Chris Martin

• provision of a variety of pharmaceutical science and product development services, with particular expertise in transdermal and oral dosage forms.

• review of research protocols and data, investigation into pipeline products, background research into new therapeutic areas, meetings with potential investors and drafting of publications.

Reviewed batch documentation for a variety of terminally sterilised parenteral medicines, instigating relevant investigations and assessing quality control data prior to review and release by a Qualified Person. Reviewed and maintained numerous technical agreements with various TP partners, including those where TP was the contract giver and those where TP was the contract acceptor. Led on the development of ICH Q3D elemental impurity and nitrosamine risk assessments for a variety of terminally sterilised parenteral medicines. Researched and authored two MHRA interim compliance reports for TP involving extensive liaison with colleagues across the business to compile the relevant information. Led review of the “request for further information” following the most recent MHRA inspection at TP and assimilation of relevant data to demonstrate that the respective audit corrective actions had been addressed. This process involved extensive liaison, and repeated follow up, with colleagues from across the business to compile the relevant information in preparation for the subsequent MHRA audit.

Provision of Clinical Trials Pharmacist services to Exeter CTU for the Bill and Melinda Gates Foundation funded, COVID-19 related, BRACE trial (BCG vaccination to reduce the impact of COVID-19 in healthcare workers). Performed thorough review of the trial Pharmacy Manual, and associated documents, to ensure the quality, management and distribution of both IMP and placebo to vaccination sites across the UK. Review stimulated the UK Principal Investigator to liaise with the Chief Investigator regarding study inclusion criteria and IMP dosing instructions.