Cambridge Healthtech Institute’s 12th Annual
Clinical Data Strategy and Analytics
Enabling Data Driven Clinical Trials
February 19-20, 2020
E-clinical technologies have changed the landscape of the clinical research industry and healthcare IT in general. Digitalization of healthcare data, mobile data capture technologies, and cloud storage of data are a few of the main technological advances
that influence clinical data management and analytics. These technological advances have been coupled with novel data visualization solutions, and this powerful duo is helping to develop a new paradigm of data-driven clinical trials. CHI’s 12th
Annual Clinical Data Strategy and Analytics conference will be bringing together top clinical research informatics experts to discuss the challenges and find solutions necessary to navigate and thrive in the rapidly changing environment.
Stay on and attend Part 2 (Thurs-Fri): Artificial Intelligence in Clinical Research
Final Agenda
Tuesday, February 18
9:00 am - 7:15 pm Registration Open (Regency Rotunda)
2:00 - 5:00 pm User Group Meetings
2:00 - 5:00 pm The NEW SCOPE China Clinical Development Partnering Forum and The NEW SCOPE Scientific
Symposium*
*Separate registration required. Must be a Best Value registered attendee.
5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards (Regency Ballroom S)
6:20 - 7:30
pm SCOPE’s Kick-Off Networking Happy Hour (Upper Pool Deck, 4th Floor)
(Co-Sponsorship Opportunities Available)
7:30 pm Close of Day
Wednesday, February 19
7:15 am Registration Open (Regency Rotunda) and Morning Coffee (Regency Ballroom S Foyer)
8:15 Morning Opening Plenary Keynotes with Light Refreshments (Regency Ballroom S) provided by 
9:40 Grand Opening Coffee Break in the Exhibit Hall (Windermere Ballroom)
10:40 Chairperson’s Remarks
John Kim, Project Manager, Pfizer
10:45 Opportunities to Apply AI in the Clinical Data Environment
Demetris Zambas, Vice President and Global Head, Data Monitoring and Management, Pfizer
This presentation will discuss various applications of AI for clinical trials operations and data management.
11:15 Modern Clinical Data Concepts – Models, Technology and Regulations
Brooks
Fowler, Senior Director and Global Head, Data Science, AbbVie
The variety of data sources has grown, new and sophisticated use cases are emerging, technology opportunities are many, and regulatory and legal aspects surrounding data privacy and ownership have become more conservative and complex.
This presentation will explore each concept, their convergence, and describe a modern environment that breaks from legacy, domain-specific technology, skill sets and processes to address current and future realities.
11:45 Reimagining Clinical Data Operations
Craig Serra, Global Head, Strategy and Innovation, Data Operations, Novartis
Clinical Data Operations is on the cusp of a revolution. Technologies that have for some time eluded us are now beginning to have an impact and the result will be a transformation in how clinical trials are conducted. At Novartis, we are
exploring how machine learning and artificial intelligence change how we build data capture solutions and how we clean clinical data. We are exploring how advanced analytics capabilities can change how we (and in the future, our regulators)
analyze clinical data. We will share some of our ongoing work and our vision for the future of Clinical Data Operations.
12:15 pm NEW: In Defense of Disruption: Overhaul Your Data Management/Analytics in Order to Leverage the Multi Data Source World
Jennifer Bush, Senior Director, Life Sciences Product Strategy, Oracle Health Sciences
If you’re losing the war on data reconciliation from new data sources, then it’s time to re-evaluate your data management technology. Unmatched data, different naming conventions, and point solutions that don’t communicate
cause massive redundancy and serious integrity issues. Application suites still require collection in multiple places. Join us to understand the advantages of a unified platform where you build a study and enter data once,
streamlining master data to eliminate mapping for analytics.
12:45 Transition to Lunch
12:50 LUNCHEON PRESENTATION: Data-Driven Site Selection and Patient Recruitment
Bennett Rosenthal, Product Manager, BioPharma, SOPHiA GENETICS
The development of personalized treatments implies that selected patient populations would benefit the most from these therapies. To date, SOPHiA GENETICS has analyzed the genetic profile of over 380,000 patients in over 1000 institutions
worldwide. Thanks to the global knowledge of this community, we will present how we can contribute to increasing clinical trial efficiency by identifying sites and patients for biomarker-driven oncology trials.
1:20 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:15 Chairperson’s Remarks
Richard Young, Vice President, Vault CDMS Strategy, Veeva Systems
2:20 NEW: Need to Un-Scale the Clinical Data and Analytics Operating Model in Order to Scale Digital Health
Brooks Fowler, Senior Director and Global Head, Data Science, AbbVie
The traditional economies of scale operating models in the clinical data and analytics space are being challenged by the variety, variability and velocity of the data enabled by the Digital Health revolution. This talk explores the
need to un-scale the clinical data and analytics operating models in order to adapt to the rapid innovation in the digital health space and to unleash the full potential of the new technology innovation.
2:45 The Evolution of Real-World Data Capture and Application
Steven Draikiwicz, MD, Global Digital Medical Lead, Sanofi
A review of a use case of Electronic Health Records to Electronic Data Capture (EHR2EDC), including additional information surrounding the regulatory climate, standards and Esource.
3:05 NEW: Real-World Data Strategy in Accelerating Clinical Trial and Research
Xia Wang, PhD,
Director, Health Informatics & Global Medicines Development, AstraZeneca
This talk presents a strategic project in AstraZeneca to evaluate the landscape of real-world data, novel capabilities and partnerships in accelerating clinical trials and clinical research innovations. We will share our approaches,
findings, learnings, recommendation of implementation and challenges.
3:25 Clinical Analytics & Innovation – Help Us Help You!
Ankit Lodha, MS, MBA, Associate Director, Clinical Metrics & Analytics, Global Development Operations, Takeda
Clinical analytics and insight can be leveraged to address a wide range of operational questions in variety of settings. It is often utilized for purposes that are beyond the original intent of these data points. At Takeda (L-Shire),
we have developed industry best practices in measuring multiple CROs performance consistently i.e. apple-to-apple comparison for all our CRO partners. We are applying best practices, but also taking a fresh approach to develop
a world-class clinical analytics metrics that will enhance our partnerships across our therapeutic areas. The goal of this presentation is to review the capability of several analytical approaches and to demonstrate how these insights
can be incorporated into all phases of a clinical development program. This presentation will also share advances from previous analytical solutions and from scaling up our clinical analytics suite of metrics in developing KPIs
to measure clinical trial performance.
3:50 CO-PRESENTATION: Reducing the Noise and Increasing the Value We Get from Our Systems
Rich Wzorek, Director, New Products & Service, Almac
Group
Kenny Kong, Director, Life Sciences & Health IT, Exostar
One of the principal goals behind the use of eClinical systems is reducing noise to allow us to hear a clear signal from the study treatment. Understanding when a process or software feature is a competitive advantage or just a standard
utility is essential for achieving that goal. The utilities can become part of shared ecosystems through standards and interoperability allowing us to focus on the processes or features that give us a competitive advantage
4:20 Find Your Table and Meet Your Moderator
For more details on the Breakout Discussions: https://www.scopesummit.com/breakouts
4:25 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest
and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. 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.
5:10 Welcome Reception in the Exhibit Hall (Windermere Ballroom)
(Co-Sponsorship Opportunities Available)
6:45 Close of Day
Day 1 | Day 2 | Download Brochure
Thursday, February 20
7:15 am Registration Open (Regency Rotunda)
7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share (Regency Ballroom T)
Mike Nolte, Chief Executive Officer, Signant Health
The increasing ubiquity of technology in clinical trials can lead to an overwhelming drain on patients' time, energy and attention - making an already stressful time even harder. Across companies and competitors, technology
providers share the responsibility to blend solutions into the background of daily lives and keep patients at the center. We will explore the timeline of a trial and the direct and indirect impact key solutions have on
the patient burden and experience.
8:15 Session Break
8:20 Chairperson’s Remarks
Bazgha Qutab, Associate Principal, ZS Associates
8:25 Modernizing the Drug Development Process: Streamlining Clinical Protocols
Michael Dawson, Director, Development Design Center, AbbVie
This presentation will discuss new approaches and templates designed to streamline clinical protocols. Case studies and examples of advanced analytics enabling innovative clinical protocol design will be shared.
8:45 The Curve Ahead: Dynamics of Clinical Trial Recruitment Projections
Ozgur Ozkan, IT Director, Clinical Decision Support, The Janssen Pharmaceutical Companies of Johnson & Johnson
Recruitment speed is a major concern for trial timelines, as it may put target deadlines at risk, run up costs and even put the whole study at risk of failure. Ability to better predict and adjust recruitment curves is a crucial
capability in trial management. In this presentation, we will share learnings from our experience in recruitment modeling. These will include the main dynamics underlying the shape of recruitment curves and how we could
use them to help with our decision making in various areas, e.g. drug supply planning. We will also touch on approaches to inform model assumptions when working with planned vs. ongoing trials.
9:05 Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development
Jonathan Rowe, PhD, Associate Principal, ZS Associates
Effective quality risk management is fundamental to ensuring the protection of human subjects and reliability of clinical trial results during the conduct of clinical trials. Risk management is a core element of an effective
quality management system (QMS). An overview of a successful end to end GCP Quality Risk Management program, along with associated analytical tools to predict quality issues, will be described.
9:25 Collaborating with Industry on a New Foundation for Clinical Data Management
Henry Levy, General Manager, Veeva Vault CDMS, Veeva Systems
The pace of change in medicine is outstripping legacy data management capabilities. Pulling from one-on-one interviews with data management leaders, this session will share how top pharmas are addressing challenges such as
expensive system integrations, difficulties reconciling data, inefficient processes, and the organizational need for complete and concurrent data.
9:40 CO-PRESENTATION: Lessons Learned Integrating EHR with EDC Systems Using Clinical Pipe
Hugh Levaux, PhD, Founder & CEO, Protocol First
Len Rosenberg, PhD, RPh, Head, Clinical Operations, The Leukemia & Lymphoma Society/Beat AML LLC
Integrating EHR and EDC systems has long been the “holy grail” of clinical research. New technologies and standards are making such integration a reality. The presenters will discuss their experience deploying such
a technology (Clinical Pipe) in a complex master trial (Beat AML) across multiple academic clinical trial centers.
9:55 Transforming Clinical Data with Intelligent Automation
Nagaraja (Sri) Srivatsan, Senior Vice President, Chief Digital Officer, Technology Solutions, IQVIA Technologies
Digital technologies are driving an unprecedented wave of new data sources from which only intelligent automation solutions will be capable of deriving meaningful outcomes. As organizations start to build more predictive
and prescriptive algorithms to guide the workforce, they need a different type of infrastructure. This session will highlight how connecting previously siloed applications into a seamless trial management experience,
combined with actionable insights, can speed time to market.
10:25 Coffee Break in the Exhibit Hall (Windermere Ballroom)
11:20 Chairperson’s Remarks
Fred Martin, Chief Product Officer, Medrio
11:25 FEATURED PRESENTATION: Digital Biomarkers: An Intersection of Clinical Research, Engineering and Data Sciences
Sina Djali, Head, Clinical and Operations Analytics, Johnson & Johnson
Clinical and outcome-based research are rapidly moving away from relying on traditional sources of data, such as Electronic Data Capture/Case Report Forms and laboratory outputs, to collecting data continuously
in real time using different digital media. This is achieved through the use of wearables and invisible (e.g. Bluetooth) miniaturized devices, and a corpus of existing images that can collect, track and predict
behavioral and physiological outcomes. These innovations have given rise to digital biomarkers as a new discipline in clinical research. Many companies and academic research institutions have dedicated Digital
Biomarker teams and projects solely focused on defining digital genotypes and phenotypes relevant to their specific areas of research. This new discipline takes advantage of new deep learning models, such as
convolutional (imaging) recurrent neural networks that can be used for both detection and prediction of a particular clinical outcome. The aim of this session is to provide an overview of some of the advances
in this field.
11:45 PANEL DISCUSSION: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Relationship with Technology Providers
Moderator: Michelle Crouthamel, DBA, Director, Digital Health & Innovation, AbbVie
Panelists: Jeremy Wyatt, President, ActiGraph
Sina Djali, Head, Clinical and Operations Analytics, Johnson & Johnson
Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)
Bill Byrom, Vice
President, Product Strategy and Innovation, Signant Health
- Where do you see the NDE play a role in the drug development process?
- Where are we as an industry regarding novel digital endpoint (NDE) development after 5+ years of exploration?
- What does the successful relationship look like between the sponsor and tech vendors today to achieve NDE development?
- What “infrastructure” have we established and what else still need to be built?
- Your call to action - from sponsor, consortia, vendor’s perspective
12:25 pm Transition to Lunch
12:30 BRIDGING LUNCHEON CO-PRESENTATION: Precision Medicine: Why Real-Time Insights Are More Important than Ever
Anand Dubey, Associate Director, Business Solution Architect, Saama Technologies
Len Rosenberg, PhD, RPh Head, Clinical Operations, The Leukemia & Lymphoma Society/Beat AML LLC
Complex Master Trials with numerous sub-protocols present distinct challenges for sponsors. Because treatments are tailored to individuals based on factors like genetic makeup, data must be managed effectively.
Using the LLS’s groundbreaking Beat AML Master Clinical Trial as an example, this presentation will explain how studies applying precision medicine benefit from technologies, including AI, that deliver
insights based on quality data and real-time analytics.
1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:00 Close of Conference
Stay on and attend Part 2: Artificial Intelligence in Clinical Research