Technology Strategy Board

Driving Innovation

Sepsis II: Advancing biomarker use in sepsis management

Competition for collaborative R&D funding September 2011

Detection & Identification of Infectious Agents Innovation Platform

Sepsis II: Advancing biomarker use in sepsis management

Competition for collaborative R&D funding
The Technology Strategy Board, in partnership with the Department of Health (DH), is to invest up to 2.5m in collaborative research and development to advance the effective use of biomarkers in the management of sepsis. The scope of the competition will include projects that aim to evaluate how biomarkers could be used more effectively to support and inform clinical decisions. The Ministry of Defence and the Home Office have also expressed an interest in funding this competition; decisions will be made on a project-by-project basis. Proposals should be collaborative and business-led. It is envisaged that applicants will establish relationships with clinical experts and microbiologists to discuss appropriate access to patient samples, and to ensure that the project design could give rise to a new generation of products of value to healthcare workers in decreasing the impact of sepsis. The competition opens on 26 September 2011. We expect most applications will be for applied research attracting up to 50% of the total project costs; but some work packages in the industry-orientated basic research category, which can attract up to 75% public funding, are expected. Projects should last up to three years. Our HealthTech and Medicines Knowledge Transfer Network will be organising events and providing further information on this competition, and offering networking and consortia-building opportunities. See https://ktn.innovateuk.org/web/healthktn The registration deadline is 1 November 2011 and expressions of interest must be received by 9 November 2011. aid clinicians in the management of sepsis but few have been thoroughly evaluated in a clinical setting. This competition will support projects that will advance this field as outlined in the scope. Addressing sepsis effectively may also reduce the inappropriate use of antibiotics, recognised as a factor in the development of antimicrobial-resistant pathogens, and which is a DH priority. This competition has been designed following a number of workshops supported by the Technology Strategy Board with advice from the innovation platforms steering group and other key opinion leaders and experts. There are three competitions in the DIIA innovation platforms second series of competitions; all three are complementary but this competition and Sepsis I: Multi-pathogen detection and/or simple discrimination, are especially linked and aim to provide a comprehensive portfolio of projects to improve the future diagnosis and management of infectious diseases and sepsis.

Background and Challenges

The DIIA Innovation Platform aims to reduce the economic burden, death and illness due to infectious agents in humans and animals by encouraging the development and clinical adoption of commercially viable diagnostic devices that will create business opportunity and wealth in the UK. One of the priorities identified by DH for the innovation platform is sepsis, a life-threatening illness caused by the body overreacting to an infection. The bodys immune system goes into overdrive, setting off a series of reactions that can lead to widespread inflammation and blood clots in vital organs. It can be triggered by bacterial, viral or fungal infection. The documented incidence of sepsis worldwide is 1.8 million cases per year, but low diagnostic rates and difficulties in tracking it in many countries mean that the true figure is likely to be significantly higher. Estimates of 18 million cases have been made. In the UK, sepsis costs the NHS about 2.3bn a year and causes 36,00064,000 deaths. The mortality rate from severe sepsis is 28-50%. Patients with severe sepsis use 46% of all intensive care unit bed days and the risk of death increases by 6-10% every hour from onset of septic shock to the start of effective treatment. There is universal agreement that in the area of sepsis the diagnostic tools available to the clinician today are inadequate and/or would benefit from further development. Numerous biomarkers have been identified that may

Scope
The term biomarker should be interpreted in its broadest sense and may include the evaluation of multiple markers in combination. Markers can include physical measurements such as temperature as well as biological molecules. The important thing is to understand how markers can assist clinicians in the management of patients. Applicants may carry out clinically-linked laboratory-based research and development to understand the role that biomarkers could play in the management of sepsis or develop tests (of proven clinical significance) on point-of-care (POC) devices. The sequential combination of the two would be in scope but applicants should be aware that projects asking for a high percentage of the funds available will need to be exceptional.

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Sepsis II:Advancing biomarker use in sepsis management Competition for collaborative R&D fundinG

In scope
K Measuring biomarkers to evaluate how they may be used to support clinical decisions: K the biomarkers included in the project should be identified upfront from literature or in-house research and development K companies can measure multiple biomarkers and develop algorithms to ascertain how they could be used in combination to maximise clinical utility K applicants are not expected to develop products but to advance this field by determining the role that biomarker measurement could play in the management of sepsis K consortia should ensure that any longitudinal studies have sufficient statistical power to advance the field. K Putting markers of known clinical utility on POC systems. Supported by strong clinical data (which applicants may hold internally), companies may put markers onto their POC platforms.

Funding allocation and project details

We have allocated up to 2.5m to fund collaborative R&D projects that are within the scope of this competition. Projects must be collaborative and can involve science-to-business or businessto-business interactions. Projects must be business-led and academics can apply only as a collaboration partner in a consortium. Projects can range from industryorientated basic research through applied research to experimental development (attracting up to 75%, 50% and 25% of total project costs respectively). For this competition we anticipate that most applications will focus on applied research but some work packages in the industry-orientated basic research category are expected. Definitions of the above categories of research can be found in the Guidance for Applicants. Applicants should ask for the level of funding required to achieve their objectives, taking into account the total funding available. We will consider both small and large projects. The most important thing is how the proposals respond to the challenge. The Technology Strategy Boards assessors will comment on value for money.

This is a two-stage competition: Stage 1: a  pplicant submits an expression of interest Stage 2: w  e invite selected applicants to submit a full application. The competition will open on 26 September 2011, applicants must register on 1 November 2011 and compulsory expressions of interest (EOIs) must be submitted by 9 November 2011. The process gives applicants the opportunity to make an initial optional EOI before submitting their compulsory EOI application. We will look at the optional EOI and provide feedback to applicants. Applicants may take advantage of this up to 10 working days before the deadline for the submission of the compulsory EOI. Applicants submit a compulsory EOI which is assessed by an independent panel of experts. As a result selected applicants are invited to submit a full application. The second stage for invited applications will open 5 December 2011 and closes on 25 January 2012. Note that ALL deadlines are at noon

Out of scope
K novel biomarker discovery incorporating, for example, proteomics or approaches that explore the fundamental pathogenesis of disease K animal studies K demonstrating proof of concept of new detection technologies.

Key dates
Competition opens Briefing day Optional expressions of interest deadline Registration deadline 26 September 2011 5 October 2011 27 October 2011 noon 1 November 2011 noon 9 November 2011 noon 5 December 2011 14 December 2011 25 January 2012 noon 24 February 2012

Looking for partners to work on your project? Go to _connect (www.innovateuk.org/connect) and search for DIIA activities under the HealthTech and Medicines Knowledge Transfer Network

Compulsory expressions of interest deadline Stage 2 opens (for invited applications) Full stage applicants briefing (for invited applicants) Deadline for receipt of full applications Applicants informed

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Sepsis II:Advancing biomarker use in sepsis management Competition for collaborative R&D fundinG

Further information
You must register for this competition to access all of the supporting documents, including the Guidance for Applicants, and the application form. For more information about this, Sepsis I and other competitions, and details of how to register and apply, please see the competitions section of our website at www.innovateuk.org.

Email: competitions@innovateuk.org Competition helpline: 0300 321 4357 Publicity

The Technology Strategy Board frequently publicises the results of competitions and this includes engagement with the media. Applicants will be asked to provide an agreed form of words for use in publicity material. E-mail pressoffice@tsb.gov.uk with any queries.

The Technology Strategy Board is a business-led executive non-departmental public body, established by the Government. Its role is to promote and support research into, and development and exploitation of, technology and innovation for the benefit of UK business, in order to increase economic growth and improve quality of life. Collaborative research and development is part of the Governments Solutions for Business portfolio.

The Technology Strategy Board North Star House North Star Avenue Swindon SN2 1UE Telephone: 01793 442700 www.innovateuk.org
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