Events

NDMC Talk Series: Invited Talk by Dr. Girish Aras

March 26, 2025

NDMC hosted an invited talk by Dr. Girish Aras on “Paradigm for Modern Drug Development"

Dr. Girish Aras, a recently retired statistician and biostatistician, boasts a diverse background encompassing academia, government service at the Centre for Drug Evaluation and Research within the Food and Drug Administration, US, and the pharmaceutical industry. Throughout his career, he has made significant contributions to statistical methodology, particularly related to drug development and regulatory processes, evident in his numerous publications. His expertise extends to late-stage drug development and clinical research, notably his work on clinical trials and observational studies for Enbrel and other products during his tenure at Amgen. He has been elected as a Fellow of the American Statistical Association.

Currently, he focuses on the mathematical foundations of causal inference and their applications across various domains, including epidemiology and clinical trials. His interests also encompass inferential aspects of drug safety, emphasising a risk-benefit paradigm for evaluating new therapies. Key concepts that he engages with include counterfactuals, propensity scores, confounders, and effect modifiers, that reflect his commitment to advancing the field of biostatistics.

Abstract: The regulatory approval process for modern drug therapies is fundamentally based on the results of two adequately controlled clinical trials. This presentation reviews the historical evolution of this approach and explains its adoption as the global benchmark in drug development. The complementary role of observational studies-and their interdependencies within this framework-is also examined. The discussion also integrates statistical, regulatory, and historical perspectives.