Having the possibility to engage face-to-face with EU regulators is the ideal situation to help with authorisation of your product. However, most interactions in the EU are in writing and very few sponsors have the opportunity for a meeting with the EMA.
The most critical meetings are those where the scientific committees of the EMA would like to question the sponsor to fully understand the data and the sponsor’s position.
Such ‘high-stakes’ meetings like CHMP oral explanations are often the final chance for a pharmaceutical sponsor to convince the EU regulators that the benefit/risk balance of their product is positive.
We recommend that you apply the pertinent Benjamin Franklin quote, throughout your planning for a successful EU ‘high-stakes’ meeting.
“By failing to prepare, you are preparing to fail”
1. Be prepared
Being well-prepared and performing professionally is the key to success. The sooner you can establish your team the better. Having your process and timelines mapped out will help prepare your team and maximise the chances of success. Plan for rehearsal sessions where you can work on the presentation, back-up slides and train comprehensively for questions and answers. If time allows, the team can be further coached by bringing in a ‘challenge panel’ of external experts who can act as a test-panel for your presentation and Q&A performance.
2. Know your data
EU regulators expect meetings like an oral explanation to be a scientific discussion based on data. To ensure this is the case, you should demonstrate intimate knowledge of your data to meet the regulators’ concerns as well as being able to present your position in a confident manner. To get to this stage takes meticulous preparation of key messages, slides and the script for the presentation and for potential questions.
One pitfall is to make use of already prepared slides as they will have been prepared with another aim in mind. Starting with a blank piece of paper, writing down the key messages that you believe the regulators need to hear gives you the best basis for creating slides that convey your key messages.
It is very important to make your slides as simple as possible, omitting any unnecessary information and this can be a challenge. Complicated slides distract the audience from your presentation; remember that the slides are there as an ‘aide memoire’ and not for the regulators to read verbatim as they will then not be listening to you!
In addition, keep graphics as simple as possible. A rule-of-thumb is a maximum of six points per slide with no more than six words in each.
3. Know your team
In many cases it makes sense to create sub-teams to address the individual topics, agree on key messages and create the slides. Group sessions can then be used to merge the slides into one presentation, optimise the script and ensure all information is in keeping with the key messages.
Additionally, there may be a need to coach key opinion leaders and/or patient representatives to speak or respond to questions on your behalf.
Finally, determining potential questions and being able to respond clearly and unequivocally to these are equally important to increase your chances of success. One way of doing this is to create a Q&A grid where all members of your team add likely questions, and questions they find difficult to answer. The team can prepare top-line responses, a more detailed explanation and any supporting slides for these potential questions and, of course, determine who is going to respond if the question is raised.
How we can help?
NDA Group supports life science companies all over the world with the single aim to streamline the global development and commercialization process in order to accelerate patient access to important medical therapies.
In Europe, we assist with Scientific Advice Group meetings, Oral Explanations, PRAC meetings and preparation for intense pricing negotiations. In the US, our Principals and Communications Strategists are particularly experienced at preparing for FDA Advisory Committee meetings, in addition to pre-IND, end of phase 2, pre-NDA/BLA, PMA, and mid- and late-cycle review meetings. We offer our clients an unparalleled breadth of global experience and expertise to drive efficient product development and health authority interactions across the US and Europe.
Whatever regulatory hurdle you’re facing, we can help you optimize every regulatory interaction and shape the dialogue about your product to create a more direct path to approval.
Article originally published on page 18 of the Jan/Feb 2019 issue of Pharmafocus
Dr Steffen Thirstrup