Cell and gene therapies offer significant potential to treat diseases with great unmet medical need, however, the unique nature of these therapies pose challenges to clinical development and regulatory approval. Our experienced team can help you navigate these complex ties to bring your therapy to market more quickly and effectively.
Cell and gene therapies are accompanied by many challenges in terms of operationalization, manufacturing, regulatory strategy, and patient evaluation and selection. At Caidya, we take a personalized approach to each study, understanding the unique scientific and medical profiles of each therapy, and offering expert guidance through the clinical trials journey.
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 chemistry, manufacturing and controls (CMC) concerns. Manufacturing capacity and starting material availability also continue to pose a challenge.
At Caidya, our experienced team can help you identify potential challenges or roadblocks ahead of time to keep your project on time and on budget.
Gene therapy clinical trials are accompanied by their own sets of considerations and challenges. This is especially true when it comes to rare diseases, as there are fewer patients to enroll in clinical trials. Much like cell therapies, gene therapy products need to be stored and shipped properly using an appropriate chain of custody which requires unique tracking systems, equipment and monitoring, as well as logistical safeguards to ensure that the product reaches the site in the appropriate condition.
Caidya’s experienced team can help you prepare for and meet these challenges successfully.
CGT Academy is an in-house educational program required for all operational personnel assigned to a cell or gene therapy study, and delivers courses covering clinical trial design, regulatory, medical, and pre-study operations considerations, and study execution/logistics. Assigned staff must complete all modules and pass all course exams. The courses are based on best practices, successful methods, and the protocols and procedures gained from our experience with CGT trials.
Supporting the needs of the patients and caregivers is key to maintaining patient enrollment and follow-up. We understand this, and work with our sponsors and sites to create an experience that is as conducive to successful clinical outcomes as it is to keep morale high for patients and caregivers.
An important tool in developing an effective recruitment strategy is determining the relevant patient pathway—from presentation to diagnosis to treatment—at the sites and what referral pathways can be put into place for additional enrollment support. It is also important to understand the site-specific patient pathways, and any referral networks that are in place, as well as any links to support groups or advocacy forums.
Ensuring high visibility of the study in the locations where patients are routinely seen will help in informing them of the study and directing them to a referring or participating physician. Caidya supports this effort by preparing reference letters and other materials.
Data mining services may also be considered to locate patients being treated outside of the main sites that have been involved in prior research and/or to identify treating physicians we can potentially reach out to in order to provide information to the patient who may be interested in alternative treatments.
We believe taking a customized Very Important Patient (VIP) approach to our studies supports our internal teams, the sites, and the patients to achieve the desired outcome of having the study conducted quickly and ultimately available faster to the population of patients eagerly awaiting treatment.
Patients, their families, and support networks respond to positive reinforcement, a strategy that takes the patient experience into consideration. It is vital to apply solutions that can ease the burden participating in the study may have on their day-to-day life. The following are strategies Caidya finds successful:
Train sites to have detailed discussions with potential patients about the protocol requirements. Failure to do so prior to consent may hinder data collection and analysis. Discussing these requirements and giving sites assistance with defining mitigation strategies will aid in the success of this study.
We recommend working with Patient Advocacy Groups (PAGs) and patient-focused groups to post study information on social media and patient-centric platforms. These groups can send information directly to patients alerting them of new clinical trials as well as provide potential patients with information about local physicians participating in these studies. These strategies raise study awareness and interest among potential patients.
Ready for the next step in your drug development journey? Learn more about how our personalized solutions can help you enable better healthcare outcomes.
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