Cambridge Healthtech Institute’s 5th Annual 

Global Site Selection, Feasibility Assessment,
Operations and Site Management
 

Improving Timelines and Outcomes with Strategy, Relationships, Data and Execution
February 24-25, 2015 | Hyatt Regency Orlando | Orlando, FL 


Data-driven global site selection, an optimized feasibility assessment process, and effective site management are critical to improving clinical trial timelines and outcomes. Too often companies fail to learn from past mistakes and take the same approach to trial planning and execution. In order to overcome challenges in clinical trial planning, operations and site management leaders should learn from the best practices of their peers, utilize data and technology to support decision making, and improve communication and relationships between Sites, CROs, and Sponsors. Cambridge Healthtech Institute’s Fifth Annual “Global Site Selection, Feasibility Assessment, Operations and Site Management” conference will cover the topics one should consider when planning and implementing a trial.

Tuesday | Wednesday | Download Brochure
Stay on for Part 2: Site-Study Activation 

Tuesday, February 24

7:30 am Registration and Morning Coffee

8:25 Opening Plenary Keynotes



9:45 Grand Opening Coffee Break in the Exhibit Hall


PROTOCOL DESIGN, FEASIBILITY AND COUNTRY SELECTION STRATEGIES

10:45 Chairperson’s Remarks

Eric LakeEric Lake, Partner, Pharmica Consulting

 

10:50 Global Trial Placement Strategies; Linking Early Research with Phase III Execution

John OidtmanJohn Oidtman, Vice President, Clinical Trial Support and Compliance & WW Clinical Operations, Pfizer

Balancing site performance, regulatory strategy, and patient access is a difficult yet achievable goal in clinical research. This presentation will provide an overview of Pfizer’s Global Trial Placement Strategies which are designed to select the right countries and right sites that allow for speed in trial conduct and regulatory approvals.

11:15 Protocol Design, Feasibility and Country Selection: Integrating Teams and Processes for Improved Trial Execution

Stephen YooStephen Yoo, M.D., Chief Medical Officer, ReGenX Biosciences

Drug development has become increasingly difficult and expensive. Exacerbating these challenges is the fact that more companies are trying to solve for unmet medical needs in diseases where the populations are heterogeneous and endpoints are poorly developed. This puts an increasing amount of pressure on ensuring the protocol design targets the intended population, data collection and interpretation are accurate, and that these trials can be delivered on time and on budget. This requires increased attention to the up-front planning, maximal utilization of the available data at hand, and processes that ensure the quality of the data during the conduct of the clinical trial. We will explore some case studies in development and focus on the impact that both newer processes and team integration.

11:40 Case Study: TransCelerate Shared Investigator Platform

Jackie KentJackie Kent, Sr. Director, Clinical Development Information & Optimization (CDIO), Eli Lilly & Co.; TransCelerate Shared Investigator Platform Leader

This presentation will focus on defining the purpose of the TransCelerate Shared Investigator Platform and the shared industry problems it addresses. Also, it will share the Future Release Roadmap and next steps. During the cross-industry multi-year effort the following points from pharma, site and investigator users were taken into account: Seamless user experience with a single point of access for interaction with multiple study sponsors; Harmonized training content delivery (e.g., GCP) and certification; Critical notifications, alerts, task lists in an integrated view across sponsors, studies; Comprehensive site personnel and facility profile that is leveraged across participating sponsors; Secure document exchange to facilitate communication during study planning and study conduct.  

12:05 pm Presentation to be Announced



12:35 LUNCHEON PRESENTATION

Speaker to be Announced

1:15 Session Break


FEASIBILITY AND SITE SELECTION FROM THE SPONSOR, INVESTIGATOR AND SITE PERSPECTIVES

1:25 Chairperson’s Remarks

Bonnie BresciaBonnie Brescia, Founding Principal, BBK Worldwide

 

1:30 Optimizing Site Selection to Initiate and Maintain a Positive Site Relationship

Christine PierreChristine Pierre, President, The Society for Clinical Research Sites (SCRS)

This presentation will provide a comprehensive look at model site selection from the sites’ perspective with consideration for industry’s limitations and deliverables. Attendees will gain a competitive advantage by understanding the site’s hurdles that ultimately impact the sponsors’ timelines. By expanding your knowledge of key elements important to sites and understanding how to provide a personal touch in an impersonal, technology-driven environment, attendees will master the initiation and maintenance of a positive site relationship. This behind-the-screens look will demonstrate a fresh approach to site selection, and will equip you with the tools to secure an effective site relationship.

1:55 CO-PRESENTATION:
Part 1: Sponsors and Sites: Getting on the Same Page With Feasibility
Part 2: Study Feasibility, the Sites’ First Hurdle

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

 

Chris HoyleChris Hoyle, President, Elite Research Network

 

Michelle Everill-FlindersMichelle Everill-Flinders, Director, Feasibility Center Of Excellence, Development Operations, Pfizer

 

This presentation from the Site and the Sponsor perspective will address what all parties are faced with during the initial point of contact until site selection. How can the Sponsors and CROs improve the process and get better results and responses from Sites? What do Sites need to better understand from the Sponsor perspective in order to improve their business process? Three presenters representing different perspectives will share the Site and the Sponsor experiences and make recommendations for efficiencies in feasibility activities.

2:45 Talk Title to be Announced

Bill GwinnBill Gwinn, MBA, Vice President, Clinical Informatics Solutions, Optum

 

HALL BREAK AND BREAKOUT DISCUSSION GROUPS

3:00 Refreshment Break in the Exhibit Hall
 

4:00 Find Your Table and Meet Your Moderator


4:05 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 key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and 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.

View Detailed Interactive Breakout Discussion Groups 


5:00 Welcome Reception in the Exhibit Hall

6:15 Close of Day


Tuesday | Wednesday | Download Brochure
Stay on for Part 2: Site-Study Activation 

Wednesday, February 25

7:30 am BREAKFAST PRESENTATION: Evaluating the ROI of Outsourcing Investigator Payments

Stuart (Stu) ThiedeStuart (Stu) Thiede, President, Global Payment Services, CFS Clinical, Part of DrugDev

Everyone knows the # 1 complaint of Investigators is slow payments to the sites. Pharmaceutical companies often outsource investigator payments to improve efficiencies, provide costs savings and build better investigator relationships. But how do you quantify whether or not you made the right decision to outsource? Do you go with anecdotal evidence and assume your goals are being realized or can you prove it with real metrics? This program will review a model that enables you to assess the ROI of outsourcing your investigator payments. See how this model measures benefits such as increased operational efficiencies, enhanced investigator relationships, improved budget management and increased compliance to determine whether or not you’re accomplishing your business objectives.

8:25 Plenary Keynote Session



9:45 Coffee Break in the Exhibit Hall


IMPROVING OPERATIONAL EFFICIENCIES IN SITE, CRO, AND SPONSOR INTERACTIONS

10:45 Chairperson’s Remarks

Stephen YooStephen Yoo, M.D., CMO, ReGenX Biosciences

 

10:50 Investigator Registries: Collaborating to Benefit Both Investigators and Sponsors in Feasibility, Site Selection, and Start-Up

Susie CamposSusie Campos, Associate Director, Clinical Trial Intelligence, Novartis

In this session we will discuss investigator registries, including a taxonomy of current registries, how they are used, the benefit to pharmaceutical companies/CROs, and value for investigators. Using the Investigator Databank as a case example, we will also discuss: the type of data shared; how this information supports feasibility, site identification, and start-up; and the added value generated through integration of multiple data sources and sharing of information across companies. The Investigator Databank is a global collaboration among Janssen, Lilly, Merck, Novartis and Pfizer whereby the members share investigator information for the benefit of both industry and investigators.

BBK Worldwide11:15 Executing Global Site Selection in an Adaptive Recruitment Environment

Bonnie BresciaBonnie Brescia, Founding Principal, BBK Worldwide

 

11:40 PANEL DISCUSSION: Two Heads Are Better Than One: The Necessary Shift of Sponsors and CROs from Adversaries to Partners

April LewisModerator: April Lewis, Director, Global Client Management, Clinical Trial Optimization Solutions, IMS Health

 

Panelists: Pfizer, Shire, Parexel

The Sponsor / CRO relationship has historically translated into more of an order-fulfillment / client-vendor relationship than anything that could have been called remotely collaborative. An emerging trend, though, is being guided by innovative sponsors looking to change that dance into one that creates more symbiotic partnerships. Several industry sponsors have put a significant focus over the last few years in building out Sponsor / Site level relationships as a key factor to performance improvement and now are realizing the same gains can be achieved with focus on relationships at the Sponsor / CRO level. there is no doubt that the relationship landscape is changing in a way that will only be beneficial to the industry. Topics to be discussed:

  • Best practices for aligning critical performance and operational data between sponsor/CRO
  • An overview of realized performance gains through partnership
  • Practical examples of alliance building through all stages of the relationship
  • The performance impact of a shared decision making platform

12:05 pm Leveraging Big Data for Trial Optimization: Myth or Magic?

David CockerDavid Cocker, Senior Consultant, ta-Scan, MDC Partners

“Nobody wants ‘data.’ What we need are answers.” Big data is an ill-defined term for a massive phenomenon that has created new expectations in science, government and the pharmaceutical industry. Today we are told of cutting-edge initiatives that disentangle the digital exhaust of thousands of trials, lab tests and healthcare records. While this big data hype sounds compelling, clinical teams now face the challenge to incorporate new knowledge discovery tools within traditional Trial Planning and Site Selection processes. This presentation will shortlist the essential characteristics of actionable data and put in perspective the potential surrounding exploitable public data for decision support.

12:20 Sponsored Presentation (Opportunity Available)

12:35 BRIDGING LUNCHEON PRESENTATION: Optimizing Protocol Planning, Feasibility, and Site Selection through an Integrated View of Clinical Trial Operations and Other Data Sources

Elisa CascadeElisa Cascade, President, Hosted Data Solutions, DrugDev.org

As the amount of available data for the support of clin ops continues to expand, organizations are challenged with the task of integrating these disparate data sources into actionable information. One novel solution to this challenge is DrugDev’sSiteCloud, a platform that offers global users an integrated view of clinical trial operations, clinicaltrials.gov, investigator entered information, and other investigator, site, and protocol level data. In this session, we will discuss available data sources; lessons learned for optimal use of data from ClTMS; and a validated technology solution for virtually matching and visualizing this information within and across companies.

1:15 Session Break/Close of Conference



Tuesday | Wednesday | Download Brochure
Stay on for Part 2: Site-Study Activation 

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Event-At-A-Glance 

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> Premier Sponsors 

 BBK 

 ClinicalInk 

Drug Dev 

IMS Health 

 Mapi 

OptumInsight 

PRA Health Sciences

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