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Co-Organized and Managed by: Cambridge Healthtech Institute
Barnett International and Cambridge Healthtech Institute Present the Inaugural
October 9-10, 2012 • Le Meridien, Cambridge, MA
O P T I M I Z I N G T R I A L P E R F O R M A N C E
October 9-12, 2012Le Meridien | Cambridge, MA
BarnettClinicalSummit.com
Impact Trial Outcomes through Strategic Investigator Meeting Planning
Part of:Corporate Sponsors
Featured Presentations:
Takeda’s Experience With Planning and Conducting Virtual Investigator MeetingsSarah Tsymbalov, MS, Program Manager, Clinical Operations, Takeda Global Research & Development
Virtual Investigator Meetings: A Coordinator’s PerspectiveAnne Looney, Research Coordinator, Research, Mid-Ohio Heart Clinic, Inc.
Technology Assessment Strategies for Virtual Investigator MeetingsNariman A. Nasser CCRP, Director, UCSF Participant Recruitment Service, Clinical & Translational Science Institute, University of California, San Francisco
Challenging Conventional Wisdom in Virtual Investigator MeetingsSteven Sulkin, Founder & CEO, MBM Productions International
Optimizing Study Start Up Timelines with Virtual Meetings InitiativesLori Vivian, Director, Clinical Research Operations, Syntactx
Dinner Short Courses (October 10)
Proactive Approaches to Vendor Management
Design Considerations for GCP Training Programs
Virtual Investigator Meeting Management
Register by September 14th & Save up to $200!
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Dear Colleague,On behalf of Cambridge Healthtech Institute (CHI) and Barnett International, we invite you to attend the second annual Barnett Clinical Summit on October 9-12, 2012, Le Meridien, Cambridge, MA. Cambridge Healthtech Institute and Barnett International have joined together to organize an exciting event which features four co-located conferences:
This four-day summit will include formal presentations from experts, as well as case studies, interactive breakout discussion groups, workshops and networking opportunities, and will provide a forum for all involved in clinical trials to share ideas, proven practices, and recent research findings. It is also an excellent opportunity to socialize and interact with colleagues from around the world who are facing similar challenges and utilizing tested strategies.
Our goal is to make this conference an informative and enjoyable experience for everyone who attends. We are grateful for the help of many dedicated faculty and program advisors, and we recognize that without their help and advice, this summit would not exist. We continue to add to this agenda and encourage you to check back for new additions and program developments. In addition, we thank you for encouraging your colleagues to attend what we believe will be a dynamic, informative and memorable conference experience.
We look forward to seeing you at the Summit!Sincerely,
Naila GanatraGeneral Manager, Barnett International,a division of Cambridge Healthtech Institute (CHI)T: (+1) 215.413.2471E: [email protected]
Rachel MeyersAssociate Director, Barnett Internationala division of Cambridge Healthtech InstituteT: (+1) 413.527.3056E: [email protected]
Clinical Project Management Forum
Virtual Investigator Meeting Management
Clinical Protocol Development
Clinical Training Forum
October 11-12October 9-10
Welcome
Summit-at-a-GlanceTuesday AM Pre-Conference Short Course Virtual Investigator Meeting Management
Tuesday PM Clinical Protocol Development Virtual Investigator Meeting Management
Wednesday AM Clinical Protocol Development Virtual Investigator Meeting Management
Wednesday PM Clinical Protocol Development Pre-Post Conference Short Course
Wednesday PM Dinner Short Courses (2)
Thursday AM Clinical Training Forum Clinical Project Management Forum
Thursday PM Clinical Training Forum Clinical Project Management Forum
Friday AM Clinical Training Forum Clinical Project Management Forum
Friday PM Clinical Training Forum
Who Should Attend?This summit particularly benefits professionals at pharmaceutical, biotech and medical device companies who work in:• Clinical Trial Management• Site Management• Study Start-up• Project Management• Monitoring• Clinical Training• Medical Writing• Protocol Development• GCP Compliance• Clinical Operations• Budgeting• CRA Management• Study Site Evaluations• Risk Management• Outsourcing
This summit is also of interest to:• Contract Research Organizations• Regulatory Agencies• Technology and Service Vendors• Consultants
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Tuesday, OcTOber 9, 2012
8:15 am Main Conference Registration and Morning Coffee
8:45 Barnett Welcome and Introductions
8:50 Chairperson’s Welcome and Opening Remarks
Virtual Investigator Meeting Decision-Making
9:00 Optimizing Study Start Up Timelines with Virtual Meetings InitiativesLori Vivian, Director, Clinical Research Operations, SyntactxTime is money. When starting up a study, whether for support of a PMA, NDA, or even post marking, shortening the timeline of site NDA completion to their first subject enrolled is imperative. The use of virtual investigator meetings or even site initiation meetings in the right setting can assuredly speed up the process, shortening the time to submission and approval or clearance. This presentation will review the benefits of using virtual meetings, including when they are appropriate for particular studies, and how to present them successfully.
9:45 Takeda’s Experience With Planning and Conducting Virtual Investigator MeetingsSarah Tsymbalov, MS, Program Manager, Clinical Operations, Takeda Global Research & DevelopmentMary Gignilliat, Sr Meeting Planner, Takeda Global Research & DevelopmentTeams are often asked to develop innovative ways of improving existing processes to make them more efficient from a time and cost perspective. Transition of F2F to Virtual investigator meetings is just one such example. This non traditional method of planning and conducting virtual IMs was explored by a team managing a large CV Outcomes trial. This presentation will focus on the logistics and best practices utilized and will describe the “Decision Tree” used to assist the decision process of utilizing the virtual platform vs. the traditional F2F platform. In addition, we will explore ways to keep participants engaged and focused on the content without the hassle of travel. Finally, we will review the current practice utilized by study team which includes the use of pre-training modules.
10:30 Coffee Break
11:00 Takeda’s Experience With Planning and Conducting Virtual Investigator MeetingsSarah Tsymbalov, MS, Program Manager, Clinical Operations, Takeda Global Research & Development
11:45 Sponsored Presentation (Opportunity Available; contact Ilana Quigley, [email protected])
12:00 Luncheon Presentation (Opportunity Available; contact Ilana Quigley, [email protected]) or Lunch on Your OwnBlended Learning Approaches to Investigator Meetings
1:15 Review of 10 Blended Learning Techniques, Including How They May Contribute to a Site’s Understanding of and Compliance with the ProtocolJulie Kernis, Associate Director, Global Training, ePharmaSolutionsIn this session, participants will be presented with and discuss 10 learning solutions that clinical teams can make available to site staff throughout the trial. The solutions may be applied to study start-up, staffing changes, newly selected sites/countries/regions, protocol amendment training gaps, protocol version training gaps, introduction of new tools while the study is ongoing, one-on-one question and answer sessions, information refreshers, and site-directed learning needs. The 10 learning techniques that will be discussed include 1) face-to-face group training; 2) webinars; 3) virtual classrooms; 4) one-on-one training; 5) basic online training modules; 6) scenario-based assessments; 7) software simulations; 8) archives of group learning; 9) mediated social forums; and 10) wikis. For each of the 10 learning techniques, implementation considerations will be discussed, including recommended application of each solution, supporting tools and technology, staffing, and potential risks.Trial timeline, tools to consider for supporting these learning techniques, potential roles needed to make the training method successful, and risks associated with implementing each technique will also be reviewed. A hand-out outlining this information will be provided to participants.
2:00 Designing Synchronous Learning - Creating Virtual Learning Programs that Make an ImpactJennifer Hofmann, President, InSync TrainingThis session discusses and explores the concerns that many training professionals have: how to keep participants engaged and active in the online environment so that the learning outcome is of the same quality as a classroom-based delivery. The session focuses on what the
Conference Overview:It has been argued that investigator meetings are at the heart of clinical trials--the success of a study depends on them. In-vestigator meetings are quite involved to organize, and costs can easily skyrocket out of control. There is also some debate about how well information retention can be achieved in such short periods of time, and whether or not it makes more sense to offer content in “segments,” so that better adult learning practices can be built in to content and program design. Web-based meetings offer huge cost and time savings, help with quality, and given people’s schedules and travel consid-erations, it can be argued that virtual investigator meetings are the platform of choice for many investigators. At Barnett/CHI’s Inaugural Virtual Investigator Meeting Management forum, stakeholders in the investigator meeting management, clinical operations and compliance arenas will come together to discuss strategies to optimize the investigator meeting through virtual meeting platforms.
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instructional designer can do via the design process in order to alleviate the Facilitator’s concerns and provide a quality learning experience for the participants. The design concepts addressed in this session include: • Interaction vs. collaboration • Concurrent and serial collaboration • Uses for interaction vs. collaboration • Best practices for designing synchronous exercises for the
following collaborative tools: breakout rooms, whiteboard, chat, synchronized web browsing, and application sharing
2:45 Challenging Conventional Wisdom in Virtual Investigator MeetingsSteven Sulkin, Founder & CEO, MBM Productions InternationalThere is much conventional wisdom that the virtual investigator meetings industry follows, but do the metrics support what have become the common approaches? The presenter will challenge some of these conventional wisdoms, not just by talk but through the examples of a variety of types of virtual meeting case studies. Specifically covered are benefits and disadvantages of live vs. recorded meetings, including the risks involved around human error and compliance. Also explored are ways that interactivity can be maintained in a variety of settings including the technologies that support best practices. In the end, the audience can decide what works and what doesn’t and how we can collectively work toward cementing virtual investigator meetings as a truly viable meeting platform.
3:30 Refreshment Break with Exhibit Viewing
Technology Vendor Showcase
4:00 Vendor Town HallThis unique Vendor Town Hall will provide attendees with an understanding of how to select and optimize vendor relationships for Virtual Meetings support. Hear vendor perspectives on virtual meetings approaches that maximize investigator participation and learning. Attendees will walk away from the session with a checklist of key vendor selection criteria, including the variables associated with different technology options and options for blended learning solutions.
5:30 Welcome Reception with Exhibit Viewing
Wednesday, OcTOber 10, 2012
Technology Considerations for Virtual Investigator Meetings
8:00 am Morning Coffee
8:30 Chairperson’s Opening Remarks
8:45 Virtual Investigator Meeting Approaches and Design ConsiderationsJim Bohlen, Senior Account Executive, Blue Sky BroadcastThis presentation will address various options available to study managers when considering virtual meetings. These include webcast platforms to choose from, doing a full virtual or hybrid meeting or a fully on-demand virtual training. The importance of utilizing a registration and eLearning portal as part of the overall process will be discussed. Finally, included is a discussion on efficiencies gained as well as other benefits that result from using
virtual meeting technologies.
Site Considerations When Planning Virtual Investigator Meetings
9:30 Virtual Investigator Meetings: A Coordinator’s PerspectiveAnne Looney, Research Coordinator, Research, Mid-Ohio Heart Clinic, Inc.Hear a research coordinator’s perspective on how research sites benefit from virtual investigator meetings, including the impact on training and learning for all research site staff, including the investigator. Hear examples of how having several “sets of ears” attending a meeting can results in greater protocol and overall compliance.
10:15 Refreshment Break with Exhibit Viewing
10:45 Technology Assessment Strategies for Virtual Investigator MeetingsNariman A. Nasser CCRP, Director, UCSF Participant Recruitment Service, Clinical & Translational Science Institute, University of California, San FranciscoIdentifying and assessing technology platforms for virtual investigator meetings can be daunting for nontechnical staff. This session will provide guidance on how to document technical requirements for RFPs, assess proposals, and select the appropriate vendor. Testing technical products before putting them into production is a critical step to ensuring it not only meets the needs but that your meetings will be glitch-free.
11:30 Independent Certification of GCP Training—Now There Is EvidenceDavid Vulcano, AVP & Responsible Executive, Clinical Research, Clinical Services Group, Hospital Corporation of AmericaRetraining investigators over and over again on GCPs is costly and upsetting to both sponsors and site staff. Unlike other areas of training, there currently exists little reciprocity between sponsors on GCP training. While independent certification from associations has been available, until now there has been no evidence of their predictability of regulatory and protocol compliance. There is now evidence from 2 studies demonstrating better protocol compliance and better FDA audits with one of these association’s model. Stakeholders are moving to accept that association’s model as de facto evidence of GCP training, saving them (and the site staff) the cost and frustration of having to repeat the training.
12:15 pm Assessing the Effectiveness of Virtual Investigator MeetingsDax Kiger, Senior Consultant, Trifecta Multimedical
1:00 Close of Conference
Don’t Miss the Dinner Short Courses*:
Proactive Approaches to Vendor ManagementDesign Considerations for GCP Training ProgramsWednesday, October 10
*Separate registration is required
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About Barnett Educational Services:Founded in 1979, Barnett International is widely recognized for its superior consulting services and its targeted education and training programs. Barnett helps clients get the most out of their research and development dollars by managing change effectively, improving organizational performance, and enhancing staff knowledge. The Barnett approach is a unique combination of strategy development and practical, hands-on implementation. The “Barnett Difference” is evident in our deep understanding of the clinical research process and in the rapid and tangible performance improvements we deliver. We help pharmaceutical, biotechnology and medical device companies maximize the speed and quality of their product development efforts. With an international presence and with many staff members working from the client site for increased benefits, Barnett is able to apply a global expertise to its projects. Our services include educational programs and products and consulting. www.barnettinternational.com
About Cambridge Healthtech Institute (CHI):Founded in 1992, Cambridge Healthtech Institute (CHI) is the industry leader offering the preeminent source of information to the leading researchers and business experts from top pharmaceutical, biotech, and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI’s portfolio of products include Cambridge Healthtech Institute Events, BioPharma Strategy Series, Barnett International, Insight Pharma Reports, Marketing Services, and Cambridge Healthtech Media Group. www.chicorporate.com
Hotel & TravelInformationPlease call the hotel directly to reserve your sleeping accommodations. You will need to identify yourself as a Cambridge Healthtech Institute conference attendee to receive the discounted room rate with the host hotel. Reservations made after the cut-off date or after the group room block has been filled (whichever comes first) will be accepted on a space-and-rate-availability basis. Rooms are limited, so please book early.
Please visit BarnettClinicalSummit.com for flight and car rental discounts.
Conference Hotel: Le Meridien20 Sidney Street, Cambridge, MA 02139Tel: 617-577-0200Discounted Room Rate: $249 s/dDiscounted Cut-off Date: September 10, 2012
Media Partners
Lead Sponsoring Publications Sponsoring Publications Media Partner Web Partners
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Sponsorship, Exhibit, and Lead Generation OpportunitiesCHI offers comprehensive sponsorship packages which include presentation opportunities, exhibit space and branding, as well as the use of the pre and post-show delegate lists. Customizable sponsorship packages allow you to achieve your objectives before, during, and long after the event. Signing on early will allow you to maximize exposure to hard-to-reach decision makers!
Agenda PresentationsShowcase your solutions to a guaranteed, highly-targeted audience. Package includes a 15 or 30-minute podium presentation within the scientific agenda, exhibit space, on-site branding and access to cooperative marketing efforts by CHI.
Breakfast & Luncheon PresentationsOpportunity includes a 30-minute podium presentation. Boxed lunches are delivered into the main session room, which guarantees audience attendance and participation. A limited number of presentations are available for sponsorship and they will sell out quickly. Sign on early to secure your talk!
Invitation-Only VIP Dinner/Hospitality SuiteSponsors will select their top prospects from the conference pre-registration list for an evening of networking at the hotel or at a choice local venue. CHI will extend invitations and deliver prospects. Evening will be customized according to sponsor’s objectives, i.e.:
• Purelysocial• Focusgroup• Receptionstyleorplateddinner• Plateddinnerwithspecificconversationfocus
Inquire about booth space & additional branding opportunities!
Looking for additional ways to drive leads to your sales team?
Cambridge Healthtech Institute can help!We offer clients numerous options for custom lead generation programs to address their marketing and sales needs, including:•LiveWebinars•WhitePapers
•MarketSurveys•PodcastsandMore!
Benefits of working with Cambridge Healthtech Institute for your lead generation needs:• Yourcampaignwillreceivetargetedpromotionto
Cambridge Healthtech Institute’s unparalleled database of over 800,000 individuals, all of which are involved in all sectors of the life sciences – lists can be segmented based on geography, research area, title and industry.
• Allcustomleadgenerationprogramsarepromotedthroughour experienced marketing team that will develop and drive targeted campaigns to drive awareness and leads to your lead generation program.
• Forourwebinarprograms,weofferassistanceinprocuringspeakers for your web symposia through our extensive roster of industry recognized speakers across multiple disciplines within life sciences, as well as provide an experienced moderator and dedicated operations team will coordinate all efforts.
• Ifchoosingawhitepaperprogram,wecanoffereditorialexperience and provide an industry recognized author to write your white paper.
For additional sponsorship & exhibit information, please contact:
Ilana QuigleyManager, Business [email protected]
If you are unable to attend but would like to purchase the Barnett Clinical Summit CD for $600 (plus shipping), please visit BarnettClinicalSummit.com. Massachusetts delivery will include sales tax.
Receive a FREE eNewsletter by signing up at chimediagroup.com
The latest industry news, commentary and highlights from Bio-IT World
Innovative management in clinical trials
A series of diverse reports designed to keep life science professionals informed of the salient trends in pharmaceutical technology, business, clinical development, and therapeutic disease markets.For a detailed list of reports, visit InsightPharmaReports.com, or contact Rose LaRaia, [email protected], +1-781-972-5444.
Barnett is a recognized leader in clinical education, training, and reference guides for life science professionals involved in the drug development process. For more information, visit barnettinternational.com.
AdditionAl registrAtion detAilsEach registration includes all conference sessions, posters and exhibits, food functions, and access to the conference proceedings link.
Handicapped Equal Access: In accordance with the ADA, Cambridge Healthtech Institute is pleased to arrange special accommodations for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting.
to view our substitutions/Cancellations Policy, go to http://www.healthtech.com/regdetails
Video and or audio recording of any kind is prohibited onsite at all CHI events.
CambridgeHealthtechInstitute,250FirstAvenue,Suite300,Needham,MA02494 • www.healthtech.com • Fax:781-972-5425
Pricing and Registration Informationshort Courses
Academic, Government, Commercial Hospital-affiliated
One short course $545 $295Two short courses $795 $545Three short courses $995 $645
Tuesday, October 9 – Morning Wednesday, October 10 – Dinner
Writing Successful Clinical Protocols: Proof of Concept, Phase II, and Phase III
Proactive Approaches to Vendor Management
Design Considerations for GCP Training Programs
ConferenCe PriCing
Multi-Conference Package - Access Full Event for Four Days
(Includes access to 2 conferences, excludes short courses)
Advanced registration until September 14, 2012 $2450 $1025Registration after September 14, 2012 and on-site $2595 $1095
Single Conference Pricing
(Includes access to 1 conference, excludes short courses)
Advanced registration until September 14, 2012 $1645 $845Registration after September 14, 2012 and on-site $1845 $945
October 9-10 October 11-12
Clinical Protocol Optimization Clinical Project Management Forum
Virtual Investigator Meeting Management Clinical Training Forum
ConferenCe disCounts
register 3 - 4th is free: Individuals must register for the same conference or conference combination and submit completed registration form together for discount to apply.
Additional discounts are available for multiple attendees from the same organization. For more information on group rates contact David Cunningham at +1-781-972-5472
How to Register: [email protected] • P: 781.972.5400 or Toll-free in the U.S. 888.999.6288
Please use keycode Vrtt f when registering!
O P T I M I Z I N G T R I A L P E R F O R M A N C E
October 9-12, 2012Le Meridien | Cambridge, MA
Barnett International and Cambridge Healthtech Institute Present the Second Annual...
