24/7 BIOPHARMA - issue 1 / October 2024

CPHI REPORT

market. The synergies we propose between complementary approaches are just scratching the surface of what is possible. If done properly, these additive insights can be quantified and valued as part of the portfolio management process reducing uncertainty and enabling informed advance, prioritise or discontinue, ultimately leading to more efficient and successful drug development. choices as to which drug candidates to

Figure 2. Impact of early drug filtering on portfolio success.

References

1. AI Combined with Real-World Evidence (RWE). 2. Digital Twins Combined with In-Silico Trials. 3. Quantitative Systems Pharmacology (QSP) Combined with Biomarker Development. 4. Predictive Analytics Combined with Advanced Portfolio Management Tools. 5. Organ-on-a-Chip Combined with High Throughput Screening (HTS) or Small Animal Modelling. The pharmaceutical industry has stepped into the digital innovation world cautiously, but we have made steady progress. The industry is gaining insight on the requirements to support new digital approaches and understand how to reap the full benefit. There is also a common thread across all these innovations: the need for highly reliable data; building a centralised intelligent data management approach; and infrastructure to support new technologies, which will allow all programs to enjoy the benefits of continued learning as it relates to data management and data quality best practices and allow a plug-and-play approach to considering new innovations. While these innovations present the potential to fully replace outdated or ineffective tools and development steps, resistance is to be expected. As health authorities create new frameworks for evaluation it is left to industry to determine how these innovations can improve. Shifting the success metrics for any innovation pilot to include its potential impact on a program’s ultimate success will allow the industry to fail faster and shift the focus and resources to programs with the best chance of reaching the Conclusion

6. O.J. Wouters et al., Quantifying Research and Development Expenditures in the Drug Industry, JAMA Network Open. 2024;7(6):e2415407. doi:10.1001/ jamanetworkopen.2024.15407 7. D. Sun et al, Why 90% of clinical drug development fails and how to improve it? Acta Pharm Sin B. 2022 Jul; 12(7): 3049–3062. Published online 2022 Feb 11. doi: 10.1016/j. apsb.2022.02.002 8. Jason Han, FDA Modernisation Act 2.0 allows for alternatives to animal testing, Artif Organs/ https://pubmed.ncbi.nlm.nih.gov/36762462/ 9. https://www.mckinsey.com/capabilities/people and-organisational-performance/our-insights/ unlocking-success-in-digital-transformations 10. Dowden H., Munro J. Trends in clinical success rates and therapeutic focus. Nat Rev Drug Discov. 2019;18:495–496 11. Harrison R.K. Phase II and phase III failures: 2013-2015. Nat Rev Drug Discov. 2016;15:817–818

BIKASH CHATTERJEE President and Chief Science Officer Pharmatech Associates, a USP company

80 TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024