Your drug development project’s acceptance and success depend heavily on your IND application. Getting it right the first time is critical. Holding a pre-IND meeting ensures you’re prepared when it’s time to file with the FDA.
This article covers several aspects of conducting a successful pre-IND meeting with FDA. Read on to learn the how, when, and why of a successful pre-IND meeting.
Why You Need a Pre-IND Meeting
Do I even need a pre-IND meeting? That’s the question you’re likely asking if you’re here.
During the IND application, things go quickly. The FDA has only 30 days to review your filing. They want quick responses from your team as questions or concerns arise. You must negotiate and address issues almost immediately to meet your deadline or you will run the risk of receiving a clinical hold.
A pre-IND meeting with FDA allows you to receive input and implement changes within your timeframe instead of by the timeframe that the agency imposes. You can address and uncover potential risks, including those in preclinical development or manufacturing.
In addition to risk assessment, planning a pre-IND meeting with a regulatory strategist helps you identify benefits and determine goals for your IND. A KreaMedica consultant can evaluate your program to ensure your CMC, non-clinical, and clinical trial designs are sufficient for a clear IND at submission, so you can begin trials in humans as soon as possible.
A pre-IND is a good idea whether you’re in Phase 1, 2, or 3. Any time you have a new indication, you must file a new IND and should consider a pre-IND meeting. Working with our regulatory strategist ensures you’re asking the right questions at the right time to file your IND seamlessly.
Considerations for Timing Your Pre-IND Meeting
Many factors influence the timing of your pre-IND meeting. A Pre-IND meeting can be conducted at any point prior to the IND filing. A typical meeting may be conducted once some toxicology data is available, often between three and six months before filing your IND. This gives you time to implement the Agency’s feedback into the planning of your program. In situations where the program is complex, or where there may be input needed prior to conducting the toxicology program, you may consider whether the program would qualify for an INTERACT meeting or some other formal meeting with the Agency to ensure you get the right input at the right time to avoid conducting unnecessary studies.
The choice of meeting(s) and its timing depends on your key risks and whether they’re within the nonclinical, CMC, or clinical trial design itself. Often, smaller companies need input from the Agency earlier than expected to fundraise. They must understand what makes sense from a development or business perspective and factor those considerations into the timing as well as the available data to help inform specific questions to the Agency. If new questions arise after a Pre-IND meeting it may be feasible to have an additional formal meeting with the Agency if warranted.
Partnering with a KreaMedica consultant can help you identify the pros and cons of your timing choices. They will help you determine a suitable meeting date, ensuring that you have ample opportunity to ask questions, make adjustments, and file on time and as prepared as possible.
The Importance of Focused Questions and Adequate Data: Justification for Your Proposed Plan in the Package
Asking the right questions of the FDA is a crucial, yet often confusing aspect of an FDA meeting. With more data, you can ask more focused questions. Make sure you understand the available guidances and precedence as well as the relevant data from your drug’s development. Focused questions will get the most meaningful input from the Agency that increases the value of your pre-IND meeting. If you provide inadequate data for the Agency to respond to, the FDA won’t be able to comment on specific aspects of your program and you may miss receiving a critical piece of information.
The questions you are most afraid to ask are usually the most important ones you need answers to. Always be bold and ask the question and be mindful to ensure you include relevant context or justification to frame the Sponsor position.
The FDA is driven by data and science, and your justifications should reflect that. Your KreaMedica consultant can assist you with conducting thoughtful planning and making sound arguments.
Building a Phase 1 Design: Choosing Healthy Volunteers vs. Patients
How do you decide whether to conduct your Phase 1 study in healthy volunteers or patients?
While uncommon during IND review for a first-in-human study, there are increasing cases where the Agency may consider a program inappropriate for a healthy volunteer population based on the benefit/risk of the drug. You must explain why you selected a healthy or patient population when justifying your study design.
However, in many cases, the argument can go both ways, and both approaches have pros and cons. Consulting with regulatory and clinical specialists will help you decide which option is best for your project. Confirming your approach at the pre-IND meeting with the FDA will be a key topic of discussion.
Review of Non-Clinical Data
Selecting the appropriate pharmacologically relevant species to conduct toxicology studies is important to ensure a successful IND. The nonclinical package is critical to dose level selection for a First-in-Human clinical trial. Any potential safety findings will also impact your clinical design. Typically, Sponsors focus on findings from the toxicology program and toxicokinetics at the pre-IND meeting, but you must also be able to justify the product’s proposed indication and ensure nonclinical pharmacology studies support development.
Do you have the appropriate animal models? Are there other studies you plan to conduct prior to filing the IND?
Describing the nonclinical package at the pre-IND meeting and asking appropriate questions ensures completion of all the required studies to enter the next stage of development.
CMC: Excipients, Stability Program, and Specifications
A successful pre-IND meeting will involve asking relevant, stage-appropriate questions about your CMC program.
If your CMC program is on a critical path, your team might not have all the data needed to support the IND at the time of the Pre-IND meeting. The pre-IND meeting package should summarize the overall plan for drug substance and drug product and supporting information in support of questions on impurities, any novel excipient, the stability programs and specifications for your project. It is crucial to qualify the impurities in GMP-grade material through nonclinical toxicology studies before advancing to clinical trials.
A pre-IND meeting is ideal for considering, evaluating, and organizing those details.
You Need the Right Team
When conducting a pre-IND meeting, the goal is not to ensure the Agency agrees with everything you propose. Instead, you want to understand potential risks and explore what’s possible for your drug development program and how you might need to mitigate risks.
As you prepare your IND, you want the right team –– clinical, CMC, and regulatory experts –– to assess your program.
The ideal regulatory consultant will lead your pre-IND meeting process and strategy. They’ll be able to
- Craft the right questions
- Provide strategic guidance and risk assessments
- Collaborate with the team to understand key development issues to ensure questions are worded appropriately and your project has adequate justification.
Your consultant ensures all relevant background information is included in the package, pulling everything together to create cohesion. They identify key messages, help all parties agree upfront, and assemble the package to ensure the message thoroughly addresses critical elements.
Your regulatory specialists bring their expertise to the table, creating a rhythm, review process, and timeline that empowers your team to execute the project.
At KreaMedica, we bring together the greatest minds in regulatory consulting to guide Sponsors through their pharmaceutical development journeys. We know what it takes to get it right the first time, setting you up for success at every juncture.
Contact our team today to schedule a meeting with a regulatory specialist who can help you conduct a successful pre-IND meeting, ensuring a complete, seamless IND filing.