Accelerating Biomarker-Based Precision Therapies to ... · generation biomarker discovery, targeted...
Transcript of Accelerating Biomarker-Based Precision Therapies to ... · generation biomarker discovery, targeted...
35+ speakers, including:
Rajesh ChopraDirector, Cancer Research UK, Cancer Therapeutics Unit, Head, Division of Cancer TherapeuticsThe Institute of Cancer Research
Maria Orr Executive Director, Personalised Healthcare & BiomarkersAstrazeneca
Katja Berg Vice President, Head of Operations & Payer Intelligence, Global Market Access Sanofi
Birgitte Volck Senior Vice President & Head of Rare Diseases R&D GSK
Heather StevensHead, Global Companion Diagnostics Strategy Roche Pharmaceuticals
Miro VenturiGlobal Head,Diagnostics,BiomarkersRoche
Frank Kramer Director, Biomarker Strategist, Experimental Medicine, Cardiovascular & Hematology Bayer Pharma AG
Liz Harrington Director, Translational Science, OncologyAstrazeneca
Ranga Sarangarajan Senior Vice President & CSO Berg Health
28th-30th March 2017, London, UK
Researched & Developed By:
Tel: +44 (0) 20 3141 8700 | Email: [email protected] @WorldCDx Companion Diagnostics
www.worldcdx-europe.com
Helping You Improve the Discovery, Validation & Clinical Utility of Biomarkers to Accelerate Precision Medicines & Patient Centric Diagnostics to Defined Populations
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
The World CDx meetings have a great balance between academia, industry and pharma. They cover a broad range of technical, regulatory, and business issues related to the advancement of personalised medicine.
Previous Speaker from Pfizer
1
3
2
4
5
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Learn best practice in validating emerging biomarkers, stratifying patient populations and defining appropriate responder cut offs to drive clinical success
Investigate the ground swell surrounding digital biomarkers and digital pathology and how AI advances can revolutionize the precision medicine industry
Understand how to robustly validate and develop new predictive markers from RNA, to new IO biomarkers, circulating biomarkers and multi-marker signatures
Combat discrepancies in coverage and coding to drive value over cost based pricing for precision medicine and CDx reimbursement
Address precision medicine and diagnostic advances outside oncology as the rare disease, cardiovascular and inflammatory disorder communities gather momentum
Innovate in clinical trial design to maximize the clinical success of drug candidates and streamline integration of CDx programmes
Scientific Highlights at World CDx Europe 2017:
Investigate new strategies for biomarker validation, patient stratification and Rx-Dx partnering in the highly competitive field of immuno-oncology
Devise the “handbook” for Rx-Dx partnering and the integration of a CDx strategy into your clinical programme to minimise risk and maximise the potential for successful co-launch and commercialization
Define and understand the economic impact of commercializing and integrating precision medicines and companion diagnostics into healthcare
Integrate systems biology and a multi ‘omic data approach to be at the forefront of the cohort medicine revolution
Understand and decipher the cost/benefit analysis of embarking on a CDx strategy for therapies being developed in your portfolio
Grapple with the nuances in European regulatory guidelines for diagnostics and develop a market access strategy for emerging and developing countries
Welcome To World CDx Europe 2017The Premier European Precision Medicine Event for Biomarker, Drug Development & Companion Diagnostic Specialists
Long established and now in its 7th year, World CDx Europe is the comprehensive, end-to-end event for next generation biomarker discovery, targeted drug and diagnostic development. As the race to market hots up in oncology and interest builds in alternative indications, such as cardiovascular and rare diseases, strengthen your network and learn from large pharma, emerging biotech, diagnostic and technology developers.
In this competitive era for precision medicines proving their worth in a value-based healthcare system, World CDx Europe provides the strategic, candid and disruptive discussions this industry needs to have in order to bring more effective therapies to specific patient groups.
Bringing you field-defining case studies and KOL insights, World CDx Europe is dedicated to laying the roadmap to help you rapidly progress from exploratory biomarker to safe, effective and commercially successful precision medicine-CDx combinations.
6
8
7
9
10
11
12
Expert Speaker Faculty
Frederic Ausseil Head of Companion Diagnostic Medical Platform, Pierre Fabre
Franck Brichory Associate Director, Personalized Medicine, Debiopharm International SA
Ralph Graeser Senior Translational Medicine Expert, Boehringer Ingelheim
Katja Berg Vice President, Head of Operations & Payer Intelligence, Global Market Access, Sanofi
Peter Groenen Head of Translational Science, Actelion Pharmaceuticals
Flora Berisha Associate Director, Companion Diagnostics, Daiichi Sankyo
Matthias Hackl CEO, TAmiRNA GmbH
Frank Kramer Director, Biomarker Strategist, Experimental Medicine, Cardiovascular & Hematology, Bayer Pharma AG
Gereon Lauer Associate Director, Discovery Biomarkers, Vertex Pharmaceuticals
Erin PedalinoAssociate Director, Regulatory Affairs International,Merck Sharp & Dohme Corp.
Chaminda SalgadoSenior Investigator, Cell & Gene Therapy Platform GSK
Ranga Sarangarajan Senior Vice President & CSO, Berg Health
Manuel Silva Director Histopathology, Global Clinical Biomarkers & Companion Diagnostics, Merck KGaA
Luc Van Rompaey Vice President, Translational Medicine, argenx
Heather StevensHead, Global Companion Diagnostics Strategy Roche Pharmaceuticals
Birgitte Volck Senior Vice President & Head of Rare Diseases R&D, GSK
Miro VenturiGlobal Head, Diagnostics, Biomarkers, Roche
Joe CluneDiagnostic Director - Immuno Oncology,Astrazeneca
Maria OrrExecutive Director, Personalised Healthcare & Biomarkers, Astrazeneca
Drug Developers
Liz HarringtonDirector, Translational Science, OncologyAstrazeneca
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Diagnostic & Technology Experts
Anthony Whetton Professor of Cancer Cell Biology, Director Stoller Biomarker Discovery Centre, Director Manchester Precision Medicine Institute University of Manchester
Academics, Advocates & Associations
Speaker to be confirmed Agilent Technologies
Colin Hill Senior Vice President Commercial Operations, Asuragen
Bob Holt Companion Diagnostic Development Manager, Hologic
Seamus Kearney CEO & Principal Consultant, Advance Regulatory Consulting Limited
Brian KellyGlobal Director, Diagnostic PartneringThermo Fisher Scientific
Peter KerrVice President, Companion Diagnostic DevelopmentAlmac Diagnostics
Vishal Sikri Vice President, Commercial Operations, Sysmex Inostics
Jessica RileySenior Director Business Development, Pharma Partnerships, Leica Biosystems
Berwyn ClarkeCEO PBD Biotech Limited
Jonathan FramptonDiagnostics Strategic Alliance Horizon
Ivan Malagurski Global Director & International Product Manager Personalised Healthcare Solutions Roche Diagnostics
Keith PageDirector Scientific Development, Asterand Bioscience Inc.
Suso PlateroExecutive Director, Immuno-Oncology & Precision Medicine Leader, Covance, Inc.
Bruce JordanVice President, International Business Leader, CompanionDiagnosticsRoche Diagnostics
Tom TuriVice President, Companion Diagnostics Covance, Inc.
Wesley BuckinghamSenior Manager, NanoStringTechnologies
John SimmonsDirector, Translational Science & Diagnostics, Personal Genome Diagnostics
Jordan ClarkManaging Director, Labceutics, Diaceutics Group
Steve AndersonChief Scientific Officer,Covance, Inc.
Denis Horgan Executive Director, European Alliance for Personalised Medicine
Rajesh ChopraDirector, Cancer Research UK, Cancer Therapeutics Unit, Head, Division of Cancer TherapeuticsThe Institute of Cancer Research
Jacqueline Hall Executive Director, IQN Path ASBL
Christian Rolfo Associate Professor & Head of Phase I- Early Clinical Trials Unit, Antwerp University Hospital
Yong-Jie Lu Reader in Medical Oncology, Barts Cancer Institute, Queen Mary University of London speaking on behalf of ANGLE plc
Fay McCracken Adviser, Office for Market Access & Technology AppraisalsNational Institute for Health & Clinical Excellence (NICE)
Simon PattonDirector, The European Molecular Genetics Quality Network (EMQN)
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Conference Day One | Wednesday 29th March, 20178.00 Breakfast & Networking
Miro Venturi, Global Head, Diagnostics, Biomarkers, Roche
8.20 Chair’s Opening Remarks
Defining the Biomarker Continuum with a “Perfect Test”Wesley Buckingham, Senior Manager, Diagnostic Product Development NanoString Technologies
8.30 Case Study presented by Nanostring Technologies• More information to follow shortly
Ranga Sarangarajan, Senior Vice President & CSO, Berg Health
9.00 Can an Evolving Appreciation of Systems Biology Finally Result in that Universal Companion Diagnostic?• 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?Bruce Jordan, Vice President, International Business Leader, Companion Diagnostics, Roche Diagnostics
9.30 Case Study presented by Roche Diagnostics• More information to follow shortly
10.15 Morning Refreshments & Networking
Stakeholder Alignment for the Advancement of Precision Medicine & Companion Diagnostics
Bob Holt, Companion Diagnostic Development Manager, Hologic
10.45 Using LDTs to Streamline CDx Development• 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)
Flora Berisha, Associate Director, Companion Diagnostics, Daiichi Sankyo
11.15 Challenges in Developing Companion Diagnostics: Alignment with Stakeholders is the Key to Success• 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
Fay McCracken, Adviser, Office for Market Access & Technology AppraisalsNational Institute for Health & Clinical Excellence (NICE)
11.45 The NICE Perspective on Precision Medicine & CDx Market Access• More information to follow
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Stream ARobustly Defined Precision Medicine: Accelerating
Biomarker Discovery & Clinical Development
Stream BReimbursement, Market Access & Precision Drug-
Dx CommercializationEvaluating the Clinical Utility of Liquid Biopsy
DiagnosticsAddressing Standardisation & Quality Control to Advance the Adoption of Companion Diagnostics
14.00 Circulating Tumour Cells: Subtypes are Important for Cancer Prognosis• More information to follow shortlyYong-Jie Lu, Reader in Medical Oncology, Barts Cancer Institute, Queen Mary University of London
speaking on behalf of ANGLE plc
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 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 approachesJohn Simmons, Director, Translational Science & Diagnostics, Personal Genome Diagnostics
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)
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 biopsiesRalph Graeser, Senior Translational Medicine Expert, Boehringer Ingelheim
15.00 Improving 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 laboratoriesJacqueline Hall, Executive Director, IQN Path ASBL
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 OncoBEAM™ assays are available for CRO
services and/or Patient testing globallyVishal Sikri, Vice President, Commercial Operations, Sysmex Inostics
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
Moderator: Colin Hill, Senior Vice President Commercial Operations, Asuragen
Panellists: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)Berwyn ClarkeCEO PBD Biotech Limited
12.15 Panel Discussion: 4 Key Stakeholders – Aligned or Misaligned Expectations?With the precision medicine & CDx industries at a crucial junction, proving its 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.
13.00 Lunch & Networking
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Bridging Exploratory Biomarkers into Clinical Drug Development Programmes
Advancing the Concept of the Perfect Test: Development, Regulatory & Adoption Challenges
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
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 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
17.00 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 Biomarker Driven Approaches in Early Clinical Development for Anti Inflammatory Drugs• Novel concepts to treat chronic inflammation require a sound
biomarker strategy and strong implementations in early clinical development
• Case example on recent experiences to demonstrate benefit of early engagement to have an optimal outcome
• Current and future approaches in inflammation Peter Groenen, Head of Translational Science, Actelion Pharmaceuticals
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
18.00 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 pipelinesFranck Brichory, Associate Director, Personalized Medicine, Debiopharm International SA
17.40 Panel Discussion: Defining the Biomarker Continuum with a “Perfect Test”: How Complementary or Companion Diagnostic Biomarkers Select Responders & Non-Responders• 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
• How far away is the “mother of all” biomarkers and “mother of all” panels?
• How do we optimize biomarker and CDx endeavours to achieve patient monitoring and show direct clinical benefit to healthcare decision making?
• What do we as an industry need to do to move away from the one biomarker, one drug, one CDx mantra?
Continued...
16.00 Afternoon Refreshments & Networking
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
• Tackling regulatory and reimbursement considerations for “next generation” diagnostic assays
• Discussing re-defining patient populations and empowering the clinical utility of multi-marker signatures
• How should we update regulatory processes to consider the rise of multi analyte multiplexing assays?
• How do we drive a shift to value based pricing for precision medicines and how can we feed this back into the clinical setting?
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, Advance Regulatory Consulting Limited
18.30 Chair’s Closing Remarks
18.40 End of Day One
The intimate nature of
this meeting differentiates itself
Director Strategic Business Improvement,
JNJ, World CDx Boston 2016
attendee
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Stream A Stream B
Defining the Roadmap for Successfully Executing a Drug-CDx Development Strategy
Innovation in Precision Medicines & Companion Diagnostics
11.30 Partnering with Pharma to Develop & Commercialise Bespoke, Flexible Companion Diagnostics• Robustly defining an appropriate diagnostics strategy with the
pharma partner• A ‘platform agile’ approach providing solution flexibility from
discovery-to-delivery• Meeting the necessary pharma timelines and resource
requirements to ensure a fully integrated drug-CDx rollout• Partnership between pharma and diagnostic stakeholders
through experienced project management and expert bioinformatics supporting services
• The quality and regulatory paradigm for successful CDx development and commercialisation in the new era of complex genomic diagnostic testing
Peter Kerr, Vice President, Companion Diagnostic Development, Almac Diagnostics
11.30 Availability of Innovative Technology to Understand & Manage Cancer Using Companion Diagnostics• Analysing the 32 companion diagnostic tests available today in
oncology, the biomarkers and platforms utilized and the lack of a universal platform and full automation of testing
• Debating how patients will be effectively triaged in precision medicine with challenges of tissue stewardship and conservation
• Discussing the impact of conflicting interests between regulatory, clinical and payer on patient treatment
Jessica Riley, Senior Director, Business Development, Pharma Partnerships, Leica Biosystems
Conference Day Two | Thursday 30th March, 20178.00 Breakfast & Networking
Steve Anderson,Chief Scientific Officer, Covance, Inc
8.50 Chair’s Opening Remarks
Advancing Precision Medicines & Companion Diagnostics In Non-Oncology Therapeutic Areas
Ivan Malagurski, Global Director & International Product Manager Personalised Healthcare Solutions, Roche Diagnostics
9.00 Advances in Non-Oncology Personalised Healthcare Solutions: Successful Model in Fertility Treatment• More information to follow shortly
Frank Kramer, Director Biomarker Strategist, Experimental Medicine, Cardiovascular & Hematology, Bayer Pharma AG
9.30 Digital Transformation of Clinical Trials in Cardiovascular Indications: Utilising Medical Devices to Select Patients & Remotely Monitor Safety & Efficacy• Debating biomarker strategies for selecting the right patient populations to monitor safety and
efficacy in proof of concept studies• Discussing new technologies that are helping to advance precision medicine in the
cardiovascular space• How to best handle and interpret the continuous data provided from potential diagnostic devices
Tom Turi, Vice President, Companion Diagnostics, Covance, Inc.
10.00 CDx Beyond Oncology• CDx uses in non-oncology therapeutic areas
• CDx in genetically defined disease
• Emerging CDx approaches and technologies
Birgitte Volck, SVP & Head of Rare Diseases R&D, GSK
10.30 Precision Medicine Advances in Rare Disease Indications• Analysing the unmet need in rare diseases: Where is the opportunity for targeted
therapies and diagnostics?
• Overcoming biomarker discovery and validation challenges linked to small population sizes and the requirement of more complex biomarker signatures
• Is the traditional CDx model appropriate for the rare disease field?
• Discussing how to develop Rx-Dx business models for rare disease CDx and precision medicine development
11.00 Morning Refreshments & Networking
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Stream ARobustly Defined Precision Medicine: Accelerating
Biomarker Discovery & Clinical Development
Stream BReimbursement, Market Access & Precision
Drug-Dx Commercialization
Advancing Clinical Development Through Innovative Trial Design
Mock CDx Partnership – Case Study Simulation of a CDx Deal in Real Time
14.00 Developing ARGX-110 in T-Cell Lymphoma & AML: Biomarker Highlights• CD70 is upregulated in many cancers, and an attractive target for
selective targeting of leukemic stem cells
• ARGX-110 is an engineered, differentiated antibody targeting CD70, currently in Phase I/II clinical trials
• Biomarker strategy based on preclinical findings and clinical experience – key data will be presented
Luc Van Rompaey, Vice President, Translational Medicine, argenx
14.00 CDx partnership models, particularly between drug developer and diagnostic company, need to evolve in order to share risk and reward in a value-based healthcare paradigm, particularly as the field strives to foster new collaborations and continued innovation. With a compelling need to balance priorities of each side and an overarching need for ROI, this is a unique opportunity to simulate a CDx collaboration with fellow industry peers in a candid setting. After an hour and a half, can you forge a mutually beneficial partnership and sign the contract?
• Regardless of your company, join either the drug developer or diagnostic side of the table
• Discuss with your peers what are your immovable points and areas of compromise in a future collaboration
• Debate across the table to agree on a possible partnership – understanding the wants, needs and must-haves
• Negotiate the likes of IP details, upfront payments, future milestones, royalties, deal structure, product timelines
12.00 The Astrazeneca Story: From Translation to Commercialisation & Launch of a Drug-CDx Programme• Addressing the identification and translational development of a
biomarker strategy• Discussing the steps needed to design and implement a CDX
strategy when the decision is made to go ahead with a drug- biomarker strategy
• Integration of regulatory considerations for the clinical progression of a drug-CDx programme
• Streamlining CDx and commercial operations to ensure market readiness
• Strategies for increasing market adoption post approval
Liz Harrington, Director, Translational Science, Oncology, Astrazeneca
Maria Orr, Executive Director, Personalised Healthcare & Biomarkers, Astrazeneca
Joe Clune, Diagnostic Director - Immuno Oncology, Astrazeneca
12.00 Analytical Testing Opportunities to Support Autologous Gene Therapy• Discussing ex-vivo autologous gene therapies to reduce the
risk of the patient mounting an immune response against the therapy, however such personalisation brings a huge unprecedented supply chain challenge
• Current testing requires extensive laboratory facilities, use of analytical staff, running labour intensive methods, ultimately adding significant time and cost to the supply of drug product to the patient
• Discussing the new market opportunity for developing diagnostics, especially POC, to test the drug itself, as opposed to screening patients
Chaminda Salgado, Senior Investigator, Cell & Gene Therapy Platform, GSK
12.30 Case Study Presented by Agilent Technologies • More information to follow
Agilent Technologies speaker to be confirmed
13.00 Lunch & Networking
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
14.30 The ICR Perspective: The Clinical Development Pipeline for Oncology Precision Medicines• What does successful look like: Have far have we come in oncology
targeted therapeutic drug development?• Dealing with cancer evolution and heterogeneity, how this can be
overcome with novel therapeutic approaches and implications for diagnostics
• How can we better align translational biomarker and therapeutic efforts to best place clinical candidates for success
• Strategies for deciphering the intricacies of patient responses in responder populations to refine clinical approaches and best show therapeutic efficacy
Rajesh Chopra, Director, Cancer Research UK, Cancer Therapeutics Unit, Head, Division of Cancer Therapeutics, The Institute of Cancer Research
15.00 Improving Clinical Trials to Advance the Success of Biomarker Driven Targeted Therapies• How do ensure appropriate set up of all clinical trial facilities to
ensure successful and standardised running of global clinical trials?• How can we maximise the use of secondary and tertiary endpoints
focussed on exploratory biomarkers and Dx technology to advance their clinical utility?
• Designing trials to accurately monitor and evaluate driver mutations clonally and longitudinally
Christian Rolfo, Associate Professor & Head of Phase I- Early Clinical Trials Unit, Antwerp University Hospital
15.30 Afternoon Refreshments & Networking
Advancing the Future Scope & Reach of Precision Medicines & Companion Diagnostics
Denis Horgan, Executive Director, European Alliance for Personalised Medicine
16.00 Enhancing the Adoption of Precision Medicines: Patient Advocacy & Healthcare Education • With an increasing complexity in biomarker signatures and responder cut offs, how do we
combine the complexity of such testing with the simplicity clinicians demand?
• “Patient Power” is key: How do we capitalize on patients getting ever more involved in their healthcare to drive the educational process?
• Addressing the disconnect between industry and healthcare to improve drug and CDx adoption
• Understanding how the life cycle management of the CDx impacts drug adoption
• Understanding the nuances in drug adoption in different geographies
Manuel Silva, Director, Histopathology, Global Clinical Biomarkers & Companion Diagnostics, Merck KGaA
16.30 The Evolving Role of Digital Biomarkers, Diagnostics & Pathology• Integrating AI and machine learning to elucidate the vast complexity as we move towards
multiple marker signatures and a systems biology approach
• How can we employ automated systems to not only deal with the vast array of clinical data being produced but to link this to clinically actionable outcomes?
• Analysing the opportunities in digital pathology and redefining the role of the pathologist in precision medicine
Steve Anderson,Chief Scientific Officer, Covance, Inc
17.00 Chair’s Closing Remarks
17.10 End of Day Two & Close of 7th Annual World CDx Europe 2017
Location:Novotel London West1 Shortlands, HammersmithLondonW6 8DR
How to Register:
If you are interested in joining the pre-conference workshop hosted by Covance, please email [email protected]
If accepted, the workshop will be free to attend as part of your conference registration. Confirmation of attendance will be given within a week of submission.
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
12.30 Workshop Registration Opens
13.00 Trends in Precision Medicine & Companion Diagnostics Steve Anderson, Covance, Inc.
13.45 Key Considerations: Changing Regulatory Framework in the EU & Globally Seamus Kierney, ARC Consulting
14:45 Break
15:00 Optimizing CDx Clinical Trial Design, Recruitment /Enrollment & Execution Suso Platero, Covance, Inc.
15:45 Multiplexing Technologies & CDx: Proteomic & Genomic Approaches Speaker confirming
16:15 Panel: Challenges & Opportunities in Drug & Diagnostic Co-Development
17.00 Adjourn
Leveraging Clinical Trial Design to Improve CDx Development & OutcomesDate: Tuesday 28th March, 2017 | Time: 12.30 – 17.00
Workshop ModeratorSteve Anderson, Chief Scientific Officer, Covance, Inc.
Speaker Faculty:• Steve Anderson, Chief Scientific Officer, Covance, Inc.• Seamus Kierney, CEO & Principal Consultant, Advance Regulatory
Consulting Limited• Suso Platero, Executive Director, Immuno-Oncology & Precision Medicine
Leader, Covance, Inc.
Pre-Conference Workshop
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Partnership Opportunities
You’ll Meet People From...
Companies Who Attend World CDx
Why Partner
World CDx Europe 2017 is dedicated to advancing the development and commercialisation of targeted therapeutics via the most innovative diagnostic platforms.
Our targeted summits bring together this multi-stakeholder network to accelerate the discovery, clinical development and patient access of biomarker-driven precision therapies.
• Develop relationships with the most influential leaders in precision medicine
• Demonstrate your solutions to senior level decision makers from your targeted audience
• Define and establish long term strategic partnerships to deliver marketable success for all
I met people whom I likely would never have met if not for World CDx.
World CDx Boston 2016 Attendee
Fantastic meeting from both a networking as well as from a content perspective.
World CDx Europe 2016 Attendee
Become a Commercial Partner at World CDx Europe 2017Contact
Sam Sarwar Commercial Director
Tel: +44 (0) 203 141 8700 Email: [email protected]
Biomarker R&D
Clinical R&D
Translational Medicine
Companion Diagnostics
Regulation, Pricing & Reimbursement
Business Development
24%
19%
13%
25%
5%
14%
Typical Attendance By Job Title
24%14%
Typical Attendance By Sector
60%10%
25%
5%
Pharma & Biotech
Academia
Dx Developers
Other
Based on previous attendance at the World CDx event series
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
World CDx Europe 2017 Partners
Hologic
Hologic’s is an independent CRO with over 30 years’ experience in the provision of molecular genetic services and as a
MHRA approved QC Testing Laboratory. With a global reach, Hologic’s diversified genomic offering is centred at our Molecular Genetics and Manufacturing facility in Manchester, UK. We offer a broad range of services for biomarker discovery, validation and companion diagnostic development in support of genomic research, clinical trials, and translational research.
www.hologic.com
Plenary Programme Partner
Asuragen
Our portfolio of proprietary enabling technologies combined with our team of industry experts and scalable partnering
approach, allows us to support all your needs from discovery through commercialization. We offer end-to-end, full-service solutions that include upfront discovery, assay development, clinical testing, regulatory filing, cGMP manufacturing and global product commercialization.
www.asuragen.com
Plenary Panel Partner
Nanostring Technologies
NanoString Technologies is a provider of life science tools for translational research and developer of molecular diagnostic
products. The company’s nCounter® Analysis System delivers highly-multiplexed, direct profiling of individual molecules in a single reaction without amplification. Applications include Gene Expression, Single-Cell, miRNA and CNV.”
www.nanostring.com
Expertise Partner
Covance, Inc.
Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug
development data in the world, helps our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver on the promise of a healthier world.
www.covance.com
Mastermind & Expertise Partner
Roche Diagnostics
Along with Roche Pharamceuticals, Roche Diagnostics is an important part of the foundation
that modern healthcare builds upon. Our broad range of innovative diagnostics tests and systems play a pivotal role in the ground-breaking area of integrated healthcare solutions and cover the early detection, targeted screening, evaluation and monitoring of disease. Roche Diagnostics is active in all market segments, from scientific research and clinical laboratory systems to patient self-monitoring.
www.roche.com
Plenary Expertise Partner
Almac Diagnostics
Almac Diagnostics is a global personalised medicine company, focusing on the discovery, development
and commercialisation of complex diagnostic and companion diagnostic tests.
Almac Diagnostics offer Pharma and Biotech companies a highly customised Drug CDx partnership approach. Creating tailored solutions, utilising complex biology, we can help differentiate your drug in the marketplace.
Our global, state of the art, CLIA-accredited labs in the USA and Europe are ready to operate both research-use-only and clinical diagnostic assays.
Find out more about partnership opportunities at: www.almacgroup.com/diagnostics
Programme Partner
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Personal Genome Diagnostics
Founded in 2010 by renowned scientists from Johns Hopkins who pioneered cancer genomics, PGDx offers unparalleled
solutions for comprehensive genomic analyses that assist researchers in identifying elusive cancer-related mutations. Paired with continuous research performed by our world class genomic and bioinformatics experts, we’ve excelled in our ability to reliably identify and interpret genetic alterations in tumor tissues and liquid biopsies.
www.personalgenome.com
Programme Partner
Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world
healthier, cleaner and safer. Through our four premier brands – Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
www.thermofisher.com
Leica Biosystems
Leica Biosystems is a global leader in workflow solutions and automation, integrating each
step in the workflow. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.
www.leicabiosystems.com
Agilent Technologies
Diagnostic certainty for every patient is a critical first step in the fight against
cancer. Agilent’s Dako pathology solutions are designed to help hospitals and pathology laboratories around the world make fast and accurate diagnoses. This enables the most effective treatment decisions for cancer patients, ultimately improving patient care and enhancing survival rates.
www.agilent.com
Programme Partner
Programme Partner Programme Partner
Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a leader in blood-based molecular diagnostics testing in oncology.
Our highly sensitive OncoBEAM™ kits and tests offer a minimally-invasive alternative for the detection of cancer gene mutations, clinical trials testing and companion diagnostics development.
www.sysmex-inostics.com
Programme Partner
Horizon Discovery
Horizon Diagnostics, a business unit of Horizon Discovery Group plc, is a leading provider of genetically defined, human
genomic reference standards, including FFPE cell line sections and purified genomic DNA. HDx™ Reference Standards offer a sustainable source of reference material to laboratories, proficiency schemes and manufacturers, providing an unprecedented level of control.
www.horizondiscovery.com
Programme Partner
ANGLE plc
ANGLE is a UK and US based medical diagnostic company. ANGLE’s Parsortix technology enables
the capture and harvest of circulating tumour cells from patient blood. The resulting liquid biopsy (simple blood test) provides a powerful tool to deliver personalised cancer care. ANGLE is currently developing its first diagnostic product in the area of ovarian cancer. The Parsortix system has CE Mark regulatory approval in Europe and an FDA approval process is underway in the US.
www.angleplc.com
Programme Partner
Diaceutics
We leverage analytics, software, services and strategy to enable the effective integration of therapies and
diagnostics into the treatment pathway. The Group’s divisions, Labceutics, Diaceutics AIS, Iceutics and Bioceutics, together provide a comprehensive suite of services to ensure that testing enables therapy prescribing across all key markets.
www.diaceutics.com
Programme Partner
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Randox Laboratories
Randox Laboratories has a longstanding reputation as a world leading diagnostic
manufacturer, with innovative, high quality solutions designed to make diagnostic testing faster, more accurate and more reliable. Built on this heritage, Randox Biosciences, part of Randox Laboratories, specialises in supplying academic centres, genetics laboratories and the global biopharmaceutical industry with products tailored to their specific needs; whether that is for research, molecular diagnostics or clinical trials.
www.randoxpharmasciences.com
Moderator Partner
Capital Biosciences
Capital Biosciences is a global CRO providing comprehensive services to pharmaceutical and life science industry partners. We have more than 10 years of experience in custom human biospecimens procurement, clinical and research project management. Our services include high-quality human biospecimens collection, study protocol development and data management. We oversee every step of the biospecimens management process, including sample collection, transportation and storage. We are collaborating with major clinical and scientific centers in USA, Europe and Asia to access a variety of well annotated samples and conduct prospective procurement projects.
www.capitalbiosciences.com
Meeting Partner
Advance Regulatory Consulting Ltd
Advance Regulatory Consulting Ltd. is a specialist consultancy providing expert services to the medical device and
diagnostic industry. Located in Northern Ireland and working with clients across the UK, Ireland and Europe, Advance Regulatory Consulting Ltd. has significant experience resolving the most complex regulatory issues, completing remedial projects and providing general advice and guidance to medical device and diagnostic companies.
www.arc-regulatory.co.uk
Panel Partner
Cureline
Cureline, Inc., is a human biospecimen CRO specializing in human tissue research projects including study design, regulatory
affairs, clinical network management, specimen collection and analysis, and complete logistics. We collaborate with major clinical centers in Europe, Asia, and the USA and maintain an extensive biorepository of human biospecimens in South San Francisco (CA, USA).
www.cureline.com
Exhibition Partner
Intuitive Biosciences
Intuitive Biosciences is a biotechnology company based in Middleton, Wisconsin. We specialize in developing
and manufacturing high quality products for custom assay development. Our proprietary AIM technology uses immobilized targets and SilverQuant® detection reagents to provide a more sensitive and reliable alternative to traditional immunoassays. Assays developed are read using the AQ1000 image capture and data analysis system, an open system for use with assays developed by Intuitive Biosciences or by the customer.
www.intuitivebio.com
Exhibition Partner
Asterand Bioscience Inc
Asterand Bioscience is the leading global provider of high quality, well characterized human tissue and human tissue-based research solutions to drug discovery scientists. Our
mission is to provide human-based solutions to accelerate the identification and validation of drug targets and enhance the selection of drug candidates with an increased likelihood of clinical success.
www.asterandbio.com
Spotlight Partner
Drug Developer & Academia
Standard Price
Conference Only £1,599 + VAT
Standard Industry
Standard Price
Conference Only £1,999 + VAT
PricingRegister
Conference Registration
www.worldcdx-europe.com/registerTel: +44 (0)203 141 8700 Email: [email protected]: Hanson Wade, 4th Floor, 52 Grosvenor Gardens,
London, SW1W 0AU
• 10% discount – 3 delegates • 15% discount – 4 delegates • 20% discount – 5 or more delegates
*Please note that discounts are only valid when three or more delegates from one company book and pay at the same time.
Team Discounts*
Venue
Pre-Conference Workshop Registration
Novotel London West 1 Shortlands, Hammersmith, London, W6 8DR
www.novotellondonwest.co.uk
If you are interested in joining the pre-conference workshop hosted by Covance, please email [email protected].
If accepted, the workshop will be free to attend as part of your conference registration. Confirmation of attendance will be given within a week of submission.
VAT will be charged at 20%
Full payment is due on registration. Cancellation and Substitution Policy: Cancellations must be received in writing. If the cancellation is received more than 14 days before the conference attendees will receive a full credit to a future conference. Cancellations received 14 days or less (including the four-teenth day) prior to the conference will be liable for the full fee. A substitution from the same organization can be made at any time.
Changes to Conference & Agenda: Hanson Wade reserves the right to postpone or cancel an event, to change the location or alter the advertised speakers. Hanson Wade is not responsible for any loss or damage or costs incurred as a result of substitution, alteration, postponement or cancellation of an event for any reason and including causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade or industrial disputes, terrorism or hostilities.
Data Protection: The personal information shown and/or provided by you will be held in a database. It may be used to keep you up to date with developments in your industry. Sometimes your details may be obtained or made available to third parties for marketing purposes. If you do not wish your details to be used for this purpose, please write to: Database Manager, Hanson Wade, Suite A, 6 Honduras Street, London EC1Y 0TH
TERMS & CONDITIONS
World CDx Europe28th - 30th March 2017 | London, UK
Tel: +44 (0)203 141 8700 Email: [email protected]
www.worldcdx-europe.com @WorldCDx Companion Diagnostics
EUROPE
Accelerating Biomarker-Based Precision Therapies to Targeted Patient Populations
Excellent meeting, exactly providing the right balance between content topics, strategic insights and networking opportunities.
Global Head, Diagnostics Biomarkers & Personalized
Healthcare, Roche, World CDx Boston 2016 attendee