Health Authority Interactions- Making the Most of Them

In my career, I have gone to great lengths in building trust equity with or better said, befriending regulators; this what we pass on to our clients. You must always remember that regulatory bodies such as FDA look to the sponsors as THE expert on the development program being presented. Yes, they are scientists with impressive credentials but when it comes to the disease being studied, the voice of the patient, the owner of the data, the manufacturing technology and the investigational drug, YOU are esteemed as the authority on the subject matter. This is important get a hold of because regulators desire to understand the why behind the what. For example, if you do not believe an additional nonclinical study is necessary prior to initiating a First-in-Humans trial, so as long as there is sound rationale that is substantiated by a data narrative conveying integrity as well as sincerity, you’ll soon learn that they come to the conversation with an open mind rather than a fixed mindset. 

That is not to say you’ll win the argument every time but our experience has consistently been that regulators are keen to understand the sponsor’s point of view and are generally amenable to creative approaches to satisfying their scientific curiosity. It is a misnomer that regulatory agencies just want you to keep generating data just for the sake of data generation; the more data you generate the more they have to review and consider in their assessment. This is not only resource intensive but be mindful that there is only so much time these scientists are given to render a decision on what they are being asked to review. Indeed, there are definitive expectations for extent of content within technical data packages, but regulators are not in the business of wanting to put patients through unnecessary clinical trials just because they do not have a fond opinion of the sponsor and just want to punish them by adding more study requirements.

Remember, you as the sponsor are the one asking for a meeting so it’s incumbent upon your team to ensure you are not only asking the right questions but that you capitalize upon those engagement opportunities to build a collegial relationship that is a true partnership in meeting patient needs. If you only view the health authorities as hindrances to your corporate objectives, or adversarial, then that tenor will be evident in your interactions with them which does not make for a positive working environment. Consider that they are privy to your competitors’ development programs and thus have a perspective that you do not have which could be advantageous if they are providing feedback based off of what they have told another sponsor. This is important is because as a key external stakeholder and the primary advocate for public health, agencies such as FDA are evaluating your data within the context of other proprietary scientific information (e.g. not in the open domain).

So how do you go about building this trust equity and establishing credibility? First, it begins with transparency; the more you can share with the regulators the better. Many sponsors have a false belief that if they remain discretionary in disclosing program challenges or a potential safety issue in early phase of development that the health authority will become a barrier to progressing their development objectives. My experience has been that the less you share, the more surprises you have resulting in inevitable delays to timelines, not to mention risking your reputation and credibility with the regulators. Shifting the mindset therefore to collaboration, allowing them to problem-solve alongside of you fosters trust. Being provocative in conversation from a position of wonder inviting their expertise tends to solicit enthusiasm with reviews. Communicating often with project managers, giving them updates on your filing strategy or R&D milestones tends to go a long way because it conveys a respect for their time and resource allocation given your program is not the only one on the docket.

Often my approach starts with introducing the  cross-functional team to the likely agency reviewer base off of our previous interactions, known areas of consternation, decisions rendered from multidisciplinary assessments , particular personality traits of scientific discipline team leads (e.g. what matters to them) etc. Role playing with mock panels are useful to encourage critical thinking and approach to respectfully debating anticipated issues with regulators. Equally important, while preparing for the interaction is thought given to how best to respond to preliminary feedback without coming across with a disposition of obstinance. And among all the other activities that go into health authority engagement, it is imperative for the regulatory strategy lead to facilitate interactions by coaching others in the background during meetings to help the team representatives exude confidence in conversation