Jenna Brager, PhD, RN, MS
Director of Regulatory Affairs for MyMD Pharmaceuticals, Inc.
July 25, 2022
The pre-IND meeting serves as the sponsor’s first formal meeting with the FDA. This meeting allows the sponsor to discuss their drug with regulatory officials and more effectively map out the full IND application. There is opportunity to review available nonclinical data, manufacturing, product quality and more. At this time, the sponsor may receive valuable guidance resulting in a more successful and well-received application. 1
The Benefits of a Pre-IND Meeting
Even though a Pre-IND meeting is not required, it affords sponsors the ability to:
- Identify and avoid unnecessary studies
- Streamline study efforts to ensure only meaningful data is obtained thus reducing costs
- Gain FDA support for a proposed strategy
- Obtain regulatory insight
- Clearly define endpoints and goals of the development program
- Allow early interactions/negotiations with the FDA 2
Additionally, information obtained in a Pre-IND meeting may help ensure the subsequent IND application is complete, helping to avoid clinical holds.
Once a sponsor determines a Pre-IND meeting is the appropriate first step, the meeting type must be determined.
There are three types of formal FDA meetings: Types A, B, and C all with corresponding timelines and procedures. 1‚2 For more information about the various meeting types, please visit the FDA website. Most pre-IND meetings are Type B meetings and will be scheduled approximately 60 days from the confirmed receipt of the request.1
Typically, the FDA only grants one Pre-IND meeting per investigational Product therefore adequate preparation is crucial.2 The following section highlights ways to prepare.
Determine the focus point(s) of the meeting
The sponsor should consider the overall scope of the meeting and whether certain disciplines (e.g., CMC, pharmacology/toxicology, clinical pharmacology) should attend in order to provide additional context to the conversation. Additionally, the appropriate personnel from the FDA should also be present.
Identify a facilitator and meeting roles
A facilitator should be pre-determined to ensure meeting runs smoothly and stays focused on the primary focus point(s). Those in attendance should also understand his or her role in the meeting. A note taker is essential to refer back to not only controverted issues, but also shared ideas.³
Rehearse effective communication
Effective communication is key to ensure your message is relayed appropriately. Responses to the FDA should be clear, concise and transparent. It is important to stay on topic and answer the questions that are raised.³ Take advantage of this time with the FDA to establish rapport with the specific review division staff by using open communication. The success of the meeting may play a role in the outcome of the actual application once submitted as the FDA staff will already be familiar with the product.
Establish contingency plans
The importance of having contingency plans especially for complex programs and unique or nuanced issues. In the event the FDA disagrees with the sponsor’s initial plan or position, alternative solutions should be readily available for discussion to which the FDA may agree.³ This requires ample preparation and evaluation well in advance of the meeting. As mentioned earlier, role determination on behalf of the sponsor will help support a smooth transition if contingency plans need to be discussed to promote positive outcomes.
Summary
The pre-IND meeting has the potential to save time in the long run and can really shape the overall strategy for drug development for the compound under study.² The meeting provides sponsors with the opportunity to communicate openly to understand the FDA’s perspectives and recommendations, as well as gain preliminary agreement on critical aspects of the proposed development program. The meeting gives sponsors the opportunity to build a relationship with FDA.1
It is vital to plan carefully to make a good impression with the FDA. It’s critical to thoroughly prepare for any question(s) the FDA may ask. Know your position and science clearly.² Adequate preparation will be apparent and will make all of the difference. Therefore, be sure to adhere to guidelines when submitting a pre-IND meeting request and be certain all the required documents are submitted to the FDA by the designated date to ensure an effective meeting and constructive experience.²
References
- Ayd, S. (2020). Beginner’s Guide to a Pre-IND Meeting.
- Rose, M. (2017). Is an FDA Pre-IND Meeting worth it?
- Al-Fayoumi, S. (2021). Pre-IND Meeting Guide: Benefits & How to Prepare.
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Jenna Brager, PhD, RN, MS, is the Senior Executive Director of Regulatory Affairs at MyMD Pharmaceuticals. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.
Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email jbrager@mymd.com.