Support for establishing the Therapy Acceleration Laboratory in Oxford to assess clinical trial samples (back translation)
Lead Research Organisation:
University of Oxford
Department Name: UNLISTED
Abstract
The Therapy Acceleration Laboratory would:
a) Set world-leading standards in quality and impact to study samples, using specialist genetic, immunological, phenotypic and pathological assays, from clinical trials to accelerate therapy development, including supporting registrational trials in partnership with academics, the NHS and industry.
b) Enable discovery and application that open new areas of biology with mechanistic studies developed using state-of-the-art technologies and methods.
c) Utilise strengths and capability across the UK, and the international biomedical landscape, to attract the most innovative clinical trials with the potential to rapidly transform human health.
Of note, there are already three academically sponsored Phase III registrational trials in advanced negotiation due to start between October and December 2021 that would be supported by the TAL.
The beneficiaries: would be patients, the three partner MRC Units, the NHS, other academic units throughout the UK, the NHS and industry.
a) Set world-leading standards in quality and impact to study samples, using specialist genetic, immunological, phenotypic and pathological assays, from clinical trials to accelerate therapy development, including supporting registrational trials in partnership with academics, the NHS and industry.
b) Enable discovery and application that open new areas of biology with mechanistic studies developed using state-of-the-art technologies and methods.
c) Utilise strengths and capability across the UK, and the international biomedical landscape, to attract the most innovative clinical trials with the potential to rapidly transform human health.
Of note, there are already three academically sponsored Phase III registrational trials in advanced negotiation due to start between October and December 2021 that would be supported by the TAL.
The beneficiaries: would be patients, the three partner MRC Units, the NHS, other academic units throughout the UK, the NHS and industry.
Technical Summary
The MRC Population Health Research Unit (PHRU) would like to actively help establish the Therapy Acceleration Laboratory (TAL), at the MRC Weatherall Institute of Molecular Medicine (WIMM), in a joint collaborative initiative with the MRC Molecular Haematology Unit (MHU) and Human Immunology Unit (HIU). The TAL will be an ISO-17025 accredited and GCLP and HTA compliant laboratory supporting first -in-human proof-of-concept trials to registrational trials that provide evidence for new drug labelling applications to international regulatory authorities. This objective fits the remit of the funding call to promote broad collaborative activity, networking and open science approaches (sharing of best practice and software tools) to build a new national asset. TAL will be open to supporting clinical trials from all academic institutions in the UK.
People |
ORCID iD |
| Colin Baigent (Principal Investigator) |
| Description | Establishing the Therapy Acceleration Laboratory in Oxford |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Human Immunology Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The period of the award, though short in duration (Jan-Mar 2021) had a significant and long last impact. Its primary purpose was to provide financial support to the MRC-PHRU for a joint collaborative initiative with the the MRC Molecular Haematology Unit (MHU) and Human Immunology Unit (HIU) Oxford, to help establish the Therapy Acceleration Laboratory (TAL), at the MRC Weatherall Institute of Molecular Medicine (WIMM). The MRC-PHRU made significant contributions in the following areas; • Drafting the Senior Laboratory Manager and Quality Manager job descriptions for the TAL and successfully interviewing candidates for these posts in October 2021 and June 2022, respectively. • Providing these posts with continuing support; sharing NDPH Wolfson laboratory expertise, providing training and quality and policy documents to initiate the TAL's quality management system. • Assisting the TAL prepare an application for ISO accreditation against ISO 17025:2017 as a testing laboratory; supporting the TAL through the assessment process and their responses to assessment findings and ultimately enabling the TAL to receive accredited status in February 2025 (UKAS number 28562). |
| Collaborator Contribution | The primary purpose was to provide financial support to the MRC-PHRU for a joint collaborative initiative with the the MRC Molecular Haematology Unit (MHU) and Human Immunology Unit (HIU) Oxford, to help establish the Therapy Acceleration Laboratory (TAL), at the MRC Weatherall Institute of Molecular Medicine (WIMM). The MRC-PHRU contribution facilitated the TAL to be established and, ultimately, receive ISO accreditation as a testing laboratory. The establishment of the TAL has enabled the collaborating partners to attract funding e.g. the Enhance 3, Gilead, Amadeus studies; and more recently the EVOLVE -1 and -2 clinical trials. |
| Impact | The primary purpose of the funding was to help establish the Therapy Acceleration Laboratory (TAL), at the MRC Weatherall Institute of Molecular Medicine (WIMM) and facilitate it achieving accredited status as a testing laboratory. Both were successfully achieved. |
| Start Year | 2021 |
| Description | Establishing the Therapy Acceleration Laboratory in Oxford |
| Organisation | Medical Research Council (MRC) |
| Department | MRC Molecular Haematology Unit |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | The period of the award, though short in duration (Jan-Mar 2021) had a significant and long last impact. Its primary purpose was to provide financial support to the MRC-PHRU for a joint collaborative initiative with the the MRC Molecular Haematology Unit (MHU) and Human Immunology Unit (HIU) Oxford, to help establish the Therapy Acceleration Laboratory (TAL), at the MRC Weatherall Institute of Molecular Medicine (WIMM). The MRC-PHRU made significant contributions in the following areas; • Drafting the Senior Laboratory Manager and Quality Manager job descriptions for the TAL and successfully interviewing candidates for these posts in October 2021 and June 2022, respectively. • Providing these posts with continuing support; sharing NDPH Wolfson laboratory expertise, providing training and quality and policy documents to initiate the TAL's quality management system. • Assisting the TAL prepare an application for ISO accreditation against ISO 17025:2017 as a testing laboratory; supporting the TAL through the assessment process and their responses to assessment findings and ultimately enabling the TAL to receive accredited status in February 2025 (UKAS number 28562). |
| Collaborator Contribution | The primary purpose was to provide financial support to the MRC-PHRU for a joint collaborative initiative with the the MRC Molecular Haematology Unit (MHU) and Human Immunology Unit (HIU) Oxford, to help establish the Therapy Acceleration Laboratory (TAL), at the MRC Weatherall Institute of Molecular Medicine (WIMM). The MRC-PHRU contribution facilitated the TAL to be established and, ultimately, receive ISO accreditation as a testing laboratory. The establishment of the TAL has enabled the collaborating partners to attract funding e.g. the Enhance 3, Gilead, Amadeus studies; and more recently the EVOLVE -1 and -2 clinical trials. |
| Impact | The primary purpose of the funding was to help establish the Therapy Acceleration Laboratory (TAL), at the MRC Weatherall Institute of Molecular Medicine (WIMM) and facilitate it achieving accredited status as a testing laboratory. Both were successfully achieved. |
| Start Year | 2021 |