Clinical Data Technology and Integration
Novel data collection modalities, integrative systems, and visual analytics are becoming game-changing features of modern clinical trials. However, the emergence and adoption of technology solutions to enhance data collection and reporting to improve overall outcomes and garner operational efficiencies, has been slower than we would like them to be. Cambridge Healthtech Institute’s Fifth Annual “Clinical Data Technology and Integration” conference will feature a broad array of topics such as data integration and accessibility, novel data visualization technologies, wearable devices, cloud storage, data security and others. We are looking forward to hosting a practical and productive knowledge and experience exchange.
Clinical Data Technology and Integration
Novel Data Collection Modalities, Integrative Systems and Visual Analytics
Wednesday, February 24
12:10 pm Bridging Luncheon Presentation:Pairing Analytics: Solutions Designed to Better Navigate Clinical Trial Data
Thomas J. Gfroerer, Executive Director, Data Analytics, PPD
Tammy Jackson, Director, Preclarus Development, Biostatistics, PPD
Sponsor companies and CROS have distinct data needs throughout the conduct of a clinical trial. Analytic solutions and visualization tools can help with efficient exploration of the data. This talk will show how coupling uniquely designed analytic solutions can help deliver new approaches to risk surveillance, study management and monitoring safety trends for both sponsors and CROs.
12:50 Coffee and Dessert in the Exhibit Hall
1:30 Plenary Keynotes - View Details
3:00 Refreshment Break in the Exhibit Hall (Last Chance for Viewing)
4:00 Chairperson’s Remarks
Kuno van der Post, Senior Vice President, Business Development, OmniComm Systems, Inc
4:05 Data Sharing: Providing Access to Data Both for Internal and External Customers at Roche
Francis Kendall, Global Head, Statistical Programming and Analysis, GLIDE Future Investigation Team Lead, Genentech
In this talk I will explain how Roche has first created a Patient Level Data Sharing group to meet the EU Regulatory requirement to give access to data and are now due to greater internal demand, developing an Enhanced Data Sharing Ecosystem within Roche.
4:30 Industry Case Studies: Why Clinical Organizations are Going Beyond EDC and Embracing Clinical Data Management
James Streeter, Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences
James Streeter, Global Vice President of Life Sciences Product Strategy for Oracle Health Sciences, will present real-world, pragmatic case studies of how clinical organizations are effectively managing data disruption by going beyond the limitations of today’s EDC technology and embracing integrated, end-to-end clinical data management – driving greater development efficiencies, increasing the speed and quality of clinical trial data and submissions, and reducing operational risk.
4:55 Integrating In-House and Cloud Based Infrastructure
Pam Duffy, IT Lead , Core Clinical Solutions & Services, Pfizer
Cloud computing bring numerous advances such as speed, agility, flexibility, elasticity and innovation. What does that mean to clinical development and how can we take advantage of it? This presentation will share Pfizer’s experience with implementing cloud computing in clinical trials and elaborate on the problems and solutions for integrating in-house and cloud-based infrastructure.
5:20 Blocking the Big Breach: An Overview of Standardized Security Systems and How They Protect Pharmaceutical Data
Moderator: 
Mollie Shields-Uehling, President & CEO, SAFE BioPharma Association
Panelists:
Andrew K. Porter, Director, Enterprise Architecture, IT Planning & Innovation, Applied Technologies, Merck
Greg Koski, Ph.D., M.D., Co-Founder & President / Chief Executive Officer, ACRES
Michael Lavoie, CISSP, PMP, Global Information Security & Identity Services, Pfizer Inc
Mary Emanoil, Lead, Content Management & Authoring, Information Management, Development Operations CoE, Pfizer Worldwide Research and Development
The proposed session is an overview of standardized security systems currently available to the pharmaceutical industry and how they are being used to protect sensitive patient data and intellectual property and to improve clinical trial efficiency. The session also will include presentations about individual company initiatives that allow for the secure free flow of information among collaborating parties within protected and trusted environments.
6:15 Reception Hosted by Exostar
7:15 Close of Day
Thursday, February 25
7:15 am Registration
7:45 Breakfast Presentation: How One (Golden) Number Can Transform Clinical Trials
Elisa Cascade, MBA, President, Data Solutions, DrugDev
For years pharmaceutical companies and CROs have struggled to collect, clean and collate site data from disparate sources so they can make better decisions about site feasibility and selection. With the DrugDev Golden Number - a universal identifier for Investigators and sites - individual pharma companies and CROs easily match and master data, and share data across collaborations like the Investigator Databank and TransCelerate. While the Golden Number began as a method for data sharing, innovators are using it to drive operational efficiencies, collaboration and integrated reporting as well. We expect it also will give regulators a more detailed view into the global investigator community, which ultimately can improve patient safety. Join this session for a discussion on the Golden Number and how it can help pharma, CROs and sites do more trials.
8:35 Chairperson’s Remarks
Steven Nathasingh, Managing Director, Vaxa Inc.
8:40 Remote Digital Biomarker Monitoring - Bringing a Smartphone-Based Diagnostic Test for Parkinson’s Disease Progression into an Interventional Trial
Christian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early Development
In clinical research – and especially in Neuroscience – objective, automated and high-frequency measures of disease progression are hard to come by. Traditional physician-led tests are only done periodically, missing the fluctuations of disease activity that strongly affect patient’s quality of life. They also lack the objectivity that is so important when developing medicines. By providing patients with mobile sensors they carry day-in and day-out to conduct tests and capture the data, we are addressing this need.
9:05 CO-PRESENTATION: Collecting, Integrating, and Analyzing Wearable Devices Data in Neurology Studies
Steven Nathasingh, Managing Director, Vaxa Inc.
E. Ray Dorsey, M.D., University of Rochester Medical Center, School of Medicine and Dentistry
Many neurological disorders, like Parkinson’s Disease, have external manifestations that make them well suited to assessment by objective wearable or portable sensors. This presentation discusses how data from wearable devices are being collected, integrated, and analyzed in Neurology studies like Parkinson’s Disease to help drive new and novel insights and therapies.
9:30 Wearable Sensors’ Impact on Trials Design and Execution
Moderator:
Steven Nathasingh, Managing Director, Vaxa Inc.
Panelists:
E. Ray Dorsey, M.D., University of Rochester Medical Center, School of Medicine and Dentistry
Christian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research & Early Development
Munther Baara, Senior Director, Development Business Technology, Pfizer
Can we leverage the power of mobile and data sensors to:
- Improve clinical trial operations while reducing costs
- Generate data-driven insights to inform drug efficacy
- Drive innovation in patient outcomes
- Transform the clinical trial experience for key stakeholders
9:55 What is the Role of CTMS in A Data-Driven Paradigm?
Brion Regan, Product Manager, eClinical Insights, ERT
With the increased adoption of cloud eTMF/eCTD, investigator payment, patient recruitment modeling, and site feasibility solutions, along with the implementation of risk-based monitoring strategies, the role of the traditional CTMS has come into question. What is its future? Where does it fit? This presentation will explore how these recent process and technology disruptions have created the need for a more connected and data-driven “CTMS”- that can help organizations adapt to the changing dynamics of clinical trials management processes.
10:20 Coffee Break
10:35 Chairperson’s Remarks
Betsy Fallen, BAFallen Consulting LLC
10:40 CO-PRESENTATION: eISF: The Next Frontier for eTMF
Joanne Malia, Director, Medical Research Process Management, Purdue Pharma
Terry Stubbs, President & CEO, ActivMed Practices & Research, Inc.
Traditionally, the TMF has been considered the sponsor’s repository of essential documentation but the site too has its collection of documents. These two repositories are separately maintained and must be manually reconciled throughout the study. The electronic Investigator Site File will revolutionize this process by digitally managing the site documents while reducing duplication and reconciliation with the sponsor eTMF. Sponsor and site representatives will speak on their business cases.
11:05 Effective Strategies for Capturing, Leveraging and Visualizing Clinical Data
Diane Carozza, Senior Engagement Consultant, Medidata Solutions
The intersection of clinical research and technology provides opportunities to improve business success by helping to control costs, mitigate risks and improve cycle times. Utilize this technology early in the protocol development lifecycle to:
- Optimize study design
- Reduce downstream quality risks
- Improve operational efficiency using analytics
11:35 CO-PRESENTATION: Integrating Data Science into Clinical Trial Planning and Operations
Debbie Profit, Ph.D., Director, Corporate Projects, Otsuka Pharmaceuticals Development and Commercialization
Shashank Rohatagi, Ph.D., Senior Director, Translational Medicine and Think Team, Otsuka Pharmaceuticals Development and Commercialization
The use of technology in the support of clinical trials has continued to increase. However, the disciplines and departments remain very distinct and in some cases siloed. In order to gain the most from your data, to make better decisions based on the data, to formulate more effective trial strategy, and to improve trial operations processes, there must be a more fluid interchange between the data scientists and trial planners.
12:00 pm Implementing a Patient Centricity Platform to Better Engage Patients and Sites in Informed Consent Process
Robert Allen, Senior Director, Digital Innovation Group (DIG), AstraZeneca
Often we forget the human-side of a clinical trial. With trial design, protocol development, and clinical data as primary concerns, we forget engaging patients and investigators is just as important. Engagement can lead to a greater understanding of the trial with the hopes of making the experiences better for everyone. This talk will focus on striking the balance between creating trial effectiveness and efficiency through technology, while putting humans at the center through a use case of implementing the Patient Centricity platform to engage patients better in informed consent process.
12:25 INTERACTIVE PANEL: Can We Shift Investigators from “1 and Done” to Repeat Performers?
Claire Sears, Ph.D., Director, Investigator Engagement, SiteStart, DrugDev
Immo Zadezensky, PharmD, Ph.D., Clinical Pharmacologist, Professional Affairs and Stakeholder Engagement (PASE), Office of the Center Director, CDER, FDA
Christine Pierre, Founder & President, Society for Clinical Research Sites (SCRS)
Jeffrey Rosen, M.D., Medical Director, Clinical Research of South Florida; Associate Professor, University of Miami Miller School of Medicine
In this session we will discuss the problem of investigator turnover – in particular, the large ‘1 and done’ population. Tufts will present information from the FDA 1572 database on the trends, characteristics and size of the ‘1 and done’ population. This information will be supplemented by a presentation of findings from the Investigator Databank related to characteristics of approximately 70,000 ‘1 and done’ sites including site level performance amongst other factors (e.g., geography, pediatrics, therapeutic area). It is clear that the high rate of attrition of investigators and the need to initiate new investigators is detrimental to site.
12:50 Closing Remarks
12:55 pm SCOPE 2016 Conference Adjourns (see you in Miami for 2017!)