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Drug Development


+Drug


development 2.0 the partnership model in practice


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.


By Dr Brian Sheehan and Marco Cerato


W


hile 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 thera- peutic options has made this model less sustain- able. 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 organisa- tions have been given the opportunity to hit the big time by capitalising on the clinical and commercial expertise of medium to large pharmaceutical com- pany 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 attri- tion rate for potential new candidates. New treat- ments can take upwards of 12 years to get to the


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point of marketing authorisation, with many inves- tigational candidates not even getting past the pre- clinical 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 increas- ingly 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 academ- ic industry collaboration designed to bridge the gap between early scientific discovery and its transla- tion into new medicine. In essence, the centres brought together the research expertise of aca- demics with the development expertise and resources of Pfizer scientists to validate a drug can- didate 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 innova- tion. 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.


Drug Discovery World Winter 2019/20


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