Leaders in IND-Enabling Science
Before a single volunteer receives your compound, the nonclinical package has to answer one question the agency will not compromise on: is it safe enough to start, and at what dose? Get the program right and the IND clears, the starting dose holds, and the clinical plan is built on solid ground. Get it wrong and you are looking at a clinical hold, a repeated study, or a first-in-human dose the division will not accept. We design and steer nonclinical programs so the science supports the clinic, not just the checklist.
A nonclinical package is only as strong as its weakest discipline. We cover all six as one integrated program, so the toxicology, the kinetics, and the safety pharmacology tell a single, consistent story to the reviewer.
The nonclinical development plan mapped to your clinical goals: which studies, in which species, in what order, and what the IND actually needs.
GLP and non-GLP toxicology design and interpretation, from single-dose to chronic, plus genotoxicity, carcinogenicity, and DART.
ADME, pharmacokinetics, and toxicokinetics that turn exposure into the human dose projection and the margins the agency will scrutinize.
Core battery cardiovascular, CNS, and respiratory assessment, hERG and proarrhythmia strategy, and off-target liability screening.
Choosing the right lab, negotiating the protocol and price, and monitoring the study so the data arrives clean and on schedule.
Study reports, Module 2.4 and 2.6 summaries, and the nonclinical case for the IND, written so the pharm/tox reviewer can follow it.
Most nonclinical overspend comes from studies designed without the clinical plan in view: a tox study in the wrong species, a duration that won't cover the intended dosing, a gap the division flags at pre-IND. We build the nonclinical development plan backward from your first-in-human design, identify the minimum package that supports it, and sequence the studies so each one de-risks the next instead of running in parallel by default.
Toxicology programs rarely come back perfectly clean, and reviewers do not expect them to. What they expect is interpretation: whether a finding is adverse, whether it's monitorable in the clinic, and what it means for the safety margin. We design the GLP battery, interpret the pathology, and build the toxicology narrative that turns raw findings into a defensible position on human safety, so a finding becomes a managed risk rather than a hold.
Toxicology findings mean nothing without the exposure that produced them. DMPK is the through-line: it converts an animal dose into a human dose projection, sets the safety margins, and explains why a species did or didn't predict a signal. We design the ADME and toxicokinetic program, interpret PK/TK across studies, and build the exposure story that lets the pharm/tox reviewer trust your first-in-human dose.
Beyond general toxicology, the agency wants a specific answer on the systems that kill fastest when a drug goes wrong: the heart, the brain, and the lungs. We plan the ICH S7A/S7B core battery, build the cardiac liability strategy from hERG through in vivo QT, and screen for the off-target activity that turns into a clinical surprise. When a signal appears, we design the follow-up that resolves it rather than letting it hang over the IND.
A GLP study is only as good as its protocol and its oversight, and a CRO will run exactly what you signed, not what you meant. We help you choose the right lab for the study, negotiate the protocol and the price, and then monitor the work: reviewing in-life observations, catching deviations early, and pushing back on a draft report before it hardens into the version that goes to the agency.
Dozens of studies reach the pharm/tox reviewer as two documents: the Module 2.4 Nonclinical Overview and the 2.6 summaries. Those are where the program is won or lost, because they are where the argument lives. We write the nonclinical sections of the IND and CTD so the safety case is explicit, the margins are clear, and every finding already has its explanation, rather than leaving the reviewer to assemble the story themselves.
Two situations demand nonclinical judgment beyond the routine package: setting the first-in-human dose, and developing a modality the standard guidance was never written for.
Every nonclinical study eventually resolves into a single decision: the dose at which a human is first exposed. We derive it the way the agency expects, NOAEL to HED with justified safety factors, or MABEL for higher-risk biologics, and document the rationale so the starting dose, the escalation scheme, and the maximum exposure all survive review.
Standard tox paradigms assume a small molecule. Biologics need a pharmacologically relevant species and immunogenicity strategy; cell and gene therapies raise biodistribution, persistence, and tumorigenicity questions no repeat-dose study answers. We build the nonclinical program these modalities actually require and align it with the division before it becomes a review problem.
Our nonclinical leads are board-certified toxicologists and former agency pharm/tox reviewers who have designed the studies, interpreted the findings, and defended the package in front of the division. You get the senior scientist who owns the safety call, not a coordinator relaying it.
Scientists who have reviewed IND nonclinical packages from inside the agency and know exactly which findings trigger a hold and which get a comment.
DABT and ERT toxicologists and toxicologic pathologists who interpret the data themselves rather than forwarding a CRO's conclusions unexamined.
Small molecules, biologics, vaccines, cell and gene therapies, and oligonucleotides, each with the nonclinical paradigm it actually needs.
Nonclinical developed alongside CMC, clinical, and regulatory, so the safety package supports the trial you're actually planning to run.
Tell us where your program stands: lead candidate, IND-enabling, or mid-study with a finding to interpret. We'll match you with a senior nonclinical lead and respond within one business day. All inquiries are strictly confidential.
Our team's perspectives on IND-enabling programs, safety interpretation, and what the pharm/tox division actually looks for: coming soon. In the meantime, reach out directly with a question you'd like to see addressed.
How the starting dose is really derived, and where sponsors lose the argument on safety factors.
Adverse versus non-adverse, and the interpretation that keeps a finding from becoming a hold.
Which studies you actually need before first-in-human, and which ones can wait.