Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), founded in 1993, is a research centre formed by the Generalitat de Catalunya's Ministry of Innovation, Universities and Enterprise (DIUiE), the University of Barcelona's Faculty of Medicine, the Hospital Clínic i Provincial de Barcelona (HCPB) and the Institut d'Investigacions Biomèdiques de Barcelona of the Council for Scientific Research (IIBB-CSIC).
The AIDS unit of HCPB is taking care of 4,418 patients (year 2012), with an hospitalization service, a day care facility (where most of the trials are performed), a home care facility, outpatients consultations, capability of control by Telemedicine and a joint program with primary care physicians. The organization has accredited laboratories of biochemistry, immunology and microbiology, integrated in the “Centre for biomedical diagnosis” (CDB) that participate in clinical trials performing the routine biologic analysis of the patients participating in the trial, including determinations of plasma viral load and CD4+ lymphocyte cell count.
Felipe García MD, PhD
Jose M Gatell MD, PhD
Joan A Arnaiz MD, PhD
Montserrat Plana MD, PhD
ITM is a postgraduate academic institution, founded in 1906. It’s mission is “to carry out and promote scientific research, education and services provision in human and animal health, with emphasis on tropical and related diseases, health problems and health care in developing countries”. ITM has a long-standing tradition in the field of HIV prevention and treatment research in Europe and Africa. At present HIV research has been integrated in IHAC (ITM HIV and AIDS Center). One focus is on epidemiology and intervention studies in Africa, mainly in the field of prevention of HIV and sexually transmitted diseases (STD), including search for immune-genetic determinants of susceptibility and resistance to HIV transmission. The Virology Unit is focusing on HIV immunotherapy, based on mRNA and is also involved in various international networks on preventive drugs, including the FP7 CHAARM (Combined Highly Active Anti-retroviral Microbicides). Our AIDS Reference Lab is monitoring international studies and trials on HIV and STD prevention and treatment, sponsored by CONRAD, FHI etc. The HIV Clinic is leading an international network of centres in Africa, Asia and South-America on various aspects of clinical care. In our own centre, we follow-up about 2,000 HIV-infected subjects, about half MSM and half migrants.
Dr. Guido Vanham, MD PhD
Dr. Eric Florence, MD PhD
Pieter Pannus, MS
The core activities of the Vrije Universiteit Brussel are education, research and social services. The university has more than 9,000 students and more than 150 research groups, including research groups that are absolute world leaders in their field. The University Hospital Brussels records about 20,000 out-patients and 27,000 hospitalised patients a year. The Laboratory of Molecular and Cellular Therapy (LMCT) of the Medical School of the VUB has participated in a FP6 Network of Excellence focused on DCs and novel immunotherapies (DC-Thera) and an integrated project entitled ‘Cancer immunotherapy’. This research has resulted in a patent on RNA-based modification of DCs (either in vivo or ex vivo) to enhance their immunogenicity. The LMCT houses a clean room facility for the manufacturing of cellular vaccines, (accredited by the Belgian competent authorities). The LMCT has implemented the structure for clinical development of innovative immunotherapy and several phase I/II clinical trials with RNA-modified DCs have been performed in cancer and HIV. A phase I study on therapeutic RNA vaccination in patients with hepatocellular carcinoma is being planned. The LMCT also uses several preclinical (mouse) model systems to study the underlying mechanisms of immune defence, resistance and escape.
eTheRNA is a small and medium sized enterprise (SME) that has a dual business model. eTheRNA provides contract manufacturing services and contract research services for third parties.
eTheRNA’s team represents a vast array of expertise in Immunology and Oncology, which gives eTheRNA the ability to perform lead development optimisation, preclinical evaluations, clinical documentation support as well as research immuno-monitoring during clinical trials. By conducting immuno-monitoring during clinical trials, an important translational aspect can be achieved which enables eTheRNA to further fine-tune the therapeutic approach in order to achieve the desired end-result.
eTheRNA has the facilities and expertise to device and produce innovative mRNA-based immuno-therapies at phase I/II scale. A GMP-compliance certificate was issued in 2012 by the Belgian Federal Agency for Medicines and Health Products for the production of mRNA as an API and in 2013 a MIA was obtained for the production of IMPs.
Sonja Van Meirvenne
Erasmus MC is the largest university medical center in The Netherlands and hosts the Viroscience lab, headed by Prof. Ab Osterhaus. The Viroscience lab brings together world-leading scientists in the fields of molecular virology, immunology, epidemiology, pathogenesis, and intervention studies on human and animal virus infections. More than 140 researchers are engaged in a state-of-the-art research programme. Viruses under research include influenza A and B virus, RSV, hMPV, measles, coronaviruses, HIV-1, HIV-2, hepatitis A, B and C viruses, West Nile virus, dengue, monkeypox, and herpes viruses. Findings are published in journals such as Nature, Science, Nature Medicine and The Lancet and include some of the most highly cited papers in the field. Recently, Viroscience lab`s scientists and collaborators identified and characterized a new human coronavirus in humans, middle east respiratory syndrome coronavirus (MERS-CoV). Viroscience lab identified the human metapneumovirus (hMPV) and human H5N1 infection in Hong Kong. It developed vaccines and anti-viral drugs against several viruses including influenza viruses. The group also played a crucial role in the identification of SARS-CoV and intervention strategies for SARS. The department houses the National Influenza Center and the international reference center for viral haemorraghic fevers for WHO. It coordinates the FP7 projects EMPERIE (223498), ANTIGONE (278976), VECTORIE (261466), FLUNIVAC (602604) and ASKLEPIOS (602825). All necessary equipment to carry out the research proposed in the project is available within the setting of the department, including cell culture facilities at the BSL-2 and BSL-3 levels, flow cytometry, sequencing facilities and a fully equipped genomics laboratory. The department has proven its ability in the performance of a previous phase I/IIa clinical trial for immunotherapy of HIV infection.
Prof. Marion Koopmans, DVM, PhD
Dr. Rob Gruters, PhD
Paul Huber, L.L.M., Msc.
Wesley de Jong, MD
Patrick Boers, BSc
Prof. Eric Van Gorp, MD, PhD
IRSICAIXA is a non-profit organisation founded in 1995 and is a leading institute and reference centre for the research and treatment of the Acquired Immuno Deficiency Syndrome (AIDS) in Catalonia. The activities of the IRSICAIXA Foundation occur primarily in the Retrovirology Laboratory of the Hospital Universitari Germans Trias i Pujol of Badalona (Barcelona, SPAIN), which combines a wide set of experts in virology and anti-viral immunology. IRSICAIXA has participated in several EU funded projects since FP6, such as VIROLAB (FP6-27446), EUREGOSIDA (FP6-LSHP-CT-2006-018632), CHAIN (FP7-HEALTH-F3-2009-223131) and CUTHIVAC (FP7-HEALTH-F3-2009-241904).
All laboratory infrastructures needed to conduct HIV-related research are in place at IrsiCaixa. In particular, a 10-hood BL3 facility, a multi laser LSR II FACS machine and 2 high throughput pyrosequencers. In addition, the retrovirology lab is only steps apart from the clinic where HIV infected individuals are being identified, treated and enrolled in vaccine related studies. Biological sample collection containing 72,000 specimens from HIV-1-infected subjects is available. Fully equipped virology laboratory (250m2 BL3 facility, a multi-laser LSR II flow cytometer, automated cell separator, epi-f microscopy, ultracentrifuge, 10 standard PCR cyclers, 1 digital-droplet PCR, 2 qPCR cyclers, 5 DNA sequencers, 2 high throughput pyro-sequencers -454-) as well as on site shared platforms (luminex, cell sorting, proteomics, electron microscopy, animal facility) are in place.
Prof. Christian Brander
Prof. Javier Martinez-Picado
Prof. Bonaventura Clotet
Synapse is a company specialized in the management of research and development projects in the biomedical sector, working with a great variety of stakeholders at both national and international levels (pharmaceutical companies, biotechnology companies, research centres, academia, hospitals, etc.). Located in Barcelona, SYNAPSE leverages the expertise of highly skilled, experienced project management professionals with a track record of over 15 years in international collaboration projects, with special attention to EC-funded projects since FP3 (including ESPRIT, INCO, TAP, LIFE, IST, ICT, HEALTH, ENVIRONMENT, NMP, IMI JU) among other programmes and funding schemes, directly supporting the co-ordinators of 8 running FP7 projects and acting as Programme Managers of the IMI JU funding for EMIF, a large-scale (48 M€) IMI project started in 2012. It regularly provides support to a variety of research institutions, companies and governmental agencies on project proposal preparation, project negotiation, execution and exploitation, and collaborators include top-level researchers in UK, Spain, Netherlands, Switzerland and Italy, both from academia and industry. SYNAPSE is also managing two major national projects in the biomedical field, involving 25M€+. SYNAPSE personnel are regularly invited to teach lectures and courses on EU projects.
The expertise of the team covers: project management; financial and legal assessment; exploitation and IPR management; knowledge management; validation and assessment; business planning; training, dissemination and communication strategies design and implementation. SYNAPSE’s interdisciplinary structure includes specialists in biochemistry and pre-clinical research, biology and clinical trials, project management, finance, law, research exploitation, psychology, education and marketing. Their role in the project will be providing a management structure that both helps and monitors the project development and integration, thus becoming a crucial tool for its success.
ASPHALION is an International Scientific and Regulatory Affairs consultancy firm based in Barcelona and Munich.
Founded in 2000, ASPHALION has consistently grown and now, consists of over 40 professional consultants with backgrounds in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine and Veterinary Medicine.
ASPHALION offers comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies.
ASPHALION can manage EU, US, Latin American and selected RoW procedures.
ASPHALION has its own experienced US agents in the fields of Pharma/Biotech, Medical Devices and In Vitro Diagnostics.
ASPHALION has also developed a network of regulatory consultants in Latin America. ASPHALION is in a position to support you in countries such as Mexico, Colombia, Venezuela, Ecuador, Peru, Brazil, Argentina and Chile.