The route to Market: Why your Health Authority relationships matter
Posted on the 25th May 2023
Christine Chirdo, Senior Director of Regulatory Affairs examines the importance of Health Authority interactions.
Sometimes daunting, often complex - Health Authority interactions are integral to the regulatory landscape.
However, understanding these bodies' intricacies, nuances, and ever-evolving requirements can be an enormous drain on already stretched resources.
At the heart of lasting, successful interactions with global Health Authorities are several key factors.
These include mutual trust, respect, a deep understanding of each other's goals and needs, and objectives that afford open lines of communication, frank discussion, and a shared desire to improve the lives of others.
It is also vital to remember that, while hugely important, influential, and comprised of world-class scientists, regulatory bodies such as the FDA look to YOU, the sponsor, as THE expert voice on the development program being presented to them.
Never lose sight of the fact that, when it comes to the disease being studied, the investigational drug, the data, the manufacturing technology, and the voice of the patient, the sponsor is esteemed as the authority on the matter.
It is an essential element of your role to work with the regulator to help them fully comprehend the ‘why’ behind the ‘what’ in every submission being brought before them.
For example, if you believe that an additional nonclinical study is an unnecessary step before the initiation of a first-in-human trial and there is a sound rationale that is supported by a strong data narrative that conveys integrity and authenticity, you will find that the regulators will approach the situation with an open mind rather than with a predetermined set of requirements.
Of course, the regulatory officials may have their own opinion on the matter.
However, often, you will find they are keen to understand the sponsor’s point of view and will be generally amenable to creative approaches that satisfy their scientific curiosity.
Another common misconception is that interactions with regulatory agencies are data-intensive and that many authorities even request the generation of additional data. However, this is a complete misnomer – the more data generated, the more there is for the regulators to review and consider as part of their assessment.
While data plays a vital role in the process, the creation of surplus information is not only resource-intensive but also creates additional unnecessary stress on the already pressurized time resources of the scientists tasked with reviewing the materials being presented to them.
There are definitive expectations for content within technical data packages, but regulators are certainly not in the habit of putting patients through unnecessary clinical trials to penalize a sponsor.
Interactions with Health Authorities are an essential and useful part of the process. They are the perfect opportunity to lay the foundations and build upon collegial relationships that create strong partnerships that ensure patient needs are met.
From the perspective of the sponsor, they are also the optimum time to raise those all-important questions directly and ensure any grey areas are fully addressed.
Viewing Health Authorities and their work as a hindrance to corporate objectives offers no benefit to anyone involved in the process. Instead, this approach tarnishes the whole working environment and relationship from the very start.
It is imperative to remember that, as a body that oversees the work of countless sponsors, Health Authorities have the advantage of a holistic viewpoint that encompasses advice and feedback based on responses provided to alternate sponsors.
This is particularly significant as Health Authorities are the key external stakeholders and primary advocates for public health and are evaluating the data provided by sponsors within the context of other proprietary scientific information (e.g., not in the open domain).
Throughout the entire process, the value and importance of trust, equity and credibility cannot be emphasized enough. At the heart of it is the key component underpinning every interaction – transparency.
Some mistakenly believe that remaining discretionary or selective in disclosing program challenges or potential safety issues in the early phase of development will help circumvent additional agency requirements.
Unfortunately, such an approach is often counter-productive and, when unforeseen circumstances arise, Health Authorities may well retreat and even become an obstacle to progressing development objectives.
At all times, it should be mandatory to remain open when working with agencies.
Indeed, the more you can share with regulators, the more stable and collegial the relationship.
By shifting the mindset to collaboration and allowing greater involvement from the regulators, they play an invaluable role in assisting in problem-solving and sharing their expertise, knowledge, and experience.
Sharing removes the element of surprise, mitigates delays, and reduces the risk of damage to company reputation and credibility with the Health Authorities.
Integral to the free flow of information is establishing frequent communication with the project manager.
Not only does this ensure updates are received on filing strategy and key milestones are met, but it also conveys respect for time and resource allocation given that your program is not the only one on the regulatory docket.
Christine Chirdo is Senior Director of Regulatory Affairs at G&L Healthcare Advisors.