This year marks a return to in-person conferences, and at Generis we jumped at the opportunity to engage with our communities once again, attending RSIDM in North Bethesda, DIA Europe in Brussels, GPRAS in Berlin, and with DIA Global 2022 in Chicago. Despite great efforts from the industry to encourage networking and idea sharing through virtual conferences, the ability to chat over a cup of coffee or attend and discuss a great presentation together is undoubtedly a more successful way to interact with one another.
We had a great opportunity to connect with many of our current customers, and as always, it’s great to hear feedback on how CARA is helping clients manage and unify their day-to-day processes. We were also able to meet many new people and pique their interest with CARA Life Science Platform.
There were many great talks from both industry and vendors, here are a few highlights:
1. Drug or device?
As a result of the U.S. Court of Appeals for the District of Columbia Circuit decision in Genus Medical Technologies v. FDA, many drugs that have been classified as such, are in the process of being reclassified as medical devices, or ‘combination’ products. The challenge here presents itself in determining whether a change for medical devices is major or minor, for example when a software update or a bug fix is needed for a component. This can be solved with an efficient QMS system through change requests and impact analysis. The result of the Genus v. FDA case has also highlighted a crucial need for standardising and centralising the terminology and technology involved to avoid inconsistent regulations.
This highlights that effective collaboration between different authorities is crucial. Keeping up with changing regulations is already a difficult task, further amplified where there is disparity between the advice given. The EMA’s strategy seems to be the most efficient so far, with them deeming any product with ambiguity around its classification as a ‘medicinal product’. We look forward to getting further clarification on this and supporting our clients through this process with the flexibility of the CARA Life Sciences Platform.
2. Good Quality Structured Data
Covid saw some great developments in medicine, but it also exposed some weaknesses within processes, for example the huge volume of adverse events emphasised the need to improve efficiency. While hiring increased, this problem couldn’t be solved by just employing more people, in order to prepare for future challenges, businesses saw the need to implement modern solutions, and equip their teams with tools for automation. Reducing manual labour in these sectors allows us to keep patient care at the forefront.
The difficulty for international life sciences companies is abiding by different standards in different countries as outlined by WHO with the 4 Levels of Regulatory Authority Maturity. The more mature markets prefer to receive information as data because they have the mechanisms and procedures in place to ingest it, while less mature markets still require PDFs. Even then, some companies will spend hours of valuable time making beautiful PDFs, only for the authority to waste more time copying and pasting individual cell data to fit their structures.
The solution here is a system which can not only store data and documents but repurpose it into different formats for different markets without additional work required from employees. This is one of CARA Life Sciences Platform’s central capabilities as the underlying ‘data lake’ allows information to be entered once, then re-used and re-purposed.
3. Is the future artificial?
As always, there were many lively discussions around the role that AI can, and should, play in the future of healthcare. One example, was for ingesting safety cases, the MHRA spoke of their AI implementation which can ingest huge volumes of text and extract information for adverse events and construct well-structured data from the case narratives. It resulted in huge time savings, and better-quality data with the AI only adding to the information and never removing any data.
One of the most frequent concerns is validation of AI, for this and other cases the strategy is to compare it against human results and to maintain a human presence in the process, in the form of a designated person who can check results. It means that while the human element isn’t completely taken out of the process, time spent was decreased by 70%, bringing the average processing time to just under 30 minutes.
We are always assessing the expansion of the use of AI in our platform, and the benefits it can bring - improved efficiency, higher volumes of better-quality data captured, earlier issue and signal detection and improved interventions across core cross-enterprise processes. Too often vendors are guilty of using AI as a buzzword without much substance. You can read more about this here.
The pandemic thrust the Life Science industry into the limelight, with the acceleration of clinical trials and vaccine development going from specialised topics to dinner table talk. Many are still invested in the latest news and developments, with it having an evident presence throughout DIA Global. We are yet to see the full effects of the past few years on our industry, but the themes of connectivity, better quality of information and efficiency are prevalent across the board.