Driving Regulatory Efficiency in the Face of COVID-19
Despite introducing a wave of new challenges for life sciences companies, COVID-19 also renewed the industry’s focus on innovation regarding how products are developed and brought to market. In their 2020 pulse survey, Gens & Associates uncovered several ways that regulatory teams are driving positive results from the pandemic, and they shared these findings on a recent webinar co-hosted by Veeva and RAPS.
Gens & Associates explained that while most companies are maintaining the status quo with little disruption, 34% of respondents are improving performance. For example, organizations have set up internal pandemic task forces to examine existing systems, accelerate decisions, and bypass slower, more complex processes.
Scott Cleve, VP of Regulatory Operations & Compliance at bluebird bio, echoed several of these COVID-19 impacts in our fireside chat during the second half of the webinar. “If we have systems that make it easy for people to access information then we’re saving a great deal of time and effort in a remote environment”, explained Cleve.
One of the biggest changes for the bluebird team is how they’re managing health authority interactions, including inquiries and response preparation. According to the Gens & Associates pulse survey, respondents saw a 44% decrease in health authority planning meetings during the pandemic, which prompted novel ways of interacting with regulatory agencies and faster incremental submissions.
Cleve shared that not only is bluebird bio adapting their approach to health authority communications, but they’re also being more strategic about how to prepare internal experts for those meetings in order to maximize time. “We’re prioritizing those discussions with the health authorities because we know their time is valuable…Our strategy going forward is to be very precise in our interactions and maintain that attention to detail throughout the process.”
To watch the full 20 minute fireside chat with Scott Cleve of bluebird bio, click here.