WHITE PAPER | Integrating Artificial Intelligence and Big Data in Pharmaceutical Development: Ethical Considerations and Legislative Frameworks

June 11, 2024

Asphalion, in collaboration with IRIS, a leading European manufacturer of photonic and artificial intelligence solutions, has released a pivotal white paper on the integration of Artificial Intelligence (AI) and Big Data (BD) in pharmaceutical development. The authors of this comprehensive report, Alexandra Poch Solà, David F. Nettleton, Diego Hernández Pedraza and Mario López de la Cruz discuss the rapid evolution of AI and BD as central technologies in drug development and manufacturing, while also addressing the complex ethical and legislative challenges that accompany these advancements.

AI and BD in Pharma: A New Era

The white paper provides a thorough background on the adoption of AI and BD within the pharmaceutical sector. It emphasizes the novelty and significance of these technologies in enhancing drug development processes, increasing supply chain traceability, and improving the overall quality and safety of medicinal products.

Ethical Considerations and Legislative Frameworks

As AI and BD technologies become more embedded in pharmaceutical practices, the ethical considerations surrounding data privacy, algorithmic transparency, and decision-making accountability become increasingly important. The authors stress the necessity of properly assessing these challenges to ensure responsible and ethical usage.

New EU Regulatory Framework

The report connects the application of AI and BD with the newly established AI regulatory framework, endorsed on March 13th, 2024. This framework aims to cultivate a balanced and principled approach to AI utilization, promoting technologies that are ethical, secure, and beneficial to society. The framework ensures that AI development respects human rights, maintains accountability, and serves the collective good.

Bridging the Gap Between ICH Guidelines and Ethical AI Usage

“Integrating Artificial Intelligence and Big Data in Pharmaceutical Development: Ethical Considerations and Legislative Frameworks” represents a first attempt to bridge the gap between the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and the ethical deployment of AI and BD in pharmaceutical development. The paper underscores the urgency of adopting forward-thinking strategies in decision-making processes to align these technological integrations with the new European legislative frameworks.


The interconnected spheres of pharmaceutical development (ICH Q8), quality risk management (ICH Q9), drug substance development and manufacture (ICH Q11), and continuous manufacturing of drug substances and drug products (ICH Q13) provide a robust framework for the pharmaceutical industry. These guidelines focus on various critical aspects of drug development and manufacturing. Within this framework, the application of AI and BD presents an unprecedented opportunity to enhance quality assurance, streamline drug development processes, increase traceability at the supply chain level, and ultimately improve the quality and safety of medicinal products. This paper discusses the ethical considerations and legislative imperatives for integrating AI and BD within the ICH guidelines to ensure responsible usage and sustainable business outcomes.

By leveraging AI and BD responsibly, the pharmaceutical industry can achieve significant advancements while adhering to ethical standards and legislative requirements. This white paper by Asphalion and IRIS is a crucial step towards a more innovative and ethically grounded future in pharmaceutical development.

For an in-depth understanding of these advancements and their implications, read our white paper: Integrating Artificial intelligence and Big Data in Pharmaceutical Development- White Paper

For further information, you can contact us at: info@asphalion.com

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