DPHARM Disruptive Innovations - theconferenceforum.org · 11.09.2014 · be engaging in a highly informative format, similar to the style of TED events. Each session will deliver

Explore significant innovation in clinical development

4th Annual

Disruptive Innovationsto Advance Clinical TrialsSEPTEMBER 11 - 12, 2014 FAIRMONT COPLEY PLAZA, BOSTON, MA

Imagine Running Clinical Trials Together

Prototyping & Testing New Approaches to Faster and Cheaper Clinical Trials

Reducing Geographic Barriers in Clinical Trials

Empowering Innovation

Demystifying “big data”

The Rise of Digiceuticals

The Real Social Media Revolution in Clinical Trials

- plus -

on September 10, 2014

Mobile + Clinical TrialsHow Mobile is Innovating Clinical Trials

DPHA

RM

HIGHLIGHTS

LED BY

Komathi StemGenentech

Craig Lipset, MBAPfizer, Inc.

Andreas Koester, MD, PhDJanssen

Jeffrey Kasher, PhDEli Lilly

REGISTER AT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Follow us on Twitter @ConferenceForum #DPharm Organized by

Executive Sponsors

http://WWW.THECONFERENCEFORUM.ORG



OVERVIEW

The Conference Forum is pleased to present the 4th Annual DPharm: Disruptive Innovations to Advance Clinical Trials event. This is the only conference truly dedicated to exploring and addressing where there is significant innovation in clinical trials.

- Radical Thinkers are Especially Welcomed -

We bring together an exceptional audience of out-of-the-box thinkers determined to make clinical trials more affordable, efficient, with higher quality data and a far better experience for patients.

It is an outcomes-focused program that not only delves deeply into the key strategic factors impeding clinical trial productivity, but also endeavors to connect change makers who can share current solutions, propose new solutions and commit to testing them and share the results. This conference is designed to be engaging in a highly informative format, similar to the style of TED events. Each session will deliver a clear set of objectives, summary and key take-aways.

Focus & Objectives

• This is a TED-style event showcasing innovations and leading practitioners in Pharma R&D with a focus on clinical research as well as innovative leaders from other industries.

• We strive to underscore the promise and challenge of innovation in advancing drug development.

• We strive to innovate a new model and find collaborations to get therapeutics to patients faster.

• We address how can we better apply the full spectrum of clinical research options and utilize insights more appropriately.

• We are dedicated to designing creative solutions and finding a way to implement them.

• We explore to whom are companies being disruptive to gain a better understanding of the impact on clinical trials.

We invite you to review the 2014 agenda and let us know if you have any questions or ideas to share. Contact us at [email protected].

Registration is open for the 2014 event at early discounted rates.

Sincerely,

Valerie BowlingExecutive DirectorDPharm

Jessica RothenbergMarketing DirectorDPharm

Meredith SandsExecutive Director, Business DevelopmentDPharm

Ciara HealySenior Conference CoordinatorDPharm

Jennifer MoranProduction AssistantDPharm

DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS OVERVIEW

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DPharm is the definitive event for innovators in the clinical trial space. The entire conference introduces novel and bold approaches to help attendees think radically differently about how we do clinical trials.



mailto:[email protected]



SPEAKING FACULTY

Mohammed AliGPM, Global Clinical Operations, Strategic Program DevelopmentNovartis

Carol AliyarSVP, Study Start-UpINC Research

Jeff Allen, PhDExecutive DirectorFriends of Cancer Research (Friends)

Santiago Arroyo, MDVP, CMO & Head of Clinical Research for Pharma TherapeuticsPfizer Worldwide R&D

Heather BellVP Program Management, IT/OperationsAstraZeneca

Robert BolandExternal Innovation, R&D ITJanssen

Zen Chu, MBA *Faculty Director and Entrepreneur-In-ResidenceMIT

Jae ChungFounderGoBalto

Sue Collier, PhDHead of Medical Operations for the Salford Lung Study, Global Respiratory Medical FranchiseGSK

Bill CooneyPresident and CEOMedPoint Digital

Steve Cutler, PhD, MBACOOICON, plc

Diana DeGetteEnergy and Commerce Committe Member

Ray Dorsey, MD, MBAProfessor of Neurology and Co-Director of The Center for Human Experimental TherapeuticsRochester Medical Center

Barbara ElashoffCEOPatient Profiles

Julie FlygareFounderProject Sleep

Marc FosterCOOTransparency Life Sciences

Matthew Galsky, MDAssociate Professor of Medicine, Medical OncologistIcahn School of Medicine at Mount Sinai

Pablo GravierCEOTrialReach

Adam Hanina, MBACEOAiCure

Josepf HaslamManaging Director of SEO & Social MediaEducationDynamics

John HollandSVP, R&DAMC Health

Stuart Horowitz, MBA, PhDPresident, Institutions & Institutional ServicesWIRB-Copernicus Group

Deborah HoweAssociate Director of Vendor Management, Global Recruitment & AnalyticsBristol-Myers Squibb

Sachin Jain, MD, MBACMIOMerck Research Laboratories

Donald Jones, MBAChief Digital OfficerScripps Translational Science Institute

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SPEAKING FACULTY DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS




Jeffrey Kasher, PhD *VP, Clinical Innovation & ImplementationEli Lilly

Joseph Kim, MBA *Director of Clinical Innovations & OperationsShire

Andreas Koester, MD, PhD *VP, Clinical Trial Innovation & External AlliancesJanssen

Issac Kohane, MD, PhDChair Informatics ProgramBoston Children’s Hospital

Katya KoganovaDirector of Marketing and Community OutreachCureLauncher

Thomas Krohn, RPh, MBADirector, Lilly Open InnovationEli Lilly

Sterling LanierCo-Founder and CEOTonic Health

Martin LeachVP, R&D ITBiogen Idec

Mark Lim, PhDMedical Research Innovation Associate DirectorFasterCures

Craig Lipset, MBA *Head of Clinical Innovation, R&DPfizer, Inc.

Ibraheem MahmoodPresident & CEODrugDev

Lynn Marks, MD *SVP, Projects, Clinical Platforms & SciencesGSK

Eddie Martucci, PhDFounder & VP, Research and DevelopmentAkili Interactive Labs

Adrian McKemeySVP, ConsultingQuintiles

Joling MewSenior Development Excellence Leader, Global Product DevelopmentGenentech, Inc.

Barry MiltonDirector, Project and Regulatory ManagementNovartis

Jules Mitchel, PhD, MBA *PresidentTarget Health Inc.

Paulo Moreira *VP, GCO, Head of External InnovationEMD Serono

Linda MorganResearch Advocate & Patients Advisory Council MemberParkinson's Disease Foundation

John Orloff, MDGlobal Head of R&DBaxter BioSciences

Ulo Palm, MD, PhD, MBA *SVP, Drug Development & Research OperationsForest Laboratories

Stephanie PetroneExecutive Director, Clinical OperationsNovartis Oncology US CD&MA

Stephanie PetroneExecutive Director, Medical Operations, US Clinical Development & Medical AffairsNovartis Oncology

Christine PierrePresidentSociety for Clinical Research Sites (SCRS)

Jeffrey RamseyConsultant, Clinical Development InnovationEli Lilly

Sanjoy RayDirector, Technology InnovationMerck

DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS SPEAKING FACULTY

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Vicki Seyfert-Margolis, MDCEOMyOwnMed

Darshan Shah *Innovation Leader, Clinical OperationsAstraZeneca

Abbe SteelFounder and CEOHealthiVibe

Komathi Stem *Senior Director, Product Development, Innovation LeadGenentech

James Streeter *Senior Director of Life Sciences Product StrategyOracle Health Sciences

Richard Van AsFounderRobohand

Joris Van Dam, PhD *Strategic Project Leader, Pharmaceutical DevelopmentNovartis

Matt WallachCo-Founder & PresidentVeeva

Rick WardSenior Director, Business DevelopmentGreenphire

Helen WestVP, Strategic DevelopmentMMG

Kate WilsonDirector, Digital Health SolutionsPATH

David Winternheimer, PhD, MBMVP, MarketingSanguine BioSciences, Inc.

* DPharm 2014 Advisory Board

DAY ONE - THURSDAY, SEPTEMBER 11, 2014

8:00 amBreakfast & Registration

8:45 amCo-Chairsʼ Welcome RemarksInnovation and Disruptive Innovation: Challenges and Overcoming Them – Who is Disrupting the Pharma Industry?

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

Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances, Janssen

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

Komathi StemSenior Director, Product Development, Innovation Lead, Genentech

9:00 amImagine 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?

Jeff Allen, PhDExecutive Director, Friends of Cancer Research (Friends)

Lynn Marks, MDSVP, Projects, Clinical Platforms & Sciences, GSK

Santiago Arroyo, MDVP, CMO & Head of Clinical Research for Pharma Therapeutics, Pfizer Worldwide R&D

9:30 amMobile Health 2.0: The Rise of Digiceuticals

The first wave of mobile health brought the platform capabilities of mobile health-oriented data collection to the consumer space. The next iteration will validate mobile data analytics, creating a “digital biome” where data collected from the patient’s pocket constitute digital biomarkers of disease. A patient-centric philosophy which

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AGENDA DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS




creates an engaging and inviting environment for the user combined with back-end data gathering can create an ecosystem where both patient and investigator benefit. Apps which are inherently useful to the user and driven by analytics validated in rigorous trial settings may garner uptake and reimbursement not unlike traditional pharmaceutics. This is Mobile Health 2.0, and the rise of Digiceuticals.

Heather BellVP Program Management, IT/Operations, AstraZeneca

10:00 amThe Salford Lung Study

GlaxoSmithKline initiated an innovative clinical trial called the Salford Lung Study in 2012 to evaluate with as little intervention from the clinical trial team as possible how its once-daily ICS/LABA Breo Ellipta impacts health outcomes versus existing treatments. Electronic health records are critical to track patients’ outcomes and health care utilization. More specifically:

• Vision

• Trial design

• Challenges

Sue Collier, PhDHead of Medical Operations for the Salford Lung Study, Global Respiratory Medical Franchise, GSK

10:30 amNetworking Break & Soapbox Presentations

Presenting companies:

• Comprehend Systems

• CureLauncher

• HealthCarePoint

• ImageIQ

• Phlexglobal

• Xhale

11:15 amA Mobile Registry for Rheumatic Heart Disease in Africa – Can the Technology Disrupt How We Run Clinical Trials in the Developed World?

Novartis is launching a mobile disease registry for rheumatic heart disease, screening 10,000 patients over a six month period. Find out what the low cost high impact way they set up a mobile disease registry, and how they are now exploring opportunities to use this same platform to run / disrupt “normal” studies as well.

Joris Van Dam, PhDStrategic Project Leader, Pharmaceutical Development, Novartis

11:30 amGamification

Video Games as Next-generation Clinical Trial Tools: How Engagement + Science are Enabling at-Home Cognitive Metrics

How can clinical trials be transformed with a platform that combines gaming and science? Our speaker will provide specific examples in running a trial with Pfizer in Alzheimer’s disease. A demo video showing actual clinical data (in the form of action video game play) from an ongoing pediatric clinical study will also be featured.

Eddie Martucci, PhDFounder & VP, Research and Development, Akili Interactive Labs

Planning a Randomized Controlled Trial for a Serious Game to Help Children with ADHD

Executing a randomized controlled trial for a serious game to help children with ADHD requires careful planning with a number of partners. The impact of the game was tested in a clinical trial and our speaker takes you through:

• The journey

• The game

• Clinical and commercial trial results

Annik WillemsManager Health Information Sciences, Janssen

11:55 amWhere are They a Year Later?

Led by:


DrugDevIbraheem MahmoodPresident & CEO

QuintilesTBA

Target Health IncJules Mitchel, PhD, MBAPresident

TrialReachPablo GravierCEO

DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS AGENDA

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12:30 pmLuncheon

1:45 pmMeet Oz

The FDA knows both industry and the National Institute of Health have to change the way they conduct clinical trials and seek alternative methods for finding patients. Find out how biomedical informaticist, physician, and i2b2 founder Dr Isaac Kohane is leading efforts to bring down the costs of clinical trials 10 times.

Issac Kohane, MD, PhDChair Informatics Program, Boston Children’s Hospital

Follow up Q&A – Enabling Patients to Donate Data. How Can this Change R&D?


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

2:05 pmAn Interview Series of Disruptive Thinkers hosted by Craig Lipset, Pfizer

Our co-chair Craig Lipset, MBA, Head of Clinical Innovation, Research & Development, Pfizer Inc. interviews the following disruptive thinkers:

Kate WilsonDirector, Digital Health Solutions, PATH

Putting Digital Innovation into Motion for Global ImpactPATH is an international nonprofit organization that transforms global health through innovation. Their approach blends the entrepreneurial spirit of business, the scientific expertise of a research institution, and the passion and on-the-ground experience of an international NGO. How is the Director of Digital Health Solutions at PATH leading her team to bridge the gap between those who understand health and people who understand IT? What is their progress so far and how is PATH looking at running clinical trials cost effectively in the developing world?

Zen Chu, MBAFaculty Director and Entreprepreneur-In-Residence,MIT

Digital Healthcare Transformation in China: Lessons Learned for Clinical TrialsOn the pulse of digital healthcare transformation in China, MIT Hackathon leader, Zen Chu updates us on:

• MHealth in China: what’s happening

• Reaching doctors via mHealth in China

• Engaged patients in China today

• Brand vs generic Trust in China

• The next wave of consumer health growth in China

Sachin Jain, MD, MBACMIO, Merck Research Laboratories

Demystifying “big data” for clinical researchSome of the realities of how diverse data is used today, and where future growth and innovation is most promising. What are some of the interesting ways EMR and real world data can be used to enhance study design and planning? Thoughts on true disruption in clinical trials. What are the challenges of building something new in something old? It is not just the what, it’s the how.

James StreeterSenior Director Life Sciences Product Strategy, Oracle

Oracle Update on Biomarker Data for Clinical TrialsOracle shares their progress on biomarker data for clinical trials where less data is needed and can be shared from other trials. The impact on trial design, patient recruitment and length of trial time is also discussed.

Mark Lim, PhDMedical Research Innovation Associate Director, FasterCures

5-Minute Review on Consortia-pediaMark Lim, PhD, author of the Consortia-pedia project, shares highlights on understanding the breadth and scope of a wide range of consortia and what they are doing to advance R&D. The Consortia-pedia project is to better understand the breadth and scope of approaches that a wide range of consortia have adopted to bring together non-traditional partners with a shared R&D goal. Mark will also address challenges that some consortia are facing as well as opportunities to further collaboration.

Donald JonesChief Digital Officer, Scripps Translational Science Institute

How Can We Marry a Digital Solution with our Drugs to Allow Us to Understand Outcomes and the Ability to Manage Regulatory and Reimbursement Demands?


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Craig Lipset, Pfizer with Krishna Yashwant, Google Ventures




3:00 pmNetworking Break

3:30 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

3:50 pmHow a Patient Helped Define a New Clinical Endpoint in Narcolepsy

Diagnosed with narcolepsy with cataplexy in 2007, award-winning author and founder of Project Sleep, Julie Flygare, shares her story on how she helped define a clinical endpoint with the FDA and what this can mean for the future of drug development.

Julie FlygareFounder, Project Sleep

4:05 pmA Collaborative IT Eco System to make Clinical Innovation Happen: A Leadership View on Getting it Right

Led by:

Martin LeachVP, R&D IT, Biogen Idec

with

Robert BolandExternal Innovation, R&D IT, Janssen

Adrian McKemeySVP Consulting, Quintiles

Sanjoy RayDirector, Technology Innovation, Merck

4:40 pm3rd Annual DPharm Idol: Quick Fire Disruptive Technology Presentations in an “American Idol” Format

This section of the program features eight short, but impactful presentations by technology disruptive developers and services. 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.

Last year’s winners, Medidata give us an update on their collaboration and progress to kick off DPharm Idol.

Judges:

Paulo MoreiraVP, GCO, Head of External Innovation, EMD Serono

Linda MorganResearch Advocate & Patients Advisory Council Member, Parkinson’s Disease Foundation

John Orloff, MDGlobal Head of R&D, Baxter BioSciences

Ulo Palm, MD, PhD, MBASVP, Drug Development & Research Operations, Forest Labs

Darshan ShahInnovation Leader, Clinical Operations, AstraZeneca

Komathi StemSenior Director, Product Development, Innovation Lead,Genentech

Presenting companies to date:

AiCure ePharma Solutions

iCTRS MedPoint Digital

MMG Patient Profiles

Veeva Systems

5:45 pmNetworking Reception


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Adrian McKemey, Quintiles at DPharm Idol

Randy Spaulding, Spaulding Clinical and Glen de Vries, Medidata




DAY TWO - FRIDAY, SEPTEMBER 12, 2014

8:00 amBreakfast

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


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


9:00 amKeynote: 21st Century Cures Update & Q&A with Rep. Diana DeGette (D-CO)

21st Century Cures is a new initiative that aims to accelerate the pace of cures and medical breakthroughs in the United States. Rep. Diana DeGette (D-CO) and House Energy and Commerce Committee Chairman Fred Upton (R-MI) are leading this initiative.

“The 21st Century Cures initiative is a rare effort in Congress where there are no preconceptions about what we are going to do before we do it.” said Rep. DeGette. “I am excited that this initiative will take a big picture look at our health care system in this country: the research, approval process, and how we get it to clinical application to make it more affective for patients and keep our preeminence in the world as the leader in biomedical research.”

In this session, Rep. Diana DeGette provides an update on the initiative and takes Q&A from our audience.

Rep. Diana DeGette (D-CO)Energy and Commerce Committee Member

9:30 amSocial Media Revolution in Clinical Trials: When?

If you want information seeking patients to find you, you must by definition, be social. The truth of the matter is that patients don’t see research and treatment as two different things. They all just want to feel better. When they know about research, they position it as treatment in their minds. In this session, Josepf Haslam, called the Godfather of Social Media, teams up with Joseph Kim, Clinical

Operations Director, Shire to address current social media and the new eco system for clinical trials.

Josepf HaslamManaging Director of SEO & Social Media, EducationDynamics

with

Joseph Kim, MBADirector of Clinical Innovations & Operations, Shire

10:00 amHow Can We Learn to Prototype and Test New Approaches to Faster and Cheaper Clinical Trials?

This session is focused on design thinking and how this leads to new ideas and amazing changes. It takes the mystery out of innovation by embedding it into a process. It involves five critical steps:

• Empathizing with the user

• Define the problem from a user perspective

• Ideate

• Prototype

• Test

Led by:


with

Joling MewSenior Development Excellence Leader, Global Product DevelopmentGenentech, Inc.

10:30 amHow Can the Healthcare Startup Model Improve Our Clinical Trials?

How can we bring a healthcare start up culture to pharma to help us be more innovative? What does the risk-taking, entrepreneurial environment look like beyond patient engagement? If a large, regulated hospital system can implement entrepreneurial risk-taking approaches, then pharma should also be able to. How are hospitals making data collection fun and patient-friendly with new approaches and technologies that could be leveraged for clinical trials to accelerate timelines, etc.?


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Joseph Kim, Shire presenting at DPharm 2013




Sterling LanierCo-Founder & CEO, Tonic Health

with

Abbe SteelFounder & CEO, HealthiVibe

10:50 amNetworking Break

11:20 amKeynote Interview: Once Upon a Time, 3D Printing, Crowdsourcing & Open Innovation Came Together to Create a Medical Device That Enabled 200 People

Richard Van AsFounder, Robohand

11:50 amEmerging & Enabling Technology Series

Led by:Jeffrey Kasher, PhDVP, Clinical Innovation & Implementation, Eli Lilly

Faster Than the Speed of Sites: How the Cloud is Accelerating Study Startup

Advanced, cloud-based collaboration platforms allow sponsors, CROs, and sites to dramatically reduce study startup timelines, eliminate bottlenecks, and reduce costs. This session addresses the how.

Carol AliyarSVP, Study Start-Up, INC Research

Jae ChungFounder, GoBalto

Barry MiltonDirector, Project & Regulatory Management, Novartis

Disrupting Trial Patient Compensation

This session addresses how to disrupt:

• The standard practice of sponsors allocating funds for patient payments in site budgets

• The standard practice of sites processing countless paper check requests

• The standard patient experience of waiting weeks to receive paper checks, and often incurring check-cashing fees

Deborah HoweAssociate Director of Vendor Management, Global Recruitment & Analytics, Bristol-Myers Squibb

Stuart Horowitz, MBA, PhDPresident, Institutions & Institutional Services, WIRB-Copernicus Group

Christine PierrePresident, Society for Clinical Research Sites (SCRS)

Rick WardSenior Director, Business Development, Greenphire

The Impact of Innovation on Clinical PartnershipsSteve CutlerCOO, ICON

12:45 pmLuncheon

2:00 pmThe SIGNATURE Clinical Trial Program: Disrupting Clinical Trials, and Making Them Better

SIGNATURE is a new kind of clinical trial developed by US Novartis Oncology. Looking at all the common challenges of enrolling cancer clinical trials, we found a way to overcome them. Using adaptive statistical design, a simple protocol, and standard documents, we developed a rapid study startup model that allows the patient to stay where they are, locally, and still have a chance to participate in innovative research. We bring “the protocol to the patient”. Any qualified Oncology Research Physician can participate, they simply contact our call center. If the patient pre-qualifies, the site is open in ~4 weeks. The study is designed to quickly find where a drug is working and move on from cancers that show no effect. Faster, easier, and more cost-effective, we are getting to proof of concept more rapidly and accelerating the research process. We aren’t just thinking, we’re doing.

Stephanie PetroneExecutive Director, Clinical Operations, Novartis Oncology US CD&MA

2:20 pmMount Sinai Hospital on Reducing Geographic Barriers to Cancer Clinical Trial Participation: Learning from the Telemedicine Intensivist Model?

The cancer clinical trials enterprise is slow, expensive, and inefficient. Our group has previously shown that approximately 20% of initiated cancer clinical trials are not completed at all, with poor accrual as the main culprit. We have also shown that cancer clinical trials are geographically inaccessible to a large proportion of the United States population. As trials focus on identifying smaller and smaller subsets of patients with tumors harboring specific molecular characteristics, the problem of geographic inaccessibility is likely to become even more


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apparent and new models of trial conduct will be needed. To address geographic barriers to critical care specialists in community hospitals, models have emerged allowing an “expert” critical care physician, through telemedicine and tele monitoring, to work with local clinicians to optimize patient care and minimize costly, burdensome, and often unnecessary, patient transfers. Dr Galsky shares his initiative with a pilot study to determine the feasibility of such a model in the conduct of a cancer clinical trial.

Matthew Galsky, MDAssociate Professor of Medicine, Medical Oncologist, Icahn School of Medicine at Mount Sinai

with

Ray Dorsey, MD, MBAProfessor of Neurology and Co-Director of the Center for Human Experimental Therapeutics, University of Rochester Medical Center

Marc Foster, MBACo-Founder and Chief Operating Officer, Transparency Life Sciences

John HollandSVP, Research and Business Development, AMC Health, New York

2:50 pmProgress... Strengthening 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?

Mohammed AligpM, Global Clinical Operations, Novartis

Jeffrey RamseyConsultant, Clinical Development Innovation, Eli Lilly

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

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.

Led by:Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances, Janssen

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

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

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

Interested in sharing your dirty laundry on the stage, please email us at [email protected].

4:30 pmConference Concludes


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Global Clinical Trials takes place the day before the Disruptive Innovations to Advance Clinical Trials event on September 10, 2014. A special rate is available for those interested in attending both events. See page 13 for details.

AGENDA - WEDNESDAY, SEPTEMBER 10, 2014

8:00 amRegistration & Breakfast

8:45 amConference Chair Opening Remarks

Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals

9:00 amGlobal trends in generating clinical evidence for Regulatory approval and Market Access

Thomas Lonngren, PhD (hc), MRPharmS, FRCPFormer Head, EMA

9:20 amGlobal Regulatory Update

Moderator:Thomas Lonngren, PhD (hc), MRPharmS, FRCPFormer Head, EMA

Panelists:Debra Barker, MDGlobal Program Head, Oncology Biosimilars, Novartis

Thomas HaagData Integrity Process Expert, Novartis

Jonathan HelfgottAssociate Director for Risk Science (Acting), OSI, CDER, Novartis

Adrian Senderowicz, MDCMO, Ignyta

10:00 amDeveloping Global Protocols that are Easier to Execute for Patients and Sites

Lori AbramsDirector, Patients Advocacy, Bristol-Myers Squibb

Jill CollinsSenior Director, Integrated Clinical Processes, INC Research

Jeremy GilbertVP, Product & Strategy, PatientsLikeMe

Rebecca Li, PhDExecutive Director, Multi-Regional Clinical Trial Center, Harvard Global Health Institute

Kate WilliamsSenior Feasibility Strategist, Bayer Healthcare

10:40 amAdaptive Trials and its Uses Globally

Phil BirchSVP Global Strategic Marketing, Aptiv Solutions, an ICON plc Company

DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS PRE-CONFERENCE EVENTS

5TH ANNUAL

EXECUTING GLOBAL CLINICAL TRIALSREDUCING COMPLEXITIES IN GLOBAL CLINICAL TRIALS

SEPTEMBER 10, 2014 THE FAIRMONT COPLEY PLAZA, BOSTON, MA

PRE-CONFERENCE EVENT

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11:30 amOptimizing Patient Enrollment in Global Clinical Trials

Moderator:Christopher Gallen, MD, PhDCEO, SK Biopharmaceuticals

Panelists:Alice DonnellyDirector, Recruitment Strategy & Operations, GR&A, Bristol-Myers Squibb

Donna Jarlenski, PMPSenior Director, Clinical Development Execution & Global Medicines Development & Affairs, Vertex Pharmaceuticals

Richard Margolin, MDVP, Clinical Development, CereSpire, Inc.

John ReitesSenior Director, Offer Development, Quintiles

12:05 pmChiltern, FORUM and Millennium Share Best Practices to Ensure Optimal CRO/Sponsor Global Partnerships

Moderator:Christopher Gallen, MD, PhDCEO, SK Biopharmaceuticals

Panelists:Carol Lewis-CullinanSenior Director, Clinical Operations, FORUM Pharmaceutical

Veronica LudenskySenior Manager, Clinical Outsourcing, Millennium: the Takeda Oncology Company

Susan RombergVP, Global Clinical Development, NA, Chiltern

12:35 pmLuncheon

1:45 pm5th Annual Country-Specific RoundtablesDebra Barker, MDGlobal Program Head, Oncology Biosimilars, Novartis

Christopher Gallen, MD, PhDCEO, SK biopharmaceuticals

Mitchell Katz, PhDExecutive Director, Medical Research Operations, Purdue Pharma

Simon Li, MD, PhDVP of Global Clinical Development, Luye America Pharmaceuticals

Thomas Lonngren, PhD (hc), MRPharmS, FRCPFormer Head, EMA

2:20 pmRethinking How we Partner with Global Investigational Sites

Roberta DuncanSenior Director, Clinical Operations, Trevi Therapeutics

Abraham GutmanPresident & CEO, AG Mednet

Maria Im Hee Shin, MS, PhDProfessor, Faculty of Medicine, Multi-Regional Clinical Trials Center at Harvard

Mitchell Katz, PhDExecutive Director, Medical Research Operations, Purdue Pharma

Christine PierrePresident, Society for Clinical Research Sites (SCRS)

3:00 pmRemote-Based Monitoring Deployments in Global Clinical Trials: Case Study

Badhri SrinivasanSVP & Global Head, Data & Safety Monitoring, Quintiles

3:30 pmSoap Box Presentations: Innovative Technologies and Services that Drive Efficiencies in Global Clinical Trials

Led by:Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals

4:20 pmGlobal R&D Guest Interview

Simon Li, MD, PhDVP of Global Clinical Development, Luye America Pharmaceuticals, Ltd

with

Christopher Gallen, MD, PhDCEO, SK Biopharmaceuticals

5:00 pmConference Concludes

PRE-CONFERENCE EVENTS DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

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Mobile + Clinical Trials takes place the day before Disruptive Innovations to Advance Clinical Trials on September 10, 2014. A special rate is available for those interested in attending both events. See page 13 for details.

AGENDA - WEDNESDAY, SEPTEMBER 10, 20149:00 amChair’s Opening Remarks

Joris Van Dam, PhDNovartis

9:10 amWhat Does the Digital Clinical Landscape Look Like?

Jeff LeemProve Health

Joris Van Dam, PhDNovartis

10:00 amDeploying Mobile/Digital Solutions: Where, What, How?

Robert HancockMobileSmith

11:00 amThe Evolution of Standards for Mobile / Digital on Clinical Trials

Kamal Jethwani, MD, MPhCenter for Connected Health

Derek Ritz, PEng, CPHIMS-CAecGroup Inc.

11:30 amQ&A with the FDA

Jonathan HelfgottFDA

Craig Lipset, MBAPfizer Inc.

11:50 amUnderstanding and Addressing the Technical, Legal & Operational Hurdles

John Holland Abbe SteelAMC Health HealthiVibe

Jeff Lee Katherine WilsonmProve Health PATH

2:00 pmNew Business Models & the Investment Climate

Jeremy SohnMPM Capital

Todd Pietri, MBAMilestone Venture Partners

2:40 pmRevolutionizing Heart Disease with Mobile Technologies: UCSF’s Health eHeart Study

Carol Maguire, RNUCSF Division of Cardiology

3:15 pmWhat Apps Do Clinical Trial Leaders Want to See?

Joseph KimEli Lilly

Craig Lipset, MBAPfizer Inc.

Joris Van Dam, PhDNovartis Institutes for Biomedical Research

3:45 pmHow Would You Create a Clinical Trial App?

Robert HancockMobileSmith

5:00 pmMobile Technology Fair (Hands on time) & Reception

Contact Elizabeth Bard at [email protected].

DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS PRE-CONFERENCE EVENTS

PRE-CONFERENCE EVENT

MOBILE + CLINICAL TRIALSHOW MOBILE IS INNOVATING CLINICAL TRIALS

SEPTEMBER 10, 2014 THE FAIRMONT COPLEY PLAZA, BOSTON, MA

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September 11 – 12, 2014Disruptive Innovations to Advance Clinical Trials

1st Early Bird - before June 13, 2014 $1,495

2nd Early Bird - before July 11, 2014 $1,595

3rd Early Bird - before August 8, 2014 $1,795

Standard - after August 8, 2014 $1,895

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

Attend one of our specialized pre-conference events in addition to Disruptive Innovations for a reduced fee:

September 10, 2014Executing Global Clinical Trials $400

Mobile + Clinical Trials $495

To register, go to our website at www.theconferenceforum.org/conferences/disruptive-innovations/registration-pricing

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.

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.

The Fairmont Copley Plaza Hotel138 St. James AvenueBoston, MA 02116617-267-5300www.fairmont.com/copley-plaza-boston/

For reservations, call 800-441-1414 or 617-267-5300 and ask for the Disrutpive Innovations group rate.

Centrally located in Boston’s historic Back Bay, The Fairmont Copley Plaza sits steps away from the Boston Public Library, Beacon Hill, and the Freedom Trail. The hotel is only a few blocks from Copley Place Mall and the boutiques of Newbury Street. The hotel recently went through a $20 million restoration project.

“Excellent! Real Disruption! Refreshing!”

- Thomas Krohn, Eli Lilly

“My colleague and I were last minute attendees at Dpharm, and we are so glad that we went. We felt at home among kindred spirits trying to accomplish something new, challenging, different, and disruptive.”

- Brendan Kelleher, Karmadata

“Kudos to the Conference Forum, Craig, John and Andreas for a truly fresh perspective on our industry. It has been very energizing and without tired topics. The format and content are top-notch and sophisticated. Well worth taking the time to attend.”

- Deirdre BeVard, Endo

“This conference was a very good mix of inspirational and specific nitty-gritty. WOW!”

- Veronica Ludensky, Takeda/Millenium

“Thank you! Excellent. The best conference I have attended in the last few years!”

- Maria Makarovskaya, Cubist Pharmaceuticals

REGISTRATION / VENUE DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

HOTEL INFORMATIONREGISTRATION & PRICING

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TESTIMONIALS



http://www.theconferenceforum.org/conferences/disruptive-innovations/registration-pricing










http://www.fairmont.com/battery-wharf-boston/





DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS SPONSORS / PARTNERS

EXECUTIVE SPONSORS

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SOAPBOX SPONSORSSUPPORTING SPONSOR

ASSOCIATE SPONSORS

EXHIBITORS

MEDIA PARTNERS

SUPPORTING PARTNERS



http://www.lifescienceleader.com











http://www.Biocentury.com








http://www.technologynetworks.com/PharmaOutsourcing





http://www.medicalnewstoday.com






Documents

DPHARM Disruptive Innovations - theconferenceforum.org · 11.09.2014 · be engaging in a highly informative format, similar to the style of TED events. Each session will deliver