Nonclinical Drug Development Strategy Consulting

With 350+ years combined drug development experience, Aclairo can develop an effective nonclinical program to get your therapeutic to the clinic or to the market.

Nonclinical Drug Development Strategy Overview

Every therapeutic development program needs a plan to characterize the potential efficacy and safety of their product before clinical trials and marketing. The nonclinical drug development strategy defines the in silico, in vitro, and in vivo studies, data, and regulatory approach required to support safe and effective progression of a therapeutic candidate from nomination to clinical trials and marketing. A well-designed nonclinical strategy integrates pharmacology, toxicology, and DMPK considerations to enable the clinical strategy and meet regulatory expectations.

At Aclairo, we support sponsors in developing comprehensive nonclinical drug development strategies tailored to their specific program, indication, and regulatory pathway. Our consultants bring extensive experience evaluating health authority expectations and designing programs that align scientific rigor with practical execution.

When is a Nonclinical Drug Development Strategy Needed?

A nonclinical development strategy is critical at multiple stages of drug development, including:

Early-stage program planning prior to IND-enabling studies
During due diligence evaluations of potential in-licensed programs
In preparation for regulatory submissions to start clinical trials (IND/CTA)
When unexpected data presents safety challenges to the program
In preparation for accelerated or full approval (NDA/BLA)

Our Expertise

Aclairo consultants have over 350 years of combined experience as regulators at FDA and as scientists in industry. We put that experience to work in evaluating and advising on regulatory authority, DMPK, pharmacology/toxicology and pathology issues encompassing virtually all classes of drugs, biologics, and therapeutic indications.

Our team supports:

Development of complete de novo nonclinical development strategies
Due diligence and gap analysis of existing drug development programs
Regulatory document development and reviews
Guidance on Health Authority interactions around complex drug development issues
Constructing an efficient nonclinical program minimizing animal use

Our Nonclinical Strategy Development Process

Aclairo consultants tailor their work to the needs of each individual client. A typical interaction for a new program would include:

Program Assessment: Review of existing data, relevant literature, client objectives, and regulatory goals
Gap Analysis: Identify missing studies, potential risks, and regulatory considerations
Strategic Planning: Develop a comprehensive cost- and time-efficient nonclinical development plan, including recommendations for health authority meetings
Ongoing Support: Provide guidance through study execution and regulatory interactions as needed, including the option to fully manage nonclinical study execution and develop regulatory documents.

Related Services

Nonclinical Drug Development Operations Scientific & Regulatory Writing Toxicology

Frequently Asked Questions

What is included in a nonclinical drug development strategy?
A nonclinical strategy typically includes primary and secondary target pharmacology, safety pharmacology, toxicology, and DMPK study plans, recommendations for regulatory interactions, and a roadmap for future nonclinical studies.
When should a nonclinical strategy be developed?
The nonclinical strategy should be initiated early in development to ensure appropriate models and reagents are available for pivotal studies. These strategies should be reviewed periodically as new data is available.
Does a nonclinical development program require animal studies?
The need for in vivo studies depends on the specifics of the product and indication. Typically, some in vivo studies are likely to be required, but well-designed programs can minimize animal use through efficient study design, regulatory alignment, and appropriate deployment of new approach methodologies (NAMs) to answer specific scientific questions.
Are nonclinical requirements different between CBER and CDER?
Both centers require rigorous data that characterizes the pharmacology, DMPK, and toxicology of their regulated products, but the specifics of those studies can differ. Aclairo consultants have experience developing programs for both centers that will meet regulatory expectations.
We are conducting our initial clinical studies outside the United States – can Aclairo design a program that will meet international expectations?
Yes – Aclairo consultants frequently support worldwide programs and international clinical trials and marketing applications.