New Approach Methodologies: From Theory to Validation

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 In March 2026, the FDA released draft guidance, “General Considerations for the Use of New Approach Methodologies in Drug Development,” outlining principles for human biological relevance, technical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.

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.

Mike Clements

Dr. Mike Clements is Senior Vice President for Scientific Partnerships and Strategy at Axion BioSystems, where he focuses on advancing the use of human stem cell-derived models and functional cell-based assays in drug discovery and toxicology. He earned his PhD in neuropharmacology from the University of Oxford and completed postdoctoral training in the UK and US.

In 2014, Dr. Clements published the first study using the Maestro multielectrode array (MEA) system with stem cell-derived cardiomyocytes, helping demonstrate their potential as predictive tools for preclinical cardiac safety assessment and contributing to work that informed the Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative. He was also editor of Stem Cell-Derived Models in Toxicology and previously served as President of the Society of Toxicology’s Stem Cells Specialty Section. More recently, he has been involved in Axion BioSystems’ effort to advance its human iPSC-cardiomyocyte MEA assay through the FDA’s ISTAND program, providing a practical example of the journey from an emerging human-relevant model toward a standardized, regulatory-ready New Approach Methodology (NAM).

Alexandre CIVIERE

Biomedical engineer with an MBA and over ten years in biotechnology at the interface of cell technology and medical devices, spanning pre-clinical and clinical R&D for innovative therapies. As Sales & Business Manager at REVIVO BioSystems in Singapore, he works with pharmaceutical and cosmetic companies on human skin models and barrier tissues for safety and efficacy studies.

Moderator:

Lowry Curley

Lowry Curley is a scientist-entrepreneur and developer of foundational neural microphysiological systems (MPS) technology that became the core platform of the first company he founded, AxoSim, which is now 28bio. He took AxoSim from a Tulane University spinout to a venture-backed company that counted nearly every top 25 global pharma company as a customer, translating early-stage research into a validated, human-relevant platform for neurological drug discovery. As founder and CEO, he built a product pipeline on IP licensed from Johns Hopkins, UC San Diego, and Tulane, and led two acquisitions to expand the platform.

He now runs Luna LifeSci, an advisory firm helping pharmaceutical and biotech companies adopt New Approach Methodologies (NAMs) in their preclinical programs, as well as helping life science founders and startups accelerate their commercialization, company building, and fundraising strategies.