How valuable is a regulatory strategy?

At SDS, clients of often ask; “Do we really need a regulatory strategy? We plan to exit this project after the phase I study”. If we were to be frank we would reply: “Well, what is the value of your development program? A less blunt answer is: “Yes, the truth is that you need a regulatory strategy from the very beginning Regulatory planning means meeting expectations from regulatory stakeholders, and to meet regulatory expectations you need to know the full path to choose the right direction. From the start!”

Also, to make an exit after a phase I study means the project needs to be attractive for a partner or buyer of the project. No buyer, no exit. When your project is up for sale you need to show any serious stakeholder that there is a compulsory regulatory roadmap that outlines the necessary steps, costs and timelines towards a Marketing Authorisation Application or New Drug Application.

For many projects there are several alternate regulatory strategies and paths to decide on choose from. A typical straight forward example is choice of indication, often there are several possibilities for a single substance. For one of the potential indications an orphan drug designation may be attainable that offers a regulatory fast lane which may shorten development time and lower the regulatory hurdles as one pivotal study will suffice. For another indication, using the same active ingredient, large comparative phase III-studies with hard endpoint may be required. Choice of development program may influence development time and cost greatly!

As general Eisenhower said “Plans are nothing, planning is everything“. To start a regulatory roadmap, you need to know where you want to go. A typical strategic regulatory plan is typically more detailed for early phases of the development project – we know exactly where we are now but depending on the outcome of the early steps in the program, the plan should be continuously revised. As explained above, in the outset there may be several potential goals that seems attractive, but you need to map out alternatives carefully and investigate them by their respective merits. The end goal is the starting point for your planning. When you know where you want to go, you work your way backwards, using regulatory knowledge and suitable guidelines to pinpoint binding studies, timelines and challenges. Typically, you also need to define the weakest points of your strategy so that those Gordian knots may be discussed with regulatory authorities, making sure they will not become showstoppers for the full project.

Your topnotch advisors for your regulatory strategy are the regulatory authorities, they have the knowledge, experience and at the end of the day, they make the final decisions. However, interaction with regulatory strategies is a lifelong learning process; regulatory knowledge, science and communication intertwined. To communicate effectively with EMA or the FDA you must come prepared. Are you planning on getting a Scientific Advice? Look out for our best advice on how to ask for Scientific Advice!