PRESENTING COMPANIES

Crafting a global development strategy5th Annual

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

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Organized by

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Lori AbramsBristol-Myers Squibb

Debra Barker, MDNovartis

Phil Birch, DPhilAptiv Solutions

Jill CollinsINC Research

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

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

Garrett SmithTransperfect

Badhri SrinivasanQuintiles

Shoshana Weiler, MD, MPATransperfect

Kate WilliamsBayer Healthcare

Executive Sponsors

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WELCOME

Welcome to the 5th Annual Executing Global Clinical Trials conference.

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. Topics include but are not limited to:

• Overview on the Current EU Regulatory Landscape

• Overcoming Regulatory Barriers in Emerging Markets

• CRO Case Study on how Remote-Based Monitoring Improved Data Quality and Patient Safety while Cutting Development Costs 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

• Identifying the Challenges of Global Investigative Sites in order to Improve Training Practices and Clinical Trial Efficacy

• 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 • China • India • Japan • Eastern Europe • Korea

Ask questions, enjoy the networking and we hope you have a great conference experience.

Sincerely,

Kristen PisanelliConference ProducerGCT

Valerie BowlingExecutive DirectorGCT

Jessica RothenbergMarketing DirectorGCT

5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS WELCOME

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SPEAKING FACULTY

Lori AbramsDirector, Patient AdvocacyBristol-Myers Squibb

Debra Barker, MDGlobal Program Head, Oncology BiosimilarsNovartis

Phil Birch, DPhilVP, Innovation Strategy, Alliance PartnershipsICON plc

Jill CollinsSenior Director, Clinical InnovationINC Research

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 and 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 Pharmaceuticals

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

Garrett SmithExecutive DirectorTransperfect

Badhri SrinivasanSVP and Global Head, Data & Safety MonitoringQuintiles

Shoshana Weiler, MD, MPAChairman, Auditing Board of Clinical TrialsClalit Health Services

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

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

Moderator:Lori AbramsDirector, Patient Advocacy, Bristol-Myers Squibb

Panelists:Jill CollinsSenior Director, Clinical Innovation, INC Research

Jeremy GilbertVP, Product & Strategy, PatientsLikeMe

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

• Strategic partnerships to drive portfolio-wide adoption

Phil Birch, DPhilVP, Innovation Strategy, Alliance Partnerships, ICON plc

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

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• 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

• What are the challenges of managing multi-national trials?

• How do you empower CROs to take ownership?

• What are the characteristics of the most successful CRO/Sponsor partnerships? What does success look like? 

Moderator:Christopher Gallen, MD, PhDCEO, SK biopharmaceuticals

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

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 • China • India • Japan • Eastern Europe • Korea

Roundtable leaders include:Debra 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

• How to best target new centers globally

• Identifying investigator challenges in order to improve training standards

• Advancements in technology for patients

• Advancements in technology/training for global sites

• Non-traditional ways of collecting data globally

• The emergence of virtual clinical trials

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AGENDA 5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

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

Panelists:Roberta DuncanSenior Director, Clinical Operations, Trevi Therapeutics

Abraham GutmanPresident and CEO, AG Mednet

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

Christine PierrePresident, Society for Clinical Research Sites (SCRS)

Shoshana Weiler, MD, MPAChairman, Auditing Board of Clinical Trials, Clalit Health Services

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 and Global Head, Data & Safety Monitoring, Quintiles

3:30 pmCompany Spotlight Presentations: Innovative Technologies and Services that Drive Efficiencies in Global Clinical Trials

• 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

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

Presenters:Dan McDonaldDirector of Business Development, DAC Patient Recruitment Services

Garrett SmithExecutive Director, Transperfect

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

with

Christopher Gallen, MD, PhDCEO, SK biopharmaceuticals

5:00 pmConference Concludes

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EXECUTIVE SPONSORS

Chiltern is a leading, full service, global Contract Research Organization with quality solutions for

conducting clinical trials across a broad range  of therapeutic areas. Our 1,700+ staff are working across 40+ countries in all types of service models. We strive to be your development partner. For more information, visit www.chiltern.com.

ICON plc is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The

company specialises in the strategic development, management and analysis of programs that support clinical development – from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently has approximately 11,100 employees, operating in 39 countries. Further information is available at www.iconplc.com.

About Aptiv Solutions:Aptiv Solutions, an ICON plc company, is a recognised leader in the design and execution of adaptive clinical trials for pharmaceutical and biotech customers. The company also has in-depth experience in the management of medical device trials and its Japanese subsidiary, Niphix, is a full-service, oncology-focused CRO serving both Japanese and international customers. For more information, visit www.aptivsolutions.com.

Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial

outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com.

ASSOCIATE SPONSORS

AG Mednet automates, expedites and improves outcomes in clinical trials by

ensuring quality and compliance within critical medical imaging processes. 25,000+ registered users across thousands of investigator sites in 60 countries use AG Mednet to participate in projects sponsored by the world’s top 20 pharmaceutical, biotech and medical device companies. For more information, visit www.agmednet.com.

A pioneer in clinical trial patient recruitment since 1992, DAC Patient Recruitment Services ―

an Imperial company ― offers strategic site selection, customized patient recruitment and retention, award-winning creative services, and CEU-certified clinical staff training. DAC has successfully managed projects impacting over 100,000 patients in 100 countries. For more information, visit www.imperialcrs.com.

INC Research is a leading, global full-service clinical research organization (CRO) providing the full range of Phase I to IV clinical development

services. As a therapeutically focused CRO, with a Trusted Process® delivery methodology, developing the medicines people need is something we take personally. For more information, please visit www.incresearch.com.

TransPerfect Life Sciences helps life sciences companies conduct clinical development,

commercialize and support life cycle management of products on a global scale. We combine our services and 21 CFR Part 11 compliant software to provide global solutions to help life sciences companies operate move to a completely paperless environment. TransPerfect offers end-to-end solutions to support clinical, regulatory, medical affairs, safety, marketing and more. For more information, visit www.trialinteractive.com.

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SPONSORS 5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

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EXHIBITORS

Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw

(Poland), London (UK) and USA. Lambda offers full spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. For more information, visit www.lambda-cro.com.

PCI partners with pharmaceutical and biotech manufacturers in supporting

their global packaging needs throughout the product life cycle — from Phase I clinical trials through commercial launch and ongoing supply — with packaging solutions that increase speed to market and commercial success. To learn more, please visit http://pciservices.com.

SUPPORTING PARTNERS

The Massachusetts Life Sciences Center (MLSC) is an investment agency that supports life sciences

innovation, research, development and commercialization. The MLSC is charged with implementing a 10-year, $1-billion, state-funded investment initiative. These investments create jobs and support advances that improve health and well-being. The MLSC offers the nation’s most comprehensive set of incentives and collaborative programs targeted to the life sciences ecosystem. These programs propel the growth that has made Massachusetts the global leader in life sciences. The MLSC creates new models for collaboration and partners with organizations, both public and private, around the world to promote innovation in the life sciences. For more information, visit www.masslifesciences.com.

The Massachusetts Biotechnology Council (MassBio), a not-for-profit organization that represents

and provides services and support for the Massachusetts biotechnology industry, is the nation’s oldest biotechnology trade association. Founded in 1985, MassBio is committed to advancing the development of critical new science, technology and medicines that benefit people worldwide. For more information, visit www.massbio.org.

MEDIA PARTNERS

5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS EXHIBITORS / PARTNERS

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