Cambridge Healthtech Institute's 3rd Annual

Leveraging Real World Data for Clinical and Observational Research:
( 臨床研究と観察研究でのリアルワールドデータの活用 )

Integrating Evidence Generation with RWD and Pre-Existing Data

2018年2月14-15日 | Hyatt Regency Orlando | フロリダ州オーランド




Wednesday, February 14

11:30 am Registration Open

12:10 pm Bridging Luncheon Presentation: Achieving Evidentiary Equilibrium

David Thompson, Ph.D., Senior Vice President, Real-World & Late Phase, INC Research/inVentiv Health

Achieving Evidentiary Equilibrium - Generating the Right Evidence for the Right Stakeholders at the Right Time Throughout the Clinical/Commercial Continuum

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Plenary Keynotes

3:00 Valentine’s Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing


4:00 Chairperson’s Remarks

Sean Mooney, Ph.D., Chief Research Information Officer, UW Medicine

4:05 Systematic Approach to Use RWD to Inform Trial Design: Going beyond Simple Feasibility

Hui_CaoHui Cao, M.D., Ph.D., Executive Director, Real-World Evidence, COE for RWE, Global Medical Affairs, Novartis Pharmaceuticals Corporation

We developed a structured framework to guide the use of RWD to inform clinical trial design. This framework consists of three dimensions: recruitability, efficacy endpoint impact and risk impact. Each major criterion in the trial inclusion/exclusion criteria can be assessed on how it would impact the size of patient pool, the efficacy endpoints and risks. This framework was validated via its application on pre-authorization pivotal trials.

4:30 RWE Analytics to Link Patient Journey with Trial Feasibility and Patient Recruitment

Jane_FangJane Fang, M.D., Head, Research & Development Information for Clinical Biologics, MedImmune Biologics Science Unit of AstraZeneca

The precision medicine behind trial design is driving rapid change in the way of traditional feasibility assessment and patient recruitment. Emerging market of healthcare information and records providers is bringing game-changing approaches to enable hypothesis generation of protocol design, deep dive analysis of patient journey and precision patient recruitment. The innovative approach of linking RWE analysis with clinical trial research and patient recruitment is critical for today and future precision trial conduct.

4:55 Leveraging Real World Data to Streamline Clinical Trials

Manfred Stapff, M.D., Ph.D., CMO, TriNetX, Inc.

Industry is encumbered with lengthy drug development timelines and high costs. These challenges are correlated with the difficulty to recruit appropriate patient populations for clinical trials. Join this session to learn how real world data is transforming the way biopharma, CROs and study sites navigate obstacles in drug development across protocol design, site selection and patient recruitment.

5:25 Current State of Real World Evidence to Support the Medicine Lifecycle

Nicolle Gatto, Group Lead, Senior Director, Epidemiology, Worldwide Safety and Regulatory, Pfizer

Observational data from electronic health records, insurance claims and disease registries are often used for premarketing studies. This presentation will describe the uses of real-world, observational data across the drug development lifecycle with particular focus on more innovative uses such as serving as a source for embedded clinical trials, for active surveillance of rare events across multiple linked data sources where relevant, case studies will be briefly described.

5:50 Close of Day

5:50 - 7:00 pm Track Reception (Sponsorship Opportunity Available)

Thursday, February 15

7:15 am Registration Open

Accenture7:45 Breakfast Presentation to be Announced


8:30 Chairperson’s Remarks

8:35 Optimize Your Clinical Trials Using Electronic Health Records: The Case of EHR4CR

Xia_WangXia Wang, Ph.D., Principal Health Informatics Scientist, Informatics Lead RIA, AstraZeneca

This talk presents the AZ coordinated IMI project EHR4CR (Electronic Health Records for Clinical Research). The objective of EHR4CR is to research and develop a trustworthy technical platform and services to allow re-use of EHR data to support clinical research in Europe. We will also share our experiences to test and evaluate the EHR4CR InSite platform for protocol feasibility and recruitment services on a growing hospital network.

9:00 Platform-Based Approaches in RWE: Approaches, Methodologies and Examples

Jyottsna_MehtaJyotsna Mehta,Principal,KevaHealth

This presentation will provide an in-depth understanding of platform-based approaches in real world evidence and provide examples to show its usefulness and value in drug development throughout the life cycle of drug products. It will also provide a framework of how and when to consider these for your studies and explain pros and cons through the use of examples.

9:25 Building Credibility with the Audience: Methodology

Elizabeth_MacLeanElizabeth MacLean, Pharm.D., Director, Global Health and Value/Outcomes & Evidence, Pfizer

Interest in the use of real world evidence to inform decision making in healthcare is growing. Importantly, concerns have been raised in the scientific and decision making communities regarding the reproducibility of observational studies using large healthcare databases. This presentation will review the concepts of reproducibility and transparency and efforts to guide researchers in this regard.

9:50 Presentation to be Announced

10:15 Networking Coffee Break


10:30 Chairperson’s Remarks

10:35 RWD from Europe to Optimize Clinical Research Processes: Creating Value for Patients, Hospitals and Sponsors/CROs

Tine_LewiTine Lewi, Ph.D., MBA, Scientific Director, Quantitative Sciences/Real World Evidence Partnerships, Janssen Global Research & Development

The European Real World Data (RWD) scene is developing at full speed. Multiple new approaches to RWD and Big Data emerge to optimize the clinical research process. An overview of the state of the art on RWD for clinical research in Europe will be provided, with a special focus on RWD from EHRs. Use cases demonstrate the value of RWD to optimize protocol design, accelerate feasibility for site selection and ultimately support the patient recruitment. These use cases will also demonstrate benefits to the patient, the hospital, the research sponsors and CROs.

11:00 Sponsored Presentation (Opportunity Available)

11:25 Brief Session Break

11:35 Conducting and Translating Research in Real-Time at Point of Care: Designing a Clinical Research Enterprise Infrastructure

Uli_ChettipallyUli Chettipally, M.D., MPH, CTO, CREST Network, Division of Research, Kaiser Permanente

Improvements in information technology have provided better tools to conduct research. Electronic health records and mobile technology are now ubiquitous in care delivery environments. The design of a clinical research enterprise infrastructure should take into account these factors. This talk will discuss the design, development, and deployment of such a system at a large integrated health system.

12:00 pm Embedding Clinical Trials in the Electronic Medical Record: Challenges of Integrating Research into Clinical Care

Ryan Ferguson, Sc.D., MPH, Director, VA Cooperative Studies Program Coordinating Center

Point-of-care clinical trials (POC-CT) are a pragmatic trial design intended to reduce the burden of research for both patient and provider and to support the learning healthcare system within the VA Healthcare System. Trials are fully embedded in the electronic medical record and use only data that can be found in the corresponding data warehouse, Medicare, and the National Death Index. With this innovative design come a number of challenges associated with regulation and implementation. We will discuss these challenges and their solutions in an active clinical trial.

12:25 Enhancing Clinical Research with Data and Technology at an Academic Health System

Sean_MooneySean Mooney, Ph.D., Chief Research Information Officer, UW Medicine

At the University of Washington, there are many clinical research touch points with our health system, UW Medicine. Not surprisingly, this is especially relevant in activities surrounding data and information technology. In this presentation, I will discuss our efforts to leverage data and IT platforms to support research activities throughout the enterprise.

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?

Moderator: Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)

Panelists: David Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)

Sean Walsh, MBA, CDO, Raleigh Neurology Associates

Beth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)

Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or from technology companies themselves. Which of these improvements actually work? How can sites implement these more effectively? Why are there barriers to adoption and how can the innovators better understand sites’ needs?

  • Share sites’ perspective on the evolving clinical research landscape
  • Discuss the reasons sites struggle with new processes and technology tools
  • Determine ways to facilitate adoption

1:15 Closing Remarks

1:20 SCOPE Summit 2018 Adjourns

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


2018 SCOPE Conference at a Glance

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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)