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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:
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.