FOR INFORMATION, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

DISRUPTIVE INNOVATIONS3RD ANNUAL DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

CHALLENGING THE STATUS QUO WITH NOVEL BOLD IDEAS TO CHANGE THE PACE OF CLINCIAL TRIALS

SEPTEMBER 19 - 20, 2013 THE FAIRMONT COPLEY PLAZA, BOSTON, MA

Jeff Kasher, PhDVP & COO, Global Medical R&DEli Lilly

Craig H. Lipset, MBAHead of Clinical Innovation, R&DPfizer, Inc.

John Orloff, MDSVP, Global Development & CMONovartis Pharma AG

Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External AlliancesJanssen Healthcare Innovation

CO-CHAIRED BY

Follow us on Twitter @ConferenceForum #DPharm

Keynote Fireside Chatwith

Krishna Yeshwant, MDGeneral Partner

Google Ventures

NEW FOR 2013

THOUGHT PROVOKING CASE STUDIES

MIT Clinical Trial Hackathon Results with

Zen ChuFaculty Director & Entrepreneur

in ResidenceMIT

Disruptive Thinkerswith

John J. Whyte, MD, MPHChief Medical Expert and VP, Health & Medical Education

Discovery Channel

How Not to Do a Traditional Clinical Trial

with Genzyme

Innovation in Alternative Clinical Settings: The Walgreens-Novartis

Collaboration with Novartis & Walgreens

An Interview Series of Disruptive Thinkers with

Medimmune, Center for Connected Health & VA Boston Healthcare

Organized by

Lead Sponsor

Supporting Partners

Executive Sponsors

FOR INFORMATION, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Each year, dozens of conferences and meetings are held to discuss specific challenges within clinical trials. Many events are tactical in nature, focusing independently on topics ranging from financing approaches, protocol design, partnering models between sponsors and clinical trial sites, technology trade shows, etc. By focusing on narrow aspects of clinical trials, past conferences have not effectively taken the necessary high-level, systemic view needed to identify innovations that can leapfrog inefficiencies in clinical trials.

The Conference Forum is presenting the 3rd Annual Disruptive Innovations to Advance Clinical Trials event. This conference is designed for drug development innovative thinkers who are determined to re-invent clinical trials. It is an outcomes-focused program that not only delves deeply into the key strategic factors impeding clinical trial productivity, but also connects 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.

Focus & Objectives• This is a TED-style event showcasing innovations and

leading practioners 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 we can 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.

Sincerely,

Valerie BowlingExecutive Director

Deirdre BeVardDevelopment OperationsEndo Pharmaceuticals

Michael Cantor, MDSenior Director, Clinical Informatics & InnovationPfizer

Jeff Carroll, PhDPatient Advocate & Assistant Professor of Neuroscience in the Department of PsychologyWestern Washington University

Iris Culbert, Sr.Clinical Project Manager, Global Clinical OpsTeva Pharmaceutical Industries Ltd.

Zen Chu, MBAFaculty Director and Entrepreneur-In-ResidenceMIT

Leonard D’Avolio, PhDAssoc. Center DirectorVA Boston Healthcare System

Elise Felicione, MPHDirector, Clinical Trial InnovationJanssen

Jamie Freedman, MD, PhDSVP, Global Clinical DevelopmentMedimmune

Dalvir Gill, PhDCEOTransCelerate

Jeff Kasher, PhDVP & COO, Global Medical R&DEli Lilly

Joseph Kim, MBAClinical Operations DirectorShire

Jeff Kingsley, DOInvestigator & CEOSERRG, Inc.

DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS OVERVIEW

OVERVIEW

2

SPEAKING FACULTY

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 different about how we do clinical trials.

FOR INFORMATION, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External AlliancesJanssen, Pharmaceutical Companies of Johnson & Johnson

Michael Koren, MDInvestigator & FounderFlorida Physicians & Research Associates

Joseph Kvedar, MDDirector, Center for Connected HealthPartners HealthCare

Andrew Lee, MDSVP, Global Clinical OperationsGenzyme

Craig Lipset, MBAHead of Clinical Innovation, R&DPfizer Inc.

Mike LukerDirector, Clinical ResearchEli Lilly & Co.

Anne Meeker O’ConnellActing Division Director, Good Clinical Practice ComplianceU.S. Food and Drug Administration

Jules T. Mitchel, PhD, MBAPresidentTarget Health

John Orloff, MDSVP, Global Development & CMONovartis Pharma AG

Eugene PatinHead of US Clinical OperationsNovartis

Christine PierrePresidentSociety for Clinical Research Sites

Todd Pietri, MBAPartnerMilestone Venture Partners

Peter Richardson, BMedSciGlobal Head Clinical & Regulatory AffairsAlcon Laboratories

Jeffrey Rosen, MDMedical DirectorClinical Research of South Florida

Tomasz Sablinski, MD, PhDFounder & CEOTransparency Life Sciences

Komathi StemSenior Director, Product Development, Innovation LeadGenentech

Bernhard WarnerReporter, ColumnistBloomberg Business Week

Elizabeth WhitsonSenior DirectorGenentech

John J. Whyte, MD, MPHChief Medical Expert & VP, Health and Medical EducationDiscovery Channel

Krishna Yeshwant, MD, MBAGeneral PartnerGoogle Ventures

Jennifer ZimmerPartnerInsigniam

3

SPEAKING FACULTY DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

FOR INFORMATION, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

7:45 amBreakfast & Registration

8:30 amChairsʼ Welcome & Opening Address: Avoiding the Trap of Incremental ChangeHow can we be disruptive to change the pace of clinical trials to meet patient needs? What kinds of leadership do we want and need to support disruption and innovation?  What is the job description for innovation as a discipline? Our chairs open the 2013 event addressing these questions and more.

Jeff Kasher, PhDVP & COO, Global Medical R&D, Eli Lilly

Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances, Janssen, Pharmaceutical Companies of Johnson & Johnson

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

John Orloff, MDSVP, Global Development & CMO, Novartis Pharma AG

8:45 amHow Not to Do a Traditional Clinical TrialIn our opening session, Dr Lee shares his story in designing a non-traditional clinical trial to reduce infrastructure, engage patients and generate credible clinical data.

Andrew Lee, MDSVP, Global Clinical Operations, Genzyme

9:15 amInnovation in Alternative Clinical Settings: The Walgreens-Novartis Collaboration

This session presents an example of innovation in an alternative clinical setting. Our presenters address:

• How to further drive clinical trials into the community

• How to make research participation easier for patients and providers

• The technology to make it possible

• Overcoming barriers

John Orloff, MDSVP, Global Development & CMO, Novartis Pharma AG

with Walgreens

10:00 amKeynote Fireside Chat with Google Ventures

Dr Krishna Yeshwant is a physician, programmer, and entrepreneur who has been working with Google Ventures since its inception. As a physician and life science investor, Dr Yeshwant has a unique perspective on a wide range of new approaches to disrupt drug development. In this fireside keynote chat we will discuss:

• How attractive for VC investors is the notion of disruptive innovation in drug development?

• New approaches to using social and mobile technologies

• How can these new platforms impact drug development?

• How big data can revolutionize healthcare and in particular the current clinical trial model; what are some of the concerns?

Krishna Yeshwant, MD, MBAGeneral Partner, Google Ventures

10:40 amNetworking Break

• Meet with Exhibiting Companies

• One-on-One Meeting Space Available

• Soap Box Presentations

11:15 amKeynote Fireside Chat with Google Ventures

Regulatory changes to support innovation is happening and our FDA presenter gives us an update on:

• Implementation barriers

• Enrichment strategies

• Safety and Innovation Act

• Patient center initiatives

• Engaging patients in the process from IND

• Approvals after Phase II

Anne Meeker O’ConnellActing Division Director, Good Clinical Practice Compliance, U.S. Food and Drug Administration

11:45 amAn Interview with TransCelerate’s CEO on Progress & Disruption

TransCelerate BioPharma with the support of ten major biopharmaceutical companies has a mission to develop shared industry research and development solutions to

DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS AGENDA

4

DAY ONE - THURSDAY, SEPTEMBER 19, 2013

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simplify and accelerate the delivery of innovative products to patients. Our co-chairs discuss with the CEO of TransCelerate the following:

• The road map on initiatives and where TranCelerate is going

• How TransCelerate is supporting and implementing initiatives

• Cross industry collaborations on sharing data and what does this really mean for pharma, CROs and Sites?

• What are the shared solutions to kill drugs faster?

• What’s been disruptive?

• What is the end game and when is it going to deliver results

Dalvir Gill, PhDCEO, TransCelerate BioPharma Inc.

12:15 pmPatient eConsent Pilot Results

Paper based consenting is a suboptimal model, resulting in error prone documentation and a non-patient centric delivery of concepts critical to the clinical research process. This session will provide an overview of the business case, rollout and lessons learned from a pilot deployment of multimedia eConsents on the iPAD.

• Clarify the issues related to paper based consents

• Learn about the key lynchpins to success

• Envision the roadmap for the future of this technology and process

• Get ahead of audit findings

• How to improve successful adoption by your organization

Joseph Kim, MBAClinical Operations Director, Shire

12:40 pmLuncheon

2:15 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:

Jamie Freedman, MD, PhD, SVP, Global Clinical Development, Medimmune discusses disruptive initiatives on how new technologies are helping informative early Go/No Go decisions in drug development.

Leonard D’Avolio, PhD, Assoc. Center Director, VA Boston Healthcare System on a trial simplification approach through the example of running randomized diabetes clinical trials at point-of-care with the VA EMR. How can we translate this approach to investigational drugs and in other settings to merge care delivery with clinical research at the point of care?

Joseph Kvedar, MD, Director, Center for Connected Health on leveraging existing and emerging tools to conduct trials remotely.

Michael Cantor, MD, Senior Director, Clinical Informatics & Innovation, Pfizer addresses the following questions: What if we could bring together all of the control arm data from our various studies to create a rich and clean database of natural disease progression? How could this resource be used to better design and plan studies? What if we could then bring together the control arm data across research sponsors to create a vast new data resource? Would we still need the same size control arms for future trials?

3:15 pmNetworking Break

• Meet with Exhibiting Companies

• One-on-One Meeting Space Available

3:30 pmThe 2nd Annual 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. Two panels of judges will ask 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 will be given to the most disruptive presenter.

Judges:

Deirdre BeVardDevelopment Operations, Endo Pharmaceuticals

Iris Culbert, Sr.Senior Clinical Project Manager, Global Clinical Operations, Teva Pharmaceutical Industries Ltd.

Jeff Kasher, PhDVP & COO, Global Medical R&D, Eli Lilly

5

AGENDA DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

FOR INFORMATION, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances, Janssen, Pharmaceutical Companies of Johnson & Johnson

Craig Lipset, MBAHead of Clinical Innovation, Research & Development, Pfizer Inc.

Todd Pietri, MBAPartner, Milestone Venture Partners

Peter Richardson, BMedSciGlobal Head Clinical & Regulatory Affairs, Alcon Laboratories

Komathi StemSenior Director, Product Development, Innovation LeadGenentech

Elizabeth WhitsonSenior Director, Genentech

Presenting companies to date:

Archimedes Spaulding Clinical

Cytel TrialReach

CRF Health Trifecta

Greenphire Verified Clinical Trials

iTrials VIS

Quintiles

5:30 pmNetworking Reception

8:00 amBreakfast

8:45 amChairsʼ Welcome & Recap

Jeff Kasher, PhDVP & COO, Global Medical R&D, Eli Lilly

Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances, Janssen, Pharmaceutical Companies of Johnson & Johnson

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

John Orloff, MDSVP, Global Development & CMO, Novartis Pharma AG

9:00 amMIT Hackathon Results to Barriers in Clinical Trials

The Founder of MIT’s Hacking Medicine program will present the results from our Barriers to Clinical Trials Hackathon, including themes, process, solutions and which ideas gained the most traction as viable solutions and ventures.

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

9:45 amVIP Guest Session: The Mobile Banking Revolution in Africa: What can Drug Developers Learn from this Extraordinary Example of Disruption?

Bernhard Warner, is a reporter who writes about disruptive innovation across a multitude of industries for Bloomberg Businessweek and other publications. In this session, Mr Warner will tell us about one of the greatest examples of disruption transforming Africa. Following his insightful story, Dr Andrew Lee, SVP, Global Clinical Operations, Genzyme will join Mr Warner in an open discussion on what we can learn and apply to clinical trials.

Bernhard WarnerReporter, Columnist, Bloomberg Business Week

Andrew Lee, MDSVP, Global Clinical Operations, Genzyme

10:30 amExecuting Disruptive Innovation: What You Need to Know and Do to Have Breakthrough Performance

Jennifer ZimmerPartner, Insigniam

11:00 amNetworking Break

• Meet with Exhibiting Companies

• One-on-One Meeting Space Available

11:30 amDiscovery Channel Interview Series

John J. Whyte, MD, MPH, Chief Medical Expert & VP, Health and Medical Education, Discovery Channel interviews prominent healthcare voices disrupting thought and leadership to advance health care.

Interviews:

Jeff Carroll, PhD, Patient Advocate, is a prominent scientific researcher in the field of  Huntington’s Disease. He is also a public advocate for families affected by the

DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS AGENDA

6

DAY TWO - FRIDAY, SEPTEMBER 20, 2013

FOR INFORMATION, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

disease, and co-founder of the HD research news platform HD Buzz. His life and work were the subject of a 2011 Gemini award nominated CBC documentary feature. Jeff Carroll is an Assistant Professor of Neuroscience in the Department of Psychology, Western Washington University.

Jules T. Mitchel, PhD, MBA, President, Target Health and John Orloff, MD, SVP, Global Development & CMO, Novartis Pharma AG discuss eSourcing and other technologies to bring innovation to life and how we can use fewer patients in clinical trials.

2012 presenters, Elise Felicione, MPH, Director, Clinical Trial Innovation, Janssen, Pharmaceutical Companies of Johnson & Johnson and Mike Luker, Director, Clinical Research, Eli Lilly discuss where they are a year later with their Cross-Pharma Pre-Competitive Investigator Databank Project.

12:40 pmLuncheon

1:45 pmDisruptive Case Study on Next Generation Clinical Monitoring

Eugene PatinHead of US Clinical Operations, Novartis

2:15 pmThe Pfizer Blue Button Project: Engaging Patients by Sharing Electronic Clinical Data

In 2013 Pfizer will launch the Pfizer Blue Button Project, a first-of-it’s-kind initiative enabling patients who have participated in clinical trials the opportunity to download their individual clinical data.  Using the Blue Button standard launched by the White House, patients will be empowered to use the data to improve their overall health and wellness, from sharing with healthcare providers to powering clinical risk assessments.  In this session Pfizer will share more on why they have launched this initiative, initial learnings, and where the project may go if successful.

3:00 pmThe Investigator POV: What Disruption is Needed to Achieve Better Relationships

After DPharm 2012, it was highly requested to hear the voice of the investigator to help us candidly understand what is needed to greatly improve our relationship with them. This interview style session with investigators addresses:

• What do we have to do to bring investigators back?

• What are the new ways we can attract investigators?

• Solutions to every day site challenges

• Thoughts on protocol writing

• What would make a great relationship?

Moderated by:

Andreas Koester, MD, PhDVP, Clinical Trial Innovation & External Alliances,  Janssen, Pharmaceutical Companies of Johnson & Johnson

Christine PierrePresident, Society for Clinical Research Sites

Investigators:

Jeff Kingsley, DOInvestigator & CEO, SERRG, Inc.

Michael Koren, MDInvestigator & Founder, Florida Physicians and Research Associates

Jeffrey Rosen, MDMedical Director, Clinical Research of South Florida

3:45 pmClinical Trial Visit of the Future: Interactive SessionThis session will simulate a future clinical trial visit using emerging technologies followed by a discussion on opportunities and challenges to include patient access, recruitment and retention. Also discussed will be uses of novel technologies in clinical trials and regulatory/patient safety implications.

Craig H. Lipset, MBAHead of Clinical Innovation, Worldwide Research and Development, Pfizer Inc, United States

Tomasz Sablinski, MD, PhDFounder & CEO, Transparency Life Sciences

Komathi StemSenior Director, Product Development, Innovation Lead, Genentech, A Member of the Roche Group, United States

4:45 pmConference Concludes

AGENDA DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

7

FOR INFORMATION, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Global Clinical Trials takes place the day before the Disruptive Innovations to Advance Clinical Trials event on September 18, 2013. A special rate is available for those interested in attending both events. See page 10 for details.

8:00 amRegistration & Breakfast

8:30 amChair’s Opening

Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals

8:45 amRegulatory Update on Global Clinical TrialsModerator:Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals

Panelists:Debra S. Barker, MDCSO, Emerging Markets, Novartis

Agustin Melian, MDHead of Emerging Markets Clinical Development, Merck

Christine H. WangSenior Director Quality Systems, EnVivo Pharmaceuticals

9:30 amHow Companies Are Re-Thinking Global Clinical Trials/Partnering with Investigative Sites

Moderator:Laurie Halloran, BSN, MSPresident & CEO, Halloran Consulting Group

Panelists:Mitchell Katz, PhDExecutive Director, Medical Research Operations, Purdue Pharma LP

Tracy Michener, PharmDDirector, Global EAP/ REMS/ R&D Supported ISRs, Collaborative Science Research & Operations, Bristol-Myers Squibb

Jodie MorrisonCEO, Tokai Pharmaceuticals

Hassan MovahhedSVP, Global Development Operations, United Therapeutics

Barry Ticho, MD, PhDVP, Clinical Development, Biogen Idec

10:15 amNetworking Break

10:40 amGlobal Site Selection

11:00 amRisk Based Monitoring for Global Clinical TrialsThomas HaagIT Systems and Processes, Development QA, NovartisDeborah Manzo, MScOLSenior Director, Clinical Business Operations and Transformation, AbbVieJules Mitchel, PhD, MBAPresident & Co-Founder, Target Health

11:40 amCompetitors Unite to Create Standardized Training in Asia for Cost-Efficient Clinical Trials

John ConstantineExecutive Director & Dean, Merck Polytechnic InstituteChair, Asia Training Consortium

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

AGENDA - WEDNESDAY, SEPTEMBER 18, 2013

4TH ANNUAL

EXECUTING GLOBAL CLINICAL TRIALSREDUCING COMPLEXITIES IN GLOBAL CLINICAL TRIALS

SEPTEMBER 18, 2013 THE FAIRMONT COPLEY PLAZA, BOSTON, MA

PRE-CONFERENCE EVENT

8

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12:00 noonGlobal CRO Update on Collaboration, Implementation and Execution of Multi-National Trials: Best Practices

Marielle Cohard-Radice, MDVP, Clinical Development Operations, Daiichi Sankyo Pharma Development

Frances GroteSenior Director, Clinical Operations Vendor Oversight, Biogen Idec

Carol Lewis-CullinanSenior Director, Clinical Operations, EnVivo Pharmaceuticals

Thomas MarchiselloGlobal Head, Portfolio Sourcing and Relationship Management, Celgene

Alan MorganCOO, RPS

Hassan MovahhedSVP, Global Development Operations, United Therapeutics

1:00 pmLuncheon

1:30 pm4th Annual Country-Specific Roundtables

2:30 pmSoap Box Session: Innovative Technologies that Drive Efficiencies in Global Clinical Trials

Moderator:Ross PettitVP, Clinical Operations, AMAG Pharmaceuticals

3:00 pmNetworking Break

3:30 pmLessons Learned from Unsuccessful Global Clinical Trials

Moderator:Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals

Panelists:Debra S. Barker, MDCSO, Emerging Markets, Novartis

Ron Corey, PhD, MBACOO, Eboo Pharmaceuticals, Inc.

Iris Culbert, Sr.Senior Clinical Project Manager, Global Clinical Operations, Teva Pharmaceutical Industries Ltd.

Cynthia HauckDirector, Global Medical, Bristol-Myers Squibb

Richard Margolin, MDSenior Director, Biomarkers, JANSSEN Alzheimer Immunotherapy

4:10 pmDesigning Patient-Centric Protocols to Increase Global Patient Engagement/Reducing Protocol Complexity

Larry Blankstein, PhDSenior Director Clinical Research, Genzyme

Marielle Cohard-Radice, MDVice President, Clinical Development Operations, Daiichi Sankyo Pharma Development

Eileen DanielSenior Director, Clinical & Data Operations, Endo Pharmaceuticals

Claire MeunierDirector, Clinical Trial Strategies, The Michael J. Fox Foundation for Parkinsonʼs Research

4:45 pmRe-Thinking Global Patient Recruitment and the Patient Experience in Global Clinical Trials

Kathy GramAssociate Director for Patient Advocacy, Millennium: The Takeda Oncology Company

Ross PettitVP, Clinical Operations, AMAG Pharmaceuticals

5:00 pmThe Patient Panel

Kathy GramAssociate Director for Patient Advocacy, Millennium: The Takeda Oncology Company

5:45 pmConference Concludes

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

9

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Adaptive Trial Designs takes place the day before the Disruptive Innovations to Advance Clinical Trials event on September 18, 2013. A special rate is available for those interested in attending both events. See page 11 for details.

8:30 amRegistration & Breakfast

9:00 amChairʼs Opening Remarks, Objectives & IntroductionsPhil BirchSVP, Global Strategic Marketing, Aptiv Solutions

Kenneth Getz, MBADirector, Sponsored Research, Tufts, CSDD

9:10 amAchieving Protocol Optimization & SimplificationKenneth Getz, MBADirector, Sponsored Research, Tufts, CSDD

10:00 amA Regulatory Viewpoint from IndustryDr Simon DayDirector, Clinical Trials Consulting & Training Limited (ex MHRA)

10:45 amNetworking Break

11:15 amProduct Development Decision-Making with Adaptive DesignStacy Lindborg, PhDSenior Director, Biostatistics, Biogen Idec

Steven Zelenkofske, DO, FACC, FACOI, FCCPSVP, Clinical and Medical Affairs & CMO, Regado Biosciences

12:00 noonOvercoming the Barriers to Adoption of Innovative Adaptive Design – A Case StudyJerald Schindler, PhDVP, Late Development Statistics, Merck

1:00 pmLunch Break & Networking

2:00 pmThe Role of Sophisticated Adaptive Designs and How to Approach ThemJudith Quinlan, MScSVP, Innovation Centre, Aptiv Solutions

2:45 pmThe Importance of Independent Data Monitoring CommitteesLee Jen Wei, PhDProfessor, Harvard

3:15 pmPanel Discussion: Combining Adaptive Design with Industry Initiatives to Drive Clinical Trial EfficiencyModerated by:Dr Simon DayDirector, Clinical Trials Consulting & Training Limited (ex MHRA)Kenneth Getz, MBADirector, Sponsored Research, Tufts, CSDDStacy Lindborg, PhDSenior Director, Biostatistics, Biogen IdecJudith Quinlan, MScSVP, Innovation Centre, Aptiv Solutions

4:15 pmSummit Concludes

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

PRE-CONFERENCE EVENT

ADAPTIVE DESIGNS IN CLINICAL TRIALSOPTIONS TO DRIVE EFFICIENCIES IN CLINICAL DRUG DEVELOPMENT

SEPTEMBER 18, 2013 THE FAIRMONT COPLEY PLAZA, BOSTON, MA

AGENDA - WEDNESDAY, SEPTEMBER 18, 2013

10

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September 19 – 20, 2013Disruptive Innovations to Advance Clinical Trials

New Early Bird - before July 1, 2013 $1,395

Early Bird - before August 2, 2013 $1,495

Standard - after August 2, 2013 $1,695

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 18, 2013Executing Global Clinical Trials $300

Adaptive Designs in Clinical Trials $150

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

Discount Programs

Group 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 Service@theconferenceforum.org or call 646-350-2580 for any questions on discount rates.

Payment Policy

Payment 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 Policy

If you are unable to attend and would like to register a substitute, please email Service@theconferenceforum.org. 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 Service@theconferenceforum.org 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

11

TESTAMONIALS

FOR INFORMATION, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Founded in 1998 by Daniel M. Perlman, RPS implemented its business plan to build the industry's first Pharmaceutical Resource Organization model. This

innovative new business model was created specifically to address the anticipated challenges facing the biopharmaceutical industry, including the need to contain costs, improve quality and accelerate the drug development process. The RPS plan was dedicated to achieving the goal of providing the biopharmaceutical industry with an alternative to traditional outsourcing models by offering customized, integrated solutions that addressed these fundamental industry challenges. Their unique ability to leverage a Sponsor's existing processes and systems; create innovative new processes that improve productivity, speed and quality; and provide highly experienced staff to manage and execute activities at the direction of the Sponsor is the foundation of the RPS integrated model. Their solutions are customized to meet the different needs of small, medium, and large biopharmaceutical sponsor companies. For more information, visit www.rpsweb.com.

Aptiv Solutions is a global biopharmaceutical and medical device development company that provides a portfolio of innovative

services including adaptive trials, translational sciences, regulatory services, pharmacovigilance, clinical resourcing and the operational support of a global clinical research organization. Aptiv Solutions is the only CRO to offer design, simulation and execution of adaptive clinical trials. For more information, visit www.aptivsolutions.com.

Insigniam is an international management consulting firm serving large-cap firms in multiple industry segments including pharmaceutical, healthcare,

consumer goods, transportation, entertainment, and aviation.  Insigniam clients have documented in aggregate more than 50x ROI in savings and business results through enterprise transformation, Breakthrough Projects, innovation, and short- and long-term change initiatives. For more information, visit www.insigniam.com.

Quintiles is the largest provider of biopharmaceutical development and commercial outsourcing

services with more than 27,000 employees globally. We have helped develop or commercialize all of the top-50 best-selling drugs on the market. Quintiles applies multiple service offerings with extensive therapeutic, scientific and analytics expertise to help customers navigate an increasingly complex healthcare environment. For more informations, visit www.quintiles.com.

Target Health Inc., a privately held New York City based full service e*CRO with staff dedicated to all aspects of Regulatory Affairs,

Chemistry, Manufacturing and controls, Clinical Research, Biostatistics, Data Management and Strategic Planning. Target Health is committed to bridging Internet-based technology with the drug and device development. For more information, visit www.targethealth.com.

Archimedes is a healthcare modeling and analytics organization. Its core technology,

the Archimedes Model, is a clinically realistic, validated mathematical model of human physiology, disease progression, interventions, and care delivery. The Model enables clients to simulate clinical trials and distinguish clinical and economic benefits between drugs and standard treatments in any population. For more information, visit www.archimedesmodel.com.

CRF Health delivers electronic Clinical Outcome Assessments (eCOA) solutions for global clinical trials. Since 2000, CRF Health has initiated more than 400 clinical trials in over 70

countries and more than 150 languages; all while delivering the industry’s highest patient compliance, data accuracy and unmatched patient and site acceptance. For more information, visit www.crfhealth.com.

DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS SPONSORS

LEAD SPONSOR

EXECUTIVE SPONSORS

ASSOCIATE SPONSORS

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Our mission at Cytel is to improve success rates in the development of drugs, biologics and medical devices. We do this by improving clinical trials through innovative

application of statistical science, operations research, and new computational methods We are leaders in adaptive trial design and implementation. All 25 leading biopharma companies rely on our technology in their clinical studies. For more information, visit www.cytel.com.

Greenphire is the industry’s leading provider of clinical payment technology, designed to change the way research professionals

work. We leverage our proprietary workflow automation and advanced web‐based payment technologies to help our clients improve operational efficiency, reduce costs, mitigate regulatory risks, increase subject retention and compliance, and produce quantifiable results that improve clinical operations and strategic planning. For more information, visit www.greenphire.com.

For more information, visit www.itrials.com.

Spaulding Clinical Research, LLC a change agent in the clinical research and medical device

industries, is focused on driving perpetual value for their clients through technology and process innovation that delivers speed, unprecedented quality and lower costs. Spaulding Clinical Research operates a 105-bed clinical pharmacology unit with 96, 12-lead ECG, telemetry beds in West Bend, Wisconsin, USA. The facility is paperless, using a customized Phase I Electronic Data Capture system with bi-directional interfaces to clinical lab, bedside devices and telemetry. Spaulding Biometrics provides full-service biostatistics, data management and medical writing services. As a Phase I-IV centralized cardiac safety provider, Spaulding Clinical offers project management, expert cardiologist ECG over-read and a complete suite of state-of-the-art equipment provisioning, including the Spaulding webECGTM diagnostic 12-lead ECG Management Solution with the purpose-built Spaulding Model 1000iQ Electrocardiograph. For more information, visit www.spauldingclinical.com.

TrialReach connects patients, researchers, and pharma companies to make the discovery of new treatments better, cheaper, and faster. Thousands of patients and pharma companies from over 15 countries use our platform every day to accelerate the

development of new medications for diseases like cancer, depression, diabetes, and many more. For more information, visit www.trialreach.com.

Trifecta is the global leader in investigator training. We’ve designed and developed training

for hundreds of clinical trials worldwide. We’re raising the industry IQ with intelligent, easy-to-use live and online solutions that give you unprecedented control over the clinical training process. For more information, visit www.trifectaclinical.com.

Verified Clinical Trials (VCT) is the HIPAA and GCP compliant clinical trials database registry designed to

promote safety and improved data quality in clinical research trials.  Partnered with many of the world's largest pharmaceutical sponsors, CROs, and research facilities, VCT identifies better quality research subjects to screen and enroll in your clinical trials.  VCT also improves study visit and dosing compliance to aid in more accurate and timely data. For more information, visit www.verifiedclinicaltrials.com.

The ViS platform is a game-changing solution to the inefficiencies of clinical trial planning. It puts comprehensive, up-to-date analytics about all research

centers at the fingertips of trial planners, while allowing sites to easily communicate their expertise through the ViS social network. This open-access sharing of information leads to faster and better trial planning at significantly lower cost. For more information, visit www.visresearch.org.

SPONSORS DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

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inVentiv Clinical Trial Recruitment Solutions uses behavioral research, proprietary data, and cutting-edge technology to improve feasibility, enrollment, and patient recruitment.  Improved patient

recruitment reduces the cost of clinical trials and accelerates time to market. For more information, visit www.inventivhealth.com.

The Healthcare Businesswomen’s Association (HBA) is now in its 4th decade (1977-2007) as a global

not-for-profit organization dedicated to furthering the advancement of women in healthcare worldwide. With 15 chapters throughout the US and Europe, the HBA is headquartered in New Jersey with offices in Philadelphia and Research Triangle Park. The HBA provides educational opportunities for women and men to develop cutting edge healthcare industry knowledge and leadership skills. For more information, visit www.hbanet.org.

PDMA accelerates the contribution that innovation makes to the economic and professional growth

of people, businesses and societies around the world. For more information, visit www.pdma.org.

Women In Bio is an organization of professionals committed to promoting careers, leadership, and

entrepreneurship of women in the life sciences. For more information, visit www.Womeninbio.org.

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