From MS to NMOSD to early Alzheimer's disease, neurologic mAbs are delivering proven clinical benefit. But as efficacy becomes less of a differentiator, what determines whether these therapies reach patients? In this art...
ICON experts frequently author or contribute to industry trade press.
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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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News travels fast - The evolution and revolution within medical communications
Michael Pellegrino, SVP of Global Medical Communications weighs in on how industry has increasingly recognised the benefits of different communications for specific purposes and audiences.
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Testing transmission in the community
ICON’s Dr. Andrew Garrett, Executive Vice President Scientific Operations, talks to Politico on clinical trials to test COVID-19 transmission in the community
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ICON supports Pfizer and BioNTech on the investigational COVID-19 vaccine trial
An article explaining how ICON was involved from the very first steps of the trial supporting Pfizer‘s and BioNTech’s implementation of a strategic plan and framework for the monitoring of the trial.
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Irish pharma group ICON carried out trial of Pfizer-BioNTech vaccine
The Irish Times discusses how ICON carried out the Pfizer-BioNTech vaccine trials.
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BARDA wants you
An article from Pharma Manufacturing which explains why BARDA is looking to recruit more partners in Pharma, featuring commentary from ICON's Dr. James Cummings.
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Pharma’s digital transformation – How to best incorporate wearables amid an evolving landscape
A thought leadership piece which examines how disruptions from COVID-19 have forced sponsors, clinicians and regulators to embrace digital's full potential to keep clinical trials moving forward.
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Pfizer COVID vaccine trial proved remote monitoring, other innovations work, ICON CEO says
ICON CEO Steve Cutler discusses how the Pfizer COVID vaccine trial proves that starting clinical trials in weeks, as opposed to months, should be possible post-pandemic.
