28th – 30th March 2017

London, UK

Novotel London West

Day One
29th March 2017

Day Two
30th March 2017

07.30
Morning Coffee & Networking

08.20
Chair’s Opening Remarks


Defining the Biomarker Continuum with a “Perfect Test”

08.30
From Biomarker Signature to a Deployed Diagnostic: The Benefits of Starting in an Early Phase with a Robust Scalable Solution

  • Wesley Buckingham Senior Manager, Diagnostic Product Development, Nanostring Technologies

Synopsis

  • Gene Expression, Protein Expression and SNV digitally counted all in the same assay
  • Proven DX – 510(k) cleared CE Marked Gene expression based prognostic assay
  • Multiple on going CDx collaborations
  • Flexible, simple robust chemistry with a fast turnaround- sample to clinical outcome

 

09.00
Can an Evolving Appreciation of Systems Biology Finally Result in that Universal Companion Diagnostic?

Synopsis

  • Widening the biomarker strategy: Understanding the influence of the environment on disease pathogenesis to develop more robust predictive markers
  • Defining how the systems biology approach can help break down complexities in disease heterogeneity to power biomarker programs
  • Establishing the clinical foundation and utility of the systems biology based approach: What will it take to achieve this goal?
  • How do we distil the data from multiple marker profiles into clear, actionable information?

09.30
Providing the Perfect Solutions for Your Biomarker Continuum

  • Bruce Jordan Vice President, International Business Leader, Companion Diagnostics, Roche Diagnostics
  • Jacob Hunter Director, Companion Diagnostics Partnering, Ventana Medical Systems

Synopsis

  • Discussing Roche’s comprehensive biomaker solutions in oncology today
  • Analyzing what the future looks like in oncology
  • Detailing how we enable you to move with the biomarker times

10.15
Morning Refreshments & Networking


Stakeholder Alignment for the Advancement of Precision Medicine & Companion Diagnostics

10.45
Using LDTs to Streamline CDx Development

  • Bob Holt Companion Diagnostic Development Manager, Hologic

Synopsis

  • Simultaneous development of a therapeutic and corresponding companion diagnostic test puts pressure on both Pharmaceutical and Diagnostic partners
  • The use of LDTs in early phase clinical trials provides a potential solution to this problem
  • Presenting an overview of the issues associated with co-development, highlighting potential solutions, introducing Hologic’s latest diagnostic platform; Panther Fusion System (in development)

11.15
Challenges in Developing Companion Diagnostics: Alignment with Stakeholders is the Key to Success

  • Flora Berisha Associate Director, Companion Diagnostics, Daiichi Sankyo

Synopsis

  • Discussing the translation of biomarker assays to full CDx
  • Overcoming challenges with the alignment of the CDx development , including filing the PMA and NDA/BLA
  • How to select and build a close relationship with the right partner who has the needed expertise to transition the assay into IUO kit
  • Developing robust plans and timelines for drug development to better align regulatory and marketing considerations

11.45
The NICE Perspective on Precision Medicine & CDx Market Access

  • Fay McCracken Adviser, Office for Market Access & Technology Appraisals , National Institute for Health & Clinical Excellence (NICE)

Synopsis

  • More information to follow

12.15
Panel Discussion: 4 Key Stakeholders – Aligned or Misaligned Expectations?

  • Colin Hill Senior Vice President Commercial Operations, Asuragen
  • Heather Stevens Head, Global Companion Diagnostics Strategy , Roche Pharmaceuticals
  • Fay McCracken Adviser, Office for Market Access & Technology Appraisals , National Institute for Health & Clinical Excellence (NICE)

Synopsis

With the precision medicine & CDx industries at a crucial junction, proving the it worth in a value-based healthcare system is critical.

This session will be an interactive discussion between 4 major stakeholders in the CDx world – Patient, Pharma, Payor and IVD Manufacturer. Our goal is to clearly highlight the future path forward that best enables CDx success by impact for all 4 stakeholders.

The flow will be 4 x 8 minute “My CDx Perspective” followed by a mediated interactive discussion between the experts and audience.

Additional panellists to be confirmed

13.00
Lunch & Networking

Evaluating the Clinical Utility of Liquid Biopsy Diagnostics

Chair: Flora Berisha

14.00 Circulating Tumour Cells: Subtypes are Important for Cancer Prognosis

  • Circulating tumour cells have been clinically used for cancer prognosis and their great potential as biomarkers yet to be explored
  • Different subtypes of CTCs have been captured by the cell size and deformability-based system Parsortix
  • Analysing subtypes of CTCs , in particular those under EMT, has great promise to increase the diagnostic/prognostic value of CTCs

Yong-Jie Lu, Reader in Medical Oncology, Barts Cancer Institute, Queen Mary University of London
speaking on behalf of ANGLE plc

14.30 NGS Solutions Across the Oncology Drug Development Continuum: From Biomarker Discovery to IVD

  • Applications of ctDNA analysis in pharmaceutical research and clinical development
  • Challenges in development of IVDs based on liquid biopsy
  • How can the decentralized assay model be applied to liquid biopsy approaches

John Simmons, Director, Translational Science & Diagnostics, Personal Genome Diagnostics

15.00 Liquid Biopsies on the Road to the Clinic

  • Use of liquid biopsies in the clinic: Diagnostic, prognostic, predictive?
  • CTCs vs ctDNA: one or the other, or both?
  • Discussing the CANCER-ID project: A public-private partnership with the goal to clinically validate liquid biopsies

Ralph Graeser, Senior Translational Medicine Expert, Boehringer Ingelheim

15.30 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’s OncoBEAM™ assays are available for CRO services and/or Patient testing globally

Vishal Sikri, Vice President, Commercial Operations, Sysmex Inostics

16.00 Afternoon Refreshments & Networking

Bridging Exploratory Biomarkers into Clinical Drug Development Programmes

16.30 Development of an Integrated Platform for Proteomic Biomarker Discovery

  • Analysing the latest innovations in MS-based technologies for high capacity throughput proteomic profiling for clinical biochemistry purposes and the creation of a digitised, quantitative, permanent record of the proteome
  • Combining with validation and verification platforms to create a platform for discovery and development of novel biomarkers for risk and stratification
  • Linking of proteomic data to electronic health records through safe haven health informatics to integrate complex molecular phenotyping with endotypic data

Anthony Whetton, Professor of Cancer Cell Biology, Director, Stoller Biomarker Discovery Centre, Director, Manchester Precision Medicine Institute, University of Manchester

17.00 Circulating microRNAs as Biomarkers for Patient Stratification in Osteoporosis & Cardiovascular Disease

  • Circulating microRNAs hold great promise as biomarkers for disease diagnosis and treatment monitoring
  • A signature of serum microRNAs (osteomiRs) was discovered and validated in serum of osteoporotic patients with short fracture-free survival
  • Platelet-derived microRNAs in plasma are indicative of platelet activation and hold utility as biomarkers for monitoring anti-platelet therapy

Matthias Hackl, CEO, TAmiRNA GmbH

17.30 Improving the Translation from Discovery to Clinical Development of New Predictive Biomarkers

  • Discussing biomarker discovery strategies and their robust development into clinically validated predictive markers
  • Considerations for future development of biomarker strategies for targeted therapeutic pipelines

Franck Brichory, Associate Director, Personalized Medicine, Debiopharm International SA

Addressing Standardisation & Quality Control to Advance the Adoption of Companion Diagnostics

Chair: Chris Anderson

14.00 How Do We Make Precision Medicine Precise?

  • Innovation is prized by the research community but feared in the clinic
  • Compromising assay sensitivity and specificity for reliability is no longer acceptable in the clinic
  • Patients deserve accurate diagnosis to determine their correct treatment
  • Strategies for maintaining innovation in a world of verification and validation studies

Jonathan Frampton, Diagnostics Strategic Alliance, Horizon Discovery

14.30 Molecular Diagnostics: A Global Perspective on the Quality of Testing

  • Quality assured diagnostic testing is essential to ensure the right patient gets the right result in the right time
  • Implementation of new CDx , and/or laboratory developed tests, for precision medicine needs to bring together all stakeholders before release to ensure quality is not compromised
  • External quality assurance as a mechanism to harmonise and raise the global standard of testing quality

Simon Patton, Director, The European Molecular Genetics Quality Network (EMQN)

14.00-15.30 Improving the Quality in Reference Laboratories

  • European quality assessment for companion diagnostics – schemes, participation and harmonization
  • Technology transfer from clinical trials to clinical practice: the role of reference materials and reference laboratories

Jacqueline Hall, Executive Director, IQN Path ASBL

15.30 Achieving Test Availability at Launch: Underestimated, Under-Budgeted & Under- Resourced

  • 200bn of therapy revenue is already dependent upon the Dx ecosystem with 70% of leading therapy brands dependent on their Dx ecosystem
  • By 2020 70% of future therapy launches will be highly Dx enabled moving this to become a predominant feature of the Pharma commercial model
  • Despite this radical shift in dependency, Pharma approaches to the parallel Dx commercialization to support asset launches remains highly variable and high risk, with an inconsistent approach to  evidence based planning
  • Addressing  some of the key weaknesses in the planning and implementation approaches suffered by unprepared therapy teams tasked with integrating testing into their launches who assume their diagnostic partner is fit for purpose

Jordan Clark, Managing Director, Labceutics, Diaceutics Group

Advancing the Concept of the Perfect Test: Development, Regulatory & Adoption Challenges

16.30 Oncomine Universal Companion Diagnostic Program

  • This case study presentation will discuss the development and commercialization of NGS based companion diagnostics test

Brian Kelly, Global Director, Diagnostic Partnering, Thermo Fisher Scientific

17.00 Bringing CDx Worldwide: Strategies for the Global Registration of Companion Diagnostics

  • Aligning drug and diagnostic approval in ‘ROW’ countries
  • Working with individual countries to support diagnostic registration
  • Discussing industry ‘guidelines’ for regulatory strategies in emerging and developing countries

Erin Pedalino, Associate Director, Regulatory Affairs International, Merck Sharp & Dohme Corp

17.30 Streamlined Application of Molecular Pathology in the Development of Novel Companion Diagnostics

  • Development of a novel tissue array-based approach to increase the efficiency in early stage IHC biomarker assay development
  • Case study: Applying a custom-made ‘IHC Validation Array’ to develop a specific, reliable and fully characterised IHC assay for Met high affinity tyrosine kinase receptor fir hepatocyte growth factor (HGF)
  • Utilising protein or RNA biomarker-specific ‘Validation Arrays’ to accelerate assay development and validation, allowing a more efficient use of resources

Keith Page, Director Scientific Development, Asterand Bioscience Inc.

17.40 Panel Discussion: Defining the Biomarker Continuum with a “Perfect Test”: How Complementary or Companion Diagnostic Biomarkers Select Responders & Non-Responders

  • The response scale: Why are we failing to accurately predict response and side effects in “responder” populations?
  • Can we convert traditional tissue diagnostics into universal platforms or will they fall by the wayside as NGS and novel assays take over?
  • Discussing how to advance robust analytical validation in the context of disease heterogeneity to more granularly define responders and non-responders
  • Moving away from the one biomarker, one assay mantra: How far away is a “universal” assay that investigates multiple markers in multiple indications?
  • What are the key strategic regulatory decision and considerations that need to be incorporated into the diagnostic development process?
  • Dissecting the impact of the new EU regulatory paradigm and the “upregulation” of diagnostic testing in Europe
  • Discussing regulatory and reimbursement considerations for NGS diagnostic assays
  • How do we optimize biomarker and CDx development to better show direct clinical benefit to healthcare decision making and patient outcomes?
  • Tackling the shift to a value based reimbursement landscape for precision medicines and diagnostics and what we can do to drive better collaboration between all stakeholders

Ranga Sarangarajan, Senior Vice President & CSO, Berg Health

Frederic Ausseil, Head of Companion Diagnostic Medical Platform, Pierre Fabre

Katja Berg, Vice President, Head of Operations & Payer Intelligence, Global Market Access, Sanofi

Gereon Lauer, Associate Director, Discovery Biomarkers, Vertex Pharmaceuticals

Seamus Kearney,CEO & Principal Consultant, ARC Regulatory

18.10
Chair’s Closing remarks

18.20
World CDx Europe Drinks Reception