Disruptive Innovations to Advance Clinical TrialsDP

HARM EUROPE

February 8 - 9, 2017 Millennium Gloucester Hotel London Kensington, London, UK

for early adapters of new ideas in clinical trials

Led By:

Sue Collier, BSc, MBchB, DRCOG GSK

Jeff Kasher, PhD Patients Can’t Wait

Follow us on Twitter @ConferenceForum #DPharmE

Organized by

Executive Sponsor

Supporting Partners

Associate Sponsors

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Speaker Representatives From:

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DPHARM: DISRUPTING CLINICAL TRIALS EUROPE WELCOME

Dear DPharm Europe Community,

Welcome to the 3rd annual DPharm Europe: Disruptive Innovations to Advance Clinical Trials event. Led by Co-Chairs Dr Sue Collier (GSK) and Dr Jeff Kasher (Patients Can’t Wait), the program presents global case studies on:

• Real World Clinical Trial Strategies and Results

• New Leadership in Driving Clinical Trial Innovation

• Strategies to Validate the Siteless Trial

• Community Outreach and Education in Clinical Trials

• New Financial Models

• Patient Involvement and Engagement

• Brexit Update and Potential Impact on R&D

• Protocol Simulation

• Adaptive Trial Model

With support from MedCity, the British Consulate and NIHR Clinical Research Network, we look forward to bringing more global examples of disrupting clinical trials and to collaborating on an even broader scale between industry and others.

Highlights for 2017 include:

• Making History: the results of crowdfunding the first clinical trial and the possibilities for the future of drug development

• Real World Data Strategy and Results to Disrupt Clinical Trials

• New European Leadership from Big Pharma Disrupting Clinical Research

• Community Collaborating with Industry to Disrupt Clinical Trials

Not all innovation is disruptive. However, as a global community, we can continue to drive down the cost of drug development and provide better access to clinical trials through innovation, while greatly enhancing the patient experience. Have a great conference.

Sincerely,

Valerie BowlingExecutive Director

Jennifer MoranConference Producer

Meredith SandsExecutive Director, Business Development

Elizabeth BardBusiness Development Manager

Jackie Della TorreBusiness Development Manager

Nancy BelisConference Logistics Planner

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SPEAKING FACULTY DPHARM: DISRUPTING CLINICAL TRIALS EUROPE

SPEAKING FACULTY

Graham Belgrave Chief Operations Officer Cmed

Parth Chakrabarti, MBA Senior Director, Transactions Johnson & Johnson Innovation, Boston

Paul Charlton Patient Ambassador

Sue Collier, BSc, MBchB, DRCOG Clinical Development Director and Physician Leader RWE Studies GSK

Valentin Hamy, PhD Clinical Development Manager GSK

Melissa Harris Senior Account Director Langland

Bert Hartog, PhD Director, R&D Operations Innovation Janssen

Mélanie Héroult Innovation Director Bayer AG

Sara James, PhDConsultant, Adoption Implementation, Clinical InnovationEli Lilly & Company

Kevin Jenkins Project Director Clinical Innovation and Digital Platforms GSK

Jeff Kasher, PhD President Patients Can’t Wait

Thomas Klein Founder and CEO Be the Partner

Alexander Masters Author, Campaigner and Co-Founder iCancer.org.uk

John Molony Patient Ambassador

Kate Moss Partner PwC UK

Jo Pisani, MBA Partner at Strategy& PwC UK

Claire Potter Acting Head of Research and Knowledge Transfer University of Birmingham

Jenny Preston, PhD Patient and Public Involvement Manager, NIHR Alder Hey Clinical Research Facility andPatient and Public Involvement Priority Lead, National Institute for Health Research (NIHR)

Emilia Quattrocchi Director Clinical Development, Rheumatology & Autoimmune Diseases GSK

Vanessa Reddy Strategic Innovation Leader Roche

Jane Rhodes, MBA, PhD Senior Director, New Initiatives Biogen Idec

Craig Ritchie, PhD Professor of Psychiatry of Ageing, Centre for Clinical Brain Sciences, University of Edinburgh and Visiting Professor, Imperial College London

Tomasz Sablinski, MD, PhD CEO Transparency Life Sciences

Janet Valentine Director Clinical Practice Research Data Link

Keith Wilson Patient Ambassador

Hakim Yadi, PhD, OBE CEO The Northern Health Science Alliance

Guy Yeoman VP, Patient Centricity AstraZeneca

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DPHARM: DISRUPTING CLINICAL TRIALS EUROPE AGENDA

DAY ONE - WEDNESDAY, FEBRUARY 8, 2017

8:00 am Registration

8:45 am Chair’s Welcome and Opening Remarks Jeff Kasher, PhD President, Patients Can’t Wait

MAKING INNOVATION A REALITY IN BIG PHARMA WITH JOHNSON & JOHNSON AND ROCHE

9:00 am New Leadership in Innovation at Johnson & Johnson Parth Chakrabarti, MBA Senior Director, Transactions, Johnson & Johnson Innovation, Boston

9:40 am Strategic Innovation at Roche/Genentech Vanessa Reddy Strategic Innovation Leader, Roche

10:15 am Networking Break

DISRUPTING PATIENT OUTREACH, ENGAGEMENT & ADHERENCE: PROGRESS

10:45 am A Clinical Trial Bus Engaging in Research: Yes, Clinical Trials on Wheels! The pioneering Health Research Bus (HRB) has been developed to further public engagement and education in clinical research and to overcome the static reality of clinical trials. The facility on wheels acts as a fully functional mobile clinical research facility and contains all the equipment necessary to perform a wide variety of clinical studies. It enables scientists to access a large population of diverse ethnic and socio-economic mix in the surrounding community. In this session, Claire Potter, Acting Acting Head of Research and Knowledge Transfer, University of Birmingham shares the journey in establishing the initiative and the lessons learned to date.Claire Potter Acting Head of Research and Knowledge Transfer, University of Birmingham

11:15 am Connecting Patients to Clinical Trials Through an Online Ecosystem: Lilly TrialGuide Traditional recruitment campaigns are time consuming, expensive, transactional and no longer optimal. With more patients going online for health information and becoming empowered to make healthcare decisions, Eli Lilly &

Company recognizes this shift in patient behavior and is evolving its approach. With Lilly TrialGuide as the centerpiece, a shift to tailored, everlasting patient centric digital recruitment campaigns focuses on content, patient experience and results. In this session, Dr Sara James, Innovation Lead, Clinical Innovation, Eli Lilly & Company discusses the steps they are taking to enable patients to find the information they need through organic searches and earned media instead of sponsors relying exclusively on paid media.Sara James, PhD Consultant, Adoption Implementation, Clinical Innovation, Eli Lilly & Company

11:45 am The Patient Ambassador Initiative Jenny Preston, PhD Patient and Public Involvement Manager, NIHR Alder Hey Clinical Research Facility andPatient and Public Involvement Priority Lead, National Institute for Health Research (NIHR)

Panelists: Paul Charlton Patient Ambassador

John Molony Patient Ambassador

Keith Wilson Patient Ambassador

12:15 pm What Is the Latest with Brexit’s Impact on Clinical Research? With the UK voting to leave the EU, pharmaceutical and life sciences organisations will no doubt be considering the impact of issues ranging from regulations and funding to migration and trade. While the result of the referendum is known, we are only just beginning to get a sense of what shape the UK’s exit will take and the impact this may have on the sector. In this session, Jo Pisani, Partner at Strategy&, PwC UK, will discuss in more detail some of the issues and opportunities that the EU transition presents to the Lifesciences industry. Jo Pisani, MBA Partner at Strategy&, PwC UK

12:35 pm Luncheon

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AGENDA DPHARM: DISRUPTING CLINICAL TRIALS EUROPE

IMPACT OF REAL WORLD DATA

1:45 pm How to Design a Clinical Trial with Real World Data Clinical Practice Research Datalink (CPRD) is a not-for-profit research service jointly funded by the NHS, NIHR and the MHRA, a part of the Department of Health. CPRD has created a seamless system to connect evidence-based recruitment, trial management and data collection.This integrated approach using real world primary care data opens up a wealth of previously untapped clinical research possibilities. In this session, Janet Valentine, Director, CPRD, demonstrates how CPRD has used the data collected in a new trial design.Janet Valentine Director, Clinical Practice Research Datalink (CPRD)

2:15 pm The Results Are In! Case Study with a Phase 2b Alzheimer Trial in a Hospital Setting Bert Hartog, PhD, Director, R&D Operations Innovation, Janssen, shares the full results of a trial simulation from a phase 2b Alzheimer study in three countries with both experienced trial participants and people new to trials. This session demonstrates lessons learned from a powerful way to generate direct insights from new and experienced participants.Bert Hartog, PhD Director, R&D Operations Innovation, Janssen

2:45 pm Building an Ecosystem of Patient Communication Beyond Trial Participation • Be the Partner will discuss how it took a "patient first"

perspective in building its platform, using patient input and feedback

• The firm will present the results from an initial pilot of the platform in a study conducted by a large pharma sponsor

• Leveraging the success of the pilot of learnings from it and further patient input, Be the Partner will discuss the future of the platform and the opportunity for pharma to create a pre-competitive, patient-centric asset

Thomas Klein Founder and CEO, Be the Partner

3:00 pm Networking Break

3:30 pm Best of Breed Innovation Models - New Collaboratives and Real World Data Hakim Yadi, PhD, OBE CEO, The Northern Health Science Alliance

4:00 pm Protocol Simulation: An AstraZeneca Case Study Guy Yeoman VP, Patient Centricity, AstraZeneca

4:30 pm Innovative Sources & Solutions: Quickfire Disruptors This is an opportunity to hear how innovative companies are helping to move clinical trials forward. All presentations focus on solving problems in clinical trials. What is the problem or challenge and how is each company using an innovative solution to solve it? This session will showcase how each company is making change possible.Presenting Companies: Cmed Graham Belgrave Chief Operations Officer

Biogen Idec Jane Rhodes, MBA, PhD Senior Director, New Initiatives

Langland Melissa Harris Senior Account Director

5:30 pm Cocktail Reception

DAY TWO - THURSDAY, FEBRUARY 9, 2017

8:00 am Breakfast

8:45 am Co-Chairs’ Opening Remarks Sue Collier, BSc, MBchB, DRCOG Clinical Development Director and Physician Leader RWE Studies, GSK

Jeff Kasher, PhD President, Patients Can’t Wait

MAKING INNOVATION A REALITY IN BIG PHARMA WITH BAYER AG

9:00 am Innovation in What You Do at Bayer

• Driving innovation culture throughout the organization

• Fostering internal and external collaboration

• Increasing agility by business experimentation

Mélanie Héroult Innovation Director, Bayer AG

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DPHARM: DISRUPTING CLINICAL TRIALS EUROPE AGENDA

9:30 am The Salford Lung Study: The Latest on Obtaining Real World Evidence The pioneering Salford Lung Study is the world’s first phase lll pRCT in asthma and chronic obstructive pulmonary disease (COPD), which recruited 2,800 patients and compared the effectiveness of Relvar Eliipta versus existing treatments. In this session, Dr Sue Collier shares the positive results and the latest on the outcomes and next steps in the analysis of this real world evidence.Sue Collier, BSc, MBchB, DRCOGClinical Development Director and Physician Leader RWE Studies, GSK

10:15 am Networking Break

WHERE ARE THEY NOW?

10:45 am Making History: Crowdfunding Clinical Trials Alexander Masters reports on a pioneering new project making global history in clinical trials.Alexander Masters Author, Campaigner and Co-Founder, iCancer.org.uk

11:30 am Building a European Adaptive Trial Delivery Machine for Dementia Craig Ritchie, PhD Professor of Psychiatry of Ageing, Centre for Clinical Brain Sciences, University of Edinburgh

12:15 pm Luncheon

1:30 pm Strategic Approach to the Siteless Trial Model Tomasz Sablinski, MD, PhD CEO, Transparency Life Sciences

2:00 pm Innovation at GSK: the mHealth Parade Study GSK Innovation team has launched a tool designed to gather in-life data from subjects without the use of traditional investigative sites. This study was designed to gather data on patients with Rheumatoid Arthritis to evaluate the potential for enrollment and compliance in a siteless model.In this session Kevin Jenkins, Project Director Clinical Innovation and Digital Platforms and Emilia Quattrocchi, Director Clinical Development, Rheumatology & Autoimmune diseases and Valentin Hamy, Clinical Development Manager will discuss how GSK planned and deployed, and will analyze this study with specific focus on:

• Vision and Introductions

• mHealth and Parade Background Fit and Objectives

• Rheumatoid Arthritis and the Parade Study

• Data Analysis and Algorithm Development

• Summary

Valentin Hamy, PhD Clinical Development Manager, GSK

Kevin Jenkins Project Director Clinical Innovation and Digital Platforms, GSK

Emilia Quattrocchi Director Clinical Development, Rheumatology & Autoimmune Diseases, GSK

2:35 pm Town Hall Meeting - A Call to Action Our innovative leaders reflect on the past two days and discuss:

• What does it all mean?

• How do we take action on the ideas shared?

Moderated by: Kate Moss Partner, PwC UK

Panelists: Jeff Kasher, PhD President, Patients Can’t Wait

Jane Rhodes, MBA, PhD Senior Director, New Initiatives, Biogen Idec

3:15 pm Conference Concludes

The 7th annual event the life science industry can rely on for the latest thinking in clinical trials for 21st century drug development.

SEPTEMBER 7-8, 2017 BOSTON, MA

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EXECUTIVE SPONSOR A global leader in serving the pharmaceuticals and life sciences industry, PwC has extensive experience working with companies on industry specific strategic, operational, and financial issues across the value chain.

Our expertise includes assurance, tax and advisory services, as well as specialised capabilities in regulatory compliance, risk management, performance improvement and transaction support. www.pwc.com/pharma

ASSOCIATE SPONSORS The biopharmaceutical industry is investing billions of dollars in clinical trials and loses countless millions on patients leaving during a clinical trial or

on patients lost to follow-up after a trial has ended. The Be the Partner platform can potentially save trial sponsors millions of dollars per trial. Be the Partner is an exclusive SaaS platform providing a means for engaging active trial participants, trial alumni and future trial participants, designers and patient advocates, while maintaining required patient anonymity. Be the Partner adds value to the services of sponsors, CROs and Health IT companies that work inside clinical trials while bringing new and unique services outside the trial. The Be the Partner platform will open a new and valuable value proposition that does not exist today: once a patient has left a trial, the sponsors will have access to this patient. The platform runs in the USA and will be expanded along with data privacy and data safety regulations to 32 countries in 2017.www.bethepartner.com

Cmed is an innovative, full service, technology-led CRO, dedicated to providing customers with a friendly, proactive and supportive customer

service. Cmed brings together a team of experienced people and its own innovative technology to inspire and drive real progress throughout the clinical trial process. Cmed’s new generation Clinical Data Suite, encapsia™, streamlines the capture, management and reporting of clinical data beyond what is currently possible. www.cmedtechnology.com

For your study to succeed, efficient patient recruitment and retention is vital. That’s why Langland combines

healthcare intelligence with creative engagement to develop innovative and effective enrollment strategies – an approach that has helped to recruit more than 350,000 patients for 350 studies across 75 countries. langlandpatientrecruitment.com

EXHIBITOR MEDICODOSE Systems is dedicated to the research and development of smart

pharmaceutical packaging, clinical software platform and data management. Our solutions enable: Real time monitoring and management of patients’ adherence to clinical trials protocols; Increased treatment efficacy and safety for patients following an improved compliance toward their medication regimens and ePRO data management and true and faithful real time access to subjects’ Cross-AdherenceTM data. medicodose.com

SUPPORTING PARTNERS

The Center for Information and Study on Clinical Research Participation (CISCRP) was founded in 2003, and is a non-profit

organization dedicated to engaging the public and patients as partners in the clinical research process. As part of its mission, CISCRP provides a variety of award-winning resources, programs and services that are designed to assist clinical research stakeholders in understanding public and patient attitudes and experiences in research as well as improving volunteer participation experiences and satisfaction. Visit www.ciscrp.org

MedCity is a collaboration between the Mayor of London and the capital’s three Academic Health

Science Centres – Imperial College Academic Health Science Centre, King’s Health Partners, and UCL Partners. Launched in April 2014 to promote and grow the world-leading life sciences cluster of England’s greater south east, it is promoting life sciences investment, entrepreneurship and industry in the region. Over the next 20 years, MedCity will position the greater south east of England as a world-leading, interconnected region for life sciences research, development, manufacturing and commercialization to stimulate greater economic growth. Learn more at www.medcityhq.com

MEDIA PARTNERS

SPONSORS DPHARM: DISRUPTING CLINICAL TRIALS EUROPE