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Risk Based Monitoring – What Does it Mean for Your Global Study?

Re-Thinking How We Globalize Outsourcing

Reducing Risk in Placebo Response in Global Clinical Research

Investigator Non-Compliance and Protocol Deviation

Special Issues in Conducting Global Trials for Rare Diseases

Social Media Techniques and Mobile Technologies to Advance Global Patient Engagement

Ethical Considerations in Global Clinical Trials

Global Clinical Supply Risk Management Strategies

3rd Annual Executing Global Clinical Trials

How to Globalize Your Study for Clinical Success

September 13 - 14, 2012 Fairmont Copley Square Hotel, Boston, MA

COUNTRY SPECIFIC ROUNDTABLES

China ● EU ● Latin America ● India ● Russia/Ukraine

Canada ● Brazil ● Eastern Europe ● Australia ● Korea

2012 KEYNOTES ON ASIA/EMERGING MARKETS

LED BY

Mitchell Katz, PhDExecutive DirectorMedical Research OperationsPurdue Pharma LP

Aleksander Skuban, MDDirectorClinical R&D Emerging MarketsMerck Research Laboratories

Barbara Skinn, PhDDirectorCollaborative Science Center of Excellence (CSCoE)Bristol-Myers Squibb

2012 CASE STUDIES & PRESENTATIONS

Debra S. Barker, MDChief Scientific Officer, Emerging MarketsNovartis

Christopher Gallen, MD, PhDCEOSK Bio-Pharmaceuticals

Organized by Executive Sponsors Co-Sponsors

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

What are the strategies in which we can be more efficient and develop higher quality data at less cost with our global clinical trials? How do we get access to international resources? How can we trust human subject protection is safe? How can we trust the quality of the data?

In our 3rd year of tracking the progress and advancements to the challenges of executing global clinical trials, we bring fresh perspectives and a new agenda addressing:

• Risk Based Monitoring – What Does it Mean for Your Global Study?

• How do We Meet the Challenges of Outsourcing and Globalization?

• Investigator Non-Compliance and Protocol Deviation

• Social Media Techniques and Mobile Technologies to Advance Global Patient Engagement

• Special Issues in Conducting Global Trials for Rare Diseases and Targeted Therapies

• New perspective with an industry veteran on Ethical Considerations in Global Clinical Trials

• The Future of Drug Development in Asia/Emerging Markets

• Global Clinical Supply Chain Risk Management Strategies

• New Approaches to Ensuring Data Quality in Global Clinical Trials

• Working Across Cultures

- 3rd 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

Canada ● Brazil ● Eastern Europe ● Australia ● Korea

You will have access to a partnering tool for one-on-one meetings as well as several networking breaks, a luncheon and reception.

When we think about global clinical trials, how do we ensure that we take in the whole scope to include regulations, country specific feasibility, infrastructure, training, support, diversity of locations, patients, culture, etc? These are some of the questions we present strategic ideas and solutions to at the 3rd annual event.

Debra S. Barker, MD Chief Scientific Officer, Emerging Markets Novartis

Bonnie A. BresciaFounding PrincipalBBK Worldwide

Penelope Dalitz, PhD Senior Study ManagerCSL Behring

Eileen Daniel Director, Clinical and Data OperationsEndo

Roberta DuncanPresident & FounderStrategic Clinical Research Consulting, LLC

Jorge EscobarSenior Manager, Clinical OperationsBaxter Healthcare Corporation

Christopher Gallen, MD, PhDCEOSK Bio-Pharmaceuticals

Frances GroteSenior Director, Clinical OutsourcingMillenium Pharmaceuticals

Donna Jarlenski, PMPSenior Director, Clinical Development OperationsMomenta Pharmaceuticals

David R. JonesExpert Scientific Assessor (Pharmacotoxicologist), Licensing DivisionMedicines and Healthcare Products Regulatory Agency (MHRA), UK

Mitchell Katz, PhDExecutive Director, Medical Research OperationsPurdue Pharma LP

Matt KibbyIntellectual Capital & TechnologyBBK Worldwide

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

Deborah Manzo, MScOLSenior Director, Clinical Development, Head Clinical Business OperationsVertex Pharmaceuticals

Jules Mitchel, PhD, MBAPresidentTarget Health Inc.

3RD ANNUAL EXECUTING GLOBAL CLINICAL TRIALS OVERVIEW

2

OVERVIEW SPEAKING FACULTY

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Ross PettitVice President, Clinical OperationsAMAG Pharmaceuticals

Renato P. Ribeiro, PhDClinical Research Manager - GCTO Brazil Merck

Barbara Skinn, PhDDirector, Collaborative Science Center of Excellence (CSCoE)Bristol-Myers Squibb

Aleksandar Skuban, MDDirector, Clinical R&D Emerging MarketsMerck Research Laboratories

Marjorie Speers, PhD President and CEOAAHRPP (Association for the Accreditation Of Human Research Protection Programs)

Steve Winyard Senior Director, Business DevelopmentMarken

Gene Wright, PhDSenior Vice PresidentZalicus

Please check our website for additions to our speaker faculty. “Excellent Hospitality and team work. Congenial and friendly atmosphere with fostered communication between speakers and attendees. Good job!”

Honorio Silva, IAFCR

“Roundtables- Great idea! Good way to share specific experiences.”

Felicia Favorito, Millennium Pharmaceuticals

“Great!”

Sergey Borisov, BBK Worldwide

“Excellent conference.”

Linda Strause, Vical Inc.

“Good organization, strong speakers, enough opportunity for Q&A from attendees and networking cocktail hour were excellent. Overall, I thought the conference was very well organized and orchestrated. Kudos!”

Matt Whalen, PhD, IMPACT LLC

“Knowledgeable and interesting, interactive and provocative.”

Brian Schrock, Eli Lilly & Co.

“A+”

Lisa McKerracher, BioAxone

“The speakers were extremely knowledgeable and I was particularly impressed with the way everyone was so willing to share information.”

Jamila Watkins, MBA, Merck Research Laboratories

“Very useful and practical information, very interactive meeting... New cutting edge info, new approaches- informative... Excellent, relevant, informative.”

Joan T. Butler, The George Washington University

“Excellent”

John Hedberg, RPS

“Thank you so much for having me here. I’ve gained a lot of information regarding Global Clinical Trials & will use.”

Aquanette T. Sass, Merck

“Outstanding session with fantastic goals for training and certification.”

MC Sullivan, MD, Caligor Rx

“Very good! Exceeded my expectations.”

Tammy Bishop, Caligor RX

“Excellent data, fun, interesting.”

Mark Szuch, UCB

“Overall engaging, excellent... Very balanced, important insights, factual, nice layout.”

Aleksandar Skuban, MD, Merck

TESTIMONIALS 3RD ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

3

TESTIMONIALS

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

7:30 am Breakfast & Registration hosted by

8:30 amCo-Chair’s Opening Remarks and State of the Industry Address

Mitchell Katz, PhDExecutive Director, Medical Research OperationsPurdue Pharma LP

As financial pressures continue to drive consolidation in the industry, large

pharmaceutical and small biotech firms alike continue to expand outsourcing key parts of the clinical development process and the number of clinical trials conducted overseas.

How do we meet the challenges of outsourcing and globalization? What is the downside of consolidation? How can we reduce costs and timelines and ensure the quality of our data? How do we get access to the right patients and ensure their safety? Industry veteran, Dr Mitch Katz sets the stage with key challenges in globalizing studies for clinical success to also include:

• How to get the correct scientific advice

• Risk evaluation and mitigation in clinical trials

• What does the FDA want to see?

• How do we get new drugs approved and paid for?

• What are other regulatory agencies primarily concerned with?

9:15 amKeynote on Emerging Markets

Debra S. Barker, MDChief Scientific Officer, Emerging MarketsNovartis

10:15 amNetworking Break

10:45 am Rethinking the Approach to Global Outsourcing: How Companies are Putting the Pieces Together Differently to Meet Milestones Across Many Regions

We don’t have the time and budget to continue to struggle with the partnership between sponsors and CROs to execute efficient and successful trials globally. How do we get the best of this very complex relationship to work efficiently, hitting agreed upon milestones across many regions? This session features experienced global operation leaders who share what’s working and why. We will address new models, CRO selection, milestones, metrics, autonomy, control and management. This panel features representation from small, medium and large companies.

Moderated by:

Mitchell Katz, PhD, Executive Director, Medical Research Operations, Purdue Pharma LP

Panelists:

Roberta Duncan, President and Founder, Strategic Clinical Research Consulting, LLC

Frances Grote, Senior Director, Clinical Outsourcing at Millennium Pharmaceuticals

Carol Lewis Cullinan, FNP, BC, Senior Director, Clinical Operations, EnVivo Pharmaceuticals, Inc.

Gene Wright, PhD, Senior Vice President, Zalicus

11:45 amHow to Do Clinical Trials in Europe: Clarifying Confusion, Changes & Updates

• An update on the clinical trial approval process in Europe

• How to get the correct scientific advice

David R. Jones, Expert Scientific Assessor (Pharmaco-toxicologist), Licensing Division, Medicines and Healthcare Products Regulatory Agency (MHRA), UK

12:15 - 1:30 pm Luncheon

1:30 - 3:00 pm 3rd Annual Country Specific Roundtables

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

• Regulatory environment

• 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 round table section is divided into two 40 minute time periods where you can choose up to two countries. In addition to the discussion points outlined

3RD ANNUAL EXECUTING GLOBAL CLINICAL TRIALS AGENDA

DAY ONE - THURSDAY, SEPTEMBER 13, 2012

4

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above, you are welcome to bring any additional issues or questions to the table.

China ● EU ● Latin America ● India ● Russia/UkraineCanada ● Brazil ● Eastern Europe ● Australia ● Korea

Penelope Dalitz, PhD, Senior Study Manager, CSL Behring

Roberta Duncan, President and Founder, Strategic Clinical Research Consulting, LLC

Christopher Gallen, MD, PhD, CEO, SK Bio-Pharmaceuticals

Frances Grote, Senior Director, Clinical Outsourcing at Millennium Pharmaceuticals

David R. Jones, Expert Scientific Assessor (Pharmaco-toxicologist), Licensing Division, Medicines and Healthcare Products Regulatory Agency (MHRA), UK

Mitchell Katz, PhD, Executive Director, Medical Research Operations, Purdue Pharma LP

Renato P. Ribeiro, PhD, Clinical Research Manager - GCTO Brazil, Merck

Aleksandar Skuban, MD, Director, Clinical R&D Emerging Markets, Merck Research Laboratories

Gene Wright, PhD, Senior Vice President, Zalicus

3:00 pmAfternoon Networking Break

3:20 pmRegulatory Update on Brazil/Latin America

Renato P. Ribeiro, PhD, Clinical Research Manager - GCTO Brazil, Merck

3:50 pm Case Study: Aligning Study Teams in Multiprotocol, Multinational Program Drives Recruitment Success

With no shortage of work to go around, study teams are challenged by the increasing need for and complexity of participant recruitment programs. Through this case study, we’ll explore how aligning roles, accountability, expertise and budgets improved outcomes for all stakeholders – from patients and sites to monitors and senior management. What four changes can you implement in every global study to improve enrollment outcomes?

Bonnie Brescia, Founding Principal, BBK Worldwide

4:30 pm Social Media Techniques and Mobile Technologies to Advance Global Patient Engagement

Through a series of studies concerning Type 1 Diabetes conducted in twelve different countries in the North America and the EU, we will explore how social media and mobile technologies were used to advance patient recruitment and engagement. We will present real metrics and actual data to compare and contrast the different

approaches to recruitment and outreach and what is required for success from one region to another.

Donna Jarlenski, PMP, Senior Director, Clinical Development Operations, Momenta Pharmaceuticals

5:00 pmGlobal Clinical Compliance and Inspection Readiness

Deborah Manzo, MScOL, Senior Director, Clinical Development, Head Clinical Business Operations, Vertex Pharmaceuticals

5:30 pmEthical Considerations in Global Clinical Trials

How do we minimize risk to patients in a global study? How do we ensure that the research staff is adequately trained to protect the patient when carrying out the study? What do sponsors need to consider when conducting trials across international lines? How do we ensure that the study is appropriate and we have the right patients enrolled? This session will explore the ethical considerations in global trials to include:

• Informed consent

• IRB and the ethics committee review

• Access to investigational products

• Trial termination

• Patient participation for health care service access –coercion

• Life-threatening disease and participation in clinical trials

• Making sure you have the right patients enrolled

• Meeting inclusion/exclusion criteria

Marjorie A. Speers, PhD, President and CEO, AAHRPP (Association for the Accreditation of Human Research Protection Programs)

5:30 pmNetworking Reception hosted by

AGENDA 3RD ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

5

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

7:45 amBreakfast & Registration hosted by

8:20 amCo-Chair’s Welcome

Barbara Skinn, PhDDirector, Collaborative Science Center of Excellence (CSCoE)Bristol-Myers Squibb

Aleksandar Skuban, MDDirector, Clinical R&D Emerging MarketsMerck Research Laboratories

8:25 amReducing the Placebo Effect in Clinical Studies: Significance for Global Drug Development and Mitigation StrategiesIn this opening presentation on day two, we address the “placebo effect” in global clinical research and how to reduce risks.

• Trends of increased placebo response and effects on clinical trial success and timelines

• Approximately 50% Phase 3 clinical trials across different therapeutic areas fail; many due to inability to show benefit over placebo

• Understanding the background and sources of placebo response in clinical trials may prevent study failure and decrease development cost

• How to minimize placebo effect? Discussion on mitigation strategies concerning patient selection, recruitment, study design and other factors

• Selected case studies illustrating research on placebo effect

Aleksandar Skuban, MD, Director, Clinical R&D Emerging Markets, Merck Research Laboratories

9:00 amKeynote: The Future of Drug Development in Asia

Christopher Gallen, MD, PhDCEOSK Bio-Pharmaceuticals

9:45 amRisk Based Monitoring – What Does it Mean for Your Global Study? How Different Organizations are Adapting to a Risk Based Approach to Monitoring in Their Global Studies

In this hot topic panel, we begin with a definition of Risk Based Monitoring, look at FDA guidance, provide a case

study, review what the data looks like and discuss parameters. Our panel will also address:

• How companies are putting guidelines into practice

• How are they complying with FDA and EMA directives in the absence of clear rules?

• What are the variables to determine how much risk we can take within FDA guidelines?

• How much monitoring of clinical trial sites is necessary to ensure quality, compliance, and safety of research participants?

• How is risk-based monitoring working in different countries and regions?

• How to go from 100% source data verification to a risk-based approach

• EDC and new technologies for remote monitoring

Moderated by:

Barbara Skinn, PhD, Director, Collaborative Science Center of Excellence (CSCoE), Bristol-Myers Squibb

Panelists:

Deborah Manzo, MScOL, Senior Director, Clinical Development, Head Clinical Business Operations, Vertex Pharmaceuticals

Jules Mitchel, PhD, MBA, President, Target Health

Ross Pettit, Vice President, Clinical Operations, AMAG Pharmaceuticals

10:30 amMorning Networking Break

11:00 amGlobal Clinical Supply Chain Risk Management Strategies - from Protocol Design to Seamlessly Managing Global Natural Disasters

Clinical Logistics is often a last minute decision that ranks it second largest budget item behind the CRO spend. There are clear strategies for handling global clinical logistics as you build your global study protocol that can minimize the cost.

3RD ANNUAL EXECUTING GLOBAL CLINICAL TRIALS AGENDA

6

DAY TWO - FRIDAY, SEPTEMBER 14, 2012

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

REGISTRATION 3RD ANNUAL EXECUTING GLOBAL CLINICAL TRIALS

• Hear up to date information about the influence of global infrastructure and site considerations that you can take back and use in planning global studies

• Discuss new logistics lessons learned from the recent London Olympics as well as unplanned natural disasters that you can implement in your current and future studies

Steve Winyard, Senior Director, Business Develoment, Marken

11:30 amSpecial Issues in Conducting Global Trials for Rare Diseases Panel Discussion

With financial pressures from expiring patents and emergence of generics, biotech and pharmaceutical companies are increasingly focusing on new therapies for rare diseases. Rare disease research poses additional challenges with smaller markets and smaller populations for participation in clinical trials and requires a different approach, particularly when conducting trails outside of the US. This session will examine the special considerations for conducting global trials for rare diseases with a focus on:

• Study design and planning issues

• Site selection, qualification and monitoring

• Patient recruitment and retention

Matt Kibby, Intellectual Capital & Technology, BBK Worldwide

Jorge Escobar Sr., Manager, Clinical Operations, Baxter BioScience

12:15 pmData Quality Deconstructed: Do More, Plan Less - A New Approach to Ensuring Data Quality in Global Clinical Trials – A Case Study This sponsor has embraced the concept that clinical studies are more than scientific experiments; they are also experimental in operation.

• Examine an ongoing global trial on how study teams can break through the cycles of activity that hinder data quality

• Setting aside SOPs, quality by design templates, quality agreements and the many associated plans to achieve data quality

• Ensuring all voices are heard early on in the protocol design

• Changing the approach to study team prep

Eileen Daniel, Director, Clinical & Data Operations, Endo Pharmaceuticals

12:45 pmTown Hall Meeting on Additional Global Clinical Trial Topics

• Investigator Non-Compliance and Protocol Deviation: Training & Support Systems

• Conducting Global Trials for Targeted Therapies

• Clinical Registries

• Cultural Competency, Working Across Cultures

Moderated by:

Barbara Skinn, PhD, Director, Collaborative Science Center of Excellence (CSCoE), Bristol-Myers Squibb

Aleksandar Skuban, MD, Director, Clinical R&D Emerging Markets, Merck Research Laboratories

1:00 pm

Program concludes

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