We kicked off our events calendar this year with RSIDM in Washington, and what a difference a year makes! It was great to see the event back in full-swing this year. We had the opportunity to connect with partners and clients once again, as well as getting to meet many industry professionals and thought leaders, spreading the word about the CARA Life Sciences Platform.
Below are some key themes and our takeaways from the many insightful presentations held over the course of the conference.
Among the great presentations there was a common theme of effective collaboration within submission management and the wider regulatory ecosystem.
Two of the presentations highlighted case studies of platforms and workspaces aimed at facilitating and enhancing collaboration between stakeholders in the healthcare ecosystem. The case studies highlight the need for, and benefit of, a single platform for enhanced collaboration across regulatory departments within an organisation as well as between Regulatory and Health Authorities.
The goal of the two systems is to tackle the issues of todays isolated submissions involving static documents, which still require a great deal of manual input. And instead, make a much needed move towards a more dynamic interaction in the data submission, review, and assessment process. However, certain challenges encountered during the examples bring to light how reducing manual input, and providing all parties with central access to data and content are critical to improving efficiency, and reducing the time it takes for submissions across the board.
The CARA Life Sciences Platform can solve these challenges, enabling real-time collaboration both with internal teams, and external stakeholders. The platform provides seamless collaborative authoring and annotation, ensuring content never leaves the control of the platform, so multiple users, partners, and external affiliates can monitor the progress of a submission in real-time and offer ongoing feedback.
Plus, with the ability to automate submission processes, CARA captures your full business process including decision points, correspondence and meeting minutes. The process is also guided, with the system providing next steps intelligently based on your type of submission and context.
As anticipated, a hot topic during the event was of course: IDMP. One presentation spoke on how regulatory authorities agree on the need to integrate data (organisational integration), the need to allocate software developers to integrate systems (technical integration) but still do not sufficiently recognise that semantics are important. Semantics could facilitate the success of organisational and technical integrations, and this lack of standardisation is limiting us as an industry, requiring standard terminology globally.
But, since this is unlikely to be achieved, instead Reference Data Management should be applied when we have to deal with multiple vocabularies for the same concept/artefact. Here’s how it would work:
Apply company preferred terms per attribute
Apply the finest granularity of the attribute
Map company preferred terms to any and all other vocabularies
This should be maintained either at the supplier site, the recipient site, or in the public domain.
Data is at the core of the CARA Life Sciences Platform and ways to make better use of it was discussed a great deal at the conference, from a number of different angles. However, a stand out discussion was from our 2022 Big Debate panellist Frits Stulp, Managing Director of Iperion Life Sciences Consultancy.
The presentation started with an overview of the current state of our product story, highlighting it’s incompleteness. Today, Submissions, Health Authority Correspondence, Queries, Commitments and IDMP data are captured and tracked differently – typically in a DMS, RMS, a shared drive, or Excel. This process leads to Regulatory Information workers having to manually maintain and query several unlinked, potentially outdated data sources.
This was followed with a vision of how the product story should look:
Everyone helps write the product story and it is only complete if we capture each chapter in one system.
The regulatory story is told by the regulatory strategists, Labelling Team, CMC Team, etc. throughout the life of a product.
When all activities are captured in 1 system this allows the entire product story (or chronology) to be available in 1 place with links to related activities in the story.
It was suggested that in order to protect the patients we serve, a broad, high-level view of the information from the perspective of the product story is required, rather than from a departmental perspective. The presentation ended with some considerations of how we can make Regulatory 3.0 happen today: “define and build your product stories & business cases, set organisational expectations for data, and drive innovation.”
Structured Content Management
The topic of Structured Content Management and Component-based Authoring was touched upon in a number of presentations, it was evident that Component Based Authoring is the next industry wide need to streamline global authoring across drug development documents. Regina Lynn Preciado, Sr. Director of Content Strategy at Content Rules, Inc. explained in her presentation how traditional processes prevent pharma companies from achieving their business goals: Reducing time to market and developing new drugs.
“There’s a lot of risk inherent to copy and paste, of introducing or perpetuating errors. You end up with content drift as well, because each writer tweaks the pasted content,” says Preciado. “Then it’s almost impossible to find all the instances of that content when you need to make an update. It costs so much time, and creates so much redundant work, to create so much redundant content. And it’s just not necessary anymore.”
Preciado outlined the potential of content reuse and automation in pharma content; namely the reuse of a single source of truth, data integration, delivering content in multiple channels and formats, automated formatting, reporting, and digital information exchange.
Clearly the general consensus is that Structured Content Management represents the next evolution in content across the pharma ecosystem.