April 24, 2019
Supply chain management readiness, Part 1: strategy
There are many critical decisions to be made when moving a large-molecule biologic out of the lab into human trials. Who will manufacture the therapy? What clinical partners will you work with? How will you establish and train your partners on your particular clinical protocol and product(s)? How will you transport your raw materials, intermediates, and final product between locations? And of extra importance in cell and gene therapy and really any personalized therapy — how will you ensure the right therapy gets to the right patient?
Before any of those questions can be tackled head-on, however, it is critical that your team have a solid strategic foundation. These fundamentals will help.
- Does your current team have the necessary members?
Personalized therapies require a team of specialized experts in multiple disciplines. Successful trials and eventual commercialization depend on establishing these roles with specific personalized therapy expertise from the beginning:
Cell and gene specific supply chain lead
This leader will need to bring a wealth of knowledge about obtaining, transporting, and delivering the therapeutic product. They will need to understand the world of specialized couriers, and “cold chain” shipping logistics, and product monitoring as well. This expertise will be key as soon as the team looks to move the product out of the bench lab setting and into the clinical trial ecosystem.
Regardless of whether your manufacturing will be done in-house or with a CMO, the manufacturing leader will be a lynchpin for how the product moves through this critical stage of product development. In addition to establishing the best manufacturing model and facility, the manufacturing lead will need to bring expertise in scaling the manufacturing capability quickly so as to stay ahead of enrollment requirements and stay in sync with each personalized product’s individual supply chain.
A key challenge for this leader is establishing a reliable manufacturing process that requires complex raw materials, including human-sourced cells, viral vectors, and other research-grade raw materials, not yet fully ready for industrialization.
Clinical Operations lead
This key individual must leverage relationships with clinical sites to begin developing proper procedures for treatment. They’ll need to be able to qualify clinical sites based on whether each site offers — or could offer — required product handling and treatment capabilities. In cell and gene therapy, those required capabilities often include being able to serve as the kick-off point for manufacturing with the collection of patient starting materials (e.g. cells), and being able to follow GMP procedures.
- Has the leadership team agreed upon the operational goals and roadmap?
This planning step has two component parts: how will the team set up the operations, and how will the team scale the operations.
- When do we want to start enrolling patients? Align on a specific date that is reasonable enough to actually be realistic and achievable, which includes protocol development, regulatory filings/approval and IRB review. Otherwise, the team risks continually changing this date with operational knock-on effects.
- How far in the future can we foresee filing our IND? An ongoing conversation around this will illuminate aspirations around trial pace and supply chain dependencies for success.
- Have we outlined all of the steps in the workflow? This process mapping requires detailed cross-functional collaboration to lay out sufficiently.
- Is the treatment process repeatable and controllable? Will its complexity still be manageable as the trial scales? If not, what parts of the process needs to be changed early?
- Is the end-to-end product journey efficient and reliable enough to support high success rates for each manufactured product?
- How can Technical Operations ensure that capacity is available throughout the workflow as needed? Confirm that essential elements — including raw materials and any subsequent staging for allogeneic therapies and personalized cancer vaccines — are in a state of “always ready.”
- Have outsourcing decisions been made?
Each internal functional team needs to align on what activities their team will handle in-house, and which parts of the process can be handled by external partners.
Does your team plan to build its own manufacturing capability? Or will your team work with a CMO? There are pros and cons to setting up your own GMP facility and working with an established facility. This trade off conversation is key for early alignment — and for your product process workflows — they will change over time with stage of development and patient volume.
Will your team work with a CRO? If so, which functions will your CRO handle, and will these include any part of the supply chain coordination and clinical site interactions (including training)? If so, which software systems will your CRO use on your behalf?
Several systems will be necessary for seamless operations. Of all your systems needs, which will the IT team have the expertise and available bandwidth to build? Where can you leverage existing off-the-shelf software excellence to move your trial as quickly and effectively as possible?
At Vineti, we support our partners in thinking through these types of questions every day. Intentionally prioritizing this strategic alignment early will save your team significant time and cost later. This post is the first of a four-part series on supply chain planning, with more tips coming soon. You can also find Vineti’s Supply Chain Readiness Checklist here.
Marc Puich has extensive experience in pharmaceutical manufacturing systems 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.