By Erin Harris, Editor-In-Chief, Cell & Gene
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I caught up with Ryan Bartock, Head of Supply Chain and Network Strategy at Spark Therapeutics, to talk through some of the gene therapy sector’s heftiest supply chain challenges. He and I covered a lot of ground, so much so that I’ve created a two-part series for you to easily digest Ryan’s insight. In Part 1, I asked Ryan what advice he has for pharma, bio executives, and CMOs to successfully manage and even streamline the supply chain? Here’s what he had to say.
Start Early — begin planning for predictable, consistent performance often before proof of concept.
Get connected with the clinical and commercial organizations to understand the target product profile and begin developing a lifecycle strategy for products and the emerging portfolio. This will take months, there will be gaps in understanding, but the sooner you get a sense for what must be true for a product to succeed clinically and commercially, the better you can diagnose if the current supply chain is fit-for-purpose and how it will need to scale.
Use supply chain maps and risk assessments to understand the capacity and reliability of your supply base. Because of the small and often academic origin of most gene therapy companies, most of the risk is likely to be concentrated among your raw material, vector manufacturing and analytical supply base. Look across capacity, performance, business continuity and redundancy. This will help you prioritize the areas of highest risk and assess where to form strategic partnerships and/or look for additional and alternative sources of supply.
Effective S&OP processes also need to be established to ensure capacity matches clinical and commercial demand. At Spark Therapeutics, we start the the process with tactical reviews where demand and supply scenarios are focused across a near term window of several months and gradually build up to a multi-year master demand and supply planning window. This ensures that sites can focus their schedules in the near term and leadership can stay aligned on available capacity, budget/workforce planning and capital investments and emerging risks across the short and long term.
Don’t linger in the weeds — a strategic operating model is just as important as tactical management.
Establishing a set of sourcing, allocation and network design principles provides a basis for making strategic decisions for the supply chain. Supply Chain Leaders can check recommendations against these for alignment or to understand where trade-offs are made. Some examples of principles include:
- First intent sites of supply (Materials, Drug Substance, Drug Product & Analytical testing);
- Network design (what will be made internally, externally and capacity utilization targets to guide investment);
- Risk management (principles around inventory, dual and second sourcing).
Involve senior leadership across R&D, Process Development, Manufacturing, Technical Operations and Commercial in an annual Strategic Operating cycle where:
- The roles of Analytical Labs and Supply Sites are clearly defined for the network and revisited;
- Emerging products are allocated across those sites proactively based on process/platform fit & technology strategy;
- Clinical and commercial demand within the 0-5yr planning horizon are aligned with network capacity;
- Constraints are identified and aligned with investment and sourcing strategies;
- Product strategy is reviewed in concert with network and technology strategies and translated to supply sites (both internal and external) to inform on priorities and objectives over the next business cycle.
Be an integrator and an innovator.
Supply Chain Functions exist to make connections between Development, Technical, Manufacturing and Commercial functions, surface their challenges and work together to solve them.
Supply Chain Leaders should encourage their internal Technical Organizations and CMOs to establish Standard Process Platforms, with associated scale down models and systems to capture the data from process experimentation and batch manufacturing. These standard platforms can be mapped to therapeutic categories, volumetric demand, or phases in a product’s lifecycle. This is a key focus for our organization since the reduced lead-time for technology transfer coupled with a better understanding of process and analytical robustness will enable us to navigate accelerated regulatory pathways and stay agile as the technology landscape for viral vectors and other platforms continue to evolve.
Opportunities for supply chain leaders to contribute to disruptive solutions aren’t just limited to our own internal organizations.
The national discussion in the U.S. around healthcare is slowly starting to turn away from volume and intensity of care and toward health outcomes. For those leaders in the gene therapy and biopharma industries who take the leap to learn more about how to balance commitment to patient access alongside budgetary concerns of public and private payers, supply chain leaders will need to be prepared to design novel distribution and order-to-cash models in response. For our gene therapy at Spark Therapeutics, this required close partnership and collaboration with specialty pharmacies, distributors and logistics providers to reduce delivery costs by selling directly to the Payer as an alternative to conventional buy-and-bill distribution models.
While gene therapy clearly presents its fair share of challenges, it also provides several exciting opportunities for supply chain leaders and CMOs to be catalysts for change inside and outside of our organizations. We’ll succeed by staying true to the fundamentals, being integrators, innovators, and building partnerships that keep a clear focus on the patient at the end of our supply chains.