Nonclinical drug development consulting · Prague
Terra Nonclinica provides expertise and support to biotech and pharma companies in nonclinical stages of drug development — from proof of efficacy through nonclinical safety to IND and first-in-human.
About
I am a veterinarian and toxicologist. My career in drug development has taken me from a contract research laboratory in Canada to big pharma in Chicago, to leading preclinical research at contract research organisations in Central Europe, and to building a preclinical safety department at a Prague biotech.
Nonclinical safety means predicting what a new drug can do to patients before it reaches them — and finding the line between tolerable and intolerable toxicity. I help sponsors move promising molecules forward on solid data, and say early when the data point the other way.
Therapeutic areas
Career path
Our role is not only to move projects forward, but also to stop them in time.
Services
From a single study review to running the whole nonclinical part of a program — on the sponsor's side, working with the CROs you already have or helping you choose new ones.
A development plan that reaches IND or CTA without detours, matched to your modality and indication.
The right study at the right CRO and at the right time — balancing expertise, cost, timelines, quality and flexibility.
Nonclinical content that answers the regulator's questions before they are asked.
Antibody–drug conjugates and other oncology modalities — the most recent focus, with 5 INDs from 10 programs.
Safety questions specific to immune-activating therapies and CAR-T cells.
An experienced view of a nonclinical package, or a head of toxicology until you have your own.
Approach
Each stage has its own questions. The work is to answer them with the fewest studies that will stand up in front of a regulator.
Pharmacology, PK/PD and an early look at target safety, to choose a candidate worth developing.
IND-enabling toxicology, safety pharmacology and genotoxicity, sized to your modality and indication.
Nonclinical modules, the Investigator's Brochure and a defensible first-in-human starting dose.
Answers to questions from the clinic, longer-term toxicology and studies for later phases.
Every study should answer a question the regulator will ask. That keeps programs lean and avoids repeats.
The right CRO for each study — expertise, cost, timelines, quality and flexibility weighed for your program, not by habit.
Moving a project forward is half of the job. The other half is recognising early when the data say it should not go on.
Encore
Notes on nonclinical drug development, collected in one place.
FAQ
IND-enabling studies are the nonclinical studies regulators expect before a new drug is given to people for the first time: pharmacology, pharmacokinetics, safety pharmacology and toxicology, usually under GLP.
Their scope depends on the modality and the indication. Oncology programs follow ICH S9, biologics ICH S6(R1) and most other programs ICH M3(R2).
Ideally before the first GLP study is placed, when the strategy still shapes the program. The earlier the plan, the fewer studies need to be repeated or added later. A review is also useful at any later point, for example as a gap analysis before a pre-IND meeting.
No. Studies are performed at contract research organisations (CROs) chosen for your program. Terra Nonclinica designs the studies, selects and manages the CROs, monitors the work and interprets the results on your side.
Programs heading for an IND with the US FDA and clinical trial applications in the European Union, based on experience in the USA, Canada and the EU.
With a short call about your molecule, its stage and your timelines. Confidential details can wait until a confidentiality agreement is signed. You then receive a proposal with scope and timelines.
Contact
Send a brief description of your inquiry. A few sentences about the molecule, its stage and your timelines are enough to start.
