The plenary is expected to address how these technologies can be applied across the development pipeline, from early discovery through regulatory evaluation. By enhancing data integration and predictive capabilities, such methods may support more efficient decision-making and reduce development timelines.
AAPS NBC 2026 To Highlight Predictive Tools in Drug Discovery with Opening Plenary
Key Takeaways
- Thomas Hartung will spotlight NAMs that integrate AI, in vitro systems, and organoids to improve human relevance in preclinical safety/efficacy assessment and reduce animal testing dependence.
- Persistent limitations of traditional preclinical models contribute to clinical trial attrition; AI paired with human-relevant biology is positioned to enhance target validation and translational predictability.
The opening plenary session at this year’s AAPS National Biotechnology Conference will spotlight AI and NAMs as tools that advance predictive toxicology and human-relevant models to improve drug safety and translational research.
The American Association of Pharmaceutical Scientists (AAPS) has announced the opening plenary session for its
Dr. Hartung’s work focuses on new approach methods (NAMs) in
“We are honored to welcome Thomas Hartung as our opening plenary speaker,” said Shuhua Bai, PhD, chair of the AAPS 2026 NBC Scientific Programming Committee, in the announcement.1 “His leadership in NAMs, AI, and human-relevant models reflects a transformative shift toward more predictive, data-driven drug development. His insights will set the tone for a conference focused on accelerating innovation and translating science into patient impact.”
How are AI and NAMs transforming preclinical development?
Dr. Hartung’s plenary session will explore how NAMs are evolving from experimental concepts into more widely adopted tools in drug development. For example, NAMs combine computational modeling with biologically relevant systems, such as brain
The integration of AI into toxicology and early-stage research reflects a broader industry effort to improve translational predictability. Traditional preclinical models have struggled to accurately forecast human outcomes, which has contributed to high attrition rates in clinical trials.4 AI-enabled systems, paired with human-relevant biological models, may offer a pathway to more reliable safety assessments and target validation.2
The plenary is expected to address how these technologies can be applied across the development pipeline, from early discovery through regulatory evaluation. By enhancing data integration and predictive capabilities, such methods may support more efficient decision-making and reduce development timelines.1
What role does computational modeling play in modern drug discovery?
The conference will also feature a closing plenary by
Together, the opening and closing plenaries reflect a thematic focus on computational and data-driven approaches to pharmaceutical innovation. According to AAPS, the conference program is designed to showcase the scientific forces reshaping biotechnology, including AI-enabled toxicology and predictive modeling tools.1,5
Why does this information matter for the future of biopharmaceutical innovation?
The emphasis on AI and computational tools at NBC 2026 aligns with broader trends across the biopharmaceutical industry, in which digital technologies are increasingly integrated into R&D workflows. These tools may enhance the ability to identify viable drug candidates, predict clinical outcomes, and streamline development processes.5
In addition to plenary sessions, the conference program is structured around two primary tracks: advancing novel medicines through precision science and applying translational principles across the development lifecycle.5
The event, scheduled for May 11–14 in San Diego, will convene scientists from academia, industry, and regulatory sectors, providing a platform for discussion of emerging modalities, including biologics, cell and gene therapies, and advanced therapeutic technologies.
The focus on AI-driven and human-relevant models indicates continued movement in the biopharmaceutical industry toward more predictive and patient-centric development strategies. Thei growing presence of such approaches in scientific forums such like NBC suggests they are becoming central to future drug development paradigms.
References
- AAPS. Thomas Hartung, MD, PhD, leading JHU expert on AI and organoids, to speak at AAPS National Biotechnology Conference. Published May 4, 2026. Accessed May 4, 2026.
https://www.aaps.org/aaps/news/media/nbc26-opening-plenary - FDA. New Approach Methodologies (NAMs). Current as of April 20, 2026. Accessed May 4, 2026.
https://www.fda.gov/science-research/science-and-research-special-topics/new-approach-methodologies-nams - Wu X, Wu MA, Zou J, Kleinstreuer N, Wu JC. Reimagining human-centric drug development with new approach methodologies. Science 2026;392:371-378. doi:
10.1126/science.aeb0045 - McChrystal R, Hanlon P, Lees JS, et al. Modeling rates of trial attrition: an analysis of individual participant data from 90 randomized controlled trials of pharmacological interventions for multiple conditions. J Clin Epidemiol. 2025;187:111971. doi:
10.1016/j.jclinepi.2025.111971 - AAPS. AI and computational drug discovery headline 2026 AAPS National Biotechnology Conference. Published March 24, 2026. Accessed May 4, 2026.
https://www.aaps.org/aaps/news/media/nbc26plenaries





