Generating a robust, focused, and convincing preclinical data package is critical in cell and gene therapy. Failure to appropriately plan and execute a suitable nonclinical development program is a common source of regulatory application failures and delays.
DHC can provide extensive, in-house subject matter expertise to assist you in successfully planning and executing such a program. Our most popular services include:
We help you to define and describe your nonclinical development plan as well as related safety and efficacy endpoints to optimally support your regulatory and clinical strategies.
We write and/or review your study protocols, reports, and regulatory submissions, ensuring that essential items are thoroughly and appropriately addressed as well as clearly communicated.
We work with you to understand your development strategy, pipeline asset, Agency interaction timelines, geographical considerations, and operating budget, all with the end goal of identifying, appraising, auditing, and recommending the most appropriate vendor(s) to successfully achieve your objectives.
Study design and oversight can take many forms, such as:
De novo nonclinical package design: We work with you to understand your intended clinical population and setting and carefully develop a nonclinical package in a relevant model with meaningful safety and efficacy endpoints.
Oversight of nonclinical study execution: Our in-house expertise can be deployed (remotely or in person, as necessary) to oversee the execution of preclinical studies and analyze the generated data.
Nonclinical data compilation and review: We compile data from your lab notebooks and study reports into a comprehensive tracking-and-trending database. We evaluate this data using statistical analysis software to help you to understand your nonclinical data and its trends in a way that you might not have previously considered.
Nonclinical package gap analysis and study design: We review your existing nonclinical data package and carefully develop a comprehensive nonclinical/preclinical roadmap to make your data package more robust, complete, and likely to succeed in gaining regulatory agency approval.
.png)
