2nd Annual Lifescience R&D Big Data Leaders Forum

BIG DATALEADERS FORUMRad i s son B lu Hote l , Be r l i n , Ger many

December 11-12th, 2014

5 EVENTS IN ONE:

Hear keynote presentations from the experts:

with more than 42 presentations from life science Big Data & clinical data leaders

Patrice P. Denèfle, Ph.D HDR, CEDEP-INSEADSenior Partner & Co-founderMedBioMix Partners, France(Former: SVP, Digital & Translational Sciences, Ipsen, France)

Paul GrantChief Innovation OfficerCreation Healthcare, UK

Tero LaulajainenRPD Global Head of Clinical OperationsRoche Diagnostics International Ltd., Switzerland

Prof. Diederick Grobbee, Project CoordinatorInnovative Medicines Initiative –“GetReal” project, Professor of Clinical Epidemiology, University Medical Center Utrecht, Netherlands

William ReinholdHead of the Genomics and Bioinformatics GroupNIH/NCI, USA

Dr. Johann ProeveGlobal Development & Strategy Advisor in Global Data Sciences & AnalyticsBayer Healthcare, Germany

Dr. Michel Mikhail, Chief Regulatory Officer & Executive Vice President Global Regulatory - Governmental RelationsFresenius Kabi, Germany

DAY 1: STRATEGIC DEVELOPMENTS IN BIG DATA MANAGEMENT TO ENHANCE R&D

Day 2 - Stream 1:LEVERAGING DISCOVERy & TRANSLATIONAL BIG

DATA TO ENHANCE INNOVATION

Day 2 - Stream 2:ENHANCING DECISION-MAKING THROUGH

EFFECTIVE CLINICAL DATA MANAGEMENT

Day 2 - Stream 3:UTILISING BIG DATA TO ACHIEVE REAL-WORLD

HEALTH OUTCOMES & PATIENT INSIGHTS

Day 2 - Stream 4:BIG DATA INFRASTRUCTURE & SySTEM DESIGN LEADERS FORUM

LIFESCIENCE R&D- 2ND ANNUAL -

Pharma & Biotech IndustryWilliam Daley, Vice President, Business Development & Licencing, NA Medical Affairs, Sanofi, USA

Tero Laulajainen, RPD Global Head of Clinical OperationsRoche Diagnostics International Ltd., Switzerland

Dr. Michel Mikhail, Chief Regulatory Officer & Executive Vice President Global Regulatory - Governmental RelationsFresenius Kabi, Germany

Nigel Hughes, Global Director, Marketing & Health Information TechnologyJanssen Diagnostics BVBA

Prof. Theo Meert, PhD., Senior Director External Innovations Discovery Sciences, Janssen Pharmaceutica, J&J, Netherlands

Sheng FengPrincipal Biostatistician, Non-Clinical & Translational BiostatisticsBiogen Idec, USA

Jan Breemans, Senior Director, Head Global Data ServicesGrunenthal, Germany

Siegfried Roesch, Director Clinical OperationsBavarian Nordic, Germany

Jon Porter, Associate Director Data Management, AstraZeneca, UK

Ingeborg CilSenior Manager, Clinical Data ManagementBaxter BioScience, Austria

Athula Herath, Statistical DirectorMedimmune (AstraZeneca Biologics), UK

Carlo Barbieri, Senior Manager Healthcare and Business Advanced Modeling EMEALA, Fresenius Medical Care, Italy

Simone Breitkopf, Head Governmental and Public Affairs Pricing and ReimbursementAlcon Laboratories, Germany

William Hayes, CTOSelventa, USA

Daniel Crowther, Department Head for Structure Design & InformaticsSanofi, Germany


Elia StupkaDirector, Computational BiologyBoehringer Ingelheim, Germany

Daniel ZiemekDirectorPfizer, Germany

Dr. Adam Baker, PhD., Head of HND DiscoveryChr. Hansen, Denmark

Nils WeskampPrincipal Scientist, Computational ChemistryBoehringer Ingelheim, Germany

Annemarie Voortman, Principal Data ManagerAstellas, Netherlands

Jennifer Park, Associate Director, ResearchSelventa, USA

Innovative Start-upPatrice P. Denèfle, Ph.D HDR, CEDEP-INSEADSenior Partner & Co-founderMedBioMix Partners, France(Former: SVP, Digital & Translational Sciences, Ipsen, France)

Paul Grant, Chief Innovation OfficerCreation Healthcare, UK

Dr. Thomas Wilckens, Chief Executive Officer, CSO & Founder, InnVentis, Germany

Gunther Weber, CTODeep Innovation, Germany(Former CTO, Vodafone, Germany)

Prof. Chris Baker, University of New Brunswick, CEO, IPSNP Computing Inc., Canada

Prof. Bruno Sobral, Founding Executive and Scientific Director, Virginia Bioinformatics Institute at Virginia Tech, Assistant VP and Head of BioSystems Informatics and Computational Microbial Ecology, Nestle Institute of Health Sciences, Switzerland

Government & Academic Research InstitutesProf. Diederick Grobbee, Project CoordinatorInnovative Medicines Initiative –“GetReal” project, Professor of Clinical Epidemiology, University Medical Center Utrecht, Netherlands


Prof. Corrado Priami, President and CEO, COSBI (Centre for Computational & Systems Biology)Professor of computing, University of Trento, Italy

Dr. Salome Scholtens, Manager Research Office, LifeLines, Netherlands

Dr. Stephan Pabinger, Scientist,AIT - Austrian Institute of Technology, Austria

Dr. Ola SpjuthHead of Bioinformatics Compute and StorageScience for Life Laboratory, Sweden

Prof. Marc Cuggia, University Professor and Hospital Practitioner (PUHP), University of Rennes, France (TBC)

Prof. Massimo Massi Benedetti, President and Scientific Director, Hub for International health ReSearch HIRS, Senior Program Advisor, IDF, Italy

Ronald P. Stolk, MD PhD, Professor of Clinical Epidemiology; Head of Department Chief Scientific Officer, LifeLines, Department of Epidemiology, University Medical Center Groningen, Netherlands

Joseph Giuliano, Director Clinical Operations, CHDI Foundation, USA

Rick Stevens, Associate Laboratory Director for Computing, Environment and Life Sciences, Argonne National Laboratory, USA

Expert Solution ProvidersDr. Arnd Kohrs, Director of Technical SalesDACH & CEE, Aspera, UK

Hans Martens, Senior IT and Equipment Compliance ConsultantRescop, Netherlands

Birgit Ehlken, ManagerIMS Health, Germany

Vienna, Austria May 6th- 8th 2013Day 1: Achieving Regulatory & Payer-Determined EndpointsDay 2 & 3 Streams: Stream 1: Oncology Health Outcomes & Market Access Measuring & demonstrating enhanced value for oncology medicationsStream 2: Achieving Quality of Life Endpoints Quantifying & determining value for patient-centric health outcomes

SPRING

Speaker sOver v iew

Event Partners:


SPRING

Event Over v iew

Target Audience:Senior executives of pharmaceutical, biotech, medical device companies, academia & government Research Institutes including:Heads of R&D, Chief Scientific Officers, Chief Information Officers, Chief Technology Officers, Knowledge & Data Management (Discovery, Clinical & Real-World Data), R&D Analytics, Informatics, R&D Innovation, External Alliances & Innovation, R&D Strategy.Also: VPs Directors & Senior Managers involved in:Stream 1: Drug Discovery, R&D, Lead Identification & Target Validation, Screening, Translational R&D, Genomics & Proteomics, Biomarker R&D, Senior Scientist, Biostatistics, Biometrics.Stream 2: Clinical Development, Clinical Data Management, e-Clinical, Electronic Data Management.Stream 3: Health Economics & Outcomes Research, Real-World Evidence Generation, Late-Phase Research, Epidemiology, Drug safety & Pharmacovigilance, Medical Information.Stream 4: Information Technology & Services, R&D IT, IT Hardware & Infrastructure, Software, Database Management.

Event Structure:DAY 1 DAY 2

Strategic Developments in Big Data Management to Enhance R&D

Stream 1:Leveraging

Discovery & Translational

Big Data to Enhance Innovation

Stream 2:Enhancing Decision-Making through Effective

Clinical Data Management

Stream 3:Utilising

Big Data to Achieve Real-World Health Outcomes &

Patient Insights

Stream 4:Big Data

Infrastructure & System Design

Leaders Forum

Event Overview:Big Data in the life sciences sector is now a strategic and operational issue for almost all stakeholders. Capturing, storing, data flow and analysis of information-rich processes affect all aspects of the pharmaceutical and medical device industries but particularly the discovery, research & development stages.

Companies who can exploit big data and advanced analytics in developing new products will have the potential to improve their competitiveness, productivity & efficiency of research and clinical trials in order to better demonstrate clinical benefit and health outcomes to researchers, internal stakeholders, physicians, consumers, insurers, and regulators to meet the promise of more informed decision-making.

The potential for Big Data to drive forward the anticipated era of personalised & precision medicines makes it an essential part of any life science organisation. In order to realise these potential benefits, a strategic shift towards big data and data-driven approaches must be implemented from senior managers and thoroughly rolled-out across the organisation.

This 2 day forum is the “must attend” event for those senior decision-makers looking to make the shift towards big data and for those looking to improve their implementation of data-driven approaches for their specific departments.

The first day will feature several keynote presentations from C-Level thought leaders on big data in the R&D space and heads of major research institutions who are at the front-end of the big data challenge. They will be discussing the strategic drivers for big data and key implementation guidance on how to make best use of this approach.

Day 2 of the Forum will feature 4 specific streams depending on the phase of R&D that is most crucial for you.

1. Leveraging Discovery & Translational Big Data to Enhance Innovation – This 1.5 day stream will focus on data driven approaches in the drug discovery process and the Why & How of implementing big data approaches including genomic & personalized medicines and innovative approaches to using big data in drug discovery & translation to clinical stages.

2. Enhancing Decision-Making through Effective Clinical Data Management – This 2 day stream will feature best practice case studies of designing, collecting & managing clinical stage data from experts in the field. Specific interest will be paid to selecting EDC technologies and working models of outsourcing DM responsibilities whilst retaining control over data quality.

3. Utilising Big Data to Achieve Real-World Health Outcomes & Patient Insights – Real-world big data has typically been used for drug safety & surveillance for regulators in post-marketing, but now with greater need for understanding product health outcome benefits for regulators, payers & other stakeholders, the amount of data to be collected and managed has massively increased. This stream will give examples of how to make sense of the requirements and processes to execute this vital function.

4. Big Data Infrastructure & System Design – One of the key barriers to executing a big data strategy in Life Sciences is often the how question as this defines timelines and budget impact of the shift to a big data approach. This one day focused stream will address the implementation aspects of Big Data in the modern life sciences organisations using case study examples form executives who have fought the battles you are about to, and have learnt the lessons (technical, budgetary and cultural) that need to be learnt to do this successfully.


SPRING

Event Str ucture

Day 1There is a widely held opinion across the life sciences industry that the current model for drug development is failing. Potential candidates often fail pharmacological requirements before they even reach the Phase 3 clinical trials. According to many experts, the Big Data could potentially solve some of these issues in the drug discovery.

Strategic Developments in Big Data Management to Enhance R&D Forum will bring together, life sciences, pharmaceutical, informatics, IT professionals as well as leading academics and other innovation leaders from across the globe. The main focus will be on the Big Data and its future role in improving human health with discoveries and advancements in information technology, data processing, analytics, genomics, molecular diagnostics and translational informatics that have a direct or indirect impact on improving the efficiency of clinical research, healthcare delivery and drug discovery.

This one day event will feature C-Level thought leaders from Pharma, Biotech, Academic & Government Research institutions who will discuss where Big Data is going and what it will take for the industry to get to that destination, from a technical, structural and corporate culture perspective.

Day 2 (Streams): One of the key barriers to executing a big data strategy in Life Sciences is often the how question as this defines timelines and budget impact of the shift to a big data approach. This one day focused stream will address the implementation aspects of Big Data in the modern life sciences organisations using case study examples from executives who have fought the battles you are about to, and have learnt the lessons (technical, budgetary and cultural) that need to be learnt to do this successfully. Common challenges in this space include designing & architecture of large scale (large capacity & large throughput) data infrastructure, which will support innovation from the R&D facing job roles, not set limits and boundaries on these staff. Also the analytics used, such as text/data analytics, visual analytics, analysis and mining software need to be addressed. The human aspects including internal customer support and issues like taxonomies & naming conventions to enable cross-referencing and searchability within data libraries need to be considered proactively, not as an afterthought which would create more time and budget pressure. This one day stream will address the architecture and implementation of big data infrastructure and will provide all participants the chance to benchmark, learn from the case studies presented, ask questions and take away vital learning points to make big data an affordable, achievable reality in their life science context.

11th December, 2014DAY 1 -08.30 Registration & Coffee 09.00 Chairperson’s Opening Remarks:

STRATEGIC DRIVERS & CHALLENGES FOR BIG DATA IN LIFE SCIENCES

09.10 Strategic shifts towards Big Data – requirement of de- compartmentalizing the data silos in a modern pharma or life science organization

❖ Expanded use of legacy, epidemiological and real-world data. ❖ Explaining the full value of Big Data in terms of possible use to

improved predictive models. ❖ Examples of successful private/public collaborations.

Patrice P. Denèfle, Ph.D HDR, CEDEP-INSEAD, Senior Partner & Co-founderMedBioMix Partners, France (Former: SVP, Digital & Translational Sciences, Ipsen, France)09.50 From Big DATA to PRECISION MEDICINE: A disruption in biopharmaceutical R&D

❖ Challenges: Why SOPs are essential and a key value driver. ❖ Personal Molecular Fingerprints: Changing discovery & clinical

development via longitudinal data sampling. ❖ New business models deriving from the disruption.

Dr. Thomas Wilckens, Chief Executive Officer, CSO & Founder, InnVentis, Germany10.30 How “Dark Data” is preventing your company from informed decision makingIn an age where processing power and storage capacity are no longer barriers to data analysis, it is nonetheless easier to acquire and store data than to make sense of it. Within our companies, oftentimes we “...don’t know what we know”, with silos of information residing in different business functions; unseen and under-utilised. In this session

❖ Exploring techniques for realising the potential of “dark data”. ❖ Demonstrating how historical and ongoing analysis of

joined up data sets can provide actionable insights to inform commercial strategies and decision making.

Paul Grant, Chief Innovation Officer, Creation Healthcare, UK

11.10 Networking & Coffee Session

11.30 Utilising Big Data for various phases of research – global diagnostics company perspective

❖ Establishing and implementing big data into every stage of product development.

❖ Real life examples of successful implementation.


12.10 The impact of big data on the development of healthcare solutions in large pharma

❖ Translational research / systems biology / high content approaches in drug discovery.

❖ Real world data and medicines adaptive pathways to patients.


12.50 Luncheon Break

14.00 The use of big data in the early discovery research ❖ Example of disease stratification using electronic medical

records, model based drug development and data integration for target discovery.

Daniel Crowther, Department Head for Structure Design & InformaticsSanofi, Germany

14.40 The use of EHR in clinical trials – long-term future challenges and opportunities

❖ Protocol feasibility. ❖ Patient and site identification. ❖ Study conduct. ❖ The challenges and potential benefits.


PUBLIC PRIVATE PARTNERSHIPS TO MAKE BETTER USE OF DATA AND KNOWLEDGE

15.20 Public private partnerships to make better use of data and knowledge

❖ The efficiency of the medicine development process will be improved by better incorporating estimates of relative effectiveness.

❖ There are several sources of real life data, including “big data” comprising health care and individual patient information, and pragmatic randomized trials.

❖ Aspects of real life evidence in drug development will be discussed in relation the IMI project “GetReal”.



16.20 The COSBI case: a private-public partnership between Microsoft Research and University of Trento - pros and cons

❖ Technology development and research in a semi-academic or semi-company environment.

❖ Research activities in a truly-multidisciplinary, international, result-driven environment.

❖ Some examples of data analysis and integration.


17.00 LifeLines: do health companies benefit from a large population-based study?

❖ LifeLines is a huge population based study focusing on healthy ageing.

❖ Data and samples are available for public and private researchers.

❖ Why industry do and why they do not collaborate.


17.40 Panel Discussion: What challenges need to be overcome to take Big Data to the next level of R&D & innovation?

❖ How is Big Data going to impact the healthcare and R&D as we know it today?

❖ How can Big Data management at a strategic level instill a Big Data “culture” enterprise-wide? What remains to happen at an individual company level?

❖ Are open-sourcing initiatives and big data collaborations the answer for this?

❖ Which elements are as yet unsatisfied from a technology point-of-view to make Big Data a reality?

Patrice P. Denèfle, Ph.D HDR, CEDEP-INSEAD, MedBioMix Partners, France (Former: SVP, Digital & Translational Sciences, Ipsen, France)

Paul Grant, Creation Healthcare, UK

Dr. Johann Proeve, Bayer Healthcare, Germany

Tero Laulajainen, Roche Diagnostics International Ltd., Switzerland

Daniel Crowther, Sanofi, Germany

Prof. Theo Meert, PhD., J&J, Netherlands

Prof. Diederick Grobbee, IMI-Get Real & University Medical Center Utrecht, Netherlands

Prof. Corrado Priami, University of Trento, Italy

Dr. Thomas Wilckens, InnVentis, Germany

18.20 Chairperson’s Closing Remarks 18.30 End of Day One

STRATEGIC DEVELOPMENTS IN BIG DATA MANAGEMENT TO ENHANCE R&D

19:30 - Exclusive Complimentary Networking Dinner for all event participants

08.30 Registration & Coffee 09.00 Chairpersons Opening Remarks:

UNLOCKING THE POTENTIAL OF NGS FOR THE FUTURE OF PERSONALIZED MEDICINE

09.10 Can we exploit the power of NGS to move towards personalized medicine?

NGS is becoming common place in a clinical environment. Generating data, however, is only the tip of the iceberg. A talk on successes, failures and challenges ahead if we want to turn NGS into the holy grail of “personalized medicine”


INNOVATIVE APPLICATION OF BIG-DATA IN DATA-DRIVEN DRUG DISCOVERy

09.50 Retrospective mining of failed drug data to generate new hypotheses for future drug investigation

❖ Introduction of the CellMiner datasets and software. ❖ Identification of candidate genetic variants that affect pharmacology. ❖ The identification of pharmacologically important molecular parameters

from drug activities. ❖ The identification of candidate treatments from molecular data. ❖ The use of preexisting data to identify therapies based on cancer-types:

drug repurposing.

William Reinhold, Head of the Genomics and Bioinformatics GroupNIH/NCI, USA

10.30 Distilling big experimental data into actionable drug discovery

❖ Next generation sequencing provides large-scale genetics and transcriptional data on population cohorts, model systems, and clinical patients.

❖ Established biomedical facts, company-internal screening data, and hypothesized interplay among molecular entities also grow continuously and constitute “big data” sets.

❖ I will give examples from Pfizer research demonstrating the use of intelligent algorithms to combine big data sets to address target discovery, safety liabilities and the search for precise biomarkers.

Daniel Ziemek, DirectorPfizer, Germany


11.40 Systematic screening approaches and Big Data enable accelerated commercial development of next generation microbes beneficial to human health

❖ Developing the Technology platforms we use to screen next generation microbes for commercial use.

❖ Using the power of Big data to support research and commercial upscale of microbes.

Dr. Adam Baker, PhD., Head of HND DiscoveryChr. Hansen, Denmark

12.20 Leveraging a company’s knowledge base to stimulate drug discovery innovation

❖ How to transfer knowledge from a past project to enhance the new ones.

❖ The importance of Big Data quality and integrity. ❖ Generating predicative models.

Nils Weskamp, Principal Scientist, Computational ChemistryBoehringer Ingelheim, Germany


DEALING WITH MASSIVE SETS OF UNSTRUCTURED AND STRUCTURED DATA, TO ACHIEVE INSIGHTS TO ENHANCE DECISION

MAKING

14.00 Utilizing Big Data, focusing specifically on two phases of research, i.e. discovery, translational

Since 2005, the longitudinal Alzheimer’s Disease Neuroimaging Initiative (ADNI) study has been validating the use of biomarkers for Alzheimer’s disease clinical trials and diagnosis. ADNI data, with at least 100 Terabits in size, is recognized as one of the largest “BIG DATA” generated in medicine. In this presentation, I will illustrate how we at Biogen Idec have used ADNI data in translational medicine studies to assist the design of a hypothesized phase 3 clinical trial. Statistical analyses, simulations and models have been applied and developed to evaluate the translatability of genetic, protein and imaging biomarkers in a typical trial under various designing scenarios. We have concluded that BIG DATA, such as ADNI, is very useful in assisting the design of a future clinical trial with appropriate questions.

Sheng Feng, Principal Biostatistician, Non-Clinical & Translational Biostatistics, Biogen Idec, USA

14.40 Cloud-enabled framework for data storage and analysis of large scale NGS discovery & screening experiments

❖ Development of a technological platform for housing & storing your big data.

❖ “App store” concept for integrating analysis modules. ❖ Pipeline for investigation of Next Generation Sequencing results.

Dr. Stephan Pabinger, Scientist, AIT - Austrian Institute of Technology, Austria15.20 Networking & Coffee Session

15.40 Designing a future infrastructure to cope with clinical sequencing and other sensitive data on a nation-wide scale

❖ Strategic infrastructure design for managing and analyzing Big Data of sensitive nature.

❖ Translating resources and competence in sequencing from academia to clinical applications.

❖ The importance of workflows to support translational science on Big Data.

Dr. Ola Spjuth, Head of Bioinformatics Compute and StorageScience for Life Laboratory, Sweden

16.20 Enhancement of biological networks using a Web-Based Collaboration Interface

❖ Construction and application of biological network models as an approach that offers a holistic way to understand biological processes involved in disease.

❖ Crowdsourcing approach as a new form of collaboration for researchers to review biological findings, and can be applied for the construction and verification of complex biological networks.

❖ Reputation-based collaborative network biology platform - Bionet.Jennifer Park, Associate Director, Research, Selventa, USA17.00 Panel Discussion: Innovative application of Big Data in data- driven drug discovery

❖ Next-generation sequencing, proteomic & genomic big data – as a source of developing new Biomarkers & personalized medicines - How do we deal with the data bottleneck?

❖ How can strategic collaborations advance data-driven drug discovery? ❖ Which advanced technological methods will be shaping the future of

Big Data? ❖ What impact will high-performance computing have on drug discovery

and translational science?

Elia Stupka, Director, Computational Biology, Boehringer Ingelheim, Germany

William Reinhold, Head of the Genomics and Bioinformatics Group, NIH/NCI, USA

Dr. Adam Baker, PhD., Head of HND Discovery, Chr. Hansen, Denmark

Daniel Ziemek, Director, Pfizer, Germany

Nils Weskamp, Principal Scientist, Computational ChemistryBoehringer Ingelheim, Germany

17.40 Chairperson’s Closing Remarks17.50 End of Day Two - Stream 1

12th December, 2014 - Stream 1DAY 2

LEVERAGING DISCOVERY & TRANSLATIONAL BIG DATA TO ENHANCE INNOVATION

08.30 Registration & Coffee 09.00 Chairpersons Opening Remarks

SELECTING & IMPLEMENTING CDM SySTEMS IN BIG PHARMA

09.10 Innovative application of new processes/technology in your CDM system

❖ Implementing and rolling out a CDM system. ❖ Developing both internal and external CDM strategies.

William Daley, Vice President, Business Development & Licencing, NA Medical Affairs, Sanofi, USA

09.50 Case study: Upgrading the clinical data warehouse

Jan Breemans, Senior Director, Head Global Data ServicesGrunenthal, Germany

10.30 Data integration in clinical trials using source data from different databases

❖ Different source data and databases used in a clinical trial. ❖ Transfer and integration of these different data in one clinical data

base. ❖ Pitfalls and lessons learned from these data transfers and

reconciliations.

Siegfried Roesch, Director Clinical Operations, Bavarian Nordic, Germany


11.40 Streamlining Clinical Data Management processes, such as Database build, Data Cleaning and Data Review and Database Lock activities to deliver efficiency and reduce timelines while still delivering quality data

From experiences in the past it was felt that more streamlining of the Clinical Data Management processes was desired to deliver efficiency and reduce timelines without jeopardizing the data quality. This was done by examining the path data takes from idea generation through collection and reporting, incorporating standards and quality for all relevant attributes (the why, when, how and for what purpose?) of data, to optimize our Clinical Data Management processes by

❖ Creating core documents earlier in study development, like, i.e. to start creating eCRF specifications at the time of synopsis and to have a SAP in place prior FPI.

❖ Reducing redundancies in the process, by defining, i.e. at the start of the study the roles and responsibilities per discipline for who is responsible for which data to check, like medical reviewer versus data management.

❖ Building in efficiency and automation by making effective use of the our system’s functions, as it was seen that we were not using them in the most effective way.

Annemarie Voortman, Principal Data Manager,Astellas, Netherlands

ENSURING HIGH qUALITy, REGULATORy COMPLIANCE AND qUALITy ASSURANCE

12.20 Clinical trials disclosure in Europe ❖ Release of Data from Clinical Trials, Proactive publication of data

by EMA. ❖ Publication and Access to Clinical Trial Data : - Open Access (O);

- Controlled Access (C) - May contain Commercially Confidential Information (CCI) European Medicines Agency POLICY / 0070.

❖ Open Clinical trial Data from all - View from regulators: Pros, Cons, and the Way Forward.

Dr. Michel Mikhail, Chief Regulatory Officer & Executive Vice President Global Regulatory - Governmental Relations, Fresenius Kabi, Germany


STRATEGIC CLINICAL DATA MANAGEMENT PARTNERSHIPS & OUTSOURCING

14.00 Obtaining value from DM outsourcing partnerships

❖ Elements to the business case. ❖ Governance oversight and issue escalation. ❖ Measuring performance. ❖ Continual improvement.


14.40 How to maintain the right level of oversight and adherence to Sponsor standards with outsourcing partners - a case study from the CDISC angle

❖ Defining and communication expectations - depending on the outsourcing approach.

❖ Monitoring quality of deliverables. ❖ Challenges and lessons learned.

Ingeborg Cil, Senior Manager, Clinical Data ManagementBaxter BioScience, Austria


EFFECTIVE USE OF ALREADy GENERATED CLINICAL DATA TO SUPPORT FUTURE DRUG DEVELOPMENT

15.40 Reusing EHR data for clinical research with clinical data warehouses: myth and reality

Prof. Marc Cuggia, University Professor and Hospital Practitioner (PUHP), University of Rennes, France (TBC)

16.20 Panel Discussion: Effective use of CDM strategies in controlling large data sets

❖ What are the criteria you should take in to consideration when selecting appropriate Clinical Trials Management System?

❖ What are the CDM issues most likely to arise with large data? ❖ How to prepare your clinical teams to provide efficient data delivery? ❖ How to minimize risk when deciding on CDM outsourcing strategies?


William DaleyVice President, Business Development & Licencing, NA Medical AffairsSanofi, USA

Siegfried RoeschDirector Clinical OperationsBavarian Nordic, Germany

Jan BreemansSenior Director, Head Global Data ServicesGrunenthal, Germany

17.00 Chairperson’s Closing Remarks 17.10 End of Day Two - Stream 2


ENHANCING DECISION-MAKING THROUGH EFFECTIVE CLINICAL DATA MANAGEMENT

08.30 Registration & Coffee09.00 Chairperson’s Opening Remarks:

ExAMINING THE ROLE OF RWD AND OUTCOMES DATA IN DECISION MAKING

09.10 Strategic drivers impacting post-marketing studies and data generated by this type of research

❖ How will the new FDA regulation affect the future design of post-marketing studies carried out by diagnostic companies.

❖ What possible solutions are out there? ❖ Possibilities to outsource PMS, is the CRO sector ready?

Tero Laulajainen, RPD Global Head of Clinical Operations, Roche Diagnostics International Ltd., Switzerland

09.50 Target drug development: How can real-world and clinical data help pharma companies’ better target future drug design and development

❖ BigData for total evidence synthesis at population level using patient-level outcomes of real-world healthcare data, clinical studies and observational studies.

❖ Ensemble outcome modelling of efficacy and safety outcomes of disease populations and Statistical landscaping of therapeutic effects.

❖ Utilising the landscape for stratification of patient populations for targeted therapy development.

❖ Statistical engineering of therapeutic entities with some examples.

Athula Herath, Statistical Director, Medimmune (AstraZeneca Biologics), UK

10.30 How to implement a Real World Big Data predictive modeling department into the overall strategy to enhance decision making

❖ Get the know how. ❖ Qualify in the scientific community. ❖ Short term result: some examples. ❖ Scale it.

Carlo Barbieri, Senior Manager Healthcare and Business Advanced Modeling EMEALA, Fresenius Medical Care, Italy


GOOD DATA GOVERNANCE PRACTICES: PRIVACy LAWS AND DATA PROTECTION

11.40 Complying with country-specific regulations set for privacy laws and data protection while getting the most out of your data

❖ Uncovering how to legally collect and process health information.

❖ Considering patient privacy issues in data mining and overcoming challenges in order to make patient data more accessible across multiple platforms.

❖ Implementing physical security procedures in order to keep data confidentiality under control and comply with country specific privacy laws.

❖ Transferring data more efficiently while ensuring data privacy. ❖ Avoiding breaches from offsite location(s) through setting

up the right objectives for long term privacy strategies and encrypting data.

Hans Martens, Senior IT and Equipment Compliance Consultant, Rescop, Netherlands


UNLOCKING THE POTENTIAL OF ANONyMIZED ELECTRONIC HEALTHCARE RECORDS, REGISTRIES AND

LARGE POPULATION BASED STUDIES13.30 The massive EUROBIROD registry to understand specific unmet needs in diabetes sub-populationsProf. Massimo Massi Benedetti, President and Scientific Director, Hub for International health ReSearch HIRS, Senior Program Advisor, IDF, Italy

14.10 European biobanking: joining population based studies to one real Big Database

❖ Solutions for data harmonization. ❖ Advantages of comparative effectiveness analyses. ❖ Transnational access to data and samples.

Ronald P. Stolk, MD PhD, Professor of Clinical Epidemiology; Head of Department Chief Scientific Officer, LifeLines, Department of Epidemiology, University Medical Center Groningen, Netherlands14.50 Using real world data to inform protocol design and feasibility for clinical trials

❖ Lessons learnt from a global observational registry study of Huntington’s Disease.

❖ Real world data can improve protocol design, speed site feasibility and increase recruitment rates in clinical trials.

Joseph Giuliano, Director Clinical Operations, CHDI Foundation, USA15.30 Networking & Coffee Session

HARMONIZING THE BIG DATA TO THE REqUIREMENTS OF INTERNAL AND ExTERNAL STAKEHOLDERS

15.50 Ensuring RWE & health outcomes data are correctly designed and appropriate for each stakeholder’s requirements

❖ Data has a lifecycle of its own, temporal and across an organization, and a lifecycle plan should take into account different stakeholder needs.

❖ Important to understand and develop the quid pro quo with each stakeholder to understand and respond to their needs with regards to data access.

❖ Stakeholders have varied challenges in terms of access, aggregation and analysis of real world data, which need to be understood and mitigated.

Nigel Hughes, Global Director, Marketing & Health Information Technology, Janssen Diagnostics BVBA16.30 Real world evidence to meet regional payers’ requirements

❖ Different sources and different objectives of real world data. ❖ Acceptance of RWE for healthcare decisions in Germany. ❖ Availability of insurance data for pharmaceutical industry in

Germany.

Simone Breitkopf, Head Governmental and Public Affairs Pricing and Reimbursement, Alcon Laboratories, Germany

17.10 The use of electronic medical records in PAES and PASSBirgit Ehlken, ManagerIMS Health, Germany

17.40 Panel Discussion: Strategic drivers for RWD and Health Outcomes Data management

❖ Examining the role of evidence and outcomes data in decision making now and in the future.

❖ How can real-world evidence help pharma companies better target future drug design and development or where potential drug – drug combinations and patent-extension opportunities may exist.

❖ Using Real World Big Data to understand the drug profile and outcomes (effectiveness) in real world use Vs clinical studies performed (efficacy) in development.

Tero Laulajainen, RPD Global Head of Clinical Operations, Roche Diagnostics International Ltd., Switzerland

Athula Herath, Statistical Director, Medimmune (AstraZeneca Biologics), UKCarlo Barbieri, Senior Manager Healthcare and Business Advanced Modeling EMEALA, Fresenius Medical Care, Italy


Simone Breitkopf, Head Governmental and Public Affairs Pricing and Reimbursement, Alcon Laboratories, Germany

18.20 Chairperson’s Closing Remarks

18.30 End of Day Two - Stream 3


UTILISING BIG DATA TO ACHIEVE REAL-WORLD HEALTH OUTCOMES & PATIENT INSIGHTS

08.30 Registration & Coffee09.00 Chairperson’s Opening Remarks:

TECHNOLOGIES AND APPLICATIONS FOR MANAGING AND SHARING BIG DATA

09.10 Big Data Federation: query of multiple heterogeneous and distributed sources of data as a single database.

❖ State-of-the-art approaches to data integration; data warehousing and workflow scripting are limited in scope, brittle and poorly reusable, and depend on highly trained technical staff for their efficient use. Data federation based on SADI semantic web services is a significant and cost effective alternative technology offering interoperable access to life science data.

❖ IPSNP’s HYDRA is a SPARQL engine for querying SADI Web Services. Based on a scalable proprietary architecture, algorithms and data structures HYDRA enables non-technical users to run multiple “self-service” and “ad hoc” queries over networks of web services.

❖ Combined with graphical query composition end users can now formulate queries in the terminology of their life science domain, without knowing how the underlying data is structured or specific mechanisms of access to the data and thereby perform complex knowledge discovery tasks.

❖ Multiple use cases in Microarray, Genome Annotation, Lipidomics, and Clinical Intelligence, illustrate the flexible rapid prototyping made possible with SADI and HYDRA for online or enterprise scale data integration.


09.50 Building the Systems Biology Knowledgebase

❖ The development of the Systems Biology Knowledgebase (KBase), a large-scale development project led by Argonne, Berkeley, Brookhaven and Oak Ridge National Laboratories and Cold Spring Harbor Laboratory and multiple university partners.

❖ Integrating data from many existing sources, building tools and services that support complex workflows enabling genome-scale modeling, reconciling experimental data with computational predictions, and providing a large-number of computational services that go beyond existing integrated biological databases.

❖ KBase is deployed on a purpose-built infrastructure spanning multiple laboratories that collectively house many petabytes of data, and support scalable computing resources on both cloud and cluster environments.


10.30 New Cloud-Based workflows power global life science innovation: Bridging Enterprise and Cloud Infrastructure for Effective Global Collaboration in Genomic Research

❖ Trends. ❖ Big data transport challenge. ❖ Aspera technology and solutions. ❖ Use Cases and examples in life sciences (Collaborative File

Sharing, Bulk Data Ingest & Cloud-to-Cloud Data Transfer, High Performance Synchronization).

Dr. Arnd Kohrs, Director of Technical Sales, DACH & CEE, Aspera, UK


11.40 Cookbook for implementing Big Data Systems in networked environments

Current systems for big data analytics in lifescience are typically closed islands. In the future, these systems will be open distributed systems. Reasons for that are i.a: multiple locations for data capture, sharing of data across institutions, distributed storage of enormous amounts of data and access to dedicated data processing centers. While creating exciting opportunities for R&D in lifescience, the implantation and operation of those systems bears some challenges and complexities. Key element for any design of a system and its operation is the protection and the integrity of the data, the most valuable and most endangered component in big data in lifescience. Various aspects to be considered in implementing such a system will be discussed, such as:

❖ Identity management of patients and personel. ❖ Anonymisation strategies. ❖ Data storage and management strategies. ❖ Anomalities management..

Gunther Weber, CTO, Deep Innovation, Germany (Former CTO, Vodafone, Germany)

12.20 A reputation-based crowd-sourced Peer Review Platform for network biology

❖ The Network Verification Challenge: New approach to make capturing large-scale network biology and validating possible.

❖ The web application is built upon the latest web technologies and uses AngularJS and Twitter Bootstrap for the front-end development and a NoSQL database backend.

❖ Benefits to the project of using these technologies and why they were selected for the project.

William Hayes, CTO, Selventa, USA


USING BIG DATA ANALyTICS TO ENHANCE THE DECISION MAKING PROCESS

14.00 Systems Science and Health ❖ We live in a time of rapidly changing environments and also in

a time where data generation has become significantly cheaper than data analysis/utilization. The trend is general, especially with unstructured data. Structuring data adequately is unaffordable. This is an unprecedented trend – one that life scientists have never faced before.

❖ Decision-making – using such data as input – is increasingly interwoven with the data itself.

❖ Despite the existence of an unprecedented amount of data, there is actually not enough to be purely data-driven in most cases and interdependency of data matters (a lot).

❖ Because of the relational nature, coevolution and connectedness of human habitats, institutions, activities, health and food systems they represent a central concept for public policy/health and individual health.

❖ Use of advanced information and communication technologies for studying, designing, anticipating or monitoring intervention effects provides new opportunities for sustainable health and health systems.


14.50 Using Big Data systems to understand healthcare professional conversations in public social mediaPhysicians and other healthcare professionals are flocking to public social media to collaborate with one another across countries and languages. They are debating clinical data, seeking advice from one another, and proactively forming networks that can shape the quality of future medical information. Movements such as #FOAMed (free open access medical education) are challenging the existing systems of knowledge transfer, and the future role of the life-sciences company within this network is yet to be defined.

❖ Exploring and interpreting interactive data visualisations demonstrating how healthcare professionals have adapted to new and emerging channels.

❖ How their networks of influence can be used to gain deep insight about unmet medical information needs.

❖ Special focus on tools and technology to enable appropriate infrastructure and system design.



16.00 Panel Discussion: Big Data Infrastructure & System Design

❖ What impact will High-Performance Computing and Big Data Process have on future life sciences?

❖ Slow adaptors of novel innovative technology solutions and the dangers of not being up to date with the technological progress.

❖ Strategic Shifts towards Big Data – requirement of de-compartmentalizing the data silos. Who should initiate and lead this process within a modern life science organization?

Paul Grant, Creation Healthcare, UK

Rick Stevens, Argonne National Laboratory, USA

William Hayes, Selventa, USA

Prof. Chris Baker, University of New Brunswick


Gunther Weber, CTO, Deep Innovation, Germany (Former CTO, Vodafone, Germany)16.40 Chairperson’s closing remarks 16.50 End of Day Two - Stream 4

12th December, 2014 - Stream 4DAY 2BIG DATA INFRASTRUCTURE & SYSTEM DESIGN

BIGDATA LEADERS FORUM 2013 ATTENDEESPfizer Global Clinical Immunology & Biomarkers LeadSelventa Senior Vice President, Platform DevelopmentDefense Threat Reduction Agency Chief Medical and Technical OfficerNIH/NCI Head Genomics and Bioinformatics GroupUniversity of Greenwich Professor and Head Pharmaceutical, Chemical and Environmental SciencesInnovative Medicines Initiative (IMI) Principal Scientific Manager Knowledge ManagementPersonal Genome Project, Director InformaticsHarvard Medical School Ipsen Vice President BiometricsMedical Prognosis Institute Chief Science OfficerObe Therapy Chairman and CSOIllumina Vice President & Chief Information OfficerBiogen Idec Lead BiostatisticianJohnson & Johnson Senior Director External InnovationSelventa Senior ScientistNovartis Lab Head, Project LeaderETH Director Center for Information Sciences and Databases Jackson Laboratory CIOVaccinogen Chairman and CEOMolecular & Clinical Cancer Medicine DirectorSanofi Vice President Cardiovascular ThrombosisRoche Clinical Data Management TrainerBaxter Innovations GmbH Clinical Data ManagerIpsen, France Director Data Management, Deputy Biometry, Global Drug DevelopmentBavarian Nordic Director Clinical OperationsBayer Global Head Data ManagementCubist Inc. Director, Clinical Data Systems & ManagementAlmirall, SA Senior Clinical Data ManagerNovartis Senior Clinical Data ManagerSanofi Senior Clinical Project ManagerShire Senior Director, Behavioural Health Medical Affairs StrategyNovartis Senior Director, Global HEOR NeuroscienceShire Global Medical Director MPS FranchiseMedimmune Statistical DirectorNovartis Global Head, quantitative BiologyCatalan Agency for quality and CEOAssessment in Health (AquAS), SpainUniversity Hospital “A. Gemelli”, Director Health Technology Assessment Catholic University of Sacred Heart UnitHealthBank CEOAxon Neuroscience SE Clinical Advisor Axon Neuroscience SE ConsultantNovartis Pharma Senior Data ManagerNovartis Pharma Clinical Data LeadNovartis Pharma Data ManagerNovartis Pharma Clinical Data ManagerBayer Trial ManagerBayer Clinical Trial ManagerTRANSGENE Senior Data ManagerTRANSGENE Data ManagerTakeda Pharmaceutical International Vice President, Global Head Pharmacometrics & Biomarker DevelopmentCatenion AssociateMakroCare Associate DirectorMakroCare PresidentF. Hoffmann-La Roche Ltd. Head Business Intelligence & Master Data ManagementElekta Director Data Management StrategyFuncional DoctorIMS Health Senior Manager, Marketing & Offering DevelopmentIMS Health General Manager, Clinical Trial Optimization SolutionsIMS Health Senior ManagerIMS Health Head Centre of Excellence Patient DataVaccinogen Director

UCB Vice President Global Data SciencesRoche Diagnostics Global Information Management R&DAstellas Pharma Inc. Research FellowRoche Senior ManagerRoche Principle Data Acquisitions SpecialistRoche Program Data LeaderRoche Data Modeling SpecialistRoche Data Acquisition SpecialistCognizant Senior Director Projects, Life SciencesCognizant Projects, EIM - Big Data Cognizant Client Partner, Life SciencesCognizant Client Partner, Life SciencesF. Hoffmann-La Roche Ltd. Informatics Business PartnerF. Hoffmann-La Roche Ltd. IT Area HeadTeva Global Head Clinical ProgrammingBayer Vital GmbH Head Global Clinical Data CenterF. Hoffmann-La Roche Ltd. Solution ArchitectBayer Vital GmbH Head Global Clinical Data CenterSAS Institute AG Director Health & Life Science Global PracticeSAS Institute AG Key Account Manager Life Science SAS Institute AG Global Account Manager Life Science Takeda Pharmaceutical Senior Director, Global Head PharmacometricsInternationalF. Hoffmann-La Roche Ltd. Solution ArchitectJanssen Data Management LeadHP Enterprise Services UK Ltd. Regional Sales Manager VERTICAHP Enterprise Services UK Ltd. Client Principal and Information Management & Analytics (IM&A) Lead for General Western EuropeHewlett-Packard Sales Executive Switzerland Information Management and AnalyticsHewlett-Packard ES MarketingHewlett-Packard Sales Executive Switzerland Information Management GovernanceHewlett-Packard Client Principal for Life ScienceF. Hoffmann-La Roche Ltd. Process AnalystEuropean ScreeningPort Chief Executive OfficerGrunenthal GmbH Senior Vice President, Head Global BiometricsIPSEN Senior Vice President Digital & Translation SciencesNovartis Pharma AG Functional Information ManagerNovartis Pharma AG Systems SpecialistNovartis Pharma AG Solution ArchitectNovartis Pharma AG Senior Project & Account ManagerIPSEN Innovation Data Warehouse ManagerF. Hoffmann-La Roche Ltd. Global Head Health Data AnalyticsF. Hoffmann-La Roche Ltd. Head Statistical Programming and AnalysisShire Senior Director Translation MedicineIPSEN Innovation Project ManagerIMS Informatics AG Global Technology InnovationNovartis Pharma AG Application Architect (HPC)IMS Health KFT Country Manager IMS Informatics AG Junior ManagerIMS Health Business Analyst, Central Europe, East Europe University of Debrecen Research Assistant Axonys Founder & OwnerActelion Data ManagerIMS Health Senior Manager Sales Solutions & Consultant HEORRoche Informatics Project ManagerHewlett-Packard Schweiz Senior Principal Solution ConsultantGmbHBoehringer Ingelheim Medical Science LiaisonHewlett-Packard Schweiz Application Service ExecutiveArcondis Group Senior Consultant Information ManagementRoche Industry Insights Manager InnVentis Founder


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SpeakerBiogr aph ies

Hans Martens, Senior IT and Equipment Compliance Consultant, Rescop, Netherlands

Hans Martens, EU Privacy and Data Protection consultant. Hans Martens has graduated from the Nijmegen University (Biochemistry) in The Netherlands. In 1994 he became

employed by Eli Lilly and Company and held a variety of positions. In 2002 Hans was appointed as the Data Protection Officer for the Dutch Lilly affiliate. In 2011 Hans was appointed as a Consultant for International Privacy and Data Protection in Europe. In 2007 Hans has completed a Master course on IT-auditing and obtained his CISA certification. Furthermore Hans obtained his CIPP/IT, CIPP/E and CIPM certification. Hans is a trained and certified fire fighter.


Professor Ronald Stolk is an internationally established researcher in clinical epidemiology, and Head of Department. Over the last years his research focuses on life course epidemiology approaches of chronic diseases, based on cohort studies and gene-environment interactions. He is Chief Scientific Officer of the LifeLines project, a three-generations longitudinal population-based study to investigate risk factors of multifactorial diseases, including 167.729 participants in three generations. He is coordinator of BioSHaRE, a large European-Canadian collaborative project on harmonization of biobank studies (currently including over a million participants), co-investigator of Maelstrom Research, an international data harmonization program, and co-investigator of several FP7 biobank collaborative studies. Moreover, he is board member of PSI (String of Pearls Initiative, a series of disease-based cohorts in all Dutch UMC’s), principal investigator of Mondriaan (a national project to provide and standardize data from clinical care for scientific research), and board member of the HAPS project (Healthy Ageing, Population and Society; a multidisciplinary research project on healthy ageing in society). He has supervised more than 35 PhD projects and published over 250 papers in international peer-reviewed journals. More information: http://www.rug.nl/research/epidemiology/stolk


Corrado Priami obtained his Laurea and PhD degrees in Computer Science at the University of Pisa, visited as associate researcher at the laboratory LIX, École Politechnique, Paris

(1995) and the École Normale Supérieure, Paris under an EC Marie Curie TMR grant (1996). He was a researcher and associate professor at the University of Verona (1997-2001). Currently, he is a professor of Computer Science at the University of Trento. The results of his PhD thesis on stochastic pi- calculus were the basis for the foundation of the Microsoft Research - University of Trento Centre for Computational and Systems Biology (COSBI), of which he is the President and CEO. He was member of the expert group on the EU 7th FP of the CRUI and has participated in many projects promoted by the European Commission for the advancement of emerging areas of research. He regularly serves on the evaluation committees for projects presented by the European Commission, is an anonymous reviewer for many international journals, and serves in the review panels of the Science Foundation Ireland for institutes of systems biology and of the Netherlands Organisation for Scientific Research. He is a member of the Scientific committee of the Fondazione Veronesi. His research covers computational methods for the modelling, analysis, and simulation of biological systems, programming languages, and formal computational theories. He published over 130 papers in international journals and conferences, given more than 40 invited talks and lectures at conferences and universities around the world, participated in the program committees for 21 international conferences (ten of which he was chair), is a member of three steering committees of international conferences (of which one he is president), is editor-in-chief of the international journal Transactions on Computational Systems Biology and member of the editorial board of the international journal Bioinformatics Research and Applications. He founded the international conferences “Computational Methods in Systems Biology (CMSB),” which is continuing to grow, and “Converging Sciences,” whose success has been described by many international journals. He was a member of ISTAG-FET (Information Society Technologies Advisory Group - Future and Emerging Technologies) of the European Commission.

Siegfried Roesch, Director Clinical OperationsBavarian Nordic, Germany

Siegfried Rösch moved into his role of Director of Clinical Operations at Bavarian Nordic after working there as Manager for CRO Liaisons. Previously, Mr Roesch has built up extensive clinical experience at the CRO Kendle International,

as well as large pharma like Bristol-Myers Squibb and Takeda. He had also years of academic experience, achieving his Masters of Science at the Albert-Ludwigs University in Freiburg, Germany and a Postgraduate Degree in Biotechnology at the Technical University in Munich. Much of his time he spent as scientist at the departments for toxicology at the Technical University in Munich and the

Helmholtz Center in Neuherberg, Germany.

William Daley, Vice President, Business Development & Licencing, NA Medical Affairs, Sanofi, USA

William L. Daley, M.D., M.P.H, is Vice President, Business Development & Licensing, Medical Affairs, Sanofi, Bridgewater, NJ. Dr. Daley received a baccalaureate degree in Arts and

Science from Boston University (Boston, MA), his Doctorate of Medicine from Boston University School of Medicine (Boston, MA), and his Master of Public Health Degree in Health Policies and Management form Harvard University School of Public Health (Boston, MA). He completed his postgraduate training, including his residency and chief residency at Nassau County Medical Center, Stony Brook University School of Medicine, Long Island NY, a cardiology fellowship and interventional cardiology fellowship at the Brigham and Women’s Hospital /West Roxbury VA Medical Center, Harvard Medical School, Boston MA., and a research fellowship at Brigham/Women’s Hospital, Harvard Medical School, Boston, MA. Dr. Daley has held academic positions at Stony Brook University School of Medicine and Harvard Medical School and hospital appointments at both the Brigham and Women’s Hospital and the West Roxbury VA Medical Center. Among many awards and honors, Dr. Daley has been the recipient of the NIH-Research Fellowship award and NIH–Career Development Award. He has been a member of several organizations including the National Medical Association, American Heart Association, Clinical Cardiology Council, American Heart Association, New York Academy of Sciences, and was a member of the editorial board Harvard School of Public Health Journal and was a member of the Board of Directors, Dimock Community Health Center, Boston, MA. Most recently, he was recently nominated as “Who is Who” in America. Dr. Daley’s research interests are in the field of vascular biology and thrombosis as it pertains to lipid metabolism, diabetes, hypertension, coronary blood flow, cardiovascular disease, women’s health and the therapeutic applications of information technology. Dr. Daley has been an invited lecturer at many scientific venues both national and international focusing on topics ranging from the molecular basis of diseases to women’s health and health disparities nationally and internationally and drug development. He is the author or co-author of many published articles and abstracts in major scientific journals including Circulation, Hypertension, Journal of Am College of Cardiology and Clinical Research. Since transitioning from Academia to the pharmaceutical industry, he has had significant roles in several practice-changing clinical trials such as, TNT, REVERSAL, VALHeFT, VALUE, VALIANT, ACCOMPLISH and NAVIGATOR.


Dr. Dr. Michel Mikhail has more than 20 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in

large multinational Research-based pharmaceutical companies as well as in the Generic industry. Dr Mikhail is a Chartered Expert in Pharmacology -Toxicology, he is a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organisations. Dr Mikhail is a Board Member of The European Generic Medicines Association (EGA) as well as member of the Executive Committee of the EGA. He is member of the British Institut of Regulatory Affairs (BIRA), the European Society of Regulatory Affairs (ESRA), both now known as the organisation for Professionals in Regulatory Affairs (TOPRA). Dr Mikhail is member of the Expert Committee for Toxicology of the United States Pharmacopea (USP). Currently Dr. Mikhail is Executive Vice President Global Regulatory Affairs at Fresenius Kabi, a Multinational Pharmaceutical company.


Biochemist from the University of Helsinki, Finland. Currently Global Head Clinical Operations, Roche Professional Diagnostics (Zug – Switzerland), leading the implementation of the overall clinical development and validation strategy. Overseeing planning, design, execution, and reporting of clinical trials that provide data for regulatory submissions. Before joining diagnostics over 20 years experience in pharmaceutical industry with Novartis, Eli Lilly and Orion in various operational, scientific and health economic roles.


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Paul Grant has spent more than two decades at the forefront of emerging technology in multimedia communication and data analysis. With a diverse history covering engineering, interaction design and engagement

strategy, he is now Chief Innovation Officer (CINO) and director on the board with Creation Healthcare. In this role he provides leadership focused on overseeing the development of specialized research techniques and technologies, systems and processes, and providing senior consultancy to the life sciences industry. He can be found traveling between the USA and UK, building an international research team around Creation Pinpoint, the world’s first and largest big data service for understanding healthcare professionals’ behaviors in public social media.


Rick Stevens is a professor at the University of Chicago and an Associate Laboratory Director at Argonne National Laboratory. He is internationally known for work

in high-performance computing, collaboration technology, and for building tools and infrastructures to support large-scale genome and metagenome analysis. He currently is a co-PI for the NIH/NIAID support PATRIC bioinformatics resource center and for the DOE/SC supported Systems Biology Knowledgebase project (KBase). For the last four years Professor Stevens has directed the Institute for Computing in Science (ICiS) which runs community driven summer programs in Park City exploring the connections between advanced computing and progress in science. He and his colleagues have developed the RAST and MG-RAST genome analysis servers that have been used by over eighteen thousand users to annotate and analyze more than 120,000 microbial genomes and metagenomic samples. At Argonne, Professor Stevens leads the Computing, Environment and Life Sciences directorate that operates one of the top five supercomputers in the world (a 10 petaflops/s machine called MIRA). In the late 1990’s he was the founding Director of the NSF Teragrid project which pioneered the concept of community science gateways built on distributed high-performance computing and data resources (the first large NSF Cyberinfrastructure project). He serves on many national and international advisory committees and still finds time to occasionally write code and play with his 3D printer.


Prof Theo F Meert is a Senior Director for external innovation in the Discovery Sciences of Janssen Pharmaceuticals of J&J, responsible for consortia

and regional collaborations, closely involved in different Public Private Partnerships and external networking. During his career at J&J, started in 1981, he is appointed to multiple international global functions. He was born in 1958 in Oostham, and obtained a Ph.D.on psychopharmacology in Experimental Psychology at the University of Brussels (1986) and a Ph.D. in Medicine/Anesthesiology at the University of Antwerp (1994). Within his various functions obtained within J&J up to senior Research Fellow, he guided different multidisciplinary research teams within the field of CNS (Psychiatry- Addiction -Pain –Neurology/ Alzheimer). The activities of these groups covered the complete drug discovery process from early TI/TV over drug candidate selection to POC and further human testing. Dr Meert also supports some Full Development products and is involved in the scientific support of novel and marketed products. He was a key driver for several advanced projects in the CNS area leading to marketed drugs and has constructed an extensive network within J&J and external scientific and clinical organizations. His scientific expertise is reflected in multiple patents (>15), publications (> 225), congress communications (> 200) and invited lectures (>130). He is professor and scientific advisor/researcher at different universities (Leuven (Dept Biological psychology), Antwerp (Dept Pharmac Biomed Vet Sciences), Brussels (VUB, Dept Biolog Psychology), Hasselt (Dept Med Biomed sciences) and Ghent (Fac Medicine and Healthsciences, dept. Anesthesiology), (co)promoter of various mainly (bio)medical PhD students. Areas of interest: Chronic and neuropathic pain, Neurodegenerative disorders, Psychiatry and mood disorders & Public Private Partnerships


He studied agro-biology and started his business life in 1980 at Bayer in Clinical Data Management. Between 1990 and 1994 he was Head of Clinical Data Management at Bayer Corp in West Haven, Connecticut, USA. Since 2000 he was the Head Global Data Management at Bayer Healthcare.In November 2013 he was appointed to Global Strategy and Development Advisor in Global Data Sciences and Analytics. He enjoys canoeing and mountain-biking


William Reinhold is currently operating as facility head of the Genomics and Bioinformatics Group in the Laboratory of Molecular Pharmacology at the NCI. He has been

central in generating multiple datasets for the NCI-60 cancerous cell lines, as well as having guided the development of the CellMiner web-application (http://discover.nci.nih.gov/cellminer/), used by ~5,000 different users per month worldwide. His activities include running the web site, dissemination and interpretation of this data, facilitating collaborations, and providing direction for the development of systems pharmacology effort within the group. He received his B.S. in Biochemistry from the University of Maryland in 1978, and currently has 71 peer-reviewed publications.


As Manager Research Office she is responsible for the data and sample release of LifeLines and consultancy on biobanking. Since 2011 she is Manager Research Office of the LifeLines project, a three-generations longitudinal

population-based study to investigate risk factors of multifactorial diseases among more than 167.000 participants in three generations. She is responsible for data and sample release of LifeLines to researchers (currently >200), as well as consultancy on biobanking.


Diederick (Rick) E. Grobbee, MD, PhD,FESC, is a Professor of Clinical Epidemiology at the University Medical Center (UMC) Utrecht, the Netherlands, and Chief Scientific Officer at Julius Clinical, an Academic Contract Research Organization (www.juliusclinical.com). In addition he is the Director of the Center for Circulatory Health at the UMC Utrecht. He was elected fellow of the Dutch Royal Academy of Sciences, and holds the chair of its Medical Advisory Committee and Medical Section. Rick Grobbee has been a (principal) investigator in many large-scale epidemiologic studies and randomized intervention trials relating to the prevention and treatment of cardiovascular disease. His experience covers the full range of study designs including trials, cohorts and case-control studies. He is listed in the top 100 global most influential biomedical researchers (Eur J Clin Invest 2013 Dec;43(12):1339-65). Rick Grobbee has been on the editorial boards of several journals and (inter)national scientific, search, and site-visit committees. Current journal roles include senior consulting editor of the European Heart Journal and editor-in-chief of the European Journal of Preventive Cardiology. He is president-elect of the European Association for Cardiovascular Prevention and Rehabilitation. To date, Prof. Grobbee has authored or co-authored over 1,100 scientific papers, chapters, and books, and has supervised more than 130 PhD fellows. His Hirsch index is 114. Rick Grobbee received an MD at the University of Utrecht and, after a residency in internal medicine, obtained a PhD in Epidemiology at Erasmus University. In 1989 he was a Visiting Associate Professor of Epidemiology at Harvard School of Public Health. He was appointed full professor of Clinical Epidemiology at Erasmus University in 1993. Subsequently he moved to the University Medical Center Utrecht where he founded the Julius Center for Health Sciences and Primary Care in 1996 (www.juliuscenter.nl), which currently is one of the most productive clinical epidemiology groups in Europe with over 500 staff and fellows. Julius Clinical was established as a spin-off Academic Research Organization in 2008 and runs investigator-initiated and pharma-sponsored clinical trials in more than 30 countries involving over 120.000 patients. Rick Grobbee holds honorary appointments at the University of Malaya, Kuala Lumpur, Malaysia, and the University of Sydney, Australia. In 2010 he was appointed distinguished University Professor of International Health Sciences and Global Health at Utrecht University. In 2012 he initiated Elevate, a platform for accredited e-learning in international health sciences (www.elevatehealth.eu).

Daniel Ziemek,DirectorPfizer, Germany

Daniel got his PhD in Bioinformatics at the University of Munich (LMU) in 2004 and then joined the computational biology group at Sanofi-Aventis in Frankfurt, Germany and Cambridge, USA. In 2008, he joined the Computational Sciences Center of Emphasis (CS CoE) at Pfizer, Cambridge, MA, USA. Recently, he received Pfizer’s WRD Achievement Award for the development and application of the Causal Reasoning Engine – a family of methods to support target validation and patient stratification based on prior biomedical knowledge. Since 2013, he is located in Berlin, Germany, leading a number of Pfizer efforts to intelligently use the plethora of experimental data to drive drug discovery forward.


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Athula Herath, Statistical DirectorMedimmune (AstraZeneca Biologics), UK

Athula Herath is currently the Statistical Director of the research statistics function within the MedImmune Biotech Unit of AstraZeneca in Cambridge, UK. Dr. Herath obtained the PhD in computational statistics from

the University of Keele UK. He subsequently became a lecture in the Department of Computer Science at Keele University. Dr Herath subsequently joined the Pharmaceutical Industry as a professional statistician and established and led biostatistical groups of several biotech and pharmaceutical companies.


Jon is currently the Associate Director for Data Management within AstraZeneca, accountable globally for Oncology Data Management deliverables together with global line management responsibilities. As part of

his role, Jon is a key member of the joint governance team working with strategic partners to monitor performance and oversee delivery. Jon has over 20 years experience in the pharmaceutical industry gained from Zeneca, Astra and AstraZeneca, within various Data Management, eClinical and Alliance Management project and line management roles.

Dr. Stephan Pabinger, Scientist,AIT - Austrian Institute of Technology, Austria

Stephan Pabinger is currently a Scientist in the Molecular Diagnostics group at the Austrian Institute of Technology (AIT), Vienna. He got his Ph.D. in Bioinformatics at the Technical University of Graz (Austria) and then joined the bioinformatics group at the Medical University in Innsbruck. After his postdoctoral stint at the Institute of Genetic Medicine, Johns Hopkins University - School of Medicine (Baltimore, USA), he joined the molecular diagnostics research group at the AIT. He is involved in algorithmic and pipeline design and his recent studies have been focusing on the analysis of Next Generation Sequencing data, including sequence assembly, bisulfite data analysis, and investigation of clinical studies.

Dr. Adam Baker, PhD.Head of HND DiscoveryChr. Hansen, Denmark

Adam holds a Ph.D. in Human Molecular Biology and Genetics from The Research Institute of Molecular Pathology (in Vienna). He did postdoctoral research

at Boehringer Ingelheim followed by Chromos Molecular Systems Inc (Vancouver, Cananda) and 7 years in Iceland as the Division head for new technologies at DeCODE Genetics understanding complex diseases. Before moving to Chr-Hansen he worked at Exiqon A/S in Denmark as the vice president of diagnostics working with microRNAs focused on gastro intestinal oncology. Today Adam is the Head of HND Discovery at Chr-Hansen focused on the development of next generation probiotics for human health programs.


Dr. Elia Stupka started his genomics career as part of the Ensembl group and the core human genome analysis team in Hinxton, where he participated to the completion and analysis of the human genome (Nature,2001). He was then asked to setup and manage the Fugu genome bioinformatics team at IMCB, Singapore where he completed the Fugu genome project (Science, 2003). He then moved to the Telethon Institute of Genetics and Medicine, where he began combining his experience in bioinformatics with a molecular biology lab, working on the understanding of non-coding DNA, and where he also collaborated with the Fantom3 project (Science, 2005). He was then Scientific Director at UCL Genomics, University College London, where he began applying NGS approaches on both rare and complex disease projects and exploring epigenomics approaches to identify novel biomarkers. Since 2011 he has been involved in a very challenging project to develop a new research center at San Raffaele Research Hospital in Milan, Italy, the first translational genomics and bioinformatics center of its kind in Italy, serving a community of over 1,500 clinical and basic scientists across a wide range of clinical applications, applying the knowledge of the human genome developed in 2001 in a clinical context for the benefit of the patients. He now serves as Director for Computational Biology at Boehringer Ingelheim within the Target Discovery Research Group.

William Hayes, CTOSelventa, USA

Dr. William Hayes has over 15 years of experience managing and supporting innovative IT solutions. His responsibilities include extending the Selventa Discovery Platform to efficiently analyze new experimental assay

data types and significantly increase the depth and breadth of capabilities for more sophisticated analyses. Prior to joining Selventa, Dr. Hayes was the Director of Decision Support and Literature Informatics, R&D IT at Biogen Idec. In this role, he was responsible for providing decision support capabilities for R&D scientists. Notably, he evolved a Corporate Library into a Literature Informatics team using state of the art text analytics and visualizations to support Biogen Idec from Discovery to the Board Room and deployed an agile data management platform based on Semantic Web. Prior to Biogen Idec, William worked at AstraZeneca and GSK in the Bioinformatics Departments. He received his Bachelor’s in Aerospace Engineering and Ph.D. in Applied Biology and Bioinformatics from Georgia Institute of Technology in Atlanta, GA.

Ingeborg CilSenior Manager, Clinical Data ManagementBaxter BioScience, Austria

Ingeborg Cil is Senior Manager, Clinical Data Management, at Baxter BioScience. She received her Master of Science in Computer Science from the Technical University Vienna. After fifteen-years working as software developer, project manager and supervisor in industry and software technology companies, Ingeborg Cil moved to Baxter and has been working in Clinical Data Management (CDM) for 14 years. She worked as a Clinical Data Manager for around 7 years and is leading the CDM SAS Programmer team as a Manager for 7 years. She has professional experience in all CDM processes, a strong background in the implementation of CDISC standards, e.g. CDASH, SDTM, and ADaM, and submissions to regulatory authorities, expertise in establishing company specific CDISC standards, and overseeing in-house as well as outsourced data management tasks. Ingeborg Cil lives in Vienna, Austria.


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Chris Baker is co-founder and CEO of IPSNP Computing Inc. established in 2011 to commercialize a unique query engine which provides fully integrated access to analytical software and online databases for the bio-pharmaceutical sector. Chris is also full professor and research chair at the University of New Brunswick focused on knowledge management, data and service integration, semantic technologies, text mining, and web services. In addition to an academic career Chris held numerous positions in industry and government research labs. Up until 2008 he was the head of the Semantic Technology Group at the Data Mining Department, I2R, (A-STAR) Singapore and served as Chief Scientific Officer for Knorex Pte Ltd (Singapore). Prior to this he was a group leader of In-Silico Discovery at Ecopia BioSciences (now BELLUS Health) and Bioinformatics Manager at Concordia University in Montreal. He received postdoctoral training in micro and molecular biology at the University of Toronto and at Iogen Corporation in Ottawa. Chris has served as invited expert at the World Wide Web Consortium (W3C) for three years.

Nils WeskampPrincipal Scientist, Computational ChemistryBoehringer Ingelheim, Germany

Nils Weskamp is a Principal Scientist, Computational Chemistry at Boehringer Ingelheim. As part of that role, he supports drug discovery research projects at all stages. He utilizes methods from Chemoinformatics, Data Mining, Predictive Analytics and related disciplines to extract knowledge from the wealth of experimental data that is available internally and externally. Recently, he led a global IT project aimed at bringing complex scientific calculation engines from the high-performance computing environment into the hands of BI’s scientists. Nils serves as a member of BI’s Research Informatics Advisory Team and contributes to the alignment of the Research and IT functions. He holds a master’s degree and a PhD in Computer Science (with a focus on Bioinformatics and Data Mining) from the University of Marburg.

Prof. Bruno Sobral, Founding Executive and Scientific Director, Virginia Bioinformatics Institute at Virginia Tech, Assistant VP and Head of BioSystems Informatics and ComputationalMicrobial Ecology, Nestle Institute of Health Sciences, Switzerland

Professor Sobral is internationally known as a systems thinker with significant executive experience building and management of research institutes, research strategy, and implementation and execution of such strategies. He has successfully built the BioSystems Informatics and Computational Microbiology team at the recently created Nestlé Institute of Health Sciences, created from scratch the Virginia Bioinformatics Institute at Virginia Tech, and was the scientific leader of the National Center for Genome Resources, combining for major experience over last 25 years leading interactions between wet-lab and computational scientists with the goals of scientific discovery and informatics infrastructure development, deployment and evolution. He is currently the PI for the PATRIC NIAID project (www.patricbrc.org), which he started and has been leading for 10 years. He is currently focused on “big data” from the engineering and informatics perspective and host-microbe-environment interactions (symbiosis) from the biological science perspective. Additionally, the current strategy has been set to branch out from the human microbiome to enable research into key chronic ailments with respect to their microbial component. Ultimately the driving questions for me is a ecological approach and conceptualization of “what is health?”

Dr. Arnd Kohrs, Director of Technical SalesDACH & CEE, Aspera, UK

As Director of Technical Sales at Aspera, an IBM company, Arnd is responsible for growing the adoption of Aspera products and services in Central and Eastern Europe. Aspera is the inventor of the FASP protocol, the high-

performance file transfer protocol, which is widely used in global digital media value-chains. Over the past years, Arnd was decisively involved in the design and successful delivery of innovative Aspera solutions within the digital media industry, in particular for recent soccer events and national broadcasters. After obtaining a degree in Computer Science from the University of Karlsruhe, he received a PhD for his research in the field of Computer Networking at the Université Nice Sophia-Antipolis, France. Arnd has more than 20 years of professional experience in the software industry with focus on digital media.

Annemarie Voortman, Principal Data Manager, Astellas, Netherlands

Annemarie Voortman Works for more than 10 years as a data manager in the pharmaceutical industry. Started her career at Chiron in the Netherlands, a biotechnology firm. Hereafter she went to Astellas Pharma Europe in the Netherlands to pursue her career in Data Management, currently in the Principal Data Manager position. Besides study related to her work, she is also involved in and leading several global initiatives and mentoring fellow data managers. Recently she obtained the Certified Clinical Data Manager (CCDM ®) qualification from the Society for Clinical Data Management.

Nigel Hughes, Global Director, Marketing & Health Information Technology, Janssen Diagnostics BVBA

Currently Global Director, Marketing and Health IT Strategy Leader, Janssen Diagnostics BVBA. A former UK NHS healthcare & voluntary sector professional working

in the pharmaceutical and diagnostics industry with a 360° experience in the blood borne virus market based on a professional heritage in the viral hepatitis, liver disease & HIV fields [google “Nigel Hughes + hepatitis” or “Nigel Hughes + liver disease”] spanning thirty years. Formerly working for Roche, Gilead, Novartis, and now Janssen, he is now focusing on strategic marketing for new diagnostic solutions for personalized medicine via bio-informatic tools, health information technologies and biomarkers in infectious or chronic diseases. In particular leading health information technology strategy for clinical registry and electronic health record implementation and expansion in the United States, Europe and wider, as well as working to develop overarching responses to the need for real world data in Pharma. Married with two adult siblings, he lives in Belgium, in the countryside with his wife and ten cats.

Dr. Thomas WilckensChief Executive Officer, CSO & FounderInnVentis, Germany

Thomas Wilckens is an MD and a serial entrepreneur. His current focus is a novel start-up project (InnVentis) with a focus on the convergence of *omics technologies with

real-world clinical data to enable Precision Medicine. Until 11/2012 served as Head of mHealth Solutions at deep innovation GmbH, where he meanwhile holds the position of an associate. Before joining deep innovation, Thomas headed a drug discovery company as CEO/CSO with a focus on inflam-matory and metabolic diseases. Thomas obtained his MD at the Ludwig-Maximilian University before heading off to basic research as a scholar of the Max-Planck Society and the Max-Kade Foundation, NY. He held several postdoc positions at leading academic institutions before becoming an entre-preneur in 1998. Aside from his work in biomedicine he developed a novel concept for value creation in research intensive industries; i.e. Symbiotic In-novation. With regard to this project Thomas is an associate at the GLO-RAD Research Center for Global R&D Management St. Gallen/Shanghai. Thomas is convinced that we will see a disruption of current R&D processes and thereby preventative/therapeutic concepts as well as related business models in the very near future. This paradigm shift will be induced by the advent of even greater computing and communication capabilities in concert with progress in *omics, nano- and biotechnology; i.e. Precision Medicine will ultimately be supported by algorithms/machine learning for diagnostics and therapeutic decision making and become available anywhere 24/7.


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EventPar tner s & Networ k ing

Are you interested in presenting your company products and services to this senior-level audience? If so please contact: [email protected] Our team will be happy to tailor a package to suit your needs and get you the optimal level of exposure!

NetworkingThe Second Annual Life Science Big Data Leaders Forum will provide all delegates the chance to meet one another through our many networking opportunities. With mid-morning and mid-afternoon breaks as a standard, this event will also feature a complimentary networking dinner for all participants. This evening will allow you to meet with our expert speaker panel who represent many stakeholder groups in a less formal setting. Our networking lunches will also allow you plenty of time to meet with your peers and colleagues whilst you refuel through the event.

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PaymentsPayment is due within 5 days of registering. A receipt will be issued within 5 days of receipt of payment. CancellationIf you have any questions or issues please contact [email protected] must be in writing and must be received by NextLevel in writing more than 10 business days prior to the event. Upon receipt of cancellation notice, NextLevel Pharma will issue a delegate credit voucher for the full amount of the payment to be used towards registration fees at any future NextLevel Pharma event held within 18 months from date of issuance (“expiration date”). All credit vouchers expire automatically expire on the Expiration Date and shall thereupon become void. If cancellation is received more than 30 calendar days before the event then the client is entitled to a 50% refund and the balance in the form of a delegate credit voucher. Participants are advised that credits for cancellations not received more than 5 days before the event will not receive credit vouchers, including cancellations due to weather and other causes beyond the registrant’s control. Substitutions are welcome and are free of charge. If for any reason NextLevel Pharma decides to cancel this conference, NextLevel Pharma accepts no responsibility for covering airfare, travel, hotel or other costs incurred by registrants, including delegates sponsors speakers and guests.Special needs: Any participants with special dietary requirements or who require access aids should notify NextLevel Pharma more than 2 weeks prior to the event.

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Complimentary invite to our very popular networking dinner for all event participants.

Full delegate list with email addresses of all participants.

Event Lunches & Networking breaks.

A word from the event’s producer: “Thanks very much to the speakers for their commitment to this event and to guiding me with the agenda development. Based on my discussions with the speakers and panelists I’m looking forward to a highly productive event with many strong, implementable take-home messages for our delegates. I look forward to meeting you in Berlin.”

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Dates & Venue:11-12th December, 2014Radisson Blu Hotel, Berlin, Germany

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Registration includes:

Includes event documentation (Folder + USB flash drive).

Complimentary invite to our very popular networking dinner for all event participants.

Full delegate list with email addresses of all participants.

Event Lunches & Networking breaks.

BIG DATA

Radisson Blu Hotel, Berlin, GermanyDecember 11-12th, 2014

L E A D E R S F O RU M

LIFESCIENCE R&D- 2ND ANNUAL -

Dear Valued Customer,NextLevel Pharma are experts in providing the ideal platform for your strategic benchmarking and networking opportunities. I am very confident that by attending this meeting, you will improve your understanding of “best practice” and enhance your strategic decision-making in this vital area.Luke Rogers, CEO, NextLevel Pharma

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Leveraging Discovery & Translational Big Data to Enhance InnovationEnhancing Decision-Making through Effective Clinical Data ManagementUtilising Big Data to Achieve Real-World Health Outcomes & Patient InsightsBig Data Infrastructure & System Design Leaders Forum

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6. Whilst all reasonable care and effort has been made, NextLevel Pharma reserves the right to alter the programme content, without notice. If, for any reason NextLevel Pharma decides to cancel, postpone or merge this conference with another conference, NextLevel Pharma will attempt to notify all participants on the contact information they have provided at registration and is not liable or responsible for covering hotel, airfare, or other expenses incurred by clients. In this case, the conference fee can be credited to a future conference. NextLevel may also consider sociopolitical factors in postponing events, which will be communicated to all participants.7. Intellectual Property & Copyright. All NextLevel Pharma materials in relation to this event are exclusively reserved and any unauthorised duplication, publication or distribution is strictly prohibited.8. This agreement shall be governed in accordance with the law of the Slovak Republic and the parties submit to the exclusive jurisdiction of the Slovak Courts. However only NextLevel Pharma is entitled to waive this right and submit to the jurisdiction of the courts in which the client’s office is located.9. Client information is kept by NextLevel Pharma and used by NextLevel Pharma to keep clients informed of other related NextLevel Pharma products which may be of interest. If the client does not wish to be contacted further, please tick this box ( ).10. NextLevel Pharma is thankful of client feedback at our events. In some situations, quotes & testimonials made by clients, may be used by NextLevel Pharma in future marketing literature. If you do not wish to be quoted, please tick this box ( ).11. *VAT Exemption: All registrations who do not supply a VAT or tax identification number when registering, will be charged 20% VAT on the delegate registration amount as per local tax laws. If VAT details submitted are incorrect, client will be informed and if NextLevel Pharma is not supplied with correct VAT details within 7 days, then the VAT amount will also be charged & invoiced to the client.

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2nd Annual Lifescience R&D Big Data Leaders Forum