Nonclinical Strategy & Target Product Profile (TPP)

Translate early data into a credible path to first‑in‑human. We align MoA, model selection, and safety hypotheses to a TPP investors can underwrite.

A scientific laboratory with a microscope in the foreground and workstations, chairs, and storage units in the background, illuminated with bright yellow lighting.

  • Decision‑grade TPP (indications, population, dosing route, differentiation claims)

  • Model & species strategy (relevance, translatability, ethical/feasibility notes)

  • Biodistribution & PK/PD plan (assays, sampling, quantitative benchmarks)

  • Dose‑setting framework (MABEL/NOAEL rationale, safety margins)

  • Risk register (assumptions, decision gates, mitigation experiments)

What you get

  • Intake & objectives — clarify outcomes.

  • Evidence review — preclinical data, prior art, competitive landscape.

  • Hypothesis mapping — de‑risk drivers tied to claims.

  • Plan & TPP — living document with milestones, budget ranges, timelines.

  • Review & handoff — slides + an operational tracker and next‑step studies.

Our process

  • Slide strategy deck (editable)

  • TPP (table + narrative)

  • Study outline sheet (biodistribution, PK/PD, tox)

  • Risk register and decision gates

Deliverables

What makes a “good” TPP at preclinical stage?
Clarity on target population, dosing route, and differentiating claims, with explicit assumptions and metrics that studies will prove/disprove.

Can you work with vendors?
Yes. We help scope, compare bids, build fit‑for‑purpose protocols and can support study execution; we do not operate as a CRO.

Do you attend pre‑IND meetings?
We prepare your package and talking points. Regulatory representation is client‑led; we join as advisors.

FAQs