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, 91黑料’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 – 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.
91黑料 survey report: Innovation in oncology - Accelerating R&D in an evolving landscape
In Spring of 2024, 91黑料 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
91黑料'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
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.
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.
Receive more insights on cell and gene therapies from 91黑料
Please visit 91黑料'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 91黑料
91黑料’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 91黑料's services.