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Tuesday, February 7

7:30 am Conference Registration and Morning Coffee

 

COUNTRY SELECTION, SITE SELECTION AND STUDY PLANNING CONSIDERATIONS 

8:15 Chairperson’s Opening Remarks
Bonnie Brescia, Founding Principal, BBK Worldwide 

8:30 Optimizing Protocol Development and Site Selection: Getting it Right in the Beginning

Joseph Kim, M.B.A., Clinical Operations Director, Shire

Protocols that are poorly designed from an operational standpoint continue to be a major source of recruitment delays and cost overruns. This presentation will cover alternative methods to assess recruitability and operability of protocols during the development stage to help mitigate the risks associated with slow recruitment and unforeseen costs related to amendments. A business case framework will also be discussed to increase the likelihood to adopt a variety of solutions.

9:00 Driving Innovation in Study Start-Up: Optimizing Site Performance through Evidence-Based Site Selection

Angela D. Graves, Trial Optimization Lead, GlaxoSmithKline

Successful trial enrollment is a key component of drug development. Yet frequently, minimal time and energy is invested to identify and select sites that are best suited for executing a given protocol. This is often due to limited upfront planning, coupled with a lack of robust performance assessment criteria and tools and the support to fully utilize them. As a result of this sub-optimal site selection and feasibility assessment process, on average ~20% of sites recruit just a single patient, while more than 50% of sites deliver less than 60% of the targeted number of patients. A significant opportunity exists to improve enrollment performance of sites, predictably deliver enrollment timelines and reduce study costs through a rigorous and disciplined approach to site selection by thoroughly understanding past performance & capabilities of sites. Using evidence to drive decisions ensures optimal selection of sites that leads to more consistent performance across trials.

Sponsored by
DAVA Oncology 
9:30 Site Selection: Lessons from Cancer Clinical Trials

John EckardtJohn Eckardt, M.D., Chief Medical Officer, DAVA Oncology, LP

Using cancer clinical trials as examples, the session will discuss the importance of finding the right investigators for clinical trials, including assessment of research infrastructure, access to appropriate patients, start-up timelines, track record of successful enrollment and, most importantly, the investigator's enthusiasm for the research question.

10:00 Coffee Break in the Exhibit Hall


10:40 Chairperson’s RemarksBonnie Brescia, Founding Principal, BBK Worldwide 

Sponsored by
OptumInsight
10:45 Finding the Best Clinical Trial Investigators

Bill Gwinn, Vice President, Clinical Informatics Solutions, QualityMetric, OptumInsightOver the entire clinical development cycle the most troublesome and the only stage that is not under the total control of the drug sponsor is the patient enrollment process. This is due to its high probability of slippage in maintaining a tightly controlled timeline. This modeling approach takes the historical account of trials run in a given therapeutic area to advise what country and which site to select for an improved patient enrollment outcome. This presentation offers a fresh alternative to the traditional method. The audience will learn the concept, will get a glimpse of the inner working of the model and take away a simple example to be expanded upon and adapted to their own situation.

11:15 Trial Sponsor Panel - Finding the Ideal Site

Moderator: 
Abbe Steel, Vice President, Patient & Physician Services, United BioSource Corporation (UBC)
Panelists:Joseph Kim, M.B.A., Clinical Operations Director, Shire
Nye Pelton, (COPM) Clinical Operations Portfolio Management, USMD, Eli Lilly
Sudeesh Tantry, Ph.D., Associate Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc.
This interactive panel will explore the various methods used by trial sponsors to appropriately identify, recruit and initiate sites for a clinical research study. Panelists will provide specific details regarding accessing the most effective data sources, maximizing the feasibility process, on-site pre-qualification visits, and leveraging historical performance metrics for finding study sites. Trial sponsors will share examples of lessons learned and suggestions for site identification improvements.

Sponsored by
Citeline
12:00 pm Luncheon Presentation - Leveraging Data-Driven Site Selection Strategies to Maximize the Average Enrollment Performance Potential of Your Clinical Trial
Sylvia Marecki, Ph.D., Product Manager, SiteTrove, Citeline, Inc.
This session will address data-driven techniques for selecting sites and clinical investigators most likely to deliver high patient enrollment performance in clinical trials. The connection between investigators’ patterns of clinical trial participation and their potential for future performance will be assessed, and the potential ROI will be quantified.

 

OPTIMIZING THE FEASIBILITY PROCESS 

1:25 Chairperson’s Remarks
Suzanne Collins, Director, Operations, Trifecta Multimedical 

1:30 Importance of Site Feasibility Process: First Critical Step to a Successful Study Outcome

Sudeesh Tantry, Ph.D., Associate Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc.

The feasibility process is the first critical step in selecting an optimal site that can provide quality patients and quality data. By implementing specific parameters and processes prior to and during feasibility process, site selection can be more efficient resulting in quality sites, quality patients and quality data. Thus, site feasibility is not only important for meeting the recruitment target but also critical for a successful study outcome. The presentation will be a practical one, based on actual experience in selecting sites and managing clinical programs.

2:00 Co-Presentation - A Collaborative Approach Looking at Feasibility: Plans to Reduce Time, Cost and Percentage of Non-Active Sites from Both the Sponsor and Site Perspective

Nye PeltonNye Pelton, (COPM) Clinical Operations Portfolio Management, USMD, Eli Lilly






 

Deena BernsteinDeena Bernstein, Director, Clinical Research, Sheridan Clinical Research

Both the sponsor and sites are aware of the high dollar and personnel resource and cost affiliated with non-active sites. We want to put a dollar amount to those resources, and share with the audiences changes that we are making at both the sponsor and site level to reduce the number of non-active sites. We are proposing ways to create a better synergy between Sponsors and Sites when assessing site feasibility. The audience will gain an awareness of the high cost of non-performing sites beyond just the dollar amount, and the need to spend more time doing robust feasibility to make sure each study is a good fit. Our format will be a shared interactive presentation from both the site and sponsor perspective.

2:25 Sponsored Presentation (Opportunity Available)

2:40 Refreshment Break in the Exhibit Hall

 

OPERATIONAL CHALLENGES IN PHASE IIIb-IV 

Shared Session with Managing Post-Marketing Studies (Phase IIIb-IV) and Registries 

 

3:10 Chairperson’s Remarks

Suzanne Collins, Director, Operations, Trifecta Multimedical 

 

Sponsored bybbk logo3:15 When Enrollment is the True Priority, Which Feasibility, Site Selection and Site Support Methods Apply Equally in Registration and Post-Approval Studies?
Jaime Cohen, Strategic Planning, BBK Worldwide
Despite differences in physician and patient motivations to participate in these research efforts, registration studies and post-approval studies have a great deal in common when it comes to planning methods and recruitment priorities. In this session, we’ll assume that the “Last Patient Enrolled” metric is the most important one and explore the many ways in which study managers risk achieving this goal. As well, we will review recent findings from site surveys that uncover simple operational improvements that significantly improve enrollment.

Sponsored byUnited BioSource3:40 Is There Patient Recruitment in a Post-Marketing Study?
Tess Dorrier, Director, Patient Recruitment Strategies, United BioSource Corporation (UBC)
Observational research doesn’t mean recruitment tactics can’t be used to enroll patients in a study. There are many ways to access patients post decision to treat to enroll for a study. This presentation will address what works and what doesn’t, and considerations to help sites manage enrollment for registries and observational studies.

 

Sponsored by
McKesson
4:05 Success in Post-Market Studies Using an Innovative Direct-to-Patient (through the Pharmacist) Model

Carrie HurwitzCarrie Hurwitz, Corporate Strategy and Business Development, McKesson Corp.

In this talk we will present results from a recent case study of a large nationwide post-market study that was successful in finding and enrolling patients through community pharmacists using the McKesson StudyLink Program. We will discuss this proven new approach using a Centralized PI and Direct-to-Patient (through the pharmacist) model. Attendees will learn about the advantages community-based pharmacists can provide as an accessible and trusted healthcare provider.
 

4:30- 5:40 Interactive Breakout Discussion Groups

 

Interactive Breakout Discussion Groups 

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

TABLE 8: Site Selection and Feasibility Process: Improving Global Site Feasibility Assessment to Identify Qualified Sites

Moderator:  Sudeesh Tantry, Ph.D., Associate Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc.

• Why proper site selection is critical for optimal study outcome?
• Speedy patient recruitment vs. quality patient recruitment
• Active site participation and involvement is a must for obtaining best data

TABLE 9: Achieving Stability in the US Investigator Pool

Moderator:  Adam Chasse, MHA, Vice President, Corporate Development, RxTrials

• What encourages/discourages physicians to begin conducting clinical research?
• Why do so few physicians remain involved long-term, and do the remaining physicians align well with industry’s therapeutic needs?
• What steps must industry take to develop investigators who will stay involved with research?

TABLE 10:  The EMR System and Its Use in Site Selection and Recruitment 

Moderator:  Christine Pierre, President, RxTrials

 

TABLE 11: Preferred Site Partnerships

Moderator: Chris Hoyle, Executive Director, Elite Research Network

• What are the key elements of a preferred site partnership?
• What do sponsors, CROs, and sites hope to achieve with preferred site partnerships?
• Who within each organization is responsible for creating and maintaining the relationship?   
• Cost savings as a result of implementation.  

TABLE 12: Driving Innovation in Study Start-Up: Optimizing Processes, Training Leaders and Leveraging Technology

Moderator:  Cecilia D'Antuono, Manager, Site Management, Regional Clinical Operations Latin America, Bristol-Myers Squibb (Latin America)

TABLE 13: Device Regulations and Clinical Research:  Let's Talk

Moderator: Kathi Durdon, Manager, Clinical Operations, Welch Allyn

• Formative and Summative Usability Testing
• Risk-based Approach to Study Monitoring
• When Your PI Says "We Don't Need an IRB"
• Training and SOPs

TABLE 14: Pay It Forward:  Measuring Your Site Selection ROI

Moderator: Lani Hashimoto, Director, Strategic Development, MMG

• Examine how to communicate and make site selection decisions easier than ever 
• Share your own performance measurement techniques and case studies   
• Discuss the return on analytics, site lists, SMO alliances, site networks, faxing, emails, and just plain telephone calls  

TABLE 15:  Who Drives Cancer Clinical Trial Participation?

Moderator:  John Eckardt, M.D., Chief Medical Officer, Accelerating Clinical Trials, DAVA Oncology, LP

• A case for patient & family
• A case for research staff
• A case for physicians

TABLE 16:  Optimizing Country Selection: Strategies for Positioning Trials for Success Using a Global Footprint

Moderator:  Andre Briola, Senior Program Manager, BBK Worldwide

• Country feasibility and selection from a patient recruitment perspective
• Quantifying qualitative country and site characteristics for a data-driven approach
• Understanding the impact of regulatory and treatment landscapes

 

5:40 - 6:40 Welcome Cocktail Reception in Exhibit Hall



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Recommended Monday Afternoon Short Course 

Social Media and Mobile Technology in Supporting Patients in Studies and Registries 

 

2012 Conference At A Glance 

Micah Lieberman 

For topic suggestions and
speaker referrals:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541-482-4709
E: 
mlieberman@healthtech.com 

Ilana Quigley 

For partnering and
sponsorship information:

Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781-972-5457
E: 
iquigley@healthtech.com 

Rich Handy 

For media and association
partnerships, please
contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com 

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