DPHARM EUROPE Disruptive...

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Exploring significant innovation with EU and US examples in clinical development

Disruptive Innovationsto Advance Clinical TrialsDP

HARM

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EUROPE

FEBRUARY 10 - 11, 2015 RADISSON BLU PORTMAN HOTEL, LONDON, UK

Organized byExecutive Sponsors

DPHARM EUROPECO-CHAIR

Jeffrey Kasher, PhDVP, Clinical Innovation & ImplementationEli Lilly

Craig Lipset, MBAHead of Clinical Innovation, R&DPfizer

Craig Ritchie, PhDProfessor of the Psychiatry of Ageing, University of Edinburgh and Visiting Professor, Imperial College London

1ST EUROPEAN ADAPTIVE TRIAL FOR DEMENTIA

DPHARM EUROPECO-CHAIR

Magnus Essand, PhDProfessor of Gene TherapyUppsala University

KEYNOTE:TRANSFORMING A FUNDING GAP

PATIENTS DESIGNING TRIALS

Tom IsaacsCo-FounderThe Cure Parkinson’s Trust

Alexander MastersAuthor, Campaigner and Co-FounderiCancer.org.uk

KEYNOTE:$2 MILLION TO BE IN A TRIAL?

http://WWW.THECONFERENCEFORUM.ORG



OVERVIEW

The Conference Forum is delighted to take the only event dedicated to disruptive innovations to advance clinical trials to Europe.

Event HistoryIt was a daunting task to develop the first industry forum on thinking radically differently about the way we perform clinical trials, but the result was this conference. The event was launched in Philadelphia in September 2011 with 125 disruptive thinkers and change makers eager to discuss current solutions in clinical development, propose innovative changes, and commit to testing and sharing the results in order to transform drug development and the industry.

The first DPharm event addressed virtual clinical trial models, adaptive design thinking, the role of EHRs in clinical data, open source, telemedicine, and self-reported patient data among many other ideas. I remember Dr Tomasz Sablinski, Founder, Transparency Life Sciences saying it was the first event he had attended in a long time where he did not leave feeling depressed.

By the time the 2nd annual DPharm program took place, the concept of applying disruptive thinking to clinical development had taken root, with many attendees bearing titles with clinical innovation in them. Fast forward to 2014, the 4th annual program we ran in September in Boston, addressed numerous examples of innovative thinking to advance clinical trials ranging from collaborative trials, mobile companionship, digital engagement to design thinking, telemedicine and more.

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

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

Sincerely,

Valerie BowlingExecutive DirectorDPharm Europe

Meredith SandsExecutive Director, Business DevelopmentDPharm Europe

Jennifer MoranProduction AssistantDPharm Europe

Jessica RothenbergMarketing DirectorDPharm Europe

DPHARM EUROPE: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS OVERVIEW

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“One of the most productive conferences for me in

terms of getting innovative ideas, as well as meeting

people of a disruptive nature, is The Conference

Forum’s Disruptive Innovations to Advance Clinical

Trials event.”

- Rob Wright, Editor-in-Chief, Life Science Leader




SPEAKING FACULTY

Benoit Arnould, PhDSenior Director, Patient-Centered Outcomes, Mapi HEOR and Strategic Marker AccessMapi

Michael ChekrounCEOCarenity.com

Jae ChungFounder and PresidentgoBalto

Ali Cimen, MDSenior Global Medical Affairs LeaderAstraZeneca

Sue Collier, BSc, MBchB, DRCOGHead of Medical Operations for the Salford Lung Study, Global Respiratory Medical FranchiseGSK

Matt Cooper, PhDLife Sciences Development DirectorNIHR Clinical Research Network

Kara Dennis, MBAChief of StaffMedidata

Lorenzo DiCarlo, MDUK Medical Director and VP, Global Clinical AffairsProteus Digital Health

Magnus Essand, PhDProfessor of Gene TherapyUppsala University

Paul FinneyDirector Europe, Business ConsultantPAREXEL

Laura GaluchieHead, Clinical Performance, Analysis & InnovationMerck Research Laboratories

Drew GartySenior Director, Product ManagementPAREXEL

Pablo GravierCEOTrialReach

Vishal Gulati, MDVenture PartnerDFJ Esprit

John HollandSVP, R&DAMC Health

Tom IsaacsCo-FounderThe Cure Parkinson’s Trust

Jeffrey Kasher, PhDVP, Clinical Innovation & ImplementationEli Lilly

Thomas Krohn, RPh, MBADirector, Lilly Open InnovationEli Lilly

Lisa LaLunaSVP, Corporate Development & ImplementationePharmaSolutions

Craig Lipset, MBAHead of Clinical Innovation, R&DPfizer

Carol Maguire, RNAdministrative Director of Clinical ResearchUCSF Division of Cardiology

Ibraheem MahmoodPresident and CEODrugDev

Alexander MastersAuthor, Campaigner and Co-FounderiCancer.org.uk

Ulo Palm, MD, PhD, MBASVP, Drug Development & Research OperationsForest Laboratories

Pinal PatelStrategic Recruitment LeadBristol Myers Squibb

Christine Pierre, RNPresidentSociety for Clinical Research Sites (SCRS)

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

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SPEAKING FACULTY DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS




Stéphane RouaultHead of Innovation Hub, Strategic InnovationF. Hoffman-La Roche

Tomasz Sablinski, MD, PhDCEOTransparency Life Sciences

Vicki Seyfert-Margolis, MDCEOMyOwnMed

Abbe SteelCEOHealthiVibe

James StreeterSenior Director of Life Sciences Product StrategyOracle Health Sciences

Norman ThompsonGlobal Studies Leader, Product DevelopmentRoche/Genentech

Paul Wicks, PhDVP, InnovationPatientsLikeMe

Hakim Yadi, PhDCEONorthern Health Science Alliance

DAY ONE - TUESDAY, FEBRUARY 10, 2015

8:00 amBreakfast & Registration

8:45 amCo-Chairsʼ Welcome RemarksJeffrey Kasher, PhDVP, Clinical Innovation & Implementation, Eli Lilly

Craig Lipset, MBAHead of Clinical Innovation, R&D, Pfizer

9:00 amHealthcare: The Perfect Storm

In this opening presentation, Dr Vishal Gulati sets the landscape for where we are and where we are going in healthcare to include: demographic changes, what’s transforming our industry and the evolution of technology. What’s disrupting pharma and where are the opportunities?

Vishal Gulati, MDVenture Partner, DFJ Esprit

9:30 amInnovation and the Impact on Clinical Trial Data in the UK

The National Institute for Health Research (NIHR) Clinical Research Network released record figures for commercial contract clinical research in the NHS in England. What changed to drive record results? Dr Matt Cooper, Life Sciences Development Director, NIHR Clinical Research Network is the CIO leading the knowledge and information function of NIHR Clinical Research Network and will share his team’s journey of innovation that has led to record figures including:

• A 26% increase in patient recruitment on the previous year

• Research delivery support to 533 new commercial contract studies, a 17% uplift on the previous year and the highest number since records began

• 86% of Trusts recruited patients onto NIHR Clinical Research Network Portfolio commercial contract studies

• Tripled the proportion of commercial contract studies delivered to 100% time and target (from 21% in 2010/11 to 73% in 2013/14)

• Matt can answer what if questions, but what if the next five years brings even more innovation?

Matt Cooper, PhDLife Sciences Development Director, NIHR Clinical Research Network

10:00 amThe Salford Lung Study

The Salford Lung Study is the world’s first phase III pRCT in asthma and chronic obstructive pulmonary disease (COPD), which aims to randomize over 7,000 patients. In this session, Dr Sue Collier shares the journey of the hurdles in overcoming the enormous effort and resources required to establish this comparative effectiveness study of a pre-licence intervention. GlaxoSmithKline initiated this innovative study to evaluate with as little intervention from the clinical trial team how its once-daily ICS/LABA combination Breo Ellipta impacts health outcomes versus existing treatments.

More specifically:

• The vision

• Trial design

• Electronic health records

DPHARM EUROPE: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS AGENDA

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• Challenges

• Progress

Sue Collier, BSc, MBchB, DRCOGHead of Medical Operations for the Salford Lung Study, Global Respiratory Medical Franchise, GSK

10:30 amNetworking Break

11:00 amNext Steps in Harnessing Big Data to Increase R&D Innovation: What’s Disruptive?

Clinical trials of the future will need to assess data from multiple sources: Passive collectors, diaries, labs, images, EMRs, m2m devices, pharmacies, and more. In this session, James Streeter of Oracle Health Sciences shares his insights on advances in next-generation cloud computing, data warehousing, standards, and clinical software to enable life sciences companies to make great strides in managing the volume, velocity, variety and value that defines ‘big data’. More specifically:

• How disruptive this data will be to our current clinical trial process

• What the end game of all this data will be in 3 to 5 years

• Advantages of data driving intelligence of all this data for clinical operations, clinicians, safety, marketing, and patients

• Actual use-cases and models for creating a single source of accurate, meaningful information, with automated data capture, cleaning and transformation workflows

James StreeterSenior Director of Life Sciences Product Strategy, Oracle Health Sciences

11:20 amPatients Driving Best Practices in Clinical Trial Designs

In this session, Abbe Steel talks with Tom Issacs about a collaborative partnership between scientists, institutions and patients with the aim of making Parkinson’s clinical trials more efficient and effective. Learn how this inspiring example is helping establish key outcomes and best practices in not only Parkinson trials, but could become a model for other diseases at both a local and global level.

Abbe SteelCEO, HealthiVibe, LLC

with

Tom IsaacsCo-Founder, The Cure Parkinson’s Trust

11:50 amHow to Get Real Patient Info: What’s Disruptive?

Transferability of clinical research findings into real world evidence face two major challenges: how can we assess Benefit-Risk from an individual perspective and how can we access to real patients who behave normally – namely, patients whose compliance is not ideal – and include unbiased samples in studies? Through the experience of a large treatment acceptance survey among Carenity patients, a French online community, attendees will learn of the results of an observational, cross-sectional, multi-diseases acceptance survey. Level of treatment acceptance and their determinants in more than 4,000 patients presenting with a variety of chronic diseases, including cancer, metabolic disorders, cardio-vascular diseases, central nervous system diseases, pain conditions, rheumatoid diseases will be presented. This approach has the potential to generate unique information regarding unmet needs, patients priorities, value of innovation, and Benefit-Risk assessment.

Benoit Arnould, PhDSenior Director – Global, HEOR & Strategic Market Access, Mapi, Lyon, France

Michael ChekrounCEO, carenity.com, Paris, France

12:15 pmLuncheon

1:15 pmRevolutionizing Heart Disease with Mobile Technologies: UCSF’s Health eHeart Study

The Health eHeart study is determined to revolutionize the way we predict, prevent, track and treat heart disease through the use of mobile technologies. The study plans to gather more data about heart health from more people than any research study has done before. Data will be used to develop strategies to prevent and treat all aspects of heart disease. The aim is to enroll one million patients.

Carol Maguire, RNAdministrative Director of Clinical Research, UCSF Division of Cardiology

Join the study! www.health-eheartstudy.org

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AGENDA DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS



http://www.health-eheartstudy.org/

http://www.health-eheartstudy.org/


1:45 pmHow TransCelerate Member Companies are Driving Industry Innovation

An update on how the 19 Member Companies of TransCelerate are driving innovation to address clinical trial execution pain points through their 11 chartered workstreams. This session will have three parts:

• The proof is in the pudding: What has TransCelerate delivered that is REALLY disruptive?

• Imagine Running Clinical Trials Together: What Would this Look Like? Imagine having the same protocol, same database, same investigators and same statistical analysis plan. We agree on the primary end points and we don’t have to agree on all the secondary end points. What truths would this reveal?

• A brief overview on looking forward, the Shared Investigator Platform is scheduled to deliver the first release in mid-2015. This platform will streamline collaboration between investigator sites and sponsors to improve clinical research productivity (definitely disruptive). Guest speaker, Jae Chung, Founder and President, GoBalto will join this portion of the session to talk about how he is helping companies make a shared investigator platform a reality.

Jeffrey Kasher, PhDVP, Clinical Innovation & Implementation, Eli LillyMember of TransCelerate Operations Committee

Craig Lipset, MBAHead of Clinical Innovation, R&D, PfizerMember of TransCelerate Operations Committee

with Guest Speaker

Jae Chung, MBAFounder and President, goBalto

2:30 pmLet’s Stop Talking about It and Do It: Implementing Game Changing Technology in Clinical Trials

Ibraheem MahmoodPresident and CEO, DrugDev

2:45 pmDesign Thinking for Clinical Trials: Taking the Mystery Out of Innovation by Embedding it into the Process

What is design thinking and how does it lead to new ideas and significant changes? How does it work and what is involved? How does it get applied to clinical trials with empathy for the end user? Our speaker walks us through the five critical steps:

• Empathizing with the user

• Define the problem from a user perspective

• Ideate

• Prototype

• Test

Stéphane RouaultHead of Innovation Hub, Strategic Innovation, F. Hoffman-La Roche

3:25 pmTransforming Clinical Trials through mHealth

For the first time, mHealth data is being linked directly with traditional clinical data in a way that meets requirements of regulatory bodies such as the US FDA, opening the door to mobile clinical trials. Drawing on case studies, including a joint initiative with GSK, Medidata's Chief of Staff, Kara Dennis, examines this mHealth breakthrough, and explores how advances in capturing and integrating mobile health data are disrupting and transforming clinical trials as well as the role of patients and clinical investigators.

Kara Dennis, MBAVP, Chief of Staff, Medidata Solutions

3:50 pmDigital Engagement: The Impact on Advancing R&D

Dr Vicki Seyfert-Margolis, CEO of My Own Med, Inc. and former Senior Advisor of Science Innovation and Policy to the FDA’s Commissioner’s Office, launched a customizable digital platform and mobile health app that captures between-visit patient health data. The aim is to better educate patients and caregivers, as well as to provide payers and health systems with new analytical tools for understanding patients’ needs. This session addresses the critical nature of user experiences in digital health tools for the long-term engagement of patients. Vicki also addresses what a social network represents for managing one’s health and ultimately how this can advance R&D.

Vicki Seyfert-Margolis, MDCEO, MyOwnMed

4:20 pmCase Study on Understanding Disease Burden with a Global Patient Panel

Find out what made this case study disruptive with

Ali Cimen, MDSenior Global Medical Affairs Leader, AstraZeneca

and

Abbe SteelCEO, HealthiVibe, LLC


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4:50 pmDPharm Idol US Winner on Paperless Clinical TrialsDemonstration of the paperless clinical trial process in one seamless system to include: site feasibility, study start up, study management, patient engagement and consent, remote site monitoring and eSource. Benefits and Metrics will be provided.

Lisa LaLunaSVP, Corporate Development & Implementation, ePharmaSolutions

5:05 pmDPharm Idol: Quick Fire Disruptive Technology Presentations in an “American Idol” Format

This section of the program features six short, but impactful presentations by technology and service companies with a disruptive mission. A panel of judges asks questions and challenge our presenters to tell us how their technologies and services are advancing clinical development. At the conclusion of the session, an award is given to the most disruptive presenter.

The Judges:Vishal Gulati, MDVenture Partner, DFJ Esprit

Jeffrey Kasher, PhDVP, Clinical Innovation & Implementation, Eli Lilly


5:45 pmNetworking Reception

DAY TWO - WEDNESDAY, FEBRUARY 11, 2015

8:00 amBreakfast

8:45 amCo-Chairsʼ Welcome RemarksJeffrey Kasher, PhDVP, Clinical Innovation & Implementation, Eli Lilly


8:50 amBuilding a European Adaptive Trial Delivery Machine for Dementia: The first of it’s kind

In this session, Dr Craig Ritchie shares his journey on how he challenged a traditional system to propose substantial changes to develop a public-private collaborative European clinical platform for preventing dementia: The EPAD (European Prevention of Alzheimer’s Dementia). More specifically Dr Ritchie addresses:

• The questions to ask in challenging old ways of doing things

• Forming and communicating a vision

• What it takes to build public, private and patient collaboration

• Execution and next steps

Craig Ritchie, PhDProfessor of the Psychiatry of Ageing, Centre for Clinical Brain Sciences, University of Edinburgh andVisiting Professor, Imperial College London

9:30 amKeynote Discussion: $2 Million to be in a Clinical Trial? Transforming a Funding Gap in Clinical Research – The Promising Story behind iCancer.org.uk and The Oncolytic Virus Fund

Frustrated that a promising therapy for a rare cancer was sitting in a freezer due to the lack of a relatively modest amount of funding, author Alexander Masters helped lead a campaign to crowd-fund a clinical trial: the result, iCancer.org.uk. The money required was indeed raised – by one wealthy individual primarily, in return for being in the trial. In this disruptive keynote discussion, we address:

• The remarkable story of the formation of iCancer.org.uk and the Oncolytic Virus Fund

• An alternative way to make clinical trials more accessible

• Ethical and moral issues

Magnus Essand, PhDProfessor of Gene Therapy, Uppsala University

Alexander MastersAuthor, Campaigner and Co-Founder, iCancer.org.uk

with host


AGENDA DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

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10:15 amNetworking Break

10:45 amA Trial that Truly Pushes the Envelope on Mobile Technology-enabled Virtual Clinical Trials

Roche/Genentech is supporting a study designed to test the limits of the virtual clinical trial, and AMC Health is providing the technology. This is a trial of ulcerative colitis patients — people who do not want to be on a bus or stuck in traffic for very long. Roche/Genentech, working with AMC Health and Transparency Life Sciences, developed a protocol in which patients never come to a central study site. A baseline endoscopy is performed by their local gastroenterologist, a mobile nurse takes blood, and vitals are done remotely, observed by the study staff for accurate technique during a video visit on a smartphone or tablet. In this session, you’ll hear from the leaders of this collaboration.

John HollandSVP, R&D, AMC Health

Norman ThompsonGlobal Studies Leader, Product Development, Roche/Genentech

11:15 amAn Interview Series of Disruptive Thinkers hosted by Jeffrey Kasher, PhD, Eli Lilly and Craig Lipset, Pfizer

Our co-chairs interview a series of disruptive thinkers.

Crowdsourcing for Cancer Clinical TrialsAs a complement to our keynote session, Dr Tomasz Sablinski, a disruptive doer has been leading efforts in the US on utilizing crowdsourcing in clinical trials and designs for clinical protocols. In this discussion, Dr Sablinski provides an update on this new reality in clinical trials.

Tomasz Sablinski, MD, PhDCEO, Transparency Life Sciences

Solving the Medication Adherence Challenge in Clinical Trials

Highly engaged patients that consistently take their prescribed medications as directed are the cornerstone of a successful clinical trial. Yet, researchers have long struggled to effectively and efficiently validate adherence—relying on an arduous and often inaccurate combination of self-reporting and lab tests. Dr. Lorenzo DiCarlo, VP, Global Clinical Affairs at Proteus Digital Health, discusses how innovative and disruptive technology can help solve this

challenge by providing automated, accurate, and timely insight into medication adherence during a clinical trial.

Lorenzo DiCarlo, MDUK Medical Director and VP, Global Clinical Affairs, Proteus Digital Health

Predicting the Outcomes of Ongoing Trials with Patient Data

Paul Wicks, PhDVP, Innovation, PatientsLikeMe

Establishing the North of England as the Most Disruptive Place to Innovate in Medicine and Clinical Practice

Hakim Yadi, PhDCEO, Northern Health Science Alliance

12:30 pmLuncheon

1:40 pmStrengthening the Clinical Trial Ecosystem through Collaboration: Putting the Investigator in Investigator Databank

Janssen announced investigatordatabank.org, a global collaboration between Janssen, Lilly, Merck, Pfizer and Novartis (with more companies to come) to share investigator information with one another that each company has on file. Investigator Databank aims to reduce administrative burden for investigators and to increase visibility of qualified investigators to research sponsors. Metrics, investigator responses and databank feasibility and site selection: Where are they now?

Laura GaluchieDirector, Clinical Performance, Analytics and Innovation, Merck

2:15 pmDisrupting the Relationship with Sites

Pinal PatelStrategic Recruitment Lead, Bristol Myers Squibb

Christine Pierre, RNPresident, Society for Clinical Research Sites (SCRS)

3:00 pmTrial Match “Patient 2 Trial” Progress

The Patients 2 Consortium effort between Lilly, Pfizer and Novartis is focused on enabling patients and those who serve them to easily pre-screen patients to clinical studies, including using their electronic medical record such as a


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Blue Button+ document. Through consistent, structured clinical trial eligibility criteria made available through an open API technical platform, so-called “matching services” can be enabled to streamline patient engagement and potential clinical trial participation.

The update will include:

• What is “P2T” or Match project

• Where are we today and what is current focus and activity including end-user collaborations

• What types of end-user collaborations are in place, what have we learned, and anticipated benefits to end-users

• What are the key learnings we have had in the consortium that have helped move this project forward

Pablo GravierCEO, TrialReach

Thomas Krohn, RPh, MBADirector, Lilly Open Innovation, Eli Lilly

3:30 pmDirty Laundry Stand-Up

Stand-up professionals share ideas that failed. They are willing to expose their dirty laundry so we can reap the benefits of the lessons learned. Come hear these five minute stories. We welcome our audience to share their dirty laundry secrets with all of us too. An award for best learning from failure will be presented. “It is fine to celebrate success, but it is more important to heed the lessons of failure.” – Bill Gates.

Point-of-Care LabsJeffrey Kasher, PhDVP, Clinical Innovation & Implementation, Eli Lilly

REMOTE RecruitmentCraig Lipset, MBAHead of Clinical Innovation, R&D, Pfizer

RecruitmentUlo Palm, MD, PhD, MBASVP, Drug Development & Research Operations, Forest Laboratories

4:30 pmConference Concludes

HOTEL INFORMATION

Radisson Blu Portman Hotel22 Portman Square, London, W1H 7BGUnited Kingdom+44 207 208 6000www.radissonblu.co.uk/hotel-london

Bookings can be made by calling the reservations department at +44 207 208 6000 or emailing [email protected].

In the heart of the West End, the Radisson Blu Portman hotel boasts an address within walking distance of a variety of transportation options and attractions. Hotel guests can visit London city centre attractions like Big Ben, the popular Oxford Street and even Madame Tussauds Wax Museum. Several Tube stations are also just minutes away, and we are located 30 minutes from Heathrow Airport and 45 minutes from the City Airport via Tube.

REGISTRATION & PRICING

February 10 – 11, 20152nd Early Bird - through Jan 9, 2015 $1,495 / £920

3rd Early Bird - after January 9, 2015 $1,695 / £920

The conference fee includes the program, morning coffee/tea, reception, luncheons, and conference documentation.

To register, go to our website at: www.theconferenceforum.org/events/dpharm-europe/

Discount ProgramsGroup Registration – Receive a 10% discount off each registration when two or more colleagues from the same company register online.

Large group discounts available.

Please contact [email protected] or call 646-350-2580 for any questions on discount rates.

Payment PolicyPayment must be received in full by the event date. All discounts will be applied to the Conference-Only fee (excluding add-ons)‚ cannot be combined with any other offer‚ and must be paid in full at the time of conference.

HOTEL / REGISTRATION DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

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mailto:[email protected]


https://theconferenceforum.org/events/dpharm-europe/

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Substitution and Cancellation PolicyIf you are unable to attend and would like to register a substitute, please email [email protected]. Please ask your substitute to provide identification on-site.

If you need to cancel your registration, please note the following policies based on the start date of the event:

Ten or more business days prior: A full refund less the administration fee of $295, or a pass to another event valid for two years from the date of issue.

Less than ten business days prior: A pass to a future event for either yourself or a colleague from the same company valid for two years from the date of issue.

To cancel and receive a refund or pass, please email [email protected] or call 646-350-2580.

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DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS SPONSORS / PARTNERS

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