A leading expert at The University of Manchester has said that the life science sector has a transformative opportunity over the next few years if it works collaboratively with regulators, academia and the wider public, in a new report.
Professor Alejandro Frangi, Bicentennial Turing Chair in Computational Medicine says new approaches for product development, including computational modelling and simulation, could realise the huge potential of new technologies in regulatory and product innovation.
The report authored by KPMG UK Life Sciences Regulatory Solutions, commissioned by The University of Manchester, is based on the findings of a detailed literature review, surveys and structured interviews with life science sector stakeholders.
Professor Frangi said returns on investment is an important barrier, arguing that although relevant skills are in short supply, they can be sourced from other traditional sectors transformed by the digital revolution, such as the aerospace, automotive industries, or manufacturing.
Another challenge is to build trust among stakeholders for these new technologies and do so in co-creation with the broader sector and society.
In the report's foreword, he said: "Computational Modelling and Simulation (CM&S) technology and In Silico Evidence (ISE) stand poised to revolutionize the future of healthcare.
"These cutting-edge methods offer a thrilling opportunity to expedite research and development (R&D), spark unprecedented innovation, and usher life-changing pharmaceutical and medical device products to market with remarkable speed and enhanced safety. The healthcare industry can easily recoup its investment in in silico methods during the R&D phase of a product's life cycle.
"But progress is being hindered by misconceptions, which largely stems from regulatory uncertainty and a lack of incentives for adopting these technologies. This report, however, provides much needed evidence that we already have the skills and financial incentives to push forwards with this agenda, added Michael Kipping, Honorary Research Fellow on Regulatory Science and Innovation at The University of Manchester.
The technologies have the potential to reduce research sample sizes and the reliance on animal testing in pre-clinical trials.
Access to novel medicines and medical devices could be democratised by employing virtual patient cohorts mirroring diverse populations, including those previously marginalized by traditional evidence approaches.
The costs of bringing a new pharmaceutical to market are currently estimated at around £2 billion.
If new technologies are employed, they have the potential to accelerate market entry for innovative products by up to two years and reduce the number of patients required for clinical studies potentially saving up to £7.8 million.
Professor Frangi said: "To fully harness the transformative potential of these new technologies, manufacturers must navigate the complex landscape of global regulatory acceptance criteria. There is a pressing need for a cross-sector effort to develop clearer regulatory guidelines, international standards, and best practices. Such initiatives will pave the way for the global harmonization of in silico technologies, if not their regulation by worldwide regulatory agencies."
"Those who dare to embrace innovation are poised to set new standards and lead the industry forward."
Anusha Foy, Partner at KPMG said: "The potential benefits for patients and global healthcare systems with the utilisation of CM&S, MIE and ISE technology is enormous and transformative and is an area we will be following closely in the next few years".
The report In Silico Regulatory Evidence Utilisation within the Life Science Sector is available for download here
