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New R&D models and regulatory measures in support of innovation: CASMI takes on the challenge

Taking a breakthrough in medicines development and translating it into tangible benefits for patients is not easy. In the current climate, the process that takes a medicine from petri dish to patient is increasingly cumbersome, as research methods and regulatory bodies have failed to keep up with scientific advances. This is the problem addressed by The UK’s Centre for the Advancement of Sustainable Medical Innovation (CASMI) which recently celebrated its official launch in London.

A joint initiative between the University College London (UCL) and Oxford University, CASMI seeks to address this challenge by bringing together professionals from an array of areas – life and biomedical sciences, business, statistics, politics, law, and more. A similarly diverse group was on hand to celebrate the virtual centre’s official launch at the Wellcome Trust on March 20.

By designing and testing new models of innovative medical research and development, CASMI hopes to help bring outdated R&D models – and associated regulatory measures – up to speed. “We will deliver a unique holistic approach to tackling what’s known as the three main ‘gaps in translation’” Dr. Richard Barker, CASMI Director explained: “Breakthroughs in the lab not producing therapies for trial; too many products failing to overcome the hurdles of regulatory approval and reimbursement; and approved products not being used effectively to deliver patient benefit.”

EFPIA, representing the innovative pharmaceutical industry in Europe, knows just how essential it is that these points are addressed, and supports CASMI’s efforts to drive change. The initiative’s adaptive licensing project is one welcome initiative, as it would allow progressive access to drugs and faster patient access to innovative medicines, specifically patients suffering from severe illnesses with limited treatment options. CASMI also recognises the need to adapt current models to facilitate the development of personalised medicines – treatments developed on the basis of a disease’s molecular makeup and a patient’s normal tissue.

The potential advances offered by medicine should not be hemmed in by an outdated legal framework. It’s a big job, pushing forward change in R&D and related regulatory measures, and requires a broad collaborative effort. If organisations like CASMI join the industry in working together with decision-makers, researchers, patient groups, and other relevant stakeholders, we can make the road less rocky for innovative medicines – and for the patients who stand to benefit from them.

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Richard Bergström

Richard Bergström was appointed as Director General of the European Federation of Pharmaceutical Industries and...
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