2nd Patient Engagement Summit: New Technologies for Engaging Patients in Clinical Trials, March 2011, Philadelphia
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2nd Patient Engagement Summit: New Technologies for Engaging Patients in Clinical Trials, March 2011, Philadelphia

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

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

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2nd Patient Engagement Summit: New Technologies for Engaging Patients in Clinical Trials, March 2011, Philadelphia Document Transcript

  • 1. RegisteR by JanuaRy 14 foR eaRly-biRd pRicing Proudly Presents:2nd Patient Engagement Summit:New Technologies for Engaging Patients in Clinical TrialsImplementing Cutting Edge Communication MARCH 1-2, 2011Technology to Facilitate Recruitment, CROWNE PLAzACompliance, 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 LeventhalFeatured Presentations: Director, Healthcare Informatics, PFIZER gretchen gollerPFIzER 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-AVENTISa Web-Based Informed Consent Process, and Virtual Follow-Up for Patient Engagement Karen Brooks Director, Clinical Projects, SANOFI-AVENTISMiguel Orri, Senior Director, Clinical Sciences (Primary Care Business Unit), PFIZER Linda DealCASE STUDY: ONLINE COMMUNITIES Director, Patient Reported Outcomes, JOHNSON & JOHNSONCreating and Nurturing Patient Driven Online Communities to Validate Interest in Study Participation Lynn SuttonLynn Sutton, Vice President, Clinical Services, ALLOS THERAPEUTICS Vice President, Clinical Services, ALLOS THERAPEUTICSMERCK’S “CENTER OF EXCELLENCE” ON gAININg INTERNAL BUY-IN: Preparing the Internal Team Mats Sundgrenfor a Study Using Tools of the 2.0 Age so Your Trial’s Clinical Data is Processed in a Timely Manner Principal Scientist, Global ClinicalMelanie Goodwin, Manager, Global Trial Optimization, MERCK Development, ASTRAZENECA Melanie goodwinePRO CASE STUDY: DEVELOPINg AND VALIDATINg A DAILY ELECTRONIC ENDOMETRIOSIS Manager, Global Trial Optimization, MERCKPAIN AND BLEEDINg DIARY (EPBD) Miguel OrriAdvances in Electronic Patient Reported Outcomes (ePRO) that Increase Accuracy Senior Director, PFIZERand Improve Compliance in Clinical Trials Joseph KimLinda Deal, Director, Patient Reported Outcomes, JOHNSON & JOHNSON Director of Clinical Operations, SHIRE PHARMACEUTICALS Lisa KaufmanUtilizing Electronic health Records To More Efficiently Director, Clinical Operations, MERSANA THERAPEUTICSidentify Potential Trial Participants Petra JaegerA PAN EUROPEAN CASE STUDY: The Benefits of the Innovative Medicine Initiative’s EHR4CR Clinical Operations Group Head Quality & Training, NOVARTIS PHARMACEUTICALSProject, which Shares Information Between 32 Partners—Including 10 Pharmaceutical Companies— GMBHAcross Multiple NationsMats Sundgren, Principal Scientist, Global Clinical Development, ASTRAZENECA Sponsored by:PACeR CASE STUDY: The Advantages of New York State’s EHR Clinical Trials NetworkDavid Leventhal, Director, Healthcare Informatics, PFIZERTO 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 Recruitmentthem throughout. New technologies such as online screening and EHRs allow ◆ Trial Optimizationclinicians to reduce recruitment time. Social media and mobile devices allow ◆ Clinical Trialssites to more closely monitor behavior and work with patients and familymembers to increase compliance. Technologies that ease communication ◆ Clinical Researchare allowing study leaders to keep in close contact with patients after the ◆ Clinical Developmentstudy is complete. ◆ Clinical Data Management ◆ Clinical Information SystemsAs more pharmaceutical companies crack the code about how to successfullyuse new technologies to meet deadlines, clinical trials leaders must maintain a ◆ ePRO (electronic patientkeen 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 Projectsattrition. ◆ Clinical Operations ◆ Clinical StudiesExl’s 2nd Patient Engagement Summit: New Technologies for EngagingPatients in Clinical Trials is your opportunity to be part of a highly quali- ◆ Healthcare Informaticsfied 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 andimprove study effectiveness. ◆ Sites ◆ Regulatory GroupsSincerely, ◆ Non-profitsDave Hoffman ◆ Universities ◆ Advocacy Groups/Dave Hoffman Kristen Hunter Online CommunitiesConference Director Team Leader, Production ◆ Recruitment/Retention Agencies2nd Patient Engagement Summit: ExL Pharma ◆ CROsNew Technologies for EngagingPatients in Clinical Trials ◆ Consultancieshotel informationOur Philadelphia hotel’s location puts you in the heart of the city. Visitors can enjoy everything fromthe famous Philadelphia Cheesesteak to the Liberty Bell. No matter what your interests, Philly isthe city that has it all. Crowne Plaza Philadelphia Downtown offers modern accommodationswith gracious amenities surrounded by Rittenhouse Square, fine dining, Walnut Street shoppingand treasured historic attractions.Room ReservationsIf you require overnight accommodations, please contact the Crowne Plaza Philadelphia Downtownat 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 thediscount. You must book your room by Monday, February 7, 2011 to be eligible for the discountedrate. 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, 2011PRE-CoNFERENCE WoRKShoP – ThE PaTiENT CENTRiC aPPRoaCh9:00 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 systems10:30 NETWORkINg AND REfRESHMENT BREAk 12:00 WORkSHOP CONCLUDES; LUNCH fOR WORkSHOP ATTENDEESMaiN CoNFERENCE BEGiNS1:00 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 Clinical1:15 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 GMBH2:45 NETWORkINg & REfRESHMENT BREAk Linda Deal, Director, Patient Reported Outcomes, JOHNSON & JOHNSON Joseph Kim, Director of Clinical Operations, SHIRE PHARMACEUTICALS 5:00 DAY ONE CONCLUDESSponsorship and Exhibiting opportunitiesDo you want to spread the word about your organization’s solutions and services to potential clients who will be attending thisevent? Take advantage of the opportunity to sponsor, underwrite an educational session, host a networking event, or distributepromotional items to attendees. ExL Pharma will work closely with you to customize a package that suits all your needs. To learnmore about these opportunities, please contact Eric Morrin at (212) 400-6228, or emorrin@exlpharma.com.
  • 4. DaY TWo • Wednesday, March 2, 20118:30 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 Participation9:00 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 interviews9:45 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 patient10:30 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 mobile11:00 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 trials11:45 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.comFive Ways to Register Group Discount Program: Discounts cannot be combined; Early Bird Rates do not apply Save 25% per person when Registering FourFax: 888-221-6750 For every three simultaneous registrations from your company, you willMail: Exl Events, inc. receive a fourth complimentary registration to the program (must register 4 at one time). This is a savings of 25% per person. 555 8th ave, Ste 310 Save 15% per person when Registering Three New York, NY 10018 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, pleasePhoNE: 866-207-6528 call 866-207-6528.oNliNE: www.exlpharma.com Make checks payable to ExL Events, Inc. and write code P907 on your check. You may also use Visa, MasterCard, Discover or American Express. PaymentsEMail: register@exlpharma.com must be received in full prior to the commencement of the conference. Cancellations: If you need to cancel your registration for an upcoming ExLRegistration Fees for attending Exl Pharma’s conference, please note the following policies derived from the Start Date of the event:2nd Patient Engagement Conference: 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.EARLY BIRD PRICING Four weeks or Less: A voucher to another ExL event valid for two years fromRegister by Friday, January 14, 2011 the voucher issue date.to Take Advantage of Early-Bird Pricing: To receive a refund or voucher, please fax your request to 888-221-6750.Conference + Workshop $1995 Please Note: Conference registrations may be transferred to other colleaguesConference Only $1695 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 aSTANDARD PRICING colleague occurring within five business days of any ExL conference.Register After Friday, January 14, 2011: Please notify ExL Pharma, info@exlpharma.com, prior to the event with theConference + Workshop $2195 name and contact information of the replacement attendee.Conference Only $1895 Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacementONSITE PRICING will be made.Conference + Workshop $2295 *The opinions of this faculty do not necessarily reflect those of the companiesConference Only $1995 they represent nor ExL Events, Inc.*To RegisTeR Call 866-207-6528 oR visiT us aT www.exlpharma.com/Kolsummit
  • 6. REGISTER BY JANUARY 14 FOR EARLY-BIRD PRICING Proudly Presents: 2nd Patient Engagement Summit: ❑ Amex ❑ Discover New Technologies for Engaging Patients in Clinical Trials Make checks payable to ExL Events, Inc. ❑ Credit Card PLEASE MENTION PRIORITY CODE: P907 ❑ Visa Implementing Cutting Edge Communication MARCH 1-2, 2011 Technology to Facilitate Recruitment, CROWNE PLAZA Compliance, and Retention in Clinical Trials PHILADELPHIA DOWNTOWN ❑ MasterCard 555 8th Avenue, Suite 310 ❑ Check Conference Chair: Name on Card Our Esteemed New York, NY 10018 Craig Lipset, Senior Director (Clinical Research) and Venture Partner Speaker Faculty: (Pfizer Venture Investments), PFIZER Craig Lipset Method of Payment: Senior Director (Clinical Research) Featured Presentations: and Venture Partner (Pfizer Venture Investments), PFIZER PFIZER CASE STUDY: ONLINE CLINICAL TRIAL David Leventhal Card Type: Card Number Director, Healthcare Informatics, Early Look at Pfizer’s Unprecedented Study—the First Clinical Trial to Exclusively PFIZER Signature Exp. Date Use Online Recruitment, a Web-Based Informed Consent Process, and Virtual Gretchen Goller Follow-Up for Patient Engagement Patient Recruitment/Compliance Strategist-Operations, SANOFI- 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 in Study Participation Linda Deal Lynn Sutton, Vice President, Clinical Services, ALLOS THERAPEUTICS Director, Patient Reported Outcomes, JOHNSON & JOHNSON ❑ I wish to receive email updates on ExL Pharma’s upcoming events Phone: 866-207-6528 MERCK’S “CENTER OF EXCELLENCE” ON GAINING INTERNAL BUY-IN: 888-221-6750 Lynn Sutton 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 ❑ YES! Register me for the Conference and Workshop Mats Sundgren Melanie Goodwin, Manager, Global Trial Optimization, MERCK ❑ I’m interested in marketing opportunities at this event Principal Scientist, Global Clinical ePRO CASE STUDY: DEVELOPING AND VALIDATING A DAILY ELECTRONIC Development, ASTRAZENECA Melanie Goodwin Zip ENDOMETRIOSIS PAIN AND BLEEDING DIARY (EPBD) Manager, Global Trial Optimization, Advances in Electronic Patient Reported Outcomes (ePRO) that Increase Accuracy Fax: MERCK and Improve Compliance in Clinical Trials Miguel OrriRegistration Form ❑ Register Me for the Conference Only Linda Deal, Director, Patient Reported Outcomes, JOHNSON & JOHNSON Senior Director, PFIZER State Title 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 Telephone Company Sponsored by: Address David Leventhal, Director, Healthcare Informatics, PFIZER Name Email Dept. City TO REGISTER: Call 866-207-6528 or visit us at www.exlpharma.com