Regulators' strategies for managing the surge in cell and gene therapies

Featuring:Jacki Jenuth, PhD, Partner and COO, Lumira VenturesRobin Quirk, PhD MBA, Vice President, Technology Sourcing and Venture Development, CCRM***In this episode, we explore the dynamics of venture capital (VC) and company creation with Jacki Jenuth, Partner and COO, Lumira Ventures, and Robin Quirk, Vice President, Technology Sourcing and Venture Development, CCRM. The conversation covers the essence of venture capital funding, from how VCs evaluate investment potential to crucial considerations for founders who are attracting investment during product development. We also discuss red flags and common pitfalls for founders seeking funding along with the current enthusiasm among VCs for investing in cell and gene therapies. Our guests explain the strategy of bundling technologies to create stronger companies. The episode concludes with a glimpse into exciting projects and investments in the cell and gene therapy space, highlighting the ongoing innovation and opportunities in this field. Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.

Featuring:Michael Rosu-Myles, PhD, Executive Director, Health CanadaJosephine Lembong, PhD, Senior Manager, Science and Industry Affairs, Alliance for Regenerative Medicine***Currently, there are more than 2,000 cell and gene therapies in clinical trials worldwide. With a goal of ensuring that safe and quality products are approved for use by patients, regulators determine whether these innovative therapies move from the lab to market.In this interview, Michael Rosu-Myles, PhD, Executive Director, Health Canada, and Josephine Lembong, PhD, Senior Manager, Science and Industry Affairs, Alliance for Regenerative Medicine, provide listeners with an exclusive look at how regulators are preparing for an increased number of applications for cell and gene therapy products in the years to come. Our guests discuss how Health Canada, the U.S. Food and Drug Administration and European Medicines Agency have created new regulatory frameworks and offices to enhance their ability to review cell and gene therapy submissions. Listeners will learn how companies that are planning a submission can prepare to work successfully with regulators, whether regulators consider the potential price tags of these therapies, and how patients benefit from regulators’ work. Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.

Featuring:Sonia Sennik, Executive Director, Creative Destruction LabGlenn MacLean, Director, Technology Sourcing and Venture Development, CCRM***In many science-oriented fields, including regenerative medicine and advanced therapies, researchers and company founders often require additional support and expertise to successfully commercialize their discoveries. With a mission of enhancing the commercialization of science for the betterment of humankind, Creative Destruction Lab is a valuable resource for start-up founders to  help de-risk their business and maximize their probability of success. Its Advanced Therapies stream supports founders solving biological, medical and healthcare problems using innovative applications of cell and gene therapies, and other biological products. In this interview, Sonia Sennik, Executive Director, Creative Destruction Lab, and Glenn MacLean, Director, Technology Sourcing and Venture Development, CCRM, discuss how Creative Destruction Lab’s processes and mentors can help drive a discovery to the market. Our guests explain the practical steps and tactics, and also discuss the program’s potential future impact on Canada’s regenerative medicine and advanced therapies sector.Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.

Featuring:Matthew Durdy, Chief Executive Officer, Cell and Gene Therapy CatapultMichael May, PhD, President and Chief Executive Officer, CCRM***Public-private partnerships are collaborations between government agencies and private-sector companies. In this interview, Matthew Durdy, CEO, Cell and Gene Therapy Catapult, and Michael May, President and CEO, CCRM, explain how these collaborations have had an impact in the regenerative medicine sector by advancing cell and gene therapies along the commercialization pathway. Our guests share highlights from their organizations, including the types of partners they have worked with, and the infrastructure and facilities they have helped to create. The interview concludes with a discussion of how public-private partnerships will benefit patients in the future by improving the factors that lead to market access and adoption, such as developing markets, promoting acceptability, reducing the cost of goods, and enabling the supply chain.Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.

Featuring:Matthew Miller, B.M.Sc., PhD, Director, Michael G. DeGroote Institute for Infectious Disease Research; Co-Director, Canadian Pandemic Preparedness Hub (CP2H), McMaster University Patrycja Thompson, PhD, Director, Strategy & Operations, the Canadian Hub for Health Intelligence & Innovation in Infectious Diseases (HI3), University of Toronto***The COVID-19 pandemic illuminated a need to scale up Canada’s biomanufacturing capacity. As a response, the Government of Canada established new research and innovation hubs at five Canadian universities. These hubs aim to combine the strengths of academia, industry, and the public and not-for-profit sectors to jointly improve pandemic readiness and enhance the nation’s biomanufacturing and life sciences[SJ1] .In this episode, we explore two of the five hubs. Matthew Miller, B.M.Sc., PhD, speaks to the Canadian Pandemic Preparedness Hub, led by the University of Ottawa and McMaster University, while Patrycja Thompson, PhD, covers the Canadian Hub for Health Intelligence & Innovation in Infectious Diseases, led by the University of Toronto. As our guests discuss how these multidisciplinary research hubs are accelerating the research and development of next-generation vaccines and therapeutics, including cell and gene therapies, listeners will also learn how they support training and development to expand the pipeline of skilled talent. Plus, hear what our guests are excited about as they look to the future of the hubs program and the field as a whole.Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.

Featuring:Mamatha Bhat MD, MSc, PhD, FRCPCHepatologist & Co-Lead of Transplant AI initiative (TAI), Ajmera Transplant Program Scientist, Toronto General Hospital Research Institute, University Health NetworkAssociate Professor, Division of Gastroenterology & HepatologyDirector, Clinician-Scientist Training Program (CSTP), Department of Medicine, University of TorontoPartnerships & Engagement Lead, Temerty Centre for AI in Research & Education in Medicine (T-CAIREM); Faculty Affiliate, VectorJulie Audet, PhD, PEng, Professor Biomedical Engineering, University of Toronto *** Although artificial intelligence (AI) is a hot topic right now, many professionals working in the regenerative medicine field may not be aware of how it is already being used to support cell and gene therapies. In this episode, Mamatha Bhat MD, PhD, FRCPC, and Julie Audet, PhD, PEng, discuss the ways that AI is being used in the life sciences and health care field, as well as in their work. Additionally, our guests highlight some positive and promising research findings that reveal how AI can be used in the regenerative medicine field, and how AI can support the manufacturing of cell and gene therapies. And addressing the concern we all have, our guests consider the possible impacts of AI on jobs in the regenerative medicine field, as well as the potential effects of AI on living therapies more broadly. Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.

Featuring:Tom Whitehead, Co-Founder, Emily Whitehead Foundation. Courtney Horvath, PhD, Global Head of Strategy, Planning & Operations, Translational Medicine, Novartis. In this episode, we hear from two parents who supported their children through cancer treatments. Listeners will hear their unflinching accounts of what the children went through, underlining the urgent need for access to innovative and less toxic treatments.Tom is the co-founder of the Emily Whitehead Foundation, named after his daughter Emily, who was the first child in the world to have her immune system trained to beat cancer through a CAR T-cell clinical trial. Since this experience, Tom and his family have dedicated themselves to paying it forward and helping other families achieve the same outcomes.Dr. Horvath’s son, Colby, was diagnosed with low-risk lymphoma at eight years old. Doctors advised that there was a 90 per cent chance of a cure if Colby underwent frontline treatment, which consisted of two-and-a-half years of intensive chemotherapy. As a toxicologist, Dr. Horvath admits that she had difficulty accepting the level of toxicity associated with this treatment regimen. She has become a tireless advocate in the pharmaceutical community about what the current standard of care means for children with cancer. Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.

Featuring:Dr. Joerg Krueger, Medical Director, CAR T-Cell Program, The Hospital for Sick Children. Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania Perelman School of Medicine.Our guests discuss the future of CAR T-cell therapies, in a conversation covering autologous and allogeneic CAR T therapies. Drs. Krueger and Levine share their thoughts on which of these two approaches is likely to pull ahead in the years to come, while acknowledging some of the challenges that will need to be overcome for each, including donor-to-donor variability. Also examined are the differences in adult and pediatric treatment options, along with the complexity involved in manufacturing CAR T cells. Recent advances in the area of solid tumours are highlighted, ending on a note that looks to the future of immunotherapy with warranted optimism.Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.

Featuring:Mark Taylor, Director of Commercialization, University Health Network Dr. Irja Elliott Donaghue Technical & IP Specialist and Patent Agent, Notch TherapeuticsIn the past, there was little evidence to challenge the idea that if a therapeutics developer did not hold a patent, it did not have anything to commercialize. In this episode, guests outline how the regenerative medicine industry changed that, proving the belief to be outdated, with some innovation being better protected by developers taking a “trade secrets” approach. Listen to hear guests examine intellectual property and commercialization issues in cell and gene therapies, with discussion of the complexities around the long-running patent battle over CRISPR technology, which has garnered international headlines in the last couple of years. Also discussed is how to protect and publish research, and the importance of having discussions with commercialization teams early in the technology development process.Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.

Featuring:Dr. Dolores Baksh, CEO of TAAV Biomanufacturing SolutionsSusan Nichols, Chief Business Officer at ViroCell BiologicsAs the cell and gene therapy industry continues to grow rapidly, Dolores Baksh and Susan Nichols emphasize the importance of nurturing a new workforce equipped with the skills to pivot and persevere—crucial qualities for the industry to grow. Join our guests as they discuss the significance of mentorship in the cell and gene therapy space, which mentorship programs they recommend, and hear why they feel an obligation to “pay it forward” to the next generation of leaders. The conversation touches on the power of mentorship at any career stage and how mentorship can be mutually beneficial. Ready to be a mentor or mentee? Listen and find out where to start.Thanks for listening to Commercializing Living Therapies with CCRM. Spread the word about this episode by taking a screen cap on your device and posting it to social media using the hashtag #CCRMpodcast. Please leave us a review on your favourite streaming service. Find more episodes at ccrm.ca/podcast.