Supply chain readiness, Part 2: operational ecosystem
by Marc Puich | May 15, 2019
(Note: this post is the second part of a four-part series on supply chain planning for personalized therapies such as cell and gene therapies or cancer vaccines. You can find Part 1 here.)
You've got strategic readiness for your personalized therapy supply chain in place. Now, you have some manor decisions to make about how to stand up the infrastructure your therapy will rely on, specifically how your therapy moves between the various entities required for production and delivery.
This ecosystem that your product will reside in is diverse in terms of its participants and geography, and you need to provide critical air-traffic control to keep it all moving effectively. As my colleague Heidi Hagen emphasized in her post last week, "Commercial lessons for clinical-phase success, Part 1: it all starts with collaboration," effective collaboration among all your supply chain participants will become a primary make-or-break factor in your therapy's success, both in early-phase development and as the treatment volume scales.
Here are the participants that typically need support and orchestration:
1. Patient material collection sites
Since medical centers are the key access points to patients receiving your cell and gene therapies, the selection of your clincial site partners will require a good fit between your therapy and hospitals' capabilities. Many sponsors start by focusing on a small set of hospitals if patient enrollment volumes can be met that way. If it can't, however, you may need to cast a wide net, including looking for ways to connect with patients internationally, even in early phases. It is critical to identify how many sites will be needed, where the sites will be located, and what resources already exist at those sites to support the therapy's workflow.
In most cases, the prescribing physician and the care coordinators often represent different participants than the collection process itself comprised of apheresis staff (for blood-based products) and / or surgical teams (for solid sample-based products). This means that even with a particular medical center - and frequently the medical center and collection center are different entities all together - multiple departments and users will be engaged in the process at various steps in varied locations.
The essential question of manufacturing strategy affects your supply chain planning as well. Here are some key areas to consider:
- Contract manufacturing or in-house? Both options require supply chain integration, as well as traceability throughout the manufacturing process. Some Contract Manufacturing Organizations (CMO) have pre-built integrations to existing supply chain solutions.
- Single-site or multiple-site manufacturing? Each option has unique supply chain considerations. For single-site manufacturing, your supply chain operations must be optimized to succeed at your chosen manufacturing location. For multiple-site manufacturing, you'll need proven supply chain flexibility to pivot reliably between locations, sometimes with erlatively short notice . Multiple sites also requires constant tracking for comparability of production at the sites.
- Single region or global? Sometimes, reaching all available trial subjects or patients means going global earlier than anticipated. Global operations require a corresponding extension in supply chain operations, including the potential of new regulatory, distribution, and language requirements
3. Third-party logistics
How will each personalized drug product move amongst the various stakeholder locations, from collection sites to inventory and manufacturing to infusion site? In almost all cases - outside of smaller academic R&D centers - a successful product journey requires highly controlled transportation services. Setting up the right partnership with specialized couriers and shippers is essential for effective supply chain operations. As with CMOs, some logistics providers offer pre-existing integrations to supply chain solutions such as Vineti.
4. Storage sites
Your treatment may require storage, which acts as an intermediate depot within the workflow. This represents an important step in your supply chain management:
- lnventory: After manufacturing, will you have final drug products that will be housed in inventory? If so, where is this inventory located, and under what conditions must the products be held? How accessible will the inventory locations be to the treatment locations? How will your supply chain operations support this process step smoothly?
- Depot: Will your treatment sites (such as infusion centers) have storage to maintain your therapy in the required condition for a sufficiently long period of time? Will you need the depot to defrost the therapy before final delivery to infusion sites without this ability? Many treatment sites may not have these capabilities for advanced therapies. If not, your drug product process may require a partnership with a depot that can hold the product until the patient is available for treatment. Your supply chain operations will need to provide support here as well.
- Technology: Key systems will make your ecosystem work. Standing up your digital ecosystem early will be a significant factor in the success of real world process optimization. Here are some solutions to consider along the spectrum of clinical maturing, in order of optimal implementation.
For an overview of this Supply Chain Readiness series, you can download a copy of Vineti's Supply Chain Readiness Checklist.
Marc Puich has extensive experience in pharmaceutical manufacturing systesm and cell therapy workflows, and is Vice President of Business Development at Vineti. If you'd like to see how Vineti's Personalized Therapy Management (PTM) platform can help you solve your advanced therapy supply chain and workflow challenges, please contact us to schedule a demo.