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DRAFT DOCUMENT – FINAL COPY TO REFLECT REAL CASE STUDIES
March 17th-19th 2015
The Central Pillar for Forging the Sustainable Path Towards Personalised
Medicine
World CDx Berlin 2015 will guide drug and diagnostic developers from understanding disease heterogeneity and the
complex underlying biology through to the drug-companion diagnostic pairing development cycle accelerating them
to market.
World CDx Berlin 2015 will enable the drug-CDx community to stratify and define patient subpopulations that will
respond to drugs in development, by harnessing novel technologies that validate predictive biomarkers.
Further, World CDx Berlin 2015 will shine the spotlight on rapidly evolving Drug-CDx partnering models along with
defining best practice to navigate the changing regulatory guidelines and the fragmented reimbursement landscapes
Proudly Supported and Sponsored by:
Confirmed Speakers for World CDx Berlin 2015 Include:
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Khusru Asadullah, Vice President, Head of Global Biomarkers, Bayer
Elia Stupka, Director, Computational Biology, Boehringer Ingelheim
Maria Orr, Executive Director Personalised Healthcare & Biomarkers, AstraZeneca
Barbara Amoroso, Director, Clinical Development, Celgene
Sanne de Haas, Scientific Manager, Oncology Biomarker Development, Roche
Iris Grossman, Global Head, Personalized Medicine & Pharmacogenomics, Teva
Richard Buller, Vice President, Oncology Clinical Development, Pfizer
Nikolas Stöcklein, Professor, University of Düsseldorf
Abderrahim Mahfoudi, Senior Director, Scientific Partnerships & Coordination, Sanofi
Lothar Bergmann, Assistant Medical Director, Oncology, J.W. Goethe University Frankfurt & Core Member, SAGOncology, EMA
Dennis Merkle, Director, Project Leader, IVD Strategy, Merck Serono
Jeroen Lammerts van Bueren, Principal Scientist, Genmab
Carla Deakin, Associate Director, Diagnostic Assessment Programe, NICE
Kenneth Thress, Oncology Translational Scientist, AstraZeneca
Alain van Gool, Professor, Personalized Healthcare, Radbound University Medical Center
If you have any comments regarding this draft please contact [email protected]
THIS IS A CONFIDENTIAL DRAFT DOCUMENT.
DRAFT DOCUMENT – FINAL COPY TO REFLECT REAL CASE STUDIES
Conference Day One, 18th March 2015
08.00 Registration, Breakfast & Networking
Companion Diagnostics: Forging the Path to Personalised Medicine
09.00 Chairman’ Opening Remarks – State of Address: Drug-Companion Diagnostic Combinations
 It’s been a huge 12 months for companion diagnostics since World CDx Europe last year and there have been
significant steps forward with a multitude of new and renewed partnerships, and technological advancements
 This opening gambit will set the scene of the companion diagnostic field and make sure everyone is on the
same page as we kick off World CDx Berlin 2015!
David Jackson, Vice President, Diagnostics & Companion Diagnostics, Arno Therapeutics
09.15
Thermo Fisher Presentation
09:45 Conversations that Matter
Close your laptops. Put down your cell phones. Eavesdrop on exclusive one-on-one interviews played out on stage with
leading executives who are driving forward targeted precision medicines as this will be your ONLY opportunity to hear
this unique content.
Be part of an exclusive conversation between companion diagnostic key opinion leaders as they discuss:
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10.30
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Are Drug-Companion Diagnostics the central pillar for forging the path to Personalised Medicine?
The Global Regulatory Landscapes: Are they improving?
When is Next Generation Sequencing going to fully translate from discovery tool to diagnostic
technology?
Why is aligning Drug-Companion Diagnostic Co-Development so important?
What is the future for “Companion Therapeutics”?
Companion Panel and Open Q&A
How will companion diagnostics continue to enable targeted therapy development?
What are the current short-comings with this burgeoning field?
How do we see the drug-CDx industry evolving over the next 12 months?
What are we expecting to learn at World CDx Berlin 2015?
Khusru Asadullah, Vice President, Head of Global Biomarkers, Bayer
Richard Buller, Vice President, Oncology Clinical Development, Pfizer
11.00
Speed Networking & Morning Refreshments
From Biomarker Discovery to Validation
Lessons Learnt from Completed or Late Phase Case
Studies
If you have any comments regarding this draft please contact [email protected]
THIS IS A CONFIDENTIAL DRAFT DOCUMENT.
DRAFT DOCUMENT – FINAL COPY TO REFLECT REAL CASE STUDIES
12.00 Opportunities and Challenges in Companion
Diagnostic Development
 Understanding biological relevance of the chosen
12.00 Developing a Robust Biomarker Strategy for
biomarker as a patient selection tool and
Celgene’s Lymphoma Program
development of an appropriate assay for the
 How best to ensure success from identification to
biomarker of interest
clinical validation of driver biomarkers
 Requirements of undertaking clinical trials to
 How to utilize the arsenal of tools and technologies
support drug and companion diagnostic
at your disposal
 Case study from AZ oncology portfolio to illustrate
the drug/diagnostic co-development process
Barbara Amoroso, Director, Clinical Development, Celgene
Maria Orr, Executive Director Personalised Healthcare &
Biomarkers, AstraZeneca
12.30 Incorporating Biomarkers into Clinical Trial Design 12.30 Case Study: Updates from the Clinic from Pharma
 Implementation of biomarker strategies in clinical
 Phase 3 results from big pharma
trials
 What has already be learnt pre-launch that we are
 Validation of promising biomarkers
taking forward?
Sanne de Haas, Scientific Manager Oncology Biomarker
Development, Roche
Iris Grossman, Global Head, Personalized Medicine &
Pharmacogenomics, Teva
1.00 Impact of Early or Late Biomarker Validation on the
Development of Companion Diagnostics
1.00 Case Study: Updates from the Clinic from Pharma
 Is there a one-size-fits all model for biomarker
 Phase 3 results from big pharma
validation?
 What has already be learnt pre-launch that we are
taking forward?
 Why is demonstrating clinical utility so imperative
at any stage?
1.30
Networking Lunch
Translating NGS from Research Tool into Clinical
Technology
Aligning Drug-CDx Co-Development
2.30 Harnessing Next Generation Sequencing in the Clinic
2.30 Non-Invasive, Blood-Based Mutation Testing in
 Factors to consider before choosing next
generation sequencing as an exploratory diagnostic Metastatic Colorectal Cancer; A Prerequisite for targeted
Therapy Selection
tool in the clinic
 The importance of RAS mutation status in mCRC
 How these technologies have already
for the selection of 1st line therapies
demonstrated huge amounts of clinical utility in
drug-CDx studies
 How to ensure all patients can access testing
Elia Stupka, Director, Computational Biology, Boehringer
Ingelheim
Dennis Merkle, Director, IVD Strategy, Merck Serono
3.00
3.00 How Best to Manage the Risk-Opportunity TradeOff Effectively when Partnering?
 More uncertainty in the pre-clinical/early clinical
phase, but greater opportunity? Factors for
Cancer Diagnostics in the Genomic Medicine
Daniel Grosu, Vice President, Clinical Development &
Medical Affairs, Illumina
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THIS IS A CONFIDENTIAL DRAFT DOCUMENT.
DRAFT DOCUMENT – FINAL COPY TO REFLECT REAL CASE STUDIES
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consideration
Demonstrating clinical utility is a vital part of this
process
3.30 Alignment of Antibody Drug Conjugate-CDx CoDevelopment?
3.30 Moving Beyond the One Biomarker One Drug
 Experience with our Phase I staged program,
Paradigm
HuMax-TF-ADC and companion diagnostic
 How is this paving the way for multiplexing
strategy
strategies in the clinic?
 Factors for consideration when aligning drug How are novel genomic technologies such as gene
CDx co-development
expression arrays and NGS
Jeroen Lammerts van Bueren, Principal Scientist, Genmab
4.00
Afternoon Refreshments
4.30 Quick Fire Innovation Talks: Only the Most Innovative Need Apply
Designed to give you a taste of some of the latest and greatest innovative ideas in the world of Drug-CDx combinations.
Get unprecedented insight into the talking points of tomorrow and understand how these innovative ideas and
products are already having impact on this ever-growing landscape:
Managing Variability in a Massively Molecular World
 Companion Diagnostics is evolving at a vigorous rate and universal reference standards need to be adopted
that will support the adoption and development of massively parallel sequencing workflows
 Horizon Diagnostics has successfully developed a range of oncology specific reference standards which are
quantitative and mimic the complexity of tumour biology
Brian Burke, Business Development Director, Horizon Diagnostics
Companion Discussions
5.10 The World CDx speaker faculty is second to none but there is just as much knowledge in the audience as there is
onstage. We want to make sure you can tap into the experience of your peers. Discover multiple perspectives on the
key issues during Roundtable Companion Discussions, specifically designed so you can learn from over 150 fellow
precision medicine experts. Drive your own learning, crowd-source ideas and get inspired!
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6.00
“Companion Therapeutics” – What do these mean for the future of Drug-Companion Diagnostic
studies?
CTC’s and Cell Free DNA – What promise does this emerging field hold and where are the latest
advancements happening?
Risk Minimization Between Drug and Diagnostic Developers – How best to decide when the best
time to commit to a Companion Diagnostic is?
Navigating Companion Diagnostic Regulatory Landscapes – How best to negotiate this landscape and
plan your strategy in accordance with the latest regulatory updates and guidance
Close of Day 1
If you have any comments regarding this draft please contact [email protected]
THIS IS A CONFIDENTIAL DRAFT DOCUMENT.
DRAFT DOCUMENT – FINAL COPY TO REFLECT REAL CASE STUDIES
Conference Day Two, 19th March 2015
08.00 Breakfast & Networking
09.00 Chairman’s Opening Remarks
David Jackson, Vice President, Diagnostics & Companion Diagnostics, Arno Therapeutics
The Regulatory Landscape: Drug-Companion Diagnostic Combinations
09.05 Personalized Medicine in Oncology and Companion Diagnostics: What are the Hurdles for Physicians and
Regulatory Issues?
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Personalized medicine in genetic subtypes and the planning of sufficient clinical trials
A look at the variability in testing and European approval of targeted agents
Lothar Bergmann, Assistant Medical Director, Oncology, J.W. Goethe University Frankfurt & Core Member, SAGOncology, EMA
09.15 Overview of the Prominent Global Regulatory Landscapes
 A look at the current regulatory guidance from the USA, EU, China and Japan
 How working closely with regulatory agencies is critical for success
09.35 Biomarker & Companion IVD Development: Focusing on Current Challenges an EU Regulation for Biotech’s
 Regulatory expectations & challenges of an ideal biomarker validation
 Case studies of stratified authorized medicines in PEI responsibility
 Regulatory pathways for biomarker versus IVD development
 Directive 98/79/EC currently under revision: On the way towards a “companion IVD”?
Jörg Engelbergs, Scientific Regulatory Expert, Paul-Elrich-Institut
09.55 Interactive Solution Finding Session: How do we Deal with the Ever-Changing Regulatory Landscape?
Dynamic format for learning and discussion facilitated by leaders in the field who are most effectively navigating the
ever-changing drug-companion diagnostic regulatory landscape. This is also your chance to discover what those, who
feel confined by the same challenges as you, are doing to navigate the global regulatory approval process.
Discuss and debate:
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How do we manage the key differences between different states within the European Union?
Are new regulations stifling LDT innovation?
Regulatory challenges when developing novel drug-CDx combinations with no “tailgating”
How should “Home-Brewed” tests be regulated?
How much regulation should be in place for exploratory companion diagnostics in the clinic?
The impact on clinical trials and how the need for clinical data to back-up your case is fundamental
Lothar Bergmann, Assistant Medical Director, Oncology, J.W. Goethe University Frankfurt & Core Member, SAGOncology, EMA
If you have any comments regarding this draft please contact [email protected]
THIS IS A CONFIDENTIAL DRAFT DOCUMENT.
DRAFT DOCUMENT – FINAL COPY TO REFLECT REAL CASE STUDIES
Jörg Engelbergs, Scientific Regulatory Expert, Paul-Elrich-Institut
10.45
Morning Refreshments & Networking
Emerging Research Approaches & Techniques
11.15 Early Validation of Targets and the Impact on
Personalised Medicine
 The use of an arsenal of “omic” approaches to
drive early target identification and validation
 The impact of this early stage research on the
future of personalised healthcare?
Reimbursement for Drug-CDx Combinations
11.15 Synergies and Challenges Related to
Reimbursement of Co-Developed RxDx
Lisse-Lotte Hermansson, Director, Global Health
Economics, ImmunoDiagnostics and Companion
Diagnostics, Thermo Fisher Scientific
11.45 Biomarkers in Personalized Health(care): Changing 11.35 Developing Methods and Processes for
Perspectives
Evaluating Companion Diagnostics Across its
 Human disease is more than one impaired
Pharmaceutical and Diagnostic Evaluation Programmes
mechanism
 The assessment of clinical and cost effectiveness
 Personalized healthcare requires a system
of companion diagnostics
approach for maximal impact
 Biomarkers as key drivers for shared innovation
 NICE evaluation options for companion
diagnostics
 Translation in health informatics is next big thing
Alain van Gool, Professor, Personalised Healthcare,
Radboud University Medical Center, TNO
Carla Deakin, Associate Director, Diagnostic Assessment
Programme, NICE
11.55 Interactive Solution Finding Session: Managing
European Reimbursement
12.15 Targeting RNA with Companion Diagnostics?
 Are we ready to focus more of our efforts on the
world of RNA-based drug-companion diagnostic
combinations
 A detailed look at exosomal and circulating RNA as
diagnostic entities
Debate and Discuss:
 How do we manage the differences between
European States?
 How do we manage the global set of challenges?
 The impact of reimbursement on clinical trial study
design
 Reimbursement for Next Generation Sequencing
Carla Deakin, Associate Director, Diagnostic Assessment
Programe, NICE
12.45
Lunch & Networking
Circulating Biomarkers for Companion Diagnostics
Constructing and Executing a Robust Drug-CDx
Strategy
1.45 Circulating Tumour Cells and Companion Diagnostic 2.15 What About Patient Access to These Tests and
Development
Technologies?
 How can circulating tumour cells advance the
 Is the field coordinated enough between all of the
different stakeholders?
world of companion diagnostics?
If you have any comments regarding this draft please contact [email protected]
THIS IS A CONFIDENTIAL DRAFT DOCUMENT.
DRAFT DOCUMENT – FINAL COPY TO REFLECT REAL CASE STUDIES
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Case studies of how these are already being
explored in the clinic
Nikolas Stöcklein, Professor, University of Düsseldorf
2.15 Levels of EGFR T790M in plasma DNA as a
Predictive Biomarker for Response to AZD9291, a
Mutant-Selective EGFR Kinase Inhibitor
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AZD9291 is currently in clinical testing in
patients with EGFRm+NSCLC who have
relapsed on EGFR-TKI therapy
ctDNA present in the plasma of patients with
NSCLC may offer a minimally invasive
opportunity to identify eligible patients unable
to provide tissue biopsies
We aimed to study plasma levels of EGFR T790M
in relation to AZD9291 drug activity
Kenneth Thress, Oncology Translational Scientist,
AstraZeneca
2.45 Clinical Relevance of Circulating Cell-Free and
Exosomal microRNAs in Blood of Breast and Ovarian
Cancer Patients
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Deregulated levels of cell-free and exosomal
microRNAs in blood of cancer patients
Influence of neoadjuvant therapy on the
serum levels of circulating microRNAs in
breast cancer patients
Association of circulating microRNAs with a
particular biology of breast carcinomas
favoring progression and metastatic spread
Heidi Schwarzenbach, Assistant Professor, University
Medical Center Hamburg-Eppendorf
3.15
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How educating patients as well as physicians is
critical to the future of companion diagnostics
David Jackson, Vice President, Diagnostics & Companion
Diagnostics, Arno Therapeutics
1.45 Factors to Consider When Selecting the Right
Diagnostic Partner: The Sanofi Experience
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The benefits of invasion with the right partner at
the right time
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Extensive planning is necessary for deciding and
executing a robust drug-companion diagnostic
strategy
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Communication and commercial mind sets are
fundamental to success in this complex field
Abderrahim Mahfoudi, Senior Director, Scientific
Partnerships & Coordination, Sanofi
2.45 Interactive Solution Finding Session: Executive a
Robust Drug-CDx Strategy
Debate and Discuss:
 How do we define meaningful progress with drugCDx combinations?
 Are we moving too fast or too slow in this field?
 How does this tie in with the wider context of
complete personalised healthcare?
David Jackson, Vice President, Diagnostics & Companion
Diagnostics, Arno Therapeutics
Abderrahim Mahfoudi, Senior Director, Scientific
Partnerships & Coordination, Sanofi
Afternoon Refreshments & Networking
Maximising the Potential of Drug-CDx Combinations
If you have any comments regarding this draft please contact [email protected]
THIS IS A CONFIDENTIAL DRAFT DOCUMENT.
DRAFT DOCUMENT – FINAL COPY TO REFLECT REAL CASE STUDIES
3.45 What Does the Future of the Companion Diagnostic Industry Look Like?
 How and where should be focusing our efforts to help ensure success?
 A summary of what the field has learnt from successful and unsuccessful drug-CDx case studies
Companion Intelligence and Survey Statistics
 Industry insight from virtual survey results collected throughout the meeting around the biggest challenges and
opportunities with drug-companion diagnostic combinations
 These results will ONLY be available in this session and will provide you with quantitative measurements about
how the rest of your companion colleagues view the field
4.45 Chairman’s Closing Remarks
David Jackson, Vice President, Diagnostics & Companion Diagnostics, Arno Therapeutics
If you have any comments regarding this draft please contact [email protected]
THIS IS A CONFIDENTIAL DRAFT DOCUMENT.
DRAFT DOCUMENT – FINAL COPY TO REFLECT REAL CASE STUDIES
Conference Workshop, 17th March 2015
A Comprehensive Guide to the Major Regulatory Landscapes
The regulatory approval process for drug-companion diagnostic submission truly is a global issue and continues to
plague both sides of the field.
Leave this workshop with:
 A comprehensive understanding of the major drug-CDx regulatory landscapes
 Clear guidelines on how to deal with the major challenges and updates that are currently being experienced
 Detailed insight from successfully approved drug-CDx combinations and what the field has learnt to take
forward
Martina Kaufmann, Managing Director, Martina Kaufmann Strategic Consulting
Conference Workshop, 17th March 2015
Construction of Companion Diagnostics Departments within Pharma & Diagnostic Organisations
Companion diagnostics development requires a close interaction and full transparency between pharma and
diagnostic partner
Leave this workshop with:
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A comprehensive understanding of the requirements for setting up and running of effective companion
diagnostic departments
Full appreciation of the other side of the drug-CDx partnerships from where you currently operate
Insights from successful case studies which have taken drug-CDx combinations to market
David Jackson, Vice President, Diagnostics & Companion Diagnostics, Arno Therapeutics
If you have any comments regarding this draft please contact [email protected]
THIS IS A CONFIDENTIAL DRAFT DOCUMENT.