Long-term follow-up for vaccines may seem to be a distant concern when clinical trials are just beginning, but it can be critical to have a plan for follow-up at the outset. Learn considerations for follow-up design, s...
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Accelerating ATMP and CGT: The importance of regulatory CMC expertise in efficient biologics development
Discover how dedicated Regulatory CMC expertise benefits biologics development, ensuring compliance and efficiency, especially for innovative therapies like ATMPs and CGTs.
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Expanding CAR T-cell Therapy into solid tumours
In this blog, learn more about a range of approaches that researchers are taking to improve the efficacy and safety of CAR T-cell therapies in solid tumours.
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Use of ddPCR and qPCR assays for PK and safety monitoring in Cell & Gene Therapy clinical trials
Immunotherapy technologies are rapidly advancing, as are the methods of ensuring their safety and reliability. ICON explores the tools used in CGT trials.
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Best practices for Cell and Gene Therapy manufacturing, handling and delivery
Cell and Gene Therapies (CGTs) offer promising ways to treat previously devastating and intractable diseases.
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Scaling up to CGT commercialisation in a transitioning market
The market for cell and gene therapies (CGTs) is rapidly transitioning from ultra-niche science to approved therapies.
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Navigating the complexity of CGT clinical trial design
This blog will explore some of the challenges of CGT clinical trial design, such as patient recruitment and data collection, and strategies for how to approach them.
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Clinical development challenges faced by advanced therapies for rare disease
Advanced therapies are a class of products based on genes, tissues or cells used to treat or deliver treatment to patients.
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Cell and Gene Therapy: Specific Market Authorisation Guidances
Therapeutic developers may benefit from working with a partner whose regulatory expertise with CGTs will help ensure that development programmes are optimal and compliant.
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The promise of glycomics in medicine
Glycomics has been a largely overlooked area of study. Nevertheless, it has the potential to have a significant impact on precision medicine and healthcare as a whole.
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Navigating complexity of cell therapy manufacturing during the COVID-19 pandemic
Over the past year, the COVID-19 pandemic significantly disrupted clinical research across the lifecycle including recruitment challenges, protocol amendments and delayed market entry.
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Navigating complexity in oncology cell and gene therapy clinical trials
As more knowledge is revealed about the genetic underpinnings of cancers, cell and gene therapies (CGT) are playing an increasingly important role in treating oncology patients
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Cell and gene therapy trials - delivering differently
The success of cell and gene therapies (CGT) has transformed the delivery of clinical trial services, requiring the design of new workflows, processes and tools.
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Sharing my rare disease story - Tamie Joeckel
ICON's Tamie Joeckel shares her personal experience with Type 3 Hereditary Angioedema.
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Enabling clinical development of cell and gene therapies on a global basis 2
In a recent podcast interview, ICON experts discuss the intricacies of CGT development, the solutions that will enable CGT development on a global basis, and the future of CGT clinical trials.
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Adoptive Cellular Transfer (ACT): Novel Cancer Trials Demand That Participating Sites Act Differently
The evolution of adoptive cellular transfer (ACT) for the treatment of lymphoma, leukaemia and myeloma patients has grown exponentially.
