CAR T-cell therapies: Lessons Learned about Canadian Potential to Navigate Regulatory & Reimbursement Pathway

Authored by Patrick Bedford, MBA, MSc, Stephanie Minnema, PhD, MBA, Sang Mi Lee, MBA, BSc Phm, RPh, Donna Yang, MSc, Lana Duan, MSc, and Jaclyn Beca, MSc.

The white paper details the CAR T-cell therapy landscape in Canada, focusing on the challenges and opportunities faced by Canadians in accessing innovative treatments. As the Canadian government invests in homegrown CAR T-cell therapies, initiatives like BioCanRx and Canada’s National Research Council aim to facilitate access while addressing regulatory and reimbursement complexities.

Our white paper offers valuable insights to Canadian researchers, clinicians, and industry professionals. It bridges the gap between scientific discovery and clinical practice while ensuring the sustainability of Canada’s healthcare system.

You may have the right scientists and clinicians on your team, but do you have the right regulatory and reimbursement perspective to transfer, translate, and commercialize CAR-T in Canada?

We can leverage our market access expertise to assist you in preparing early for opportunities and challenges when bringing a cell and gene therapy product to market.

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AUTHORS

Patrick Bedford, MSc, MBA, RAC (Can)

Founder & Managing Director, weCANreg Consulting Group, Inc.

Co-Founder & Director, weCANdev & weCANtrial Consulting Groups, Inc. Vice President of Regulatory Affairs, Morphocell Technologies

LinkedIn: https://www.linkedin.com/in/patrick-bedfordregulatory-expert/

Stephanie Minnema, PhD, MB

Principal, Skyline Value and Access

LinkedIn: https://www.linkedin.com/in/sminnema/

Sang Mi Lee, MBA, BSc Phm, RP

Executive Director, MORSE Consulting Inc.

LinkedIn: https://www.linkedin.com/in/sang-mi-lee-mba-bsc-phm-rph-8836531/

Donna Yang, MSc

Market Access Analyst, MORSE Consulting Inc.

LinkedIn: https://www.linkedin.com/in/donna-y-054818165/

Lana Duan, MSc

Market Access & Data Analytics Manager, MORSE Consulting Inc.

LinkedIn: https://www.linkedin.com/in/lana-duan/

Jaclyn Beca, MSc

Director of Pharmacoeconomics and RWE, MORSE Consulting Inc.

LinkedIn: https://www.linkedin.com/in/jaclynbeca/

Access the full white paper on our website to explore regulatory and reimbursement lessons learned, strategic clinical trial design considerations, and innovative strategies for successful product launches. Let's pave the way for the future of CAR T-cell therapies in Canada.

Special thanks to Patrick Bedford, whose extensive knowledge in regulatory affairs and experience from Health Canada, industry, consulting, and academia played a pivotal role in creating the white paper.

Download White Paper


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New Navigate the Evolving Canadian Cell & Gene Therapy Market