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Site Selection 

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Tuesday, February 5

7:30 am Conference Registration and Morning Coffee



OPERATIONAL IMPACT OF STRATEGIC ALLIANCES 

Shared Session between Global Site Selection and Strategic Alliances

8:00 Chairperson's Opening Remarks

Bonnie BrescaBonnie Brescia, Founding Principal, BBK Worldwide - Biography 

» 8:05 Keynote Co-Presentation: 

Part 1: Industry Partnerships and the Operational Impact of Strategic Alliances

Christine PierreChristine Pierre, President & Leadership Council Chair, Society for Clinical Research Sites (SCRS) - Biography 







Part 2: Making Partnerships Work: Aligning Incentives, Avoiding Traps

Douglas PeddicordDouglas Peddicord, Ph.D., Executive Director, Association of Clinical Research Organizations (ACRO) - Biography 

What do partnerships that work do? They negotiate meaningful metrics, they standardize operations, they assess quality - they align incentives, and they reward success. This panel will discuss the perspectives of investigators, sponsors and CROs in creating partnerships that work.
 


8:50 Global Trial Location and Strategy

Jorge Rodriguez-LarrainJorge Rodriguez-Larrain, Head, Global Site Management, Global Clinical Operations, Alcon - Biography 

9:15 Co-Presentation: Establishing and Implementing an Effective Vendor Selection Process

Lisa Sergas, Senior Manager, Strategic Outsourcing, Global Business Operations, Santen, Inc. - Biography 

Bruno GagnonBruno Gagnon, Vice President, Clinical Operations, BioMarin Pharmaceutical, Inc. - Biography 

There is a lot of risk associated with vendor selection and the performance of our vendors is critical for a successful trial. It is important to spend the time up front to ensure the appropriate vendor is selected and that risks are mitigated and documented from the beginning. We will discuss from a mid-size/small biotech perspective how to ensure the best-fit vendors are selected, selection criteria and considerations, time and resources needed and risk mitigation and expectation setting. We will also discuss the operational aspects and success factors of the selection process such as: ownership, decision making, governance structure and oversight models.

DSP Clinical10:00 Coffee Break in the Exhibit Hall



COUNTRY SELECTION, SITE SELECTION AND STUDY PLANNING 

10:40 Chairperson's Remarks

Suresh KannanSuresh Kannan, Vice President, DecisionView Products, IMS Health - Clinical Trial Optimization Solutions - Biography 







10:45 Featured Presentation: Global Trial Placement Strategies; Linking Early Research with Phase III Execution

John Oidtman, Vice President, Clinical Trial Support and Compliance, Pfizer - Biography 

In 2010 Pfizer implemented a global trial placement (GTP) strategy that established targeted measures for country allocation aligned with our research and business priorities. Now deemed as a critical business decision that maximizes the value of global clinical research, this strategy has been implemented supporting clinical teams to streamline allocation process while maintaining flexibility required for critical development needs. The strategy had a coordinated implementation plan and governance; it was supported by an operational process that bridges early development and Phase III execution. GTP also had supporting activities that included maintaining country intelligence inclusive of a succinct Investigator and site strategy that included partnership with key sites and investigator networks.

PhESi 11:10 Performance-Based Site Selection and Metrics: Driving Decisions with Data

Gen LiGen Li, Ph.D., Founder & President, PhESi - Biography 

To enroll required number of patients in a defined timeframe has been and will continue to be the most challenging task in clinical development. Moreover, we have little or no understanding to the key components relating to patient enrollment, and even less so to the relationships among those components. Armed with the largest clinical development database and proprietary understanding to the relationships among the components, PhESi has developed a performance based site selection method. Over the past seven years, this method has been able to provide site candidates with superior enrollment results to more than 60 clinical trials.

11:35 Optimizing Site Selection for Global Clinical Trials

Vadim PaluyVadim Paluy, M.D., former Senior Director, Clinical Research, BHR Pharma, LLC - Biography 

This presentation focuses on a model-driven approach for optimal site selection including: Problems and analysis of identifying and selecting investigator sites; analysis of current approaches and tools for site selection; optimization of site selection aligned with site value, trial budget, enrollment target, site capacity, and trial power; contingency planning in site selection process; and a case study for a Phase III global trial.

ims health 12:00 pm Luncheon Presentation: Leveraging The Best Available Data and Analytics to Optimize Your Study – from Feasibility through Site Selection

Suresh KannanSuresh Kannan, Vice President, DecisionView Products, IMS Health - Clinical Trial Optimization Solutions - Biography 

The pharmaceutical industry is making significant progress in embracing new approaches to clinical operations in an effort to improve R&D productivity, and the next few years will show how well drug companies have been able to innovate. One of the most promising areas of focus is using performance data and analytics to improve and optimize clinical trial processes. The availability of aggregated clinical trial performance data is increasingly being augmented by massive "Big Data" datasets that capture drug sales, prescriptions, and patient medical history and demographic information. Analytics applied to these data assets can help optimize the clinical trial process from planning through trial initiation and execution, in areas such as protocol feasibility, country allocation, site selection, patient enrollment and recruitment, and data management. This presentation identifies the best opportunities to apply data and analytics across the clinical trials spectrum, and the types and sources of data assets you can use to optimize your operations.



FEASIBILITY ASSESSMENT PROCEDURES FOR GLOBAL CLINICAL TRIALS 

1:25 Chairperson's Remarks

Joseph BedfordJoseph Bedford, Ph.D., Director, Marketing, Almac Clinical Technologies - Biography 

1:30 Strategic Feasibility Assessment in Clinical Studies

Silke EwaldSilke Ewald, M.D., Head, Trial Feasibility Assessment, Global Clinical Development, Bayer - Biography 

Bayer has created a new group and rolled out a new feasibility process for clinical studies. Feasibility assessment is an evaluation of the key parameters to run a clinical project and associated studies, ensuring the project and studies are viable in the medical and regulatory environment and the most suitable countries and sites are approached to participate in the feasibility process. This may concern various topics, for example: target patient population, external environment, competitive landscape, challenges within a proposed project, whether the study protocol is executable at an investigational site.

1:55 The Feasibility Assessment; New Tools and Methodology to Support Your Assessment

Sameer TandonSameer Tandon, Group Head, Outsourcing, Sourcing, Novartis Pharmaceuticals Corporation - Biography 

The purpose of this presentation will be to provide some tactics/tips on the components of feasibility, some tools and metrics to consider, and the proper use of the Feasibility Questionnaire. The audience will gain an appreciation of current methodology in feasibility and applying some new tactics/technology in conducting their assessments.


BBK Worldwide2:20 The Continuous Feasibility Assessment

Bonnie BrescaBonnie A. Brescia, Founding Principal, BBK Worldwide - BiographyYou have a promising compound and solid development plan. You have designed a comprehensive Phase 2 protocol. An enrollment timeline is in place and sites are selected. A budget is finalized and investigators are projecting low screen-failure rates. The hard part is over, right? This presentation will explore the role of feasibility both at initial assessment and throughout the life cycle of a compound from early phase to pivotal studies.

OptumInsight 2:45 Finding the Best Clinical Trial Investigators Worldwide

Bill Gwinn, Vice President, Clinical Informatics Solutions, Optum

How do you find the best investigators? Where are they? What are their statistics that predict performance? How do you access insurance claims and other data? This discussion will present a worldwide census of investigators and their profiles, followed by a discussion of metrics that predict success, such as therapeutic areas of past trails, number of trials, specialty, and patient counts measured by insurance claims.

DSP Clinical3:00 Refreshment Break in the Exhibit Hall

3:40 Site Selection and Optimization of the Site Feasibility Process: Clinical Trials for Medical and Diagnostic Devices

Adam RuskinAdam Ruskin, M.D., Director, Clinical Affairs, GenturaDx, Inc. - Biography 

A large part of this industry involves clinical trials with diagnostics and devices required for FDA approval. Many of these trials are laboratory based instead of physician based, and require the same level of rigor as any investigational pharmaceutical product trial. Yet, few vendors know how to conduct feasibility or select high enrollment sites for these types of studies, leaving this task to the sponsor. Sites also have individual restrictions making them prohibitive to enroll in certain studies. This presentation will review specifics to look for when conducting feasibility for these types of studies so you don't go too far down the wrong paths during site selection.

Citeline 4:05 Driving Better Decisions by Leveraging Unbiased Data the Power of Citeline's Suite of Integrated Products

Sylvia MareckiSylvia Marecki, Ph.D., Product Manager, Sitetrove, Citeline, Inc. - Biography 

How long will my trial take to enroll? Which investigators are most likely to perform? These and other critical clinical operations questions will be addressed in this session. A case study will illustrate the power of benchmark datasets drawn from a suite of fully integrated products to inform strategic clinical development decisions.


4:30 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 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: Leveraging Performance Data for Site Selection

Moderator: Suresh Kannan, Vice President, DecisionView Products, IMS Health - Clinical Trial Optimization Solutions

• Discuss best practices in finding the best sites
• What metrics are most relevant? How does that change depending on each therapeutic area? Each country?
• The role of the global and local teams in site selection

TABLE: My CRAs Have Great Relationships with All of the Investigators We Are Using in Our Trial. Why Would We Want to Move to Uncharted Waters?

Moderator: Sylvia Marecki, Ph.D., Product Manager, Sitetrove, Citeline, Inc.

• Can objective site and investigator selection help improve enrollment performance in my trial?
• What are the biggest challenges in achieving target enrollment today?
• How do you mitigate the risk of your investigators taking on trials that may compete for patients needed for your trials?

TABLE: Innovative Approaches to Finding the Best Sites and Conducting Feasibility Assessments

Moderator: Sameer Tandon, Group Head, Outsourcing, Sourcing, Novartis Pharmaceuticals Corporation

• Cost-effective techniques
• Using high/low tech solutions
• Leveraging technology and driving innovation 

TABLE: Risk-Based Monitoring from the Sponsor Perspective

Co-Moderators: Christine Pierre, President & Leadership Council Chair, Society for Clinical Research Sites (SCRS)
Bruno Gagnon, Vice President, Clinical Operations, BioMarin Pharmaceutical, Inc.

• What tools have been used successfully to execute a Risk-Base Monitoring (RBM) strategy (e.g., CTMS, IXRS, EDC, computer modeling)?
• RBM: quality initiative or cost-saving initiative?
• What kind of culture change is needed to implement RBM? Top down or bottom-up? 

TABLE: Harnessing Online Conversations to Support Your Clinical Research Study

Moderator: Aaron Fleishman, Social Media Marketing, Social Media, BBK Worldwide

• Basics: What you can’t do without
• Social Media Successes
• Content Aggregation: The next step forward

5:30 Welcome Reception in the Exhibit Hall

6:30 End of Day



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