InPharma — A fully integrated, animal-free, end-to-end modelling approach to oral drug product development

Results in brief

A fully integrated, animal-free, end-to-end modelling approach to oral drug product development

Oral medicines are preferred by patients worldwide due to ease of self-administration and overall higher patient compliance. Yet, the challenges around formulating molecules into medicines for oral administration have increased substantially over the last 30 years, mainly because most drugs coming through the drug discovery pipeline are too poorly soluble to be dissolved and efficiently absorbed from the gastrointestinal tract. Furthermore, due to the considerable challenges in formulating poorly soluble drugs for oral delivery, the number of animals used to screen oral absorption of formulation prototypes is increasing, despite the EU’s commitment to reducing animals in research. In order to ensure a rich pipeline of new oral medicines for European patients and to avoid unnecessary animal testing in oral drug product development, a quantum leap is needed in identifying the optimal formulation design for a new drug candidate. The InPharma consortium aims to solve these important challenges through pioneering research focused on advancing an integrated, end-to-end, animal-free approach to formulating poorly soluble drugs for oral administration. InPharma is the first European Industrial Doctorate (EID) that aims to eliminate animals from the development of oral drug formulations. The InPharma consortium brings together leading pharmaceutical scientists from six multi-national pharmaceutical companies, five world-class research institutions and eight partner organisations, from complementary technology and service providers (SMEs) to additional pharma and regulatory representatives to create a research network involving nine European countries. The main research objectives in InPharma are to develop a fully integrated, end-to-end model-based approach to oral drug development, linking ‘big data’ available from drug profiling repositories with computational tools to predict oral formulation design, generating innovative physiologically relevant in vitro tools and adapting computational models to predict drug absorption from ‘enabling’ oral drug formulations in clinically relevant scenarios.

Data: CORDIS, © European Union

Project objective

Oral drug products are preferred by hundreds of millions of patients in Europe. Yet, the challenges around formulating drugs for oral administration have increased tremendously over the last 30 years, mainly because most drugs coming through the Pharma pipeline are too poorly soluble to be efficiently absorbed from the GI tract. A quantum leap in identifying the optimal formulation for a new drug in the most efficient way possible is urgently needed to keep the Pharma industry in Europe competitive. Further, due to the enormous challenges in formulating poorly soluble drugs for oral administration, the numbers of animals used to screen formulation prototypes are increasing, despite EU commitment to reducing animals in research. The InPharma Consortium provides a unique solution to solving these important challenges.The InPharma EID will strengthen Europe’s innovation capacity and leadership in the Pharma sector, specifically in drug formulation. Exceptional intersectoral training will be provided to 13 ESRs through pioneering research focused on harnessing computational pharmaceutics, Biorelevant in vitro testing and PBPK modeling, generating an integrated, end-to-end, animal-free approach to formulating poorly soluble drugs for oral administration. ESRs will undergo specialized training program to build proficiency in essential research and industry disciplines, while training in professional skills and entrepreneurship will prepare them to become trailblazers in pharmaceutical formulation.A highlight of InPharma is the proven, successful collaboration among Consortium experts in the design, evaluation and implementation of enabling formulations for oral delivery. This EID will immerse ESRs in highly dynamic industrial environments under the supervision of leading academics, exposing them to all elements of pharmaceutical formulation, fostering collaboration, catalyzing synergies across the network and ultimately creating a truly unique training experience.

Original text from CORDIS.

Participants

UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK · CorkCoordinatorIreland
ASTRAZENECA AB · SodertaeljeSweden
BAYER AKTIENGESELLSCHAFT · LeverkusenGermany
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON · ATHINAGreece
F. HOFFMANN-LA ROCHE AG · BaselSwitzerland
FACHHOCHSCHULE NORDWESTSCHWEIZ FHNW · WindischSwitzerland
FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV · MunchenGermany
JANSSEN PHARMACEUTICA NV · BeerseBelgium
SOLVIAS AG · KaiseraugstSwitzerland
SYDDANSK UNIVERSITET · Odense MDenmark
ZENTIVA KS · PRAHACzechia

InPharma · A fully integrated, animal-free, end-to-end modelling approach to oral drug product development

Results in brief

A fully integrated, animal-free, end-to-end modelling approach to oral drug product development

Project objective

Participants

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