Tuesday 10th March - Main Conference Day One - PT (Pacific Time, GMT-08:00)
- Dong Seong Cho - Technical Development Associate Scientist, Genentech
- Kathryn Beal - Principal Scientist: Process Development, Pfizer, Inc.
- Neil McCracken, Ph.D - Principal Research Scientist, Upstream Process Development Group Leader, Elanco Animal Health
Case studies detailing how companies leveraged standardized platforms, early risk assessments, and digital knowledge management to ensure seamless tech transfer across global manufacturing sites, aligning with supply chain planning and regulatory expectations.
Case studies on optimizing purification processes to manage high upstream titers, including new capture methods, improved resins, and process adjustments to maintain product quality.
A high-level overview of CGT market trends, manufacturing challenges, and regulatory updates, providing context for the technical discussions that follow.
Presentations on how biomanufacturers have strengthened raw material and single-use supply chains post-COVID-19, through supplier diversification, inventory management, and digital tools for real-time visibility and risk mitigation.
Case studies on scaling allogeneic (off-the-shelf) cell therapies from lab to commercial scale, with emphasis on process modeling, automation, and strategies to reduce cost of goods
A forward-looking discussion on how manufacturing innovation, digitalization, and improved supply chains can expand patient access and to viable business cases.
- Mahesh Bule - Associate Director, Kite Pharma a Gilead Company
- Zheng Zhang - Head of Cell Line Development, BeiGene
- Lianchun Fan, Ph D. - Research Fellow, Head of Cellular & Molecular Biology Science, Biologics Development Launch, Abbvie Bioresearch Center
Industry and regulatory experts will address how CLD can be designed to anticipate lifecycle changes, comparability, and commercial scalability, with emphasis on drug substance and drug product integration.
- Prasad Pathange - Senior Manager, Bayer U.S.
Intensified/Continuous? This panel will move beyond the “which is better” debate to address how leading companies evaluate and select the right upstream strategy across their portfolios. Experts will share case studies and business studies on decision-making frameworks, considering factors such as molecule type, clinical phase, cost of goods, regulatory expectations, facility readiness, and long-term scalability. Discussions will also explore the role of modeling, digital twins, and AI-driven analytics in simulating productivity and risk trade-offs between fed-batch, intensified, and fully continuous processes.
Presentations on retrofitting legacy facilities for gene therapies, mRNA vaccines, and other advanced modalities, with emphasis on modular designs, single-use systems, and digital infrastructure to enable multiproduct flexibility.
- Dimple Chavan - Senior Scientist, AstraZeneca
Case studies highlighting analytical and QC strategies for CGT products, including rapid potency testing, impurity monitoring, and chain-of-identity management for autologous therapies.
A comparative panel on the unique manufacturing, supply chain, and scalability challenges of autologous vs. allogeneic approaches, with emphasis on future trends and digital tools for decision-making.