To implement any change in the biopharmaceutical manufacturing industry it is important to engage with and collaborate with the regulators. Set up two years ago, BPOG’s Regulatory Interaction team has been developed to help phorums and workstreams to connect with regulators in the most constructive way. Over this period they have formed a strong team who have devised the best ways making sure that our teams knock on the right doors at the right time with the right message. In this article, we will describe how the Regulatory Interaction team works and the benefits it brings to all BPOG members.
The 30 regulatory experts from over 20 biopharmaceutical companies that comprise the team, bring extensive regulatory expertise and a wealth of experience gained from not only their own companies but from their extended networks and their connections to regulators and other industry groups.
Regulatory Interaction has been described as ‘helping with opening doors’ with regulatory authorities/agencies. But what might this mean in practice?
Is the door already open?
The Regulatory Interaction team is well placed through its networks to understand the key priorities for regulators. Insight and advice is provided on how to make appropriate connections from BPOG activities to current and future priorities for regulators. Even if a topic may be a priority for regulators, there might be understandable resistance to cross the threshold at an individual company level. The Regulatory Interaction team, however, provides a forum for sharing experiences and best practices, encouraging transparency and cross-industry alignment. A good example of this is around new technology where connections have been established with the related teams in the FDA and the MHRA.
Which Door or Doors?
Often industry and regulators are interested and motivated in progressing a particular topic, however, what may not be so obvious is to whom and how to make the right connections. In consultation with the Regulatory Interaction team, workstreams can discuss their goals and determine how best to engage with regulators. This can be a ‘direct’ contact with a regulatory agency but may need to start in a more ‘indirect’ manner via a number of other doors – for instance, the preparation of a white paper and then presenting this at a conference, hopefully resulting in more direct contact. Regulatory Interaction has the expertise and networks to counsel on which routes might be effective. A current example in progress is for BioPhorum to provide a training seminar for the FDA regulatory product reviewers that will include early sharing of current industry thinking and direction, enabling further engagement and alignment.
‘But that door worked before?’
Organizations evolve over time and another role for the Regulatory Interaction team is to keep aware as regulatory organizations change and ensure that they maintain a current understanding of how to access and contact them and share this across BPOG.
Helping us to knock on the right doors?
In thinking about doors, there are a number of ways to attract attention, assuming you know the person you’d like to meet. The Regulatory Interaction team continues to develop its networks so the right contacts can be made in the right way. A recent example exploring the widely held industry perception that an authority did not really understand a particular process step that was necessary to justify a process change, discovered that in fact, this wasn’t the case. Discussing it with Regulatory Interaction tested this assumption and it became clear from benchmarked cross-company observations and experiences, that in fact the process technology is well understood by regulators. The actual problem, in this case, was diagnosed as being about the understanding of supporting scientific rationale. In this example, industry should have been able to demonstrate they fully understand the science and theory. The workstream has now adapted their planned engagement approach that has subsequently led to a planned joint session between industry and regulators in this area.
BioPhorum’sRegulatory Interaction team is now routinely providing the needed regulatory expertise and advice to the BioPhorum phorums and workstreams for both immediate issues and future strategic opportunities. Designed to enable more effective regulatory engagement planning through better interaction preparation (publications, conferences, meetings), the team’s work increases confidence in achieving successful execution. As plans develop for new phorums, the Regulatory Interactions team has work to do in ensuring that the thinking is ‘Global’, for example as in the case of emerging markets.
Finally, it’s clear that regulators are also looking to innovate. If doors are redesigned, for instance sliding doors, the BioPhorum Regulatory Interaction team are proactively positioned to advise on that too.