Drug Discovery
Drug Development 2.0
Drug development 2.0 - The partnership model in practice

Drug development 2.0 - The partnership model in practice

By Dr Brian Sheehan and Marco Cerato

Over the last decade there has been a fundamental shift in the way in which drugs are developed and brought to market. Some years ago, the industry started to see profits falling as research and development (R&D) costs continued to soar.

While the powerhouse pharmaceutical companies of old had extensive R&D departments embedded within their structures, the emergence of agile start-ups and a drive for efficiencies in the delivery of new therapeutic options has made this model less sustainable. Cash-strapped healthcare systems demand value and, to be fair, the pharmaceutical industry has responded with mixed results. This has forced the industry to evolve and adapt.

Strategic partnerships now play an increasing role in how medicines are developed and delivered to patients. Smaller biotechs and research organisations have been given the opportunity to hit the big time by capitalising on the clinical and commercial expertise of medium to large pharmaceutical company partners who, in turn, see an opportunity to reduce R&D costs by taking on candidates that are further along the pipeline. The life science R&D ecosystem that has evolved over the past decade is now driven primarily by partnerships.

The evolution of R&D

Research and development is, by definition, an extensive and expensive process with a high attrition rate for potential new candidates. New treatments can take upwards of 12 years to get to the point of marketing authorisation, with many investigational candidates not even getting past the preclinical phase. In the long-term the sustainability of a company rests on its ability to match R&D investment with revenues and this can be increasingly difficult given the huge range of medicines that are now available, including generic options and biosimilars. The days of the blockbuster drug are well and truly behind us, forcing a change in approach throughout the industry.

In 2010, Pfizer launched its Centers for Therapeutic Innovation (CTI), a model for academic industry collaboration designed to bridge the gap between early scientific discovery and its translation into new medicine. In essence, the centres brought together the research expertise of academics with the development expertise and resources of Pfizer scientists to validate a drug candidate so that it could be moved into further clinical testing. Around the same time, GlaxoSmithKline (GSK) adopted a more entrepreneurial approach to R&D, dividing its scientists into small Discovery Performance Units (DPUs) to encourage innovation. Each DPU was tasked with making a case for its share of the overall R&D budget, encouraging a change in mindset and a greater focus on return on investment.

The shift in Glaxo’s R&D structure was also evidenced by its creation of Centres of Excellence for Drug Discovery (CEDDs), each focused on a different research track. The company subsequently went on to establish a Centre of Excellence for External Drug Development (CEEDD), sharing some of its assets for development by others when more potential targets were generated than GSK had the internal resource to develop.

Where big pharma led, others followed and, alongside academic collaborations, a proliferation in the number of biotechs in the last decade has seen an increase in partnerships across the board and an array of licensing arrangements for new assets.....

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