Recent Projects

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A university department wanted to understand the commercial potential of a diagnostic they were developing. Specifically, would it be useful and be rapidly integrated into the current diagnostic pathway. John reviewed the medical literature and current treatment guidelines, then mapped the current patient pathway and interviewed health care professionals in primary, secondary and tertiary care to understand their knowledge of and interest in the new diagnostic. He identified the gaps seen in the current data and how to fill them, provided some potential research partners and advocates to the university and suggested a regulatory framework to follow. He suggested some important areas of groundwork such as developing a quality management system that the university could start in order to be prepared for the regulatory hurdles to come. These findings and suggestions were provided in a comprehensive report.

A pharmaceutical company wanted to develop a biomarker to measure the effect of their new product. The company had two preferred sites in the UK to perform trial work with. John provided feedback on the protocol and identified the possibility of using the low interventional study route. After discussion with the investigators, he wrote the IRAS clinical trial application and developed a patient information sheet and consent form for patients entering the study. The protocol is now progressing with the company.

Following a phase 3 study with a failed primary endpoint, John led interaction with FDA to develop a second phase 3 study. John delineated the issues in the original protocol, and identified key areas of expected superiority for the developmental drug. He then wrote an initial protocol synopsis, developing a primary endpoint that should best show the benefit of the new product, and worked with clinical and regulatory colleagues to finalise the study protocol. John then led a team to present the study to the FDA, and then negotiated a Special Protocol Assistance agreement. The study has since completed and has demonstrated significant benefit for patients with the new treatment and is being used for future regulatory development of the product.

John was asked to develop a post-marketing pharmacovigilance service for a late stage development company. John reviewed and presented options to the company management. He then ran an RFP for an outsourced pharmacovigilance provider and shortlisted and interviewed providers. He presented comparison data on safety, geographical reach and services and costings to the board and appointed a provider. Following this he worked with the provider to develop the pharmacovigilance infrastructure and wrote a risk management plan for the company's first product. Following this the product was licensed and successfully launched across Europe.