Consultations and Meetings
with Health Authorities

Pre-IND Consultation

Pre-IND meetings are a valuable source of information for any sponsor intent on submitting an IND. However, a Pre-IND consultation may be recommended first. Frequently, sponsors arrange for a Pre-IND meeting with authorities hoping to develop or finalize the plan for their IND together, but are surprised to learn that authorities like the FDA will not recommend a course of action, and instead only provide feedback on a fully developed plan. A Pre-IND consultation with Aleon’s team of experts and former FDA reviewers will help you finalize a complete IND strategy before sitting down for a formal meeting and assure that your Pre-IND meeting provides the information vital for a successful IND submission in the future.

Pre-IND Meeting

A Pre-IND meeting is an essential step for almost all novel drug development plans. Getting the most out of this time with regulatory authorities is essential, which is why the team at Aleon has spent so much time perfecting our Pre-IND approach. With more than 100 Pre-IND meetings completed with the FDA our team of former FDA reviewers and industry experts will provide everything needed to ensure you get the most out of your Pre-IND meeting. This includes:

• Liaising with authorities
• Providing example questions and reviewing/revising sponsor questions
• Drafting and submitting the meeting request
• eCTD team for compiling, publishing, QC and submission
• Pre-IND Meeting Package Preparation
• Pre-IND Meeting Preparation and Rehearsal (for teleconference meetings)
• Pre-IND meeting Follow up

End of Phase 1 Meetings

An end of phase 1 meeting is typically held to review the data gained from phase 1 clinical testing with the express purpose of reviewing and reaching agreement on the design of phase 2 controlled clinical trials (the goal being to ensure phase 2 design will adequately provide data on the drug's safety & effectiveness according to the authorities). While not a requirement for all sponsors, those with questions following the completion of phase 1 clinical trials should strongly consider this option before moving into phase 2. Aleon’s rich experience with End-of-Phase meetings can be a valuable asset as sponsors plan their next steps.

End of Phase 2 Meetings

There are certain points during the drug development process where input from authorities can provide valuable insight to prevent sponsors from wasting time and money, and one of the most important ones is at the end of Phase 2 clinical trials. The FDA confirms that meetings at the end of Phase 2 are particularly important in planning later studies. Phase 3 studies are a large investment that necessitate careful planning, the End of Phase 2 meeting serves as an important opportunity not only to assess the adequacy of the data gained in Phase 2, but to identify any additional information necessary to support a marketing application for the product once trials are complete.

Biosimilar Initial Advisory (BIA) and Biological Product Development (BPD) Meetings

The FDA conducts five different types of formal meetings for Biosimilar or interchangeable products, including BIA and BPD1-4. A BIA meeting serves to help sponsors determine whether or not their product will meet the requirements of 351(k), a unique pathway for products “highly similar” to an approved FDA reference product. BPD meetings deal with a range of issues for Biologic development programs including data review, specifics issues and clinical holds. Determining the right meeting for your program and the right timing can be tricky, but with Aleon’s experienced team at your side we will guide you every step of the way!

Q-Submission

Initiated in 2019 the Q-Submission program is an expanded version of the previous Pre-IDE program, intended to provide early feedback for sponsors working on medical devices, although certain INDs and BLAs submitted to the CBER (Center for Biologics Evaluation and Research) qualify for the Q-Sub program as well. Requests can include Pre-Submissions, Submission Issue Requests, Study Risk Determinations, Information Meetings, and more.

Pre-NDA/BLA Meetings

A Pre-NDA or Pre-BLA meeting is an opportunity to set your program up for success with authorities. While it is not a requirement, Aleon recommends this step for all sponsors seeking to submit an NDA or BLA to the FDA. Not only will this meeting serve to confirm that you are organized and set up for a successful submission, but it will also notify the FDA to be prepared for your submission and ready the necessary resources. During the meetings sponsors can get feedback on pivotal clinical data (including late-breaking data), CMC (importantly the extent of stability data), and the content of the Integrated Summary of Effectiveness/Safety. The key to a successful Pre-NDA meeting is proper preparation. Aleon’s team of experts will make sure that your team is ready for any questions from authorities, and that your NDA/BLA is set up for success!

Other Type A/B/C Meetings

The FDA is happy to arrange meetings with sponsors and does not charge any fee for their participation, however they will quickly reject meeting requests that are premature, out of scope, or if the request is missing a required element. As such, it is important to understand the different types, timings, and requirements of each meeting planned with the FDA. This can be a headache for sponsors and it is rarely the best use of their time to keep up to date with the latest meeting guidance the FDA has issued. At Aleon we take pride in our status as regulatory affairs experts, and can help sponsors with all meeting types at the FDA. After a brief review of your program, our team of former FDA reviewers and industry experts will determine which meetings will best serve your program, and assure your product is set up for success.