Welcome to our very first newsletter!

To help to set the right expectations from the start, it is important that you know whether this newsletter is for you.

With this series of newsletters, we hope to reach you who are new to drug development, who have just discovered a new molecule or substance and are taking your first steps towards pre-clinical research. Our goal with this newsletter is to equip you with practical and relevant information, along with expert tips and reflections, to help make your drug development experience smoother and more successful.  

If you are a seasoned developer with several programs behind you already, we recommend you take a look at some of our amazing thought leadership articles that you can find on our website NDA Thought Leadership

Regulatory Affairs and when you should start thinking about it

Here at NDA, we specialize in Regulatory Affairs - the crucial development discipline ensuring that drugs are developed, manufactured, and marketed in full compliance with all applicable laws and regulations.

Failure to comply with regulatory requirements can lead to delays in approval, additional testing requirements, or even result in the rejection of your treatment altogether. That's why having a thorough understanding of regulatory affairs is essential for the success of your drug development efforts.

Setting the scene

NDA CEO, Johan Str?mquist, says “Drug development is complicated. I would say that on average, getting a medicine from idea to market takes anywhere between 8 to 15 years and just like any other business, developing a new pharmaceutical product or a medicine is prone to running into numerous hurdles along the way. And a lot of it we often don't think about.”

Laurie Smaldone Alsup, Chief Medical and Scientific Officer at NDA adds “It is not uncommon for us to see developers skip steps early on in development because their science is exciting, and they are not objective enough to anticipate risks and hurdles to development.”

When should you start thinking about Regulatory Affairs?

Understanding the implications of regulatory affairs early in your development process is crucial to the success of your program. With less than 1:10 of drugs entering Phase I, a carefully planned regulatory strategy is key to advance your drug candidate to clinical trial.

By developing a regulatory strategy, your company can prioritize resources and budget to achieve your objectives. It provides direction on research and development, clinical trial design, product development, value, and market access. It is essential to have a clear and agreed-upon goal for the project from the very beginning, and the regulatory strategy evolves during the development of the product.

An effective strategy:

• Identifies and analyses the key regulatory issues and opportunities,
• Defines go/no go decisions from a regulatory perspective,
• Defines regulatory pathways and how to reach agency approval with optimal timing,
• Outlines challenges and risks and how to mitigate them, and
• Optimizes the value of a drug after its commercial launch.

Key Takeaways

Start thinking about your regulatory strategy now as the benefits to you and your development include:

1. Creating an efficient and cost-effective drug development program, helping you avoid potential delays and rejections, which can be costly and time-consuming,
2. The ability to generate data that is acceptable to regulatory agencies and can help accelerate and de-risk your approval process, and
3. An informed decision-making process ensuring that you prioritize the activities that are most critical for approval and avoid spending time and money on unnecessary activities.

Our upcoming newsletters will focus on the key steps you will need to take on the path to the clinic, including creating a Target Product Profile, Translational strategy, CMC considerations and Regulatory Interactions.

If you are developing a treatment that you believe addresses an Unmet Medical Need, don’t miss our upcoming webinar with our NDA Advisory Board Member Jan Sj?berg (former IWA, SAWP and CHMP member), who will discuss unmet medical need as a key criterion for drug development, based on his experience as a former EU regulator.

Learn more and register here!