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

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

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.

Coordinator

UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK

Address

Western Road
T12 Yn60 Cork

Ireland

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 531 349,20

Participants (9)

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JOHANN WOLFGANG GOETHE-UNIVERSITATFRANKFURT AM MAIN

Germany

EU Contribution

€ 747 649,44

ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON

Greece

EU Contribution

€ 484 773,84

UNIVERSITY OF BATH

United Kingdom

EU Contribution

€ 546 575,76

FACHHOCHSCHULE NORDWESTSCHWEIZ

Switzerland

EU Contribution

€ 530 453,52

H. LUNDBECK AS

Denmark

MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN

Germany

EU Contribution

€ 249 216,48

PHARMATEN ANONYMOS VIOMICHANIKI KAI EMPORIKI ETAIREIA PHARMAKEFTIKON KAI KALLYNTIKON PROIONTON

Greece

EU Contribution

€ 242 386,92

PION INC.(UK) LTD

United Kingdom

EU Contribution

€ 273 287,88

JANSSEN PHARMACEUTICA NV

Belgium

EU Contribution

€ 250 560

Project information

Grant agreement ID: 674909

Status

Ongoing project

  • Start date

    1 May 2016

  • End date

    30 April 2020

Funded under:

H2020-EU.1.3.1.

  • Overall budget:

    € 3 856 253,04

  • EU contribution

    € 3 856 253,04

Coordinated by:

UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK

Ireland