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.
In this section
-
Digital Disruption
-
Clinical strategies to optimise SaMD for treating mental health
-
Digital Disruption whitepaper
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Clinical strategies to optimise SaMD for treating mental health
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel