In the News
ICON experts frequently author or contribute to industry trade press.
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Overcoming IVDR challenges for companion diagnostics
Angela Brown, Global Head and Senior Director, Regulatory Affairs and Nicole Cowan, Director, Project Management, IVD Operations & Strategy, provide expert commentary on overcoming IVDR challenges for companion diagnostics.
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Best practices in managing CGT from protocol design to data management
Though the fields of immunotherapy and cell and gene therapies have seen significant growth since April 2012, CGT clinical research remains a challenge. ICON's Tamie Joeckel offers expert commentary on managing and executing CGT clinical trials.
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COVID-19 trial of alternating vaccines begins in the UK
Recruitment has begun in the UK for a world-first study to investigate whether using different COVID-19 vaccines for first and second doses is as effective as using the same type of vaccine for both. ICON’s Dr Garrett provides commentary.
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No10 launches world's first trial into whether mixing and matching coronavirus vaccines can enhance protection
ICON's Dr. Garrett comments on the UK government's new 'Com-Cov' study of over 800 patients, designed to test mixing doses of the Oxford and Pfizer COVID-19 vaccines, as well as different intervals between doses.
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Inside a vaccine trial
Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.
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Communicator Q&A with Morgan Hill, Principal, Scientific Excellence & Strategy, Global Medical Communications
Morgan Hill, Principal, Global Medical Communications, offers insights on the evolution of healthcare messaging and how ICON is staying at the forefront of communicating healthcare messages and data.
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Navigating the EU’s IVDR compliance deadlines amid uncertainty
With the COVID-19 pandemic, Brexit, and the rapidly approaching deadlines to comply with the new European Regulation on in vitro diagnostics (IVDR), IVD manufacturers will need to prepare for an ever-evolving clinical and regulatory landscape, and create mitigation strategies that allow for quick, agile changes to keep studies on track. Additionally, manufacturers will need to adopt a strategy to address gaps in meeting new regulations to avoid potential UK and European Union product availability issues. Understanding current guidance and adapted regulations is the first step to navigating the transformations undergoing the diagnostics field and the broader healthcare industry. In this article, Angela Brown and Nicole Cowan provide an overview of today’s regulatory setting and discuss how manufacturers can develop strategies to ensure a successful transition to comply with the IVDR by the 2022 deadline, including: overcoming the shortage of Notified Bodies; assessing product portfolios and quality systems; planning and implementing technical file remediation; and managing the IVD lifecycle.
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Shaping the future
An article discussing how the pandemic spread caused disruption but also a rapid deployment of solutions to ensure continuity in clinical trials and preserve and build resilience into ongoing research programmes.
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Patient involvement in medical publications
Michael Pellegrino, SVP of Global Medical Communications, outlines research on patient involvement in the journal review process.
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Moderna is designing a new version of its COVID-19 shot to fight the variant first found in South Africa
ICON’s David Morse, VP, Global Regulatory Affairs Consulting Services talks to Business Insider on regulatory pathways for development of new vaccines and vaccine boosters to address emerging COVID-19 variants.
