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
Day 1 | Day 2 | Download Brochure
Tuesday, February 18
9:00 am - 7:15 pm Registration Open
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
*Separate registration required. Must be a Best Value registered attendee.
5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards
6:20 - 7:30 pm SCOPE’s Kick-Off Networking Happy Hour
(Co-Sponsorship Opportunities Available)
7:30 pm Close of Day
Wednesday, February 19
7:15 am Registration Open and Morning Coffee
8:15 Morning Opening Plenary Keynotes
9:40 Grand Opening Coffee Break in the Exhibit Hall
10:40 Chairperson’s Remarks
Pam Duffy, Senior Director & Digital Strategic Planning and Demand Lead, Pfizer
10:45 Opportunities to Apply AI in the Clinical Data Environment
Demetris Zambas, Vice President and Global Head, Data Monitoring and Management, Pfizer Inc.
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
Dermot Kenny, Global
Head, 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 Presentation to be Announced
12:45 Transition to Lunch
12:50 LUNCHEON PRESENTATION: Data-Driven Site Selection and Patient Recruitment
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
2:15 Chairperson’s Remarks
Richard Young, Vice President, Vault CDMS Strategy, Veeva Systems
2:20 Need to Un-Scale the Clinical Data and Analytics Operating Model in Order to Scale Digital Health
Nareen Katta, Head,
Clinical Analytics, 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 CASE STUDY: DMD Phase II and Phase III Study Lessons Learned with Various eData Collection
MPH, Senior Director, Data Monitoring and Data Management, Global Product Development, Pfizer Inc.
The Phase II study collected 12 types of eData, including activity monitoring (wrists and ankles), ePRO, biomarkers, immunogenicity, imaging, labs and biopsy data. This presentation will review the process of how Pfizer decides on the data collection
strategy through the data analysis. With >70% of the data collected in our trials coming direct from source, we need to change how we manage our data. This presentation will highlight how we work today and where we are going.
3:05 The Evolution of Real-World Data Capture and Application
Draikiwicz, MD, Global Medical Bioinformatics 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.
3:25 CO-PRESENTATION: Real-World Data Strategy in Accelerating Clinical Trial and Research
Xia Wang, PhD, Director, Health
Informatics & Global Medicines Development, AstraZeneca
Jane Fang, MD, Head, Clinical
Business Management & Analytics, MEDI Biologics Unit, 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.
3:50 CO-PRESENTATION: Talk Title to be Announced
Rich Wzorek, Director, New Products & Service, Almac
Kenny Kong, Director, Life Sciences & Health IT, Exostar
4:20 Find Your Table and Meet Your Moderator
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
6:45 Close of Day
Day 1 | Day 2 | Download Brochure
Thursday, February 20
7:15 am Registration Open
7:45 Breakfast Presentation to be Announced
8:15 Session Break
8:20 Chairperson’s Remarks
Venkat Sethuraman, PhD, MBA, Global Clinical Lead , R&D Excellence Practice, 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, Executive Director & Head, Quality Performance and Risk Management, Pfizer
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 Presentation to be Announced
10:25 Coffee Break in the Exhibit Hall
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: Speakers of the Day
This panel will discuss managing relationships with technology providers.
12:25 pm Transition to Lunch
12:30 BRIDGING LUNCHEON PRESENTATION: Practical Applications of AI in Patient Data Analytics
Srinivasan Anandakumar, Senior Director, Clinical Analytics, Saama Technologies
1:00 Coffee and Dessert Break in the Exhibit Hall
2:00 Close of Conference
Stay on and attend Part 2: Artificial Intelligence in Clinical Research
Day 1 | Day 2 | Download Brochure