The success of developing a cellular therapy rests on the ability to deliver a viable, potent product. This positive end-result is directly attributable to the strategy in place and the supporting processes. A reliable cell therapy development strategy is imperative to ensuring your therapeutic materials remain viable from the point of collection, through manufacture, to the final clinical site delivery.
This webinar will review some of the key components to consider when developing your strategy to minimize risk, manage cost, and ultimately deliver a product to market.
Key Learning Objectives:
- Minimizing variability through the use of collection and administration kits and SOPs
- Understanding the importance of validating process and qualifying equipment as well as data collection early and throughout Study/Phase 1 to commercial
- Leveraging data to maintain cell integrity, improve process, reduce risk, analyze and strengthen weak points
- Maintaining chain of custody and real time communications
- Understanding the importance of tracking and monitoring to ensure the right patient receives the right material at the right time
- Considering scalability from Day 1
Kristen Franklin, Client Services Manager, Cell Therapy, Fisher BioServices
Kristen Franklin is the Client Services Manager for Cell Therapy projects at Fisher BioServices. In her current role, Kristen manages a team of Project Managers who interact with clients to provide logistic and strategic support for cell therapy clinical trials, as well as commercialization operations. Kristen’s background is in process development and manufacturing of biologics, as well as project management. She holds a Master’s degree from the University of Maryland in Biotechnology Management.
Amy Hendricks, Project Manager, Fisher Bioservices
Amy Brankin is a Global Project Lead for key cell therapy clients who are currently moving into the commercial space. She has a Masters in Science and Public Health in Epidemiology. Her previous experiences include development of and managing clinical trials and field studies at the NIH, Johns Hopkins, World Bank and Washington University.
Who Should Attend?
Cell therapy developers in mid to late stage clinical trials looking ahead to commercialization
As the leading service provider to the cell and gene therapy community, Fisher BioServices is uniquely positioned with the experience, resources, and global expertise to support our customers on their path towards commercialization. Our global infrastructure enables customers to seamlessly conduct clinical trials across multiple geographies while providing patients around the world with access to life changing therapies. Our cryogenic storage and logistics, combined with proven components and validated procedures, allow us to configure and replicate each site to meet the specific requirements of individual clinical trials with minimal variation, regardless of volume or geographic location. This is supported by a global comprehensive and integrated Quality System based on regulatory requirements, industry best practices and trained personnel. Fisher BioServices can help you navigate many of the unforeseen challenges associated with cell therapy clinical development and commercialization. To learn more, visit www.fisherbioservices.com.
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