The supply chain that exists for traditional pharmaceuticals is woefully insufficient for regenerative medicine, according to Robert Lechich, principal manufacturing and supply chain consultant for Global OT/IT – Quality Services. The new supply chain model must be far more flexible and aligned more tightly to the product than the traditional pharmaceutical supply chain.
The reason, he explained during an Xconomy webinar, is based on the very nature of regenerative products. Whereas traditional pharmaceuticals are made in batches that may supply tens of thousands of doses and are shipped globally through distributors, regenerative therapies – including cell, gene and tissue products – are made very close to the patient. Manufacturing, therefore, is performed and small scale. It’s often laboratory oriented. The products are frequently made-to-order, and distribution for many products means taking them directly to a treatment facility.
Because of these differences, “regenerative medicine developers need a robust supply chain to ensure that any variations with the demand and supply will have minimal impact on the availability of the product at point of care,” Lechich said.
Supply chain digitization provides that.
Digitization is more than converting analog data into digital or data into information, he explained. It is, to quote the Gartner Group, “the use of digital technologies to change a business model and provide new revenue and value-producing opportunities.”
The regenerative medicine supply chain is a natural candidate.
“For regenerative medicine, the supply chain really is an ecosystem,” Lechich said, and it’s more than being part of the traditional supply chain. “We often see small clinical companies develop a product, without having manufacturing or supply chain capabilities. Other ecosystem members are experts at manufacturing but need logistics help. There’s a mutual dependence.”
In such an interdependent ecosystem, trust is paramount yet, he said, trust is the biggest element missing from the current ecosystem.
“This is the least tangible thing that people want to hear, but they must build relationships of trust,” Lechich said. “You have to have each other’s backs to make each other successful. You can talk about contracts and agreements, but you ultimately must be comfortable with the organizations you deal with. Trust takes a lot of effort and doesn’t happen off the bat, but trust is a really big piece of the picture. It’s the number one thing.”
The more tangible items are easier to address, however. First, he recommended rethinking business processes to determine which are needed and which should be reengineered, determining how the governance model should operate across the supply chain, and identifying ways to apply lean concepts to reduce waste across the supply chain.
The benefits include:
- Enhanced visibility to mitigate risks and enhance efficiency
- Improved, near-real-time, demand forecasting
- More collaborative business practices
- Better Track and Trace capabilities
- Predictive intelligence and analytics
- Actionable insights
- Timely decision-making
- Flexibility and agility for customers, partners and suppliers
“It’s never too early to think about the supply chain,” Lechich said.
Plan and develop it as early as possible, with new potential business models in mind. A robust supply chain must be attuned to product variations that are inherent in autologous and, especially, allogeneic products. This includes not just variations in product output and the product itself, but for allogeneic products, changes in patients’ schedules that affect the manufacturing process.
Such agility should accommodate new and evolving roles for the players, too. For example, initially, therapeutics may be made by a contract manufacturing organization (CMO), but once the product is commercialized, the CMO may transfer the process to other facilities or the developer may bring manufacturing in-house. Therefore, a tech transfer process must be considered early.
“It’s never too early to talk about the supply chain,” Lechich said. “Think early about bringing on partners, changing them, and sharing information with them. Understand that there always will be variations, so strive to minimize them.”
One example is as simple as storing an inventory of product containers at manufacturing centers so they’re less vulnerable to shipping disruptions, like those caused by the current pandemic or natural disasters.
Lechich also advised developers to leverage technological applications.
“We need more analytics,” he said.
Analytics applications are mature and, with artificial intelligence (AI), can be mined for better understanding of the patients and the process, thus enabling predictive analytics. The same technology can be used to understand process variability on the factory floor.
Developing an information portal from mobile devices to the factory floor provides important perspective. When the portal is vendor-neutral and integrated throughout the supply chain, ecosystem partners can share information that makes the entire supply chain more efficient.
The Internet of Things (IoT) and wearable technologies are part of this. The IoT makes it possible to connect more devices than ever before, and widespread connectivity lets patients share information with manufacturers in novel ways. Yet, more integration is needed.
“Enterprise resource planning (ERP) applications typically are single-company based, but I propose they become inter-organizational,” Lechich said.
Supply chain-wide integration, he explained, would allow “apheresis equipment to message a manufacturing site to plan a patient order, organizations to use RFID technology to generate incontrovertible chain of custody documentation. It could support automated manufacturing to generate electronic batch records and labeling, and create a shared information repository for donor collection centers, transfusion centers, patient and hospital information centers and manufacturing and logistics operations.
“This is very different from the supply chain today, and is very challenging,” he continued, “but this is where we need to get to.”