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European Training Network for innovative drug development strategies and regulatory tools

PEARRL is a European Training Network (ETN) funded under the Horizon 2020 Marie Sklodowska-Curie actions. It brings together the European pharma industry, academia and regulatory agency partners in a multi-sectorial team to deliver novel bio-enabling formulations and new biopharmaceutics tools to predict their in vivo performance as a means to improve efficiency and cost-competitiveness in drug development. This thus helps to facilitate earlier access of patients to “breakthrough therapies”.

The European Pharmaceutical and Biopharmaceutical industries are a major contributor to EU well-being, both in public health and economic terms. To maintain global leadership, it must respond to challenges of declining product pipelines, and increasing Research & Development costs by bringing new drug molecules to the market in a streamlined, cost-effective manner.

Authorities in the EU have introduced a regulatory framework to bring important new drugs to patients as quickly as possible, with the aim of facilitating earlier patient access to breakthrough therapies. To fully realise the potential of this initiative, the pharmaceutical industry must respond to challenges by developing novel, bio-enabling formulations that unleash the full potential of new drug candidates and at the same time compact their development into the tightest of time-lines.

Funded under the Horizon 2020 Marie Sklodowska-Curie Actions, nine beneficiaries and ten organisations joined together and formed the PEARRL project (Pharmaceutical Education and Research with Regulatory Links) to pursue this goal.

PEARRL officially started in May 2016 and runs for four years. It combines an innovative research programme with an excellent training programme for Early Stage Researchers (ESR). The main objectives of this research programme are to deliver novel bio-enabling formulations and new biopharmaceutics tools to predict their in vivo performance as means to improve efficiency and cost-competitiveness in drug development, facilitating earlier access of patients to “breakthrough therapies”. Without a bio-enabling formulation, most drugs would be ineffective if given orally, simply because not enough of the dose would be absorbed to achieve a therapeutic response.

PEARRL will create innovation in all these areas to ensure streamlined molecule-to-market time-lines for poorly soluble drugs and thus ensure the future competitiveness of Europe’s Pharma industry. Simultaneously, PEARRL will train 15 ESRs who can develop such new bio-en¬abling formulations (“better drugs”), biorelevant and in silico methods to pre¬dict 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.

With its unique multi-sectorial approach, PEARRL will have a significant impact on two distinct sectors. Firstly, PEARRL will enhance innovation-related human resources for the pharmaceutical industry and improve the individuals’ skills and their working conditions in order to assure the realization of their full potential. The newly trained ESRs will belong to a new calibre of pharmaceutical development scientists, with a state-of-the-art knowledge base, making them the natural future leaders in industry, regulatory agencies and academia.

Furthermore, the research training with PEARRL will provide the ESRs with new career perspectives by transmitting a new skill set for challenging working conditions. Secondly, PEARRL will contribute to the EU’s objectives in Horizon 2020 with its emphasis on excellent science, industrial leadership and tackling societal challenges. Long-term collaborations between partners in research and training will be pursued to increase Europe`s innovation capacity. PEARRL will drive innovation, economic growth and create job opportunities for highly qualified researchers.

Source:http://cordis.europa.eu/news/rcn/125820_en.html?isPermaLink=true?WT.mc_i...

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