He did so by comparing ‘structured content’ adoption in Life Sciences with the state of adoption in other industries. He notably compared Life Sciences with the following ‘leading’ industries: Media and Publishing, Manufacturing, Aviation, Hardware, and Software.
Structured Content in Life Science
Structured content has had attention in Life Sciences for quite a while. Understandable, because the submission processes for medicine tick many boxes for structured content.
- Submissions have a strictly defined document structure;
- Within dossiers there is a high level of content repetition and reuse;
- Across markets, submissions are largely but not completely identical, making a case for automated document generation;
- Regulators are moving in the direction of digital, data-centric submissions;
- Documents are populated with data from other systems within the company; preferably done by automated content/data integration.
Despite all this, to date, structured content in Life Science companies has only reached limited implementation.
When discussing similarities and differences between the various industries, a few observations came up:
- Life Science historically has had substantial budgets available. The cost reductions of structured content have not been enough of an argument to outweigh the effort of change-management.
- Regulators are moving slower than expected in their evolution from document-driven to data-driven submissions. Formatted PDF, accompanied with metadata, is still the digital format that forms the core of most submissions.
- Typically, structured content projects (most of them in Proof of Concept stage) have been strongly IT-driven. They have also received less support from the business side of companies.
Structured content — climbing Gartner’s slope towards productivity
As Gartner’s 2018 Hype Cycle Report says, Structured Content and Component-Based authoring are climbing the slope toward productivity. Companies are adding structured content capabilities to their IT landscape — after expectations were inflated, tempered, and now are gradually growing.
Vendors such as AMPLEXOR are integrating structured content capabilities in their end-to-end solutions. They expect that in 2–5 years, the use of content components will replace the document-centric practice of today.
One of the questions remaining is what the drivers behind wide adoption (plateau of productivity) will be.
As concluded during the conference, the following developments will continue to push towards structured content authoring
- The question is not if regulators will take further steps towards data-driven content submissions, but when and how exactly. A policy-event would likely accelerate structured content adoption.
- The rise of tailored medicine, which increases the variants of products to register, which increases the need for efficient submission.
- Tangible proof of how structured content accelerates filing will move interest from cost and risk management towards reaching extra revenue.
Last but not least, technology has advanced to a level that makes structured content authoring feasible for non-XML experts. Most of the PoCs that pharma companies have done were conducted 5–10 years ago. This means their authoring solutions typically led to resistance from business stakeholders because of their complexity.
User-friendly solutions like Fonto, mostly embedded in an industry-specific workflow solution, have been shown to be capable of onboarding authors in industries such as Media, Publishing, Manufacturing, Aviation, Regulatory and others. In Life Sciences, we feel that structured content will indeed enter the ‘Plateau of Productivity’ in the years to come.
