Maria Serrano

Background

About Maria Serrano

Clinical Trial Manager and Research Associate, UCL. Clinical Trial ATIMP Coordinator and Research Associate, UCL.(until mid September 2013): Clinical Trials Co-ordinator and Research Associate leading first-in-human gene and cell therapy studies within EU guidelines regulating clinical trials with Advanced Therapy Medicinal Products (ATMPs). ATMPs include gene therapy medicinal products (GTMPs), cell therapy medicinal products (CTMPs) and tissue-engineered medicinal products (TEMPs). The role includes: As a Clinical Trials Coordinator, developing the ATMP trials portfolio across UCL sites and her Partner NHS Institutions. Responsible for the set-up and management of multicentre phase I/II gene therapy clinical trials, working closely with the Chief Investigator and Regulatory Managers (ATMP Trials) at the Sponsors office (UCL, Joint Biomedical Research Unit). Acting as the key point of contact for the internal and external site trials teams, external parties, R&D offices, GTAC and the MHRA in the set-up and management of the clinical trials ensuring work is conducted in line with the protocols, GCP other applicable regulatory requirements and sponsor's SOPs. As Research Associate, generating the Investigational Medicinal Product, retrovirally transduced T cells, under GMP laboratory requirements for use in Phase I/II trials.