GlaxoSmithKline S.A in Tres Cantos, Spain, is a GlaxoSmithKline (GSK) Local Operating Company dedicated since 2001 to the development and commercialization of new medicines, vaccines and Consumer Healthcare products. Within GSK S.A. the Clinical Research Area is responsible for the set up and conduct of clinical research programs activities. These activities range from identifying investigational sites, preparation of clinical trials and Epidemiologic documentation for Competent Authorities and Ethical Review Boards (including development of informed consent forms), monitoring the study conduct and publication of results.
Role in the project
GSK will contribute providing the Industry Sponsor point of view in Clinical Research. Pharmaceutical Industry accounts for a large percentage of the clinical trials conducted in EU and therefore the private pharmaceutical experiencie and perspective can help to better understand the current situation and to facilitate adoption of the new guidelines resulting of this project in the future. As an Innovative Industry looking for new treatments, GSK SA works in partnership with Health Institutions, Physicians, nurses, RECs and Authorities to develop new drugs and vaccines to cover unmet medical and public health needs. GSK will take part in all the project WPs with its highest dedication in WP3.
Mrs. Olga Maria Martinez-Casares
Olga Maria Martinez-Casares is head of clinical research strategy, clinical development early phases, and patient advocacy in the Medical Department of GSK.
She has a degree in Pharmacy and a Master degree in Direction and Management of Research, Development and Innovation in Health Sciences.
She has a long experience both in technical and managerial positions in clinical research, including team and matrix leadership in local and international teams.
M. REYES BOCETA MUÑOZ
Clinical Operations Head Vaccines in Spain with large experience in Clinical Research Vaccines (since 97), including all steps from feasibility, monitoring activities, resource allocation, budget planning and control, interaction with Research Ethics Committees and Regulatory Authorities, clinical study report and publication activities. Vaccines Clinical Studies (Phase I-IV) developed in multiple medical areas: Preventive Medicine, Pediatrics, Neonatology (preterm), Gynecology and Obstetrics, Nephrology, Oncology, Hematology, Pneumology, HIV and Infectious Diseases.
Wide experience in team management and leading local matrix teams with an active participation in multiple working groups at regional and global level as European representative within GSK Vaccines.
ELENA LOPEZ SANTOS
Senior Project Manager at the GSK DDW in TresCantos. She has acted as project manager (appointed by Coordinator) in charge of the administrative and financial management in several EU funded consortiums. She is also program manager at the COFUND-Tres Cantos Open Lab Fellowship Scheme and invited evaluator expert by the EC.
FRANCISCO JAVIER RUBIO POMAR
Senior Project Manager at the GSK Medicines Development Center in Madrid-TresCantos, a Research Centre for developing new drugs against Diseases of the Developing World (DDW) that operates in an open collaborative scheme. He has participated in +10 successful EU-Funded proposals, and is actively involved in the promotion and implementation EC Marie Sklodowska Curie, and RTD-Euraxess actions.
MARIA CUBILLO DIAZ-VALDES
Graduate degree in Pharmacy and Biotechnology (European University of Madrid), and post-graduate diploma in Biotechnology Management (University of California Riverside). She began her professional career in the Pharmaceutical industry in the field of Clinical Research, monitoring Oncology clinical trials. Now she participates in i-Consent project focusing on Task 1.2 regarding “Differences in Online communication by gender”. She is also collaborating on the IC guidelines development (WP3) and on “New strategies for improving health literacy for participants in clinical trials” (Task 2.7). Ethical issues on informed consent (D1.4) and Sociological and psychological factors on informed consent (D1.7) have also been under her collaboration.