The pharmaceutical industry spends billions of dollars on R&D every year, resulting in an interesting and dynamic business where innovative new ideas and concepts to improve human health are created daily. However, one of the biggest challenges of this on-going innovation for the regulatory professional is how to guide organizations to effectively develop their newest complex drug product so it can be approved for use. Across my career, I have found three key things help navigate this process:
1. Do the Right Thing At the very end of every pharmaceutical development is a patient. It might be you, your parents, or your children, so even where guidance is available, the priority should be to maximise the benefit while minimising the risk. From concept to launch, developing a new drug product is risky, so you must base your programme on doing the right thing. Most regulatory guidance is grounded in history and what has come before, so it may not apply to your novel technology. In the absence of specific guidance or in the struggle to balance conflicting requirements, I have found the soundest position from which to start is putting the patient first. Always challenge yourself by asking, “Are we doing the right thing?” Regulatory regimens are only interested in your product's quality, safety, and efficacy. So, if you can justify that your development programme is in the patient's best interests, then you stand a much better chance of getting regulator agreement and approval, irrespective of any prevailing guidance. In this situation, the regulatory professional's skill is putting together patient-centric justification and explaining why what was done was the right choice. 2. Collaborate and Network Most regulatory authorities are reactive rather than proactive regarding guidance and advice, so regulatory professionals need to empower themselves to guide their companies through the development minefield. One of the best ways to do this is never to miss an opportunity to interact with regulators. Many regulatory authorities have pre-submission or pre-development meetings, which are excellent opportunities to explain a new product and highlight the potential patient benefit. On a more general note, regulators often speak at conferences, and many authorities run their seminars on various topics, so build your network whenever you can. Take every opportunity to get to know your regulators and strengthen that critical regulatory partnership. You may not get all the answers you want from these interactions. Nonetheless, early and regular engagement with regulators gives you a seat at the table, which becomes particularly important when you have something novel to discuss. You will have multiple opportunities to educate regulators throughout the development and licensing process, but it is best to begin your regulatory collaboration early, before data submission or before they are generated.One of the biggest challenges of this on-going innovation for the regulatory professional is how to guide organizations to effectively develop their newest complex drug product so it can be approved for use.
