illumina genomics forum panel with Aparito

Aparito at the Illumina Genomics Forum

Last week our CEO Dr Elin Haf Davies was in San Diego to participate in the Illumina Genomics Forum, a four-day event with an impressive lineup of speakers including Former President Barack Obama, Bill Gates (Gates Foundation), Anne Wojcicki (23&me – consumer genetics) and tennis star Chris Evert, all with a personal ambition to realise the value of the genome.

Elin Haf moderated a panel on the need to end the odyssey of diagnosis, a particularly important issue for the rare disease community who can often encounter numerous incorrect diagnoses and as long as a 7-year delay in diagnosis, delaying access to genetic counselling, opportunity to take part in clinical trials, and access to treatment.

With global representation from the UK, US, Brazil and Israel on the panel the complexities of cultural, religious and infrastructure differences were discussed. But two common fundamental aspects of the global widespread adoption of whole genome sequencing agreed upon by all are trust and communication, tied to the importance of a truly informed consent process.

While the science and technology might be already here, society as a whole needs an opportunity to keep afoot of the rapidly changing approach to medical care and the impact on them as individuals, families and communities, set against a backdrop of increased distrust towards government, big tech and science.

Newborn screening that enables access to life-saving treatment before a baby becomes critically ill is an obvious advantage. But what other risk factors, carrier status and variants do excited new parents need to know within two weeks of birth? 

  • Can too much data be a bad thing? 
  • Does data really empower individuals to lead to better health? 
  • Data is knowledge and knowledge is power is the old adage but is it true for all individual people in relation to their own health?

Many similar challenges apply to the widespread adoption of digital health. Cost, the vast amount of data, secure and accessible infrastructure, equity and education.

As we endeavour to make digitised clinical trials, electronic Clinical Outcome Assessments and hybrid or decentralised clinical trials a viable patient-centric option for the rare disease community most of the barriers are those linked to beliefs, perception and fear of change or the unknown.

The world is changing. Genomics and digital health are here to stay. Pandora is out of the box! It’s down to us to ensure that communication and trust are integrated into the development of both by building strong relationships with individual people, patient communities, regulators and industry.

To finish with an old African proverb, which is apt to note as we risk creating more inequalities in health,

“If you want to go fast, go alone. If you want to go far, go together.”


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Symptoms and risk factors for long COVID in non-hospitalized adults

Aparito is delighted to contribute to a landmark Long COVID paper with the Centre for Patient Reported Outcome Research (CPROR) team at the University of Birmingham as part of the Therapies for Long COVID (TLC) study. The Aparito Atom5™ platform collected data from patients allowing them to self-report symptoms, quality of life and work capabilities.
Symptoms and risk factors for long COVID in non-hospitalized adults paper
“Symptoms and risk factors for long COVID in non-hospitalized adults” provides a comprehensive assessment of symptoms and risk factors for Long COVID. Published in Nature Medicine, the study found that people with Long COVID experience a wider set of symptoms than is officially recognised by the WHO.

Abstract

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection is associated with a range of persistent symptoms impacting everyday functioning, known as post-COVID-19 condition or long COVID. We undertook a retrospective matched cohort study using a UK-based primary care database, Clinical Practice Research Datalink Aurum, to determine symptoms that are associated with confirmed SARS-CoV-2 infection beyond 12 weeks in non-hospitalized adults and the risk factors associated with developing persistent symptoms. We selected 486,149 adults with confirmed SARS-CoV-2 infection and 1,944,580 propensity score-matched adults with no recorded evidence of SARS-CoV-2 infection. Outcomes included 115 individual symptoms, as well as long COVID, defined as a composite outcome of 33 symptoms by the World Health Organization clinical case definition. Cox proportional hazards models were used to estimate adjusted hazard ratios (aHRs) for the outcomes. A total of 62 symptoms were significantly associated with SARS-CoV-2 infection after 12 weeks. The largest aHRs were for anosmia (aHR 6.49, 95% CI 5.02–8.39), hair loss (3.99, 3.63–4.39), sneezing (2.77, 1.40–5.50), ejaculation difficulty (2.63, 1.61–4.28) and reduced libido (2.36, 1.61–3.47). Among the cohort of patients infected with SARS-CoV-2, risk factors for long COVID included female sex, belonging to an ethnic minority, socioeconomic deprivation, smoking, obesity and a wide range of comorbidities. The risk of developing long COVID was also found to be increased along a gradient of decreasing age. SARS-CoV-2 infection is associated with a plethora of symptoms that are associated with a range of sociodemographic and clinical risk factors.

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Harnessing the power of patients with Gaucher Disease Type 2 and Type 3

Harnessing the power of patients: Developing and validating the Neuronopathic Gaucher Disease Patient Reported Outcomes (nGD-PRO) and Observer Reported Outcomes (nGD-ObsRO) to measure HRQoL in patients with Gaucher Disease Type 2 and Type 3 documents over three and a half years of research to develop and assess the content validity of nGD-specific patient-reported outcomes (PRO) and observer-reported outcomes (ObsRO) measure in partnership with patients, caregivers, and other
stakeholders as part of the GARDIAN project.

GARDIAN is a patient-owned registry developed by the IGA together with Cerner Enviza and Aparito to improve Gaucher disease understanding, management and support for patients with Gaucher Disease Type 2 and Type 3. It also provides a research platform to provide evidence-based data for advancing disease management, designing safer treatments and improving patient outcomes.

This poster documents how the Neuronopathic Gaucher Disease Patient Reported Outcomes (nGD-PRO) and Observer Reported Outcomes (nGD-ObsRO) were developed and validated to measure HRQoL in patients with Gaucher Disease Type 2 and Type 3!

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ALS Liga Belgium join Patient Group Accelerator Programme

On Amyotrophic lateral sclerosis (ALS) awareness day, we are extremely proud and happy to announce our partnership with ALS Liga Belgium and welcome them into Aparito’s Patient Group Accelerator Programme

About the Accelerator

Aparito launched the Accelerator in 2020 to provide an initiative where a company and patient community, with the support of patient advocacy groups, can collaborate as peers.

The Accelerator is designed to understand and ideally fulfil the patients’ needs, by working closely with patient organisations and finding new endpoints that would be relevant to their specific conditions. 

By developing technological solutions, novel endpoints and digital biomarkers (Digital vs traditional) designed for and with the patients (Patient involvement), the objective is to collect sufficient exploratory data as a starting point for future validation and use in clinical trials. 

About ALS

ALS, also known as Motor Neurone Disease (MND) affects nerve cells in the brain and spinal cord that control voluntary movements of muscles, progressively causing muscle weakness, paralysis and eventually death, within 2-5 years of diagnosis. The cause of ALS is still unknown, and the course of the disease and life expectancy varies from patient to patient. ALS results in loss of strength in hands or limbs and then spreads to other parts of the body. As the disease progresses, patients lose the ability to swallow, speak and breathe. 

While there is no cure for ALS yet, a few approved treatments help slow the progression and manage ALS symptoms and there are new experimental drugs in the ALS treatment pipeline. Due to its rapid progression, ALS may benefit from specific digital biomarkers that would allow more frequent remote monitoring and mitigate the high attrition rates of ALS patients involved in clinical trials.

The first stage of the Accelerator programme will be dedicated to exploring and understanding the unmet needs of ALS patients regarding digital outcomes measures through a co-creation approach in partnership with the ALS Liga Belgium. 

Using Aparito’s Atom5TM we will co-develop a prototype to test the usability and potential clinical utility of such a platform to capture and analyse digital biomarkers that are relevant to ALS patients. 

We are very excited to launch this new partnership with ALS Liga Belgium as part of the Accelerator Programme. This is an excellent opportunity to co-develop patient-driven solutions to support the ALS patient community

Dr Elisa Ferrer Mallol, Patient Advocacy Manager, Aparito

In our second year of the Patient Group Accelerator we are thrilled to see the programme grow from strength to strength. The Accelerator is a critical part of Aparito’s DNA and vision for a patient centric solution to conveying what’s important to them. Partnering with ALS Belgium is an exciting reflection of this and a strong addition to the partnership that we have with DuchenneUK and PCD Support UK

Dr Elin Haf Davies, CEO, Aparito

About Aparito

Aparito is a global health tech company that brings clinical trials to patients and unlocks real-world data through mobile apps, video assessments & wearable devices. Aparito provides a patient-centric platform that integrates clinical & regulatory expertise to capture patient data and develop digital endpoints for hybrid and decentralised clinical trials. 

Earlier this year Aparito received the EURORDIS Company Award for Health Technology at the 2022 EURORDIS Black Pearl Awards, a great recognition from the rare disease community to acknowledge that Aparito makes a difference in the rare disease space. 

Learn more about Aparito’s Patient Group Accelerator Programme here.


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Development of SARAhome, a New Video-Based Tool for the Assessment of Ataxia at Home

SARAhome is a digital assessment of ataxia at home. Ataxias are a heterogeneous group of rare movement disorders and the core clinical features of these disorders are progressive gait disturbance, impaired coordination and speech disturbance. 

Aparito documented the story behind the development of SARAhome by Dr Marcus Grobe-Einsler MD and the team at Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. and below is an extract from the paper that led to this breakthrough!

Background

Clinical scales such as the Scale for the Assessment and Rating of Ataxia (SARA) cannot be used to study ataxia at home or to assess daily fluctuations.

The objective of the current study was to develop a video-based instrument, SARAhome, for measuring ataxia severity easily and independently at home.

Methods

Based on feasibility of self-application, we selected 5 SARA items (gait, stance, speech, nose-finger test, fast alternating hand movements) for SARAhome (range, 0–28). We compared SARAhome items with total SARA scores in 526 patients with spinocerebellar ataxia types 1, 2, 3, and 6 from the EUROSCA natural history study.

To prospectively validate the SARAhome, we directly compared the self-applied SARAhome and the conventional SARA in 50 ataxia patients.

To demonstrate feasibility of independent home recordings in a pilot study, 12 ataxia patients were instructed to obtain a video each morning and evening over a period of 14 days.

All videos were rated offline by a trained rater.

Authors: Marcus Grobe-EinslerArian Taheri Amin Jennifer FaberTamara SchaprianHeike JacobiTanja Schmitz-HübschAlhassane DialloSophie Tezenas du MontcelThomas Klockgether

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TASTY: Feasibility of facial expression analysis as an objective palatability assessment of paediatric medicine

Dr Clare Matthews and Dr Rabia Aziza’s poster presentation at the Child Health Technology Conference 2022 showcased a fascinating project that Aparito have worked on with University College London to explore “Feasibility of facial expression analysis as an objective palatability assessment of paediatric medicine”.

This project utilised Aparito’s innovative video capture & analysis technology via the Atom5™ clinical trial platform to enable study participants to upload videos capturing their responses to taste. The videos were analysed by our data science team and their findings were disseminated via the poster.

Feasibility of facial expression analysis as an objective palatability assessment of paediatric medicine poster

Below is the transcript from Dr Matthews’ presentation along with a link to download the poster in PDF format!

Dr Clare Matthews, Senior Data Scientist at Aparito

“The palatability of drug formulations is an important factor to consider when developing paediatric medicines as it has a strong impact on treatment adherence and clinical outcomes. At Aparito we specialise in collecting data from studies and trials within a home setting. This reduces the burdens associated with clinical assessments for both patients and caregivers, but can also provide more accurate data, as children especially are likely to behave more naturally in a home environment. As part of this study, participants recorded videos of themselves testing four different taste strips. 

The videos, along with a five-point smiley-face-based rating of the taste, are uploaded using Aparito’s Atom5™ app.

Dr Clare Matthews, Senior Data Scientist, Aparito

We’re looking at the feasibility of analysing facial expressions in the videos using pose estimation and facial recognition software to explore how facial points move in response to children’s reactions to different tastes, specifically, the tastes of sweet, sour and bitter. 

All participants tasted a blank control strip first. The remaining three strips were then tested in one of three different orders, which were assigned randomly via the app. From the five-point hedonic scale rating that the participants submitted for each strip, we found the somewhat expected result that children like sweet, dislike bitter and have a varied response to sour. However, this result validates our methodology by illustrating that we can get meaningful data from a decentralised approach. 

From the videos, we see a lot of variation in the magnitude, duration and timing of the reactions to the taste trips. Our approach has been to initially identify single frames from the videos to illustrate a baseline, or no reaction, and a best reaction facial expression. We generate quantitative measures based on the relative position of specific landmarks in these facial expressions. 

These measures are then the input features on which our machine learning models are trained and we’re developing models to classify both the strip taste and the hedonic ratings.”


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Rating ataxia using video capture: the development of the SARAhome assessment

Rating ataxia using video capture: the development of the SARAhome  assessment

A particular highlight of our webinar, Video Capture for Patient-Centered Clinical Trials, this article features Dr Marcus Grobe-Einsler MD of Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE, the German Centre for Neurodegenerative Diseases) and the story behind digitising the Scale for the Assessment and Rating of Ataxia, SARA, into SARAhome.

What is SARAhome?

SARAhome is a digital assessment of ataxia at home. Ataxias are a heterogeneous group of rare movement disorders and the core clinical features of these disorders are progressive gait disturbance, impaired coordination and speech disturbance. 

“We usually see our patients once a year at least, and we need some kind of objective measurement for the severity of ataxia. SARA, the scale for assessment and rating of ataxia, is established as the golden standard in the examination of ataxic patients, it’s been broadly validated, we all use it, and we have a lot of information about reliability, validity, linearity, sensitivity to change,” says Marcus.

“What we actually do with the patients when applying SARA is we assess gait, standing, sitting, speech disturbance, finger chase nose-finger tests, fast alternating hand-movements and a heel-shin slide test.” 

The severity of each symptom is rated on a point scale, which is differently weighted depending on how severe the functional impairment is for these patients in their daily life.

Limitations of in-clinic assessments

Ataxia patients experience fluctuations in the severity of their ataxia during everyday life, and they report that. But we cannot measure it, because we only have this snapshot visit. “So we see them once a year and it’s really hard to get more information about these fluctuations,” says Marcus “because we can only ask them, but don’t have a home assessment.”

Marcus continued, “SARA is a very useful instrument, but we know that there are limitations to it. And the most important limitation is that it takes place in a clinical setting so we don’t get the information about the situation at home, that real-life data. And you have the necessity of an investigator, so you always need to have to travel for one of those persons.” 

If the patient comes to the clinic, or even if the doctor comes to the patient once a year, there is very little (or even zero) information about daily fluctuations in severity.

Dr Marcus Grobe-Einsler, DZNE

So Marcus’s team went back to the original SARA score and tried to identify those items that the patient would be able to perform by themselves after instruction by investigators. They settled on: 

  • Gait 
  • Stance 
  • Speech disturbance
  • Finger-to-Nose-Test 
  • Fast Alternating Movement 

“We identified those five items to keep and we eliminated the sitting and the heel shin slide because they’re less feasible at home. Patients would have to climb on a high chair or lie down for these items. We also eliminated the finger chase, just for the obvious reason that for the moving target we’d need a second person at home. We included standardised speech that is not included in the original SARA score but delivers a lot of information that we can use for the development of automatic ratings.”

“One question we had to answer was: can we eliminate three items (from SARA) without destroying what the score tells us about the severity of ataxia?”

The original SARA publication from 2006 in part answered this question as the internal consistency is high in this score, meaning that if you eliminate an item it doesn’t really destroy the meaning of the score. 

DZNE wanted more information about that so they used data from a closed retrospective study,  the EUROSCA trial, including patients with spinocerebellar ataxia types one, two, three, and six – these are autosomal dominantly inherited disorders, with ataxia as a core feature – and looking at the SARA scores from the baseline and comparing those with the extraction of only those items used for SARAhome showed a very high correlation between those scores. 

Marcus points out, “But we, of course, need to demonstrate this, so high correlation always means that you have a narrow distribution of those points here (around the line). At this point, we also wanted to develop some kind of help for the patients when they use it at home.”

This led to the development of the SARAhome assessment in Aparito’s Atom5TM clinical trial platform.


Developing SARAhome in Atom5TM

“We started cooperation with Aparito to develop the app version of SARAhome. We created written instructions and instructional videos that are implemented in the app that guide patients through the task performance.”

The app allows recording of these assessments at home and, most importantly, secure data transfer of those videos for rating by experienced investigators.

“One advantage that we see here is that we can be flexible in combination with other PROs as it’s a modular system”, says Marcus “and we can easily add a questionnaire if we need one. The app also automatically sends out reminders for upcoming assessments.” 

Validation of SARAhome

The DZNE team subsequently went into the prospective validation phase and recruited 50 patients with mixed cerebellar ataxia; not only spinocerebellar ataxia but any disease that impacts the cerebellum. ”We performed a conventional SARA score on these patients and then we instructed the patients to record a SARAhome score on their own. We had an experienced investigator that was not involved in this assessment to rate the videos of the SARAhome.” 

This provided a video rating of SARAhome versus a conventional SARA score in the same study for a head to head comparison and there was a very high correlation between those two scores.

“So,” continues Marcus, “we have a validated score, but what we actually want to do is measure fluctuations and show that the score actually works. We recruited additional patients and asked them to continue recording SARAhome for 14 days; once in the morning, once in the evening.”

The results brought into sharp relief two findings:

  1. 14 days is a long period of time and applies a significant burden to patients. The DZNE team’s analysis of their data concluded that five days of assessment may be sufficient (pending confirmation via a larger cohort). 
  2. an average SARAhome score from five days of assessments provides a more meaningful measure and severity of ataxia than a conventional snapshot visit conducted once a year. 

Conclusion

“So,” declared Marcus, “we have a validated home-based digital assessment of ataxia with SARAhome. We demonstrated the feasibility, safety and acceptance in a pilot study. And SARAhome is implemented in Aparito’s Atom5TM app and is available for immediate use. 

We asked what was next for Marcus. He responded, “We have ongoing and future studies investigating the effects of the fluctuations. We want to see these effects in a higher number of patients in a genetically homogeneous population in spinocerebellar ataxia type three in a multicentric setting and want to investigate the reasons for why we see these fluctuations.”

To learn more about the fantastic work of DZNE please visit them at www.dzne.de/en/

Four benefits of video assessments

1. Video promotes comparability – video assessments reduce inter-rater reliability because a video assessment means that clinicians score the same investigation with a centralised grading.

2. A large number of recordings – at-home assessments provide information about disease burden in real-world settings.

3. Increased frequency of assessments – video capture can help study the therapeutic effects of interventions and measure fluctuations by asking for assessments to be carried out twice or thrice daily

4. Reviewing an assessment – ​​we can replay a video, we can pause it, or we can slow it down, allowing us to study an assessment in ways that is not feasible with in-clinic assessments

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Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research

The latest paper to publish work by Aparito’s Dr Elin Haf Davies applies focus to Patient-Reported Outcomes (PROs) and features contributions from over 30 institutions including the University of Birmingham, the FDA, the NIHR and Janssen!

Published in JAMA, Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research asks the question, “what ethical considerations should be considered by researchers, research ethics committees, and funders when conducting or reviewing patient-reported outcome (PRO) clinical research?

Abstract: Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research

Importance

Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.

Objective  

To develop international, consensus-based, PRO-specific ethical guidelines for clinical research.

Evidence Review  

The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network’s guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.

Findings  

Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans.

Conclusions and Relevance  

The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

Bonus Podcast!

Dr Melanie Calvert, PhD from the University of Birmingham, one of the paper’s contributors, also took part in a podcast to discuss the implications of the paper’s findings which you can listen to on the JAMA website here.

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Patient reported outcome (PRO) assessment must be inclusive and equitable

Aparito is delighted to contribute to another paper with the Centre for Patient Reported Outcome Research (CPROR) team at the University of Birmingham!

Nature Medicine paper

This time we appear in Nature Medicine with “Patient reported outcome assessment must be inclusive and equitable“.

The paper explores how patient-reported outcomes are increasingly collected in clinical trials and in routine clinical practice, but strategies must be taken to include underserved groups to avoid increasing health disparities.

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Authors

Melanie J. Calvert, Samantha Cruz Rivera, Ameeta Retzer, Sarah E. Hughes, Lisa Campbell, Barbara Molony-Oates, Olalekan Lee Aiyegbusi, Angela M. Stover, Roger Wilson, Christel McMullan, Nicola E. Anderson, Grace M. Turner, Elin Haf Davies, Rav Verdi, Galina Velikova, Paul Kamudoni, Syed Muslim, Adrian Gheorghe, Daniel O’Connor, Xiaoxuan Liu, Albert W. Wu and Alastair K. Denniston

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Aparito shortlisted for the prestigious Prix Galien UK award

Aparito has been shortlisted in the Best Digital Health Solution category at the 2022 Prix Galien UK Awards for our clinical trial platform, Atom5™!

atom5

The Prix Galien is UK life sciences’ most prestigious award for innovation and Aparito appears amongst a field of digital health luminaries including Behold.ai, Big Health, Cera, Docobo Ltd, Feedback Medical Ltd, ieso Digital Health, Holmusk, Huma, syd™, Islacare, Spirit Health, Tympa Health Technologies Ltd, uMotif, and Wondr Medical.

To be shortlisted for the Prix Galien UK Awards is a thrilling milestone for the whole team and further recognition of our collective mission to bring clinical trials to patients, from ultra rare genetic diseases to others such as Long COVID which impact thousands.

Dr Elin Haf Davies, CEO of Aparito

According to the press release, The Prix Galien UK Awards launched in 1990 and have been awarded to 36 products since its inception. Winners are selected every two years by the Prix Galien UK Awards Committee, which is comprised of 14 experts in the field. The Committee comprises numerous of the UK’s leading luminaries in healthcare. The distinguished panel is guided by the conviction that acknowledging research-driven innovation is key to the improvement of healthcare in the UK and human health globally.

The winner will be announced during the Prix Galien UK Awards ceremony which takes place May 12 2022 at London’s Natural History Museum.

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