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H2020Doctoral network2016–2020

PEARRL · Pharmaceutical Education And Research with Regulatory Links: Innovative drug development strategies and regulatory tools tailored to facilitate earlier access to medicines

Horizon 2020 — Marie Skłodowska-Curie Actions

Duration
2016-05-01 → 2020-08-31
EU contribution
€3,856,253
Participants
10
Scheme
MSCA-ITN

Lines connect the coordinator with its partners.

Results in brief

Pharmaceutical Education And Research with Regulatory Links: Innovative drug development strategies and regulatory tools tailored to facilitate earlier access to medicines

Europe’s pharmaceutical industry is facing unprecedented challenges in the development of new medicines due to long development timelines, high failure rates and the increasing costs of testing new drug candidates. Solutions are urgently needed to streamline ‘molecule-to-market’ timelines to ensure that patients have access to breakthrough therapies as early as possible, while keeping prices affordable. The PEARRL Project developed innovative development strategies for oral medicines as well as regulatory tools to facilitate early access to them. One highlight was the application of molecular modeling techniques to choose the optimizing drug formulations to improve the drug’s absorption from the digestive tract. This approach can replace the traditional “trial-and-error” approach of choosing excipients. Another highlight was the design of laboratory tests to predict how medicines are absorbed in certain patient types such as those with ulcerative colitis and in children. Moreover, by combining the results of these tests with sophisticated computer models describing the absorption of drugs, it became possible to predict the influence of a drug’s formulation on its therapeutic effectiveness. All three aspects significantly advance both the optimization and streamlining of oral drug development. The project brought together 18 leading European institutions, including 9 representatives from the pharmaceutical industry, 5 academic institutions and 4 regulatory agencies in a multi-sectorial consortium. 15 Early Stage Researchers (ESRs) were recruited, all of whom have either graduated with their PhDs or are finalizing their dissertations. These scientists will now serve as “communication bridgers” between industrial development and regulatory science, helping new medicines to be brought to the market faster, with lower failure rates and reduced overall costs.

Data: CORDIS, © European Union

Project objective

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.

Original text from CORDIS.

Participants

  • UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK · CorkCoordinatorIreland
  • ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON · ATHINAGreece
  • FACHHOCHSCHULE NORDWESTSCHWEIZ FHNW · WindischSwitzerland
  • H. LUNDBECK AS · ValbyDenmark
  • JANSSEN PHARMACEUTICA NV · BeerseBelgium
  • JOHANN WOLFGANG GOETHE-UNIVERSITAET FRANKFURT AM MAIN · Frankfurt Am MainGermany
  • MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN · DarmstadtGermany
  • PHARMATEN ANONYMOS VIOMICHANIKI KAI EMPORIKI ETAIREIA PHARMAKEFTIKON KAI KALLYNTIKON PROIONTON · PALLINIGreece
  • PION INC.(UK) LTD · Forest RowUnited Kingdom
  • UNIVERSITY OF BATH · BATHUnited Kingdom

Links

Data: CORDIS, © European Union