Ever wondered about the commercialization pathway and when to start engaging in Regulatory activities?
Have a peak at this short animated video that walks you through the process.
I suggest you can use regulatory activities to support early development pitches and de-risk your commercialization plans, then use niche regulatory expertise to accelerate submissions.
A Regulatory Perspective on Gene Therapy Development and Commercialization. Presented to University of Toronto's Senior College (Virtually) (2021-03)
Augmenting Biotech Commercialization with a Regulatory Perspective. Presented for e-Seminars on Translational Biomedical Engineering (Virtually) (2021-Jan)
Cell Therapy Development for Academics. Presented for Stem Cell Network's "Stem Cells from the Sofa Speaker Series" (Virtually) (2020-Sept)
Global Regulatory Perspectives - Key Topics in Combination Products. Presented to the International Society of Cellular Therapy (ISCT) in Paris (Virtual) (2020-May)
Canadian Factors to be Considered for “Same Surgical Procedures” or “hospital Exemptions. Presented to Health Canada’s Cell Therapy Stakeholder Group. Ottawa, ON (2018-Apr)
Opportunities and Risks in Commercializing Regenerative Medicine Technologies in Canada. Presented to the University of Toronto & Canadian Institutes of Health Research’s Training Program in Regenerative Medicine, University Health Network, Toronto, ON (2018-Mar)
Latest Trends in Cell-, Gene- and Regenerative Medicine-Based Commercialization. AUTM 2018 Annual Meeting. Phoenix, Arizona (2018-Feb)
Planning for a Successful Pathway to Adoption. Panel Moderator for Medicine by Design’s 2nd Annual Symposium. Toronto, ON (2017-Dec)
An Overview of Canadian Regulations for Regenerative Medicines. Biomaterials Course Lecture at the University of Waterloo, ON (2017-Nov)
Setting the Stage for Risk-Sharing Models. Workshop Chair at the Risk-Sharing Models to Advance Payer Paradigms for Precision Medicines. Banff, AB (2017-Jun)
Cell Therapy Regulation. Panel presenter for RegMedNet. International Broadcast (2017-Jun)
Full day workshop on Regulatory Affairs. Instructed Course for Summer by Design. Toronto, ON (2017-Jun)
Practical steps towards iPSC Clinical Trial Applications in Canada. Presented to the OIRM Clinical Trial Initiative Workshop. Toronto, ON (2017-Apr)
Personalized Medicine and the Challenges of Getting Therapies into Clinical Trials and Beyond. Presented at StemCellTalks. Toronto, ON (2017-Mar)
Overview of Canadian Regulatory Landscape. Presented at the StemCellNetwork/CCRM funded Workshop on autologous cell therapies. Montreal, QC (2017-Mar)
Strategically Planning for Manufacturing Changes Between Early and Late Clinical Trials. Presented at the Cell & Gene Therapy Revolution: CellCAN’s First Pancanadian Strategic Forum. Montreal, QC (2017-Mar)
Soft Skills Training Workshop in Regulatory Affairs. Course Instructor for NSERC CREATE students. Toronto, ON (2017-Feb)
Innovative Development Strategies for Regenerative Medicines. Presented at the World Stem Cell Summit 2016. West Palm Beach, Florida, USA (2016-Dec)
Strategies for Translation and the Improvement of the Human Condition. Panel Moderator at the World Stem Cell Summit 2016. West Palm Beach, Florida, USA (2016-Dec)
Regulations for Regenerative Medicine Lecture. Presented to the University of Toronto & Canadian Institutes of Health Research’s Training Program in Regenerative Medicine, University Health Network, Toronto, ON (2016, March)
Working to Address Regulatory Challenges in this Emerging Field. Presented to Health Canada's Science Symposium: Stem Cells – From Promise to Product, Ottawa, ON (2016, January).
Health Canada Cell therapy clinical trial guidance experience (consultation report), Presented to European Medicines Association and US Food and Drug Administration, (2015, October).
Academic to Commercial Translation of Clinical Products. Presented to the International Society of Cellular Therapy (ISCT) in Las Vegas, Nevada (2015, May)
International Regulatory Convergence. Presented to the International Society of Cellular Therapy in Las Vegas, Nevada (2015, May).
Health Canada Activities Update. Presented to Cell Therapy Stakeholders Group (at its inaugural meeting), Ottawa, ON (2015, April)
Regulations for Regenerative Medicine Lecture. Presented to the University of Toronto & Canadian Institutes of Health Research’s Training Program in Regenerative Medicine, University Health Network, Toronto, ON (2015, March)
Regulatory Developments for Advanced Therapy Medicinal Products, Presented to the National Institute for Health and Care Excellence / University of Alberta Regenerative Medicine Workshop, London, England (2014, December)
Assessing the Federal Regulator’s Toolbox for “Personalised Medicine”, Presented to Health Canada’s Science Advisory Board, Ottawa, ON (2014, September)
Regulation of Subsequent Entry Biologics: Policy Considerations, Presented to Canadian Agency for Drugs and Technologies in Health in Ottawa, and via Teleconference (2013, May).
Regulations for Regenerative Medicine Lecture. Presented to the University of Toronto & Canadian Institutes of Health Research’s Training Program in Regenerative Medicine, University Health Network, Toronto, ON (2013, April) & (2012, March)
Regulation of Cells, Tissues & Organs in Canada Training Video. Presented for:
-Health Canada’s Regulatory Knowledge Library (2011, November)
-Health Canada’s International Regulatory Forum, Ottawa, ON (2011, October)
Health Canada's Guidance for Subsequent Entry Biologics. Presented to
-American Association of Pharmaceutical Scientists (AAPS), San Francisco, CA (2011, May)
-Health Canada's International Regulatory Forum, Ottawa, ON (2010, October)
-Canadian Society for Pharmaceutical Sciences (CSPS) – Webinar (2010, June)
-4th Annual Regulated Bioanalysis Workshop, Montreal, QC (2010, April).
-Canadian Association of Professional Regulatory Affairs (CAPRA) Montreal, QC (2010, April)
-Canadian Association of Professional Regulatory Affairs (CAPRA) Toronto, ON (2010, April)
Health Canada’s Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). Presented at the 3rd Annual Canadian Summit on Biologics, Toronto, ON (2009, June)
The Role of Ethics in a Regulatory Environment. Presented to Health Canada's Progressive Licensing Project Team, Ottawa, ON (2007, February)
The Disposition of Cryopreserved Embryos that are Abandoned. Presented at Dalhousie University, Halifax, ON (2006, January)
Bedford, P. Orientation to the Canadian Regulatory Context for Regenerative Medicine Developers. Toronto, Ontario: Centre for Commercialization of Regenerative Medicine (2018)
Sullivan, S., et al., Quality control guidelines for clinical-grade human-induced pluripotent stem cell lines. Regenerative Medicine (2018) 10.2217/rme-2018-0095
Bedford, P., Jy, J., Collins, L., Keizer, S. Considering Cell Therapy Product “Good Manufacturing Practice” Status. Frontiers in Medicine. 2018;5:118
Ogbogu, U., et al., "Research on Human Embryos and Reproductive Materials: Revisiting Canadian Law and Policy." Healthcare Policy (2018, 13(3), 10-19).
Bedford, P. Expert Insight: Opportunities in Pricing and Reimbursement. Advanced Therapies Investment Report (2017)
Chisholm, J., von Tigerstrom, B., Bedford, P., Fradette, J., Viswanathan, S. Workshop to address gaps in regulation of minimally manipulated autologous cell therapies for homologous use in Canada. Cytotherapy 2017 Sep 27. pii: S1465-3249(17)30689-8
Master, Z., Bedford, P. CRISPR Gene Editing Should Be Allowed in Canada, but Under What Circumstances? Journal of Obstetrics and Gynaecology Canada October 12, 2017
Knoppers, B.M., Isasi, R., Caulfield, T., Kleiderman, E., Bedford, P., Illes, J., Ogbogu, U., Ravitsky, V., Rudnicki, M. Human Gene Editing: Revisiting Canadian Policy. NPJ: Regenerative Medicine 2017 (2:3)
Lipsitz, Y., Bedford, P., Davies, A.H., Timmins, N.E., Zandstra, P.W. Achieving Efficient Manufacturing and Quality Assurance through Synthetic Cell Therapy Design. Cell Stem Cell. 2017(20)
Agnes V Klein, Jian Wang, Patrick Bedford. Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses. Generics and Biosimilars Initiative (GaBi) Journal: 2014 (3:3)
Bedford, P., Gillham-Eisen, LA. International Regulatory Perspectives: Degree of Regulatory Oversight for Eight Categories of Cell Therapy Products. International Pharmaceutical Regulator’s Forum – Cell Therapy Group. (2013, April)
Savoie, N., et al., White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance. Bioanalysis (2010, 2(12), 1945-1960)
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