5 papers
Artificial Intelligence in Pharmaceutical Development: Building Rigorous, Decision-Ready Evidence
Xin Luo, Margaret Gamalo, Achilleas Livieratos +6
Artificial intelligence (AI) and machine learning (ML) are reshaping the pharmaceutical lifecycle, from discovery and clinical development through manufacturing and regulatory revi…
Characterizing Estimator-Regime Transitions in Adaptive Enrichment Trials
Xin Luo, Maria Kudela, Margaret Gamalo
Adaptive enrichment trials that identify responsive subpopulations allocate a fixed sample across them and estimate each one's effect from the resulting data. For a synthetic contr…
M3D-FLOW: A Monolithic 3-D-Stackable Processing-Near-DRAM Architecture for Generative Normalizing Flow Applications
Bipin Thapa Magar, Ishan Thakkar, Sudeep Pasricha
Normalizing Flows (NFs) have shown strong results in generative modeling, recently reaching state-of-the-art image generation performance. However, their repetitive, sequential ope…
Transporting Randomized Trial Effects to Real-World Populations via Riesz-Calibrated Optimal Transport
Anik Burman, Margaret Gamalo, Promit Ghosal +1
Randomized trials support causal inference, but differences between trial and target populations can limit the transportability of treatment effects to real-world settings. Many ex…
Proactive Anomaly Screen for Multiple Endpoints Using Bayesian Latent Class Modeling: A k-Step Ahead Approach
Yuxi Zhao, Margaret Gamalo
In clinical trials, ensuring the quality and validity of data for downstream analysis and results is paramount, thus necessitating thorough data monitoring. This typically involves…