LBTSF - Almirall joins FACILITATE a patient-driven Innovative Medicines Initiative (IMI) project to enable the use of clinical trial data by study participants

• FACILITATE aims to create a framework for clinical trial participant’s data access and reutilisation for a fully transparent and ethical ecosystem

• Almirall brings its experience in privacy matters and pharmaceutical law, as well as in the development of guidance, standards, and recommendations for returning clinical trials data to patients

• The project will last four years and involves 27 partners from 16 EU and extra-EU Member States, including patient associations, hospitals, universities, SMEs, and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA)

Almirall, S.A. (ALM) , a global biopharmaceutical company focused on skin health, today announced that it is participating in FACILITATE , ( F r A mework for C l I nica L tr I al participants’ da TA reutilization for a fully T ransparent and E thical ecosystem) a patient-driven Innovative Medicines Initiative (IMI) project aimed to create a framework for access and reutilization of clinical trial participant data for a fully compliant and ethical ecosystem . FACILITATE main objective is to help return the clinical trial data to the study participants, ready for reuse in either further research or in healthcare practice, improving the current situation where clinical data are isolated in separate repositories and cannot be used outside the clinical trial.

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Almirall's main contribution focuses on providing expertise in privacy and pharmaceutical law issues, as well as in developing guidance, standards, and recommendations for the return of clinical trial data to patients. In addition, the company also contributes with its expertise in the specification of clinical trial use cases, stakeholder requirements, and the development of end-user tools.

Facilitate is based on a patient-centred, data-driven technology platform with 27 partners from 17 EU and non-EU Member States . Participants include patient associations, hospitals, universities, innovative small and medium-sized enterprises, and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA), and with the Università degli Studi di Modena e Reggio Emilia as project coordinator. The project, which was approved by the IMI Joint Undertaking (European Commission and EFPIA) in 2021, has been launched this year together with the FACILITATE website.

“ The launch of FACILITATE further advances patient empowerment in clinical trials. At Almirall, we are excited to contribute to this patient-driven IMI project with our solid experience in clinical trials and our commitment to ethics and transparency. This project is fully aligned with our patient-centricity strategy aimed at improving their quality of life,” stated Diego Herrera, Almirall’s FACILITATE Project Leader.

"FACILITATE is an IMI-JU project that builds on the collaborative efforts of many public and private partners and has the purpose to manage the return of individual clinical trial data in a trusted legal and ethical environment. Leveraging on a patient's needs, FACILITATE aspiration is to develop a prototype process which enables the return of clinical trial data during and after the clinical trial and allows for the secondary use of that data" , said Prof Johanna Blom, University of Modena-Reggio Emilia (UNIMORE) vice-coordinator of FACILITATE

FACILITATE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 101034366. The JU gets support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

For more information about FACILITATE, please visit https://facilitate-project.eu/

About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros.

For more information, please visit almirall.com

Legal warning

This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements". These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law.

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