As a drug developer, you have to live with the answers and comments you get from regulatory authorities. Therefore, it’s essential that you choose your questions carefully and avoid questions you don’t need answers to. Let’s take a closer look at how to approach these meetings:
Why should you conduct regulatory meetings?
Even when existing regulatory guidelines are clear and your project plan appears foolproof, there are still many good reasons to periodically meet with the authorities throughout the development process. They know a lot that companies may not.
First, they can learn from everything they see in other companies’ plans and results. Second, existing guidelines are often a few years old, and new knowledge may have raised the bar on what is or will be required.
Arguably the most important factor for a majority of companies, though, is that meeting with regulatory authorities reduces the apparent risk of the project in the eyes of the outside world. Any seasoned investor, for example, will want to know how the authorities view your development plans. What will it take to start your subsequent clinical trial? What will ultimately be required to reach the market? These questions and more can be addressed at the appropriate time by meeting with regulatory authorities.
How to prepare for a regulatory meeting
Health agencies, such as the US Food and Drug Administration, European Medicines Agency, or Sweden’s Medical Products Agency, need to gather the right expertise for scientific advice meetings, so a drug developer will need to submit several specific questions to the agency in advance.
First, you will need to develop a “company position,” i.e., your rationale for your development plan that the agency can weigh in on. It’s important to have a logical line of thought in your arguments and, of course, the facts to back them up.
Second, it’s crucial to consider the timing for these meetings. When will you have enough knowledge and data to get your desired answers? Should some questions be saved for a later date? Unfortunately, these are rarely straightforward considerations, and you need to know what options there are for authority interactions. This is particularly true as the agencies from time to time create additional meeting types and pilot projects for collaboration on specific topics.
Lastly, consider how you phrase your questions. Let’s say your questions are too vague, and the positions are unclear or poorly justified. You run the risk of the authorities misunderstanding essential aspects of your project and plans. In the long run, this may lead to inadequate answers that are to your disadvantage.
Choose your questions carefully
Remember that the regulatory body isn’t a consultancy that can help you craft your development plan. What they can do is offer comments and guidance on the plan you present to them, and whether your plan is meeting the appropriate guidelines.
Questions should therefore be about your plans (or your problems/concerns, if you have any) and any clarifications needed regarding, for example, quality (manufacturing, etc.), preclinical or clinical studies, methodology, and statistics. Regulatory questions may cover the choice of regulatory procedures or the possibility of pursuing various expedited pathways.
How to get your phrasing and wording on point
It’s more than just needing questions about the right things — how you phrase them is important too, and can be challenging, to say the least. My best tip is to keep the questions short and concise rather than open and vague. Here’s an example of a poorly worded question:
“What would a good clinical development plan look like for our product?”
The question should be more specific in both content and structure. It’s open-ended and unspecific because it lacks a “company position.” It’s a question that you need to have sorted out yourself or with the help of consultants before the meeting. This question does not make it evident that you have done your homework; you want to show that you have already considered what a good development plan would look like by referring to expert advice, relevant guidelines, prior knowledge in the field, your data, and published data from others.
But we can fix this by including your position and keeping the question closed:
“Based on our company position, do you agree that the proposed clinical trial is sufficient to establish the dosing regimen for the pivotal study program?”
Authority meetings and scientific advice in different countries
Does it work differently in different countries? The short answer is: yes and no. There are practical differences in how national European authorities, EMA, FDA, PMDA (Japan), and other authorities hold advisory meetings. Indeed, we have had to adapt to new procedures since the beginning of the pandemic. Physical sessions are oftentimes replaced by digital sessions, or even just written responses. Other differences include costs, timelines, and the extent of background documentation that should be provided.
Despite the differences, however, the challenges for those developing a drug are more or less the same. Asking the right questions at the right time and having a well-founded, logical development story in your argumentation are still the keys to successful regulatory meetings.
Need help preparing for a regulatory authority meeting?
You might need to contact regulators for authority meetings at any stage of the drug development program. Cytel’s Therapeutics Development Team can help you to identify critical questions to ask authorities, prepare the meeting package and justifications, join you for the meeting, and write meeting minutes. In other words, support you throughout the entire regulatory process.
Getting in touch with us below is a good start. 👇
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