In this interview with Thierry Van Nieuwenhove, Quotient Sciences' Chief Executive Officer, we delve into the unique factors that set the company apart, the strategic growth plans aimed at enhancing the delivery of innovative drug development programs, and how the dedication of our more than 1,300 colleagues across the United Kingdom, United States, and Europe is instrumental in helping our customers accelerate drug development every day.
Since joining Quotient Sciences in October 2023, what have been your impressions of the company so far?
TVN: It was humbling to see the impact that Quotient Sciences’ Translational Pharmaceutics® platform has delivered for our customers such as Ensysce Biosciences , DayOne Therapeutics, Oxilio, and many others over the past 16 years. The relationships that we have built, both with small biotechs and with large Fortune 100 pharmaceutical companies, have been impressive to see.
Each program we’ve supported has come with its own development story, but all ultimately resulted in expedited delivery of medicines to patients—an important goal that we always keep in mind and share with clients.
There is not a CDMO or CRO out there today that offers a platform quite like Translational Pharmaceutics®, let alone one proven to remove a year or more from conventional drug development timelines in the way that Translational Pharmaceutics® can when it comes to integrating drug substance, drug product, and clinical testing activities.
We’ve supported over 500 drug development programs via Translational Pharmaceutics® for a broad range of clients, including many repeat customers. I am proud to be part of a company that is not only delivering drug development in a unique way for our customers but with a track record of impactful time and cost savings that ultimately helps increase the success rate of new medicine approvals.
Did anything surprise you about the company?
TVN: Quotient Sciences is known for its reputation of providing deep technical and scientific consultation in the design and manufacture of small-molecule drug products, with proven formulation development expertise. As a company, though, we offer even more than some may realize to make us a more holistic CDMO/CRO outsourcing partner with integrated capabilities.
Capabilities and expertise for drug substance API synthesis and manufacturing from our Alnwick, UK facility, and complimentary services through our partnership with Charles River Laboratories provide early opportunities to partner with customers coming out of candidate and preclinical development. Additionally, we are expanding our preclinical development services this year with new capabilities being added at Nottingham.
From our Miami, FL, and Nottingham, UK facilities, we offer clinical pharmacology services, including the ability to conduct Phase I clinical programs with healthy volunteers and support services for data science and analytics. Downstream, we can scale up drug products for later-stage trials, although we don’t have a hand in conducting those trials directly with patients, and can commercially supply drug products for marketed products.
Ultimately, no matter how a customer chooses to work with us and where they work with us, I want our customers to know that the dedication and expertise of our more than 1,300 colleagues will help deliver success.
How does Translational Pharmaceutics® add value to client programs?
TVN: Translational Pharmaceutics® integrates formulation development, on-demand and adaptive GMP manufacturing, healthy volunteer clinical testing and data analysis within a single organization. A unified project management team helps coordinate all activities.
In that sense, Translational Pharmaceutics® transforms the traditional outsourcing model, where a combination of CDMOs and CROs are usually required with handovers at different points throughout a drug program. In doing so, the platform offers significant success rates linked with time and cost efficiencies. Translational Pharmaceutics® helps clients access information faster so they can make more informed decisions based on emerging human clinal data, gives flexibility to optimize formulation compositions within a study, and reduces drug substance consumption by up to 85%.
A recent application of Translational Pharmaceutics® was our collaboration with YourChoice Therapeutics, a pioneer of hormone-free family planning products. Having established a scale-up-ready synthetic route for the YCT-529 API at our Alnwick, UK facility, our team developed the initial product formulation and the first-in-human (FIH) clinical protocol in parallel. Once approved, this allowed our Nottingham, UK facility to perform on-demand drug product manufacturing for precision dose escalation, removing extensive and costly upfront product manufacturing. The YourChoice team also complemented our relationships with UK regulatory bodies, which helped navigate and overcome regulatory hurdles to bring YCT-529 to clinical testing sooner.
What are some of the Company’s top priorities this year?
TVN: Although 2023 was a difficult year for the entire industry, CDMOs such as Quotient Sciences continued to thrive by providing innovative solutions, a deep understanding of science, and strategic partnership to clients. In 2024, we’re seeing signs of recovery, with some increased biotech industry funding again to support the growing number of new molecules in the development pipelines.
Looking ahead, the growth of our drug product and drug substance businesses, as well as the expansion of our Translational Pharmaceutics® platform in the US remain key objectives. Many of our customers are based in the United States where we currently have three manufacturing facilities that complement our facilities in the United Kingdom. Our Garnet Valley, PA facility develops simple and complex small molecule oral drug products supporting programs from the preclinical stage to clinical proof-of-concept, and a nearby facility in Boothwyn, PA offers scale-up to late-phase manufacturing and commercial drug product supply. From there, our clinical pharmacology facility in Miami, FL allows us to conduct first-in-human Phase I clinical trials on-site with healthy volunteers and features a compounding pharmacy.
Applying Translational Pharmaceutics® under US regulations complements capabilities already offered from our Nottingham, UK facility, so US-based clients have flexibility in where they choose to work to realize the time- and cost-saving benefits that Translational Pharmaceutics® delivers.
Ultimately, no matter how a customer chooses to work with us and where they work with us, I want our customers to know that the dedication and expertise of our more than 1,300 colleagues will help deliver success.