As part of a strategic move, Quotient Clinical, a drug development services organization, was renamed to Quotient Sciences. Following the acquisitions of Co-Formulate, QS Pharma and SeaView Research, this new identity aims to depict the company’s global footprint and extended range of services.
 
Quotient is focused on providing a portfolio of services, including formulation development, clinical trial and commercial manufacturing, and clinical pharmacology. The company has 700 employees and five operating sites across the U.S. and the UK.

Contract Pharma spoke with Quotient Sciences chief executive officer, Mark Egerton, regarding integrating services typically found in disparate CDMOs and CROs, as part of an effort to help customers improve R&D productivity and accelerate drug development. –KB


Contract Pharma: What are the key elements to the company’s rebranding efforts to Quotient Sciences, and how the business has evolved?

Mark Egerton: Our rebrand to Quotient Sciences represented a significant milestone in the continued evolution of our business. It builds on our commitment to bring new science and innovation to support our customers’ drug development, which is a fundamental cornerstone of our business strategy.

The rebrand followed a number of transatlantic acquisitions. It signifies our global footprint and extended portfolio of services that now extends beyond Translational Pharmaceutics to include early phase through to commercial contract development and manufacturing (CDMO) services and clinical pharmacology services.

Critically, our rebrand supports our commitment to deliver “one business, one experience” to our customers irrespective of which of our sites is delivering their program of work. Integration of our sites, capabilities and project teams is an essential aspect of being able to deliver this vision to a global customer base.

Contract Pharma: Quotient Sciences made several acquisitions in 2017 (SeaView Research and QS Pharma). Please discuss the company’s business strategy and the more recent acquisition of Pharmaterials.

ME: Translational Pharmaceutics was developed by Quotient in the U.K. in consultation with the U.K. regulatory authority — the Medicines and Healthcare products Regulatory Agency (MHRA). Historically, Quotient has served an international customer base from the U.K. despite many of our customers being based in the U.S. However, to enhance our ability to access the U.S. market, we set out to replicate Translational Pharmaceutics in the U.S., enabling our U.S. customers to access Translational Pharmaceutics domestically and to operate under an investigational new drug (IND) approval granted by the FDA. To that end, we acquired QS Pharma, a CDMO based in Philadelphia, and SeaView Research, an expert clinical pharmacology business based in Miami, essentially to provide us with U.S. operational “make and test” capabilities.

In 2017, we also acquired Pharmaterials, a U.K. CDMO. This brought further expert preformulation and formulation development skills into our business and allowed us to expand our manufacturing capabilities and scale in the U.K. We now support clients from candidate selection through to commercial manufacturing, with the ability to manufacture clinical trial material in the E.U. or U.S. for patient studies globally.

Contract Pharma: Does Quotient have any expansion plans for 2018?

ME: Further CDMO expansion is in progress through a 45,000-square-foot expansion of our Philadelphia, U.S., facility and a 30,000-square-foot-expansion of our Reading, U.K., facility — both of which are scheduled to be on line later in 2018. These new facilities will primarily focus on early-phase formulation development and clinical trial manufacturing activities and are in direct response to customer demand. Our ability to adapt a manufacturing program specifically to the requirements of a clinical trial is proving to be a highly attractive service offering and a natural follow-on to a Translational Pharmaceutics program. Our expertise spans all types of oral and inhaled drug products, with particular formulation experience in modified release systems and solubilization technologies including spray drying, hot melt extrusion, lipidic systems and micronization.

Contract Pharma: Why is Translational Pharmaceutics important?

ME: Translational Pharmaceutics is a new and more efficient way of delivering drug development programs. It transforms the traditional approach of outsourcing development work to a separate CDMO and CRO, simplifying and streamlining outsourcing and program management. By integrating CDMO and CRO activities, we deliver significant benefits to pharma and biotech customers including acceleration of project timelines and reduction in costs.

Translational Pharmaceutics integrates formulation development, real-time adaptive manufacturing and clinical testing into a tailored development program that is run by a single project manager and project team. It brings together the “make” and “test” supply chains, allowing the manufacturing program to be tailored to the specific needs of the clinical trial.

Contract Pharma: What are the barriers in the traditional drug development process?

ME: The evolution of Translational Pharmaceutics has coincided with a transformation in the pharmaceutical industry that has witnessed a proliferation in the number of molecules in the R&D pipeline to 15,000 in 2018 and an expansion in the number of companies with new molecules active in drug development to 4,100 in 2018.¹

Outsourcing has become a common strategy across all of these companies and projects to a greater or lesser extent. Unfortunately, however, the outsourcing industry has evolved along functional boundaries (silos) with businesses focused on discrete aspects of the process, e.g., CDMOs that develop and manufacture drug products and CROs that test them.

Contract Pharma: Why is it important to integrate formulation development and real-time adaptive manufacturing with clinical research through Translational Pharmaceutics?

ME: Horizontal integration of formulation development, real-time adaptive manufacturing and clinical testing is especially advantageous in the early stages of drug development (from first-in-human to proof-of-concept). When sponsors can outsource all these functions to a partner that offers these capabilities under a single organization and with a dedicated project manager, they can significantly ease their management and contracting burdens. The integrated approach also addresses a major shortcoming of the conventional, multi-vendor outsourcing approach: the lack of operational or know-how synergy between vendors, which can stymie innovation. Rather, under Translational Pharmaceutics, the formulation development and drug product manufacturing specialists understand exactly what the clinical trial personnel need and vice versa, fostering a consistent exchange of information.

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Mark Egerton, Ph.D., is chief executive officer at Quotient Sciences, a global pharmaceutical development, clinical pharmacology, and clinical and commercial manufacturing organization that delivers customized solutions for pharmaceutical and biotech customers through both individual and integrated services.

References
1.     Informa Healthcare, 2018. Pharmaprojects Pharma R&D Annual Review 2018.

 

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