Author: Jonathan Wofford, General Manager of WellSky’s Biotherapies Division
As operations for cell and gene therapy programs become more demanding and supply chain management becomes more complex, your program may face various challenges adapting to these changes. For example, increasing manufacturing and procedure volumes in combination with new and changing protocols will require the use of more automated, flexible and efficient processes. Tightening regulations will require greater documentation and process control. As cell and gene therapies continue to grow in clinical application, payers, study sponsors, and other agencies will require more data and reporting.
Many programs suffer from siloed, paper-based workflows and data fragmentation across collection, manufacturing, and treatment processes. This makes adapting to changes in a rapidly growing industry even more challenging. This tip sheet outlines five strategies that can help your program succeed in the fast-changing industry of cell and gene therapies.
1. Establish flexibility
As organizations manage standard therapies plus more novel therapies, many of which may be in a research or development phase, flexibility in process is key. The software running your manufacturing or clinical operations must be able to adapt to process changes as they occur. Successful change management occurs when your entire organization runs on a single technology platform, so that innovations carry through seamlessly across your organization.
In particular, you will need to adapt quickly to changing business models. An organization that initially focused on cord blood or tissue banking may move into CAR-T therapies. Many organizations are exploring a move from autologous to allogeneic therapies. The solution must be able to accommodate these changes in business operations without requiring new modules or system upgrades.
2. Automate complex manufacturing protocols
The increasing variety of cell therapy programs, trials, and protocols creates significant variability in processes. The ability to harmonize manufacturing workflows across your organization requires a data management system that can:
• Manage prescribed variabilities
• Apply conditional logic
• Automate simple and complex calculations
• Support electronic signatures
• Identify out-of-process deviations, such as out-ofspecification results and rejected lots
• Track investigations
• Send in-process alerts and automated reports based on rules in each manufacturing protocol
Each organization has its own unique requirements that your software will need to meet.
3. Optimize supply chain management
The typical process for a gene or cell therapy program involves a collection site, manufacturing – either internal or a contract manufacturing organization, and the clinical program treating the patient. Nearly every successful transplant represents the cumulative effort of multiple departments or organizations. Yet most organizations only pay attention to what happens within their four walls. It is now increasingly important, both operationally and from a regulatory compliance perspective, to establish visibility and connectivity across the supply chain.
This involves both the physical flow of manufactured products and the information flow of all the data associated with the transplant or procedure.
Software supporting these programs must securely manage the inclusion of all entities involved in the chain while ensuring and maintaining proper product identification. The system not only needs to maintain chain of custody throughout the process, it also needs to be able to manage the coordination of each part of the process, and the scheduling of each element (for example, equipment, people, materials, etc.) involved in each phase.
4. Gain competitive insights through improved analytics
With cell and gene therapies, various analytical methods can be used to assess critical quality attributes during development and manufacturing. These include measures such as identity, potency, purity, safety, and stability of the product. Methods used here can be complex and non-standardized. An effective software solution must support on-demand reporting and analytics to allow clients to use their data as needed to support manufacturing operations, research, and outcomes analysis.
Today a number of visual analytics tools make it possible for programs to see and share their data in new ways, to identify opportunities to enhance efficiency, yields, outcomes, data quality and more.
5. Collaborate with the broader healthcare system
As the number of stakeholders involved in gene and cell therapy programs continues to grow, your organization must be able to share data effectively with health systems, payers, pharmaceutical companies, accreditors, peer review panels, and more. In short, you will need a system that is interoperable.
The underlying platforms that enable the features and functions described in this guide must also be optimized for performance and usability. Many solutions may promise the same key features, but it’s important to investigate performance and configurability as well as interoperability.
Many cell therapy companies are thriving in today’s market where demand for transplants exceeds the supply. This will change as heightened competition and regulation place new demands on your organization. That’s why now is the time to open up siloed data, automate manual processes, and streamline your supply chain.
Successful organizations will be nimble enough to stay ahead of an industry that is changing at breakneck pace. Now is the best time to adopt these five strategies that will determine your success in the market.
About the Author
Jonathan Wofford has an extensive background in the fields of hematopoietic cell transplant and cellular therapy, applying statistical theory to evaluate the safety, purity and potency of these therapies. Prior to joining WellSky, he spent over a decade as the bioinformatics lead for Cardinal Glennon Children’s Medical Center, The St. Louis Cord Blood Bank and was a member of the transplant committee for St. Louis University Medical Center.
As novel cell and gene therapies continue to expand, you need a solution that can manage the complete product development process from discovery and development through pre-clinical and clinical research, through post-market safety monitoring. WellSky Biotherapies allows you to build workflows and manufacturing procedures to effectively manage autologous and allogeneic protocols. It expands your ability to centralize and share data through a single system while decreasing batch review, approval, and release times, accelerating understanding of therapeutic outcomes.