Fueled in no small part by a global pandemic, pharmaceutical companies are facing immense pressure to get products to market faster and more effectively while also being transparent and open with regulatory submission information. These firms are looking for any means to improve both efficiency and transparency without sacrificing quality – causing them to invest heavily in Digital Transformation.
A recent article from the Journal of Pharmaceutical Sciences, “The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management,” highlights these trends and the critical role Structured Content
plays in these Digital Transformation initiatives:
Structured content practices allow organizations to reduce manual and redundant labor throughout the product lifecycle
Structured content improves data discoverability
Structured content improves interoperability between platforms and systems
Structured content authoring streamlines the regulatory submission process
Structured content is the building block for innovation
Not surprisingly, these same ideas are concepts that DCL has long proposed as a leader in the Structured Content industry. This article distills key points from the “Future of CMS Regulatory Submissions” article combined with key tenets DCL maintains.
"One strategy to increase efficiency and speed of drug development is to restructure a sponsor's current data management ecosystem and content authoring process to facilitate improved regulatory submission and review."
What is Digital Transformation?
Digital transformation is the adoption of digital technology by an organization, and it can involve spending thousands, hundreds of thousands, or even millions of dollars purchasing new tools and technologies. If you’re in a Fortune Global 2000 company, you’ve most likely witnessed this firsthand. Even before the pandemic, a Gartner survey reported that 42% of CEOs had implemented “digital business transformation” of some kind.
The Life Sciences industry tends to be cautious to adopting new things, however, so many pharma, biotech, health science organizations, and regulators are in the beginning steps of their digital transformation journey. What they are finding is that no matter how many new tools, systems, and funds you put toward transforming your organization, none of these investments will truly transform your business outcomes unless you also address your content and data.
Transforming content and data includes the development and implementation of structured content through both Structured Content and Data Management (SCDM) and Structured Content Authoring (SCA). The Ultimate Goal of SCDM implementation would be to achieve a digital transformation of all data and information from a global perspective across clinical trials, labelling, quality, safety, packaging, and marketing.
Pharma is Unique
The Pharmaceutical Industry is distinctive in many ways in terms of Digital Transformation. I’ll address 3 of these.
1. Reuse and Data
While reuse can be compelling in other industries, there’s a growing emphasis around incorporating data into pharma/life science content which is different from other disciplines.
With technical documentation, we want to reuse content like steps and legal information, but we’re not trying to incorporate a bunch of research data.
In parts management, we’ve got a lot of numbers and data, but it doesn’t necessarily flow into sentences and “content;” it’s more often table information only.
In scholarly publishing, incorporating data is critical, but reuse is not (in fact, reuse is often called by another name in academia: PLAGIARISM!)
In pharma, however, both data and content reuse are critical.
Furthermore, every version and every change to both content and data must be traceable. In Pharma there is much more of a focus and importance placed on traceability and bi-directional genealogy queries than in other industries.
Unfortunately, the data required for this traceability is usually spread across a variety of systems. These systems are typically not semantically connected, but are more “row/column” based, which causes:
Difficulties in data assembly
Difficulties in parsing
Also contributing to traceability problems is the fact that the data in these various systems often exists in multiple formats with no consistent metadata.
3. Data Standards
This leads to another key differentiator for Pharma: industry standards have not been universally adopted across companies and geographies. The pharma specialization for DITA (formerly the OASIS DITA Pharmaceutical Content Subcommittee) seems to have been abandoned a few years back and there is no standard like we see in scholarly publishing with JATS or in aerospace with S1000D. We do have SPL (structured product labeling), but that’s FDA specific and US centric. The EU is implementing IDMP standards. There are CDISC standards and eCTD standards and others, but many are more templates for document structure and not true structured content data models.
"The dynamics of the pharmaceutical industry cannot sustain the outdated, isolated, and static data retrieval methodologies utilized by both sponsor and health authorities in strategic decision-making and risk-based analysis."
HL7 provides a framework (and related standards) for the exchange, integration, sharing, and retrieval of electronic health information. These standards define how information is packaged and communicated from one party to another, setting the language, structure and data types required for seamless integration between systems. However, HL7 has not developed a standard unified data model yet.
While individual companies could build their own unified data model, and while some industry groups are trying to retrofit Microsoft Word for this purpose, Digital Transformation initiatives will be FAR more efficient and impactful as a Structured Content model is harmonized across the pharmaceutical industry in partnership with global harmonization efforts such as those within the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
Not only will a harmonized data model allow the collective expertise to build a more robust data model for SCA, it will eventually also allow the submission of a digital data package for the statistical assessment, data trending, and analytical comparison by Health Authorities around the world. Instead of pushing individual submissions to each relevant Authority, an industry standard data model will eventually allow Pharma companies to submit one file to a Global Labeling exchange platform like Accumulus Synergy which could then accessed by all the global Heath Regulatory agencies.
Structured Content and Data is the Future, and the Future is Now
If there is no industry data standard yet, is there a business case for Structured Content now?
Moving to Structured Content in some format today will allow organizations to easily pivot to an industry standard model when it becomes available, giving them a competitive advantage.
Implementing structured content enables pharma companies to create content five times faster.
A componentized Structured Content model resolves challenges with dynamic access and traceability inherent in document-based and PDF-oriented approaches.
Structured Content is designed specifically to facilitate both content and data reuse.
By extracting and enriching data, organizations accelerate digital transformation to innovate, meet modern consumer expectations, propel business forward, and enable the use of AI technologies. Simply having information in a digital format, such as a Word file or an image-based PDF, is not enough.
"Static, PDF-locked documents produce unique challenges for automation, dynamic access and review of data, and intelligent analysis of data. Taking advantage of data and content formats, which are not as restrictive as PDF formats, would digitally transform the pharmaceutical industry."
For content to be easily discovered, exchanged, and used via modern platforms, it must be converted into a multidimensional content or data format from which machines can extract pertinent information and humans can more effectively manage. Structured content and data management in combination with cloud technologies will enable the ability to construct regulatory filings concurrently, submit filings simultaneously to multiple health authorities, allow collaboration between agencies, and simplify the information requests from each health authority.
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 A great description of Structured Content can be found at https://www.fontoxml.com/blog/what-is-structured-content/.
 Structured Content and Data Management (SCDM) is defined in the article as “The integration of structured content with structured data and the management of those integrated components...At the heart of SCDM is a core design principle which aims to shift a company's focus to managing data instead of managing documents.”
 Structured Content Authoring (SCA) is defined in the article as simply “Automation of regulatory authoring.” A more robust definition may be found at https://www.scriptorium.com/2017/04/structured-authoring-and-xml/, describing it as “a publishing workflow that lets you define and enforce consistent organization of information in documents, whether printed or online.”
 From The Pharma Content Evolution: Content Reuse and Automation by Val Swisher and Regina Lynn Preciado