For some pharmaceutical applications, approval hangs in the balance at the 180-day review mark, as unresolved issues prevent a positive decision. In these high-pressure situations where marketing authorization is at stake, companies may be granted an oral explanation - a meeting presenting the final chance to directly address any outstanding concerns with Committee members. These important presentations offer the last opportunity for dialogue before regulators make their decision.
Obtaining approval for new drugs requires extensive research, testing, and review. At the 180-day checkpoint, outstanding issues may remain. Here, companies have an important opportunity in an oral explanation meeting to resolve any lingering concerns with regulators. How companies approach addressing scientific queries during these important interactions will impact the assessment outcome and subsequent developmental steps. Comprehensive preparation helps ensure that the data tells its full compelling story to the regulators.
On Day 180 of the assessment procedure, the Committee of Medicinal Products for Human Use (CHMP) discusses any major objections preventing a positive opinion on the marketing authorization application. If these critical unresolved issues remain, the committee may require an oral explanation from the company to directly address the objections. Such meetings provide one final opportunity to directly engage with committee members and respond through in-person discussion.
For pharmaceutical companies, oral presentations to regulatory committees are undoubtedly a stressful event. Securing a successful outcome requires both robust scientific evidence supporting the drug's safety and efficacy profile, as well as a skillfully delivered presentation that clearly and concisely addresses any remaining questions or concerns raised during the review process.
Why You Can’t Wing It
The stakes could not be higher, as the CHMP oral explanation effectively serves as the final hurdle. If the company can adequately convince the committee that the benefits of the new product outweigh its risks, this results in a majority vote authorizing marketing across European countries. The companies must therefore use their 20 minutes at the oral explanation meeting wisely to address outstanding objections and make their case for approval. Under these pressure-packed conditions with limited time, a favorable decision depends on impeccable pre-planning and rehearsal.
The team should start by carefully aligning the key objectives and messaging, then develop slides, scripts, and rehearsals to synergistically convey the intended takeaways.
The questions to address are:
- What are the fundamental issues anticipated to remain unresolved?
- What are the main messages we wish to communicate to the Committee to resolve the issues?
- What are the key data supporting those main messages?
There is an important distinction between how scientists and regulatory professionals approach presentations. Scientists typically deliver results by first sharing data and building up to the conclusion.
However, when presenting to a regulatory agency, it is key to take the inverse approach. The most effective strategy is to start with your central argument and then systematically provide supporting evidence, findings and rationale. Beginning with the primary takeaway message ensures it is top of mind for the audience from the outset as additional context is weaved around it, rather than risking it getting lost amid data points.
Align as a Team, Impress as One
Determining potential questions and being able to respond clearly will increase your chances of
success. The team can prepare top-line responses, a more detailed explanation, and supporting
slides for these potential questions. It is important not to introduce new data that the committee has not previously reviewed, as this runs the risk of an unfavorable reception.
The slide deck is intended to support the messaging, providing visual guidance, and highlighting the most important arguments. Therefore, the complexity and information on the slides should be reduced to a minimum. Keeping the slides simple helps them reinforce your message effectively without becoming a distraction.
The company should schedule practice sessions to refine the presentation. If time permits, the team can be further coached by bringing in an external "challenge panel" of industry experts. These experts can act as a test audience for the presentation and evaluation of the Q&A performance. Receiving feedback from a dry run with outsiders will help confirm the team is well prepared ahead of the actual meeting.
With one single opportunity to directly influence the committee weighing heavily, companies drawing on experienced advisory services can refine every aspect of the oral explanation through rigorous training. If backed by robust evidence and confidently delivered to resolve doubts, such intense preparation maximizes the chances of a positive opinion, satisfactory conclusion of the review process, and important goal of regulatory approval.
Conclusion
Oral explanations to the CHMP present both challenges and opportunities for pharmaceutical companies. On one hand, they represent the final hurdle in a long regulatory review process, with approval or denial hanging in the balance. However, they also offer a critical chance to directly address committee members face-to-face. While high-pressure, these meetings don't need to be daunting with the right preparations. Proven strategies like cross-functional team alignment, well-crafted visual materials, and mock presentation sessions help representatives feel confident and rehearsed. With thorough preparation, applicants can make the most of this key opportunity.
By working directly with our team of former EU regulators, you'll gain unparalleled strategic and tactical preparation that maximizes your chances of a positive outcome at your upcoming oral explanation meeting.
