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PEARRL SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

PEARRL project word cloud

Explore the words cloud of the PEARRL project. It provides you a very rough idea of what is the project "PEARRL" about.

time health breakthrough approval industrial medicines enriched gain goals drug economic realise saving fruition pearrl strategy expedite public life billion global regulatory 15 excellent array individual market combined tools cooperation formulation pharma earlier camps urgently train learning stage exposure contributor esr team brings molecules integral manner leadership bio training formulations performance china first pharmaceutical scientists output vivo producers communication competitive academia ongoing science predict silico sectorial secondments patients boot academic wealth biorelevant biopharmaceutics drugs bridgers interests companies leaders sales underscored online synergistic portals 200 serve comprising streamlined rate accelerated gt regulators slams contributions impacts innovative industry

Project "PEARRL" data sheet

The following table provides information about the project.

Coordinator	UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK Organization address address: WESTERN ROAD city: Cork postcode: T12 YN60 website: www.ucc.ie contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Ireland [IE]
Project website	http://www.pearrl.eu
Total cost	3˙856˙253 €
EC max contribution	3˙856˙253 € (100%)
Programme	1. H2020-EU.1.3.1. (Fostering new skills by means of excellent initial training of researchers)
Code Call	H2020-MSCA-ITN-2015
Funding Scheme	MSCA-ITN-ETN
Starting year	2016
Duration (year-month-day)	from 2016-05-01 to 2020-08-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK Organization address address: WESTERN ROAD city: Cork postcode: T12 YN60 website: www.ucc.ie contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IE (Cork)	coordinator	531˙349.00
2	JOHANN WOLFGANG GOETHE-UNIVERSITATFRANKFURT AM MAIN JOHANN WOLFGANG GOETHE-UNIVERSITATFRANKFURT AM MAIN Organization address address: THEODOR W ADORNO PLATZ 1 city: FRANKFURT AM MAIN postcode: 60323 website: www.uni-frankfurt.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (FRANKFURT AM MAIN)	participant	747˙649.00
3	UNIVERSITY OF BATH UNIVERSITY OF BATH Organization address address: CLAVERTON DOWN city: BATH postcode: BA2 7AY website: http://www.bath.ac.uk/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (BATH)	participant	546˙575.00
4	FACHHOCHSCHULE NORDWESTSCHWEIZ FACHHOCHSCHULE NORDWESTSCHWEIZ Organization address address: BAHNHOFSTRASSE 6 city: WINDISCH postcode: 5210 website: www.fhnw.ch contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (WINDISCH)	participant	530˙453.00
5	ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON Organization address address: 6 CHRISTOU LADA STR city: ATHINA postcode: 10561 website: www.elke.uoa.gr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	EL (ATHINA)	participant	484˙773.00
6	PION INC.(UK) LTD PION INC.(UK) LTD Organization address address: RIVERSIDE FOREST ROW BUSINESS PARK city: FOREST ROW postcode: RH18 5DW website: www.sirius-analytical.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (FOREST ROW)	participant	273˙287.00
7	JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV Organization address address: TURNHOUTSEWEG 30 city: BEERSE postcode: 2340 website: www.janssenpharmaceutica.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BEERSE)	participant	250˙560.00
8	MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN Organization address address: FRANKFURTER STRASSE 250 city: DARMSTADT postcode: 64293 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (DARMSTADT)	participant	249˙216.00
9	PHARMATEN ANONYMOS VIOMICHANIKI KAI EMPORIKI ETAIREIA PHARMAKEFTIKON KAI KALLYNTIKON PROIONTON PHARMATEN ANONYMOS VIOMICHANIKI KAI EMPORIKI ETAIREIA PHARMAKEFTIKON KAI KALLYNTIKON PROIONTON Organization address address: DERVENAKION STREET 6 city: PALLINI postcode: 15351 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	EL (PALLINI)	participant	242˙386.00
10	H. LUNDBECK AS H. LUNDBECK AS Organization address address: OTTILIAVEJ 7-9 city: VALBY postcode: 2500 website: www.lundbeck.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (VALBY)	participant	0.00

Map

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.

Deliverables

List of deliverables.
PEARRL Outreach Plan	Documents, reports	2020-01-30 17:24:47
PEARRL website	Websites, patent fillings, videos etc.	2020-01-30 17:24:47

Take a look to the deliverables list in detail: detailed list of PEARRL deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2019	Ioannis Loisios-Konstantinidis, Rodrigo Cristofoletti, Nikoletta Fotaki, David B. Turner, Jennifer Dressman Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. Case example: Naproxen published pages: 105170, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.105170	European Journal of Pharmaceutical Sciences	2020-01-30
2019	Christina Pentafragka, Mira Symillides, Mark McAllister, Jennifer Dressman, Maria Vertzoni, Christos Reppas The impact of food intake on the luminal environment and performance of oral drug products with a view to inÂ vitro and in silico simulations: a PEARRL review published pages: 557-580, ISSN: 0022-3573, DOI: 10.1111/jphp.12999	Journal of Pharmacy and Pharmacology 71/4	2020-01-30
2019	Georgia Tsakiridou, Christos Reppas, Martin Kuentz, Lida Kalantzi A Novel Rheological Method to Assess Drug-Polymer Interactions Regarding Miscibility and Crystallization of Drug in Amorphous Solid Dispersions for Oral Drug Delivery published pages: 625, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics11120625	Pharmaceutics 11/12	2020-01-30
2020	Marina Statelova, Konstantinos Goumas, Nikoletta Fotaki, RenÃ© Holm, Mira Symillides, Christos Reppas, Maria Vertzoni On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants: an Exploratory Study Highlighting the Importance of Infant Food published pages: , ISSN: 1550-7416, DOI: 10.1208/s12248-019-0380-4	The AAPS Journal 22/1	2020-01-30
2019	Felix Ditzinger, Catherine Dejoie, Dubravka Sisak Jung, Martin Kuentz Polyelectrolytes in Hot Melt Extrusion: A Combined Solvent-Based and Interacting Additive Technique for Solid Dispersions published pages: 174, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics11040174	Pharmaceutics 11/4	2020-01-30
2019	Felix Ditzinger, Daniel J. Price, Anita Nair, Johanna Becker-Baldus, Clemens Glaubitz, Jennifer B. Dressman, Christoph Saal, Martin Kuentz Opportunities for Successful Stabilization of Poor Glass-Forming Drugs: A Stability-Based Comparison of Mesoporous Silica Versus Hot Melt Extrusion Technologies published pages: 577, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics11110577	Pharmaceutics 11/11	2020-01-30
2019	Mirko Koziolek, Stefano Alcaro, Patrick Augustijns, Abdul W. Basit, Michael Grimm, Bart Hens, Caroline L. Hoad, Philipp Jedamzik, Christine M. Madla, Marc Maliepaard, Luca Marciani, Annalisa Maruca, Neil Parrott, Petr PÃ¡vek, Christopher J.H. Porter, Christos Reppas, Diana van Riet-Nales, Jari Rubbens, Marina Statelova, Natalie L. Trevaskis, KateÅ™ina ValentovÃ¡, Maria Vertzoni, Dubravka Vitali ÄŒ The mechanisms of pharmacokinetic food-drug interactions â€“ A perspective from the UNGAP group published pages: 31-59, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.04.003	European Journal of Pharmaceutical Sciences 134	2020-01-30
2020	Daniel J. Price, Anita Nair, Johanna Becker-Baldus, Clemens Glaubitz, Martin Kuentz, Jennifer Dressman, Christoph Saal Incorporation of HPMCAS during loading of glibenclamide onto mesoporous silica improves dissolution and inhibits precipitation published pages: 105113, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.105113	European Journal of Pharmaceutical Sciences 141	2020-01-30
2019	Rafael Leal Monteiro Paraiso, Ayahisa Watanabe, Cord J. Andreas, David Turner, Patricia Zane, Jennifer Dressman Inâ€vitroâ€“inâ€silico investigation of the negative food effect of zolpidem when administered as immediateâ€release tablets published pages: 1663-1676, ISSN: 0022-3573, DOI: 10.1111/jphp.13161	Journal of Pharmacy and Pharmacology 71/11	2020-01-30
2019	Sandra Jankovic, Patrick J. O\'Dwyer, Karl J. Box, Georgios Imanidis, Christos Reppas, Martin Kuentz Biphasic drug release testing coupled with diffusing wave spectroscopy for mechanistic understanding of solid dispersion performance published pages: 105001, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.105001	European Journal of Pharmaceutical Sciences 137	2020-01-30
2018	Daniel J. Price, Felix Ditzinger, Niklas J. Koehl, Sandra Jankovic, Georgia Tsakiridou, Anita Nair, RenÃ© Holm, Martin Kuentz, Jennifer B. Dressman, Christoph Saal Approaches to increase mechanistic understanding and aid in the selection of precipitation inhibitors for supersaturating formulations - a PEARRL review published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12927	Journal of Pharmacy and Pharmacology	2020-01-30
2018	Simone Aleandri, Sandra Jankovic, Martin Kuentz Towards a better understanding of solid dispersions in aqueous environment by a fluorescence quenching approach published pages: 130-139, ISSN: 0378-5173, DOI: 10.1016/j.ijpharm.2018.08.029	International Journal of Pharmaceutics 550/1-2	2020-01-30
2018	Joseph P. O\'Shea, RenÃ© Holm, Caitriona M. O\'Driscoll, Brendan T. Griffin Food for thought: formulating away the food effect - a PEARRL review published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12957	Journal of Pharmacy and Pharmacology	2020-01-30
2018	Felix Ditzinger, Daniel J. Price, Alexandra-Roxana Ilie, Niklas J. KÃ¶hl, Sandra Jankovic, Georgia Tsakiridou, Simone Aleandri, Lida Kalantzi, RenÃ© Holm, Anita Nair, Christoph Saal, Brendan Griffin, Martin Kuentz Lipophilicity and hydrophobicity considerations in bio-enabling oral formulations approaches - a PEARRL review published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12984	Journal of Pharmacy and Pharmacology	2020-01-30
2018	Mariana GuimarÃ£es, Marina Statelova, RenÃ© Holm, Christos Reppas, Moira Symilllides, Maria Vertzoni, Nikoletta Fotaki Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products - a PEARRL review published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12955	Journal of Pharmacy and Pharmacology	2020-01-30
2018	Chara Litou, Angela Effinger, Edmund S. Kostewicz, Karl J. Box, Nikoletta Fotaki, Jennifer B. Dressman Effects of medicines used to treat gastrointestinal diseases on the pharmacokinetics of coadministered drugs: a PEARRL Review published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12983	Journal of Pharmacy and Pharmacology	2020-01-30
2018	Sandra Jankovic, Georgia Tsakiridou, Felix Ditzinger, Niklas J. Koehl, Daniel J. Price, Alexandra-Roxana Ilie, Lida Kalantzi, Kristof Kimpe, RenÃ© Holm, Anita Nair, Brendan Griffin, Christoph Saal, Martin Kuentz Application of the solubility parameter concept to assist with oral delivery of poorly water-soluble drugs - a PEARRL review published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12948	Journal of Pharmacy and Pharmacology	2020-01-30
2017	Daniel Price, Christoph Saal, Anita Nair, Jennifer Dressman A Novel In Silico Screening Protocol For The Selection Of Optimized Precipitation Inhibitor Systems For Supersaturable Formulations published pages: , ISSN: , DOI:		2020-01-30
2018	Laura J. Henze, Niklas J. Koehl, Joseph P. O\'Shea, Edmund S. Kostewicz, RenÃ© Holm, Brendan T. Griffin The pig as a preclinical model for predicting oral bioavailability and inÂ vivo performance of pharmaceutical oral dosage forms: a PEARRL review published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12912	Journal of Pharmacy and Pharmacology	2020-01-30
2018	Patrick J. O\'Dwyer, Chara Litou, Karl J. Box, Jennifer B. Dressman, Edmund S. Kostewicz, Martin Kuentz, Christos Reppas In vitro methods to assess drug precipitation in the fasted small intestine - a PEARRL review published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12951	Journal of Pharmacy and Pharmacology	2020-01-30
2018	Angela Effinger, Caitriona M. O\'Driscoll, Mark McAllister, Nikoletta Fotaki Impact of gastrointestinal disease states on oral drug absorption - implications for formulation design - a PEARRL review published pages: , ISSN: 0022-3573, DOI: 10.1111/jphp.12928	Journal of Pharmacy and Pharmacology	2020-01-30
2017	Patrick O\'Dwyer, Karl Box, Robert Taylor, Hayley Watson In Vitro Modelling Of Propranolol Immediate Release And Extended Release Formulations Using A Three Chamber Dissolution Apparatus published pages: , ISSN: , DOI:		2020-01-30
2019	Laura J. Henze, Niklas J. Koehl, Joseph P. O\'Shea, RenÃ© Holm, Maria Vertzoni, Brendan T. Griffin Toward the establishment of a standardized pre-clinical porcine model to predict food effects â€“ Case studies on fenofibrate and paracetamol published pages: 100017, ISSN: 2590-1567, DOI: 10.1016/j.ijpx.2019.100017	International Journal of Pharmaceutics: X 1	2020-01-30
2019	Daniel J. Price, Anita Nair, Martin Kuentz, Jennifer Dressman, Christoph Saal Calculation of drug-polymer mixing enthalpy as a new screening method of precipitation inhibitors for supersaturating pharmaceutical formulations published pages: 142-156, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.03.006	European Journal of Pharmaceutical Sciences 132	2020-01-30
2018	Felix Ditzinger, Uta Scherer, Monica SchÃ¶nenberger, RenÃ© Holm, Martin Kuentz Modified Polymer Matrix in Pharmaceutical Hot Melt Extrusion by Molecular Interactions with a Carboxylic Coformer published pages: 141-150, ISSN: 1543-8384, DOI: 10.1021/acs.molpharmaceut.8b00920	Molecular Pharmaceutics 16/1	2020-01-30
2019	Ioannis Loisios-Konstantinidis, Rafael L. M. Paraiso, Nikoletta Fotaki, Mark McAllister, Rodrigo Cristofoletti, Jennifer Dressman Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review published pages: 699-723, ISSN: 0022-3573, DOI: 10.1111/jphp.13070	Journal of Pharmacy and Pharmacology 71/4	2020-01-30
2019	Niklas J. Koehl, RenÃ© Holm, Martin Kuentz, Brendan T. Griffin New Insights into Using Lipid Based Suspensions for â€˜Brick Dustâ€™ Molecules: Case Study of Nilotinib published pages: , ISSN: 0724-8741, DOI: 10.1007/s11095-019-2590-y	Pharmaceutical Research 36/4	2020-01-30
2019	Brendan T. Griffin, Jennifer B. Dressman The PEARRL reviews - innovative drug development strategies tailored to facilitate earlier access to new oral medicines published pages: 439-440, ISSN: 0022-3573, DOI: 10.1111/jphp.13083	Journal of Pharmacy and Pharmacology 71/4	2020-01-30
2019	Chara Litou, Nikunjkumar Patel, David B. Turner, Edmund Kostewicz, Martin Kuentz, Karl J. Box, Jennifer Dressman Combining biorelevant in vitro and in silico tools to simulate and better understand the in vivo performance of a nano-sized formulation of aprepitant in the fasted and fed states published pages: 105031, ISSN: 0928-0987, DOI: 10.1016/j.ejps.2019.105031	European Journal of Pharmaceutical Sciences	2020-01-30

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