In this article, published in November's edition of Pharmafocus, Dr Ingela Loell, Scientific writer, and Dr Steffen Thirstrup, Advisory Board Director, provide insight into oral explanations and what you need to emphasize when you engage with EU regulators.
What exactly is at stake when you’re faced with an oral explanation? For a pharmaceutical company, it is years, probably even decades of hard work, a fortune in investments, the chance of regulatory approval, and future sales. A high-stakes meeting unquestionably requires robust data, but to secure a successful outcome a well delivered, concise presentation, is equally crucial.
For a pharma company, there are ‘make-or-break’ regulatory events along the way to market. An oral explanation can be a tipping point for the success of a new drug hoping to achieve marketing authorisation in the EU. As it is a critically important step in the regulatory review process and presents an opportunity for the applicant to influence the outcome, preparation is essential. Backed by robust science, a high-quality presentation and well-prepared Q&A response strategy can resolve the issues and result in a positive opinion.
Preparing and presenting at an oral explanation to the Committee of Medicinal Products for Human Use (CHMP) is possibly one of the most stressful tasks that drug companies might face. These meetings are intended to give the applicant the opportunity to explain their position and arguments. This happens when there are still major objections at Day 180 of the assessment procedure, preventing the relevant EMA Committee* from adopting a positive opinion concerning the application. For applicants the aim is to get a positive majority vote for marketing authorisation. However, these meetings are not public but held behind closed doors, and the applicant is not present for most of the discussion. During the assigned one-hour meeting with the CHMP, you have 20 minutes to make your case.
One of the biggest differences between a scientist and a regulatory person is that in science you normally present your result starting with the data leading up to the conclusion, while presenting at an agency meeting you must do the opposite. Always start with your key point and build your supporting message. Dr Steffen Thirstrup, advisory board member at NDA, has attended more than 100 oral explanations during his time as CHMP member and has a firm understanding of the ‘dos and don’ts’ during this critical event.
“Stick to the science,” he emphasises.“ There is no room for speculation or emotion, you need to have your message perfectly packaged; what you show, what you say and how you say it, it must all come together in synergy. ”
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