Drug development

Konrad Schmidt, Alessandro Bentivogli, Sarah Hedtrich. Chapter 6 - Microphysiological systems. In: Catharine E. Krebs, Gail A. Van Norman, eds. Moving Toward Nonanimal Approaches in Medical Research and Testing. Academic Press; 2027:89-103. https://www.sciencedirect.com/science/article/pii/B9780443265143000023.

Catharine E. Krebs, Emily Anderson, Janine McCarthy, Eryn Slankster-Schmierer, Jarrod Bailey, Elizabeth Baker. Chapter 12 - Overcoming inertia against nonanimal research and testing in the United States. In: Catharine E. Krebs, Gail A. Van Norman, eds. Moving Toward Nonanimal Approaches in Medical Research and Testing. Academic Press; 2027:191-209. https://www.sciencedirect.com/science/article/pii/B9780443265143000138.

Mariana Dias, Catarina A. Custódio, João F. Mano. Human protein-based biomaterials in preclinical modelling. Nature Reviews Bioengineering. 2026;4(5):399-400. doi:10.1038/s44222-026-00425-7

Laura Lotfi, T. William O’Neill, Angela Wilcox, Steven Bulera. Virtual control groups in nonclinical research: A Re-analysis of 20 studies using virtual control group data. Regulatory Toxicology and Pharmacology. 2026;168:106077. doi:10.1016/j.yrtph.2026.106077

Ryan Posey, Alican Özkan, Donald E. Ingber. Human organ-on-a-chip technology as a catalyst for drug discovery. Advanced Drug Delivery Reviews. 2026;236:115920. doi:10.1016/j.addr.2026.115920

Dilyana Filipova, Wolfgang Boomgaarden, Leyla Fox, et al. Need for NAMs: A systematic evidence synthesis revealing over half a century of drug development failure. NAM Journal. 2026:100119. doi:10.1016/j.namjnl.2026.100119

Tyna Dao, Nakissa Sadrieh. A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs. Regulatory toxicology and pharmacology: RTP. 2026;165:106007. doi:10.1016/j.yrtph.2025.106007

Yanning Hao, Tyna Dao, Nakissa Sadrieh. Applications of in vitro new approach methodologies (NAMs) in drug development: A scoping analysis of titles of nonclinical study reports submitted to the FDA. Regulatory Toxicology and Pharmacology. 2026;172:106246. doi:10.1016/j.yrtph.2026.106246

Natalie Burden. New approach methodologies to reduce reliance on animal toxicity testing. Nature Reviews Bioengineering. 2026:1-2. doi:10.1038/s44222-026-00480-0

Tyna Dao, Nakissa Sadrieh. A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs. Regulatory toxicology and pharmacology: RTP. 2026;165:106007. doi:10.1016/j.yrtph.2025.106007