The New Drug Development Paradigms (NEWDIGS) program, led by the Center for Biomedical Innovation (CBI) at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts brings together pharmaceutical companies, academic researchers, patient advocacy groups, government agencies involved in healthcare and other experts to collaborate on ways to reliably and sustainably deliver new, better, affordable therapeutics to the right patients faster.
“Through NEWDIGS we’ll work with others to explore how our guidance development processes can contribute to faster and better drug development and delivery,” said Professor Sarah Garner, NICE’s associate director for R&D. “The initiative uses the principles of systems engineering – something MIT is famous for – to design and test scenarios for the development of new drugs.”
The field of systems engineering is interested in the design and management of complex projects, ranging from bridge building to spacecraft design. Systems engineers use a variety of different tools, including modelling and simulation, to redesign work processes. Knowledge from different branches of engineering and science is used to introduce technological innovations into the planning and development stages of a system – in this case drug development.
“NEWDIGS’s approach to designing, evaluating and catalysing change in new drug development and delivery is built around participation of a broad range of stakeholders,” said Gigi Hirsch, MD, NEWDIGS’ program director and executive director of MIT CBI. “Through its role in providing evidence-based guidance and technology assessments, NICE is a key member of the biomedical innovation ecosystem. NICE has been a valuable contributor to our initiatives and we look forward to their expanded role as a NEWDIGS collaboration partner.”
Already, NICE’s link with NEWDIGS has contributed to the European Medicines Agency pilot scheme looking at whether a more stepwise approach to medicine development and authorisation – known as adaptive licensing – could enhance timely patient access to new drugs whilst providing important information on a medicine’s benefits and risks.
NICE is also collaborating on another NEWDIGS initiative, the Janus Program, which is exploring what effects new and different ways of developing drugs may have on the healthcare system – from the basic science at one end to the patient at the other. Janus will use a number of different techniques to do this. At its heart it will give industry, scientists, government and patients the opportunity to come together to try to create different approaches to drug development, and hopefully create a ‘toolkit’ to make this easier in the future.
The third project involving NICE will use the results from the NEWDIGS JANUS Program to look at the contribution of ‘real world’ data which is gathered on the use of a drug in clinic rather than as part of a traditional clinical trial. As part of a European Union-funded project called GetReal, this data could supplement information from standard clinical trials to give valuable insights to healthcare decision makers about the effectiveness of new drugs in practice.
Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE, said “NICE’s advisory committees consider a wide range of evidence and information when appraising technologies, and we are always looking at how to improve the quality of these inputs. We welcome the opportunity to work with NEWDIGS partners, who share our aim of getting innovative technologies to the patient more quickly.”
Cross posted on NICE’s website