Universitat Autònoma de Barcelona
Description
The UAB is the leading Spanish university, 
ranking 176rd in the world (QS- ranking 2012). UAB participates in 122 FP7 projects, acting as a coordinator for 13 of them and received more than 34 millions Euros of funding. UAB hosts 6 excellent projects funded by the European Research Council and participates in 85 European research projects outside FP7.
Two internal UAB groups will closely collaborate in this project: the Biostatistics Unit at the Faculty of Medicine and the Department of Pharmacology, Therapeutics and Toxicology.
The Biostatistics Unit has focused its research on translational bioinformatics and applied statistics, with broad experience in non-standard clinical trial design and conduction, including sequential methods and expertise in regulatory applied medical statistics.
The Department of Pharmacology, Therapeutics and Toxicology Department will work decentralised at two of the teaching Hospitals belonging to the Faculty of Medicine: Corporació Sanitària Universitària Parc Taulí and Hospital de la Santa Creu i Sant Pau. The group at Hospital de la Santa Creu i Sant Pau has a strong and long-lasting involvement in regulation and orphan diseases, while the team at Parc Taulí has been focused mostly on design and regulatory aspects of clinical trials in early phases of development.
Main tasks
UAB contribution will include WP5 leadership, aiming to integrate the output from the project into tangible results for patients: through practical application of new methodological approaches to real examples, and aiming to propose innovative ways to assess treatments for rare diseases.
UAB will integrate expertise in methods and statistics with understanding of the need of clinical results for these unprotected populations, as well as of the amount of evidence that can be considered safe and fair to balance the need of early access and evidence based objective decisions, all of which will be useful for input into WP4 and WP6.
Key personnel
The PI, Ferran Torres, MD PhD, is a clinical pharmacologist, member of the Scientific Advice Working Party (SAWP) and member of the Biostatistics Working Party (BSWP) at EMA. He is also leading the ECRIN group for data management in Spain and has 20 years of experience in study design and assessment of clinical trials.
Caridad Pontes, MD PhD, is in charge of the Clinical Pharmacology Unit at Corporació Sanitària Universitària Parc Taulí, has a strong background in design, execution, analysis and reporting of early phase clinical trials, as well as on pharmacoepidemiology and regulatory affairs due to her previous experience in managing positions at pharmaceutical industry for 15 years. She is a member of the Independent Ethic’s Committee at her hospital and an external expert to the Spanish Agency on Medicines; as such, she collaborates in Scientific Advice procedures at the EMA several times a year. She is a principal investigator and director of several investigator-promoted independent clinical projects.
Josep Torrent-Farnell, MD PhD, clinical pharmacologist in Hospital de la Santa Creu i Sant Pau, is the current Spanish member and former chairman (2000 to 2006) of the Committee on Orphan Medicinal Products (COMP) at the EMA; he was also member of the SAWP (2009-2012). He was also Director of Spanish Medicines Agency from 1999 to 2000. Deeply involved in research and regulation of orphan diseases, he participates in International Rare Diseases Research Consortium IRDiRC, is a consultant of Catalan Health System and collaborates closely with EURORDIS (European association of patients with Rare Diseases).
Rosa Morros, MD, clinical pharmacologist, has a wide experience in designing clinical studies and evaluating clinical trials from a regulatory point of view. She is a member of the Spanish Committee on Human Medicines of the Spanish Agency of Medicines as an expert in drug evaluation. Her current focus of research is the use of medicines in real clinical practice in primary care, which she does at the Institut de recerca en Atenció Primària - Fundació Jordi Gol. She is a principal investigator and director of several research projects, using population-based databases of medical records and a number of investigator-promoted independent clinical trials.
José Rios, MSc, is a statistician and an expert in statistical methodology applied to clinical trials. He has been providing support for statistical design and analysis of biomedical and clinical studies with many diverse methodologies for the last 15 years, including analysis of clinical trials, epidemiological studies and gene-expression data.
Roser Vives, MD MSc, is a pharmacologist and an epidemiologist specialized in the design and conduction of clinical studies, with 15 years of experience at research positions in the pharmaceutical industry. At the Clinical Pharmacology Unit at Corporació Sanitària Universitària Parc Taulí, she is involved in several investigator-promoted independent clinical projects, and as an external expert to the Spanish Agency of Medicines she collaborates in Scientific Advice procedures several times a year.
Mónica Gómez-Valent, PharmD, is a hospital pharmacist at Corporació Sanitària Universitària Parc Taulí and a PhD student at UAB. Her focus of interest is in drug evaluation and pharmacology and she is now involved in a number of studies on the use of drugs in real practice.
Manel Fontanet, PharmD, is a hospital pharmacist at Hospital de la Santa Creu i Sant Pau and a PhD student at UAB. His main focus of interest includes pharmacology, drug regulation and orphan medicines. He is responsible for the technical office of the Consell Assessor Tractaments Farmacològics Alta Complexitat from the Catalan Health System, which evaluates orphan drugs and advanced therapies, and he is also advisor of the Spanish federation of patients with rare diseases.
Mercedes Campillo, PhD, and Leonardo Pardo, PhD, are the leading professors of the Biostatistics Unit at the Faculty of Medicine and responsible for the Laboratory of Computational Medicine. They have a wide statistical background and deep knowledge of bioinformatics. They also provide extensive experience in the coordination and management of multinational projects including FP6.
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Dr. Ferran Torres |
Dr. Caridad Pontes |
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Dr. Roser Vives |
Roger Borras |
