Navigating Pre-IND Submissions: A Guide for Small and Start-Up Pharma Companies

Preparing to submit an Investigational New Drug (IND) application is a critical step for small and start-up pharmaceutical companies aiming to advance a drug candidate into clinical trials in the U.S. A successful IND submission hinges on a well-prepared pre-IND process, where companies engage with the FDA to align on expectations, clarify regulatory questions, and address any safety or scientific concerns early on. This guide walks you through what to expect during the pre-IND submission process, so you can confidently prepare for a smooth transition to the IND application phase.

1. Pre-IND Meeting Request

The first step in the pre-IND process is to submit a meeting request to the FDA. This is a formal request where you outline your intention to discuss your development program, including the drug's scientific background, proposed indication, and any potential areas for regulatory guidance. This is crucial for small and start-up companies that may need direction to address early-stage questions effectively.

Tips for Success:

• Clearly state your meeting objectives.

• Provide a concise summary of your product's development, indication, and key questions or concerns.

• Submit the request at least 60 days before the desired meeting date to allow adequate preparation time for both parties.

2. Preparing the Pre-IND Meeting Briefing Package

Once your meeting request is accepted, the next step is to prepare a comprehensive briefing package. This document outlines your drug’s development plan, specific questions for the FDA, and supporting data, including preclinical results, toxicology studies, and manufacturing information. It’s your chance to provide the FDA with a clear picture of your program’s scientific foundation and areas where feedback is needed.

Key Components of the Briefing Package:

• Cover Letter: An introduction to the company, the drug candidate, and the purpose of the meeting.

• Development Program Overview: Include the drug’s intended indication, target population, and anticipated therapeutic benefits.

• Supporting Data: Relevant preclinical data, safety studies, and any completed pharmacology or toxicology reports.

• Specific Questions for the FDA: Keep questions clear and targeted to address pivotal regulatory or scientific concerns that could impact IND preparation.

3. Responding to FDA Comments

After submitting your briefing package, the FDA will review your materials and may provide preliminary responses. Take time to carefully evaluate their feedback. In some cases, the FDA will clarify specific requirements or request additional data. This is your chance to refine your approach based on FDA input and resolve potential issues ahead of your IND submission.

How to Handle FDA Feedback:

• Stay Organized: Categorize responses by topic to avoid missing details.

• Evaluate Impact: Consider how their guidance might impact your development plan, including any additional studies needed.

• Prepare Follow-up Questions: If there’s a need for clarification on certain points, be prepared to bring those questions to the pre-IND meeting.

4. Conducting the Pre-IND Meeting and Submitting Meeting Minutes

During the meeting, FDA representatives will discuss your program, address questions, and provide feedback. The insights gained can be invaluable, helping you adjust your development plan to better align with FDA requirements. It’s essential to keep a record of the discussion, as the FDA will not provide meeting minutes.

Drafting and Submitting Your Meeting Minutes:

• Be Comprehensive: Document key discussion points, agreed-upon actions, and specific guidance given. Remember meeting minutes, if done correctly, should serve as a clear record of agreements for all involved and the next steps. Any areas of ambiguity should be made clear and documented within the minutes for future reference. 

• Submit Promptly: FDA expects meeting minutes to be submitted within 30 days of the meeting.

• Request Confirmation: Send the meeting minutes to the FDA and request confirmation to ensure alignment on action items discussed.

Final Thoughts on Pre-IND Submissions

The pre-IND process is designed to facilitate a smoother IND submission and reduce the risk of delays. For small and start-up companies, these interactions can offer valuable insights and help bridge any gaps in understanding FDA’s expectations. By following a structured pre-IND process, small pharma companies can navigate regulatory hurdles more effectively and enhance their IND application’s success potential.

Ready to start the pre-IND process or have questions about your pre-IND submissions? Whether you need help preparing a strategy that aligns with FDA requirements, minimizes risk and maximizes efficiency, or need someone to take care of your eCTD-compliant preIND submissions, The Sugar Water Operations Team is here to help. With no long-term contracts required, we're with you however you need us for as long as you need us. Contact us to let us know how we can help.