Research shows over half drug development professionals feel undermined by regulations

Published: 15-Dec-2022

Regulations are shown to slow down the digital transformation for most drug development companies

More than half (54%) of professionals working for drug development companies or manufacturers say industry regulations are undermining their digital transformation ambitions, according to new research. Pharmaceuticals manufacturers (57%) are the most likely group surveyed to suffer this impact, while just under half (49%) of respondents from biopharma and biotechnology companies said regulations were undermining their transformation aspirations.

However, a large proportion (46%) of the overall survey sample say that regulations do not undermine their digital transformation initiatives, which shows that attitudes are mixed.

These are among the key findings of a study commissioned by Aspen Technology, a global leader in industrial software, which surveyed 400 global professionals with expertise in drug development or manufacturing to gauge where drug manufacturing is headed over the next 3-5 years.

Regulation may be slowing the march to digitalisation for some pharma companies

Gareth Alford oversees GSK’s external collaborations with governments and extended industry partners to spark conversations around how innovation ambitions interact with regulatory frameworks. “These collaborative environments provide opportunities to iteratively de-risk elements through the development innovation process,” said Alford. “Interactive discussions can build confidence and open up a dialogue with regulators around compliance and opportunities for innovation.”

To overcome the challenges discussed and meet market demands, pharma businesses are prioritising initiatives that focus on ‘operational agility and efficiency.’ 44% listed this among their top three strategic goals for their organisation’s digital transformation journey, significantly higher than their next strategic aim: streamlining product innovation (ranked by 33% among their top three aims).

Raman Bhatnagar, Vice President and General Manager at Aspen Technology, said: “Regulation may be slowing the march to digitalisation for some pharma companies, but the most innovative and forward-looking are proactively engaging with regulatory agencies, boldly moving forward and using advanced technologies that drive a raft of benefits for their own businesses and for the broader community.”

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