How will the regulatory science profession shape the healthcare environment?

David Jefferys

Senior Vice President at Eisai Medical Research and former President of TOPRA

The life science industry has to convince governments and healthcare providers that it is the major contributor, providing solutions to secure affordable and sustainable global healthcare. Today industry is seen as the problem and the driver of unaffordability and unsustainability. Change in healthcare takes time and a realistic timescale is 2025–30.

What are the major challenges? They are the ageing population, managing expectations, affordability and climate change. The last is already influencing global healthcare through mass migration and emergence of new and changing patterns of infective diseases. On a global level, we have seen remarkable achievements through the programme on neglected tropical diseases launched by the global pharma industry with the London Declaration in 2012 and, this year, the launch of the Accelerated Access Initiative , a unique programme involving IFPMA (co-ordinating the pharmaceutical industry), the World Bank and Gates Foundation. This is necessary as we see a disturbing combination of chronic and tropical diseases manifesting with new disease presentations.

In the developed world, sustainability requires focusing on early diagnosis and on disease prevention. Digital health and connectivity should be major drivers of change in healthcare delivery from telemedicine, through to health monitoring, promotion and assistive technologies enhancing home care. Artificial intelligence should be integral to hospitals in 2025–30.

Regulatory science should be the facilitator – the bridge connecting new disciplines into the drug development and delivery system, ranging from early access programmes such as PRIME and Sakigake and onto pullthrough development. We should see more shared development using open platforms and crowd funding.

In dementia, regulatory science can facilitate the entry of second generation disease modifiers and third-generation cures using gene technology. Regulatory science should also play a prominent role in regenerative medicines and truly personalised immunotherapies.

Regulatory science can enable healthcare systems to meet the challenges of 2020, 2025 and beyond.