Cambridge Healthtech Institute’s Fourth Annual  

Integrating and Leveraging Clinical Trial Operations Data:  

Novel Integrative Systems, Visual Analytics, Performance Metrics
February 25-26, 2015 | Hyatt Regency Orlando | Orlando, FL
 


We are witnessing an unprecedented burst of technology that completely changes the way we run clinical trials. The use of technology in the support of Clinical Trials has continued to increase including solutions such as Investigator Portal, EDC, IRT, ePRO, etc. Cambridge Healthtech Institute’s Fourth Annual Integrating and Leveraging Clinical Trial Operations Data conference will feature an array of topics such as data integration and accessibility, novel data visualization technologies, data sensors and others.

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Wednesday, February 25


TRANSFORMING CLINICAL DEVELOPMENT THROUGH ANALYTICS AND COLLABORATION

1:25 pm Chairperson’s Remarks

Matt Kiernan, Partner, Pharmica Consulting

1:30 Next-Generation Data Visualization and Collaboration

Ed Kellar, Director, Global Data Management Operational Support, Data Management, Astellas

In an effort to streamline clinical, operational and safety data analysis at Astellas, advanced analytics and event-driven collaboration capabilities were employed worldwide. The key to the system is a novel clinical data review tool built around a virtual on-demand data warehouse that provides dependable decision making based on a single source of truth. The solution equipped end users with the ability to perform self-service data discovery and report building without having to rely on IT or biostatistics for report generation so they could focus on higher value-add tasks.

1:55 Using English Language Queries To Gain Insights Into Clinical Data

Munther Baara, Senior Director, Development Business Technology, Pfizer

Clinical staff have traditionally had to work with programmers in an iterative process to gain insights into clinical data. Using revolutionary technology, users are able to gain insights into the data by asking questions in plain English. At Pfizer, we piloted the use of this technology to augment our Enhanced Quantitative Drug Design process for selected studies related to our product. I will share the outcome of our pilot.”

2:20 Visual Analytics: Sailing Big Data in Clinical Research

Charles Romano, Senior Director, Clinical Research, Amniox Medical

Whether designing a hot new study or standing in the remnants of a terminated project, determining whether a program is excelling or stalling is an old science with some new tools. With millions of dollars, new indications and patients’ lives depending on our innovation, what do you watch in the spyglass to see where your program is going? In this session, we will examine some useful measures for study startup, execution and conclusion.

2:45 Talk Title to be Announced

Jennifer Goldsmith, Vice President, Vault R&D, Veeva

3:15 Refreshment Break in the Exhibit Hall


IT TECHNOLOGY TO ADDRESS PARTICULAR CHALLENGES

4:05 Chairperson’s Remarks

4:10 Meeting Recruitment Targets: Improving Your Chances to Randomize That Last Subject on Time

Ozgur Ozkan, Ph.D., Principal Decision Scientist, Biometrics and Information Sciences, AstraZeneca

Accurate estimation of recruitment performance as well as better assessment of alternative strategies could improve the delivery of clinical studies. For this purpose, a model is developed to track activities at country, site and patient level and simulate trial progress given actual and planned performance. The model is used to estimate the probability distribution of time to randomize the last patient and calculate confidence in completing recruitment by planned timeline. The approach is tested with ongoing trials and alternative strategies are evaluated.

4:35 Sponsored Presentation (Opportunity Available)

4:50 Technology Framework to Operationalize Precision Medicine

Brenda Yanak, Ph.D., Director, Precision Medicine Leader, Clinical Innovation, Pfizer

Biomarkers become an integral part of clinical trials. In order to run a biomarker-driven trial we need to put in place an effective system of sample and biospecimen management and tracking. IT technologies come instrumental in this process. This talk will discuss the use of a specimen management framework to operationalize biomarker- focused clinical research and the precision medicine development.

5:15 A Study of eClinical Technology Usage and Standards Adoption

Mary Jo Lamberti. Ph.D., Senior Research Fellow, Tufts CSDD, Tufts University

Tufts CSDD in collaboration with CDISC conducted a study among biopharmaceutical, CRO companies and vendors in order to examine uptake and usage of eClinical trial technologies and standards adoption. Both overall perceptions and utilization is assessed as well as the challenges and barriers to adoption. Other key areas will be explored included integration of systems, planned implementation of standards, and satisfaction with current processes.

5:40 Reception in the Exhibit Hall

7:00 Close of Day


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Thursday, February 26

7:30 am BREAKFAST PRESENTATION: What’s New in Protocol Feasibility: An Exploration of the Six Key Elements of Data-Driven Feasibility and What Has Changed

Chris Frega, Senior Director, Head, Global Feasibility & Patient Recruitment, Quintiles
Conducting protocol feasibility assessments and developing operational strategies is evolving at an increasingly quick pace to provide better and more robust planning for clinical studies. There is a strong need to include the latest and most relevant data and insights in study planning. This presentation will discuss the essential six elements of protocol feasibility so trial managers can ensure that the critical data is gathered with actionable insights to maximize the potential for operational success of their trial or program.


CASE STUDIES: NOVEL DATA INTEGRATION TECHNOLOGIES

8:15 Chairperson’s Remarks

8:20 CO-PRESENTATION: Using Clinical Dashboard to Drive Clinical Trial Metrics Improvement

Ron Bourque, R&D IS Senior Manager, Clinical Business Management and Analytics, MedImmune

Graham Irvine, Director, Therapeutic Area & Capacity Management, MedImmune

MedImmune has developed a clinical dashboard to drive clinical trial metrics improvement and operational information compliance. The dashboard utilizes project management and operational data from major clinical systems and provides an easy access and view of trial summary information and key metrics information. It enables R&D executive review and study teams’ review. It provides a single source of truth of critical clinical management information. The dashboard technology also enables view of information from mobile devices such as iPad and iPhone.

8:55 CO-PRESENTATION: Workbench: Improving How We Progress the Portfolio

Eric Grande, Associate Director, Application Architecture, Novartis

David Yee, Ph.D., Translational Sciences Project Leader, IT & Process Improvement, Novartis

Novartis enjoys a rich portfolio with many projects in multiple disease areas managed across many line functions. As such, cross-functional coordination and alignment is challenging. We are designing a simplified environment to enable us to better communicate, collaborate, and manage our work. Our approach is to establish a modern platform based upon a common data model. The benefits of the Workbench include more agile decision making, reduced bureaucracy, and more efficient use of resources.

9:35 Sponsored Presentation (Opportunity Available)

10:00 Coffee Break in the Exhibit Hall

10:40 Closing Plenary Keynote



1:10 pm SCOPE 2015 Conference Adjourns (see you in Miami for 2016!)



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