Transforming Cell Therapy with Precise Human Biology Replication (Part 2)

*Full transcript available below

In part two of an interview with BioPharm International® ahead of the J.P. Morgan Healthcare Conference, Daniel Delubac, PhD, CEO and co-founder, iOrganBio, outlines a bold vision: using advanced in-vitro systems to recreate human biology in the lab with precision and reproducibility. By defining and controlling cell states—healthy, aged, and multi-stage diseased tissues—this approach aims to deliver standardized biological models that accelerate drug discovery, de-risk clinical development, and support regulatory decision making, Dr. Delubac emphasizes.

"The goal is to recreate human biology in the lab," Dr. Delubac states.

Central to this strategy, Dr. Delubac notes, is achieving fine-grained control over the cell state. High-resolution models of human tissue, including those in progressive disease states, enable developers to test therapies earlier and more accurately. The use of such models, he explains, not only improves prediction of clinical outcomes but also ensures that manufacturing outputs reliably match design specifications, which Dr. Delubac highlights is a critical factor for consistent quality and patient safety.

How can digitized, industrial-scale biology transform next-generation cell therapies?

Dr. Delubac says that iOrganBio’s platform uses digitization and iterative optimization to continuously refine biological models toward optimal performance. “This approach can save drug developers millions of wasted resources and money and ensure patients’ needs are met,” he states.

Equally important is achieving industrial scale. Dr. Delubac stresses that scaling these systems for broad accessibility can help the biopharmaceutical industry establish shared standards for cell types, representative cell states, and regulatory-grade in-vitro assays that accurately mimic human biology. This systematic approach directly targets the primary barrier to curative cell therapy adoption, high manufacturing cost, and enables more commercially viable and widely accessible next-generation cell therapies, he adds.

View Part 1 of Dr. Delubac’s interview here.

Dr. Delubac will be giving a talk at the J.P. Morgan conference at 11:00 AM ET on Tuesday, Jan. 13.

Click here for more conference coverage.

About the speaker

Daniel Delubac, PhD, CEO, iOrganBio

Dr. Delubac is a technical leader with a strong track record in building transformational laboratory products and techbio platforms across AI, software, robotics, and process engineering. He has built some of the most impactful healthcare products in non-invasive prenatal testing at Counsyl, liquid biopsy at Guardant Health, early cancer detection at Freenome, patient-derived models of cancer at Xilis, and the first AI-agentic synthetic chemistry platform at Chemify. Dr. Delubac trained as an applied physicist, then earned a PhD in Biomedical Engineering from Carnegie Mellon University. At iOrganBio, he is rethinking cell-based products from an engineering and data-driven perspective and building the next generation, AI-enabled infrastructure designed to manufacture the exact same cells we have in our body—that will model biology in vitro accurately, restore degraded bodily function, cure disease, and power population-scale, affordable, holistic, regenerative medicine.

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Speaker 1

The goal is to recreate human biology in the lab. We need to be able to define exactly where human biology is and recreate it in the lab precisely and reproducibly. We currently do not know how to do any of those things with perfect performance, with greater control, and thus the ability to resolve cell state with more accuracy. We can recreate very precisely the models of any cell state, either healthy tissue, young or old, disease tissue with multiple stages of progressive disease to support drug discovery, with control over the final state of cells, we can ensure the output of manufacturing meets design requirements, and let's provide high quality standard models for industry to use at large but also for regulatory testing and release of material post manufacturing. The digitization process also allow us to iterate on models towards optimality, preempting failure rates at the clinical stage. This approach can save drug developers millions of wasted resources and money and ensure patients needs are met.

Speaker 1

The industrial scale of our approach is critical to make sure that the systems and solution that we are creating are accessible by as many users as possible, we can start to think about and develop standards for cell types and the states that are representative of the cells type. We can develop in vitro assays that accurately mimic human biology for regulatory purposes the scale is necessary to enable the adoption and commercial success of next generation curative cell therapy by systematically cracking the cost of manufacturing, which is currently the primary limitation to the commercial success of those novel technologies.