by Jason Hirschhorn

Optimizing the regulatory content management and submission process can reduce time to market for critical medicines.

The world has seen many firsts since the onset of the COVID-19 pandemic. Among those firsts was the record-time development, design, regulatory submissions, approval and deployment of the COVID-19 vaccine. As impressive as these feats were, they are obviously nowhere near the norm in how drugs are traditionally brought to market. According to the Food & Drug Administration (FDA), median approval time for New Drug Applications (NDAs) is 240 days – nearly 8 months – meaning some companies take more than a year to even get their applications filed. Since we’ve now seen that it is possible to speed up the drug approval and development timeframe, the question on many people’s minds is: why can’t we speed development time for all drugs?

Accelerating the drug development pipeline is becoming a strategic imperative for most companies. There are multiple levers that can help make this happen. A key and often overlooked lever is optimizing clinical and regulatory content to enable efficient reuse of more standardized content. Biotech companies have recognized the need to adapt approaches in managing, reusing and automating data and content used in regulatory filings, yet don’t quite know where to begin. Industry estimates indicate up to 25% of all drug development costs are related to documentation.

Critical medicines can get to patients faster by focusing on the content, processes and technology used to manage the content used in regulatory submissions across the clinical lifecycle and for new drug approvals. As a starting point, firms should seek to:

  • Analyze clinical and regulatory content and understand where the data and content used originates from a process and functional standpoint. This will help determine the stakeholders that need to be involved.
  • Work with stakeholders to analyze your content and define standards and reuse models to eventually drive more automation. Opportunities exist to auto generate key sections of clinical study reports, safety narratives, statistical analysis plans and others. However, to realize the value from those opportunities content needs to be standardized. And you can’t get to standards unless you have systematically analyzed your content.
  • The structured content management (SCM) and submission management technology landscape is rapidly evolving for the pharma industry. Use technology proof of concepts to refine requirements and demonstrate what is possible. Technology solutions can play a major role in enabling this transformation and accelerating timelines. Areas to consider include SCM vendor landscape (types of solutions, need to integrate up and downstream); natural language generation/automation solutions; real-time cloud submission (future); and value of proof of concepts/experiments.
  • Analyze how information flows across the lifecycle. Identify internal ‘customers’ that reuse your information and determine whether that information has been created with the various customers and their needs in mind.
  • Treat your content as you would data or other critical information. It needs to live in a system. You need to analyze it, define standards and governance, and maintain, manage and utilize automation where possible for maximum benefit.
  • Evaluate the benefits of implementing structured content management systems. In such a system, content is not managed at the document level but in more granular reusable components with appropriate metadata applied. This helps content becomes F.A.I.R (Findable, Accessible, Interoperable and Reusable).
  • Opportunities exist to auto generate regulatory content utilizing natural language generation tools based on underlying business rules/logic.

The Bottom Line

Filing timelines for regulatory approval of new medicines can be improved from current state. This matters to patients and has obvious financial benefits as well. It also allows medical writers to focus on higher value activities instead of copying and pasting information or performing manual compliance checks. Keep in mind that it’s a cross functional journey that requires bringing together multiple capabilities and functional groups and requires working with health authorities to ultimately shift from the current paradigm. There is a maturity evolution around this work that your organization needs to define for itself and embrace. Point B can help you assess where you are and move up the maturity curve. We understand the challenges facing global filing teams, regulatory leaders, documentation and medical writing teams, and we stand ready to partner to and help speed critical drug development timelines.