regulatory and clinical expertise
Knowing when and how to engage with regulatory bodies is also key in optimising clinical study designs and overall development programmes.
Vectura has a strong team of experienced professionals in all development-related disciplines required for taking drugs and drug-device combinations from pre-clinical development right through to regulatory submission (MAA – Marketing Authorisation Application or NDA – New Drug Application) and post-approval.
This has recently been demonstrated in the planning and successful execution of the VR647 pharmacokinetic and methodology studies in the US. The clinical development plan was constructed using the team’s knowledge and expertise of respiratory disease, and with a comprehensive understanding of the regulatory framework and legislation for combination products and medical devices. Key opinion leader engagement was sought to ensure clinical protocol designs would meet expected patient need and would be operationally feasible. Knowing when and how to engage with regulatory bodies is also key in optimising clinical study designs and overall development programmes. Our combined experience in clinical, regulatory and statistics has ensured the VR647 clinical results are optimally interpreted and summarised to discuss with the FDA, supporting future Phase III activities.