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|Divya Chadha Manek|
|National Institute for Health Research, UK|
|ScientificTracks Abstracts: J Bioanal Biomed|
|The Biosimilars market is going to heat up considerably over the next three years - but is the NHS ready for the biosimilars boom? The NIHR Clinical Research Network (NIHR CRN) - the research delivery arm of the NHS - offers a unique insight into the biosimilars clinical trial landscape in the UK. The NHS deals with over 1 million patients every 36 hours. It is one of the largest single users and purchasers of all categories of medicines. In this context, biosimilars are a no-brainer. With the promise of a smaller price tag than original biologics, they have the potential to deliver NHS cost-savings and help ensure the sustainability of public healthcare systems, whilst also broadening access to healthcare so that greater numbers of patients can be treated with cutting edge biologic medicines. What’s not to like? But as with anything new, there are always early adopters and skeptics. The NIHR CRN is an independent, government-funded organisation. As a data rich organisation it has oversight of the majority of clinical research happening in England and with that comes unique insight into the clinical trial landscape. (We currently support over 80% of all clinical research in England commercial and non-commercial). The NIHR CRN can report that despite some challenges, the tide has turned and attitudes, appetites and acceptance in relation to biosimilars in the UK are changing. Sharpening the competitive edge: The UK (and Europe) are approximately ten years ahead of the US our approach and acceptance of biosimilar drugs and therefore offer a more permissive market for the developers of biosimilar drugs. At a joint presentation on biosimilars at American Society of Clinical Oncology (ASCO) in June 2016, the EMA presented information on the large numbers of biosimilars approved (20 approved marketing authorisations) compared to the FDA (which is currently just four authorisations). Despite this, it came to light, some of our life science industry partners were overlooking the UK as a destination for biosimilar trials claiming that the appetite for delivering these types of trials was low. The National Institute for Health Research Clinical Research Network was drafted to sharpen the UK’s competitive edge. In this presentation we can reveal why life science companies were overlooking the UK to deliver their trial 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 the UK with confidence and get ahead of the game when it comes to study set-up, feasibility, and patient recruitment. A range of perspectives: Within this presentation we can also bring you a range of perspectives (via video clips) which illustrates how the UK’s appetite, capacity and capabilities to deliver biosimilar clinical trials have developed in parallel with the expansion of the biosimilars market - which is forecast to be worth $25 billion by 2020. 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.|
Divya Chadha Manek is the Head of Business Development (Commercial) for the NIHR Clinical Research Network (CRN). Divya’s role is to maintain strategic relationships with Global and UK life sciences companies. Divya facilitates key discussions between life sciences industry and the Clinical Research Network. Divya provides advice and works collaboratively with companies on how they are able to tap into the Clinical Research Network services to ensure clinical studies are set up quickly and effi ciently so that they recruit to time and target. Divya also leads on ensuring that the Clinical Research Network is abreast of new study delivery innovations to ensure that the organisation is evolving to service life sciences industry requirements.
Email: [email protected]
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