TrakCel and McKesson to build supply service for late-stage cell therapies
The collaboration agreed between the supply chain management services providers, McKesson and TrakCel, comes after the companies have jointly taken on the market entrance of a T-cell based allogeneic therapeutic product of an undisclosed late-stage biopharmaceutical developer.
The commercial launch of this product, which will be the first ‘off-the-shelf’ product available, is expected in the fourth quarter of 2020, Akshay Peer, VP of sales and account management at TrakCel, told us.
Under the partnership and in order to serve this commercialization, as well as other future product launches, the two companies will develop a combined program, utilizing McKesson’s patient services alongside TrakCel’s data management software platform.
Different supply needs at different stages of development
The special supply chain requirements of personalized treatments, such as cell and gene therapies, are due to the developers need to manage ‘multiple players and organizations’ concurrently, according to Peer.
“This includes different teams within site of care, shipping and logistics, manufacturing and storage,” Peer added.
More specifically, according to TrakCel’s VP, the product journey consists of the below ‘stations’:
- Site of Care: Identifying the patient, confirming benefits verification, enrolling the patient, scheduling collection of starting material in line with manufacturing capacity etc. are essential.
- Logistics: Knowing which site is expecting a pick-up or drop-off when in advance. Ensuring the right product is being shipped to the right location.
- Manufacturing: Ensuring the product is manufactured correctly and shipped to the right patient.
Layne Martin, VP of specialty distribution solutions at McKesson Life Sciences, commented that, as the ‘wave’ of over 900 cell and gene products currently under review by the FDA come to market, supply chain service providers “can begin to offer some standards to improve outcomes.”
As the products evolve to the latest stages of development, “a number of processes including patient scheduling and care have to be mapped,” said Peer, adding that the case management teams that are in-charge of communicating with the patient and healthcare professionals need a ‘dashboard view’ of the entire lifecycle development of the therapy.
Forethought to answer these needs
According to the companies, the integrated platform is expected to enable the scale-up of products towards market delivery, for the increasing number of developers approaching the commercial launch of cell and gene therapies.
The platform will include automatic scheduling of product-specific workflows across multiple supply chain partners and care team members, and validated chain-of-identity tracking to guarantee correct drug product delivery. “These capabilities ensure that the patient receives the correct, uncompromised treatment at the right time,” McKesson stated.
Therefore, the integrated suite which will result from the collaboration is expected to provide a ‘control tower’ view of the product distribution.