advanced analytics for clinical data full event guide

February 1-2, 2017, San Francisco

Researched & Developed By:

The Leading Event Dedicated to the Successful Application of Advanced Analytics in Clinical R&D

Tel: +1 212 537 5898 | Email: [email protected]

www.advancedanalytics-clinicaldata.com

Hear from 18+ Expert Speakers Including:

James Cai, PhD.Head of Data ScienceRoche

Ray Liu, PhD.Senior Director & Head of Statistical Innovation & Consultation Takeda Pharmaceuticals Inc.

Spyros Papapetropoulos, PhD.Vice President & Global Head of Neurodegeneration, Movement Disorders & Clinical Research InnovationTEVA Pharmaceuticals

Todd Townsend, PhD.Commissioner’s FellowUnited States Food & Drug Administration (FDA)

Margaret McDonald, PhD. Senior Director, Real World Data & Analytics Pfizer

Advancing Your Understanding of Clinical Data Science

This is a great event! Something that provides a much needed direction to the Big Data community.

Sanofi, Past Attendee, Hanson Wade Event

Book now and save up to $800

Pre-Conference WorkshopJanuary 31, 2017

Advanced Analytics for Clinical Data

http://www.advancedanalytics-clinicaldata.com

mailto:[email protected]

https://www.linkedin.com/groups/8574619/profile

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Advanced Analytics for Clinical Data | San FranciscoFebruary 1-2, 2017

Tel: +1 212 537 5898 Email: [email protected]

www.advancedanalytics-clinicaldata.com Advanced Analytics for Clinical Data

Hear practical case studies on how to implement data analytics from biostatistics, to omics or wearables

Use analytics to unlock efficiency from risk based monitoring

It was a very helpful meeting and I was glad to share some of our current methods of data analytics with the others present at the occasion.

Purdue Pharma, Past Attendee, Hanson Wade Event

A great meeting of minds on the subject of Big Data. It attracts an excellent mix of thought leaders and fresh young thinkers.

Moderna Therapeutics, Past Attendee, Hanson Wade Event

I found the meeting very valuable as it brought together industry leaders with insightful presentations. This was a great development opportunity.

Astellas Pharma, Past Attendee, Hanson Wade Event

Discover how leading organizations are extracting real value from massive data sets and new data sources

Get ahead as the industry moves from ‘data management’ to ‘data science’

Hear What Previous Attendees Have To Say:

Tackle the main challenges in data quality, standards and integration

Understand how Real World Data can be harnessed to optimize clinical trial design

10 reasons why you can’t miss Advanced Analytics for Clinical Data 2017

Learn how to enable new and adaptive trial designs for the era of precision medicine

Explore how mHealth and wearable devices can reduce costs and accelerate clinical trials

Enhance operational analysis in clinical trials to improve feasibility assessments and site selection

Understand the existing FDA regulations and standards in the use of wearables for real time monitoring in clinical trials

Welcome to Advanced Analytics for Clinical Data 2017Discover How the Data Revolution is Allowing for Better Decision-Making Across the Drug Development Process

Advanced Analytics for Clinical Data 2017 brings together the leading experts in clinical data science, clinical innovation and clinical data management from major pharmaceutical and biotechnology companies. This meeting focuses on how to effectively implement big data analytics and data-driven methodologies in your clinical research.

This industry-led agenda will enable you to learn from the experience of institutions that are successfully applying advanced analytics to accelerate clinical R&D – from biostatistics to data visualization, Real World Data and wearables.

Engage with your peers to address key areas of common interest including machine learning and data mining, as well as new data sources and real time monitoring.

This summit will ensure that you leave with an essential guide to how your organization can integrate data analytics to deliver increasingly better, faster and more efficient outcomes in clinical trials.

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SpeakersAbhik Bhattacharya, PhD.Senior Director & Global Head of Analytics Astellas US LLC.

David S. Reasner, PhD. Vice President, Data Science & Head, Study Endpoints Ironwood Pharmaceuticals

Elena Izmailova, PhD. Senior Director of Devices & Novel Data Streams, Data Science InstituteTakeda Pharmaceuticals Inc.

Ankit Lodha Analytics Operations Lead in Clinical Systems & Analytical Reporting (CSAR) Amgen

Elizabeth Cheney Director & Head of Clinical Data Management & Programming Karyopharm Therapeutics Inc.

David Moriarty, PhD. Vice President, Clinical Operations, Data Management & Strategic Outsourcing Jazz Pharmaceuticals

James Cai, PhD. Head of Data Science Roche

John Rodermund Global Head Clinical Research Data Management & Centralized Monitoring AstraZeneca

Leonardo Rodrigues, PhD. Associate Director, Advanced Analytics Berg LLC.

Margaret McDonald, PhD. Senior Director, Real World Data & Analytics (RWDnA) Pfizer

Nina Mian Head of BiomedicalInformatics, Advanced Analytics Center AstraZeneca

Rajneesh Patil Senior Director, Clinical DevelopmentQuintiles

Ramses Sadek, PhD. Professor of Biostatistics & Head of Cancer Clinical Trial Biostatistics Unit, Georgia Cancer Centre Augusta University

Ray Liu, PhD. Senior Director & Head of StatisticalInnovation &Consultation Takeda Pharmaceuticals Inc.

Sandy Farmer, PhD. Executive Director, Enterprise Scientific Technology Operations, Worldwide R&D Pfizer

Spyros Papapetropoulos, PhD. Vice President & Global Head of Neurodegeneration, Movement Disorders & Clinical Research Innovation TEVA Pharmaceuticals

Todd Townsend, PhD. Commissioner’s Fellow United States Food & Drug Administration (FDA)

Tony Cavaliere Global Head of Data Sciences & Standards Novartis










Conference Day One | Wednesday, February 1, 2017

8.00 Registration

Tony Cavaliere, Global Head of Data Sciences & Standards, Novartis

8.50 Chairman’s Opening Remarks

Data Science in Clinical Drug Development – Big Data & Advanced Analytics

James Cai, PhD., Head of Data Science, Roche

Sandy Farmer, PhD., Executive Director, Worldwide R&D, Pfizer

Spyros Papapetropoulos, PhD., VP & Global Head of Clinical Research Innovation, TEVA Pharmaceuticals

9.00 Keynote Panel: The Rise of Data Science – Understanding the Ground-Breaking Changes Behind Clinical Research• Evaluating the power of data science in revolutionizing clinical trials

• Assessing the new era of Precision Medicine – what leads and defines the strategy in pharmaceutical companies in the ever-growing data-driven clinical R&D landscape

• Driving innovation in the clinical research phase of drug development: from new data sources, to new analytic tools and capabilities – what to look out for

• Discovering the potential of data analysis in the development of new trial designs

James Cai, PhD., Head of Data Science, Roche

9.45 Keynote Case Study: Making Use of Data & Data Science to Boost Clinical R&D• Understanding Clinical Data Science – the different angles around the impact of data

analytics in the clinical research environment

• Uncovering the use of genomic data to find and validate biomarkers when no pre-clinical data is available

• Making use of data sets from various sources to enable better patient monitoring

• Evaluating the data-driven initiative at Roche to expand existing adult patient drugs to pediatric cancer care – assessing the population and developing new algorithms to analyze data

• Using smartphone data and wearables as digital biomarkers and predicting patient phenotypes

10.15 Morning Refreshments & NetworkingMeet your peers in this structured and interactive networking session designed to ensure you make the most new connections possible in the early stages of the conference. Bring plenty of business cards!

The meeting was very well-organized and the overall calibre of the speakers was very high.

Genzyme, Past Attendee, Hanson Wade Event







Ankit Lodha, Analytics Operations Lead in Clinical Systems & Analytical Reporting (CSAR), Amgen

David S. Reasner, PhD., VP, Data Science & Head, Study Endpoints, Ironwood Pharmaceuticals

Leonardo Rodrigues, PhD., Associate Director, Advanced Analytics, Berg LLC.

Ray Liu, PhD., Senior Director & Head of Statistical Innovation & Consultation, Takeda Pharmaceuticals Inc.

11.00 Panel Discussion: Big data in Clinical Trials – Leveraging Data to Extract Meaningful Insight• Making use of data sets – why is only a small fraction of data being used?

• Evaluating the new data sources that can impact clinical trials and the main challenges around them including:

• Real World Data• Omics• Data collected from wearables

• Harnessing the full potential of clinical data – what are the possibilities and how to leverage that?

• Addressing the major technical challenges

• Data selection and standardization• Data cleaning and filtering• Data integration• Data analysis• Data visualization

• Tackling the major cultural challenges – changing the industry’s mindset to embrace and understand data innovation

Ray Liu, PhD., Senior Director & Head of Statistical Innovation & Consultation, Takeda Pharmaceuticals Inc.

11.45 Joint Analysis – Statistical Innovation to Maximize the Insights from Big Data Integration• Evaluating the new challenges and opportunities for data scientists presented by big data

integration

• Discovering how appropriate joint analysis increases power and generates novel insights on integrated data

• Exploring case studies on various joint analysis frameworks and their utilities

12.15 Lunch & Networking


1.15 Clinical Analytics – Next Generation of Predictive & Prescriptive Dashboards for Clinical Trials• Defining Clinical Analytics – understanding the capabilities and usefulness of insights in

the clinical development program

• Developing metrics for big data analysis in clinical trials – handling industry best practice and company specific metrics

• Mining different layers of data – the challenges of clinical data analysis and visualization for stakeholders

• Harmonizing data – how to combine multiple data sets

• Case studies on how to uncover unmet needs, spot growth opportunities, inform trial design, and competitive differentiation using advanced analytics

Leonardo Rodrigues, PhD., Associate Director, Advanced Analytics, Berg LLC.

1.45 The Multi-Omics & AI Approach – Incorporating Data-Driven Actionable Insights Into Drug Development• Harnessing high throughput proteomics, lipidomics and metabolomics for biomarker

identification and drug response prediction – implementing patient stratification

• Applying AI algorithms and analytical tools to structure, process and analyze different types of data from trial screenings (clinical, biological, demographics and outcomes data)

• Delivering insight in a way that actionable measures can be taken by senior management – properly communicating results

• Housing omics, analytics and R&D under the same roof – the competitive advantage of inter-team collaboration







The Current Challenges in Clinical Data Management

David Moriarty, PhD., VP, Clinical Operations, Data Management & Strategic Outsourcing, Jazz Pharmaceuticals Elizabeth Cheney, Director & Head of Clinical Data Management & Programming, Karyopharm Therapeutics Inc. John Rodermund, Global Head Clinical Research Data Management & Centralized Monitoring, AstraZeneca Rajneesh Patil, Senior Director, Clinical Development, Quintiles

2.15 Panel Discussion: The Paradigm Shift of Clinical Data Management – From Support to Driver in Clinical R&D• Analyzing the new emergence of Clinical Data Management – both a practical and

cultural shift

• Marrying centralized monitoring and traditional data management – looking into the future of an increasingly technical role

• Exploring new Clinical Data Management skills – data visualization and data analytics

• Assessing the evolution of risk-base monitoring – data quality, data integrity and completeness of data

• Ensuring a data governance structure

Rajneesh Patil, Senior Director, Clinical Development, Quintiles

3.00 Advanced & Predictive Analytics – Implementation Aspects in Risk Based Monitoring• Identifying and developing analytics methodologies for clinical trial conduct – case

studies for advanced analytics• Implementing the right analytics strategies for Risk Based Monitoring – an

approach to implementable analytics• Assessing how Novel Predictive Analytics capabilities provide new levels of insights

for study monitoring• Advancing the use of data sciences in managing site risks, subject safety risks and

study level trends

3.30 Afternoon Refreshments & Networking

John Rodermund, Global Head Clinical Research Data Management & Centralized Monitoring, AstraZeneca

4.00 Risk-Based Monitoring – Understanding Risk Through Data• How to evolve from human monitoring into data driven approaches• Understanding high risk sites through data – how to redirect monitoring

resources• More data, more accuracy, more efficiency, less resources – implementing better

data monitoring by harnessing current computing powers• Evaluating Data Science and the improvement of Risk Management

David Moriarty, PhD., VP, Clinical Operations, Data Management & Strategic Outsourcing, Jazz Pharmaceuticals

4.30 Implementing & Running Data-Driven Trial Management – A Case-Study• Linking together Data Management and Clinical Operations – why Jazz

Pharmaceuticals is getting these functions to collaborate increasingly closer • Periodic reviewing of trial data – guiding trial management professionals by data

sources • Evaluating the challenges and benefits resulting from the data-driven approach to

trial management • Independence of Analytics Platforms from the CROs

Elizabeth Cheney, Director & Head of Clinical Data Management & Programming, Karyopharm Therapeutics Inc.

5.00 Data Management – The Central Piece Between the Clinical Perspective & Analytics• Making sure data management strategy and methodologies are at par with industry standards• Assessing the need to bring clinical people on board with data management

requirements and standards at the planning stage• Ensuring the correct delivering and process of data for analytics – bringing clinical

programming in line with the data management strategy


5.30 Chairman’s Closing Remarks

5.45 Close of Conference Day One







Conference Day Two | Thursday, February 2, 2017 Tony Cavaliere, Global Head of Data Sciences & Standards, Novartis

8.45 Chairman’s Opening RemarksKey Takeaways & Lessons Learned from Day One

Clinical Trial Monitoring in Real Time: mHealth & Wearable Devices

Spyros Papapetropoulos, PhD., VP & Global Head of Neurodegeneration, Movement Disorders & Clinical Research Innovation, TEVA Pharmaceuticals

9.00 The Future of Digital Health – Challenges & Opportunities of Data-Driven Approaches in Clinical Trials• Exploring the prospects for digital health and data science in clinical research

• Data collection – addressing the major challenges around data intellectual property, data sharing and data standards

• Assessing the variability of collected data and how to deal with the different paces of technology development

• Evaluating data privacy approaches – the struggle behind handling privacy issues

• Reaching actionable insight – data collection is just the first step towards data-driven decision-making

Elena Izmailova, PhD., Senior Director of Devices & Novel Data Streams, Data Science Institute, Takeda Pharmaceuticals Inc.

9.30 mHealth & Wearables – Collecting Clinical Outcome Data Remotely• Exploring wearable technologies and their applications in drug development

• Consumer and medical grade devices – fit-for-purpose principle

• Overview of existing regulations for wearables

• Addressing the challenges and potential solutions of deploying wearable devices in the clinic

Nina Mian, Head of BiomedicalInformatics, Advanced Analytics Center, AstraZeneca

10.00 Sensational Sensors & Wonderful Wearables – Uncovering the Promise of Multivariate, Continuous, Individual Data in Clinical R&D• Developing capabilities to manage, integrate and analyze data collected from wearables –

a case-study on the efforts at AstraZeneca Advanced Analytics Center to derive meaning and value for the clinical pipeline and patients

• Understanding the areas of opportunity, challenges, and successes we gleaned from our experience to-date

• Diving into the detail of defining novel digital disease biomarkers, phenotypes and endotypes

• Realizing value in clinical trials, and how we may forge a path to novel outcome measures

10.30 Morning Refreshments & Networking

Elena Izmailova, PhD., Senior Director of Devices & Novel Data Streams, Data Science Institute, Takeda Pharmaceuticals Inc.

Nina Mian, Head of Biomedical Informatics, Advanced Analytics Center, AstraZeneca

11.00 Panel Discussion: One Step Further on Clinical Trial Outcome Monitoring – Key Benefits & Challenges Around mHealth & Wearables• Unravelling the possibilities behind remote real-time data acquisition during clinical trials

• Proof of concept – is the technology and/or the industry ready to embrace this new approach?

• Are regulation standards in the way or working the way towards clinical trial monitoring with wearable devices?

• Return on investment – understanding if the results driven from wearables compensate implementation and maintenance costs

• Patient compliance and device wearability – how to find the right balance between technical accuracy and reliability and patient comfort







Todd Townsend, PhD., Commissioner’s Fellow, United States Food & Drug Administration (FDA)

11.45 Can Data Collection & Reporting from Wearable Devices Cloud, Supplement or Replace Standard Measures in Clinical Trial Reporting? – A Regulatory Perspective• Maximizing data collection and analytic capacity to enrich clinical trials – balancing the

power of data volume with outcome fidelity and measurement accuracy • Identifying, testing and mitigating risk by (theoretically and experimentally) exploring

worst case scenarios• Ensuring biometric validation and physician sign-off – formalizing the process and

preventing data manipulation• Understanding fit-for-purpose device accuracy and adequacy for diverse case studies –

high level overview• Evaluating the reality of challenges of combining (unapproved) devices and drug discovery

in (FDA-Center crossing) clinical research – approval and implementation considerations for wearable devices

12.15 Lunch & Networking

Interactive Round Table Discussions1.15 These moderated, interactive roundtable discussions give you the chance to spend time in facilitated debate and exchange

on the issues most concerning you. Sessions are ‘off the record’ and enable to share best practice and discuss practical solutions with peers from across the industry facing the same challenges you face every day.

3.15 Afternoon Refreshments & Networking

Real World Data in Clinical Research

Margaret McDonald, PhD., Senior Director, Real World Data & Analytics (RWDnA), Pfizer

3.45 Real World Data (RWD) Sources – the Health Data Revolution in Clinical Research• Real World Data – how to leverage RWD sources in the drug development phase and

throughout the life to support internal strategy and decision making• Using EHRs– addressing the current challenges of data quality and granularity and

unfolding the new possibilities• Using RWD to optimize clinical trial design and execution

Abhik Bhattacharya, PhD., Senior Director & Global Head of Analytics, Astellas US LLC.

4.15 Assessing Clinical Trial Operational Feasibility – the Role of Data Analysis Before Trial Start up• Designing clinical trials – data analysis for decision making in the operational context• Selecting where to operate the trial – which country, which site?• Assessment factors – discussing start-up time, site performance, etc.• Developing the algorithms to analyze design data• Exploring potential new applications of RWD in feasibility assessments


4.45 Chairman’s Closing Remarks

5.00 Close of Conference Day Two & End of Conference

Todd Townsend, PhD., Commissioner’s Fellow, United States Food & Drug Administration (FDA)

Abhik Bhattacharya, PhD., Senior Director & Global Head of Analytics, Astellas US LLC.

Rajneesh Patil, Senior Director, Clinical Development, Quintiles


Regulation & Guidance for the Future

of Data in Clinical Innovation: Wearables,

RWE & Adaptive Trials

Real World Data in Clinical Trials

CDM in Clinical “Research:” Centralized

Monitoring, Analytics & Risk-Based

Monitoring

Advanced Analytics in Clinical R&D







Biostatistics are involved in almost every step of the clinical research process: from study design, to protocol development, data management and monitoring, data analysis or clinical trial reporting.

However, effective communication between non-statistician clinical trial professionals and statisticians is sometimes impaired due to misinterpretation of statistical methods and statistical concepts.

Key Takeaways:• Understanding the full extent the role of Biostatistics in

Clinical Research• Exploring statistical concepts that statisticians convey when

defining the statistical strategy for a clinical study• What factors affect sample size and power determination? • What is involved in the sample size and power estimation?• What is the difference between clinical significance and

statistical significance?• How to increase the power of your study? • Is bigger always better?

In this workshop, you will learn how to ensure successful trial design and analyses by understanding complicated statistical terminology and getting up to speed with the key statistical concepts in clinical R&D, with the focus on sample size and power for study that is affected by:

• Types of endpoints• Type of variables to be measured• Study design• Study phase• Statistical method and models• Effect size• Risk to be taken when making a decision• Confidence Intervals vs. Test of hypotheses• Multiplicity• Subgroup Analysis

Understanding Biostatistics in Clinical Research – Sample Size & Power Considerations in Clinical ResearchDate: Tuesday, January 31, 2017 | Time: 9 am – 12 pm

Dr. Sadek joined the Georgia Cancer Center in 2013 as Head of the Cancer Clinical Trials Biostatistics Unit and Professor of Biostatistics, Department of Biostatistics and Epidemiology. Dr. Sadek came to Augusta University from BioMerieux, Inc., in Durham, NC, where he was the Global Senior Director of Biostatistics and Data Management. He has also served as Senior Director of Biostatistics and Data Management at the NCI-funded Radiation Therapy Oncology Group. Dr. Sadek’s academic interests include oncology research, clinical trials design and analysis, incomplete data analysis, laboratory data analysis, survival analysis, logistic regression, experimental design, and longitudinal studies. Dr. Sadek’s research has focused on oncology studies, sickle cell disease, HIV, infectious diseases, anthrax, and diagnostics. He has received several awards from the Centers for Disease Control and Prevention, where he was a team leader for 12 years, and an Outstanding Teamwork Award from the American College of Radiology and the Education Excellence Award from the Augusta University.

Workshop leaderRamses Sadek, PhD, Professor of Biostatistics & Head of Cancer Clinical Trial Biostatistics Unit, Georgia Cancer Centre, Augusta University

Pre-Conference Workshop

Act now to reserve your place at Advanced Analytics for Clinical Data 2017

Register online at:

www.advancedanalytics-clinicaldata.com/register

http://www.advancedanalytics-clinicaldata.com/register







Sponsorship Opportunities

You’ll Meet People From...

Companies Attending Include

Advanced Analytics for Clinical Data 2017 will host the top data experts from leading pharmaceutical and biotechnology companies across the U.S., including Directors, Managers and Heads of Clinical Data Science, Clinical Innovation, Clinical Research and Clinical Data Management, to discuss the need for a data-driven approach to clinical research and drug development.

This is the perfect place to demonstrate your capability and showcase your solution to an audience of potential buyers.

Meet and interact with stakeholders managing the purchase and implementation of technologies such as eClinical

platforms, EDC, EPRO, clinical trial management systems, cloud platforms, mHealth and wearables and advanced analytics tools.

One of the biggest challenges in this market is the very high number of largely undifferentiated vendors, with many offering unsatisfactory or incomplete solutions.

By sponsoring this meeting, you will be positioned to stand out from the crowd and get ahead of the competition in the eyes of the leading decision makers.

Contact us today to discuss how you can get the best from this opportunity.

The networking opportunities were fantastic.

Biogen, Past Attendee, Hanson Wade Event

I really enjoy this event, very well organized, interesting presentations and effective networking sessions

Merck, Past Attendee, Hanson Wade Event

Become a SponsorContact

Jonathan Elliot Business Development Manager


Pharmaceutical 35%

Biotech 25%

CRO 5%

Academic 5%

Vendors 30%

Clinical Data Science 30%

Clinical Data Management 30%

Clinical Innovation 25%

Clinical Operations 15%

Attendance by Company

Type:

Attendance by Job Title

35%30%

25%5%

5%

15%30%

30%

25%

*Expected attendees for 2017 based on recent industry research





Industry

Register & Pay before Friday October 21, 2016

Register & Pay before Friday November 18, 2016

Register & Pay before Friday December 16, 2016 Standard Prices

Conference + Workshop $2598(save $800)

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Workshop Only $699

Vendor

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Conference Only $2699 (save $300)

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Pricing

Registerwww.advancedanalytics-clinicaldata.com/register

Tel: +1 212 537 5898

Email: [email protected]

Mail: Hanson Wade 4th Floor, 52 Grosvenor Gardens, London, SW1W 0AU

• 10% discount – 3 delegates

• 15% discount – 4 delegates

• 20% discount – 5 or more delegates*Please note that discounts are only valid when three or more delegates from one company book and pay at the same time.

*Academics are entitled to a 40% discount off the Industry Pricing using the code ‘ACA’

(Please note: Discounts cannot be combined with any other offer)

Team Discounts* Top 3 Benefits of Attending

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Discover how to extract real value from massive data sets and new data sources into your clinical research endeavors

Be in tune with the industry shift from ‘data management’ to ‘data science’

Understand how to meaningfully support crucial decision-making for drug development

Venue

Sheraton Fisherman’s Wharf 2500 Mason Street San Francisco, CA, 94133

www.sheratonatthewharf.com

Please note: Overnight accommodation and travel are not included in the registration fee.

Full payment is due on registration. Cancellation and Substitution Policy: Cancellations must be received in writing. If the cancellation is received more than 14 days before the conference attendees will receive a full credit to a future conference. Cancellations received 14 days or less (including the four-teenth day) prior to the conference will be liable for the full fee. A substitution from the same organization can be made at any time.

Changes to Conference & Agenda: Hanson Wade reserves the right to postpone or cancel an event, to change the location or alter the advertised speakers. Hanson Wade is not responsible for any loss or damage or costs incurred as a result of substitution, alteration, postponement or cancellation of an event for any reason and including causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade or industrial disputes, terrorism or hostilities.

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TERMS & CONDITIONS




The talks were high quality and the interaction among participants was excellent.

Genentech, Past Attendee, Hanson Wade Event




http://www.sheratonatthewharf.com




advanced analytics for clinical data full event guide

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