The pathway to an approved drug involves a long, expensive journey through basic research, preclinical development, clinical trials, and regulatory approval. Before sponsors invest significant amounts of time and money developing a product, it is important that they seek input from the regulatory agency that will approve their drug. Doing so will guide preclinical and clinical strategies and cultivate a target product profile early in the development process, which increases the probability of a successful development program and decreases the likelihood of encountering costly delays. Within this context, of particular concern is clarity regarding the Investigational New Drug (IND) process. Understanding the logistics of a pre-IND meeting with the US Food and Drug Administration (FDA) can facilitate a sponsor’s pathway to approval. This article will describe how sponsors can derive maximum benefit from engaging the FDA to help guide the development process. (Note: This article focuses on drug development as an example, but a similar process, called a pre-submission program, is applicable to development of a device.)
Sponsors looking for pre-IND guidance must request a Type B meeting with the FDA, which can be an opportunity to build a relationship with the FDA and gain valuable feedback on any questions regarding drug development. Although the FDA does not require these meetings, they are recommended because such meetings can confirm the requirements of the development process. It may be advantageous to meet with the FDA early in the drug development process so that any recommendations and answers to questions can be integrated into the development program. These meetings are most effective when they are focused on specific scientific or regulatory issues, such as clinical trial design, pharmacology studies, toxicology studies, acceptability of novel formulations, dosing limitations, data requirements for an IND application, and regulatory requirements for demonstrating safety and efficacy to support a new drug approval.
In order to request a pre-IND meeting, sponsors must submit a formal letter to the responsible project management staff or other designated personnel of the Division of Transplant and Ophthalmology Products.1 In order for the request to be as complete as possible and to give the FDA an accurate understanding of what the sponsor hopes to obtain from the meeting, the meeting request should contain the following elements:1
The teleconference is a popular meeting format because they are easier to schedule and manage and are less costly than face-to-face meetings. Speculative and open-ended questions are difficult to address; meetings are typically most productive when questions are focused and specific. Questions for the FDA should be posed in such a way that the agency can either agree or disagree with the question. Here are some sample questions:
The timing of the pre-IND meeting often depends on the complexity of the discussion topics. Sponsors that prefer to obtain confirmation of toxicology plans and manufacturing will benefit from a meeting held 6 months to 1 year prior to the planned IND submission. In such cases, a meeting request should be submitted approximately 60 days prior to the desired meeting date. The FDA will respond to a request for a pre-IND meeting within 21 days of receiving the request.1
If the FDA meeting is granted, sponsors must provide a pre-IND meeting briefing package to the Division of Transplant and Ophthalmology Products at least 4 weeks prior to the meeting.
In addition to pre-IND meetings, the FDA offers other opportunities to formally engage for guidance on development programs.1 Type A meetings are held to help move along a stalled development program. Reasons for stalled programs might include dispute resolutions, issues with the program that have put the clinical program on hold, or special reviews of a clinical study design (called special protocol assessments). Type C meetings are any other meeting between the FDA and a sponsor regarding the development of a product.
Building a strong relationship with the FDA is essential for a successful drug program. This begins with taking advantage of the valuable information that can be gleaned from pre-IND meetings. Proper utilization of pre-IND meetings may reduce the drug’s time to market and ensure that the proposed studies are designed to provide useful information. Sponsors who are forthcoming with potential issues of concern during the drug development process will benefit from input provided by the regulatory agency.
Aron Shapiro is vice president of retina at Ora in Andover, Massachusetts.