By Sanjin Zvonic, PhD, Director, Technology & Business Development
The Future is Now
In the future, physicians will write prescriptions for manufactured engineered cell therapeutics, as they do now for prescription medications. However, unlike pharmaceuticals, cell therapy products (CTPs) require geographically dispersed networks of cell/tissue collection, engineering, manufacture, distribution, and clinical treatment facilities.
The Challenges of Cell Therapy Development
Throughout the course of cell therapy commercialization, the developers are faced with many challenges, including:
- Converting great science into therapy
- Integrating product characterization
- Establishing and maintaining comparability
- Designing and supporting clinical trials
- Optimizing economics, manufacturing capacities and distribution logistics
- Managing the evolving regulatory framework
- Developing and strengthening the developer’s IP position
Further, cell therapy developers are confronted by unanticipated commercialization obstacles as they move towards their goal. We believe the top 5 obstacles are:
- Patient accrual rate for clinical trials
- Market acceptance and penetration
- Source material collection and product “delivery” to patients
- Staffing and staff training
- Reimbursement
Develop with Commercialization in Mind
The best way to address these obstacles is to develop cell therapeutics with commercialization in mind. What does this mean? At each step throughout the course of development, the product manufacturing, control, and logistics resources need to be streamlined and utilized in an incrementally more efficient manner to arrive at the true commercial economy of scale needed for the product marketplace acceptance and penetration.
Gaining Efficacy of Scale
Underlying this ramp up is a resource shift during commercialization as resources are moved from clinical development to manufacturing and delivery infrastructure.
Resource Shift During Commercialization