Harmonizing the Assessment of Real-World Evidence Study Submissions
A Roundtable Discussion
Thursday, October 29, 2026 | 9:00AM - 3:00 PM ET
In-Person and Online
Joseph B. Martin Conference Center at Harvard Medical School and Zoom
Background
Real World Evidence (RWE) is increasingly being used by regulators and health technology assessment (HTA) bodies to support the approval of new medications. Although RWE is being extensively used for evaluating post-marketing safety and characterizing disease burden, it has played a limited role in informing regulatory and HTA decision-making regarding efficacy and effectiveness. This public hybrid event will bring together stakeholders from regulatory bodies, HTA institutions, professional societies, pharma, academic and industry groups to discuss efforts to improve transparency and consistency in the review and assessment of RWE submissions.
Meeting Information
For in-person attendees: The roundtable will be held in the Pechet Family Conference Room, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston, MA 02115. This room is located on the first floor (see map). Public parking is available nearby. Breakfast will be served from 8:00-9:00AM ET, and an early lunch at around 11:45 AM ET.
For online attendees: The roundtable will be hosted via Zoom. Webinar details will be shared with registered attendees one week before the event.
Both in-person and virtual attendees are encouraged to ask questions, either live during the discussion or through the Zoom chat.
Please complete this registration form to confirm your attendance. If you have any further questions regarding registration or if you require any accomodation to participate in the event, please contact Haritha Pillai or Blake Hyatt.
Agenda
All times listed below are in Eastern Time (ET).
8:00-9:00 AM
Light breakfast
9:00-9:15 AM
Welcome
Sebastian Schneeweiss, Professor of Medicine and Epidemiology, Harvard Medical School; Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
9:15-10:30 AM
Updating HARPER (Workgroup 1)
Brief overview and summary of recommendations (~10 minutes)
- Shirley Wang, Associate Professor of Medicine, Harvard Medical School; Associate Epidemiologist, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
Panelists (~45 minutes)
- Wei Hua, Associate Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration (FDA), United States
- Takashi Waki, Epidemiologist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Wei Liu, Director, R&D Data, Data Science & AI, Johnson & Johnson Innovative Medicine
- Stephen Motsko, Associate Vice President, Center for Observational Research, Amgen
Moderator:
- Laura Pizzi, Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Audience discussion and Q&A (~20 minutes)
10:30-11:45 AM
Co-development of HARMONIZED review assessment template (WG2)
Brief overview and summary of recommendations (~10 minutes)
- Shirley Wang, Associate Professor of Medicine, Harvard Medical School; Associate Epidemiologist, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
Panelists (~45 minutes)
- Marie Bradley, Senior Advisor, Real-World Evidence Analytics, Office of Medical Policy, Food and Drug Administration (FDA), United States
- Patrice Verpillat, Head of Real World Evidence, European Medicines Agency (EMA)
- Páll Jónsson, Programme Director for Data and Evidence, National Institute for Health and Care Excellence (NICE), United Kingdom
- Stine Hasling Mogensen, Chairman at Pharmadanmark, Scientific Senior Advisor at the Danish Medicines Agencys Data Analytic Centre (DAC)
- Steve Farmer, Senior Partner, ABIG Health; Former Chief Strategy Officer for Coverage, Centers for Medicare and Medicaid Services (CMS), United States
Moderator:
- Katsiaryna Bykov, Assistant Professor of Medicine, Harvard Medical School; Pharmacoepidemiologist, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
Audience discussion and Q&A (~20 minutes)
11:45-12:30 PM
Light Lunch and Conversation
12:30-2:30 PM
Prototype agentic AI tool: Overview and demonstration
Overview and framing (~10 minutes)
- Shirley Wang, Associate Professor of Medicine, Harvard Medical School; Associate Epidemiologist, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
Agentic AI demonstration (~20 minutes):
- Jie Yang, AssistantProfessor of Medicine, Harvard Medical School; Lead Investigator, Division ofPharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
- Jiageng Wu, Research Fellow, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
Panelist discussion (~45 minutes)
- Foluso Agboola, Senior Vice President of Research, Institute for Clinical and Economic Review (ICER)
- Carol Koro, Vice President, Head of Global Epidemiology and Real World Evidence, GlaxoSmithKline
- Amy Mullick, Biostatistician and Real World Evidence Researcher, Bayer
- Arup Pramanik, Head of Global Real World Evidence and Health Economics and Outcomes Research Strategy, Union Chimique Belge (UCB)
- Daniel Prieto-Alhambra, Professor of Regulatory Health Data Science, University of Oxford, United Kingdom
- Fatma M. Shebl, Epidemiologist, Food and Drug Administration (FDA), United States
Moderator:
- Mina Tadrous, Associate Professor, Drug Safety Health Services and Policy Research, Leslie Dan Faculty of Pharmacy, University of Toronto
Audience Discussion and Q&A (~30 minutes)
2:30-2:45 PM
Summary and closing remarks
Sebastian Schneeweiss, Professor of Medicine and Epidemiology, Harvard Medical School; Chief, Divisionof Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
3:15-4:15 PM
Closed door idea exchange (invitation only)
Pre-Reading Materials
- Wang SV, Pottegård A, Crown W, et al. HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force. Pharmacoepidemiol Drug Saf. 2023;32(1):44-55. doi:10.1002/pds.5507
- Bykov K, Jaksa A, Lund JL, et al. APPRAISE: A Tool for Appraising Potential for Bias in Real-World Evidence Studies on Medication Effectiveness or Safety. Value Health. Published online August 6, 2025. doi:10.1016/j.jval.2025.07.024
- D’Ambrosio M, Rodriguez P, Emmott N, Hendricks-Sturrup R. Operational Tools and Best Practices to Support Electronic Health Record-Sourced Data Quality, Relevance, and Reliability at the Data Accrual Phase. Duke-Margolis Institute for Health Policy. 2025.
Organizer Information
This roundtable is organized and sponsored by the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School. The HARMONIZE project is funded by an industry consortium including Amgen, Bayer, GSK, J&J, UCB. For questions about the event, please contact Haritha Pillai or Blake Hyatt.
Please note: While Brigham and Women’s Hospital (BWH) is a teaching hospital affiliate of Harvard Medical School, HARMONIZE roundtable is not a Program, activity or unit of Harvard University.
