Thermo Fisher Scientific - One strategy adjustment to accelerate clinical trials

Is there data supporting the choice of a singlesource supplier versus multiple suppliers?

Leon Wyszkowski: It stands to reason that a single-source supplier - one-stop shopping, if you will - would simplify supply chains while saving time and resources. Now, independent research conducted by the Tufts Center for the Study of Drug Development and recently published in Clinical Therapeutics appears to confirm that.

Tufts researchers compared dual-vendor (separate drug substance and drug product vendors) versus single-vendor contract development and manufacturing organisations (CDMOs) on cycle times and development costs. They concluded that sponsors enjoyed substantial financial benefits from using a single CDMO outsourcing model rather than multiple, fragmented vendors, even after accounting for somewhat higher sponsor fees. Benefits included millions of dollars in cost savings associated with shorter development times, enabling products to reach the market sooner.

What criteria should guide a sponsor in selecting a single-source supplier?

Franco Negron: Sponsors should seek a supplier capable of providing a fully integrated drug development and manufacturing solution - a partner for every step of the process, from substance to clinical trial to commercial product - with global reach.

This means a supplier with a proven ability to create or source ingredients, design the ideal formulation, scale to the next milestone, develop a clinical supply strategy, accelerate clinical research and deliver a successful commercial launch.

Regarding manufacturing, anyone can follow a recipe and churn out product. That's not good enough. A sponsor should look for a supplier capable of helping develop stable and scalable products with the right solubility profile, while reducing capital spent on raw materials or rework on formulation. The supplier should offer drug development services that include elements such as formulation and process development, because the aim is not merely manufacturing the sponsor's product, but manufacturing the best version of that sponsor's product or products.

That requires additional capabilities. It means using a chemical API manufacturing process that uses the fastest, most stable route and a minimum number of steps. Fewer steps means decreased raw materials, which reduces cost when the sponsor scales up their drug substance.

Streamlined services will enable molecules to reach the clinic faster than ever before due to supply chain simplification.
- Leon Wyszkowski

It requires identifying and correcting solubility issues early in drug development, making certain that the formulation will scale as the molecule progresses from phase to phase.

With respect to biologics, it calls for assisting with cell line development and upstream/downstream process development to maximise yield and get the product to the clinic as quickly as possible.

LW: The supplier should be an expert at managing, optimising and streamlining the clinical supply chain from early strategy development through the enrolment, maintenance and closeout phases of a trial. This includes everything from studyplanning and forecasting to logistics and shipping to clinics.

The supplier should also offer service options from which sponsors can choose, depending upon their needs. For example, clinical supply optimisation services to assist with clinical supply forecasting, planning and execution; programme management to keep the molecule on its critical path; and total transportation management to help customers manage their transportation spend. This includes recommending the best transportation options to ensure that products arrives on time, in full and at the correct temperature, regardless of location.

What are the benefits of partnering with a single-source supplier?

LW: I spoke earlier about research indicating that use of a single-source supplier results in substantial cost savings to sponsors, as well as shorter drug development times.

For small and emerging companies, accelerating development can increase their companies' valuation and thus enabling them to continue to fund innovation.

For all sponsors, a single-source supplier mitigates risk. Minimal handoffs in the supply chain reduce communication gaps and the likelihood of problems, resulting in end-to-end visibility of supplies with improved process efficiency and overall metrics.

Another benefit is decreased administrative burden. A single supplier minimises the time and personnel required for a sponsor to manage the relationship and handle paperwork. While a reduced administrative burden is relevant to all sponsors, it's particularly important for small companies managing limited resources.

A relationship with one supplier also facilitates nimbleness, flexibility and problem-solving. Sponsor and supplier can identify solutions quickly when problems arise, ensuring that drug supplies reach the patients when they need them.

How is use of single-source suppliers likely to impact the industry?

FN: We're seeing the effects of contract development and manufacturing (CDMO) consolidation on the way in which pharma companies are outsourcing. I predict that we'll continue to see greater consolidation of outsourced services in the form of additional acquisitions, enabling the big players to rise to the top.

Pharma companies should use these developments to their advantage, rather than fragmenting their outsourcing across multiple small vendors that could potentially go out of business.

LW: Exactly. Streamlined services will enable molecules to reach the clinic faster than ever before due to supply chain simplification.

Many small companies reject the idea of building a secure supply chain early in development because they perceive it as too expensive and time-consuming. What they don't realise is that when a compound enters Phase 2b, company valuation will be higher if a sophisticated supply chain is in place. If a company is managing multiple suppliers and switching suppliers throughout the development process, it won't have a single source of documentation, project management or accountability. Management may want to consider these elements if their exit strategy involves selling the company.

Which sponsors benefit most from working with a single-source supplier?

LW: The full continuum of sponsors - from large pharma companies to emerging biotechs - stand to benefit from working with a single-source supplier, although they have different needs when they outsource services.

Large companies can choose between insourcing and outsourcing. When they opt to outsource, they should choose a supplier that will ensure the establishment of a secure supply chain and that every batch of clinical trial material reaches clinics on time. The focus must be on consistent and reliable delivery, because patients are waiting.

FN: It's also worth noting the difference in circumstances with respect to emerging biotechs. Unlike large pharma companies, most biotech companies don't have the luxury of deciding whether to insource or outsource, or the funding to invest in capital assets. In working with a small company, a singlesource supplier acts as an extension of that customer's team.

For small companies, it's about giving their molecule the best chance at success - and doing that quickly. It's about maintaining the focus on the customer and enabling the customer's success.

What advice would you offer sponsors about working with single-source suppliers?

FN: Engage with the supplier in a strategic rather than a tactical way. In the past, the relationship between a sponsor and a supplier was largely tactical, but it has evolved over the years. That's a good thing.

By acknowledging the expertise that each brings to the table and working together, a sponsor and supplier can generate value for the sponsor and, ultimately, contribute to the improvement of human health.

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