Cell and Gene Therapies
Insights on delivering cell and gene clinical trials in multiple therapeutic areas based on lessons learned and best practices
Therapeutic spotlight: Precision medicine considerations in rare diseases
In our latest therapeutic spotlight, ÃÛÌÒ´«Ã½¡¯s experts explore the evolving therapeutic landscape of precision medicine with a special focus on the unique application in ALS. We outline key considerations for developing patient-centric, streamlined precision medicine programs that promote patient engagement, improve protocol adherence and reduce dropout rates ¨C ultimately accelerating the delivery of meaningful therapies to patients.
De-risking clinical development of precision medicines in oncology
This whitepaper reviews the most pressing challenges and opportunities facing the oncology therapeutic landscape in the emerging era of precision medicine, and reports on how those opportunities and challenges vary by organisational size and region.
ÃÛÌÒ´«Ã½ survey report: Innovation in oncology - Accelerating R&D in an evolving landscape
In Spring of 2024, ÃÛÌÒ´«Ã½ conducted a survey of 104 professionals engaged in oncology drug development in North America and Europe, representing organisations ranging from small to large biotech and pharmaceutical companies.
Approaching the CAR T-cell therapy horizon
Approved CAR T-cell therapies have shown remarkable results in patients with certain types of blood cancers, but further innovations are needed before the technology can reach its full potential. In this whitepaper, we explore the most exciting clinical developments in CAR T-cell therapy, and relate them to limitations of approved therapies.
Mainstreaming Cell and Gene Therapies
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.
Long-term follow-up studies of cell and gene therapies
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.
The affordability hurdle for gene therapies
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.
The promise and complexity of living therapies
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.
Enabling clinical development of Cell and Gene Therapies on a global basis
ÃÛÌÒ´«Ã½'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 .
Cell and Gene Therapies blogs and media contributions
Marking the Path Ahead: Integrating Oncology Biomarkers Into Clinical Development' has published
In this article, ÃÛÌÒ´«Ã½ experts discuss strategies to implement biomarkers in clinical development, saving sponsors time and money while positioning therapies for success.
Combination therapies may be the future of oncology ¨C How can we navigate development challenges today?
In this article, ÃÛÌÒ´«Ã½ experts discuss common ways oncology therapies are combined to achieve synergistic effects, and considerations oncology developers should employ to de-risk combination therapy development.
To be precise: How oncology therapies can stand out in a diverse, uncertain landscape
Targeted product profiles and biomarkers for patient screening are essential elements of success for oncology treatment developers, according to our recent survey. This article explores why both prove challenging for drug developers.
Survey shows varied views on impact of new cancer drugs
This article published in The Pharma Letter highlights findings from an ÃÛÌÒ´«Ã½ survey has found that despite the increasing investment in emerging oncology-related therapeutics, developers have varied views on the impact of new cancer drugs for patients.
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.
Biomarker Identification a Challenge and Opportunity in Cancer Drug Development, Survey Finds
This news piece from Precision Medicine Online provides an overview of the findings from ÃÛÌÒ´«Ã½¡¯s recent survey of professionals engaged in oncology-related clinical research. It shares respondents' insights on how precision medicine approaches are changing development strategies and the to the extent these therapeutic advances will benefit patients in the future.
Pharma Horizons: Cell and Gene Therapy
In this report, experts in the field explore some of the latest innovations in the cell and gene therapy space, from development and quality control, through to manufacturing and clinical trials.
Engineering CAR T-cell sharpshooters
In this article, ÃÛÌÒ´«Ã½'s Brian Huber explains why and discusses the prospects for the next-generation of CAR T-cell therapies engineered to be more adaptable, precise and controlled.
Practical considerations for managing cell and gene therapy supply chains
In this article, Alyssa Gilliam, Vice President, CSM & IRT and Chad Crafford, Clinical Supplies Manager outline practical considerations for managing CGT supply chain.
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.
Logistical considerations in mRNA vaccine development
In this article, ÃÛÌÒ´«Ã½¡¯s Andreas Dreps and Martin Lachs discuss the logistical considerations in mRNA vaccine development.
Innovative laboratory testing methods for clinical monitoring of cell therapies using flow cytometry DDPCR and QPCR assays
This article explores how unique applications of PCR and flow cytometry can be used to provide critical and complementary data that is needed to bring new life-saving treatment options to patients.
Receive more insights on cell and gene therapies from ÃÛÌÒ´«Ã½
Please visit ÃÛÌÒ´«Ã½'s Preference Centre and select 'Cell and Gene Therapies' under 'Therapeutic Areas of Interest' to receive new insights on cell and gene therapies.
Cell and Gene Therapies at ÃÛÌÒ´«Ã½
ÃÛÌÒ´«Ã½¡¯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 ÃÛÌÒ´«Ã½'s services.