Cambridge Healthtech Institute’s 4th Annual

Leveraging RWD for Clinical and Observational Research

Data Integration and Real-Time RWE Generation

February 20-21, 2019

The abundance of data generated during routine health care is growing in significance and should be used for clinical and observational research. Patient electronic records, registries, data from pharmacy and social media, and wearable sensors have been increasingly used as eSources. This process requires strategizing, utilizing novel data technologies, as well as close collaboration between pharmaceutical companies and organizations that possess the data. Cambridge Healthtech Institute’s 4th Annual Leveraging RWD for Clinical and Observational Research conference will discuss challenges and solutions with secondary use of existing healthcare data to support the medicine lifecycle.

Final Agenda

Arrive early and attend Part 1 (Tues-Wed): Late Stage Research Strategy and Operations

Wednesday, February 20

11:30 am Registration Open (Convention Level)

12:30 pm BRIDGING LUNCHEON PRESENTATION: Late Stage Research Strategy and Operations

Meg RichardsMeg Richards, PhD, MPH, Executive Director, Scientific Affairs, Real World Solutions, PRA Health Sciences

1:10 Coffee and Dessert Break in the Exhibit Hall (Plaza International Ballroom)

2:10 Plenary Keynotes (Regency PQ)

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing (Plaza International Ballroom)

Florida A

4:05 Chairperson’s Remarks

Marc Berger, MD, Chair, Real World Evidence Advisory Committee, SHYFT Analytics

4:10 Using Learning Health Systems to Capture Real World Data in Routine Care

Charles Makin, Global Head, Real World Evidence Strategy, Biogen

As the availability and use of RWD continues to increase rapidly, demand is outpacing supply. While a variety of data sources abound, individual data gaps and lack of interconnectedness create unique challenges for users vying for precise insights. In this evolving scenario, learning health systems are emerging as a comprehensive source of patient-level data, combining patient information that traditionally resides in discrete verticals. This session discusses the best practices, challenges and limitations of this approach.

4:40 Challenges and Opportunities with Use of Real World Evidence in Drug Development

Alemayehu_DemissieDemissie Alemayehu, PhD, Vice President, Biostatistics, Pfizer

With the growing demand for new medicines to meet critical healthcare needs with speed and efficiency, it has become essential to explore novel approaches and data sources. Thanks to the prevailing digital revolution, and advances in predictive analytics and computing platforms, a new frontier has emerged to enhance the drug development process. We elucidate pertinent aspects of the use of real world evidence in regulatory settings, with emphasis on study design, analytical strategies, data quality and regulatory requirements.

Oracle-Health-Sciences 5:10 Automation Beyond CRF Population. Why a Disruptive Platform to Support Multiple Data Sources Will Future Proof Your Clinical Trials

Jones_GregGreg Jones, Enterprise Strategy Architect, Life Sciences, Oracle Health Sciences

Please join this provocative session to discover how preparing your clinical research platform for EHR as a data source to automate population of CRFs can serve as a catalyst for full disruption of your clinical research approach.  Implementing strategies to manage expanding data sources is the path to the future of conducting clinical trials. Join this session to understand how you can prepare for this new world.  Why planning beyond CRF automation, and looking at full scale data management of legacy and emerging data sources, as well data sources we haven’t imagined yet, will help future-proof your clinical development.

5:40 RWD Strategies for Improving Development and Access to Innovative Therapeutics

Daniel_gregGregory Daniel, PhD, Deputy Center Director, Duke-Margolis Center for Health Policy, Duke University

This presentation will include an overview of the requirements on FDA, established by the sixth reauthorization of PDUFA and the 21st Century Cures Act, to consider the use of RWE. This session will also include emerging recommendations by stakeholders regarding a framework and approaches for evaluating data quality, improving observational studies, and how broader RWE might be considered along with other factors to reach regulatory evidentiary requirements.

DrFirst 6:107:10 Networking Reception (Regency Foyer)

Thursday, February 21

7:15 am Registration Open (Convention Level)

Medidata 7:45 BREAKFAST PRESENTATION: A User's Perspective into a Unified Imaging and EDC Approach (Regency P)

Troy SchneiderTroy Schneider, Director, Imaging Strategy, Medidata

Halek_SarahSarah Halek, Head, Innovation Design, ICON Medical Imaging

Come hear from a client on how using an imaging management technology on a unified platform considers the entire clinical trial process, providing configurable, intelligent workflows that complements the users and aligns to protocols, automating de-identification, edit checks, and workflow management, thereby reducing clinical trial timeline, cost, and risk. The platform ensures that correct data is presented to the right users at the right time, eliminating data reconciliation tasks and bringing visibility and access.

8:15 Session Break

Florida A

8:20 Chairperson’s Remarks

Kyle Ricketts, Marketing Manager, Bio-Optronics

8:25 Creating the Extensible Data Platform of the Future to Better Leverage Real World Data (RWD)

Yonchuk_John John Yonchuk, Manager, Digital Clinical Trials, GlaxoSmithKline

With the ever expanding number and types of real world data (RWD) sources, it is more critical than ever for Pharma to be able to analyze, interpret, and act upon RWD in a fast, efficient, interoperable, and extensible manner. Creating a data model and a data platform across a clinical operations organization presents opportunity but also challenges that Pharma must get right in order to succeed. 

9:00 CO-PRESENTATION: Real-World Data & Analytics Empowered Clinical Trials Design

Wang_Xia Xia Wang, PhD, Director, Health Informatics & Global Medicines Development, AstraZeneca

Fang_Jane Jane Fang, MD, Head, Clinical Business Management & Analytics, MEDI Biologics Unit, AstraZeneca

Patient-centric drug product development starts with a characterization of the targeted patient population. Real world evidence data (RWD) provides a new way to gain such insights. Incorporating RWD-use into current study planning process will advance and innovate trial design, conduct and patient recruitment. The talk will feature a RWD-empowered trial feasibility and patient recruitment process that has joined the expertise from different fields such as feasibility function, informatics and data scientists, study teams, technologists and sites.

9:35 Data-Driven Patient Recruitment with Real World Data

    Liping Jin, Data-Driven Patient Recruitment Lead, Pharma Research and Early Development, pREDi Early Development Workflows, Roche

With the increasing use of Real World Data (RWD) in the pharma industry, Data-Driven Recruitment (DDR) team at Roche Pharm Research & Early Development (pRED) would like to share our experience of integrating RWD (e.g. insurance claims, EMR) with trial metrics data to optimize study protocol design and target patient recruitment strategy. While the team has received positive feedback from our business partners (translational medicine, clinical program teams, and study leaders), we would also like to share the challenges to expanding the effort in broader US, Europe and international settings.

9:55 Leveraging RWD for Clinical and Observational Research

Jane Quigley, Senior Vice President, Real World Evidence, PRA Health Sciences

When will be ready for the real world? Let's find out together!




10:25 Networking Coffee Break (Sponsorship Opportunity Available) (Regency Foyer)

Florida A

11:10 Chairperson’s Remarks

Marion Brayer, Head, Clinical Operations, SOPHiA GENETICS

11:15 Supplementing Clinical Trials in Oncology with Real World Evidence

Sail_Kavita Kavita Sail, PhD, Associate Director, Health Economics and Outcomes Research, AbbVie

Real world evidence is growing in importance and can be used effectively in oncology to test sub-populations, identify risk groups and even inform the right population prior to conducting a clinical trial. Studies using big data require expertise in handling and pose unique challenges related to potential bias and complex data management strategies. It’s important that these studies are conducted with expert data scientists alongside medical and clinical reviewers for correct data interpretation.

SophiaGenetics 11:45 SOPHiA Trial Match: Leverage RWE to Bring the Right Clinical Trials to Patients

Brayer_Marion_PH42Marion Brayer, Head, Clinical Operations, SOPHiA GENETICS

Finding the appropriate population is one of the biggest challenges in clinical trials. SOPHiA, the AI empowering Data-Driven Medicine, has analyzed over 300’000 genomic profiles to date... one every five minutes!  Now, SOPHiA uses RWE solutions to maximize clinical trial efficiency, matching patients to clinical trials based on their genomic and radiomic profiles.

12:15 pm Transition to Shared Sessions

Regency Q

Chairperson’s Remarks

Ronald Waife, MPH, President, Waife & Associates, Inc.

12:20 Blockchain Opportunities for Patient Data Donation & Clinical Research

Baara_Munther Munther Baara, MS, Head, New Clinical Paradigm, Pfizer

Imagine a solution that makes it easy to aggregate health data in a secure, trusted, automated, and error-free way. A solution which enforces rules, privacy, and regulations in a mutually agreed upon manner, resulting in a smart-contract between patient and healthcare stakeholders. This enables patients to aggregate their data from diverse health sources and share what they choose to with their physicians and researchers.

12:40 Blockchain and Pragmatism: A Necessary Marriage

Waife_Ronald Ronald Waife, MPH, President, Waife & Associates, Inc.

Biopharma is improving its track record in adopting advances in software and work process. However, the use of blockchain technologies may be too immature and unproven to expect rapid incorporation into clinical research. A productive approach for biopharma may be to select a focused business problem. For instance, the “mining” of data from RWD sources could be more feasible with blockchain security. But biopharma will need to follow best practices for technology evaluation, process impact, compliance assurance, vendor management and user acceptance.

1:00 INTERACTIVE PANEL: Blockchain in Clinical Research

Moderator: Ronald Waife, MPH, President, Waife & Associates, Inc.

Panelists: Munther Baara, MS, Head, New Clinical Paradigm, Pfizer

Professor Dr. Dorothee Bartels, Chief Digital Science Officer, BI X GmbH, Boehringer Ingelheim

Greg Plante, Principal, Digital Health & Technology, IQVIA

The most significant costs to clinical trials are in time and resources to insure the com-pleteness, accuracy and integrity of patient data. Blockchain technology has the potential to transform and simplify the exchange of data among business partners in clinical re-search. Can blockchain solutions be applied to reduce the time to bring new biopharmaceu-tical products to market while reducing the cost of achieving that objective? The presenta-tions and discussion will address this opportunity and the path to its implementation.

  • What is the realistic path for the adoption of innovations such as block chain for sponsors, sites and CROs?
  • Do service providers (CROs) play a leading or trailing role in the facilitating for the industry and why?
  • Unlike EDC, block chain technology requires sites to take an active role rather than waiting for sponsors/CROs to deliver the capabilities, how does that impact adoption?
  • Thoughts on global adoption
  • Thoughts on business process implications and feasibility for transition

1:20 Transition to Lunch

Accenturebyustvexrzrzfusaawry 1:25 LUNCHEON PRESENTATION: Intelligent Operations: Envisioning a Better Way to Deliver R&D Outcomes

Jennifer Duff, Managing Director, Life Sciences, Accenture

The research and development landscape is changing and new technology is presenting complex challenges to traditional ways of working. In order to successfully navigate this change, the industry needs to transform their core ways of working. Accenture will share perspective on how these forces are shaping the future of R&D Operations, elaborate on how Accenture is partnering with the industry to enable the pivot, and how this transformation is key to long-term success and improved outcomes.

1:55 Closing Remarks

2:00 SCOPE Summit 2019 Adjourns

Arrive early and attend Part 1 (Tues-Wed): Late Stage Research Strategy and Operations

video recap

SCOPE 2019 is dedicated to the life and memory

Christine K. Pierre
September 8, 1958 - October 23, 2018

Read More…

“SCOPE Featured Author”
Emmanuel Fombu, MD, MBA
Global Commercial Strategy and
Digital Innovation, Johnson & Johnson

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