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

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

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

Clinical Data Innovation: Harnessing The Power of New Technology

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

Zambas_DemetrisDemetris 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

Fowler_BrooksBrooks 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

Kenny_DermotDermot 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_BennettBennett 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

DATA DEPARTMENTS TO ADJUST TO DIGITALIZATION OF CLINICAL TRIALS

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

Katta_NareenNareen 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

Bornstein_SusanSusan Bornstein, 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_StevenSteven 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

Wang_XiaXia Wang, PhD, Director, Health Informatics & Global Medicines Development, AstraZeneca


Fang_JaneJane 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

Wzorek_RichRich Wzorek, Director, New Products & Service, Almac Group


Kong_KennyKenny Kong, Director, Life Sciences & Health IT, Exostar


INTERACTIVE BREAKOUT DISCUSSION GROUPS

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

Thursday, February 20

7:15 am Registration Open

7:45 Breakfast Presentation to be Announced

8:15 Session Break

ADVANCED ANALYTICS TO ENABLE CLINICAL TRIAL DESIGN AND OPERATIONS

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

Dawson_MichaelMichael 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

Ozkan_OzgurOzgur 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

Rowe_JonathanJonathan 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

Levy_HenryHenry 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

Levaux_HughHugh Levaux, PhD, Founder & CEO, Protocol First


Rosenberg_LenLen 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

AN INTERSECTION OF CLINICAL RESEARCH, ENGINEERING AND DATA SCIENCES

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

Djali_SinaSina 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

Crouthamel_MichelleModerator: 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

Anandakumar_SrinivasanSrinivasan 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

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

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. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. 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: www.scopesummit.com/breakouts

 

Stay on and attend Part 2 (Thurs-Fri): Artificial Intelligence in Clinical Research