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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

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
Net EU contribution
€ 531 349,20
Address
Western Road
T12 YN60 Cork
Ireland

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Region
Ireland Southern South-East
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00

Participants (9)

JOHANN WOLFGANG GOETHE-UNIVERSITAET FRANKFURT AM MAIN
Germany
Net EU contribution
€ 747 649,44
Address
Theodor W Adorno Platz 1
60323 Frankfurt Am Main

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Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
Net EU contribution
€ 484 773,84
Address
6 Christou Lada Str
10561 Athina

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Region
Αττική Aττική Κεντρικός Τομέας Αθηνών
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITY OF BATH
United Kingdom
Net EU contribution
€ 546 575,76
Address
Claverton Down
BA2 7AY Bath

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Region
South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Bath and North East Somerset, North Somerset and South Gloucestershire
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
FACHHOCHSCHULE NORDWESTSCHWEIZ
Switzerland
Net EU contribution
€ 530 453,52
Address
Bahnhofstrasse 6
5210 Windisch

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Aargau
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
H. LUNDBECK AS

Participation ended

Denmark
Net EU contribution
€ 0,00
Address
Ottiliavej 7-9
2500 Valby
Region
Danmark Hovedstaden Byen København
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN
Germany
Net EU contribution
€ 249 216,48
Address
Frankfurter Strasse 250
64293 Darmstadt

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Region
Hessen Darmstadt Darmstadt, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
PHARMATEN ANONYMOS VIOMICHANIKI KAI EMPORIKI ETAIREIA PHARMAKEFTIKON KAI KALLYNTIKON PROIONTON
Greece
Net EU contribution
€ 242 386,92
Address
Dervenakion Street 6
15351 Pallini

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Region
Αττική Aττική Ανατολική Αττική
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
PION INC.(UK) LTD
United Kingdom
Net EU contribution
€ 273 287,88
Address
Riverside Forest Row Business Park
RH18 5DW Forest Row

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
South East (England) Surrey, East and West Sussex East Sussex CC
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
JANSSEN PHARMACEUTICA NV
Belgium
Net EU contribution
€ 250 560,00
Address
Turnhoutseweg 30
2340 Beerse

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Region
Vlaams Gewest Prov. Antwerpen Arr. Turnhout
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00