AI/ML Working Group

Preclinical

Members

Accomplishments

1. CSLAN: Cross-Species Latent Alignment Network for Trauma-Related Cell-Type Classification
   bioRxiv 2025 — DOI: 10.1101/2025.06.09.655966
2. CSLAN: A Cross-Species Latent Alignment Network for Trauma-Related Cell-Type Classification
   Poster — New England Rare Disease Statistics (NERDS) Workshop, 2025
3. Connecting the Dots: Leveraging AI/ML Tools to Increase Interpretability of Genomic Signatures from Mouse to Human
   Invited sessions: JSM 2026 and RISW 2026

Working Group Activities

1. Cross-Species Latent Alignment Network for Trauma-Related Cell-Type Classification — Completed
2. Translation of Mouse Perturbed Genomic Signature to Human Using TrVAE — Completed
3. Translation of Mouse Perturbed Genomic Signature to Human Using scGPT Foundational Model — Ongoing
4. AI-assisted Bayesian–Frequentist Hybrid Inference with an application in scRNA-seq — Ongoing

Real-World Data/Evidence

Members

Accomplishments

1. Explainable Machine Learning: A primer for clinicians 
   Manuscript forthcoming
2. Neural Boltzmann Machine-Based Framework for Longitudinal Disease Risk Prediction and Synthetic Patient Generation
   Code development completed
3. Transforming Heart Failure Treatment: Leveraging CausalML Powered Real-World Evidence for Personalized Guideline-Directed Medical Therapy
   Invited session: JSM 2025

Working Group Activities

1. Causal Machine Learning in Healthcare Delivery: Current Applications, Methods, and Future Directions for Clinical Practice — Ongoing [Manuscript in preparation]
2. Synthetic Data and Digital Twins in Drug Development — Ongoing [Manuscript in preparation]

Post-Authorization HEOR & Safety

Members

Accomplishments

1. Superior Performance of Generative AI After Application of Mixture-of-Agents LLMs in Outcomes Research 
   ISPOR 2025 — Abstract
2. Open-Source LLMs Performance on Information Retrieval Tasks for Health Outcomes Research
   ISPOR 2025 — Abstract
3. MetaMind: A Multi-Agent Transformer-Driven Framework for Automated Network Meta-Analyses
   medRxiv — Preprint
4. RISW 2025 Invited Session on AI/ML for Drug Safety and HEOR Applications
5. From Retrieval to Verdict: A Hybrid LLM Pipeline for Evaluating Medical and Economic Claims
   ISPOR 2026
6. Agent-Atom-Gradient: A Next-Gen AI Architecture for Evidence Driven Outcomes Research
   ISPOR 2026

Working Group Activities

1. Participation in RISW 2026 and ISPOR 2027 regarding AI/ML applications in HEOR and safety analytics 
2. Building international collaborations with academic institutions to advance methodological innovation and global impact 
3. Publication on Exploring FAERS Across Medicine — pharmacovigilance analysis
4. Publication on AI across the Pharmaceutical Industry — applications to drug development, regulatory science, and safety monitoring
5. Publication on AI and Clinical Practice — bridging real-word data and clinical decision-making
6. Advancing transformative AI methodology development to revolutionize the pharmaceutical sector 

Clinical Development

Members

Accomplishments

1. The Current Landscape of Artificial Intelligence in Clinical Development 
   Manuscript forthcoming
2. RISW Invited Session
   

Working Group Activities

1. Survey of pharmaceutical industry practice for AI/ML adoptions in clinical development — Ongoing
2. Landscape paper on AI in clinical development — Ongoing