Accelerate your IND timeline by 6-12 months with expert preclinical toxicology leadership
PhD, DVM, DABT with 20+ years helping biotech and pharma navigate FDA requirements, so your preclinical program clears review the first time.
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Available for fractional and interim nonclinical safety leadership.
Services
IND-enabling toxicology programs that pass FDA review
RSS designs and manages comprehensive nonclinical toxicology programs built to meet FDA, EMA, and OECD expectations on first submission.
Gene therapy and rare disease nonclinical strategy
RSS has built IND-ready nonclinical packages for gene therapy and CNS-directed programs across ALS, Parkinson's, oncology, and prion disease, spanning intravenous and direct-deposition delivery routes.
Data Analysis
I work directly with Ponemah, EMKA, and Notocord data, from raw waveform through summarized, analyzable results, with descriptive statistics in SigmaPlot or GraphPad. Stuck on an acquisition or analysis problem? I can troubleshoot the method, not just the output.
Laboratory animal medicine, surgery, and IACUC compliance
As Attending Veterinarian and IACUC committee member at multiple institutions, I provide surgical guidance for vascular access ports, telemetry implantation, and tissue collection, plus protocol development and compliance review for vivariums standing up their first in-house program.
Additional expertise
Fractional and interim nonclinical leadership
I've directed an 82-person GLP department generating $3.2M in annual revenue and served as interim executive for a 185-person CRO. If you need nonclinical safety leadership before you're ready for a full-time hire, or through a transition, I step in as fractional or interim Head of Nonclinical Safety: 10 to 20 hours a week, or full-time, for as long as you need it.
CRO selection and qualification
Picking the wrong CRO costs months and real money. I've qualified CROs from the sponsor side at Vertex, and run the CRO being qualified at Ricerca and AmplifyBio. I'll evaluate your shortlist, assess sites, and give you a clear recommendation before you sign.
Regulatory compliance and inspection readiness
Twenty years working under FDA, EMA, EPA, OECD, AAALAC, and USDA oversight. Before an inspection or audit, I'll review your program against the standard the agency will actually apply and flag the gaps while there's still time to fix them.
Our Scientific Journey
Meet Dr. Michael Stonerook: your preclinical success partner
Rook Scientific Services is a consulting practice for preclinical toxicology, safety pharmacology, and nonclinical program leadership.
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Michael Stonerook, PhD (physiology), DVM, DABT, has spent more than 20 years across sponsor companies (Vertex, Parke-Davis) and global CROs (Battelle, Ricerca, AmplifyBio), directing 40 to 60 toxicology and safety pharmacology studies a year to ICH, FDA, EMA, and OECD standards. He's led an 82-person, $3.2M GLP department, served as interim executive for a 185-person CRO, and built IND-ready nonclinical packages for new chemical entities and gene therapy products across ALS, Parkinson's, oncology, prion disease, and CNS-directed programs. Study programs have run through partners in Asia, Europe, and Canada.
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He holds an active Ohio veterinary license, board certification in toxicology (DABT, recertified through 2030), and has taught pharmacology and toxicology as associate professor and course director. He authored the respiratory safety pharmacology chapter in Springer's Principles of Safety Pharmacology and co-authored "The Shifting Landscape of Safety Pharmacology."