4TH ANNUAL GLOBAL CLINICAL TRIALS€¦ · • What is happening in emerging markets/challenges and opportunities • How industry has been successful doing their audits to get sites

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Organized by

2013 PRESENTING COMPANIES

Associate Sponsors

Debra S. Barker, MD

Novartis

Larry Blankstein, PhDGenzyme

Marielle Cohard-Radice, MDDaiichi Sankyo Pharma Development

John Constantine

Merck Polytechnic Institute /

Asia Training Consortium

Ron Corey, PhD, MBAEboo Pharmaceuticals, Inc.

Iris CulbertTeva Pharmaceutical Industries Ltd.

Christopher Gallen, MD, PhDSK Bio-Pharmaceuticals

Kathy GramMillennium: The Takeda Oncology Company

Frances GroteBiogen Idec

Thomas GrundstromQuintiles

Thomas HaagNovartis

Laurie Halloran, BSN, MS Halloran Consulting Group

Cynthia HauckBristol-Myers Squibb

Mitchell Katz, PhDPurdue Pharma LP

Carol Lewis-Cullinan, FNP, BC

EnVivo Pharmaceuticals, Inc.

Deborah Manzo, MScOL

AbbVie

Thomas MarchiselloCelgene

Richard Margolin, MDJANSSEN Alzheimer Immunotherapy

Claire MeunierThe Michael J. Fox Foundation for Parkinsonʼs Research

Tracy Michener, PharmDBristol-Myers Squibb

Jules Mitchel, PhD, MBATarget Health Inc.

Alan MorganRPS

Jodie MorrisonTokai Pharmaceuticals

Ross Pettit

AMAG Pharmaceuticals

Fabio Thiers, MD, MSc, PhDViS Research Institute

Barry Ticho, MD, PhDBiogen Idec

Christine WangEnVivo Pharmaceuticals

4TH ANNUAL

GLOBAL CLINICAL TRIALSREDUCING COMPLEXITIES IN GLOBAL CLINICAL TRIALSSEPTEMBER 18, 2013 THE FAIRMONT COPLEY PLAZA, BOSTON, MA

Executive Sponsors

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Welcome to the Fourth Annual Executing Global Clinical Trials conference. The 2013 program is being offered as a one-day intensive followed by the option to attend the Disruptive Innovations to Advance Clinical Trials conference.

The conference covers solutions to the current barriers and challenges in planning and executing successful global clinical trials and in particular, how to reduce the complexities of them. The 2013 agenda covers:

• Lessons Learned from Unsuccessful Global Clinical Trials

• Regulatory Update on Global Clinical Trials and in particular Emerging Markets

• How Companies are Re-Thinking Global Clinical Trials

• Partnering with Global Investigative Sites

• CRO Best Practices in Collaborations, Implementation and Execution of Multi-National Trials

• Risk Based Monitoring for Global Clinical Trials

• Technologies Driving Efficiencies in Global Clinical Trials

• Designing Patient-Centric Protocols to Increase Global Patient Engagement

• Reducing Protocol Complexity

• Re-Thinking Global Patient Recruitment and the Patient Experience in Global Clinical Trials

• Audit Inspections Update

• Trends of Approvals Outside the US

- Fourth Annual Regional Roundtables -

One of the best-rated sections of the conference is the regional round tables for one-on-one questions with an expert in the following areas:

China • EU • Latin America • India • Russia/Ukraine Japan • Canada • Brazil • Eastern Europe

Middle East/North Africa • Korea

Special Offers & Discounts

Take advantage of the early bird discount by registering before July 1 for best pricing. This conference is offered as a one-day event or can be combined with the Disruptive Innovations to Advance Clinical Trials conference on September 19-20 in the same venue. The conference includes breakfast, breaks, and a luncheon. For any questions, contact us at [email protected].

Debra S. Barker, MDChief Scientific Officer, Emerging Markets Novartis

Larry Blankstein, PhDSenior Director Clinical ResearchGenzyme

Marielle Cohard-Radice, MDVP, Clinical Development OperationsDaiichi Sankyo Pharma Development

John ConstantineExecutive Director & Dean, Merck Polytechnic Institute and Chair, Asia Training Consortium

Ron Corey, PhD, MBACOOEboo Pharmaceuticals, Inc.

Iris CulbertSenior Clinical Project Manager, Global Clinical OperationsTeva Pharmaceutical Industries Ltd.

Christopher Gallen, MD, PhDCEOSK Bio-Pharmaceuticals

Kathy GramAssociate Director for Patient AdvocacyMillennium: The Takeda Oncology Company

Frances GroteSenior Director, Clinical Operations Vendor OversightBiogen Idec

Thomas GrundstromVP, Integrated Processes and TechnologieQuintiles

Thomas HaagIT Systems and Processes, Development QANovartis

Laurie Halloran, BSN, MSPresident & CEO Halloran Consulting Group

Cynthia HauckDirector, Global MedicalBristol-Myers Squibb

Mitchell Katz, PhDExecutive Director, Medical Research OperationsPurdue Pharma LP

4TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS OVERVIEW

OVERVIEW

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SPEAKING FACULTY

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Carol Lewis-Cullinan, FNP, BCSenior Director, Clinical OperationsEnVivo Pharmaceuticals, Inc.

Deborah Manzo, MScOLSenior Director, Clinical Business Operations and TransformationAbbVie

Thomas MarchiselloGlobal Head, Portfolio Sourcing and Relationship ManagementCelgene

Richard Margolin, MDSenior Director, BiomarkersJANSSEN Alzheimer Immunotherapy

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

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

Jules Mitchel, PhD, MBAPresidentTarget Health Inc.

Alan MorganCEORPS

Jodie MorrisonCEOTokai Pharmaceuticals

Ross PettitVP, Clinical OperationsAMAG Pharmaceuticals

Fabio Thiers, MD, MSc, PhDCEOViS Research Institute

Barry Ticho, MD, PhDVP, Clinical DevelopmentBiogen Idec

Christine WangSenior Director Quality SystemsEnVivo Pharmaceuticals

8:00 amRegistration & Breakfast

8:30 amChair’s Opening

Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals

8:45 amRegulatory Update on Global Clinical Trials

• Update on FDA, EMA, MHRA and NICE, PMDA, SFDA

• FDA New Initiatives

• EMA guidance on Non-Interventional Studies and Reporting Serious Adverse Events and Non-serious Adverse Events

• What is happening in emerging markets/challenges and opportunities

• How industry has been successful doing their audits to get sites ready and ensure quality is being done

• Update on FDA and EMA joint inspections: why they are happening and the challenges people are facing

Moderator:Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals

Panelists:Debra S. Barker, MDChief Scientific Officer, Emerging Markets, Novartis

Christine H. WangSenior Director Quality Systems, EnVivo Pharmaceuticals

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

• In what areas in the global conduct of clinical trials are sponsor companies and CROs driving higher levels of efficiency, data quality and investigative site performance at lower cost?

• Re-thinking the use of investigative sites in clinical research

• How companies are restructuring operations to meet the demand of the changes in science

• How to model success rates and gain insights to learn from quantitative success

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SPEAKING FACULTY 4TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

AGENDA - WEDNESDAY, SEPTEMBER 18, 2013

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

• Risk Evaluation and Mitigation Strategies (REMS)

- When are REMS needed? What are the components?

- How are people implementing it? What are the resources and cost of going along with it?

• Partnering with patient advocacy groups

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

Barry Ticho, MD, PhDVice President, Clinical Development, Biogen Idec

10:15 amNetworking Break

10:40 amGlobal Site Selection

11:00 amAn Update on Risk Based Monitoring for Global Clinical Trials

• Simple approaches, best practices and strategy

- Best practices for cross-functional training at all levels, including site level, to ensure effective implementation

- Technology for implementation

• What the KPIs are and how metrics are monitored and applied

• What are the challenges and risk points?

• Expectations from FDA and regulatory authorities

• Does it lower the research burden or cost?

Thomas HaagIT Systems and Processes, Development QA, Novartis

Deborah Manzo, MScOLSenior Director, Clinical Business Operations and Transformation, AbbVie

Jules Mitchel, PhD, MBAPresident & Co-Founder, Target Health

Thomas GrundstromVP, Integrated Processes and Technologies, Quintiles

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

In response to the rapid growth of the healthcare industry in Asia that is being stymied by the supply of quality talent available in the regions, several companies in the Pharmaceutical and CRO industries came together to form the ATC for Pharmaceutical Professionals. This collaboration represents an innovative, industry-wide approach for attracting and training more and better talent for the management and conduct of clinical trials. John Constantine will discuss the challenges organizations face from the talent perspective, specifically in Asia, solutions already put in place by the Asia Training Consortium (ATC), and plans for expanding this effort globally to include training for clinical research sites.

John ConstantineExecutive Director & Dean, Merck Polytechnic Institute and Chair, Asia Training Consortium

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

• How has global outsourcing evolved to meet the demands of global clinical trials?

• Which models best allow you to adapt and change operational requirements to meet the needs and changes in the science?

• Geographic reach considerations in choosing an outsourcing partner

• Is the resource scalable to allow you to expand both functionally and geographically?

• What are the challenges and potential risks from having CRO providers maintain patient privacy from Europe’s Data Protection Directive and how will that impact outsourcing models?

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

4TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS AGENDA

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TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

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 MovahhedSenior Vice President, Global Development Operations, United Therapeutics

Speaker TBA, Quintiles

1:00 pmLuncheon

1:30 pm4th 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

• Patient recruitment, enrollment and engagement

• Site selection

• Government protection of intellectual property

• Market access

• Cultural differences and idiosyncrasies

• Key questions for CROs

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

The country specific roundtable section is divided into two 30-minute time periods where you can choose up to two countries. In addition to the discussion points outlined above, you are welcome to bring any additional issues or questions to the table.

China • EU • Latin America • India • Russia/Ukraine Japan • Canada • Brazil

Eastern Europe • Middle East/North Africa • Korea

2:30 pmSoap Box Session: Innovative Technologies that Drive Efficiencies in Global Clinical TrialsThis soapbox session gives a comprehensive view on key technologies in the global clinical space that answer the following questions:

• How to use technology 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

Moderator:Ross PettitVice President, Clinical Operations, AMAG Pharmaceuticals

Presenting Companies

1. ViS Research Institute

Fabio Thiers, MD, MSc, PhDCEOViS Research Institute

2. TBC

3. TBC

3:00 pmNetworking Break

3:30 pmLessons Learned from Unsuccessful Global Clinical TrialsThousands of clinical trials are conducted globally, of which most will face many hurdles and obstacles. Sharing the lessons learned from failed trials is perhaps the most valuable lesson in ensuring more successful future trials across industry. In a time of welcoming collaboration, our panelists come together to share lessons learned.

Moderator:Christopher Gallen, MD, PhDCEO, SK BioPharmaceuticals

Panelists:Debra S. Barker, MDChief Scientific Officer, Emerging Markets, Novartis

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AGENDA 4TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Ron Corey, PhD, MBAChief Operating Officer, Eboo Pharmaceuticals, Inc.

Iris CulbertSenior 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

• How do we make protocols less complex and more patient-centric?

• How do we incorporate patient ideas into the protocol?

• How do you build quality by design into actual development of protocol and the process itself?

• How do you make protocol design more closely aligned with data capture?

• What are the tools that people are using to get protocol design teams to force matching data elements to study objectives and endpoints to eliminate corresponding costs?

• How do patient advocacy groups get patients and companies interested in trials?

Larry Blankstein, PhDSenior Director Clinical Research, Genzyme

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

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

• Update on social media and new technologies to engage patients

• What are technologies to use to make it easier for patients to participate in clinical trials?

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

Ross PettitVice President, Clinical Operations, AMAG Pharmaceuticals

5:00 pmThe Patient PanelA panel of patients who have participated in clinical trials will address the following:

• Patient Awareness: How did you find out about the trial? How was it presented? Were there any uncertainties or reservations? Why did you agree to participate?

• Patient Enrollment Process: Ease of Process, Consent Forms, Time Commitment. Were all your questions answered at enrollment?

• Clinical Management: Quality of Care, Health Team Involvement

• Quality of Life: Impact on ADL’s, Outcome Measurement Tools. Overall level of satisfaction: would you recommend or refer it?

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

5:45 pmConference Concludes

The Fairmont Copley Plaza in Boston138 St. James Avenue Boston, MA 02116617-267-5300www.fairmont.com/copleyplaza

For reservations, call 800-441-1414 or 617-267-5300 and ask for the Global Clinical Trials group rate, or use the following link: http://bit.ly/17oLJ0y.

4TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS AGENDA

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HOTEL INFORMATION

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Executing Global Clinical Trials Conference OnlySeptember 18, 2013New Early Bird - before before July 1, 2013 $895

Early Bird - before August 2, 2013 $995

Standard - after August 2, 2013 $1,095

Executing Global Clinical Trials Conference withDisruptive Innovations to Advance Clinical TrialsSeptember 18 - 20, 2013New Early Bird - before before July 1, 2013 $1,695

Early Bird - before August 2, 2013 $1,795

Standard - after August 2, 2013 $1,995

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

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 [email protected] 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 [email protected]. Please ask your substitute to provide identification on-site.

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

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

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

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

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REGISTRATION / SPONSORS 4TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

REGISTRATION & PRICING EXECUTIVE SPONSORS

ASSOCIATE SPONSORS

SUPPORTING PARTNER

MEDIA PARTNERS

Sponsorship

Do You Want To Reach the Audience at This Event?Share your expertise and showcase your product or services to key industry decision makers.

For information on sponsorship or exhibit opportunities, please contact our Sales Department at [email protected] or 646-350-2586.

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580