Negative to Positive: How we turned a double rejection into a successful medical technology ready to market!
The Challenge
Oftentimes, Accelagen is approached when businesses have been unsuccessful in obtaining the approval required to get their product or device to market. It is our unique approach to process that focuses on asking the right questions, getting the right team in place early on, and ensuring clarity on the outcome to devise the right pathway that creates the impressive differential in the outcomes we generate for our clients.
During 2022, Accelagen has enjoyed tackling this very challenge while working closely with a US-based Medical Device development organisation who was previously unsuccessful in obtaining Ethics approval for its new and innovative technology intended to manage post-operative pain in adults. The technology is designed to deliver analgesia through avoiding the commonly used medications, including powerful narcotics, and provide an alternative to therapies that are well documented as leading to possible opioid addiction.
Two prior Ethics Committee submissions for this First in Human clinical study were rejected, with the Company feeling unclear on a way forward when we met.
The Analysis
A look at exactly what resulted in the rejections was our first step together as part of our strategic consultation. We understood that the initial rejection may have been attributed to a misunderstanding of the technology and its mode of action. and the second – which included additional data intended to manage the initial rejection – was the result of ambiguity in data intended to address Committee questions. Following an initial, in-depth discovery session with the Client, the Accelagen team identified that robust data was available that supported a positive risk/benefit evaluation, a critical feature of the NHMRC’s National Statement on Ethical Conduct in Human Research.
The Solution
Using our extensive regulatory experience, the team at Accelagen was tasked with revising the data within the Investigators Brochure and Clinical Investigational Plan and guiding the reviewer through the technology’s development journey. Key data outcomes from the comprehensive investigations used to support safety and performance were highlighted and connected with study outcomes. Risks identified were discussed and appropriate mitigations described. No changes to the clinical study design or outcomes was required, rather an emphasis on the important questions the initial program would address.
Through Accelagen’s strong alliance partnership with St Vincent’s Hospital Melbourne (SVHM), our team engaged with key staff to discuss a possible pathway to gain Ethics approval. Accelagen, together with our Client, discussed the technology and its history with the SVHM team and chartered a new pathway forward that focused on key data needed, whilst maintaining transparency of interactions with other Committees.
Following the initial submission, Accelagen facilitated all steps of the submission process, with final approval granted 42 calendar days later. Despite initially receiving two negative outcomes, our collaborative strategy design, high quality delivery and perseverance of the Accelagen team was able to gain our Client the approval needed through to commercialisation.
Since our inception, Accelagen has always looked to innovate and to improve. We are driven by passion and ingenuity and have never accepted the status quo, nor been prepared to settle for ‘the way things have always been done.’ We look beyond the challenges and are ni business to identify robust solutions that accelerate the landscape of health and wellness.
Get in touch with our expert team to see how together we can accelerate the future of human health and wellness.