MEDICINAL CHEMISTRY
The ‘federated’ CRO model: delivering drug discovery expertise
Dr Simon Hirst introduces the concept of the ‘federated CRO model’ and discusses how it is possible for a coalition of expert CROs, with a cohesive project management structure and IT infrastructure, to become a significant player in outsourced integrated discovery services.
rising costs, drugs coming off-patent, an innovation deficit and financial pressure from health care providers, the need for a new approach to drug discovery and development has been long apparent. The pharmaceutical companies’ response has been increasingly focused on reducing costs and outsourcing their R&D activities to contract research organisations (CROs). Some of these CROs have now become large organisations in themselves.
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Sygnature Discovery Limited is a provider of integrated drug discovery services to the pharmaceutical industry and recently announced a strategic alliance with Pneumolabs (UK) Limited, a contract research company offering a range of preclinical research services focused on respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). Under the terms of the agreement, Sygnature and Pneumolabs are collaborating to provide a fully-integrated drug discovery service to accelerate clients’ drug discovery programmes into development. I see this kind of alliance as being a natural way for smaller companies to operate and as being a natural consequence of big pharmaceutical companies’ business models undergoing major structural change.
A new CRO model
The establishment of this recent strategic alliance represents the further growth of a collaborative network that Sygnature terms a ‘federated’ CRO (fCRO) model. The new alliance complements a series of existing strategic alliances and research collaborations that has been carefully pieced together over a five-year period. The first of these was formed in 2007 with leadering preclinical in-vitro ADME/tox services company Cyprotex Discovery and proved a
20 sp2 Inter-Active September/October 2012
ith significant changes being forced on the shape and structure of the global pharmaceutical industry due to
critical first step in the development of the federated model. Why form an alliance of this type when, with major pharmaceutical companies shedding large numbers of highly skilled scientists, Sygnature could have decided to build its own internal ADME group? The decision was clear-cut; Cyprotex already had a world-class scientific team of more than 60 ADME specialists with a turnover of samples and analyses even major pharmaceutical companies could only dream of achieving. To build expertise of that quality and capability would have taken an enormous investment in time and capital. It just wasn’t possible, in our view, to achieve the same result internally. Very rapidly the benefits of the collaboration became clear, and within weeks the first collaborations were benefitting from world- class ADME support. It was apparent, however, that excellent communication and close working were essential to make the collaboration work smoothly and mechanisms were created to ensure rapid turnaround, information-sharing and problem-solving. Sygnature’s clients and their programmes soon saw the benefits of the alliance with increased knowledge around the profiles of lead molecules leading to better decision- making within the projects.
Since that first strategic alliance, Sygnature has developed a strategy of a broad capability-driven research network to deliver complex and challenging integrated discovery programmes. For example, and more recently, another strategic alliance, this time with Saretius in Reading, UK, added preclinical discovery services in the area of pain, CNS disorders and metabolic diseases. The network is now comprised of complementary CROs in which high-quality science is a core value and with which Sygnature has built a close working relationship. The network covers most aspects of preclinical drug discovery and development ranging from structural biology CROs to companies delivering preclinical disease models all
based around Sygnature’s core expertise in medicinal chemistry, computational chemistry and i- vitro bioscience. Sitting in the hub of the network, Sygnature’s strong drug discovery experience and project management ensures smooth running for the multidisciplinary projects. An overarching legal agreement covers the activities within the network and means that the client can work with the entire collaboration through a single agreement. Figure 1 illustrates the network structure.
Advantages of the fCRO model Sygnature believes that the model itself presents a number of significant advantages over the traditional model of the one-stop- shop in which larger CROs have tried to build all capabilities in-house. It is my view that perhaps some of these large CROs have inadvertently begun to emulate their ‘Big Pharma’ clients by losing some of the flexibility and innovative qualities that originally enabled them to offer R&D support more efficiently and cost-effectively than their clients. The federated model accommodates the smaller, focused and more innovative
The fCRO model showing the integrated relationship between Sygnature Discovery and its partners.
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