How was 2021 for Quotient Sciences, particularly within the US?

In February 2021, Quotient Sciences expanded its portfolio of services to include drug substance and bioanalysis capabilities by acquiring the Alnwick facility from Arcinova, a UK-based CDMO. Over the past year, we have been focused on fully integrating these capabilities into our core Translational Pharmaceutics® platform, saving our customers significant time and costs by integrating drug development and clinical testing services within a development program under a single clinical protocol. We also went through a series of organic investments at five of our seven sites, where we have been increasing drug substance, clinical trial manufacturing, and clinical testing space. These investments have either been completed or are ongoing and will be completed in 2022.

In recent years, there has been phenomenal investment in pharmaceutical R&D, and the number of molecules continues to grow. Aligned with this increase, Quotient Sciences’ customer base has grown to approximately 500 customers across the US and Europe. We have operating sites in both the UK and the US, but 80% of our revenues are generated from US-based customers.

Can you explain the importance for drug developers to have a CDMO that can manage both drug substance and drug product in parallel?

Previously, customers would use service providers upstream from us and make decisions on which compounds to progress without much consideration of what would happen downstream. The customer would sometimes manufacture the drug substance only to find out later they had made an error in the compound selection process. Having already made significant investment, they are reluctant to take a step back and thus start to make compromises for their downstream development plan.

Quotient Sciences wants to support our customers with their molecules earlier in the development process, from the point at which the drug candidate molecule is selected from the discovery program. By incorporating our scientific expertise and development technologies at an early stage, we can help them make the most data-informed decision possible. We can then implement a seamless program of work that integrates drug substance synthesis and manufacturing into our Translational Pharmaceutics platform to provide time and cost savings.

Have you noticed increased interest in the development of more targeted drugs?

Approximately 50% of drugs approved by the FDA over the past five years have been for orphan/rare disease indications, where the total market and patient population is quite small. This presents a unique challenge and opportunity to the industry, as historically service providers and pharmaceutical companies looked for big blockbuster drugs that would be prescribed to millions of patients. Today, patient populations are becoming more targeted with an increased focus on rare diseases. To support this, supply chains must be more flexible. When we manufacture a product, the customer then delivers it to patients, either in clinical trials or on the market. In the case of products for orphan diseases, the customer can either make a significant upfront investment and manufacture a large amount of product with an extended shelf life or wait until patients have been recruited and deliver the product on an almost just-in-time basis. Quotient Sciences has created the protocols and methodology to just-in-time manufacture, package, label, ship, and deliver product to clinics within a two-week time frame. With this model, managing the supply chain and logistics is fundamental. We are currently looking at acquisition targets that will help us bridge more firmly into this space, given our belief that just-in-time manufacturing will play an integral part in the future of drug manufacturing, specifically in more specialized and targeted therapeutic areas. 

At what stage of the drug development process is the element of speed or integration most critical to customers?

Our principal focus is on the early phases of drug development, from the point of candidate selection through to proof of concept. Through the eyes of a drug developer, this phase of development is loaded with risk. For the first time, data is obtained on how a drug performs in the human body. Unfortunately, it is not uncommon for compounds to fail efficacy testing or for formulation compositions to require specific modifications. This process is more difficult if the customer is working with multiple outsourced parties. The focus of our integrated Translational Pharmaceutics programs is to address that challenge head-on, to provide the customer with a development platform capable of responding in real-time to emerging development data and maintain an overall timeline to proof of concept.    

Quotient Sciences is investing US$8 million into expansion efforts for in-house API synthesis and manufacturing. What is the company’s goal with this investment, and how does it fit into the company’s broader objectives for the years ahead?

We have seen increased demand towards local API production in both the US and the UK due to supply chain challenges caused by the pandemic and geopolitical issues. Our API capacity expansion will allow us to manage the drug substance and drug product supply chains in-house for our customers and ensure that APIs are supplied on time and at the right quantity and quality to drive the development program. Overall, Quotient Sciences will continue to strive to increase our capabilities and invest in our people to meet the growing needs of our customers.