TRANSLATIONAL RESEARCH THEORY AND PRACTICE. Ian Weeks Professor in Translational Biochemistry School of Medicine Cardiff University

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1 TRANSLATIONAL RESEARCH THEORY AND PRACTICE Ian Weeks Professor in Translational Biochemistry School of Medicine Cardiff University

2 Translational research: Bench to bedside Not just clinical trials Encompasses pharma, medical technologies, medical diagnostics Generally involves University/Industry collaboration

3 Chemiluminescence The emission of light during a chemical reaction A B + hʋ Light-emitting molecules can be attached to other substances to detect and quantify them

4 The first translational research project involving light: Let there be light and there was light and He saw that it was good

5 Blood sample Antibody reagent Test reaction Blood vessel In vitro diagnostic test Label

6 Detectability of labels used in biochemical assays Colourimetric (absorption) Fluorescence Chemiluminescence mol N.B. 125 I radioactive emission mol

7 The Eureka Moment - It works

8 Clinical Chemistry, Vol 29, (1983) Acridinium esters as high-specific-activity labels in immunoassay I Weeks, I Beheshti,F McCapra,AK Campbell and JS Woodhead

9 Immunochemiluminometric Assay for TSH Clinical Endocrinology, 4, (1984) A High Sensitivity Immunochemiluminometric Assay for Human Thyrotropin I. Weeks, M. Sturgess, K. Siddle, M. K. Jones, J. S. Woodhead

10 Molecular Light Technology Limited The Vehicle to Develop and Exploit the Technology

11 Immunodiagnostics (Now Siemens Healthcare Diagnostics) the acridinium ester immunoassay labelling technique was originally developed in Cardiff and is now an integral part of the chemiluminescence technology that underpins the success of the Advia Centaur. It's quite incredible to think that the starting point of acridinium ester was just a small flash of light and how it's grown into the sale of 100 Advia Centaur systems in the UK, 1000 in Europe and over 3000 worldwide News Release from: Bayer Diagnostics, 4 August 2003

12 Dual kinetic assay Dual-wavelength assay

13 Gene-based Tests MLT is a UK-based biotechnology company that developed the technology which forms the basis of Gen-Probe's chemiluminescent Hybridization Protection Assay ("HPA") detection technology Gen-Probe Website

14 In November 2005, President George W. Bush named Gen-Probe a 2004 National Medal of Technology Laureate in recognition of the Company's pioneering work in the development and commercialization of new blood-testing technologies and systems for the direct detection of viral infections, including direct identification of West Nile Virus and simultaneous identification of HIV-1 and Hepatitis C virus in plasma of human blood and organ donors prior to transfusion. The National Medal of Technology is the nation's highest honor for technological innovation. Gen-Probe s CEO receiving the medal for its products based on chemiluminescence technology developed in Cardiff and licensed to Gen-Probe by MLT

15 In 1998 the University of Wales College of Medicine (UWCM) was awarded The Queen s Anniversary Prize in Medicine, Health & Welfare for Chemiluminescence: research and development in clinical diagnosis The Citation acknowledges that the initial discovery, subsequent research and continuing development have led to improvements in healthcare around the world. Heavy commercial investment and continued collaborative research with the college have led to the production of automated analytical systems that are both wealth creating for the college and an important tool in further medical research, as well as in other scientific fields.

16 In 2006, together with key discoveries such as the structure of DNA, cloning and stem cell research, Chemiluminescence Technology was cited as one of the top 100 life-changing discoveries in the UK by Universities UK in its publication Eureka UK which was published to celebrate 50 years of life-changing research. The technology, which was first developed by a group of scientists at the former University of Wales College of Medicine (now Cardiff University School of Medicine) in the early 1980s, is now in use in laboratories all around the world. It is estimated that more than 50 million tests are performed annually on a worldwide basis. Eureka UK, 2006

17 NESTA Research Report: March 2011 Improving cross-sector collaboration in the UK biomedical industry Collaboration produces more advanced innovations Collaborative research has greater impact (a study has shown that collaborative papers have a greater citation impact than purely academic papers) NHS and universities should adopt a more strategic approach to pricing (Full Economic Costing model can be a barrier to being competitive) Introduce standards for researchers in universities which mesh with industry

18 Some points for consideration Biomedical industry important to UK economy - Generates 30 billion in turnover - Employs people - Represents 9% of exports UK is one of the world leaders but is being caught up Wales has aspirations to have a world-leading bioscience cluster Translational research is vital to achieving this Wales must be outward-looking not just inward-looking and support must reflect this Support for translational research must have flexibility built into funding strategies

19 Chemiluminescence Technology Development University project Ultimately resulted in income to School of Medicine > 10m Highest IP earner of all UK academic institutions during 1990s (Welsh Economic Review 16.2, 2004) Spin-out company MLT Research Ltd University held equity realised upon sale of company Funded/co-funded approx. 25 scientists in university departments Approx. 45 employees Four times named Technology Fast 50 Company (Deloitte) Wales Merit Award for Export Achievement Successful licensing leading to products having global impact

20 Current Translational Projects National Institute of Health Research Invention for Innovation (i4i) Development of rapid tests for liver fibrosis Rapid diagnostic tests for genitourinary cancers