8 DECEMBER 2024LIFE SCIENCES REVIEWIN MY OPINIONIN MY OPINIONFROM COMPLEX TO COMPLIANCE: 3 KEYS FOR UNLOCKING THE REGULATORY PATHWAYBy Nicholas Smalley, Vice President of Regulatory Affairs, Kindeva Drug Delivery 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 ThingAt 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 NetworkMost regulatory authorities are reactive rather than proactive regarding guidance and advice, so regulatory TNicholas Smalley
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