New around here? Start with the flagship paper
Dan Liu
Operator. Scientist. Bioengineer.
Flagship work
A biomimetic microphysiological system predicts the impact of sepsis therapeutics on neutrophil-endothelial dynamics
Testing sepsis drugs in vessel-like channels with human cells should read out closer to clinical response than a static well plate.
- Temple Presidential Fellow
- 14 years in pharma
- 3 peer-reviewed papers
- RAC (US and EU)
About
I spent fourteen years on the industry side of drug development. The first half was close to the plant floor: process engineering, cGMP API manufacturing, production management. The second half was product and CMC, running global pharma product lines worth $12 to 15 million a year and leading teams of ten to twelve. I left industry as Associate Director for drug-device combination products at Lupin, serving as CMC lead on five complex assets, two of which advanced into clinical trials.
Then I went back for the science. I am now a Presidential Fellow at Temple University finishing a PhD in bioengineering. My research asks how to test sepsis drugs on something closer to a real blood vessel: a chip-scale model that runs human neutrophils and endothelial cells under flow, paired with proteomics and network modeling to repurpose approved drugs by sepsis phenotype.
It is not a career change so much as a combination. Most platform scientists have never run a manufacturing line or filed a product. Most operators never train as bench scientists. I bring both to the same table.
The NAMs wave
The FDA is moving away from animal testing, and its roadmap leans into the disciplines I work in. The FDA Modernization Act 2.0 opened the door in 2022; in April 2025 the agency published a roadmap that starts with safety testing for monoclonal antibodies and aims to make animal studies “the exception rather than the norm” in preclinical safety testing within three to five years — naming organ-on-chip systems, human cell-based assays, and in-silico models as the path forward, alongside adjacent approaches like organoids and AI predictive modeling.
March 2026 brought CDER’s draft validation framework for using NAMs in regulatory submissions; September 2026 brought a direct final rule rewriting “animal” to “nonclinical” across FDA drug regulations. Overlapping squarely with that shift is my own research:
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A published chip that predicts drug response
A biomimetic microphysiological system that predicts how sepsis therapeutics affect neutrophil–endothelial dynamics: primary human endothelial cells and neutrophils, chemoattractant gradients, and physiological flow. Not a static well plate — something closer to a living vessel. Lab on a Chip, Jul 2026.
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Network models that prioritize repurposed drugs
Neutrophil proteomics mapped into protein interaction networks, ranking FDA-approved drugs by how well each one normalizes a patient’s sepsis phenotype. Computation that is cheap, biology that is human — the in-silico layer of a NAMs-style evidence package. Frontiers in Immunology, Aug 2025.
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Human cells as the assay foundation
Primary human endothelial cells and neutrophils power the chip, while the repurposing pipeline builds on neutrophil proteomics from sepsis patients — immune phenotypes defined by human molecular data rather than murine surrogates. Human relevance from the molecular level up.
The direction is clear. And the operator side of me reads it a second way: throughput, standardization, and regulatory confidence are now the bottlenecks. I have stood on the submissions side of that divide for fourteen years; now I build from the other side.
Research
My lab work is about one question: how do we test sepsis drugs on something closer to a real blood vessel? The work below runs from the biological case, to finding candidates, to testing them on the chip itself.
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Flagship paper
A biomimetic microphysiological system predicts the impact of sepsis therapeutics on neutrophil-endothelial dynamics
Why it matters. Testing sepsis drugs in vessel-like channels with human cells should read out closer to clinical response than a static well plate.
We built a chip that behaves like a living microvessel. It combines primary human endothelial cells, human neutrophils, and controlled chemoattractant gradients under physiological flow. Dose it with candidate therapeutics, and it shows how each drug changes the neutrophil-endothelial interaction that drives sepsis organ damage.
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Prioritizing FDA approved therapeutics for treating sepsis phenotypes: a network modeling approach based on neutrophil proteomics
Why it matters. Repurposing approved drugs against matched phenotypes is faster and cheaper than new molecule programs.
We mapped neutrophil proteomics from sepsis patients into protein interaction networks, then ranked FDA-approved drugs by how well each one could normalize a given neutrophil phenotype. The analysis surfaced three distinct targets: H2AC21 in the Hyperimmune phenotype, VTN in the Hybrid phenotype, and TRPV2 in the Hypoimmune phenotype.
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The critical role of neutrophil-endothelial cell interactions in sepsis: organ-on-chip, omics, immune cell phenotyping, and in silico modeling to identify new therapeutics
Why it matters. The scientific case for the chip and the repurposing work that followed.
A review of why the neutrophil-endothelium interaction is the right therapeutic target in sepsis, and why it takes organ-on-chip models, omics, and in silico modeling working together to find drugs. Sepsis accounts for more than 1 in 5 deaths worldwide, and animal models and traditional in vitro assays have repeatedly failed to translate.
Industry record
Fourteen years across manufacturing, product leadership, and CMC: engineering, operations, commercial development, and drug-device combination products.
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Apr 2023 –
May 2026Lupin Research Inc.
Associate Director, Drug/Device Combination Products
CMC lead on five complex assets, including inhalation and drug-device combinations. Advanced two complex generics into clinical trials. Managed ten-plus projects at once and supervised two junior PMs.
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Jul 2019 –
Apr 2023Lupin Pharmaceuticals
Senior Product Manager, Development Operations
Operational leadership for drug product development programs, from development strategy through launch readiness.
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Jan – Jul 2019
Frontage Laboratories
Director of Business Development, CMC
Closed over $4M in CMC services in under seven months. Brought in 15+ new client accounts.
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Sep 2014 –
Sep 2019Thermo Fisher Scientific (including Patheon)
Global Pharma Product Manager
Started as a Process Engineer in pharma API manufacturing at Patheon, before the Thermo Fisher acquisition. Owned global product lines worth $12–15M a year and led teams of ten to twelve.
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2012 – 2014
Cambrex
Production Engineer / Project Manager
Production engineering and project management in API manufacturing.
Notes
I am starting to write about the intersection I live in: running drug programs and building the science they depend on. Short pieces, no fixed schedule, first drafts in progress.
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The operator's view on NAMs
What industry would actually need to adopt organ-on-chip in place of animal models: throughput, standards, and trust.
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AI drug discovery's validation problem, from someone who builds the assays
Computational predictions are cheap. The bottleneck is a believable bench model to test them in.
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Phenotype first, molecule second
The repurposing lesson from sepsis: match the patient subgroup before you pick the drug.
Until these land, shorter takes go on LinkedIn.
Contact
Talk to me about chips, CMC, or sepsis.
The fastest way to reach me is LinkedIn. I am always up for a conversation about microphysiological systems, drug repurposing, combination products, or what it takes to move a molecule from the lab to the patient.