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.
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 help you to define and describe your nonclinical development plan as well as related safety and efficacy endpoints to optimally support yourfuture regulatory and clinical strategies.
An effective roadmap to IND considers both efficacy and safety through the lens of the client’s business strategy and risk tolerance. It addresses timeline and budget, including an in-depth expectation of what a client’s future capital needs will be over time.
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, from package design to execution, data compilation to analysis, and more.
For clients currently without internal leadership focused on this domain, senior DHC experts can provide interim expertise and leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.
We oversee achievement of your project milestones, including maintaining up-to-date project timelines, organizing project team meetings, capturing meeting minutes, establishing RACI (responsible, accountable,consulted, informed) matrices, and following up on achievement of action items.
