Preclinical programme design and CRO oversight
Most preclinical programmes fail not because the compound was wrong, but because the study could never have answered the question that was asked of it.
01Design
Choosing a study that can answer the question
Design work starts from the decision the data has to support. Which model, which endpoints, how many animals, measured when and by whom — and what result would actually change your mind. A study that cannot produce a negative result is not an experiment.
That includes writing the protocol. Thirty-plus transgenic model protocols authored and taken through IACUC approval, so the regulatory paperwork is not an afterthought bolted on once the design is fixed.
Hands-on model experience
Rodent microsurgery, right-heart catheterisation and arterial pressure measurement. Hypoxia chamber models of pulmonary hypertension. Transgenic breeding, genotyping, conditional and full knockouts. Xenograft and experimental carcinogenesis models. Large-animal work including fetal sheep models of systemic inflammatory response.
02Oversight
Reading what your vendors send back
Sponsors without internal preclinical staff are in a difficult position: the CRO produces the data and also interprets it, and there is no one on your side of the table qualified to push back. That is a structural problem, not a reflection on any particular vendor.
Independent review covers histology quality and scoring, sequencing analysis choices, flow panel design and gating, and statistical handling. The point is to surface problems while they are still cheap to fix.
Because we own no instruments, there is no incentive to route work toward equipment that needs keeping busy. Recommendations on which CRO to use and whether a dataset supports its stated conclusion are made without a commercial stake in the answer.
03Track record
Programmes taken through
A CHAT-expressing CD4+ T-cell vasodilator strategy for pulmonary arterial hypertension — full preclinical package including adenoviral transduction optimisation, flow characterisation of the engineered product, and right-ventricular systolic pressure endpoints. Published as first author in Translational Research, 2025.
In-vivo efficacy studies of a UCHL1 inhibitor and an anti-NAMPT monoclonal antibody in transgenic models.
IL-18 as a mediator of sickle cell cardiomyopathy, established in knockout models with ex-vivo and in-vivo inducible tachycardia endpoints — Blood, first author.
—Also
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Designing a study, or unsure about one you have already run?
A twenty-minute call is usually enough to establish whether the design can answer your question, or what would need to change so that it could.