Nonclinical Pharmacology Consulting

Aclairo provides expert nonclinical pharmacology consulting to help Sponsor subject matter experts craft a compelling narrative and integrate on- and off-target activity into the safety profile of their drug product.

Nonclinical Pharmacology Consulting Overview

Aclairo nonclinical pharmacology consultants work with Sponsor subject matter experts to design pharmacology programs that characterize the on- and off-target effects of a drug product and meet regulatory expectations. A well-designed pharmacology strategy is critical for dose selection, demonstrating the biological relevance of toxicology species, justifying the prospect of direct benefit to special patient populations, and identifying potential off-target toxicities early in development.

Aclairo provides nonclinical pharmacology consulting across a wide range of therapeutic modalities, including small molecules, biologics, and cell and gene therapies. Our experts can help identify opportunities to reduce animal use through in vitro, in silico and other methods (e.g. new approach methodologies [NAMs]). Our consultants integrate pharmacology with toxicology and regulatory expectations to ensure that pharmacology programs are scientifically robust, efficient, and aligned with development and clinical goals.

When is Nonclinical Pharmacology Consulting Needed?

Nonclinical pharmacology consulting is critical at multiple stages of drug development, particularly when defining strategy or addressing regulatory expectations:

Early-stage drug discovery to define pharmacology strategy
Selection and development of in vitro and in vivo models
Evaluation of off-target pharmacology risks
Integration of safety pharmacology into toxicology programs
Development of secondary pharmacology strategies
Translational planning from preclinical to clinical dosing

Expertise in Nonclinical Pharmacology

Aclairo consultants bring deep expertise across pharmacology and toxicology, enabling integrated strategies that support complex development programs. We routinely help clients with:

Pharmacology strategy for small molecules, biologics, as well as cell and gene therapies
Development of pharmacologically relevant in vitro and in vivo models
Generation of submission-ready pharmacology reports
Minimizing animal use in pharmacology studies
Secondary pharmacology strategies appropriate for the modality
Interpretation of off-target risks
Safety pharmacology and/or incorporation of these endpoints into general toxicology studies to reduce animal use

Related Services

Nonclinical Drug Development Strategy Scientific & Regulatory Writing

Frequently Asked Questions

What is the difference between pharmacology and toxicology?
In drug development, pharmacology evaluates intended drug effects and mechanism of action, while toxicology focuses on the safety implications of both on- and off-target effects, including at high doses.
What are secondary pharmacology studies?
Secondary pharmacology studies assess off-target effects, with an emphasis on those that may impact drug safety. The most appropriate secondary pharmacology studies vary by modality and should be designed with the specific program and target in mind.
Are pharmacology studies required for IND submission?
The pharmacology data needed to support an IND can vary significantly between programs depending on the modality and indication. Therapeutics whose effects are not reversible typically require more data than those that are more quickly eliminated.
How can pharmacology studies reduce animal use?
Through strategic model selection, prioritizing use of in vitro systems, and integrated study designs aligned with 3Rs (replacement, reduction, refinement) principles.

Find out how Aclairo can strengthen your nonclinical pharmacology strategy with expert guidance.