eSource Symposia and Seminars

Launched August 2020

Leadership

  • Co-Chair: Dr. Rebecca D. Kush | President, Catalysis; Chief Scientific Officer, Elligo Health Research; Founder and President Emeritus, Clinical Data Interchange Standards Consortium (CDISC)

  • Co-Chair: Jonathan Chainey | Global Head, Data Standards & Governance, Data Strategy & Delivery, Data Sciences, Product Development, F.Hoffmann-La Roche & Genentech Inc.

  • Contact: Joshua C. Rubin - +1.914.393.6740 - Josh@JoshCRubin.com

 

Thank You Learning Health Community Advocates

  • Thank You Learning Health Community Advocates

    • Eli Lilly and Company

    • Elligo Health Research

    • Saama Technologies, Inc.

    • Sense Corp

    • Verily

November 2022 eSource Symposium: Where is Your Data? The Silos of Healthcare, Clinical Research, and Public Health Data

  • Announcement

  • Registration link: https://Whereisyourdata.eventbrite.com

  • Moderator: Rebecca D. Kush, PhD, President, Catalysis Research and President Emeritus, CDISC

  • Panelists:

    • Joshua C. Rubin, JD, MBA, MPH, MPP, Founding President and CEO, Learning Health Community

    • Rhonda Facile, Vice President, Partnerships and Development, CDISC

    • Matthew Cowperthwaite, PhD, Vice President, Data Sciences, Elligo Health Research

    • Sagar Anisingaraju, Strategic Advisor, Saama Technologies

  • Slide deck

  • Topics: RWD, AI, Standards, and Learning Health Systems

  • Date and time: Please join us on 15 November 2022 at 12 noon – 1:30 pm US EST

  • Format: virtual

  • Background paper:

  • Contact: Kaci Sykora - kaci.sykora@cgi.com

Consensus Deliverables

  • Proceedings of the August 2020 Learning Health Community eSource Symposium (30 Nov 2020 Update)

background reading and Resources

  • Description of the imCORE (immunotherapy Centers of Research Excellence) Network (Nov 2016)

  • Publication Titled “Patient empowerment and the Learning Health System” in the Learning Health Systems Journal (9 Jun 2017)

  • Publication Titled “Developing a framework for integrating health equity into the learning health system” in the Learning Health Systems Journal (26 Jun 2017)

  • Publication Titled “Transforming the future of health together: The Learning Health Systems Consensus Action Plan” in the Learning Health Systems Journal (25 Apr 2018)

  • Publication Titled “Use of EHRs data for clinical research: Historical progress and current applications” (16 Jan 2019)

  • Publication Titled “Advantages of large medical record database for outcomes research: Insights into post‐menopausal hormone therapy” in the Learning Health Systems Journal (25 Apr 2019)

  • Publication Titled “The Long Road to eSource” (May 2020)

  • Publication Titled “FAIR data sharing: The roles of common data elements and harmonization” (12 May 2020)

  • Publication Titled “A maturity grid assessment tool for learning networks” in the Learning Health Systems Journal (26 Jun 2020)

  • TransCelerate eSource Initiative and Assets

  • Society of Clinical Data Management eSource Implementation Consortium:

  • EU-Pearl: EU Patient-Centric Clinical Trial Platforms

  • PharmaLedger: Blockchain Enabled Health Care

  • ASCO Publication: “Call for Data Standardization: Lessons Learned and Recommendations in an Imaging Study” (2019) JCO Clin Cancer Inform 3:1–11; DOI: 10.1200/CCI.19.00056

  • mCODE Initiative

  • HL7 Vulcan Accelerator

  • CDISC Therapeutic Area-specific Data Standards

  • University of Chicago Pediatric Cancer Data Commons

  • National COVID Cohort Collaborative

  • Reagan-Udall Foundation and Friends of Cancer Research Evidence Accelerator

  • COVID-19 Best Evidence Front Door

  • Morehouse School of Medicine National COVID-19 Resiliency Network

background documents

  • Day 1: 20 August 2020 Agenda: Current Perspectives on eSource, RWD, and Regulations

  • Day 2: 25 August 2020 Agenda: Technology, Data Standards, and Harmonization to Support eSource

  • Day 3: 27 August 2020 Agenda: Expanding Learning Through Systems, Standards, and Research

  • Bios of Speakers

Presentations (Day 1: 20 August 2020)

  • Presentation: Welcome, Opening Remarks, and Context-setting

    • Josh Rubin, Kaci Sykora, Rebecca Kush

  • Presentation: TransCelerate’s eSource Initiative

    • Rakesh Maniar, Novartis

  • Presentation: EMA Perspective on eSource, RWD, and Opinion on eSource/DDC

    • Lisbeth Bregnhøj, DKMA (Good Clinical Practices Inspector)

  • Presentation: FDA Guidance, Standards, and Strategy on eSource and RWE

    • Mary Ann Slack, FDA

  • Presentation: Personalized Medicine and True eSource

    • Jesper Kjær, DKMA (Data Analytics Center Director)

  • Presentation: The Common Data Model Harmonization Project

    • Mitra Rocca, FDA

  • Presentation: Real World Experience With RWD in Community Practices

    • Michael Ibara, Elligo Health Research

Presentations (Day 2: 25 August 2020)

  • Presentation: Welcome, Opening Remarks, and Context-setting

    • Josh Rubin, Kaci Sykora, Rebecca Kush

  • Presentation: Common Data Models, CDEs, and BRIDG

    • Denise Warzel, NCI

  • Presentation: Digitizing Therapeutic Areas: Increasing Standardization and Reusability

    • Peter Van Reusel, CDISC

  • Presentation: ONC’s Interoperability Rule: Implications for Access and Use of US CORE

    • Ida Sim, University of California, San Francisco

  • Presentation: mCODE, CODEX Accelerator Experience

    • Monica Bertagnolli, Harvard University

  • Presentation: Vulcan Accelerator

    • Amy Cramer, Pfizer

  • Presentation: Unleashing the Full Potential of Data From a Global Network of Academic Research Institutes to Accelerate Breakthroughs in Cancer Immunotherapy for Patients

    • Jonathan Chainey, F. Hoffmann-LaRoche and Genentech, Inc

Presentations (Day 3: 27 August 2020)

  • Presentation: Welcome, Opening Remarks, and Context-setting

    • Josh Rubin, Kaci Sykora, Rebecca Kush

  • Presentation: A Maturity Model for Learning Health Systems

    • Charles Friedman, University of Michigan

  • Presentation: A Systems Approach Applied to COVID-19

    • Francisco Ros, President, First-Tech Engineering; Former Secretary of State for Telecommunications and the Information Society, Spain

  • Presentation: The National COVID Cohort Collaborative (N3C)

    • Ken Gersing, NIH/NCATS

  • Presentation: International Data Sharing – Pediatric Cancer Data Commons

    • Sam Volchenboum, University of Chicago

  • Presentation: Evidence Accelerator - Experience in Use of RWE for Regulatory Decisions

    • Susan Winckler, Reagan-Udall Foundation

  • Presentation: Systems Thinking and Synergy

    • Martin Kohn and Mary Tobin, ACRES

eSource Seminar (8 September 2021)

  • Participation and Zoom Information

  • Special Guest Presenters

    • Dr. Christopher Chute, Bloomberg Distinguished Professor of Health Informatics, Professor of Medicine, Public Health, and Nursing at Johns Hopkins University, and Chief Research Information Officer for Johns Hopkins Medicine

      • Summary: “The Synergy Between Federated and Centralized Clinical Data Repositories and Its Impact on Data Quality”

    • Frank Nogueira, CEO, Accumulus

      • Summary: “Accumulus Synergy | Learning Health Symposium”

  • Agenda Overview

  • Bios of Presenters

  • Accumulus Synergy White Paper

eSource Seminar (26 April 2022)

  • Participation and Zoom Information

  • Special Guest Presenter

    • Dr. Dipak Kalra, President of The European Institute for Innovation through Health Data (i~HD), Professor of Health Informatics at University College London (UCL), Visiting Professor at University of Gent

      • Presentation: “Scaling up Trustworthy RWD for Clinical Research: The Momentum in Europe”

      • Summary of the Seminar

  • Agenda Overview

  • Bio of Presenter