80TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 Strategic Implications Predictive modelling and AI-driven analytics are fundamentally reshaping how pharmaceutical science and manufacturing operate. These tools are no longer just about speeding up timelines; they are about reducing failure risk, improving regulatory clarity and maximising the impact of every dollar invested. As regulatory agencies, investors and manufacturers coalesce around data-driven approaches, predictive modelling is shifting from competitive differentiator to baseline expectation. Companies and their investors that embrace this transformation will not only accelerate product development, but also de-risk their pipelines, improve supply resilience and increase the value of their assets in the eyes of regulators and investors alike. The future of pharmaceutical innovation will not just be faster it will be smarter. References 1. https://www.ey.com/en_us/life-sciences/biotechoutlook 2. https://www.gibsondunn.com/life-sciences2024-outlook/ 3. https://www.bain.com/insights/topics/globalhealthcare-private-equity-report/ 4. https://www.svb.com/trends-insights/reports/ healthcare-investments-and-exits/2024-midyear/ 5. https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/considerationsuse-artificial-intelligence-support-regulatorydecision-making-drug-and-biological 6. https://www.fda.gov/media/167973/download 7. https://www.fda.gov/media/166973/download 8. https://www.fda.gov/media/154985/download 9. https://www.ema.europa.eu/en/documents/ scientific-guideline/guideline-qualificationreporting-physiologically-basedpharmacokinetic-pbpk-modelling_en.pdf 10. https://www.researchgate.net/ publication/335140753_Food_Product_ Design_A_Hybrid_Machine_Learning_and_ Mechanistic_Modeling_Approach This is an abridged article from DeFacto’s 2025 BioBeat Report [previously branded as the CPHI Annual Report] — one of the industry’s most trusted barometers of innovation and investment trends. Please click here to read the full report, which provides expert analysis on drug development and AI, an in-depth review of China’s bio-innovation landscape, forward-looking biotech investment insights, and the results of our annual industry survey and predictions. PHARMATECH ASSOCIATES BIKASH CHATTERJEE President, Chief Science Officer Pharmatech Associates - a USP company
RkJQdWJsaXNoZXIy MjY2OTA4MA==