Deepali Suri, President of ICON Biotech, has been published in Pharmaceutical Executive. Her article draws on insights from 163 biotech leaders across North America, EMEA and APAC, supported by a supplementary survey o...
ICON experts frequently author or contribute to industry trade press.
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How cancer regulation is — and isn’t — changing at FDA: a BioCentury podcast
Dr. Liz O’Brien, Senior Director of Global Drug Development at ICON and former EMA regulator, joined the BioCentury This Week podcast to share insights on navigating FDA’s Project Optimus, the EMA’s Joint Clinical Assessment and highlight the key differences between the two regulatory regimes.
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Preparing For The Biosimilar Era Of ADCs And BsAbs In Oncology
In a recent interview with Citeline, the head of ICON's Centre for Biosimilar Drug Development discussed the upcoming patent expirations in oncology biologics, the opportunities, regulatory pathways and challenges this presents for developers and greater treatment access for patients.
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Regulatory Strategy, The Maestro
As part of Pharma Tech Outlook's Regulatory Strategy, The Maestro Q&A series, ICON answers a range of questions around regulatory in clinical trials, timing and other considerations.
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Preparing to Achieve with Joint Clinical Assessments
Since Regulation (EU) 2021/2282 (HTAR) came into effect, HTDs need to plan for a Joint Clinical Assessment (JCA) in addition to submitting their CTD to the EMA or medical device technical file to their notified body. In this article, ICON discusses this new requirement, factors to consider and the benefits.
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Regulatory strategy implications for foetal medicine
In the February edition of TOPRA's Regulatory Rapporteur, ICON summarises the European legislation related to Regulation (EC) 1901/2006 and how it incorporates PIPs but omits the unborn foetus. We also review the guidelines and other application precedents while providing insight into distinctions that may be made by the agency in this matter, as well as highlighting relevant precedents which were identified during this peer reviewed article.
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Set for success. Avoiding the pitfalls of clinical data conformity in medical device trials
It would seem intuitive that in order to pass a clinical trial and be compliant with EU MDR/IVDR, the trial data would need to conform to the processes and rules set out by the Notified Bodies. Surprisingly, in practice this is not always the case. Learn more about potential pitfalls and how to mitigate against them.
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Developing Robust Submission Strategies for Combined Studies
Medical interventions increasingly involve the use of technology and devices. New treatments may involve a medical device, combination product or in vitro diagnostic device. For sponsors this means their studies have additional regulatory requirements to meet, each on very distinct submission pathways. Read the full article.
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Understanding EU regulatory requirements for studies with medical devices and in vitro diagnostic devices
Treatments are being developed that use medical devices, combination products and in vitro diagnostic medical devices. However, before patients benefit from these new treatments, use of these devices within clinical trials is subjected to scrutiny by different regulatory agencies.
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Innovation and flexibility in long-term follow-up studies
Read insights from Harpreet Gill VP, Real World Solutions, on how sponsors can optimise their LTFU studies to be flexible and cost-effective, with strategic planning and innovation, overcoming challenges while capturing valuable data insights.
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Cover Story - Regulatory CMC: Enhancing Biologics Development
Preventing delays and accelerating the progression of these critical therapies.
