Clinical Pharmacology & Biopharmaceutics
Open Access

Abstract

Is the NHS ready for the biosimilars boom? to most, biosimilars are a no-brainer. But as with anything new, there are early adopters and sceptics. The NIHR CRN is an independent, government-funded organization which supports delivery of the majority of clinical research in England - and with that comes unique insight. The NIHR CRN can report that attitudes, appetites and acceptance in relation to biosimilars in the UK are changing. Despite being approximately ten years ahead of the US our approach and acceptance of biosimilar drugs, in 2015 it came to light, some commercial trial sponsors were overlooking the UK as a destination for biosimilar trials - claiming that the appetite for delivering these types of trials was low. The NIHR Clinical Research Network was drafted to sharpen the UK�¢����s competitive edge. In this presentation we will reveal why life science companies were overlooking the UK to deliver their trials, and how these challenges are being overcome using the Clinical Research Network structure which is unique to the NHS in England. Companies can now continue to place their biosimilar trial in UK with confidence and get ahead of the game when it comes to study set-up, feasibility, and patient recruitment. This presentation will present a range of perspectives (via video clips) which illustrate how the UK�¢����s appetite, capacity and capabilities to deliver biosimilar clinical trials have developed in parallel with the expansion of the biosimilars market. You will hear from those involved in conducting biosimilar trials - the clinicians, investigators and nurses at the coal face of research delivery in the NHS. We�¢����ve also captured the NHS Trust R&D viewpoint, along with some thoughts from the NHS pharmacy team. The British Biosimilar Association offers up some interesting ideas, but probably the most memorable perspective is that of the patient.

Biography

Divya Chadha Manek is the Head of Business Development (Commercial) for the NIHR Clinical Research Network (CRN). Her role is to maintain strategic relationships with global and UK life sciences companies and the Clinical Research Network. She also leads on ensuring that the Clinical Research Network is abreast of new study delivery innovations to ensure that the organization is evolving to service life sciences industry requirements. With a degree in Clinical Psychology and a Master’s in Clinical Research, she has worked with the Clinical Research Network for the past nine years. Her first role with the CRN was delivering commercial contract clinical research within a National Health Service (NHS) hospital. Prior to her current role, she worked as the Industry Manager within the Mental Health team, performance managing and maintaining oversight of the national mental health portfolio of studies. She has experience of clinical research from a site level and from a national perspective in the UK. She is currently studying PhD in Dementia Care. Theo Christie is a Business Development Manager (Commercial) for the NIHR Clinical Research Network (CRN). Theo facilitates key discussions between industry and the Clinical Research Network and is a point of contact for the life sciences companies engaging with the Clinical Research Network. Theo is able to provide advice to companies on how they are able to tap into the Clinical Research Network study support services to ensure clinical studies are set up efficiently and recruit to time and target. With a degree in Clinical Sciences, Theo has been with the Clinical Research Network for over four years. He previously worked within the Research Delivery Directorate of the CRN, collaborating with the life sciences industry and national specialty groups across 10 therapeutic areas, providing operational support through feasibility, set up and patient recruitment.