Clinical Development of A Drug-Device Combination

Added: 14th November 2016

A US-based client wished to conduct a first-in-human clinical trial of a novel drug-device combination product in the UK. Both the medicinal substance and the medical device were well-known and approved separately in the EU but for different indications and intended purposes. CellData Services was part of a UK-based team assembled to accelerate the setting up and approval of the clinical investigation. From the regulatory affairs perspective there are significant differences in approach between the US and the EU regarding regulation of combination products so our first objective was to ensure that the client became familiar with device investigations in the EU. We then undertook a detailed review of the product development data and provided a gap analysis and guidance on critical aspects essential for EU clinical investigations. In particular we focused on ensuring the suitability of the drug substance data against EU medicinal product data requirements. We were able to maximise the use of published data and demonstrate its applicability to the novel combination to facilitate a rapid and uncomplicated approval for the clinical investigation.

" With over 10 years of experience of using consultants and other suppliers for all sorts of activities, I can truly say that Alison Wilson is a rare find.  Alison was our UK regulatory consultant for a first in human clinical trial for a combination product.  Our internal project team did not have previous experience with combination products, clinical trials, and let alone the first human clinical trial outside the US.  Alison was critical to our success from the very beginning to the very end of that trial.  What I found to be so commendable about Alison is not just her technical skill and experience that we were hiring her for, but her clear communication style and personal commitment to the project team and overall project success.  Alison on several occasions, made herself available outside business hours to accommodate the time difference between the UK & US and support hitting deadlines.  She took the time to dig into details and truly understand technical data in order to write a strong submission.  She also took the time to not just check the boxes and tell us what to do from a regulatory perspective, but to educate us on the benefits of different strategic approaches and background of the MHRA's potential interpretation.  "

Christine Kearney - Principal Engineer - CareFusion Inc, USA