A view from the TOPRA Summit

I approached the first TOPRA Summit in London at the end of May knowing that the world of healthcare regulation is in a state of constant change. I’d been asked to chair a debate with industry leaders on ‘how the regulatory function might change in the future’. To make sure I fully grasped the scale of change that’s expected I spoke to seven VPs of Regulatory Affairs before the summit. They came from start-ups, top ten pharma companies and leading CROs, all with global or EU responsibility.

Change needs new skills

The interviews and the debate taught me a lot about the impact that change is having on the people who work within regulatory. Professionals in this sector have always needed a strong scientific and technical skill set and this remains unchanged. What’s new is the need for them to enhance their skills for the future, and substantially so. Foremost will be the development of leadership, emotional intelligence and softer skills such as vendor and stakeholder management plus an ability to ensure that everyone around them gets the big picture.

A perfect storm

So what’s going on, why the change?

First of all, outsourcing is becoming more common as companies look to drive down costs. This applies especially to transactional activities, such as licence variations and renewals. While opinion was split about the benefits, those who have outsourced stressed the need to work as partners with their suppliers and have robust systems in place to ensure good communications and compliance.

Then there’s the global vs regional debate. Two recent cases were highlighted of pharma companies that reorganised from a regional to a global structure. This led to them closing their EU HQs with management moving to the US. While the reasons behind this were largely understood, it was felt that this approach can only work if the new teams have a truly global mindset and avoid being too US-centric. Quite a challenge and the delegates were somewhat sceptical of the chances of success.

Health technology assessments

Another area which split the debate was health technology assessments (HTAs). While some regulatory teams work closely with their HTA colleagues, many still don’t have that chance. There was broad agreement of the need to build HTA/regulatory collaboration in drug development programmes to avoid an extra wait for patients after regulatory approval; this is especially true for some smaller pharma and biotech companies that have yet to see the benefit of this approach. The regulatory and HTA teams need to work closely in early development and take much more of a holistic approach. Lack of homogenisation in the HTA across Europe was a key issue but the skill sets of the individuals and their abilities to bring change about will be the deciding factor here. To achieve patient uptake, regulatory is becoming more about internal, change and external management of stakeholders.

Disruptive technology, disrupted people

Finally, ‘disruptive technologies’ was a theme that ran through the summit.

The rise and rise of digital health was seen as an area where business is playing catch-up and there’s a large skills gap. The impact of Real World Data has yet to be fully recognised but, as one delegate stated, “Regulatory were likely to become flooded with data and there was a real risk of them drowning”. These are areas where there’s a need to build capabilities and bring in new talent from outside.

Adapt and thrive

So, all in all, there’s a lot of change coming – changes of practice, thinking and behaviour. All of which represents challenge and opportunity. Those who recognise it and adapt will, as ever, be the ones that succeed.

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