From Data to Drug Approval: Bioinformatics in Clinical Development

This session explores how human genetics is transforming clinical development. PharmaLex walks through the use of pharmacogenomics, AI, and real-world data to improve trial design, enable precision medicine, and deliver more efficient and targeted therapies. The talk also covers the infrastructure, regulatory considerations, and collaboration required to make these advances operational in today’s clinical research environments.

Key Takeaways:

1. Genomics is powering smarter trials. Human genetic data is being used across the drug development lifecycle to optimize patient selection, dosing, and endpoint refinement.
2. Scalable, compliant infrastructure is critical. High-throughput genomic analysis demands modern platforms that support reproducibility, data integrity, and regulatory readiness.
3. Progress requires interdisciplinary collaboration. Real impact comes from integrating data science, pharmacology, clinical expertise, and AI into a unified development strategy.