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Special Coverage on:

• The Economics of Global Trials and SPA

• Regulatory Updates with invited speaker Ni Khin, MD, Medical Team

Leader, US Food & Drug Administration

• Patient Recruitment: 3-Part Section on Recruitment Speed,

Globalizing your Study, Social Media & Communication & Privacy

Hot Topic Discussions:

• Managing Global Clinical Studies During an Acquisition

• Cultural Impact on Study Execution

• Optimizing Resource Utilization

• Using Data Mining Techniques to Identify Patient Locations

Featured Panels:

• How to Investigate and Identify the right KOL and CRO for your trial

implementation

• It’s A Team Effort! Best Practices in Executing Global Trials with Sponsors,

CROs and Investigators

Round Tables by Region:

Latin America ● Eastern Europe ● China

Korea ● Europe ● India ● Japan

Executing Global Clinical Trial Operations

How to globalize your study for clinical success

September 28 - 29, 2010

Embassy Suites Washington DC - Convention Center

HIGHLIGHTSSTATE OF THE INDUSTRY ADDRESS

Mitchell Katz, PhD Purdue

SPEED OF RECRUITMENTPeter Carberry, MDAstellas

CLINICAL PARTNERSRaymond Panas, PhDSucampoPharmaceuticals

REGIONAL REGULATIONSGene Wright, PharmD, PhDCombinatoRx

EMERGING MARKETSAleksander Skuban, MDOtsuka Pharmaceutical Development & Commercialization

ETHICSDavid Perlman, MDPenn Center for Bioethics

Executive Sponsors:

Supporting Sponsor: Presented by:

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Dear Colleague,

The Conference Forum has broken through the ceiling in research to present a new standard of content in peer-to-peer learning. Executing Global Clinical Trial Operations is scrupulously researched and approved by industry peers and leaders to ensure a conference event that meets the following learning objectives:

1. Best practices in executing global trials collaboratively with the sponsors, CROs and investigators.

2. How to investigate and identify the right clinical partner to implement your global trial by different regions.

3. Lessons learned from leaders with recent hands-on experience in executing global trials.

4. Peer-to-peer information sharing on the hottest issues cultural differences, resource utilization, data mining and strategies to managing a global trial during an acquisition.

5. Analyze a complex and interactive case study involving several ethical problems in conducting global clinical trials.

6. Best practices on how to win in the contest of speed to complete recruitment vs value in data from representative populations in pivotal clinical trials.

7. Understand the pros and cons of social media and networking for global patient recruitment and the investment risks.

8. Identify the expectations of implementing a global recruitment strategy from beginning to end.

9. Informed consent simplification and improvement strategies.

10. Identify solutions to enhance patient privacy.

11. Best practices on how to conduct global protocols in regions with untested or developing clinical research infrastructures (eg, emerging markets).

12. How to clarify regulatory acceptance of global results for national registrations.

13. Understand epidemiological resources in non-US/EU countries to allow for clinical assessments of disease opportunities, validation of study sites/protocols, conduct of observational/pharmacoepidemiological studies in those countries.

14. Get clarification on what is acceptable with regards to safety reporting, risk evaluation and mitigation plans.

15. Tips on how to create a working environment that is flexible enough to deal with the regulatory environment.

16. Understand what sponsors can do to make the review process easier.

Please take a look at the sessions and speaking faculty. We are confident that this is the most comprehensive and cutting-edge event on executing efficient and safe global clinical trials with patient and partner success.

Sincerely,

Mitchell Katz, PhDExecutive Director, Medical Research OperationsPurdue & Conference Co-Chair

Aleksandar Skuban, MDDirector, Global Development & CommercializationOtsuka Pharmaceutical Development & Commercialization& Conference Co-Chair

The Conference Forum is grateful for the guidance and support of the Global Clinical Trial’s Dedicated Advisory Board:

Larry Blankstein, PhDSenior Director Clinical ResearchGenzyme

Peter Carberry, MDSenior Vice President, Global Development OperationsAstellas

Graeme Currie, PhDVice President, Clinical OperationsSepracor

Shobha Dhadda, PhDAssociate Director, BiostatisticsAstellas

Pierre Etienne, MDInstitut Douglas/Douglas Institute

Chris Gallen, MD, PhDExecutive Vice President of Research and DevelopmentCombinatoRx

Peter K Honig MD, MPHIndependent Consultant

Mitchell Katz, PhDExecutive Director, Medical Research OperationsPurdue

Mark LanfearVIce President, Worldwide Strategic AlliancesKforce

Jack LawlerDirector of Clinical OperationsCephalon

Dilip Mehta, MD, PhDPartnerRadius Ventures, LLC

Gary Meininger, MDDirector, Clinical ResearchMerck

Raymond Panas, PhD Director of International Clinical DevelopmentSucampo Pharmaceuticals

Honorio Silva, MDPresidentInter-American Foundation for Clinical Research

Aleksandar Skuban, MDDirector, Global Development & CommercializationOtsuka Pharmaceutical Development & Commercialization

Linda Strause, PhDExecutive Director, Oncology TrialsVical

Nancy WidnerExecutive Director of Central Clinical OperationsBMS

EXECUTING GLOBAL CLINICAL TRIAL OPERATIONS! ADVISORY BOARD

2

ADVISORY BOARD

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

The Conference Forum is pleased to announce the following

industry leaders who are speaking at this event:

Peter Carberry, MD

Senior Vice President, Global Development Operations

Astellas

Claudia Chavarro

Associate Director, Clinical Operations

RPS

Scott H. Connor

Vice President, Marketing

Acurian, Inc.

Shobha Dhadda, PhD

Associate Director, Biostatistics

Astellas

Mitchell Katz, PhD

Executive Director, Medical Research Operations

Purdue

Ni Khin, MD (invited)

Medical Team Leader

Division of Psychiatry Products

US Food and Drug Administration

Jack Lawler

Director of Clinical Operations

Cephalon

Raymond Panas, PhD

Director of International Clinical Development

Sucampo Pharmaceuticals

Mark Paxton

Assoc. Vice President, International Regulatory & Scientific Affairs

PhRMA

David Perlman, PhD

Senior Lecturer, Penn Nursing

Associate Fellow

Penn Center for Bioethics

Viq Pervaaz

Senior Vice President, Corporate Transaction

AON Consulting

Laurence G. Poli, PhD

Vice President and General Manager

TTC, llc

Brian P. Schrock

Director, Global Enrollment Optimization

Eli Lilly & Company

Honorio Silva, MD

President

Inter-American Foundation for Clinical Research

Aleksandar Skuban, MD

Director, Global Development & Commercialization

Otsuka Pharmaceutical Development & Commercialization

Anne Trontell, MD, MPH

Program Director

AHRQ

Gene Wright, PharmD, PhD

Senior Vice President, Chief Development Officer

CombinatoRx

This event is designed for pharmaceutical and biotech executives

in senior management or director roles with responsibilities in:

• Global Clinical Operations

• Clinical Research & Development

• Clinical Outsourcing

• Clinical Project Management

• Clinical Design

• Clinical Strategy

• Biostatistics

• Patient Recruitment/Enrollment

• Medical Director

• Investigators *

• Ethics

• Protocol Design

• Distribution

• Regulatory Affairs

This conference is also of interest to CROs, Patient Recruitment,

Logistic and Translation companies.

* Please see special rate for Investigators when registering.

• To provide attendees with content that has been scrupulously

researched and approved by industry peers and leaders

• To provide attendees with an experienced speaking faculty

• To provide attendees with stimulating and interactive sessions

• To provide attendees with useful data and information to help

them do their jobs better

SPEAKING FACULTY! EXECUTING GLOBAL CLINICAL TRIAL OPERATIONS

3

WHO SHOULD ATTEND

SPEAKING FACULTY

PRINCIPLES OF THE EVENT

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

8:00! Registration & Morning Coffee/Tea

8:30" Chair’s Welcome and Opening Remarks on How Companies are Coming to the Decision to Execute Global Clinical Trials

Mitchell Katz, PhD

Executive Director, Medical Research OperationsPurdue

8:40! State of the Industry Address • The contrast between trials in the US vs globally

• How to create a working environment that is flexible

enough to deal with the regulatory environment?

• Overview of global requirements for NDA/BLA

applications in established and emerging markets

• Regulatory acceptance of global results for national

registrations (eg, US FDA or CHMP Acceptance of

foreign clinical trial data)

• Conducting global protocols in regions with untested or

developing clinical research infrastructures (eg,

emerging markets)

• Epidemiological resources in non-US/EU countries to

allow for clinical assessments of disease opportunities,

validation of study sites/protocols, conduct of observational/

pharmacoepidemiological studies in those countries

• What PhRMA is doing to support global trials

Mitchell Katz, PhD! Mark Paxton

Executive Director,! Assoc. Vice President,

Medical Research! International Regulatory &

Operations! Scientific Affairs

Purdue! PhRMA

9:30! Grounding Realities in Conducting International Trials -Trans-Regional Regulatory Issues • The CTA approval process in the European Union,

China, India and Latin America

• Timelines predictions

• Country requirements

• Multiple translations

• How to select regional and country regulatory experts

Gene Wright, PharmD, PhD

Senior Vice President, Chief Development Officer

CombinatoRx

10: 15 Updates & Q&ANi Khin, MD (invited)

Medical Team Leader

Division of Psychiatry Products

US Food and Drug Administration

10:45 ! Networking Break

11:15 ! A Breakdown and Comparison of Costs in Conducting Trials Globally (Survey Results)

Laurence G. Poli, PhD

Vice President and General Manager

TTC, llc

11:45 ! Ethical Considerations in Conducting Global TrialsAt the end of this session, participants should be able to:

• Describe and use ethical principles and theories that

underlie clinical research

• Analyze a complex, interactive case study involving

ethical problems in conducting global clinical trials

• Understand several ethical considerations for

particularly "sticky" issues in conducting global clinical

trials, including:

1. medical exploitation

2. use of placebos

3. ensuring proper standards of trial conduct

4. avoiding undue influence in recruitment and

participation

5. ensuring adequate ethical oversight

David Perlman, PhD

Senior Lecturer, Penn Nursing

Associate Fellow

Penn Center for Bioethics

12:30! Luncheon with Round Tables organized by the following RegionsAttendees will have the opportunity to enjoy lunch

followed by the rotation of two regions of their choice

where they can ask questions specific to those regions.

An experienced facilitator will lead each region.

1. Latin America

2. Eastern Europe

3. China

4. Korea

5. Europe

6. India

7. Japan

2:30! 3-Part Patient Recruitment!

Part I - How to Win in the Contest of Speed to Complete Recruitment vs Value in Data from Representative Populations in Pivotal Clinical Trials• Do we simply meet regulatory needs to collect data on

populations of special interest or do we seek to

understand the differing responses to an investigational

medication through stratifying for this phenomenon?

EXECUTING GLOBAL CLINICAL TRIAL OPERATIONS! AGENDA

4

DAY ONE - TUESDAY, SEPTEMBER 28, 2010

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

• Is this a relevant question for every therapeutic area and

indication being studied?

• Do these questions influence and direct country and site

selection? If not, what assumptions, models or

algorithms do we use to address the differences that

show up in the data?

• What is the optimal approach to managing the conflict

between time and need to understand differences, at the

study, program and CTD levels?

• Case studies and examples

Peter Carberry, MD! Shobha Dhadda, PhD

SVP, Global Development! Associate Director,

Operations! Biostatistics

Astellas! Astellas

3:15 ! Part II - Social Media & NetworkingLeveraging eRecruitment for Clinical Trial Enrollment: Case StudyWith Web 2.0 and social media continuing to gain

mindshare with consumers and marketers alike, the focus

surrounding its effectiveness in recruiting patients for

clinical trials has increased dramatically in recent months.

Acurian and Eli Lilly provide insight into the pitfalls and

possibilities of eRecruitment as a global patient enrollment

strategy, including performance metrics from recent trials.

Brian P Schrock! Scott H Connor

Director, Global! Vice President, Marketing

Enrollment Optimization! Acurian, Inc

Eli Lilly & Company

3:45 ! Networking Break

4:00! Part III - Globalization of the Recruitment Strategy and How it Best Applies in Different Regions - Sponsor & CRO Communications in a Global World• Expectations in implementing an end-to-end strategy

• Development and review cycles at the vendor, sponsor,

legal and ethics / regulatory boards

• Addressing the challenges of roles and responsibilities

• Who is accountable to select the sites?" Is it the vendor

or the sponsor?" If the sponsor suggests sites, does the

CRO feel obliged or enabled?"

• The use of EHR data to drive decision-making in trial set

up, both at the CRO and sponsor level

• Cultural differences

• Relationship and communication strategies

• Training

• CRO and site selection

• Enrollment strategies

• Registries for prospective and retrospective studies

• After the recruitment phase is completed, what is the

impact on the country?

• How to follow up with investigators and regulators?

• What are the business implications?

• What about presentation or publication of study results?

• What is the current situation with bridging studies and

intellectual property issues?

• What is the current situation with bridging studies and

intellectual property issues?

• What is being done and what can be done to design

protocols that are more patient focused

• Building the protocol to match the SOC (as much as

possible) and putting strategies in place to make it

simple for both the site and the patients regardless of TA

• Messaging options to patients, and how they are

different in different parts of the world

Open Session

5:00! Networking Reception hosted by

9:00" Chair’s Welcome & Opening RemarksAleksandar Skuban, MD

Director, Global Development &

Commercialization

Otsuka Pharmaceutical Development & Commercialization

9:30" It’s a Team Effort! Best Practices in Executing Trials Globally with the Sponsors, CROs and Investigators With the patient at the center of the trial, Sponsors, CROs

and Investigators present together on each key topic to

identify better solutions to execute clinical trials globally.

This interactive team approach will allow us to better:

1. Understand the key issues and elements around each

topic

2. Provide recommendations and better solutions

More specifically:

• Contracting decisions

• How can you execute to meet the demands for the

timelines?

• Identifying better solutions to get the quality of data you

need and resourcing your clinical trials

• Do any outsourcing models work better than any other?

• What are the key elements that make them work?

• Incentives for performance

• Clinical trial start up and protocol sign up to start up

• First patient treated

• Data base lock and Data privacy

• Patient reported outcomes

AGENDA! EXECUTING GLOBAL CLINICAL TRIAL OPERATIONS

5

DAY TWO - WEDNESDAY, SEPTEMBER 29, 2010

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

EXECUTING GLOBAL CLINICAL TRIAL OPERATIONS! AGENDA

• Global trial distribution

• Identifying better solutions to get drugs, equipment and

patient samples in and out of these emerging countries

• Logistical issues/samples/distribution

Mitchell Katz, PhD! Jack Lawler

Executive Director,! Director of Clinical Operations

Medical Research! Cephalon

Operations

Purdue

Raymond Panas, PhD! Honorio Silva, MD

Director of International! President

Clinical Development! Inter-American Foundation

Sucampo! for Clinical Research

Pharmaceuticals

10:30! Networking Break

11:00! 2-Part Training Investigators!

! Part I - Training Experienced AND Naive Site Investigators: Moving from a One Country Pilot Plan to a Full Implementation Approach across Latin America

Claudia Chavarro

Associate Director, Clinical Operations

RPS

! Part II - Training and Certification of Investigators: Contributions to Leverage Health Care in the Emerging Markets• Investigator in the emerging world (demographics,

distribution, etc. UNESCO data)

• Barriers to efficient clinical research in the USA & abroad

• AAMC recommendations for investigators training and

other regulatory requirements

• On-going programs for training and certification of

investigators (ACRP, Argentina, Brazil, USA," IAFCR) and

expected benefits

Honorio Silva, MD

President

Inter-American Foundation for Clinical Research

11:45 ! How to Investigate and Identify the Right Clinical Partner to Implement your Global Trial• How do you start your search?

• How to seek and network for key opinion leaders?

• Identifying specialties from each region

• Coordinating project teams to work with global CROs

Jack Lawler! Raymond Panas, PhD

Director of Clinical! Director of International

Operations! Clinical Development

Cephalon! Sucampo Pharmaceuticals

12:15 ! Luncheon

1:15 ! Emerging Markets Future Outlook: Economic Definitions, Regulatory and Research Experience From Patient Recruitment to Innovation Hubs • Diverse regions and unique countries

• Changing global landscape: Emerging countries of past,

present and future

• What are the major incentives and advantages of clinical

trials in emerging countries?

• True challenges, ethical questions and possible solutions

• Awareness of health landscape and differences in

medical practices in various countries

• Matching clinical trial indications with patient

populations in need-mutual benefit

• Outsourcing and partnership, getting it right

• Contrasts and similarities among Eastern European

countries in global clinical research

Aleksandar Skuban, MD

Director, Global Development & Commercialization

Otsuka Pharmaceutical Development &

Commercialization

2:00! Open Group Discussion Led by Experienced Facilitators on Peer-to-Peer Information Sharing on Hot TopicsHot topic # 1

Managing Global Clinical Studies During an Acquisition—

Strategies for Maintaining the Focus and Momentum

• When the original team does not go with the acquisition

• How acquisition should work and how they sometimes

work

• Factors to ensure continuity

Hot topic # 2

Cultural impact on study execution

Hot topic # 3

Factors to consider in optimizing resource utilization

Hot topic # 4

The use of data mining techniques to identify patient

locations

Viq PervaazSenior Vice President, Corporate Transaction

AON Consulting

3:00! Comparative Effectiveness• Definition and Methods

• Recent mandate to AHRQ

• HTA in other countries (NICE)

• Objectives and impact of CE on drug development and

payer decision making

Anne Trontell, MD, MPH

Program Director

AHRQ

4:00! Conference concludes

6

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! Industry! Government, Non-Profit ! ! & InvestigatorsEarly-Bird -Before August 13, 2010! $1495! $595

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REGISTRATION, VENUE & SPONSORSHIP! EXECUTING GLOBAL CLINICAL TRIAL OPERATIONS

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SPONSORS AND MEDIA PARTNERS! EXECUTING GLOBAL CLINICAL TRIAL OPERATIONS

EXECUTIVE SPONSORS

8

MEDIA PARTNERS

SUPPORTING SPONSOR

EXHIBITOR