selection: Criteria for defining cutoffs, protocols of robust validation and downstream impact on clinical success

Sunita Badola, Director, Functional Genomics, Takeda

Advancing the Real World Adoption of Precision Medicine Drug-Diagnostic Products

11.30 The Impact of Patient Access on Market Adoption for Precision Medicines and Diagnostics

  • Evaluating how biomarkers can be used as part of a new business model to accelerate access and payment for patients
  • Getting precision medicines to patients: How do we approach the testing and application of speciality targeted therapeutics in a timely, patient-centric fashion?
  • Acknowledging and integrating advocacy insight and its incorporation into building a market access strategy

Robert Goldberg, Vice President & Co-Founder, Center for Medicine in the Public Interest

12.00 Integrated Diagnostic Information Services to Power Development and Clinical Implementation of Precision Medicine

  • Evaluating the role of clinical labs in setting up and implementing a Dx test and registering the new technologies with the reimbursement parties
  • Understanding how the diagnostic is utilized and integrated into a labs workflow to streamline strategy for further healthcare adoption
  • Defining the role of the pathology lab in precision medicine adoption and pricing impacts associated with running diagnostic
  • Strategies to overcome reimbursement challenges and include our semi-centralized lab strategy

Jay Wohlgemuth, Senior Vice President & Chief Medical Officer, R&D, Medical & Employee Health, Quest Diagnostics

12.30 Group Discussion: Improving Patient Advocacy & Physician Adoption

  • Understanding the power of patient advocacy to boost enrolment into clinical trials
  • Rethinking test reporting to improve physician education, subsequent utilization and adoption
  • Integrating NGS into healthcare and EHR: How to minimize turn around time to provide timely advice to physicians
  • Discussing how Pharma can better engage with diagnostic education to promote the adoption of their drug
  • How do we change the physician behaviour to next generation assays to get them to adopt the use of these more complex diagnostics?

Moderated by Christina Bender, Director, Global Oncology, Diagnostic Pipeline Strategy, Novartis

13.10 Companion Diagnostics: Challenges and Solutions

  • When development of drug and diagnostics is not aligned = risk of economical loss
  • What are the risk factors to be aware of?
  • How to reduce the risk?
  • Real-life example using a centralized laboratory approach

Steen Thaarup, Business Development Manager, Pharma, Unilabs

13.20 Networking Lunch

Rx-Dx Partnering Roundtable

14.20 Evolving Rx-Dx Partnering Models to Maximize ROI for Both Parties

This years’ interactive World CDx roundtable focusses exclusively on the Rx-Dx paradigm and how to ensure continued CDx development with appropriate risk and reward. Jason Christiansen will lead discussion on the following topics:

  • Debating cost and ROI for a pharma company embarking on the development and commercialization of a CDx: How to ensure your diagnostic provides the upmost value to your market access strategy?
  • Money Talks: Discussing the imbalances in value and ROI in an Rx-Dx partnership
  • Evolving deal structure: how do we build better partnerships to improve the market share of both drug and diagnostic?
  • Bringing partnering global: How to align your partnering strategy to improve the global reach of commercial launch into

Moderaters:

Jason Christiansen, Vice President, Diagnostics, Ignyta

Steve Anderson, CSO, Covance

15.20
Close of 8th World CDx Educational Program

15.25
World CDx Afternoon Networking Session

Synopsis

Join us after the end of our educational program for an informal networking event. Make those final connections, wrap up your business conversations and become a central part of our World CDx family.

16.30
Close of Day Two & End of 8th Annual World CDx