The basics first
Do you have to conduct regulatory meetings? You may think that existing regulatory guidelines are clear and that your own project plan is foolproof. However, there are still many good reasons to meet with the authorities. They know a lot that companies don't.
Firstly, they can learn from everything they see from other companies' plans and results. Secondly, existing guidelines are often a few years old and newer knowledge may have raised the bar on what is actually required. Both in terms of the current situation and how requirements might change over the years of the project.
And perhaps most importantly for a majority of companies - it is also a way of reducing the risk of the project in the eyes of the outside world. For example, any seasoned investor will want to know how the authorities view your development plans. What will it take to start your next clinical trial? What will ultimately be required to reach the market?
What the questions should be about
In order for a health agency (such as the MPA, EMA or FDA) to gather the right expertise for a scientific advice, you as a drug developer need to submit a number of specific questions to the agency. In relation to the questions, you should have what we call a "Company Position", i.e. your position on each question. The most important thing when formulating these is that there is a common thread in your arguments as well as facts to back it up. Here you may also realize that the choice of timing for meetings is crucial. When do you have enough knowledge and data to get the answers you want? Perhaps some questions should be saved for a later date? These are, unfortunately, not always straightforward considerations.
Let's say the questions are vaguely phrased and the positions unclear or poorly justified. You then risk a situation where the authorities misunderstand important aspects of the project. In the long run, this may lead to inadequate answers that are to your disadvantage.
Ask the right type of questions
So how should you ask questions to an authority? The perspective question first. Remember that the authority is not made up of consultants who can help you craft your development plan. That's your job.
Instead, the questions should be about your plans (or problems/concerns, if you have any) and clarifications regarding, for example, quality (manufacturing, etc.), preclinical and/or clinical studies, methodology and statistics. Regulatory topics may concern for example the choice of regulatory procedures, or the possibility of obtaining various forms of expedited pathways.
Getting the questions right
It is not just that the questions need to be about the right things. Formulating them 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 is vague in both content and structure. It is open-ended and unspecific because it lacks a ''Company Position''. It is a question that you sort out yourself or with the help of consultants. It should also be evident that the company has done its homework, for example by referring to expert advice, relevant guidelines and prior knowledge in the field. Your own data as well as 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?''
Scientific advice in different countries
Does it work differently in different countries? The short answer is: yes and no. There are practical differences in the way national European authorities, EMA, FDA, PMDA (Japan) and other authorities hold their advisory meetings. Indeed, we have had to adapt to new procedures because of the pandemic. Physical meetings have been replaced by digital, 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 medicine are more or less the same. Asking the right questions at the right time and having a well-founded, red thread in your argumentation are still the keys to successful regulatory meetings.
Need help with preparing for a scientific advice meeting?
You might find yourself in need to get in touch with regulators för scientific meetings at any stage of the drug development program. SDS can help you to identify key questions to ask authorities, prepare the meeting package and justifications, join you for the meeting and write minutes. In other words, support you throughout the entire regulatory process.
Getting in touch with us below is a good start. 👇