Cell and Gene Therapies
Platform Approaches and Technologies
Sunday 3/17/2024, 8:00 -11:00 AM
Gene & cell therapies have gained significant interest and increased momentum in the biopharmaceutical industry as viable and effective treatments for a wide array of diseases. With recent and upcoming clinical readouts and commercial launches, ongoing clinical trials, growing involvement from larger biopharmaceutical companies, increasing industrial collaborations with academia, and formation of new start-ups, the field of gene & cell therapy promises to be a major player and potential game-changer for 21st century medicine. While demonstrating great promise, these therapies are still relatively new to the biopharmaceutical manufacturing industry and require further study to reach the depth of understanding typically associated with established biologic therapeutics. Like what was done 20 years ago for biologics, we are starting to see the emergence of platform processes for gene therapies and viral vectors that hold great promise in improving scalability and reducing time-to-clinic for these groundbreaking therapies. In that spirit, this session calls for abstracts focused on the development and production of Cell Therapies, Gene Therapies and Viral Vectors, with a focus on platform technologies in various phases of development from both academia and industry.
Process Development and Optimization
Monday 3/18/2024, 8:00 -11:00 AM
Cell therapies have demonstrated their efficacy to treat or be curative in oncology and non-oncology applications. Multiple avenues have been explored in the cellular therapy space to increase the potency but also simplify the process of generating cell therapy products, for example CAR-T, TCR-based therapies, and other gene-edited cells such as engineered NKs. This session will encompass various aspects of cell therapy process development including new rapid manufacturing processes in the autologous and iPSC approaches in the allogeneic cell therapy manufacturing space. This would include advances in the isolation, expansion, gene modification, media optimization, process scale up, analytics and characterization of cell-based therapy products. Topics covering the impact of clinical pre-treatments and the cellular heterogeneity of the starting material on drug product potency and some of the control strategies to reduce this impact are invited. Additionally, novel drug products, cryopreservation and delivery strategies for in vivo use along with improved or novel viral vector production systems will be included in this session. Papers relevant to these topics are highly encouraged, including those focusing on novel process improvements, control and optimization strategies, equipment and reagents design and characterization.
Advanced Therapies Medicinal Products
Tuesday 3/19/2024, 8:00 -11:00 AM
Advanced Therapies Medical Products (ATMPs), comprising cell therapy, gene therapy, and tissue engineering, have emerged as powerful tools in the fight against a wide range of diseases. The field of gene & cell therapies especially promises to transform healthcare in the 21st century. This surge of interest has spurred extensive research and development by academic institutions and industry alike, leading to a proliferation of new start-ups and multidisciplinary collaborative efforts. This session invites abstracts that focus on the development and production of cell and gene therapies but not limited to them within the ATMP space. We’re interested in platform technologies in various stages of development, whether they stem from academia, industry, or government. We encourage contributions that discuss challenges and breakthroughs in the field. We also extend the call to works that highlight innovative solutions for scalability and manufacturing