Session 2: CMC Strategy Supporting Cell & Gene Therapy Translation From Concept to Clinical Products and Beyond
November 27, 2023
Speakers:
Patrick Bedford, M.Sc., RA, Managing Director, weCANreg Consulting Group Inc.
Patrick is an experienced leader and certified regulatory professional focused on translating cell & gene therapies. He is the Founder & Managing Director of weCANreg Consulting Group, Inc, which provides regulatory strategy, interaction, and submission services. weCANreg is growing the weCANtranslate Network with additional Partners to offer integrated technical expertise to early-stage companies. The weCANtranslate Network will continue to help dozens of global cell & gene therapy companies develop and grow in Canada each year.
Patrick previously developed consulting services for a Canadian Network Centre of Excellence; planned 2 Canadian CAR-T New Drug Submissions; supported an early-stage CRISPR gene engineering venture; and led teams at Health Canada responsible for developing guidance for biosimilars, transplant material, and cell & gene therapies. While leading Health Canada’s regulatory policy initiatives, Patrick also supported Health Canada’s Classification Committees and championed international harmonization initiatives.
In his spare time, Patrick regularly advises emerging businesses through Creative Destruction Labs; trains Canadian researchers, technicians, and entrepreneurs; lectures at 10+ Canadian Universities; helps to shape Canadian & US regulatory policies; and presents at multiple conferences, workshops, and training programs. He completed an Honours Bachelor of Health Sciences degree at the University of Western Ontario (2003), a Master’s degree in Bioethics and Health Law at the University of Otago (2005), a Regulatory Affairs Certificate from the Regulatory Affairs Professional Society (2016), a training program in Cost Effectiveness Modelling from the University of Alberta (2017), and expects to complete his Masters of Business Administration in 2023.
Panos Chrysanthopoulos, Ph.D., Co-Founder and Director, weCANdev Consulting Group Inc., Chief Development Officer, Morphocell Technologies
Panos is an accomplished leader in Cell Therapeutic Product Development, with a PhD in Biomedical Engineering from The University of Queensland. With an extensive research background in Systems Biology dating back to 2005, he brings a deep understanding of advanced technologies to the forefront of therapeutic innovation. His expertise lies in the development of cutting-edge cell and gene therapies, translating early-stage discoveries into clinically relevant manufacturing processes and analytics. With a strong focus on Systems Biology and Quality by Design (QbD) principles, he has successfully built robust CMC strategies for comprehensive PSC-derived and CAR-T cell therapies. Dedicated to fostering a culture of continuous improvement, Panos takes great pride in his experience of building and leading world-class process and analytical development teams, instilling the principles of excellence and innovation. In his role, he leads the Company's product development efforts and oversees Technical Operations, ensuring a scalable and sustainable product pipeline.
Calley Hirsch, Ph.D., Principal Consultant, weCANdev Consulting Group Inc.
Calley is the co-founder and director of the weCANdev Consulting Group, Inc., a partner of the weCANtranslate Network. Holding 17+ years of international experience, she is a specialist in cell and gene therapy product development with a Ph.D. in Biochemistry from the University of Saskatchewan. Demonstrating a deep understanding in stem cell biology, gene engineering, lean process and analytical development, advanced technologies, and integrated CMC strategies she has advanced numerous stem cell-derived and primary cell therapies to the clinic during her appointments at CCRM, BlueRock Therapeutics, Artisan Bio, and weCANdev. Driven by her learnings and passion for innovation, Calley is highly committed to building and developing world-class products, infrastructure, and teams to support a sustainable cell and gene therapy ecosystem.