Of all our services, G&L Scientific is best known for collaborative Health Authority Interactions resulting in positive outcomes.
Without question, Health Authority interactions are one of the most critical aspects of any drug development program. Although there are predetermined times and key milestones when a sponsor is to engage a regulatory Agency, our philosophy is that you can never overcommunicate during development.
All meetings with regulatory Health Authorities require thorough preparation, which begins well before actual engagement.
The G&L team will begin by holding a kick-off meeting with your team and key stakeholders. This meeting introduces our approach and provides insight on the disposition of the Agency division and composition of the Agency review team (e.g., those who are likely to be present at the meeting).
For those on your team who are new to Health Authority interactions, we will prepare them to make sure that they go into any Agency meeting with the confidence of knowing what to expect, and how to respond.
The G&L team will then lead the cross-functional team of subject matter experts to explore what key questions the regulatory body needs to be asked.
Each functional area will be challenged in order to pressure test their respective strategies as they relate to the development program. It is always important to remember that this is yourmeeting; you will only get from the Agency what you put before them to react to. Companies often have the expectation that Health Authorities will identify their issues for them, resulting in ambiguous discussion points and suboptimal outcomes.
Our experience helps to identify the discussion topics and specific questions that support the best exchange of information with government officials. We would encourage you to be as transparent as possible and provide all information and data available so that the downstream activities for a major filing are ‘de-risked’.
Once questions, by discipline, are agreed to, the team will be led through the G&L ‘messaging’ process which conveys a succinct takeaway on what the data support. This process fully prepares your team for the submission of a meeting request.
Your G&L team will serve as an advisor, whereby your team authors the meeting request and we provide an expert review. Alternatively, G&L can drive content creation by leveraging our highly experienced medical writers (i.e., clinical, nonclinical, CMC).
Once the meeting request is submitted, the next phase of preparation includes constructing the briefing package.
The Briefing Package
The briefing package, also known as a briefing book or information package, is one of the most important documents you will write, as it forms the basis upon which the Health Authority is:
1) informed of the patient population being examined
2) made aware of your drug candidate (e.g., MOA) and the development program
3) introduced to the existing data
4) given an opportunity to learn “the why behind the what” – that is, they may be keen to understand the sponsor’s rationale behind study design, endpoint selection, or other components of the research plan.
Once the briefing package is submitted, the G&L team will schedule a series of preparation meetings where the team will be encouraged to think like the Health Authority.
At this stage, the team will come up with potential feedback from the Agency, to which the team will compose a company response. In this process, the team defines guardrails as to what they are willing to accept, or possibly challenge, along with a justification to that end. We have found that our approach is so effective that seldom are our clients’ teams surprised by the comments they receive back from the Health Authority.
If required by the client, G&L will assemble a mock panel to run through rehearsals. Once the Agency’s preliminary comments are received, we will assist the team in providing formal responses.
Additionally, we will counsel the team on whether to proceed with the meeting based on the need for additional clarification, or to cancel in the event that no feedback is required.
Our Value Proposition
While the overall process has been described above, it is important to point out that our clients benefit greatly in their Heath Authority interactions as a result of G&L’s experience and knowledge of them.
Our approach to these interactions includes the essential component of forging regular and transparent communication with Health Authorities. In essence, we are not simply assisting our clients with the development of meeting requests, briefing packages and preparation sessions.
We are intimately involved in building the relationship between the sponsor and the Agency, which builds trust equity and develops rapport with Agency representatives.
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