Cell therapy clinical trials pose a number of challenges, including material supply risks due to single-source materials, temperature and time sensitivity throughout the supply chain process, the need for accelerated regulatory pathways and associated testing data, as well as CMC concerns. Additionally, viral vector development and manufacturing capacity and starting materials are becoming increasingly competitive and can affect lead times, while risks to clinical trial enrollment and screening failure remain high.
We have a growing pool of experienced cell therapy professionals in various roles, including: Executive Leaders, PMs, Clinical/Site Managers, Clinical Research Associates (CRAs), Medical Directors, Biostatisticians and Data Managers. From this pool, we select specific study team members who bring relevant disease and operational experience to execute each study.
Cell therapy studies can be particularly complex and challenging in terms of sample management. This is especially true for cell/sample collection procedures, such as leukapheresis. We utilize a dedicated logistics coordinator (LC) role within the Caidya study team to ensure communication between sites, sponsor, and logistics vendors. The LC’s central role in coordinating shipping and tracking of samples, ensures proper chain of custody and subsequent treatment of patients with the targeted therapy. All of this requires careful timing and detail-oriented management.
Caidya offers dedicated LCs for each region in which the study is operating to support sites and vendors within their own time zones, as well as to ensure rapid response to questions and provide guidance and support as needed.
Manufacturing failure rate is an important consideration in autologous cell therapy trials. If not already assessed, feasibility is often an endpoint of early-phase trials involving such products (e.g., failure-to-treat). In addition, as potential dose ranges can be substantial, management of scenarios in which a subject’s product cannot be manufactured to achieve the target dose should be explicitly described. Quality control/assurance parameters of the manufactured product will need to be explicitly stated, such as viability, purity, sterility, etc. Our CMC experts can assist with clearly delineating how manufacturing failures, delays, or quality issues should be handled.
Before enrolling patients in a cell therapy trial, the clinical trial protocol and investigational product must receive approval from local and country-level regulators. Sponsors must ensure their technology is acceptable in all countries in which they plan to operate to avoid incurring additional costs. In the U.S., studies may need to be reviewed by institutional biosafety committees (IBCs). In Europe, studies must meet the standards of the advanced therapy medicinal product (ATMP) directive and may need to be reviewed by national GMO experts. These steps are important to ensure proper handling procedures are implemented and patient or public safety is protected. It is essential for companies to understand the current regulatory landscape and anticipate any changes that may impact their development goals.
Caidya’s regulatory team has worked on many studies in cell therapy and has the expertise to help navigate this complex landscape.
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