th 3 patient engagement summit new technologies for...

March 19-21, 2012 | Lowes Philadelphia Hotel | Philadelphia

3rd Patient Engagement Summit New Technologies for Engaging Patients in Clinical Trials

OUR ESTEEMED SPEAKER FACULTY

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

Heather Almonte, Associate Director, Clinical Operations, OCTAPHARMA USA

Sandra Gazel, Associate Director of Clinical Operations, ABBOTT LABORATORIES

Donna Jarlenski, PMPc, Clinical Operations Head, MOMENTA PHARMACEUTICALS

Lisa Kaufman, MS RN ACNP-BC, Independent Consultant

Joseph Kim, MBA, Clinical Operations Director, SHIRE PHARMACEUTICALS

Susie Kim, MPH, Global Trial Optimization Specialist, MERCK

Jordan Lateiner, MS, MBA, Assistant Director, Clinical Development, FOREST RESEARCH INSTITUTE

Elizabeth Mascherino, Associate Clinical Operations Director, SHIRE PHARMACEUTICALS

Jenni Prokopy, Editrix, CHRONICBABE.COM

Russell Sobel, Director of Clinical Research, CHUGAI PHARMACEUTICALS

Joris van Dam, PhD, TS Strategic Projects Leader, NOVARTIS INSTITUTE FOR BIOMEDICAL RESEARCH

Tim Verfaillie, International Clinical Project Manager, ABBOTT VASCULAR

FEATURED SESSIONS INCLUDE:

Register Now 866-207-6528 | www.crownclinical.com/3rdpteng

KEYNOTE PRESENTATION: How Do Patients View Pharma Companies’ Efforts to Use Social Media to Involve them in Clinical Trials?Jenni Prokopy, Editrix, CHRONICBABE.COM

PRE-CONFERENCE WORKSHOP

Electronic Health Records: Leveraging Pre-Engagement Technologies to Optimize Your Patient Recruitment Strategies Joseph Kim, Clinical Operations Director, SHIRE PHARMACEUTICALS

PRIMARY IMMUNE DEFICIENCY CASE STUDY: Developing Study Protocol and Recruiting Patients Using Existing Online CommunitiesHeather Almonte, Associate Director, Clinical Operations, OCTAPHARMA USA

ONLINE RECRUITMENT:A Presentation on the Abbott Canada Web Site Dedicated to Clinical Trial Participants Sandra Gazel, Associate Director of Clinical Operations, ABBOTT LABORATORIES

CLINICAL TRIAL ALERTS: Engaging Patients and Physicians in Clinical Research Through Electronic Health Records Joris van Dam, PhD, TS Strategic Projects Leader, NOVARTIS INSTITUTE FOR BIOMEDICAL RESEARCH

OFFICIAL MEDIA PARTNER

Part of ExL Pharma’s

SPONSORS

Register by FEBRUARY 3RD 2012 for EARLY BIRD PRICING

6th Forecasting and Optimizing the Clinical Supply Chain3rd Annual Clinical Site Feasibility, Selection and Start-up5th Lean Sigma & Kaizen for Pharma R&D8th Latin America Clinical Trials Conference

Dear Colleague,

It is with great pleasure that I introduce you to ExL Pharma’s 3rd Patient Engagement Summit: New Technologies for Engaging Patients in Clinical Trials. At this conference,

clinical trial leaders will share best practices about the wonderful opportunities that online communities, mobile devices, electronic health records, and other new technologies open up for identifying and working with patients in clinical trials.

Trial leaders can now more effectively spread the word about their trial, send instant reminders, and even remain engaged with patients after the trial ends. To make the most of these tools, clinical trial planners must use them in ways that people respond to. Trial leaders must stay up to date with the latest trends if they are to maximize the potential for patient recruitment, engagement, and retention that these tools provide.

Since last year’s event, the world has been introduced to the iPad 2 and Google +, and users eagerly await discovering the mysteries of Windows 8. These are the platforms where today’s clinical relationships transpire. Countless apps, programs, and online communities have already been upgraded or evolved to benefit from technological advances. Whether it is technology or consumer preferences that drive these changes, patients are likely to adapt. ExL Pharma’s 3rd Patient Engagement Summit: New Technologies for Engaging Patients in Clinical Trials is where you can hear from your colleagues and industry leaders about how they have shortened cycle times and improved the quality of their data using new technologies to their full potential.

This year’s event is not to be missed because it:• Includes a patient’s perspective, Jenni Prokopy, editrix of the web community, chronicbabe.com• Offers case studies highlighting new uses of mobile app and EHR alert systems• Is part of our five conference CROWN (Clinical Research Operations & Worldwide Networking) Summit (registration provides access to all five events)• Features the return of the highly popular vendor showcase

We look forward to seeing you in March!Sincerely,

Dave Hoffman Matt MillmanConference Director Team Leader, ProductionExL Pharma ExL Pharma

LOEWS PHILADELPHIA HOTEL1200 Market StreetPhiladelphia, PA 19107

1-888-575-6397

Directly across from the Penn Convention Center, the Loews Philadelphia Hotel is 15 minutes from Philadelphia International Airport, five minutes from Amtrak’s 30th St Station and steps away from the historic district, shopping, restaurants, and sports arenas.

To make reservations please call The Loews Reservations Center at 1-888-575-6397 and request the negotiated rate for ExL’s CROWN. You may also use the following weblink to make reservations online: www.loewshotels.com/en/Philadelphia-Hotel GroupPages/253EXL. The group rate is guaranteed until February 27, 2012.

Who should attend?Pharma, biotech, and medical device company professionals with responsibilities in:

Sponsorship and Exhibit OpportunitiesDo 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, Business Development Manager (212) 400-6228 or [email protected].

99 Patient9Recruitment99 ePRO9(electronic patient reported outcomes)99 Trial9Optimization99 Clinical9Trials99 Clinical9Research99 Clinical9Projects

99 Clinical9Affairs99 Clinical9Studies99 Scientific9and9Medical9Affairs99 Clinical9Data9Management99 Clinical9Information9Systems

You will also meet representatives from:

99 Sites99 Regulatory9Groups99 Non-profits99 Universities

99 Advocacy9Groups/Online9Communities99 Recruitment/Retention9Agencies99 CROs999 Consultancies

HOTEL9INFORMATION


DAY ONE | TUESDAY, MARCH 20, 2012

8:00 Registration and Continental Breakfast for Workshop Participants

9:00 PRE-CONFERENCE WORKSHOP Electronic Health Records: Leveraging Pre-Engagement Technologies to Optimize Your Patient Recruitment Strategies

Patient recruitment begins with the protocol, and no patient engagement technology will overcome an ill-fitting set of inclusion criteria. While much of the industry buzz has been concerned with the theoretical applications of electronic health records, clinical teams are still woefully behind in understanding the basic principles of this technology and how to use it effectively. This workshop will focus on real world applications of leveraging this transformative technology so that your patient engagement technologies are set up for success. You will learn:

• How can EHR help optimize a protocol?• Caveats of EHR• What are ontologies and why are they important?• Implications of relationships between data points• How to pick an EHR surrogate - direct and temporal

Joseph Kim, MBA, Clinical Operations Director, SHIRE PHARMACEUTICALS

10:30 NETWORKING AND REFRESHMENT BREAK

11:00 WORKSHOP RESUMES

12:00 WORKSHOP CONCLUDES

8:00 Registration and Continental Breakfast

9:00 Chairperson’s Welcome and Introduction Joseph Kim, MBA, Clinical Operations Director, SHIRE PHARMACEUTICALS

9:15 BEYOND TEXT MESSAGING PANEL DISCUSSION: Using Mobile Technology to Keep Patients Motivated and Engaged in the Trial Process

• Reducing “radio silence” between reminders • Educating patients about their condition• Reminding them of the importance of the study and disease treatment in general• Referring patients to appropriate education materials

Moderator Jordan Lateiner, MS, MBA, Assistant Director, Clinical Development, FOREST RESEARCH INSTITUTE Panelists Judith Teall, Director of Patient Recruitment, EXCO INTOUCH Donna Jarlenski, PMPc, Clinical Operations Head, MOMENTA PHARMACEUTICALS

10:00 PRIMARY IMMUNE DEFICIENCY CASE STUDY: Developing Study Protocol and Recruiting Patients Using Existing Online Communities9 Primary9Immune9Deficiency9is9a9condition9that9afflicts9the9young.9As9a9result,99 parents9tend9to9aggressively9seek9out9medical9advice9and9peer9support9online.99 This9study9was9able9to9engage9parents9and9target9the9hard9to9reach9adolescent99 market.9Learn9how9the9trial9leaders9used9these9active9online9communities9to99 conduct9research9for9the9study9protocol9and9recruit9patients. Heather Almonte, Associate Director, Clinical Operations, OCTAPHARMA USA

10:45 Networking and Refreshment Break

11:15 RECRUITMENT PLANNING CASE STUDY: How a Monte Carlo Simulation can Help Establish Expectations of Recruitment Campaigns9 This9session9looks9at9the9role9of9Monte9Carlo9Simulation9(MCS)9in9determining999 whether9there9is9a9need9for9recruitment9support.9As9new9recruitment9techniques999 develop9it9is9essential9to9decide9the9appropriate9tactics9for9your9trial.9An9MCS9can999 provide9research9and9analysis9to9justify9the9associated9resources. Susie Kim, MPH, Global Trial Optimization Specialist, MERCK

12:00 CLINICAL TRIAL ALERTS: Engaging Patients and Physicians in Clinical Research Through Electronic Health Records

Clinical trial alerts are tools for making patients aware of upcoming trials they may become eligible for based on data in their electronic health records, allowing physicians to instantly consider and discuss the clinical trial with the patient. This approach was already described, and successfully implemented, for a diabetes study at Cleveland Clinic in Ohio in 2005. Yet despite the successful results in this study, the lack of data standards, concern about data quality, the need for cross-organizational collaboration and innovative business models have hampered the adoption of this model going forward. In this presentation, we review a number of recent approaches Novartis has taken to replicate this model – with different vendors and in different studies. We discuss our approaches to implementation of the model and the impact these approaches have made on clinical trial recruitment.

Joris van Dam, PhD, TS Strategic Projects Leader, NOVARTIS INSTITUTE FOR BIOMEDICAL RESEARCH

12:45 Lunch

1:45 HEALTHCARE APPS CASE STUDY: Leveraging Health Tracking Apps for Clinical Trial Recruitment9 Patients9are9now9readily9adopting9mobile9and9online9apps9to9track9and9manage99 their9own9disease9states.9This9case9study9focuses9on9leveraging9these9applications99 to9notify9patients9of9upcoming9trial9opportunities9as9a9feature9of9the9health9app99 itself.99Results9and9lessons9learned9will9be9discussed,9along9with9future9innovations99 which9may9match9patients9to9trials9based9in9data9entered9into9the9app9as9part9of9its99 tracking9and9management9function. Elizabeth Mascherino, Associate Clinical Operations Director, SHIRE PHARMACEUTICALS

2:30 SITE NETWORKS CASE STUDY: Leveraging the Extensive Dermatology Web Sites Managed Within a Network of Investigators

Clinical9investigative9site9networks9are9defined9as9a9group9of9independent9clinical9sites9that9function9as9one9entity,9so9they9can9realize9the9benefits9of9synergies9and9economies9of9scale,9while9retaining9their9independence.99This9session9describes9how9one9site9network9leverages9an9extensive9network9of9dermatology9websites9currently9managed9by9investigators9to9provide9doctor-vetted9information9to9patients9and9the9lay9public9while9providing9insight9into9upcoming9and9ongoing9clinical9trials.

9 Rodney Butt, MSc, MBA, Principal, HAMILTON MEDICAL CONSULTANTS GROUP

WORKSHOP | MONDAY, MARCH 19, 2012PR

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MAIN CONFERENCE BEGINS

9:00 Chairperson’s Day Two Welcome and Recap of Day One Joseph Kim, MBA, Clinical Operations Director, SHIRE PHARMACEUTICALS 9:15 KEYNOTE PRESENTATION How Do Patients View Pharma Companies’ Efforts to Use Social Media to Involve them in Clinical Trials?

This session offers a firsthand account of how patients who are not connected to the pharmaceutical world view researchers efforts to connect them with clinical trials. The speaker will discuss examples where companies have successfully reached out, as well as areas of miscommunication. The audience will be encouraged to ask questions about how to avoid common mistakes and more effectively communicate with patients who can benefit from their studies.

Jenni Prokopy, Editrix, CHRONICBABE.COM

10:00 CONFOUNDING VARIABLES: Risks Involved when Patients are Socially Engaged During a Clinical Trial

• Patients and sharing eligibility criteria for the trial• Accounting for records when patients share observations of the active drug versus

the placebo• How safety signals may be skewed when patients share information (for example,

patients may be more likely to report a headache if they know it is a symptom) Bonnie Brescia, Co-Founding Principal, BBK WORLDWIDE


11:15 MEASURING RESULTS PANEL: Creating Metrics to Measure Online Interactions

With limited resources, you must make decisions about which engagement tools to use. But online, social media is diverse, and when you add video and mobile technology, setting up direct comparisons can become tricky. This panel will feature trial leaders discussing how they measure one method of engagement against another.

Panelists: Russell Sobel, Director of Clinical Research, CHUGAI PHARMACEUTICALS Lisa Kaufman, MS RN ACNP-BC, Independent Consultant Tim Verfaillie, International Clinical Project Manager, ABBOTT VASCULAR

12:00 NOVEL TECHNOLOGY SHOWCASE AND FOCUS GROUP: A Series of Mini-Presentations Premiering the Newest Advances Cutting Edge Technology for Recruitment, Compliance, and Retention Showcase Leaders: Matthew Stumm, Creative Director, BBK WORLDWIDE

IfyouareinterestedinparticipatingintheNovelTechnologyShowcase, pleasecontactEricMorrinat(212)400-6228

12:45 Lunch

1:45 TRIAL FOLLOW-UP: Constructing an Online Community for Participants who Complete Studies

This9presentation9discusses9the9key9components9of9REMS9assessments9and9best9practices9to9successfully9complete9FDA9compliant9assessments.

• Introducing the ability to continue to share information and retain relationships with the patients

• Share future learnings about the clinical trial with patients• Gather data from patients at a future time

Russell Sobel, Director of Clinical Research, CHUGAI PHARMACEUTICALS

2:30 ARE NEW STRATEGIES FOR PATIENT RECRUITMENT WORKING: Rethinking Recruitment in Terms of Overall Study Execution

This9session9examines9whether9or9not9updated9approaches9and9the9use9of9new9technologies9really9improve9recruitment9and9enrollment.9The9speaker9will9review9what9alternatives9might9exist9to9re-think9existing9approaches9to9overall9study9execution9as9a9means9for9achieving9improved9recruitment.9

Lisa Kaufman, MS RN ACNP-BC, Independent Consultant

3:15 Chairperson’s Closing Remarks Conference Concludes

DAY TWO | WEDNESDAY, MARCH 21, 2012


3:45 ONLINE RECRUITMENT CASE STUDY A Presentation of the Abbott Canada Web Site Dedicated to Clinical Trial Participants

• Communicating of clinical trial interim results to patients during the study. • Learn about barriers to patients participating in clinical trials from research

conducted by Canadian patients focus groups• Do Canadian regulatory, infrastructure, and cultural differences have an impact on

the adoption of new technologies for patient recruitment? • Review the results of a survey of Canadian clinical research professionals on their use

of patient recruitment strategies9 Sandra Gazel, Associate Director of Clinical Operations, ABBOTT LABORATORIES

4:30 THE OLD FASHIONED WAY: Reaching Populations that May Not be Connected Online and with Mobile Devices

While much of the world has adopted new internet and mobile habits, many have not. Some populations, such as those over 65, may be difficult to reach if you rely too heavily on electronic technology. This session will review how to make the best use of your advertising dollars by matching your marketing initiatives by indication, by advertising vehicle, or by geographic location to most effectively reach the people most likely to benefit from being part of your study.

9 Tim Verfaillie, International Clinical Project Manager, ABBOTT VASCULAR

5:15 End of Day One

Part of ExL Pharma’s C.R.O.W.N., which stands for the Clinical Research Operations and Worldwide Networking Summit, is the combination of five flagship ExL conferences: 3rd Patient Engagement Technologies; 3rd Site Selection, Activation & Management; 6th Forecasting & Optimization of the Clinical Supply Chain; 5th Lean Sigma for Pharma R&D; and the 8th Latin America Clinical Trials Conference. The vision for the March 19-21 Summit it to build upon last year’s effort of providing a one-stop information resource local for clinical research professionals to network, learn, and bring back solution-driven ideas to their respective organizations. All events will share a networking hall, meals, and cocktail reception for one of a kind networking opportunities within the convenience of the Philadelphia area.

FAX: 888-221-6750

MAIL: ExL Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018

PHONE: 866-207-6528

EMAIL: [email protected]

ONLINE: www.crownclinical.com

FIVE WAYS TO REGISTER

EARLY BIRD PRICING Register by Friday, February 3, 2012 to Take Advantage of Early-Bird Pricing:

Conference + Workshop $1995

Conference Only $1695

MEDIA PARTNERS

STANDARD PRICING Register After Friday, February 3, 2012:



ONSITE PRICING



GROUP DISCOUNT PROGRAM: Save 25% Per Person when Registering FourFor every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). This is a savings of 25% per person.

Save 15% Per Person when Registering Three Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 866-207-6528.

Make checks payable to ExL Events, Inc. and write code P915 on your check.You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full prior to the commencement of the conference.

Cancellations: If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date of the event:Four weeks or more: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for 18 months from the voucher issue date.Four weeks or less: A voucher to another ExL event valid for two years from the voucher issue date.

To receive a refund or voucher, please fax your request to 888-221-6750.

Please note: Conference registrations may be transferred to other colleagues in the event you are unable to attend. There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of any ExL conference.

Please notify ExL Pharma, [email protected], prior to the event with the name and contact information of the replacement attendee.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement will be made.

*The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*

Do you have a question about the event? Would you like to get involved as a speaker or discussion leader at our 4th Patient Engagement Summit Please email Conference Director, Dave Hoffman at [email protected]

“I really appreciated the size and pace of the conference. It enabled very robust discussion

and sharing of ideas in the patient recruitment space.”

Joseph Kim, MBA, Clinical Operations Director, SHIRE

“A unique gathering focused on the trial

participant – from ePRO to recruitment to novel

engagement technologies and strategies.”

Craig Lipset, Head of Clinical Innovation, Worldwide Research and

Development, PFIZER

3rd Patient Engagement Summit

New Technologies for Engaging Patients in Clinical Trials

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ExL Events, Inc.555 8th Avenue, Suite 310New York, NY 10018

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

PROUDLY PRESENTS

KEYNOTE PRESENTATION: How do Patients View Pharma Companies’ Efforts to Use Social Media to Involve them in Clinical Trials?

PRIMARY IMMUNE DEFICIENCY CASE STUDY: Developing Study Protocol and Recruiting Patients Using Existing Online Communities

HEALTHCARE APPS CASE STUDY: PushingClinical Trial Information to People Using Health Tracking Apps

ONLINE RECRUITMENT: A Presentation on the Abbott Canada Web Site Dedicated to Clinical Trial Participants

CLINICAL TRIAL ALERTS: Engaging Patients and Physicians in Clinical Research Through Electronic Health Records

March 19-21, 2012 | Lowes Philadelphia Hotel | Philadelphia


REGISTER TODAY . . .

Register Now 866-207-6528 | www.crownclinical.com/3rdpteng

th 3 patient engagement summit new technologies for...

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