PRESENTING COMPANIES

Crafting a global development strategy5th Annual

Global Clinical TrialsSEPTEMBER 10, 2014 FAIRMONT COPLEY PLAZA, BOSTON, MAGC

T

Organized byExecutive Sponsors

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

Lori AbramsBristol-Myers Squibb

Debra Barker, MDNovartis

Phil BirchAptiv Solutions

Jill CollinsINC Research

Shannon CookeTransPerfect

Alice DonnellyBristol-Myers Squibb

Roberta DuncanTrevi Therapeutics

Christopher Gallen, MD, PhDSK biopharmaceuticals

Jeremy GilbertPatientsLikeMe

Abraham GutmanAG Mednet

Thomas HaagNovartis

Jonathan HelfgottCDER, FDA

Maria Im Hee Shin, MS, PhDMulti-Regional Clinical Trials Center at Harvard

Donna Jarlenski, PMPVertex Pharmaceuticals

Mitchell Katz, PhDPurdue Pharma

Carol Lewis-CullinanFORUM Pharmaceuticals

Rebecca Li, PhDMulti-Regional Clinical Trials Center at Harvard

Simon Li, MD, PhDLuye America Pharmaceuticals

Thomas Lonngren, PhD (hc), MRPharmS, FRCPEMA

Veronica LudenskyMillennium: the Takeda Oncology Company

Richard Margolin, MDCereSpir, Inc.

Dan McDonaldDAC Patient Recruitment Service

Christine PierreSociety for Clinical Research Sites (SCRS)

John ReitesQuintiles

Susan RombergChiltern

Adrian Senderowicz, MDIgnyta

Badhri SrinivasanQuintiles

Kate WilliamsBayer Healthcare

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

OVERVIEW

The Conference Forum is pleased to present the 5th Annual Executing Global Clinical Trials conference. The 2014 program is being offered as a one-day intensive followed by the option to attend the DPharm: Disruptive Innovations to Advance Clinical Trials on September 11-12 in the same venue.

The purpose of the 2014 conference is to help:

1. Make global clinical trials easier for patients and for sites

2. Craft a global development strategy

The conference offers concrete topics impacting management of clinical studies globally by finding the right balance between recruitment, cost savings, future regulatory obligations, and managing relationships with global service providers.

• Lessons Learned from Unsuccessful Global Clinical Trials

• Overview on the Current EU Regulatory Landscape

• Regulatory Barriers in Emerging Markets

• The effect of Remote-Based Monitoring on Regulatory Approval in other countries

• CRO Case Study on Remote-Based Monitoring in Global Clinical Trials

• Reducing Global Protocol Complexities for the Patient and Sites

• Working with Patient Advocacy Groups in Global Clinical Trials

• Driving Faster Global Patient Enrollment Rates

• Communication Strategies for Global CRO/Sponsor Partnerships

• Partnering with Global Investigative Sites

• Understanding the Use of Adaptive Trials and Adaptive Design in Multi-National Trials

• Best Practices and Lessons Learned from Conducting Trials in Asia

• Technologies Driving Efficiencies in Global Clinical Trials

- 5th Annual Regional Roundtables -

One of the best-rated sections of the conference is the regional roundtable session for one-on-one discussions with an expert in the following areas:

EU • Latin America • India • JapanEastern Europe • Middle East/North Africa • Korea

The conference includes breakfast, networking breaks, and a luncheon. For any questions, contact us at Service@tcfllc.org.

We look forward to welcoming you on September 10 in Boston. For those of you planning on attending DPharm: Disruptive Innovations to Advance Clinical Trials, take advantage of the combined discount.

Sincerely,

Valerie BowlingExecutive DirectorGCT

Kristen PisanelliConference ProducerGCT

Jessica RothenbergMarketing DirectorGCT

5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS OVERVIEW

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

SPEAKING FACULTY

Lori AbramsDirector, Patient AdvocacyBristol-Myers Squibb

Debra Barker, MDGlobal Program Head, Oncology BiosimilarsNovartis

Phil BirchSVP, Global Strategic MarketingAptiv Solutions, an ICON plc Company

Jill CollinsSenior Director, Integrated Clinical ProcessesINC Research

Shannon CookeProject ManagerTransPerfect

Alice DonnellyDirector, Recruitment Strategy & Operations, GR&ABristol-Myers Squibb

Roberta DuncanSenior Director, Clinical OperationsTrevi Therapeutics

Christopher Gallen, MD, PhDCEOSK biopharmaceuticals

Jeremy GilbertVP, Product & StrategyPatientsLikeMe

Abraham GutmanPresident & CEOAG Mednet

Thomas HaagData Integrity Process ExpertNovartis

Jonathan HelfgottAssociate Director for Risk Science (Acting), OSICDER, FDA

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

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

Mitchell Katz, PhDExecutive Director, Medical Research OperationsPurdue Pharma

Carol Lewis-CullinanSenior Director, Clinical OperationsFORUM Pharmaceutical

Rebecca Li, PhDExecutive DirectorMulti-Regional Clinical Trials Center at Harvard

Simon Li, MD, PhDVP, Global Clinical DevelopmentLuye America Pharmaceuticals

Thomas Lonngren, PhD (hc), MRPharmS, FRCPFormer HeadEMA

Veronica LudenskySenior Manager, Clinical OutsourcingMillennium: the Takeda Oncology Company

Richard Margolin, MDVP, Clinical DevelopmentCereSpir, Inc.

Dan McDonaldDirector of Business DevelopmentDAC Patient Recruitment Services

Christine PierrePresidentSociety for Clinical Research Sites (SCRS)

John ReitesSenior Director, Offer DevelopmentQuintiles

Susan RombergVP, Global Clinical Development, NAChiltern

Adrian Senderowicz, MDCMOIgnyta

Badhri SrinivasanSVP & Global Head, Data & Safety MonitoringQuintiles

Kate WilliamsSenior Feasibility ExpertBayer Healthcare

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SPEAKING FACULTY 5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

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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

• Drivers for change in the way clinical evidence is generated

• Trends in what regulators are looking for?

• Trends in what the payers are looking for?

• Interventional vs non interventional clinical studies

• Consequences for the pharmaceutical and the CRO industry

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

9:20 amGlobal Regulatory Update

• Overview on regulatory changes

• Overcoming regulatory barriers when conducting trials in emerging markets

• Remote-based monitoring considerations for small, medium and large companies and their affect on global approval

• Progress for accelerated approval: Breakthrough Designation and Adaptive Licensing

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, FDA

Adrian Senderowicz, MDVP, Sanofi Oncology & Global Regulatory Affairs, Sanofi

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

• Strategies for upfront planning

• Making protocols less complex and more patient-centric

• Taking investigator and patient feedback and incorporating this in study design

• Building quality by design into actual development of protocol and the process itself

• Tapping into patient insights during the design process

• Working with patient advocacy groups

Lori AbramsDirector, Patient Advocacy, Bristol-Myers Squibb

Jill CollinsSenior Director, Integrated Clinical Processes, INC Research

Jeremy GilbertVP, Product & Strategy, PatientsLikeMe

Rebecca Li, PhDExecutive Director, Multi-Regional Clinical Trials Center at Harvard

Kate WilliamsSenior Feasibility Strategist, Bayer Healthcare

10:40 amAdaptive Trials and its Uses Globally

• Communicating the value proposition for adaptive trials

• Understanding the use of adaptive trials in both exploratory and late phase development

• Increased use of adaptive design software by regulatory agencies

5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS AGENDA

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• Strategic partnerships to drive portfolio-wide adoption

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

11:00 amNetworking Break

11:30 amOptimizing Patient Enrollment in Global Clinical Trials

• Overcoming enrollment issues due to changes in country requirements

• How to create less burdensome global protocols with the patient in mind

• How to decrease the cost of medicines and care

• How to incorporate local assessments/reduce travel

• Mobile technologies used in global enrollment procedures

• The potential of registries to enhance recruitment

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

• Establishing communication norms to ensure a positive CRO/Sponsor relationship

• Empowering CRO/sponsor teams to communicate up to management effectively

• How to develop the infrastructure collaboratively to quickly and easily share data

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 RoundtablesIn this very popular section of the conference, global clinical trial leaders with experience on the ground and expertise in different countries will address:

• Regulatory environments

• How to work globally with different regulatory agencies

• Market access

• Patient recruitment, enrollment and engagement

• Site selection

• Government protection of intellectual property

• Cultural differences and idiosyncrasies

• Key questions for CROs

• What does it mean to “have a presence?”

Attendees may choose one country-specific roundtable in this section. In addition to the discussion points outlined above, you are welcome to bring any additional issues or questions to the table.

EU • Latin America • India • JapanEastern Europe • Middle East/North Africa • Korea

Roundtable leaders include:

Debra Barker, MDGlobal Program Head, Oncology Biosimilars, Novartis

Christopher Gallen, MD, PhDCEO, SK Biopharmaceuticals

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AGENDA 5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

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

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

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

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

2:20 pmRethinking How We Partner with Global Investigational Sites

• How to best target new centers globally

• Identifying investigator challenges in order to improve training standards

• Advancements in technology for patients

• Advancements in technology and training for global sites

• Non-traditional ways of collecting data globally

• The emergence of virtual clinical trials

• Update on TransCelerate’s work to collaborate and optimize site partnerships

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

This presentation will describe an implementation of risk-based monitoring (RBM) aimed at improving data quality and patient safety, while significantly reducing development costs. The initial focus of cost reduction was to be achieved by reducing the number of on-site visits and implementing a risk-based approach to site management. The speaker will explain how this evolved into a centralized

data monitoring solution that optimized resources, while maintaining and/or improving data quality, throughout the study.

This was a truly collaborative approach, using the client’s systems with Quintiles data management staff driving much of the execution in collaboration with client study teams and global site monitoring providers. The scope included:

• reducing source document verification (SDV)

• increasing use of remote monitoring; reducing the number of onsite visits

• enabling triggered monitoring

• expanding to centralized medical and clinical data review

Quintiles Infosario-based applications were used to monitor cleanliness status of the subject and also to perform medical review. Innovative tools were developed and deployed for data readiness, data visualization and project management.

The outcome of the project has resulted in improved data with metrics far exceeding the targeted industry standard improvement goals. The client has continued to use this approach for more studies.

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

3:30 pmSoapbox Presentations: Innovative Technologies and Services that Drive Efficiencies in Global Clinical TrialsQuick fire presentations. This soapbox session gives a spotlight on key technologies/services in the global clinical space.

• How to use technologies to better plan and design global clinical trials

• How you can change your business model and manage clinical trials with “e-source”

• The use of mobile technologies, i.e. remote ECGs and home monitoring

• Quality data capture and management

• The use of digital and social media technologies for patient recruitment and engagement

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

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4:00 pmNetworking Break

4:20 pmGlobal R&D Guest InterviewIn this section of the program, we introduce the head of R&D of Luye America Pharmaceuticals who shares best practices and lessons learned in conducting trials in Asia.

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

with

Christopher Gallen, MD, PhDCEO, SK biopharmaceuticals

5:00 pmConference Concludes

HOTEL INFORMATION

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 Global Clinical Trials 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.

REGISTRATION & PRICING

1st Early Bird - before June 27, 2014 $895

2nd Early Bird - before August 8, 2014 $995

Standard - after August 8, 2014 $1,095

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

To register, visit our website at: www.theconferenceforum.org/events/global-clinical-trials/

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 Service@theconferenceforum.org 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 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.

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VENUE / REGISTRATION 5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

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EXECUTIVE SPONSORS

ASSOCIATE SPONSORS

EXHIBITORS

MEDIA PARTNERS

5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS SPONSORS / PARTNERS

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