Implementing Cutting Edge Communication Technology to Facilitate Recruitment, Compliance, and Retention in Clinical Trials

1. RegisteR by JanuaRy 14 foR eaRly-biRd pRicing
Proudly Presents:
2nd Patient Engagement Summit:
New Technologies for Engaging Patients in Clinical Trials
Implementing Cutting Edge Communication MARCH 1-2, 2011
Technology to Facilitate Recruitment, CROWNE PLAzA
Compliance, and Retention in Clinical Trials PHILADELPHIA DOWNTOWN
Conference Chair: our Esteemed Speaker Faculty:
Craig Lipset
Craig Lipset, Senior Director (Clinical Research) and Venture Partner Senior Director (Clinical Research)
(Pfizer Venture Investments), PFIZER and Venture Partner (Pfizer Venture
Investments), PFIZER
David Leventhal
Featured Presentations: Director, Healthcare Informatics, PFIZER
gretchen goller
PFIzER CASE STUDY: ONLINE CLINICAL TRIAL Patient Recruitment/Compliance Strategist-
Early Look at Pfizer’s Unprecedented Study—the First Clinical Trial to Exclusively Use Online Recruitment, Operations, SANOFI-AVENTIS
a Web-Based Informed Consent Process, and Virtual Follow-Up for Patient Engagement Karen Brooks
Director, Clinical Projects, SANOFI-AVENTIS
Miguel Orri, Senior Director, Clinical Sciences (Primary Care Business Unit), PFIZER Linda Deal
CASE STUDY: ONLINE COMMUNITIES Director, Patient Reported Outcomes,
JOHNSON & JOHNSON
Creating and Nurturing Patient Driven Online Communities to Validate Interest in Study Participation
Lynn Sutton
Lynn Sutton, Vice President, Clinical Services, ALLOS THERAPEUTICS Vice President, Clinical Services,
ALLOS THERAPEUTICS
MERCK’S “CENTER OF EXCELLENCE” ON gAININg INTERNAL BUY-IN: Preparing the Internal Team
Mats Sundgren
for a Study Using Tools of the 2.0 Age so Your Trial’s Clinical Data is Processed in a Timely Manner Principal Scientist, Global Clinical
Melanie Goodwin, Manager, Global Trial Optimization, MERCK Development, ASTRAZENECA
Melanie goodwin
ePRO CASE STUDY: DEVELOPINg AND VALIDATINg A DAILY ELECTRONIC ENDOMETRIOSIS Manager, Global Trial Optimization, MERCK
PAIN AND BLEEDINg DIARY (EPBD) Miguel Orri
Advances in Electronic Patient Reported Outcomes (ePRO) that Increase Accuracy Senior Director, PFIZER
and Improve Compliance in Clinical Trials Joseph Kim
Linda Deal, Director, Patient Reported Outcomes, JOHNSON & JOHNSON Director of Clinical Operations,
SHIRE PHARMACEUTICALS
Lisa Kaufman
Utilizing Electronic health Records To More Efficiently Director, Clinical Operations,
MERSANA THERAPEUTICS
identify Potential Trial Participants Petra Jaeger
A PAN EUROPEAN CASE STUDY: The Benefits of the Innovative Medicine Initiative’s EHR4CR Clinical Operations Group Head Quality
& Training, NOVARTIS PHARMACEUTICALS
Project, which Shares Information Between 32 Partners—Including 10 Pharmaceutical Companies— GMBH
Across Multiple Nations
Mats Sundgren, Principal Scientist, Global Clinical Development, ASTRAZENECA
Sponsored by:
PACeR CASE STUDY: The Advantages of New York State’s EHR Clinical Trials Network
David Leventhal, Director, Healthcare Informatics, PFIZER
TO REgISTER: Call 866-207-6528 or visit us at www.exlpharma.com

2. Who Should attend:
Dear Colleague, Directors, Managers, Heads, Vice Presidents
and Coordinators of:
This is an exciting time for recruiting patients into clinical trials and engaging ◆ Patient Recruitment
them throughout. New technologies such as online screening and EHRs allow
◆ Trial Optimization
clinicians to reduce recruitment time. Social media and mobile devices allow
◆ Clinical Trials
sites to more closely monitor behavior and work with patients and family
members to increase compliance. Technologies that ease communication ◆ Clinical Research
are allowing study leaders to keep in close contact with patients after the ◆ Clinical Development
study is complete. ◆ Clinical Data Management
◆ Clinical Information Systems
As more pharmaceutical companies crack the code about how to successfully
use new technologies to meet deadlines, clinical trials leaders must maintain a ◆ ePRO (electronic patient
keen awareness of what tools are available, or risk falling behind competitors reported outcomes)
who more quickly recruit patients and more effectively engage them to avoid ◆ Clinical Projects
attrition. ◆ Clinical Operations
◆ Clinical Studies
Exl’s 2nd Patient Engagement Summit: New Technologies for Engaging
Patients in Clinical Trials is your opportunity to be part of a highly quali- ◆ Healthcare Informatics
fied group of clinical trial leaders looking to make informed decisions about You will also meet representatives from:
acquiring and integrating new technologies that will help meet deadlines and
improve study effectiveness. ◆ Sites
◆ Regulatory Groups
Sincerely,
◆ Non-profits
Dave Hoffman ◆ Universities
◆ Advocacy Groups/
Dave Hoffman Kristen Hunter Online Communities
Conference Director Team Leader, Production ◆ Recruitment/Retention Agencies
2nd Patient Engagement Summit: ExL Pharma
◆ CROs
New Technologies for Engaging
Patients in Clinical Trials ◆ Consultancies
hotel information
Our Philadelphia hotel’s location puts you in the heart of the city. Visitors can enjoy everything from
the famous Philadelphia Cheesesteak to the Liberty Bell. No matter what your interests, Philly is
the city that has it all. Crowne Plaza Philadelphia Downtown offers modern accommodations
with gracious amenities surrounded by Rittenhouse Square, fine dining, Walnut Street shopping
and treasured historic attractions.
Room Reservations
If you require overnight accommodations, please contact the Crowne Plaza Philadelphia Downtown
at 215-561-7500 to book your room. ExL has reserved a block of rooms at a discounted rate for con-
ference participants. Please mention ExL Pharma and the conference name to take advantage of the
discount. You must book your room by Monday, February 7, 2011 to be eligible for the discounted
rate. Please book your room early, as the rooms available at this rate are limited.
TO REgISTER: Call 866-207-6528 or visit us at www.exlpharma.com

3. DaY oNE • Tuesday, March 1, 2011
PRE-CoNFERENCE WoRKShoP – ThE PaTiENT CENTRiC aPPRoaCh
9:00 Better Engaging Clinical Trials Participants with a “Patient Centric” Approach, and How Technology Can Help You Interact
in Patients’ Most Comfortable Setting
Lisa Kaufman, Director, Clinical Operations, MERSANA THERAPEUTICS
Patients in the 21st Century will no longer accept being viewed as “subjects” to be studied. The spirit of the internet era dictates that patients expect to be
viewed as partners in all endeavors, especially when it comes to their health. Sponsors that stick to old methods will be left behind as competitors adopt new
technologies to recruit patients, facilitate compliance, reduce attrition, and follow up in a way that increases quality assurance for future trials.
This workshop will review not only what new technologies are available, but how to approach patients in a way that best allows for speedier recruitment and
more thorough engagement throughout.
• Instilling a “patient centric” mindframe into clinicians, both internal and on site
• How patients view trial sponsors, and how to make that work when recruiting through online communities
• The newest technology available for mobile devices, and a review of appropriate uses of text messaging reminders to patients and their support systems
10:30 NETWORkINg AND REfRESHMENT BREAk
12:00 WORkSHOP CONCLUDES; LUNCH fOR WORkSHOP ATTENDEES
MaiN CoNFERENCE BEGiNS
1:00 Chairperson’s Welcome and Opening Remarks PaCeR CaSE STUDY
Craig Lipset, Senior Director (Clinical Research) and Venture 3:15 The Advantages of New York State’s EHR Clinical
Partner (Pfizer Venture Investments), PFIZER
Trials Network
iNTERNal BUY-iN David Leventhal, Director, Healthcare Informatics, PFIZER
• Overview of the New York State Partnership to Advance Clinical
1:15 Preparing the Internal Team for a Study Using Tools of the 2.0 Electronic Research (PACeR) Collaborative
Age so Your Trial’s Clinical Data is Processed in a Timely Manner • Adjusting protocols based on information in the EHR clearinghouse
Melanie Goodwin, Manager, Global Trial Optimization, MERCK • Using EHRs to target geographic areas containing appropriate
patients for site selection
• Getting buy in from study team members using new patient engage-
ment tools and techniques
• Effectively interacting with 2.0 patients by developing a “patient RoUNDTaBlE DiSCUSSioNS
centric” mindframe
• Evaluating study goals and technology options to help meet 4:00 Audience Members will Split into Smaller groups for
benchmarks Interactive Discussions on key Issues
Participants choose from the following topics:
UTILIzINg ELECTRONIC HEALTH RECORDS TO MORE 1. THICS: What Ethical Issues should be considered in Social Media
E
EFFICIENTLY IDENTIFY POTENTIAL TRIAL PARTICIPANTS and Mobile Technology
2. EVEL Of ENgAgEMENT: Can Client Engagement Become too
L
a PaN EURoPEaN CaSE STUDY Invasive and Discourage Enrollment?
2:00 The Benefits of Innovative Medicine Initiative’s EHR4CR Project 3. ININg ONLINE DATA: Reducing Time in Finding Qualified Study
M
Patients by Using Online Communities, Networks, and Advocacy Groups
Mats Sundgren, Principal Scientist, Global Clinical Development, 4. NLINE COMMUNITIES: Creating and Nurturing Patient Driven
O
ASTRAZENECA Online Communities to Validate Interest in Study Participation
• Reducing recruitment time by a potential factor of 10 with a new 5. IRTUAL SCREENINg Using a Trial Specific Website for Online
V
multi-country EHR sharing project Screening to Increase Efficiency in Recruitment
• How the project handles de-identification, legal, and ethical issues 6. PRO: Advances in Electronic Patient Reported Outcomes (ePro)
E
• Understanding the business model and how it addresses technical that Increase Accuracy and Improve Compliance in Clinical Trials
and semantic issues of sharing information between 32 partners – Moderators include:
including 10 pharmaceutical companies – across multiple nations Petra Jaeger, Clinical Operations Group Head Quality & Training,
NOVARTIS PHARMACEUTICALS GMBH
2:45 NETWORkINg & REfRESHMENT BREAk Linda Deal, Director, Patient Reported Outcomes,
JOHNSON & JOHNSON
Joseph Kim, Director of Clinical Operations,
SHIRE PHARMACEUTICALS
5:00 DAY ONE CONCLUDES
Sponsorship and Exhibiting opportunities
Do you want to spread the word about your organization’s solutions and services to potential clients who will be attending this
event? Take advantage of the opportunity to sponsor, underwrite an educational session, host a networking event, or distribute
promotional items to attendees. ExL Pharma will work closely with you to customize a package that suits all your needs. To learn
more about these opportunities, please contact Eric Morrin at (212) 400-6228, or emorrin@exlpharma.com.

4. DaY TWo • Wednesday, March 2, 2011
8:30 Chairperson’s Recap of Day One and Roundtable Discussions 12:30 LUNCHEON
Craig Lipset, Senior Director (Clinical Research) and Venture
Partner (Pfizer Venture Investments), PFIZER CaSE STUDY: oNliNE CoMMUNiTiES
1:30 Creating and Nurturing Patient-Driven Online Communities
ExECUTiVE PaNEl DiSCUSSioN to Validate Interest in Study Participation
9:00 Sharing Experiences in Building a Research Culture that Lynn Sutton, Vice President, Clinical Services,
Encourages Trial Sponsors to Embrace New Patient ALLOS THERAPEUTICS
Engagement Technologies • Understanding interactivity as a tool to encourage participation
Moderator: • Managing confounding factors of patient communication in existing
Joseph Kim, Director of Clinical Operations, independent communities
SHIRE PHARMACEUTICALS • Encouraging compliance through effective site moderation
• Building an online patient community from scratch
Panelists:
Karen Brooks, Director, Clinical Projects, SANOFI-AVENTIS
Mats Sundgren, Principal Scientist, Global Clinical Development,
ePRo CaSE STUDY
ASTRAZENECA 2:15 Developing and Validating a Daily Electronic Endometriosis
• Overcoming practical barriers to acceptance of new technology Pain and Bleeding Diary (EPBD) to Increase Accuracy and
• Altering or addressing habits of colleagues with entrenched patient Improve Compliance in Clinical Trials
engagement practices
Linda Deal, Director, Patient Reported Outcomes,
• Handling unexpected challenges that occur when new technologies
JOHNSON & JOHNSON
are adopted to avoid inadvertently slowing down the recruitment
process • Developing and validating an EPBD for assessing patient reported
treatment related changes in endometriosis symptoms
• A review of study methodology, including focus groups and
oNliNE aDVERTiSiNG cognitive interviews
9:45 Using Online Advertising for Total Market Penetration • Study outcome, and areas for further research
and to Target Different Demographics and Ensure Enrollment
Deadlines are Met MoBilE TEChNoloGY
Joseph Kim, Director of Clinical Operations, SHIRE 3:00 Increasing Patient Compliance by Using Mobile Technology
PHARMACEUTICALS as an Engagement Tool
• The goals of online advertising versus traditional advertising in Gretchen Goller, Patient Recruitment/Compliance Strategist-
recruitment and education Operations, SANOFI-AVENTIS
• What additional patients can be reached using web based advertising
• The limitations of online advertising as a tool for recruiting patients Judith Teall, Director of Patient Recruitment, EXCO INTOUCH
• The importance of establishing good communications with the patient
10:30 NETWORkINg & REfRESHMENT BREAk • Combining the use of automated text messages and emails to most
effectively enable and encourage patients to continue within the
study and remain compliant
PFiZER CaSE STUDY • Facilitating family and support network engagement through mobile
11:00 Early Look at Pfizer’s Unprecedented Study – the first Clinical technology that can transmit reminders and behavioral reports
Trial to Exclusively Use Online Recruitment, a Web-Based
Informed Consent Process, and Virtual follow-Up for Patient PaNEl: RUlES oF ENGaGEMENT
Engagement 3:45 Strategies for Overcoming Regulatory Barriers in
Miguel Orri, Senior Director, Clinical Sciences (Primary Care Patient Communication
Business Unit), PFIZER Moderator:
Lessons learned in sourcing and consenting trial patients online Daniel Kracov, Partner, ARNOLD AND PORTER
• Overcoming the legal challenges in the 50 “United” States Panelists:
• Best practices in having patients self report study results Petra Jaeger, Clinical Operations Group Head Quality & Training,
using electronic correspondence and mobile devices NOVARTIS PHARMACEUTICALS GMBH
• Pioneering demonstration to remotely monitor patient safety using
a centralized PI Lisa Kaufman, Director, Clinical Operations, MERSANA
• Unprecedented follow up with the patients after the trial ends THERAPEUTICS
Lynn Sutton, Vice President, Clinical Services, ALLOS
NoVEl TEChNoloGY ShoWCaSE aND FoCUS GRoUP THERAPEUTICS
• Regulatory and FDA backdrop on clinical trials
11:45 A series of Mini Presentations Premiering the Newest • Overcoming ethical and compliance restrictions with supplying
Advances in Emerging and Cutting Edge Technology Solutions tools to and communicating with patients
for Retention, Compliance, and Retention ◆ What’s allowed?
◆ Successfully approaching your counsel/regulatory team
• The Valuable Role of the Technology
◆ The Right Type of Study • Confidentiality issues with trial sites and online communities
◆ The Right Patient Type • Comparison of regulatory considerations for doing research in
• The Best Approach for Implementing other countries
• Followed by Audience Feedback and Questions
If you are in interested in participating, please contact 4:30 CONfERENCE CONCLUDES
Eric Morrin at (212) 400-6228

5. Media Partners
Do you have a question about the event? Would
you like to get involved as a speaker or discussion
leader at our 3rd Patient Engagement Summit:
New Technologies for Engaging Patients in Clinical
Trials? Please email Conference Director, Dave
Hoffman at dhoffman@exlpharma.com
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Implementing Cutting Edge Communication MARCH 1-2, 2011
Technology to Facilitate Recruitment, CROWNE PLAZA
Compliance, and Retention in Clinical Trials PHILADELPHIA DOWNTOWN
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Craig Lipset, Senior Director (Clinical Research) and Venture Partner Speaker Faculty:
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Featured Presentations: and Venture Partner (Pfizer Venture
Investments), PFIZER
PFIZER CASE STUDY: ONLINE CLINICAL TRIAL David Leventhal
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Early Look at Pfizer’s Unprecedented Study—the First Clinical Trial to Exclusively PFIZER
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Use Online Recruitment, a Web-Based Informed Consent Process, and Virtual Gretchen Goller
Follow-Up for Patient Engagement Patient Recruitment/Compliance
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Miguel Orri, Senior Director, Clinical Sciences (Primary Care Business Unit), PFIZER AVENTIS
CASE STUDY: ONLINE COMMUNITIES Karen Brooks
Email: register@exlpharma.com
Director, Clinical Projects, SANOFI-
Creating and Nurturing Patient Driven Online Communities to Validate Interest AVENTIS
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Preparing the Internal Team for a Study Using Tools of the 2.0 Age so Your Trial’s Vice President, Clinical Services,
Clinical Data is Processed in a Timely Manner ALLOS THERAPEUTICS
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ePRO CASE STUDY: DEVELOPING AND VALIDATING A DAILY ELECTRONIC Development, ASTRAZENECA
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ENDOMETRIOSIS PAIN AND BLEEDING DIARY (EPBD)
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Advances in Electronic Patient Reported Outcomes (ePRO) that Increase Accuracy
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Joseph Kim
Online: www.exlpharma.com Utilizing Electronic Health Records To More Efficiently
555 8th Ave, Ste 310
Director of Clinical Operations,
New York, NY 10018
SHIRE PHARMACEUTICALS
Identify Potential Trial Participants Lisa Kaufman
Mail: ExL Events, Inc.
Director, Clinical Operations,
A PAN EUROPEAN CASE STUDY: The Benefits of the Innovative Medicine MERSANA THERAPEUTICS
Please contact me:
Initiative’s EHR4CR Project, which Shares Information Between 32 Partners— Petra Jaeger
Including 10 Pharmaceutical Companies—Across Multiple Nations Clinical Operations Group Head
Quality & Training, NOVARTIS
Mats Sundgren,
TO REGISTER: Principal Scientist, Global Clinical Development, ASTRAZENECA
Call 866-207-6528 or visit us at www.exlpharma.com PHARMACEUTICALS GMBH
PACeR CASE STUDY: The Advantages of New York State’s EHR Clinical Trials Network
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City
TO REGISTER: Call 866-207-6528 or visit us at www.exlpharma.com