I have over 10 years’ experience in human vaccine testing, development and research. My works were done in collaborative environment between first class universities and global vaccine manufacturing companies such as GSK and Sanofi. I was appointed as senior vaccinologist/immunologist at the Hull York Medical School (HYMS) at the University of York in open competition in July 2011. I lead a group focussing on Phase I clinical trial for a leishmania therapeutic vaccine. I have successfully completed a Phase-IIb CMV vaccine clinical trial in solid organ transplant patients (2007-2011) while working as senior immunologist at the Royal Free Hospital, London. The vaccine was developed by Sanofi as a subunit recombinant protein vaccine. My responsibilities in these two vaccine clinical trials were managing the projects, setting and conducting immunological assays and quality control and assurance. As briefly outline below:
Writing, reviewing and working to Standard Operating Procedures.
Conducting and setting all immunological assays (ELISpot, Intracellular Cytokines and antibody ELISA, protein expression analysis by SDS PAGE and FACS).
Critical review of data and ensure work is documented appropriately.
Testing the imunogenicity and safety of the vaccine in animal models.
Preparation of documents for internal and external meetings, including meetings with regulatory agencies.
Ensuring all “GXP” service providers are audited prior to initiation of key activities or supplier selection.
Ensuring all appropriate SOPs in place to manage internal aspects of clinical trial activities.
Involved in protocol development, risk assessment, sponsorship application and regulatory arrangements.
Planning practical aspects of study management with researcher, nurse, and clinician to ensure the protocol is fit for purpose and the funding and staffing adequate to support good quality trial conduct.
Studies on preclinical animal model for novel vaccine development and research
Supervising staff and training junior members
Transcriptomics analysis using next generation sequencing.