Last Updated : September 16, 2024
In September 2023, we established a time-limited task force to identify opportunities and barriers for using industry real-world evidence (RWE) in our Post-Market Drug Evaluation (PMDE) Program. The task force builds upon the recently released Guidance for Reporting Real-World Evidence.
The task force represents a first-of-its-kind collaboration between the pharmaceutical industry, Canada’s Drug Agency, and Health Canada. Its goal was to formally explore sharing industry-sponsored RWE with our Post-Market Drug Evaluation (PMDE) Program. The task force provided a forum for constructive dialogue about how to effectively operationalize access to and use of industry-sponsored RWE and demonstrates an innovative approach to improving access to data in Canada. Over the course of 4 meetings, the task force examined issues related to evidence sharing such as scope, ownership, transparency, operational requirements, privacy, process, and collaboration.
Summary Report
The Industry Task Force developed a summary report that proposes key actions to enable the use of industry-sponsored RWE to improve our understanding of the safety and effectiveness of treatments.
The report, published in August 2024, emphasizes early engagement between manufacturers and Canada’s Drug Agency to reduce delays in accessing data and better anticipate future needs. The report also provides a rationale for, and suggests who should lead, proposed actions that can help to facilitate the use of industry-sponsored RWE.
The summary report does not represent an approved plan, but it will inform the PMDE Program and its Advisory Committee. Our aim is to incorporate some of the proposed actions into the current PMDE query process before the end of the year.
Report Brief: Industry Task Force Summary Report
Membership |
|||
|---|---|---|---|
| Facilitator | |||
| Don Husereau | Adjunct Professor, Adjunct Professor, School of Epidemiology and Public Health, University of Ottawa |
||
| Industry Representatives | Health Canada | ||
| Véronique Gaudet | Senior Manager, Real-World Evidence, Bausch Health, Canada Inc. | Kelly Robinson | Director General, Marketed Health Products Directorate, Health Canada |
| Virginie Giroux (Industry Lead) | Director, Health Economic and Outcomes Research, Merck | CDA-ACM Representatives | |
| Jennifer Glass | RWE Lead Canada, Eli Lilly | Tarry Ahuja (CDA-AMC Lead) | Director, Post-Market Drug Evaluation |
| Nikolas Goyert-Stephens | Senior Manager, Market Access, Biogen | Nadine Sulatycky | Manager, Post-Market Drug Evaluation |
| Jason Lee | Head of Market Access and Stakeholder Relations, Amylyx | David Stock | Scientific Advisor, Post-Market Drug Evaluation |
| Maria Luckevich | Health Economics Associate Director, Novo Nordisk | Brendan McIntosh | Senior Drug Program Advisor, Pharmaceutical Reviews |
| Kevin Pollock | Director of Real-World Evidence, International Markets, Bristol Myers Squibb | Farah Husein | Director, Science and Methods |
| Subra Seshadri | Manager Access for Anti-Virals and Hospital Business, Pfizer | Heather Logan | Vice-President, Strategic Relationship Initiatives |
| Jefferson Tea | Vice-President Medical and Scientific Affairs, Takeda | Trish Caetano | Director, Drug Data Services and Analytics |
| Jennifer Wu | Health Data Strategy Lead, Roche | Peter Dyrda | Director, Pharmaceutical Policy and HTA |
| David Shum | Director, Strategic Access and Pricing, Roche (meeting 4) | ----------- | ---------- |
Meeting Schedule
The task force met monthly initially for 6 months:
- Meeting 1: September 26, 2023
- Meeting 2: October 24, 2023
- Meeting 3: November 28, 2023
- Meeting 4: January 16, 2024
- Meeting 5: March 26, 2024
Meeting Summaries
Meeting summaries for meetings 1 to 4 are available. Meeting 5 was used to co-create the summary report.
Files
Last Updated : September 16, 2024