Catherine Njue
Catherine Njue is a Canadian regulatory official based in Gatineau, Quebec. She serves as Manager of the Office of Biostatistics in the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada.1)
Njue is a member of the Women in Statistics Committee for the Statistical Society of Canada.2)
History
Education
Njue received her PhD from the University of Manitoba in 2001. Her dissertation was titled “On the Efficiency of Testing Procedures in the Linear Model for Multivariate Longitudinal Data,” advised by John Brewster.3) 4)
Career
Njue participated with CancerCare Manitoba in a study called the “Canadian Case Ascertainment Project”, which ran from September 2000 to August 2002. The project was funded by Statistics Canada.5)
Starting in early 2010, Njue participated as a member of the Industry/FDA/Academia Safety Graphics Working Group alongside representatives from Actelion, Amgen, Eli Lilly, the Food and Drug Administration, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, the University of California Davis and Vanderbilt University.6) 7)
Njue has been the target of several lobbying activities by Ross Wallace, Santis Health consultant, on behalf the Canadian Biosimilars Forum in 2016 and 2017.8)
On April 3, 2019, Njue participated in an International Council for Harmonisation (ICH) consultation between Health Canada and the Food and Drug Administration (FDA) where she discussed “statistical principles for clinical trials.”9)
COVID-19
COVAX
On April 14, 2021, Njue participated in a workshop held by COVAX titled “Multivalent COVID vaccines to help address emergence of variants: CMC and clinical implications.” Alongside Dean Smith, she delivered “an overview of current regulatory thinking on multivalent vaccines and requirements for nimble regulation during a pandemic.”10)
On May 28, 2022, Njue participated as a career panel speaker for the Tenth Annual Canadian Statistics Student Conference (CSSC) hosted by the Statistical Society of Canada.11)
On August 9, 2022, Njue was announced as a member of the new Real-World Evidence (RWE) Guidance Working Group within the Canadian Agency for Drugs and Technologies in Health (CADTH).12)
Two days later, she participated in the 2022 Joint Statistical Meetings (JSM) Conference held by the American Statistical Association. The portion she participated in, titled “Implementation of the Estimand Framework: Next Steps for Steady and Consistent Progress?” was organized by representatives from Janssen.13)
2022 Canada Annual Meeting
Njue participated as a speaker at the 2022 Canada Annual Meeting held by the Drug Information Association (DIA) in October 2022.14)
Her fellow speakers included representatives from:
Sponsors for the event included PCI Pharma Services and SYSTRAN Software.15)