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
Wednesday, February 20
11:30 am Registration Open (Convention Level)
12:30 pm BRIDGING LUNCHEON PRESENTATION: Late Stage Research Strategy and Operations
Meg 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)
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
Demissie 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.
5:10 Automation Beyond CRF Population. Why a Disruptive Platform to Support Multiple Data Sources Will Future Proof Your Clinical Trials
Greg 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
Gregory 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.
6:10 – 7:10 Networking Reception (Regency Foyer)
Thursday, February 21
7:15 am Registration Open (Convention Level)
7:45 BREAKFAST PRESENTATION: A User's Perspective into a Unified Imaging and EDC Approach (Regency P)
Troy Schneider, Director, Imaging Strategy, Medidata
Sarah 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
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)
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
Xia Wang, PhD, Director, Health Informatics & Global Medicines Development,
AstraZeneca
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
When will be ready for the real world? Let's find out together!
10:25 Networking Coffee Break (Sponsorship Opportunity Available) (Regency Foyer)
11:10 Chairperson’s Remarks
Marion Brayer, Head, Clinical Operations, SOPHiA GENETICS
11:15 Supplementing Clinical Trials in Oncology with Real World Evidence
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.
11:45 SOPHiA Trial Match: Leverage RWE to Bring the Right Clinical Trials to Patients
Marion 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
Chairperson’s Remarks
Ronald Waife, MPH, President, Waife & Associates, Inc.
12:20 Blockchain Opportunities for Patient Data Donation & Clinical Research
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
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
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