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FOREST ROW, United Kingdom

Agency: Cordis | Branch: H2020 | Program: MSCA-ITN-ETN | Phase: MSCA-ITN-2015-ETN | Award Amount: 3.90M | Year: 2016

The European Pharma industry is a major contributor to EU well-being, both in public health and economic (sales >200 billion /year) terms. To maintain global leadership, it must respond to challenges from low-cost producers e.g. China by bringing new drug molecules to market in a streamlined, cost-effective manner. This strategy is underscored by recent initiatives of European regulators to expedite the approval of breakthrough drugs so patients can gain earlier access to life-saving drugs. To realise these goals, scientists with an integral understanding of drug development and regulatory approval processes are urgently needed. PEARRL will train 15 Early Stage Researchers (ESR) who can develop new bio-enabling formulations (better drugs), biorelevant and in silico methods to predict formulation performance in vivo (streamlined development) and serve as communication bridgers between research and regulatory science (accelerated approval), thus bringing Pharma and regulatory objectives to fruition. PEARRL brings a multi-sectorial team, comprising key European regulatory authorities, academic leaders in bio-enabling formulations and biopharmaceutics tools, and an array of Pharma companies with a wealth of combined experience in bringing molecules to market, together for the first time to deliver a unique research and training programme. Key PEARRL elements are individual research projects with synergistic output; exposure of all ESR to academia, industry and regulatory in secondments; and ongoing innovative learning via Online Portals, Science Slams and Boot Camps. Key PEARRL impacts will be availability of excellent pharmaceutical researchers; streamlined drug development with a higher success rate for the industrial partners; enriched academic research through cooperation with industry and regulatory; earlier availability of breakthrough medicines to patients; a competitive pharma industry in Europe and contributions to European public health interests.

The CRYDIS exchange programme will establish and support international and inter-sectoral transfer of knowledge and expertise in pharmaceutical and instrument science between several EU research institutes and industrial companies. It will also enhance understanding of the value of inter-sectoral exchange mechanisms for taking research to market. CRYDIS undertakes innovative, collaborative research on the clinically-important topic of dissolution of drug substance particles in bio-relevant media and the undesired subsequent nucleation and re-precipitation of the drug prior to its absorption. Using innovative advances in UV imaging technology, CRYDIS investigates the utility of novel dissolution assays as key tools to obtain fundamental data on the mechanism and kinetics of undesired nucleation and re-precipitation during or following dissolution, a significant problem for the pharmaceutical industry which struggles to obtain sufficient exposure to poorly soluble drug substances to ensure an effective dose is absorbed by the patient. The key technologies in this proposal offer a step change in capability and functionality, offering the potential to undertake more detailed studies of the dissolution/re-precipitation processes relevant to pharmaceutical materials. Access to this key technology and the further development of its capability offers the potential for breakthroughs in development of process understanding and of robust and widely applicable protocols. Additional value is brought to CRYDIS through close working with synergistic European networks, leveraging a greater knowledge input and impact outreach. Running parallel with the science programme, an innovation management work-package analyses effectiveness of the exchange mechanism in building a shared culture, transferring knowledge and developing understanding of processes that drive a product to market. The outcomes of this will be used to advise and drive potential future exchange activities.

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