Independent consultant · County Waterford, Ireland

Clinical and regulatory consulting in companion-animal drug development

Stuart Fitzgerald MVB MANZCVS

Independent consulting on the clinical and regulatory development of medicines for cats and dogs, for animal-health companies and for investors and boards assessing a programme.

Chief Scientific Officer of TriviumVet from 2020 to March 2026, responsible for regulatory strategy and clinical development: principal contact with FDA’s Center for Veterinary Medicine (CVM) and with EMA, and principal author of the company’s regulatory submissions. Three products from those programmes have since been approved or authorised.

I am a veterinarian. I qualified from University College Dublin in 2001 and was in small-animal practice until 2017, the later years as a hospital owner.

Consulting

A single defined piece of work, or continuing support for a programme.

Regulatory strategy: Whether and by which route a programme can reach approval in the United States and the EU, including conditional approval.
Development plans: Preparation and review of development plans: regulatory requirements, sequence of studies, timelines.
Agency meetings: Presubmission conferences with CVM and EMA scientific advice: preparation and attendance.
Regulatory writing: Briefing packages, technical sections, protocol justifications and responses to the agency.
Study design: Protocols and endpoints for pilot and pivotal studies in client-owned animals; development of outcome measures.
Data: Pilot data exploration; interpretation of study results; data presentation to regulatory bodies.
Programme support: Clinical and regulatory lead for a company without the capability in-house.
Independent review: Review of a development programme for an investor, board or acquirer.

Experience

Regulatory FDA Center for Veterinary Medicine and EMA

Principal point of contact with CVM and with EMA for seven years, to March 2026.
Regulatory strategy for companion-animal therapeutics: pathway, indication and evidence requirements.
Extensive experience of the conditional approval pathway, including expanded conditional approval.
Presubmission conferences with CVM: briefing packages and conduct of the sponsor’s side of the meeting.
Principal author of TriviumVet’s submissions on effectiveness and target animal safety. Filings and correspondence with the two agencies ran to several hundred items.
EMA scientific advice, and regulatory lead on a centralised application for marketing authorisation, granted in 2025.

Clinical development

Design of clinical programmes and individual studies in cats and dogs. Programmes in cardiology, neuropathic pain, gastroenterology and renal disease.
Pilot and pivotal field studies in client-owned animals, to Good Clinical Practice, in collaboration with investigators at university hospitals and specialist referral centres.
Protocol and data-capture development; endpoint selection and development.
Target animal safety studies, in collaboration with contract laboratories.
Conception, development and clinical validation of the CHASE questionnaire, an owner-completed outcome measure for Chiari-like malformation and syringomyelia in dogs, in collaboration with veterinary neurologists at NC State and Ohio State (Valentino et al., 2026).

Data analysis and interpretation

Critical interpretation of clinical study results for their clinical and regulatory significance. This includes exploratory analysis, the issues that affect interpretation and the limits of what the formal analyses establish.
Extrapolation of biomarker signals to clinical relevance.
Translation of study results into regulatory arguments and submissions.
Analysis strategy, sample size and statistical analysis plans, in collaboration with biostatisticians.

Approved products

Felycin-CA1 Sirolimus delayed-release tablets

FDA conditional approval, March 2025

Conditionally approved for the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy. CVM described it as the first product approved for use in cats with HCM for any indication.

Regulatory strategy and clinical development lead at TriviumVet; principal author of the FDA submissions.

CVM announcement

Liavium-CA1 Pregabalin chewable tablets

FDA conditional approval, May 2026

Conditionally approved for the management of pain and clinical signs associated with Chiari-like malformation and syringomyelia in dogs. It is the first drug approved in the United States for this indication.

Regulatory strategy and clinical development lead at TriviumVet to March 2026.

CVM announcement

Omeprazole TriviumVet Gastro-resistant capsules

EU marketing authorisation, April 2025

Authorised throughout the EU under the centralised procedure, as an aid in the treatment of NSAID-induced gastric ulceration in dogs.

Regulatory lead on the application at TriviumVet.

EMA product page

Publications and patents

Peer-reviewed papers

Valentino A, Moore SA, Fitzgerald S, Kennedy S, Farrell A, Costello M, Roynard P, Olby NJ. Development and validation of the Chiari-like malformation and syringomyelia evaluation: the CHASE questionnaire. Journal of Veterinary Internal Medicine 2026;40(1):aalaf040. doi:10.1093/jvimsj/aalaf040
Shaverdian M, Nguyen N, Fitzgerald S, Grubb L, Stern JA, Li RHL. Ex vivo effects of low dose delayed release rapamycin on agonist-induced platelet aggregation, activation and procoagulant platelet phenotypes in domestic cats. Scientific Reports 2026;16:16696. doi:10.1038/s41598-026-46991-z
Tolbert MK, Darrow J, Grubb L, Fitzgerald S, Bergee R, Price J, et al. Pre-clinical enteropathy in healthy soft-coated wheaten terriers. Journal of Veterinary Internal Medicine 2025;39(2):jvim17293. doi:10.1111/jvim.17293
Kaplan JL, Rivas VN, Walker AL, Grubb L, Farrell A, Fitzgerald S, et al. Delayed-release rapamycin halts progression of left ventricular hypertrophy in subclinical feline hypertrophic cardiomyopathy: results of the RAPACAT trial. Journal of the American Veterinary Medical Association 2023;261(11):1628–1637. doi:10.2460/javma.23.04.0187
Rivas VN, Kaplan JL, Kennedy SA, Fitzgerald S, Crofton AE, Farrell A, et al. Multi-omic, histopathologic, and clinicopathologic effects of once-weekly oral rapamycin in a naturally occurring feline model of hypertrophic cardiomyopathy: a pilot study. Animals 2023;13(20):3184. doi:10.3390/ani13203184
Gaier A, Price J, Grubb L, Fitzgerald S, Tolbert MK. A prospective, randomized, masked, placebo-controlled crossover study for the effect of 10 mg omeprazole capsules on gastric pH in healthy dogs. Journal of Veterinary Internal Medicine 2021;35(2):887–891. doi:10.1111/jvim.16061

Patent families

Brennan T, Grubb L, Byrne L, Fitzgerald S. Veterinary formulations comprising rapamycin and methods of using the same for treating animal disease. US 12,599,590 B2, granted 2026.
Brennan T, Byrne L, Fitzgerald S, Grubb L. Veterinary compositions for use in the treatment of neuropathic pain. WO 2024/068242. Pending.
Grubb L, Fitzgerald S, Byrne L. Bienzymatic biosensor for the detection of lactulose in blood. WO 2021/165343. Pending.
Grubb L, Fitzgerald S, Byrne L, Horgan S. An assay for determining gastrointestinal permeability. CA 3,226,909. Pending.

Google Scholar

Background and contact

2026 to date: Independent consultant, as Stuart Fitzgerald, Clinical & Regulatory Consulting. County Waterford, Ireland.
2020 to 2026: Chief Scientific Officer, TriviumVet, Waterford.
2017 to 2020: Clinical Affairs Manager, EirGen Pharma, Waterford.
2005 to 2017: Director and small-animal clinician, Brittas Veterinary Hospital, Thurles.
2001 to 2005: Veterinary surgeon, The Park Veterinary Group, Leicester.
Qualifications: MVB, University College Dublin, 2001. Member of the Australian and New Zealand College of Veterinary Scientists, Medicine of Cats Chapter, 2014.
Advisory: Appointed to the Industry Advisory Council, NC State College of Veterinary Medicine, 2023.

Contact

stuart@stuartfitzgeraldmvb.com