What do market changes mean for drug development?

Mark Egerton, CEO, Quotient Clinical, discusses reformulation drug development services for a changing market

Outsourcing of drug development activities is now a core strategy for many organisations across the pharmaceutical sector, allowing internal resources to be focused on activities mostly likely to result in a marketable product. However, managing a network of CROs and CDMOs brings new communication and logistical challenges – which can be particularly evident once a candidate drug enters the clinical phase – potentially delaying the regulatory approval and launch of new drug products.

One approach which has been designed to streamline the outsourcing of clinical phase development is Quotient Clinical’s Translational Pharmaceutics platform. This innovative approach integrates formulation development, real-time GMP drug product manufacturing and clinical testing, helping to significantly reduce the time and cost of drug development by eliminating the difficulties of coordinating formulation development, tech transfer, manufacturing and clinical trials across multiple organisations and, sometimes, continents.

An elegant solution

The benefits of this innovative approach have already proved popular, with over 50 leading pharmaceutical and biotech companies globally choosing Translational Pharmaceutics to accelerate development of products for a variety of indications and routes of delivery. As more organisations recognise the advantages of combining formulation development with real-time manufacturing and testing, there is a noticeable shift in the way companies use these services. Just a few years ago, only around 10% of Quotient Clinical projects involved formulation development; clients approached the company with formulations they had already developed, only outsourcing the real-time manufacturing and clinical testing. In contrast, 50-60 % of Quotient’s projects now include on-site formulation development.

This shift correlates with the growth of Quotient’s formulation development experience and strengthening credentials, in combination with pharma and biotech customers recognising the time and cost savings available by performing the whole process under one roof. This has had a ‘ripple effect’ within the industry, with an ever increasing number of pharma companies re-evaluating the way they go about drug development, challenging the traditional approaches and working in partnership with specialist providers to create more efficient, streamlined and integrated workflows.

Meeting demand

To address the growing demand for formulation development and testing, Quotient has expanded both the breadth and depth of its services. For example, it has recently doubled the size of its formulation development laboratories and created an additional GMP manufacturing facility based at the MediCity life science innovation hub, just a few miles from the main Quotient Clinical site in Nottingham.

The new MediCity manufacturing centre has also delivered an unexpected benefit for the company’s formulation services – the addition of formulation development specialist Co-Formulate to the Quotient Clinical group. Based adjacent to the GMP facility, Co-Formulate is ideally placed to complement existing Quotient Clinical capabilities, bringing a wealth of expertise in helping customers to develop diverse solid, semi-solid and liquid formats, as well as formulations for paediatric and geriatric patients.

Broader horizons

Integration of formulation development with clinical testing isn’t only applicable to newly developed drugs either. The Co-Formulate team has many years of experience in managing product life cycles, working with over-the-counter medicines and generic products to improve consumer satisfaction. By combining this expertise with Quotient Clinical’s GMP manufacturing and clinical facilities, Translational Pharmaceutics can be used to enhance existing products, creating key differentiators in a competitive marketplace.

The continued expansion of Quotient Clinical’s formulation development services into these new markets will further support the current industry trend towards outsourcing early drug development. With the added knowledge and understanding of consumer healthcare that Co-Formulate brings to existing capabilities, it will also provide additional tools for the life cycle management of existing drug products through the development of new formulations and routes of delivery, and will be interesting to see how this flexibility affects the future direction of the market.