The Drug Information Association has once again succeeded in bringing together a stellar line-up of experts to discuss some of the hottest topics in the Life Sciences industry today. With the virality of trailblazing AI so far this year in the form of Chat-GPT and similar tools, it’s no surprise that it was a topic on many presenters’ lips, along with a common theme of digital transformation, and its impact on the future of various domains within the drug development ecosystem.
Below are some of our key takeaways from the 35th Annual DIA Europe Conference:
Digitisation & AI
AI has truly permeated our personal and professional lives, and traditionally this idea has been associated with people losing their jobs and sentiments of ‘the machines are taking over’. One presentation highlighted the importance of staying up to date with these advancements in order to maintain a broader perspective around changes on a large scale. Rather than roles disappearing, it was suggested there must be an evaluation of roles, with an emphasis on equipping people with the right tools and knowledge to upscale existing skills, providing the ability to utilise advancements in AI and automation to make existing roles easier.
What we are seeing is the full digital transformation of the Regulatory workforce itself, what a regulatory position may look like in the next 5 years. The presentation discussed a People Training approach, investing in the time to provide people with the right training in subjects unfamiliar to much of the workforce; namely AI and programming. The drivers of change and progress in this industry are the people, and discussions on the day suggested that it is crucial to not only begin these changes at the curriculum level for students, but to also invest in up-skilling of the ‘older’ workforce, and with the right training approach they can learn to adapt to the new tools being introduced and can even pick up new roles altogether. This way, knowledge can be scaled across the organisation at all levels.
One such occurrence is the rise of citizen developers, people with only a small amount of background knowledge who are able to configure and make changes to systems to avoid outsourcing and wasting time communicating with external consultants, you can read more here about the role of low code development and the new roles it creates here.
Unlock the Potential of Data
Better data management is at the heart of many digital transformation initiatives, specifically data integrity. One presentation discussed how data integrity is a prerequisite to obtaining digital transformation in R&D. With such consistent and rapid change in the drug development ecosystem, there is an ever-increasing amount of data sources, but often the full potential of this data is left locked away unless there are measures in place to ensure the integrity of the data collected. The presentation showed how data integrity can be breached in numerous ways; lack of adequate access controls, data not accurately documented, and critical deviations not investigated.
The key to obtaining a fully integrated business begins with a strong data foundation to ensure high quality data, and there are several critical aspects to this, including: Data governance, Master Data Management (MDM), Data quality, Interoperability, and Security & Compliance. But how do you enable that data to achieve business outcomes like informed decision making and a faster time to market?
· Technology: Selecting the right tools and technologies to leverage trusted data for value-adding decision making
· Automate: Automate end-to-end processes to break down silos, increase efficiency and reduce manual work
· Advanced analytics: Utilise advanced analytics to drive data causality and gain deeper insights.
Another presentation touched upon some other obstacles to utilising data effectively. Firstly was Data Consistency, storing data in separate systems and silos makes it difficult to ensure consistency across various sources. This also impacts Data Governance, but by storing data in a single data lake you enable centralised management and control of the data, simplifying the process of quality checks, while other governance policies can be applied consistently across all data sources. A single repository can have massive impacts on the potential use of data, including its availability, scalability, and the security of that data.
Harmonisation and iSPOC Critical Medicines Reporting
Discussions on iSPOC Critical medicines reporting to EMA suggested that the creation of a common standard has temporarily led to a more complex shortage notification process, this is due to a lack of available technology, common understanding and a need for further clarification. Learnings from the first 6 months of the new regulation suggested that harmonisation and integration should happen at the start of the notification process.
It can be difficult for organisations to keep up with new regulations and submission formats if they don’t have a modern, agile platform with the capability to provide automations for notifications, and to reformat and leverage existing data to align with changing needs rather than starting from scratch each time. Even with modern technology available, too many companies are still relying on outdated and disparate systems including spreadsheets and email chains to manage health authority communications including. This is an area where automations are key, pre-configured notifications, auto-rendering, formatting and concatenation can all be made much easier with the right tools in place, preventing non-compliance and time wasted.
It was great to join our clients and partners at DIA Europe this year. It was a great opportunity to connect with industry professionals and develop a shared goal and understanding of the direction the industry is heading in with the latest innovations in AI, Machine Learning, and Digitisation across the board.