In Silico Regulatory Evidence Utilisation within the Life Science Sector

In an era marked by rapid technological advancements and the transformative rise of artificial intelligence, the integration of Computational Modelling and Simulation (CM&S) technology and In Silico Evidence (ISE) is set to revolutionize healthcare. These innovative methods promise to expedite Research and Development (R&D), foster unprecedented innovation, and bring life-changing pharmaceutical and medical device products to market with enhanced speed and safety. By minimizing research sample sizes and reducing reliance on animal testing, in silico clinical trials (ISCT) can democratize access to medical breakthroughs, ensuring new treatments are effective across diverse populations.

This report explores the benefits of CM&S and the challenges manufacturers face in adopting this pivotal technology. It highlights the essential steps for advancing CM&S and ISE implementation safely and effectively, emphasizing the potential to streamline the development of new products, reduce R&D timelines, costs, and risks, and promote the availability of innovative treatments for unmet medical needs. The report underscores the significant cost savings and efficiency gains offered by ISCTs and ISE, including the potential to accelerate market entry and reduce clinical study patient requirements.

To fully harness the transformative potential of CM&S and ISE, manufacturers must navigate global regulatory acceptance criteria, develop robust methodologies, validate models, and provide compelling evidence. Establishing National Centres of Excellence on ISE will unify industry, academia, and regulators, fostering R&D investment and cultivating a skilled workforce. A cross-sector effort to develop clearer regulatory guidelines, international standards, and best practices is crucial for global harmonization of in silico technologies.

Despite the promise of this technology, challenges such as a skills gap and perceptions of poor return on investment persist. However, evidence shows that relevant skills can be sourced from other digitally transformed sectors, and the healthcare industry can recoup its investment in in silico technologies during the R&D phase. Embracing innovation will set new standards and lead the industry forward.

Recognizing the diversity in CM&S and ISE generation, validation, credibility, and acceptance is essential. Developing guidance and regulation that acknowledges this diversity will ensure the benefits of this technology are realized with appropriate safeguards, promoting a robust risk-benefit profile for patients. This report calls for a collaborative journey to embrace the potential of CM&S and ISE to transform healthcare and improve lives worldwide.

Download report: zenodo.org/records/12735158/files/KPMG%20In%20Silico%20Regulatory%20Evidence%20Utilisation%20within%20the%20Life%20Science%202024.pdf?download=1