Last year I attended a summit titled 'Translational immunology supporting biomedical countermeasure development for emerging vector-borne viral diseases’ hosted by The Trudeau Institute in partnership with the State University of New York Upstate Medical University. This summit brought together physicians, scientists and experts in global health with keynote speakers from the International Vaccine Institute (IVI), Coalition for Epidemic Preparedness Innovations (CEPI) and the US National Institutes of Health (NIH).
The theme for the summit focused on determining how prepared the world is for Disease X, an emerging disease that could have devastating impacts. Dr Melanie Saville, Director of Vaccine Development at CEPI theorised that Disease X could be a completely new disease, an existing disease that we understand like Ebola, or an existing disease we don’t fully understand such as Zika. And that Disease X is likely to be zoonotic, as we know that 60% of pandemics have originated from an animal.
The Gates Foundation recently presented a key example modelled by the Vaccine Modelling Initiative. This model looked at the Spanish flu pandemic from 1918 and modelled the impact, were it to emerge today. The model showed that the disease would likely impact all major cities and more than 32 million would be dead in 6 months. It’s critical that we are prepared for this unknown disease and there is much to do to improve our preparedness.
COVID-19 clinical operations
Keeping your clinical trial on track in an evolving environment.
A live example is the Coronavirus (COVID-19). There is significant concern about this pandemic which has now spread throughout the world. Likely to have originated in the Wuhan district in China, the disease is suspected to have come from a bat in a live food market but tracing patient zero is an almost impossible task, it can take up to 14 days for Coronavirus symptoms to show. As of 13th March the virus has infected more than 137,000 people globally with over 5,000 deaths and numbers are expected to increase.
The international response to the Coronavirus is focused on a number of key steps; containing the disease, saving the lives of those infected and developing vaccines and products to prevent a future outbreak. The international press has reported the lockdown of entire cities in China, country-wide quarantine in Italy and the global cancellation of many large sporting, entertainment and business events, all aiming to limit the spread of the pandemic.
Doctors have been testing many existing antivirals and sharing the results through online forums. Through this process they have discovered several antivirals that could inhibit viral infection of cells such as Remdesivir, which was developed for Ebola and Marburg but is showing promise for the Coronavirus. Several companies are developing monoclonal antibody cocktails or a polyclonal solution to address COVID-19 as both a prophylactic as well as a treatment for this infection.
There are already over 30 companies developing novel vaccines globally to prevent a further outbreak. Additionally, there are 70 clinical trials started or planned according to clinicaltrials.gov. However, it can take 12-18 months for a vaccine to be developed. At that point, the current wave of this outbreak may be over or significantly reduced. This could mean that the trials will have limited numbers of patients to test the products’ effectiveness, which has been a challenge for product development with other outbreaks in the past.
Diagnostics is another area that will need to be addressed in a holistic response to this pandemic. Better diagnostics that have a quicker turn-around time and can be placed further forward, nearest to point of care, will be essential in quantifying the denominator of this outbreak as well as facilitating rapid treatment and potential quarantine.
There is much that remains unknown about this COVID-19 pandemic and natural history studies to better understand the pathology and impact of this virus should be ongoing. Resources are being directed against this outbreak by groups like CEPI, BARDA, NIH, CDC, WHO and others, to provide better information and solutions moving forward, but more needs to be done. Further investment in emerging and re-emerging pathogen response and improved biosurveillance will enable us to better prevent, detect and respond to these global health threats.
Infectious diseases and vaccines insights
ICON's Infectious Diseases and Vaccines teams contribute regularly to media and industry conversations in addition to the production of thought leadership content in the form of whitepapers and blogs.
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
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Personalising Digital Health
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The triad of trust: Navigating real-world healthcare data integration
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
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Exploring the patient perspective from different angles
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Patient Voice Survey - Decentralised and Hybrid Trials
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Transfer of marketing authorisation
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Advanced therapies for rare diseases
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