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Dr Robert Watson from the Fairfax Group has been on Secondment for a Term to the Medical Research Council, working for the Due Diligence Team for UK-CTAP, assessing candidate therapeutics for Covid-19.

What is UK-CTAP?

UK-CTAP (Covid Therapeutics Advisory Panel) is the UK Government’s independent advisory body, recommending drugs to England’s Chief Medical Officer for inclusion into publicly funded Covid-19 trials in the UK.

These trials cover the whole spectrum of Covid-19 disease stages and encompass both phase III and early phase II studies, ranging from pre-exposure prophylaxis (PROTECT-V), pre- or post-exposure prophylaxis (PROTECT-CH), early community treatment (PRINCIPLE), hospital treatment (RECOVERY and the Phase II RECOVERY+), critical care (REMAP-CAP) and post-discharge care (HEAL-COVID), as well as Phase I/II (AGILE). UK-CTAP is run and administered by UKRI – the parent organisation of the MRC.

UK-CTAP is a committee of clinicians and scientists from across the UK and USA with a broad range of expertise. Candidate therapeutics are proposed to UK-CTAP by way of an open web portal.

These proposals are then assessed, and detailed briefing documents are prepared for an expert advisory group overseeing a specific domain – such as immunology, prophylaxis or antiviral treatment. The advisory panels consider the compounds in detail before providing advice to UK-CTAP who make a final decision whether to recommend the therapy to the CMO for inclusion in one of the above trials.  A number of members of UK-CTAP and the advisory groups come from Oxford – including PIs here at the MRC WIMM – and indeed a number of the Chief Investigators (CIs) of the above trials are Oxford academics.

The role – Due Diligence team

As part of the Due Diligence team, I have had responsibility for triaging proposed therapies and prioritising them for panel review. We then perform in-depth due diligence on the candidates, independently reviewing the literature and evaluating the scientific rationale for using the therapy in Covid-19. In addition, we also review the available clinical data, map the current trial landscape, study the safety profile, model the pharmacokinetics and pharmacodynamics, and understand the availability and manufacturing issues associated.

All of this information is compiled into a comprehensive objective briefing document by the Due Diligence team and passed to the subpanels for their consideration. We also attend all meetings, enabling to us to gain insight from the panel discussions and answer any questions that the panel may have. In addition to this, we have been working closely with HMG’s Therapeutics Taskforce to proactively seek out promising therapies, invite proposals to UK-CTAP and identify areas of unmet need. I have approached a number of industry entities and been successful in generating multiple submissions to CTAP, as well as keeping on top of emerging trial read-outs from around the world, frequently liaising with trial CIs to get early sight of the data.

My time with UK-CTAP has been a unique and valuable experience, providing insight into the drug-development pipeline ‘on speed’!
- Dr Robert Watson

Benefits of the experience

The work has been fast-paced, at times reactive to emerging developments, and exciting. As someone with an interest in drug discovery, it has been fascinating to experience first-hand the process of evaluating compounds for late phase clinical trial entry,  albeit in a highly unusual context and timescale. Gaining an understanding into what the features of a successful compound might look like, and the process of evaluation that takes place, has been extremely informative. I have read an enormous volume of scientific literature, expanding my understanding of immunology as well as refreshing my undergraduate pharmacology. It has been equally fascinating to observe how some very strongly held opinions as to the merit of some candidates can at times be supported by limited evidence when you dig below the surface. It has reinforced the importance of truly understanding data, reading papers with a critical eye and ensuring that claims are not simply taken at face value.

The opportunity to observe key meetings, where top-level decisions are made, and listen to scientific perspectives on the therapies that we have scrutinised has provided interesting insights and context for all the reading, whilst hearing the discussions with the trial CIs has improved my understanding of critical aspects of trial design. Further, it has been enjoyable to identify, approach and liaise with key industry contacts and trial CIs from around the world. Finally, whilst I have been but a tiny cog, it has felt very rewarding and worthwhile to contribute to the national effort of finding effective treatments for Covid-19 and to use my medical and scientific training to this end.

Robert is currently undertaking a DPhil on a Wellcome Trust fellowship in Ben Fairfax’s Molecular oncology group at the MRC WIMM.

 

UK-CTAP is looking for more secondees and invites applications from MRC/Wellcome/other Fellows. For further details please complete this webform for expressions of interest.

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