New Approach Methodologies (NAMs) are redefining how preclinical safety and efficacy are evaluated by shifting away from traditional animal models toward human-relevant, technology-driven approaches such as complex in vitro systems, 3D organoids, organs-on-chips, and in silico modeling. These methods aim to improve the predictive power of human responses, reduce development time and cost, and minimize the ethical and scientific limitations of animal testing, aligning with broader efforts across the life sciences to modernize drug development. NAMs are increasingly central in conversations about AI-enhanced 3D models, microphysiological systems, and data-rich platforms that can better capture human biology at the preclinical stage.[fda] In the United States, recent FDA policy initiatives have begun to operationalize this vision by providing a formal validation and regulatory framework for NAMs in preclinical drug development. In March 2026, the FDA released draft guidance, “General Considerations for the Use of New Approach Methodologies in Drug Development,” outlining principles for human biological relevance, technical characterization, and fit-for-purpose use of NAMs in nonclinical safety packages submitted with INDs. Complementary actions under broader modernization efforts, such as Operation TrialBlazer, explicitly encourage the use of NAMs—including AI-powered models and organ-on-chip systems—as alternatives to animal toxicology for dose selection and safety assessment, signaling that regulators now expect sponsors to consider NAMs when they can improve human predictivity and support safer, faster translation to first-in-human trials.[fda] In this upcoming virtual event, our panelists will focus on the latest technical development, industry adoption, and regulatory landscape surrounding approaches using biofabrication and microfluidics-focused platforms.
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Speakers:
Andrew Lee
Andrew is the co-founder and senior scientist at FluidForm Bio, a team based in Boston looking to develop a cure to diabetes. Broadly, Andrew’s interests are in building functionally accurate and sophisticated human tissues that can one day be utilized in a repair, regeneration, and replacement.
Graham Craig
Graham Craig is Chief Commercial Officer at VoxCell, a Canadian biotechnology company developing high-resolution, vascularized 3D tissue models as New Approach Methodologies (NAMs) for drug development. He leads VoxCell’s commercial strategy, global business development, and strategic partnerships, working to put more human-relevant preclinical models into the hands of pharmaceutical companies, CROs, and research institutions, so teams can generate decision-enabling data earlier and reduce reliance on traditional animal testing.
Graham brings more than 18 years of experience in commercialization and strategic partnerships across the pharmaceutical and biotech sectors. Before joining VoxCell he was Director of Corporate Development at AbCellera and held senior roles at STEMCELL Technologies. Earlier in his career he spent seven years as a commercial strategy consultant at IQVIA, advising pharmaceutical companies across Europe, Asia, and North America.
Pranav Joshi
Dr. Pranav Joshi is a translational biomedical scientist and Senior Scientist at Bioprinting Laboratories Inc., where he leads the development and validation of human-relevant 3D cell and organoid platforms for predictive toxicology, drug discovery, and new approach methodologies (NAMs). His work integrates human iPSC-derived brain and liver organoids, microarray 3D bioprinting, dynamic perfusion culture, high-content imaging, and scalable assay development to improve the reproducibility and translational relevance of preclinical testing. He has served as principal investigator on multiple NIH SBIR/STTR projects focused on gene-edited liver organoids, engineered brain organoids for developmental neurotoxicity testing, and pillar/perfusion plate systems for scalable organoid culture.
At Bioprinting Laboratories, Dr. Joshi has played a central role in translating organoid and microphysiological system technologies from research concepts into commercially deployable platforms for high-throughput screening. His recent work focuses on the scale-up, quality control, cryopreservation, and assay-ready deployment of human organoids for toxicology and drug screening. He also served as technical lead for an NIH I-Corps program focused on understanding barriers to adoption of advanced human-relevant models, and his team’s “Human Brain Organoids to Predict DNT” project was selected as a Phase 1 winner of the NIH Complement-ARIE NAMs Reduction to Practice Challenge. His broader research interests include developmental neurotoxicity, metabolism-mediated toxicity, organoid standardization, and the validation of fit-for-purpose NAMs for academic, industrial, and regulatory applications.
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