2nd patient engagement summit: new technologies for engaging patients in clinical trials, march...
DESCRIPTION
Implementing Cutting Edge Communication Technology to Facilitate Recruitment, Compliance, and Retention in Clinical TrialsTRANSCRIPT
RegisteR by JanuaRy 14 foR eaRly-biRd pRicing
TO REgISTER: Call 866-207-6528 or visit us at www.exlpharma.com
Conference Chair:Craig Lipset, Senior Director (Clinical Research) and Venture Partner (Pfizer Venture Investments), PFIZER
2nd Patient Engagement Summit: New Technologies for Engaging Patients in Clinical TrialsImplementing Cutting Edge Communication Technology to Facilitate Recruitment, Compliance, and Retention in Clinical Trials
Proudly Presents:
MARCH 1-2, 2011CROWNE PLAzA PHILADELPHIA DOWNTOWN
our Esteemed Speaker Faculty:Craig Lipset Senior Director (Clinical Research) and Venture Partner (Pfizer Venture Investments), PFIZERDavid Leventhal Director, Healthcare Informatics, PFIZERgretchen goller Patient Recruitment/Compliance Strategist-Operations, SANOFI-AVENTISKaren Brooks Director, Clinical Projects, SANOFI-AVENTISLinda DealDirector, Patient Reported Outcomes, JOHNSON & JOHNSONLynn Sutton Vice President, Clinical Services, ALLOS THERAPEUTICSMats Sundgren Principal Scientist, Global Clinical Development, ASTRAZENECAMelanie goodwin Manager, Global Trial Optimization, MERCKMiguel Orri Senior Director, PFIZERJoseph Kim Director of Clinical Operations, SHIRE PHARMACEUTICALSLisa Kaufman Director, Clinical Operations, MERSANA THERAPEUTICSPetra Jaeger Clinical Operations Group Head Quality & Training, NOVARTIS PHARMACEUTICALS GMBH
TO REgISTER: Call 866-207-6528 or visit us at www.exlpharma.com
Featured Presentations:PFIzER CASE STUDY: ONLINE CLINICAL TRIALEarly Look at Pfizer’s Unprecedented Study—the First Clinical Trial to Exclusively Use Online Recruitment, a Web-Based Informed Consent Process, and Virtual Follow-Up for Patient Engagement Miguel Orri, Senior Director, Clinical Sciences (Primary Care Business Unit), PFIZER
CASE STUDY: ONLINE COMMUNITIESCreating and Nurturing Patient Driven Online Communities to Validate Interest in Study ParticipationLynn Sutton, Vice President, Clinical Services, ALLOS THERAPEUTICS
MERCK’S “CENTER OF EXCELLENCE” ON gAININg INTERNAL BUY-IN: Preparing the Internal Team for a Study Using Tools of the 2.0 Age so Your Trial’s Clinical Data is Processed in a Timely MannerMelanie Goodwin, Manager, Global Trial Optimization, MERCK
ePRO CASE STUDY: DEVELOPINg AND VALIDATINg A DAILY ELECTRONIC ENDOMETRIOSIS PAIN AND BLEEDINg DIARY (EPBD)Advances in Electronic Patient Reported Outcomes (ePRO) that Increase Accuracy and Improve Compliance in Clinical TrialsLinda Deal, Director, Patient Reported Outcomes, JOHNSON & JOHNSON
Utilizing Electronic health Records To More Efficiently identify Potential Trial ParticipantsA PAN EUROPEAN CASE STUDY: The Benefits of the Innovative Medicine Initiative’s EHR4CR Project, which Shares Information Between 32 Partners—Including 10 Pharmaceutical Companies— Across Multiple NationsMats Sundgren, Principal Scientist, Global Clinical Development, ASTRAZENECA
PACeR CASE STUDY: The Advantages of New York State’s EHR Clinical Trials NetworkDavid Leventhal, Director, Healthcare Informatics, PFIZER
Sponsored by:
hotel informationOur 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 ReservationsIf 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
Who Should attend:Directors, Managers, Heads, Vice Presidents and Coordinators of:
◆ Patient Recruitment◆ Trial Optimization◆ Clinical Trials◆ Clinical Research◆ Clinical Development◆ Clinical Data Management◆ Clinical Information Systems◆ ePRO (electronic patient
reported outcomes)◆ Clinical Projects◆ Clinical Operations◆ Clinical Studies
◆ Healthcare Informatics
You will also meet representatives from:
◆ Sites◆ Regulatory Groups◆ Non-profits◆ Universities◆ Advocacy Groups/
Online Communities◆ Recruitment/Retention Agencies◆ CROs ◆ Consultancies
Dear Colleague,This is an exciting time for recruiting patients into clinical trials and engaging them throughout. New technologies such as online screening and EHRs allow clinicians to reduce recruitment time. Social media and mobile devices allow sites to more closely monitor behavior and work with patients and family members to increase compliance. Technologies that ease communication are allowing study leaders to keep in close contact with patients after the study is complete.
As more pharmaceutical companies crack the code about how to successfully use new technologies to meet deadlines, clinical trials leaders must maintain a keen awareness of what tools are available, or risk falling behind competitors who more quickly recruit patients and more effectively engage them to avoid attrition.
Exl’s 2nd Patient Engagement Summit: New Technologies for Engaging Patients in Clinical Trials is your opportunity to be part of a highly quali-fied group of clinical trial leaders looking to make informed decisions about acquiring and integrating new technologies that will help meet deadlines and improve study effectiveness.
Sincerely,
Dave HoffmanDave Hoffman Kristen HunterConference Director Team Leader, Production2nd Patient Engagement Summit: ExL PharmaNew Technologies for Engaging Patients in Clinical Trials
Sponsorship and Exhibiting 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 at (212) 400-6228, or [email protected].
1:00 Chairperson’sWelcomeandOpeningRemarks
Craig Lipset, Senior Director (Clinical Research) and Venture Partner (Pfizer Venture Investments), PFIZER
iNTERNal BUY-iN1:15 PreparingtheInternalTeamforaStudyUsingToolsofthe2.0 AgesoYourTrial’sClinicalDataisProcessedinaTimelyManner
Melanie Goodwin, Manager, Global Trial Optimization, MERCK• 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
centric” mindframe• Evaluating study goals and technology options to help meet
benchmarks
UTILIzINg ELECTRONIC HEALTH RECORDS TO MORE EFFICIENTLY IDENTIFY POTENTIAL TRIAL PARTICIPANTS
a PaN EURoPEaN CaSE STUDY2:00 TheBenefitsofInnovativeMedicineInitiative’sEHR4CRProject
Mats Sundgren, Principal Scientist, Global Clinical Development, ASTRAZENECA• Reducing recruitment time by a potential factor of 10 with a new
multi-country EHR sharing project• How the project handles de-identification, legal, and ethical issues• Understanding the business model and how it addresses technical
and semantic issues of sharing information between 32 partners – including 10 pharmaceutical companies – across multiple nations
2:45 NETWORkINg&REfRESHMENTBREAk
PaCeR CaSE STUDY3:15 TheAdvantagesofNewYorkState’sEHRClinical TrialsNetwork
David Leventhal, Director, Healthcare Informatics, PFIZER• Overview of the New York State Partnership to Advance Clinical
Electronic Research (PACeR) Collaborative• Adjusting protocols based on information in the EHR clearinghouse• Using EHRs to target geographic areas containing appropriate
patients for site selection
RoUNDTaBlE DiSCUSSioNS4:00 AudienceMemberswillSplitintoSmallergroupsfor InteractiveDiscussionsonkeyIssues
Participantschoosefromthefollowingtopics:
1.ETHICS: What Ethical Issues should be considered in Social Media and Mobile Technology
2.LEVELOfENgAgEMENT:Can Client Engagement Become too Invasive and Discourage Enrollment?
3.MININgONLINEDATA: Reducing Time in Finding Qualified Study Patients by Using Online Communities, Networks, and Advocacy Groups
4.ONLINECOMMUNITIES: Creating and Nurturing Patient Driven Online Communities to Validate Interest in Study Participation
5.VIRTUALSCREENINg Using a Trial Specific Website for Online Screening to Increase Efficiency in Recruitment
6.EPRO: Advances in Electronic Patient Reported Outcomes (ePro) that Increase Accuracy and Improve Compliance in Clinical Trials
Moderatorsinclude:Petra Jaeger, Clinical Operations Group Head Quality & Training, NOVARTIS PHARMACEUTICALS GMBH Linda Deal, Director, Patient Reported Outcomes, JOHNSON & JOHNSONJoseph Kim, Director of Clinical Operations, SHIRE PHARMACEUTICALS
5:00 DAYONECONCLUDES
DaY oNE • Tuesday, March 1, 2011PRE-CoNFERENCE WoRKShoP – ThE PaTiENT CENTRiC aPPRoaCh9:00 BetterEngagingClinicalTrialsParticipantswitha“PatientCentric”Approach,andHowTechnologyCanHelpYouInteract inPatients’MostComfortableSetting
Lisa Kaufman, Director, Clinical Operations, MERSANA THERAPEUTICSPatients 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 NETWORkINgANDREfRESHMENTBREAk
12:00 WORkSHOPCONCLUDES;LUNCHfORWORkSHOPATTENDEES
MaiN CoNFERENCE BEGiNS
8:30 Chairperson’sRecapofDayOneandRoundtableDiscussions
Craig Lipset, Senior Director (Clinical Research) and Venture Partner (Pfizer Venture Investments), PFIZER
ExECUTiVE PaNEl DiSCUSSioN9:00 SharingExperiencesinBuildingaResearchCulturethat EncouragesTrialSponsorstoEmbraceNewPatient EngagementTechnologies
Moderator:Joseph Kim, Director of Clinical Operations, SHIRE PHARMACEUTICALSPanelists:Karen Brooks, Director, Clinical Projects, SANOFI-AVENTISMats Sundgren, Principal Scientist, Global Clinical Development, ASTRAZENECA• Overcoming practical barriers to acceptance of new technology• Altering or addressing habits of colleagues with entrenched patient
engagement practices• Handling unexpected challenges that occur when new technologies
are adopted to avoid inadvertently slowing down the recruitment process
oNliNE aDVERTiSiNG9:45 UsingOnlineAdvertisingforTotalMarketPenetration andtoTargetDifferentDemographicsandEnsureEnrollment DeadlinesareMet
Joseph Kim, Director of Clinical Operations, SHIRE PHARMACEUTICALS• The goals of online advertising versus traditional advertising in
recruitment and education• What additional patients can be reached using web based advertising• The limitations of online advertising as a tool for recruiting patients
10:30 NETWORkINg&REfRESHMENTBREAk
PFiZER CaSE STUDY11:00 EarlyLookatPfizer’sUnprecedentedStudy–thefirstClinical TrialtoExclusivelyUseOnlineRecruitment,aWeb-Based InformedConsentProcess,andVirtualfollow-UpforPatient Engagement
Miguel Orri, Senior Director, Clinical Sciences (Primary Care Business Unit), PFIZERLessons learned in sourcing and consenting trial patients online
• Overcoming the legal challenges in the 50 “United” States• Best practices in having patients self report study results
using electronic correspondence and mobile devices• Pioneering demonstration to remotely monitor patient safety using
a centralized PI• Unprecedented follow up with the patients after the trial ends
NoVEl TEChNoloGY ShoWCaSE aND FoCUS GRoUP11:45 AseriesofMiniPresentationsPremieringtheNewest AdvancesinEmergingandCuttingEdgeTechnologySolutions forRetention,Compliance,andRetention
• The Valuable Role of the Technology ◆ The Right Type of Study ◆ The Right Patient Type• The Best Approach for Implementing• Followed by Audience Feedback and QuestionsIfyouareininterestedinparticipating,pleasecontactEricMorrinat(212)400-6228
12:30 LUNCHEON
CaSE STUDY: oNliNE CoMMUNiTiES1:30 CreatingandNurturingPatient-DrivenOnlineCommunities toValidateInterestinStudyParticipation
Lynn Sutton, Vice President, Clinical Services, ALLOS THERAPEUTICS• Understanding interactivity as a tool to encourage participation• Managing confounding factors of patient communication in existing
independent communities• Encouraging compliance through effective site moderation• Building an online patient community from scratch
ePRo CaSE STUDY2:15 DevelopingandValidatingaDailyElectronicEndometriosis PainandBleedingDiary(EPBD)toIncreaseAccuracyand ImproveComplianceinClinicalTrials
Linda Deal, Director, Patient Reported Outcomes, JOHNSON & JOHNSON• Developing and validating an EPBD for assessing patient reported
treatment related changes in endometriosis symptoms • A review of study methodology, including focus groups and
cognitive interviews• Study outcome, and areas for further research
MoBilE TEChNoloGY3:00 IncreasingPatientCompliancebyUsingMobileTechnology asanEngagementTool
Gretchen Goller, Patient Recruitment/Compliance Strategist-Operations, SANOFI-AVENTISJudith Teall, Director of Patient Recruitment, EXCO INTOUCH• The importance of establishing good communications with the patient• Combining the use of automated text messages and emails to most
effectively enable and encourage patients to continue within the study and remain compliant
• Facilitating family and support network engagement through mobile technology that can transmit reminders and behavioral reports
PaNEl: RUlES oF ENGaGEMENT3:45 StrategiesforOvercomingRegulatoryBarriersin PatientCommunication
Moderator:Daniel Kracov, Partner, ARNOLD AND PORTERPanelists:Petra Jaeger, Clinical Operations Group Head Quality & Training, NOVARTIS PHARMACEUTICALS GMBHLisa Kaufman, Director, Clinical Operations, MERSANA THERAPEUTICSLynn Sutton, Vice President, Clinical Services, ALLOS THERAPEUTICS• Regulatory and FDA backdrop on clinical trials• Overcoming ethical and compliance restrictions with supplying
tools to and communicating with patients ◆ What’s allowed? ◆ Successfully approaching your counsel/regulatory team• Confidentiality issues with trial sites and online communities• Comparison of regulatory considerations for doing research in
other countries
4:30 CONfERENCECONCLUDES
DaY TWo • Wednesday, March 2, 2011
To RegisTeR Call 866-207-6528 oR visiT us aT www.exlpharma.com/Kolsummit
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 [email protected]
Five Ways to RegisterFax: 888-221-6750Mail: Exl Events, inc. 555 8th ave, Ste 310 New York, NY 10018PhoNE: 866-207-6528oNliNE: www.exlpharma.comEMail: [email protected]
Registration Fees for attending Exl Pharma’s 2nd Patient Engagement Conference:EARLY BIRD PRICING
Register by Friday, January 14, 2011to Take Advantage of Early-Bird Pricing:Conference + Workshop $1995Conference Only $1695
STANDARD PRICINGRegister After Friday, January 14, 2011: Conference + Workshop $2195Conference Only $1895
ONSITE PRICINGConference + Workshop $2295Conference Only $1995
Group Discount Program: Discounts cannot be combined; Early Bird Rates do not apply
Save 25% per person when Registering Four For 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 P907 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.
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Four weeks or more: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for two years 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 nor ExL Events, Inc.*
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PLEASE MENTION PRIORITY CODE: P907
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TO REGISTER: Call 866-207-6528 or visit us at ww
w.exlpharm
a.com
Conference Chair:Craig Lipset, Senior Director (Clinical Research) and Venture Partner (Pfizer Venture Investm
ents), PFIZER
2nd Patient Engagement Summit: New Technologies for Engaging Patients in Clinical TrialsIm
plementing Cutting Edge Com
munication
Technology to Facilitate Recruitment,
Compliance, and Retention in Clinical Trials
Proudly Presents:
MARCH 1-2, 2011
CROWN
E PLAZA PH
ILADELPHIA DOW
NTOWN
Our Esteemed Speaker Faculty:Craig Lipset Senior Director (Clinical Research) and Venture Partner (Pfizer Venture Investm
ents), PFIZERDavid Leventhal Director, Healthcare Inform
atics, PFIZERGretchen Goller Patient Recruitm
ent/Compliance
Strategist-Operations, SANOFI-
AVENTIS
Karen Brooks Director, Clinical Projects, SAN
OFI-AVEN
TISLinda Deal Director, Patient Reported Outcom
es, JOHN
SON & JOHN
SONLynn Sutton Vice President, Clinical Services, ALLOS THERAPEUTICSM
ats Sundgren Principal Scientist, Global Clinical Developm
ent, ASTRAZENECA
Melanie Goodw
in M
anager, Global Trial Optimization,
MERCK
Miguel Orri
Senior Director, PFIZERJoseph Kim
Director of Clinical Operations, SHIRE PHARM
ACEUTICALSLisa Kaufm
an Director, Clinical Operations, M
ERSANA THERAPEUTICS
Petra Jaeger Clinical Operations Group Head Quality & Training, N
OVARTIS PHARM
ACEUTICALS GMBH
TO REGISTER: Call 866-207-6528 or visit us at ww
w.exlpharm
a.com
Featured Presentations:PFIZER CASE STU
DY: ONLIN
E CLINICAL TRIAL
Early Look at Pfizer’s Unprecedented Study—the First Clinical Trial to Exclusively Use Online Recruitm
ent, a Web-Based Inform
ed Consent Process, and Virtual Follow
-Up for Patient Engagement
Miguel Orri, Senior Director, Clinical Sciences (Prim
ary Care Business Unit), PFIZER
CASE STUDY: ON
LINE COM
MU
NITIES
Creating and Nurturing Patient Driven Online Com
munities to Validate Interest
in Study ParticipationLynn Sutton, Vice President, Clinical Services, ALLOS THERAPEUTICS
MERCK’S “CENTER OF EXCELLEN
CE” ON GAININ
G INTERNAL BUY-IN:
Preparing the Internal Team for a Study Using Tools of the 2.0 Age so Your Trial’s
Clinical Data is Processed in a Timely M
annerM
elanie Goodwin, M
anager, Global Trial Optimization, M
ERCK
ePRO CASE STUDY: DEVELOPIN
G AND VALIDATIN
G A DAILY ELECTRONIC
ENDOM
ETRIOSIS PAIN AND BLEEDIN
G DIARY (EPBD)Advances in Electronic Patient Reported Outcom
es (ePRO) that Increase Accuracy and Im
prove Compliance in Clinical Trials
Linda Deal, Director, Patient Reported Outcomes, JOHN
SON & JOHN
SON
Utilizing Electronic Health Records To More Efficiently Identify Potential Trial ParticipantsA PAN EU
ROPEAN CASE STUDY: The Benefits of the Innovative M
edicine Initiative’s EHR4CR Project, w
hich Shares Information Betw
een 32 Partners—Including 10 Pharm
aceutical Companies—Across M
ultiple Nations
Mats Sundgren, Principal Scientist, Global Clinical Developm
ent, ASTRAZENECA
PACeR CASE STUDY: The Advantages of New York State’s EHR Clinical Trials Netw
orkDavid Leventhal, Director, Healthcare Inform
atics, PFIZERSponsored by: