Insights on delivering cell and gene clinical trials in multiple therapeutic areas based on lessons learned and best practices
Until now US payers have absorbed and managed the cost of ultra-expensive therapies, but how long can they continue to do so? Read our whitepaper to understand the payer perspective on advanced therapy medicinal products.Read the whitepaper
Sponsors are showing more interest in stand alone long term follow-up (LTFU) cell and gene therapy studies given new regulatory requirements, which in some cases call for 15 years of monitoring of patient outcomes and safety. While stand-alone LTFU studies are not new, the models have evolved with the advent of these potentially transformative therapies and treatments. Watch our on-demand webinar for insights on various models of LTFU studies and their applications.
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As development of cell and gene therapies (CGT) accelerates, so will the demand for best practices, and better tools and solutions. For advanced therapies, the product and patient journey is entirely different from traditional trials. As such, biotech and pharma companies will need to overcome challenges and complexities from regulatory pathways and patient recruitment to logistics and manufacturing. Adopting strategic partnerships with deep CGT expertise with a broad spectrum of solutions and services is vital to the success of a development programme.Read the eBook
ICON's CGT team share insights on best practices, custom resources and innovative tools for enabling clinical development of cell and gene therapies on a global basis in this BioInsights podcast (40 mins).
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How data flows in cell therapy studies differ from other studies and strategies to manage the high volume of data in CGT trials is highlighted in this Q&A with ICON expert Olivier Saulin.
A discussion on best-practice approaches to CGT studies and what the future could hold for this exciting area.
Over the past year, the COVID-19 pandemic significantly disrupted clinical research across the lifecycle including recruitment challenges, protocol amendments and delayed market entry.
Cell and gene therapies (CGT) are playing an increasingly important role in treating oncology patients.
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.
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.
The evolution of adoptive cellular transfer (ACT) for the treatment of lymphoma, leukaemia and myeloma patients has grown exponentially.
Clinical trials for cell and gene therapies (CGT) present unique challenges as they require special resources and training.
As this new frontier of medicine continues to expand a growing number of pharmaceutical and biotech companies will delve into CGT clinical trials.
Automation, digitalisation, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.
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.(PDF)
As the incidence of chronic diseases, such as cancer, is rising, so too is the interest from industry in the area of cell and gene therapies.
Allogeneic CAR-T cells can be manufactured using T cells from just one, single healthy donor and can be used in multiple patients. (PDF)
A three session webinar series exploring the significant opportunities and challenges posed by CGT clinical trials, and how a CRO partner may be uniquely placed to help a pharma innovator navigate them.
Working with “living therapies” during COVID-19 has changed access, resource planning and management in CGT trials.
A key challenge for manufacturers is to demonstrate value to payers in a health technology assessment (HTA) setting.
Explore how cell and gene therapy related experience can promote quality of data and higher patient accrual.
The emergence and rise of gene and cell therapies has the potential to significantly change the way we manage and treat disease.
ICON’s Cell and Gene Therapy (CGT) Solution was designed to expedite every aspect of a cell therapy clinical trial and address specific needs of CGT product development. The CGT Leadership Team leads your trials with innovative technologies and standardised tools for CGT trial execution, management of high data volumes, and extensive team and site training. Read more about ICON's services.
Read more about ICON's services in cell and gene therapies