Post-Market Drug Evaluation Advisory Committee

PMDE Industry Task Force (Interim)

CADTH is establishing a time-limited industry task force to identify opportunities and barriers for using industry real-world data (RWD) in our Post-Market Drug Evaluation (PMDE) Program, building upon the recently released Guidance for Reporting Real-World Evidence.

This group is task-oriented and will work collaboratively to develop a summary report for CADTH. This report will advise on best practices and potential approaches for using industry RWD as well as identify ways to mitigate risks and barriers. The summary report will include proposed approaches that will be considered by the PMDE Advisory Committee and CADTH. CADTH intends to share information about the industry task force and the options paper with its stakeholders.

Membership

 

Facilitator

 
Don Husereau  Adjunct Professor, University of Ottawa, SEPH  

Industry Representatives

 
Véronique Gaudet Field Medical Advisor, Bausch Health  
Virginie Giroux (Industry Lead) Director, Health Economic and Outcomes Research, Merck  
Jennifer Glass RWE Lead Canada, Eli Lilly  
Nikolas Goyert-Stephens    Senior Manager, Market Access, Biogen  
Jason Lee Head of Market Access and Stakeholder Relations, Amylyx  
Maria Luckevich Health Economics Associate Director, Novo Nordisk  
Kevin Pollock Director of Real-World Evidence, International Markets, Bristol Myers Squibb  
Subra Seshadri Manager Access for Anti-Virals and Hospital Business, Pfizer  
Jefferson Tea Vice-President Medical and Scientific Affairs, Takeda  
Jennifer Wu Health Data Strategy Lead, Roche  

Health Canada

 
Kelly Robinson Director General, Marketed Health Products Directorate, Health Canada  

CADTH Representatives

 
Tarry Ahuja (CADTH Lead) Director, Post-Market Drug Evaluation  
Trish Caetano Director, Drug Data Services and Analytics  
Peter Dyrda Director, Pharmaceutical Policy and HTA  
Farah Husein Director, Science and Methods  
Brendan McIntosh Drug Program Advisor, Pharmaceutical Reviews  
David Stock Scientific Advisor, Post-Market Drug Evaluation  
Nadine Sulatycky Program Lead, Post-Market Drug Evaluation  

Meeting Schedule

The task force will meet monthly initially for 5 to 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 and the final summary document will be made publicly available. Please check back for regular updates. 

PMDE Industry Task Force - Meeting 4 Summary

PMDE Industry Task Force - Meeting 3 Summary

PMDE Industry Task Force - Meeting 2 Summary

PMDE Industry Task Force – Meeting 1 Summary