Speaker bio: https://3dheals.com/new-approach-methodologies-from-theory-to-validation/
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What does it take for a biologically sophisticated model to become a tool that pharma, CROs, and regulators can actually trust?
In this 3DHEALS panel, experts in human-relevant in vitro models, 3D bioprinting, organoids, microfluidics, and drug development explore the transition from promising New Approach Methodologies (NAMs) to decision-ready assays. The discussion moves beyond the simplistic question of whether NAMs can replace animal models and instead focuses on a more practical challenge: how can these systems generate reliable evidence that improves drug-development decisions earlier?
Mike Clements examines the path from stem-cell-derived cardiac safety assays to regulatory-facing tools, including the importance of functional readouts, reproducibility, standardization, and clear context of use. Graham Craig brings a commercial perspective on why NAMs create value when they help teams advance, deprioritize, or stop programs before expensive downstream studies. Andrew Lee discusses fit-for-purpose 3D-bioprinted cardiac tissues designed to measure contractility, conduction, calcium dynamics, and arrhythmogenic behavior. Pranav Joshi explains how organoids can become assay-ready through engineering control, lifecycle quality control, standardized recovery, and transferable workflows. Alexandre Civiere shares practical skin-on-chip applications spanning permeation, wound healing, and tissue-aging models.
The panel also addresses adoption bottlenecks: model complexity versus utility, physiologic relevance, cell density, operator variability, QC gates, automation, standardization, regulatory engagement, and the role of cross-sector consortia.
Featuring:
Dr. Mike Clements, Axion BioSystems
Graham Craig, Voxell Bio
Andrew Lee, FluidForm Bio
Pranav Joshi, Bioprinting Laboratories
Alexandre Civiere, Revivo Biosystems
Moderated by Dr. Lowry Curley, Luna LifeSci
00:01:20 - 3DHEALS Mission And Networking
00:03:11 - Why Most Stem Cell Models Stall
00:05:40 - Cardiac MEA Assays And Regulators
00:10:32 - Standardization Roadmap From CIPA
00:14:33 - The Commercial Case For NAMs
00:19:20 - Fit For Purpose Beats More Complexity
00:27:08 - 3D Bioprinted Cardiac Tissues In Practice
00:35:12 - Arrhythmia Patterns And Disease Geometry
00:39:30 - Organoids To Assay Ready Workflows
00:45:57 - QC Gates Across The Organoid Lifecycle
00:50:02 - Skin Chips Permeation And Wound Healing
00:56:43 - Aging Models And Regulatory Reality
00:59:29 - Panel What Changed In Five Years
01:07:55 - Adoption Where It Moves Fast
01:13:20 - Physiological Relevance Versus Reproducibility
01:15:03 - Standardization Who Must Drive It
01:21:30 - Operator Variability And Automation Fixes
01:27:30 - Contamination And Process Traceability
01:30:12 - Why Organ Chips Still Lag
01:35:55 - AI That Helps Versus AI Theater
01:41:50 - How Much Animal Testing Can Shift
01:44:10 - Final Hopes And How To Help
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