Insights on delivering cell and gene clinical trials in multiple therapeutic areas based on lessons learned and best practices
The cell and gene therapy (CGT) market is rapidly transitioning from ultra-niche cutting-edge science to approved and available therapies that can address previously intractable and often devastating diseases.Read the whitepaper
Regulators typically expect that Sponsors collect up to 15 years of follow-up data on patients who’ve received cell and gene therapies either through a clinical trial or in clinical practice.Read the whitepaper
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
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).
Download the full transcript here.Listen to podcast
This roundtable will explore 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.
This roundtable will identify successful strategies that underpin currently-marketed therapies and examine how establishing a framework early in development helps keep long-term production and commercialisation goals on track.
This roundtable will review the necessary considerations and logistics of conducting CGT trials, and how sponsors and service providers can optimize their clinical research to maximize the prospect of success.
Considerable strides have been made in the development of cell and gene therapies since the first autologous CAR T therapy was approved by the FDA four years ago.
New regulatory requirements have sparked more interest in stand-alone long-term follow up studies for monitoring patient outcomes and safety.
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.
In this article, Brian Huber and Tamie Joeckel, consider how cell and gene therapies could change the future of cancer treatments and bring new options to patients.
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.
Advanced therapies are a class of products based on genes, tissues or cells used to treat or deliver treatment to patients.
Brandon Fletcher offers his insights on the key changes in regulatory guidance documents released by the US Food and Drug Agency.
Therapeutic developers may benefit from working with a partner whose regulatory expertise with CGTs will help ensure that development programmes are optimal and compliant.
Brian Huber considers the affordability, access and reimbursement challenges within the gene therapy market.
Tamie Joeckel discusses the challenges of making cell and gene therapies affordable for payers and patients alike.
Brandon Fletcher, CGT Principal, discusses how oncology is adapting to cell and gene therapy, and what can be done to improve take-up across the industry.
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)
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