Regulatory Innovation in the Life Sciences


A Charnwood Campus Cluster Business Support event, part of a series of events to celebrate the achievements and support the growth of the life science organisations clustered around Charnwood Campus Science, Innovation and Technology Park.

Leading regulatory experts, life sciences companies, medtech manufacturers, entrepreneurs and innovators gathered at Charnwood Campus, as part of the 2023 Leicester Business Festival, to discuss the regulatory landscape. Regulatory issues are constantly quoted as a leading challenge and barrier that is preventing the life sciences industry in the region reaching its full potential. With the increasing pace of innovation, the deployment of AI, and the development of increasing novel technologies early engagement with regulatory experts is essential and much discussion focused on ensuring novel technologies developed in the region can gain regulatory approval and reach market, improving life for patients. Anxiety

The event was expertly chaired by Isabel Teare, from Mills & Reeve, who gave an excellent legal viewpoint on proceedings. Delegates had the opportunity to engage, discuss and question regulatory experts covering a whole range of pertinent topics, from legals to AI, to exporting and EU market access. The event also marked the launch of a new In Vitro Diagnostic (IVD), white paper, from IMed Consultancy. The global IVD market size was valued at 132.95 billion USD in 2022, and in the UK approximately 70% of clinical decisions are based on IVD tests, thus an exceptionally important market for companies in our cluster. 

Gosia Khrais, Commercial and Marketing Director, Charnwood Campus commented: “Regulatory issues are a roadblock for our cluster and the discussion in the room day has highlighted where innovation and early engagement with the regulatory authorities can help accelerate product to market. Our business support at Charnwood Campus has been specifically designed to ensure companies in our region can access the best advice to ensure our region continues to grow and be successful. Being able to bring together the calibre of speakers today at one event covering all aspects of regulatory landscape within the region is unique. The development of our knowledge economy is accelerating, please reach out to us if you would like to join us on Campus or if you would like to know more, details can be found on our website Charnwood Campus UK Science Park.”

Isabel Teare, Senior legal adviser, Life Sciences, Technology, Healthtech, Mills & Reeve and Event Chair said: “The event underlined the exciting promise of this dynamic region, with its wealth of research activity and growing businesses. Speakers encompassed a wide range of issues, enabling delegates to understand and get to grips with the issues affecting them. We all want to see ground-breaking research thrive for the benefit of patients and healthcare providers alike, and that’s why we see forward-thinking regulators working hard to enable innovative technologies.

Peter Barry, Consultant Clinical Advisor, Centre for Guidelines, National Institute for Health and Care Excellence, added: “This was an exciting opportunity to talk about the role of NICE in supporting the health care sector, discussing our range of guidance, and focusing on our support for medical technologies. The Health and Care system is changing, and NICE is transforming too, focusing on what matters most to people and the health and care system, providing useful and usable advice and learning from Data and implementation, while preserving our core values of transparency, rigour and independence”.

Posted in ,