Project purpose
Pharma.Aero concluded a Cell & Gene Therapies project in 2023 to document the logistic challenges that are specific to advanced therapy medicinal products (ATMP).
Now, as part of a larger, multi-level initiative, Pharma.Aero aims to strengthen the desk research findings with a hands-on project that adds test data. In addition, due to their novelty and relative lack of available research, radioligand therapies (RLT) are included within the scope of this project.
The test shipments will demonstrate the practical implementation and obstacles in a real-world environment which is of high value for both the industry and logistic stakeholders and will support them in making strategic decisions for their future business models.
The Precision Therapy Logistics project helps shape the delivery strategy for highly critical and valuable medicinal products.
The project covers in this phase:
- Precision therapies in the form of ATMPs (gene therapy, cell therapy, tissue engineering and combined ATMP) and RLTs
- Desk research and interviews
- Framework for optimal lane design
- A total of 5 – 10 test shipments spread over the EU and US
- Report and presentation detailing test shipment findings
Project objective(s)
The project objectives are to:
- Understand different ATMP and RLT classes and their logistics considerations
- Set up and perform test shipments covering identified product classes
- Collect and analyse data from test shipments, and present findings to the broader community
Project status and key-takeaways
The project commenced by understanding the different logistics requirements of each product class, to thereafter perform test shipments. It follows a stepwise approach as detailed below:
1. Desk Research – completed
Define ATMPs, RLTs and their classes according to regulatory standards
Map the logistics journey and requirements for the different classes if generally known/available
2. Interviews – completed
List companies developing precision therapies via a survey and perform interviews
Understand precision therapies they produce and their logistics parameters
3. Gap Analysis – completed
List all therapy categories and the identified companies along with logistics parameters
Determine which classes should be further included in the test shipments based on availability, relevance and feasibility
- PTL Workshop on Day 2 of the Pharma Logistics Masterclass, Dallas Fort Worth, October 1st
4. Parameter Mapping – ongoing
Map all parameters that should be considered for the setup of the lane validation
Cluster classes based on parameters with the highest impact
5. Lane Validation Design – ongoing
Based on the parameters, design the most optimal lane while accounting for external influences
Define the steps, type of partners and material required
Work closely with Pharma.Aero and partners to establish design
6. Test Shipments
Ensure that a clear protocol is designed and that all parties are trained
Conduct test shipments and monitor performance
Project support and collaboration
🔹Pharma.Aero Board liaison: Brussels Airport
🔹Project leads: Brussels Airport, Dallas Fort Worth Airport, Novartis
🔹Project manager and expert team: Nassim Benhamou, An D’hondt, Morgane Franck & Kevin Missault, PWC