While a Pre-IND meeting is not required prior to submission of an IND, it offers many advantages and is therefore, highly recommended. [1]
Accelerate
The Pre-IND meeting will facilitate IND review by:
Recognizing and avoiding unnecessary pre-clinical studies and instead, identifying the necessary safety and pharmacology pre-clinical studies appropriate for your AAV asset and disease of interest. This also minimizes wasted time and costs in your overall program.
Identifying inadequate or missing required CMC tests in the manufacturing process that could lead to IND (an order issued by a regulatory agency, such as the FDA, which stops or suspends clinical trials for your investigational drug). For more information on grounds and procedures for clinical holds, refer to this guidance by the FDA. [5]
Confirming that the Phase 1 clinical study is designed to meet its intended objectives while maintaining subject safety.
Discussing any concerns or potential IND hold ups prior to submission of the IND. Addressing these with the FDA gives you an opportunity to correct these when you have time on your side.
Identifying possible designations that will advance the clinical trial or marketing application review process. Through this meeting, you may wish to discuss the proposed designations with the FDA.
These suggestions will expedite the IND preparation process and reduce the time in which your therapeutic candidate or AAV product will get to clinical trials.
Close gaps
Your organization may be new to drug development, and it is likely that your product is intended to treat a serious or life-threatening disease, and/or is intended to treat a population with a currently unmet medical need. The Pre-IND meeting will assist you in resolving any unique development aspects in your IND and answer any questions you may have with time to resolve them before submission. Alternately, it would also be where you put forth proposals to the FDA and agree to a common plan forward given the unique and tailored development process for AAV products.
Build a relationship with the FDA
The Pre-IND meeting is an important opportunity to introduce your organization and investigational therapy to the FDA. The regulatory process should be viewed as a collaborative approach between the Sponsor and the FDA. This meeting will serve both introductory and informational purposes, particularly with regards to scientific strategies, which will benefit future product development – data-driven rationale should be utilized to gain feedback on plans to accelerate product development.
Gaining early Agency insight and ensuring the endpoints and goals of your program are well-defined and complete will go a long way in your regulatory journey.
Although the FDA may be open to some communication (requests for advice) post Pre-IND meeting/before IND submission, only one Pre-IND meeting is granted per IND, so make it count. [1]