The drug development process is long and expensive. You are doing yourself and your product a huge advantage if you enter and go through the process with a well-researched plan.
When planning your FDA submission, you need to “play the long game.” This means that you must have more than just set a goal. It is crucial that you consistently do the right things along the way in order to set yourself and your product up for future success.
That’s right. You should begin planning your submission very early in the development process, and simply make incremental modifications to this plan as you move through each step. Over time, that plan will turn into a tangible collection of clinical and nonclinical data that is compiled in a specified format for the FDA’s review.
The Pre-IND Meeting is the first major milestone meeting held during the development process. It marks your first formal interaction with the FDA, and it is in this meeting that you introduce your product’s concept and outline how you intend to turn that concept into reality. This meeting gives you the opportunity to validate your development program before you get to work.
When conducted effectively, the Pre-IND Meeting can serve as fuel for your ongoing development strategy. This is your first opportunity to obtain official regulatory insight, and done right, the outcome can help you identify and avoid unnecessary studies. In addition, it can also help you clearly define goals for each stage of your development program. It also provides insight into FDA expectations. Since the goal of drug development is to meet these, that insight is essential.
The discussions that take place in this meeting are extremely strategic in nature. The sponsor sets the agenda for this meeting, giving you the power to elicit information that will help you plan and adjust your long game.
The book entitled 7 Habits of Highly Effective People states that habit #2 of people who are effective in achieving their goals is to begin with the end in mind. That’s a poetic way of saying that before beginning any endeavor, you must set a goal. And, it’s great advice.
When planning your submission to the FDA, your overarching goal is to get your product approved and on the market as quickly and efficiently as possible. However, there’s more to it than simply having the end in mind. An important part of playing the long game is following the data. Drug development doesn’t happen in a straight line. Although you are steering your development program toward approval, there are likely to be a few twists and turns along the way.
Following the data may mean that your development program goes in an entirely different direction than you planned. There are many stories of drugs that were intended for one indication or population, but ended up best serving a different indication or population. When the sponsors followed the data, they reached their goal of getting their product approved. They played the long game, followed the data, and won.
When your data is telling you something, it is important that you listen to it. Take the long perspective and understand that the data is drawing the path for your submission.
Earning approval for your product means having a good regulatory strategy. When you understand where you intend to go, you can determine the best way to get there, making any necessary adjustments along the way. Should you need help, you can rely on ProPharma. Our experience and positive working relationship with the FDA means that we can help you set your goals and follow the data as you efficiently play the long game towards approval.
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