As the Founder of weCANreg Consulting Group Inc, I created the company to fill a gap in Canada because I want innovative medicines to succeed here. This remains the core of what we do.
Regulatory uncertainty was identified by global pharmaceutical executives as a more significant concern facing stem-cell derived therapies and gene therapies than lack of funding. However, Canadian science is strong and Canadian regulations (and regulators) are flexible enough to allow drugs to move to the bedside as soon as there is sufficient evidence demonstrating that their benefits are likely to outweigh their risks. Throughout my career at Health Canada I enjoyed turning perceived barriers into answerable questions and navigating issue resolutions. I practiced this further at a not-for-profit Network Centre of Excellence, which is what solidified my conviction: Reaching regulatory milestones should be made easier for scientists and clinicians! ...But it requires dedicated efforts because it can take significant time for people who do not do it every day.
I still see a need to help. weCANreg will remain at the forefront of the ever-evolving field of cell & gene therapy regulation, and we will continue to help shape it in Canada. I truly hope that I have the opportunity to support your efforts!
Founder & Principal Consultant
weCANreg Consulting Group Inc
Certified Regulatory Affairs Professionals
Led biosimilar, transplant material, and cell therapy clinical trial guidance development at Health Canada
Supported International harmonization initiatives
Attended dozens of cell & gene therapy pre-submission meetings with Health Canada
Received Health Canada reviewer training
Planned 2 CAR T New Drug Submissions
weCANreg Consulting Group Inc.
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