Pharma and life science companies can reduce time to market by optimizing regulatory content management and submission processes.
Accelerating the drug development pipeline is becoming a strategic imperative for most companies. While there are multiple levers that can help make this happen, a critical yet 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. Some industry estimates indicate up to 25% of all drug development costs are related to documentation.1
Focusing on the content, processes and technology used in regulatory submissions across the clinical life cycle and is critical, but you may need to swim upstream from regulatory to where content originates (e.g., clinical science). As a starting point, companies should seek to:
Analyze clinical and regulatory content, work to understand the flow of data and content across the value chain, and determine which stakeholders need to be involved in designing and approving more standardized content that can be reused. Content may originate, for example, with a clinical science or biometrics stakeholder but may then be reused across the value chain by medical writers, regulatory and medical information professionals. Stakeholders from these different areas need to come together to agree on “the standard” that will meet a specific need while allowing maximum reuse. Standardizing, structuring and working towards more technology-enabled reuse across this chain drives consistency, efficiency and productivity.
Work with stakeholders to analyze content and define standards and reuse models that can be enabled using structured content management (SCM) systems and, eventually, automation solutions. Opportunities exist to auto generate key sections of clinical study reports, safety narratives, statistical analysis plans and others. To realize the value from those opportunities requires that content is standardized.
The SCM and submission management technology landscape is rapidly evolving for the pharma industry. Use technology proof of concepts with SCM vendors 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, Word vs. web browser interface); natural language generation/automation solutions; real-time cloud submission (future); and defining the value of proof of concepts/experiments.
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 around it, and maintain, manage and utilize automation where possible for maximum benefit.
Evaluate the benefits of implementing SCM 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).
Manage expectations accordingly. An SCM or any solution that automates the generation or reuse of content is not a panacea and will not result in a “one click” submission. All of these are tools to help medical writers and filing teams operate more efficiently but submissions will still “authored” for the foreseeable future.
Filing timelines for regulatory approval of new medicines can be improved. It has obvious financial benefits and allows medical writers to focus on higher value activities instead of copying and pasting information or performing manual compliance checks. Keep in mind that this is a cross functional journey that requires bringing together multiple capabilities and functional groups and may also require working with health authorities to shift the current document/dossier paradigm.
Transforming content management practices in pharma is a multi-year maturation journey and will look slightly different in each organization. The journey starts with identifying specific pain points around content authoring, review and approval, defining specific goals, and developing a plan to move along a maturity curve.
Jason Hirschhorn is senior managing consultant for life sciences and pharma at Point B, a consulting company that helps organizations in the areas of customer engagement, growth investments, workforce experience and operations excellence.