Toxistrategy Llc

Toxistrategy provides embedded, fractional nonclinical and toxicology leadership for early-stage biotech and pharma teams approaching IND. We step in when programs reach decision-critical moments - before a full-time Head of Toxicology makes sense, but after the risks of “outsourced-only” execution become real. Our role is to own nonclinical interpretation and strategy, not just oversee studies: → Fractional Head of Toxicology leadership → IND-enabling nonclinical strategy and oversight → Study sequencing tied to development decisions → Dose and species justification → Signal interpretation and risk framing → Regulatory-ready nonclinical narratives : → Have data but no clear risk hierarchy. → Need senior judgment without a full-time hire → Depend heavily on CROs but lack internal tox ownership → Are approaching FDA interactions without a clear nonclinical story We work as a true extension of your leadership team - translating complex nonclinical data into clear, defensible decisions that protect programs and accelerate development. If your program is approaching IND and nonclinical decisions lack clear ownership, this is where fractional leadership adds value. Reach out today.