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Call for novel lateral flow antibody pairs as licensable reagents for next generation industry tests
A consortium of UK lateral flow providers, contract research and manufacturing partners is collaborating to deliver a high capacity pipeline of novel lateral flow tests for SARS-2 COVID-19 infectiousness (antigen tests) which may be used during the current pandemic.
The consortium, working with government, is calling to academia and industry for novel reagents which are available now and could form the basis for next generation industrial tests.
The consortium seeks novel, high affinity monoclonal epitope recognition (primary) antibodies or affimers to either spike or capsid epitopes and also paired capture antibodies for the primary, or other affinity molecule pair, e.g. nucleic acid, carbohydrate.
The desired primary reagent will have an KD of <100pM, ideally proposed antibody pairs would also have associated kinetic data derived from using solid state techniques such as Biocore or surface plasmon residence (SPR). However affinity data derived from ELISA techniques are acceptable.
Upon receipt of Initial interest, the consortium will provide a simple questionnaire. It will use the content of this to select reagents for structured industrial evaluation starting in December using industry standard, functional lateral flow environments. This will occur under a MTA, with data shared back to suppliers. Suitable reagent pairs and any available Biologicals needed for their production may then be licensed by interested industrial parties or government in return for royalty payments, and form part of next generation tests.
Interested parties should contact Jason Ryall ([email protected]) by return.
There will be further calls in early 2021 to access those reagents currently being prepared or that are yet to be created.
[24 November] Interview by Marks & Clerk: How ReagentGenie switched from selling research only test kits to rolling out a Coronavirus test distribution network
Numerous companies had to adjust rapidly and dramatically to meet the threat posed by Covid-19. In this interview, CEO Colm Ryan tells Alicia Gailliez of One Nucleus how ReagentGenie switched from selling research only test kits to rolling out a Coronavirus test distribution network in double quick time and Simon Portrman of Marks & Clerk sheds light on the legal and contractual challenges this gave rise to. A fascinating insight into the technological and logistical front line in this battleNumerous companies had to adjust rapidly and dramatically to meet the threat posed by Covid-19. In this interview, CEO Colm Ryan tells Alicia Gailliez of One Nucleus how ReagentGenie switched from selling research only test kits to rolling out a Coronavirus test distribution network in double quick time and Simon Portrman of Marks & Clerk sheds light on the legal and contractual challenges this gave rise to. A fascinating insight into the technological and logistical front line in this battle
[22 October] UCL Vax Hub explainers
UCL Vax Hub have produced a couple of documents which are an excellent overview of developing and manufacturing vaccines:
[11 September] Guidance for employers on private testing
The government has published guidance for employers and third-party healthcare providers on voluntary testing in the workplace to ensure all new private testing programmes are as reliable and effective as possible and developed in accordance with legal obligations and best practice.
[03 September] London Strategy monthly deck on COVID-19
London Stretgy have created an informative resource looking at the impact of COVID-19 on the life sciences sector and the response from industry.
[21 August] Government releases new guidance for employers on self-isolating after returning to the UK.
Specifically, workers with 'specialist technical skills' for 'essential' goods will be exempt from the need to self-isolate if they travel for work, but not if they travel on holiday. Senior leadership or CEOs are unlikely to be considered to have 'specialist technical skills'.
The Government has merged Public Health England and NHS Test and Trace into a new National Institute for Health Protection. The new organisation's primary focus is public health protection and infectious disease capability. Baroness Dido Harding will be the interim Executive Chair.
The Department of Business, Energy and Industrial Strategy has awarded £100 million to fund a Cell and Gene Therapy Catapult Manufacturing Innovation Centre to accelerate production of a COVID-19 vaccine in the UK.
An additional £4.7 million will be awarded for upskilling in advanced therapy and vaccine manufacturing.
The new NHS Covid-19 vaccine research registry will help large numbers of people be recruited into the trials over the coming months, potentially leading to an effective vaccine being identified and made available to the UK public against coronavirus earlier.
Hopes for a vaccine to address the global spread of coronavirus have been raised after Oxford University’s experimental version was revealed to be safe and to generate a strong immune response in the people who volunteered to help trial it.
This framework sets out how national and local partners will work with the public at a local level to prevent, contain and manage outbreaks.
[16 July] Update on the COVID-19 National Testing Programme webinar | Slides
[10 July] Government R&D Roadmap
The Department of Business, Energy and Idustrial Strategy is seeking views on its UK Research and Development (R&D) Roadmap. The survey closes on 12 August and more details can be found here.
Government guidelines have been updated. Latest additions include, across all workplaces, new guidance on local lockdowns, keeping records of staff shift patterns and what to do in the event of a COVID-19 outbreak in the workplace.
Businesses now have the flexibility to bring furloughed employees back to work on a part time basis. Full guidance can be found here and a link to videos and to register for free webinars is available here.
The government’s Sustainable Innovation Fund will be open to companies across all parts of the UK who need urgent financial support to keep their cutting-edge projects and ideas alive.
[27 June] University research package
[25 June] Life Sciences Recovery Roadmap published
Together with the Association of British Pharmaceutical Industry (ABPI), the Association of British HealthTech Industries (ABHI), British Generic Manufacturers Association (BGMA) and the British In Vitro Diagnostic Association (BIVDA) we have put out a call to action on the UK life sciences industry’s commitment to fighting COVID-19. The Life Sciences Recovery Roadmap sets out how the sector can work with the Government and the NHS to put life sciences at the heart of the UK’s economic recovery from the pandemic and support the NHS in getting cutting-edge healthcare to patients.
About 300 people will have the vaccine over the coming weeks, as part of a trial led by Prof Robin Shattock and his colleagues, at Imperial College London.
PrecisionLife’s unique AI platform has found 68 genes associated with risk of developing severe COVID-19 after analysis of the genomes of 929 patients from the UK Biobank who had a severe response to SARS-CoV-2.
Symbiosis and AstraZeneca Sign Supply Agreement for Sterile Manufacture of COVID-19 Vaccine for Clinical Trials
There have been many more promising contributions and ideas shared on the Testing Methods crowdsourcing platform, and so we are pleased to share a further nine potential solutions. These cover wide-ranging areas including multiplexing, saliva sampling and blood collection.
[16 June] The NIHR-UKRI rapid response rolling funding call
The NIHR-UKRI rapid response rolling funding call will close to new applications on 30 June 2020.
The NIHR has launched a new Recovery and Learning funding call to better understand and manage the health and social care consequences of the global COVID-19 pandemic beyond the acute phase. This call is for research proposals of up to 24 months’ duration.
Under the UKRI umbrella, the Medical Research Council (MRC) will focus on funding research into COVID-19 mechanisms and interventions, and the Economic and Social Research Council (ESRC) will continue to accept social science led proposals on health and social care that do not fit with the NIHR call scope.
MRC and ESRC applications should be submitted to the UKRI rolling call. The duration of individual grants available under this scheme is 18 months.
More information is here.
The nature of high-risk infections has necessarily generated more rigorous procedures which are likely to increase the detrimental environmental impact of testing. How can we improve or minimise the impact going forwards?
The Vaccines Manufacturing and Innovation Centre (VMIC) has announced a partnership with Oxford Biomedica which involves the organisations collaborating to enable scaled-up manufacture of viral vector based vaccines, with an immediate focus on a vaccine for COVID-19 – the first of which is the University of Oxford and AstraZeneca adenovirus vector vaccine candidate AZD1222 (previously known as ChAdOx1 nCoV-19).
The Government has published further information on those from our sector who are exempt from the 14-day post-travel quarantine requirement. An online locator form and detailed information from the Department of Health and Social Care on self isolation has been produced.
A leading figure in drug development, Clive Dix is CEO of C4X Discovery, a pioneering drug discovery company, and is well qualified to help lead the Vaccine Taskforce, with extensive experience as a scientist and managing pharmaceutical companies.
As we move towards the winter flu season, we must consider how to include COVID 19 viral detection into the wider respiratory virus and/or gastrointestinal virus testing regimes. We are seeking testing kits that will deliver multiplexed or syndromic respiratory and/or gastrointestinal viral detection and that will operate on either existing rapid turnaround laboratory platforms, existing near patient care platforms or new technologies that can be deployed into NHS and PHE testing laboratories. These should be ready to deploy within 4-6 weeks.
[01 June] The Academy of Medical Sciences launches COVID-19 preclinical drug development database
The database maps emerging COVID-19 preclinical drug development research across the UK. The aim is to help researchers identify collaborations, share expertise, materials and methods, avoid duplicating effort and prioritise the most promising research.
Following the latest government/industry webinar, Dido Harding has written a letter to the diagnostics industry about the Test and Trace Service.
LifeArc is providing £10m for clinical trials to find effective therapies for COVID-19. All 15 projects – involving nearly 30 different organisations – were selected for their ability to rapidly start trials in patients and the likelihood of success.
Oxford Biomedica has signed a one year Clinical & Commercial Supply Agreement with AstraZeneca. The Agreement relates to the GMP manufacture of the adenovirus vector based COVID-19 vaccine candidate, AZD1222, which recently entered clinical trials at multiple sites in the UK.
New guidance means those who have been in close contact with someone who tests positive must isolate for 14 days, even if they have no symptoms.
The service will help identify, contain and control coronavirus, reduce the spread of the virus and save lives.
Guidance on the NHS test and trace service for employers, businesses and workers can be found here.
Gilead's anti-viral medicine is being made available on the NHS, early data suggests the treatment can shorten recovery time.
The NIHR has developed a ‘Framework for restart’ , which is a guidance document to support local decision-making
New funding is available for projects to repurpose manufacturing for rapid production of vital medical supplies and equipment needed for testing, treatment and prevention, as well as develop medical technologies and digital tools to improve detection, surveillance and patients care. Deadline for submissions is 11 June 2020.
The British Business Bank has published details of how to apply for Future Fund convertible loans, which opens on Wednesday 20 May, to support to innovative UK companies that typically rely on equity investment and are currently affected by Covid-19
Up to £93 million government investment to open the UK’s first dedicated Vaccine Manufacturing and Innovation Centre 12 months early
Up to 20,000 people are being asked to take part in a new UK Biobank-led study to further track the extent of the coronavirus spread across England, Scotland and Wales
The Prime Minister outlines the main elements of the government's plans for the next stage of tackling the coronavirus pandemic
Funding includes £65.5 million for the vaccine being developed at the University of Oxford and £18.5 million for Imperial College London
The Taskforce is supporting efforts to develop a vaccine by working with regulators and scaling up manufacturing. The BIA is working closely with the Taskforce, bringing together a whole range of businesses keen to use their expertise to mass-produce vaccines, as soon as one is ready.
Trials for specially-trained ‘COVID dogs’ that may be able to detect coronavirus (COVID-19) in humans, even before symptoms appear, are set to begin as part of new research
The Innovate UK business innovation support package includes £90 million in continuity grants for existing Innovate UK award holders and £210 million for continuity loans to organisations that have a challenge in continuing a live project for which they are have an award from Innovate UK
Roche in talks with the UK government to roll out its coronavirus antibody test kits in the country after they are cleared for UK use by Public Health England
A whole genome sequencing study will involve up to 20,000 people currently or previously in an intensive care unit with coronavirus, as well as 15,000 individuals who have mild or moderate symptoms understand whether a person’s genetics may influence their susceptibility to the virus
5 of the 8 coronavirus innovation projects announced today by the European Commission have UK involvement and two are led by UK organisations
The government’s Coronavirus Job Retention Scheme will remain open until the end of October, the Chancellor announced today
The government has produced guidance to help ensure workplaces are as safe as possible, including working in labs and research facilities
Baroness Harding will lead on the new NHS COVID-19 app, swab and antibody testing, contact tracing, national surveillance as well as immunity certification.
[7 May] CMOs reinforce importance of continued recruitment into clinical trials
The Chief Medical Officers and NHSE Medical Directors have written an open letter to the NHS about recruiting patients into clinical trials for COVID-19 therapeutics, highlighting that a lot of other valuable research is being undertaken across the health and care system.
Data scientists from AI precision medicine company, PrecisionLife, have used a proprietary AI enabled precision medicine platform to identify 59 repurposing drug candidates that could be used to develop new therapeutic strategies to increase the survival rate of patients who develop sepsis while suffering from severe COVID-19
Two additional challenges have been launched to identify (1) alternatives to swabs for sampling and (2) increasing end to end efficiency and speed of testing
AstraZeneca and the University of Oxford agree global development and distribution of the University’s potential recombinant adenovirus vaccine
A new programme of home testing for coronavirus will track the progress of the infection across England and is being led by Imperial College alongside colleagues at Imperial College Healthcare NHS Trust, and supported by Ipsos MORI.
The ACCORD (Accelerating COVID-19 Research & Development) study brings together a single, UK-wide clinical trial platform provided by the clinical research company IQVIA and NIHR to rapidly test potential drugs through early stage clinical trials and feed them into the UK’s large-scale COVID-19 studies such as the RECOVERY trial, currently the world's largest randomised controlled clinical trial for COVID-19 treatment.
The Government has today announced a new scheme for those in need of smaller loans. Businesses can apply for the new Bounce Back Loans up to a maximum of £50,000, or 25% of turnover, with the government paying the interest for the first 12 months. The loans will be available from 9am on Monday and the Government will support lending by guaranteeing 100% of the loan.
The Government has published guidance on Covid-19 testing which means that essential workers who are self-isolating (not able to leave home) can now apply for themselves and for their household to get tested for coronavirus.
20,000 households in England are being contacted to take part in the first wave of a major new government study to track coronavirus (COVID-19) in the general population.
Construction of the UK’s New Vaccines Centre by Glencar Construction Starts Well Ahead of Schedule as Timelines are Fast Tracked Due to Covid-19
The National COVID Testing Scientific Advisory Panel has published a paper showing the performance of current lateral flow devices is inadequate for most individual patient applications
BIA has welcomed the news that UK businesses driving innovation and development will be helped through the coronavirus outbreak with a £1.25 billion government support package, announced today.
The Government’s Coronavirus Job Retention Scheme went live today, with businesses able to claim up to £2,500 a month towards staff wages.
The government has announced a £14 million investment pot to rapidly progress treatments and vaccines. The money announced will support the manufacturing process of COVID-19 vaccines.
Following an outstanding response to generate new ideas through the testing methods crowdsourcing platform, the taskforce are calling for further input to review the best ideas on RNA extraction
HM Treasury have announced an extention to 30 June of the Coronavirus Job Retention Scheme for employees on temporary leave ('furlough'). A new online claim service for the scheme is now available to allow organisations to submit claims to cover wages
All firms with a turnover of more than £45 million will now be able to apply for up to £25 million of finance, and up to £50 million for firms with a turnover of more than £250 million.
Employers can now claim for employees that were employed and on their PAYE payroll on or before 19 March 2020
the Government has determined that current measures must remain in place for at least the next 3 weeks and set out 5 criteria to be assessed before it will consider it safe to adjust any of the current measures
UK biotech firms could go bankrupt within six months making them easy takeover targets for large overseas companies as the country grapples with the economic fallout from coronavirus, the BioIndustry Association has warned.
In advance of a procurement process, CEPI is looking for organisations with capability and interest in acting as sponsors or CROs for clinical trials involving one or more COVID-19 vaccine candidates - deadline Sunday 19th April 2020, 15:00 CET.
[14 April] CEPI launches expression of interest (EoI) for drug product stage of manufacturing including fill, finish
CEPI have launched an EoI survey (password: COVID-19) to identify manufacturing capabilities that are well established and large scale (>1 million units / month). After collecting initial information, they will look to introduce their COVID19 vaccine developers with organisations who have capabilities, capacity and ability to commit to the response.
Sanofi and GSK today announce that they have signed a letter of intent to enter into a collaboration to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic.
Ideas are requested in 4 areas: dry swabs for use in virus detection; transport media that inactivates the virus; desktop PCR equipment for point of care testing; and RNA extraction
The request is specifically for companies who can manufacture and supply consumables and equipment for coronavirus testing; new or existing types of coronavirus tests for antigens or antibodies; and lab capacity
[9 April] The government has launched a new online portal providing companies with specifications for the most urgent requirements to help with the response to coronavirus
Companies with proposals able to deliver on these specifications quickly and at scale may be able to access a range of support, including accelerated regulatory approval, centralised procurement support if appropriate and, in some cases, development grants.
[9 April] Secretary of State for Business, Energy and Industrial Strategy has written a letter to UK companies to clarify that there is no restriction on manufacturing continuing under the current rules
UK’s top pharmaceutical and diagnostic companies are teaming up to rapidly develop and roll out millions of coronavirus tests in the coming months as part of the next phase of the government’s 5-pillar national testing strategy
[7 April] The Centre for Evidence-Based Medicine has published the results of an assessment of molecular and antibody point-of-care tests to support the screening, diagnosis and monitoring of COVID-19
Some devices showed high diagnostic accuracy during controlled testing, but performance data from clinical settings, and a clear understanding of the optimal population and role for these tests in the care pathway, are currently lacking
A new testing laboratory will be set up by AstraZeneca, GSK and Cambridge at the University’s Anne McLaren laboratory. This facility will be used for high throughput screening for COVID-19 testing and to explore the use of alternative chemical reagents for test kits in order to help overcome current supply shortages.
GSK is collaborating with Vir Biotechnology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options for COVID-19
Sir John notes that no tests to date have performed well and the government will be working with suppliers to identify alternative solutions to scale up antibody testing
The paper sets out how the government intends to scale up testing programmes to provide a test to anyone who needs one
Almost 1,000 patients from 132 different hospitals have been recruited and thousands more are expected to join the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial.
Grants of up to £50,000 are available for technology and R&D businesses to develop innovations that encourage new ways of working and ensure continued productivity across key UK industries. The deadline for applications is 17 April 2020 12:00pm.
Government is looking for organisations that can manufacture and supply testing consumables, equipment and laboratory PPE as part of the coronavirus (COVID-19) response.
Exscientia will first apply its advanced biosensor platforms to rapidly screen 15,000 clinically-ready molecules against key viral drug targets of SARS-CoV-2
A coronavirus app that alerts people if they have recently been in contact with someone testing positive for the virus "could play a critical role" in limiting lockdowns
UK biotech Synairgen has started dosing patients in its phase 2 trial of SNG001, an inhaled formulation of interferon beta-1a that aims to treat coronavirus infections
[31 March] EMA issues Update on treatments and vaccines against COVID-19 under development
The OPENCORONA consortium has been awarded €3million funding by Horizon 2020 to support emergency research and development against the COVID-19 outbreak
Oxford University are developing a vaccine against Covid-19 and are now recruiting volunteers to take part in a clinical trial. The trial will provide information on the safety aspects of the vaccine, as well as its ability to generate an immune response.
The Self-employment Income Support Scheme (SEISS) will support self-employed individuals (including members of partnerships) whose income has been negatively impacted by COVID-19
NIHR has published a statement about establishing and implementing a single, national process to prioritise the COVID-19 studies which hold the most potential
BioCentury reports that a grand-scale behind-the-scenes effort by the pharmaceutical companies is under way to expedite the creation of therapies and vaccines to treat COVID-19
The government has announced that six coronavirus research projects, including two focused on vaccination trials, will be the first to benefit from a share of £20 million investment.
[19 Mar] The Government has published guidance on the definition of critical workers
This includes “those working as part of the health and social care supply chain, including producers and distributers of medicines and medical and personal protective equipment”.
Update 20 March: The government has confirmed that a company letter confirming their role is critical to business continuity should be sufficient for employees to provide to schools asking for evidence of their status.
[20 Mar] The MHRA have announced new arrangements for MHRA Good Practice (GxP) inspections due to coronavirus
[20 Mar] The DHSC has announced that more than 80 medicines used to treat patients in intensive care units have been banned from parallel export from the UK
[18 Mar] UK biotech company Synairgen has announced it is immediately starting clinical trials on Covid-19 after receiving expedited approvals from MHRA.