AI Set to Transform Drug Discovery, Clinical Trials and Regulatory Processes

Artificial intelligence is set to transform drug discovery, clinical trials and regulatory processes, marking a new scientific revolution in biotechnology. AI-driven tools can accelerate drug discovery, shorten research timelines, and make research processes more cost-effective, thereby strengthening affordable healthcare delivery.

AI is fundamentally changing how science is conducted across research and development. "Science changes when a fundamental technology disrupts the way we understand and work. AI is now driving such a model revolution in our industry," the chief scientific officer and senior vice-president of global research at Amgen said at the BioAsia 2026 summit.

AI is being used from the earliest stages of molecule discovery to clinical development. The company has invested in computational infrastructure, including advanced supercomputing systems, to analyse laboratory data and biological images at scale. AI tools help identify patterns, predict outcomes and accelerate decision-making in drug development and clinical trials.

Large-scale genomic datasets covering hundreds of thousands of individuals are now being analysed using machine learning models to identify disease-causing mutations. "AI enables us to test millions of mutations computationally, something that was previously not feasible," the executive said. AI models were trained to distinguish between harmful mutations and incidental genetic variations in cancer research.

Deep learning is also being applied to design DNA sequences that can control gene expression in specific cell types. AI-designed biological sequences have in some cases outperformed natural sequences in laboratory experiments. This was described as a form of information compression, where complex biological rules are distilled into efficient, functional designs.

In manufacturing, AI is helping optimise production processes and improve efficiency by modelling multiple variables simultaneously. The integration of AI with automation, large-scale biological data and collaborative research is accelerating the pace of therapeutic innovation. "There has never been a better time for drug discovery. AI is reshaping the future of medicine," the executive said.

The executive also spoke about the ambition of zero-shot antibody design, where computational models can generate therapeutic antibody candidates directly from a target sequence without traditional experimental screening.

"AI does not operate in isolation, but thrives on strong digital infrastructure and high-quality data," said Union Health and Family Welfare Minister JP Nadda as he launched two pioneering digital health initiatives - SAHI (Secure AI for Health Initiative) and BODH (Benchmarking Open Data Platform for Health AI) during the ongoing India AI Impact Summit 2026. The launch marks a significant milestone in advancing safe, ethical, and evidence-based deployment of Artificial Intelligence in India's healthcare ecosystem.

India recognised the transformative potential of AI in pharmaceuticals and life sciences early and began laying its digital foundations nearly a decade ago. In 2015, the government launched the Digital India programme to transform India into a digitally empowered society. Interoperable systems have been enabled across platforms, and large-scale, consent-based health data frameworks are being developed to empower citizens while ensuring data privacy and security.