siRNA
Nonclinical safety ownership across siRNA candidates, including study strategy, endpoint selection, and the internal risk positions that follow from the data.
Capability
Modality breadth that is genuinely rare.
Nonclinical safety accountability across seven modalities. The toxicology of these does not transfer cleanly between them — conjugates, vectors, and delivery systems each fail in their own way.
Modalities
Seven, each with its own failure mode
Exon-skipping oligonucleotides
Safety strategy across a $25M exon-skipping and AAV portfolio, setting what was investigated, what was monitored, and what warranted escalation.
Antibody-oligonucleotide conjugates
Conjugate toxicology where antibody and oligonucleotide liabilities interact rather than sit independently — the basis of the DYNE-251 clearance.
Antibody-drug conjugates
Molecular pathology lead to Pfizer's global investigative ADC team, including patient-selection assay development and validation.
AAV gene therapy
Program-level safety across AAV delivery at Sarepta and gene therapy for neurological disease at Novartis.
LNP-delivered mRNA
Platform safety agenda for four lipid-nanoparticle mRNA candidates, from study design through IND documentation.
Small molecules
Mechanistic investigative toxicology, including kinase-inhibitor-induced hyperglycemia across a six-month rat study.
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What the function covers
Core competencies
The remit of a nonclinical safety function, from the study bench to the health authority.
- Preclinical development leadership and safety strategy
- IND-enabling program design and regulatory defense
- GLP and non-GLP study design, monitoring, and interpretation
- CRO sourcing, contracting, oversight, and report review
- Nonclinical authorship: INDs, NDAs, investigator brochures
- FDA and international regulatory representation
- Investigative and mechanistic toxicology
- Molecular pathology: IHC, ISH, RNAscope, qRT-PCR, western blot
- Translational biomarker and patient-selection assay development
- Team leadership, hiring, and functional management
- Cross-functional partnership with discovery, CMC, clinical, regulatory
- Portfolio and budget management
Method
Read the data, do not merely receive it.
Outsourced toxicology arrives as a report. Whether that report is fit for a submission is a separate question — one that requires knowing what the study should have shown, where the design was compromised, and which finding a reviewer will stop on.
Eleven years of mechanistic investigative toxicology and molecular pathology at Pfizer is what makes that judgement possible: pursuing why a toxicity occurred, not only whether it did.