The cell and gene therapy process is highly nuanced, involving the removal of cells, DNA, or proteins from patients or donors. The removed material then needs to be re-engineered to develop a highly personalized gene/cell that is reinfused into the patients. While the market opportunity is certainly there, skill shortage is a major problem.
This blog is an excerpt from the whitepaper, “Closing the Skill Gap in the CAGT Manufacturing Sector with World-Class Training Management”.
According to recent research, 70% of adverse events reported across clinical trials are preventable. Of these, more than 60% are caused by technical errors and 17% by the inappropriate diagnosis. In CAGT trials, additional sources of quality risks include:
Key Areas for Upskilling:
Regulatory and Site Start-up: To accelerate study initiation at sites, the following three aspects are key; (i) strategizing and coordinating the submission of CAGT trial information to regulatory bodies, (ii) an understanding of GMO and non-GMO requirements, and (iii) training operational delivery teams on country-specific requirements.
CAGT Logistics: The labile nature of the autologous/allogeneic cells, viral vectors, and bacterial transposons and the urgency of the treatment means that we need a better way to manage critical path tasks across the value chain. The CAGT operational team needs to be trained in adhering to health authority-mandated audit trails for the chain of custody and chain of identity while being able to identify and mitigate risks in real-time. In addition to experience, the team can also benefit from an understanding of logistics workflows and risks, identification of thresholds for compliance, and ensuring patient safety.
Patient Treatment and Follow-up: On receiving the investigational product (IP), the team needs to prepare the patient for treatment. The team should identify the associated risks, handle the product by complying with appropriate standards, administer the correct and compliant dose, and document the process and the follow-up. There must also be an alternative plan in case the IP does not meet the specifications.
Data and Administrative Compliance: The CAGT case book is nearly 50% larger than that for conventional therapies. More than 3/4th of the patient data has to be recorded in the first few weeks of dosing. It can be a challenge considering the volume of data to be entered in a short timeline that can be overcome through training, preparation, and knowledge sharing.
Patient Retention and Ongoing Engagement: After administering the dose, operational teams should follow up with the patient for several years to understand the impact of the therapy on the patient’s health and quality of life. If successful, it will enable the sponsor to file for marketing authorization. The team needs to be oriented towards the period of follow-up, the various evaluations to be performed, and the kind of data that needs to be collected.
CAGT manufacturing companies need to develop a dynamic training program that aligns with the on-the-job needs of their employees. It must be delivered in a way that enables self-learning, continuous on-the-job training, periodic performance assessments, and ongoing additions to the curriculum. But how can CAGT Manufacturers customize training programs, understand the skills, identify gaps, deliver, and keep track of all the training needed? They need the right technology.
Technologies like CQ’s Training Management Solution are built with a strong understanding of regulatory standards governing the life science industry in general, and advanced therapies in particular built for the complexities of CAGTs, CQ’s Training Management solutions use AI and data to track and monitor progress, customize training, measure performance and properly document all trainings and certifications that CAGTs need on their way to regulatory approval.
ComplianceQuest’s Training Management Software for CAGT Companies
The Training Management Software from ComplianceQuest, built on Salesforce, helps businesses ensure that their workforce is trained, skilled, and certified to drive productivity and maintain compliance.
Integrated with the CQ EQMS solution, it supports a stable, reliable, and repeatable training management process, ensuring that the employees are equipped with the knowledge they need to discharge their duties responsibly and in compliance with GMP guidelines, international standards, and government regulations.
CAGT manufacturers can manage the training of all personnel based on their functions to make them job-ready, improving visibility and traceability of knowledge acquisition. It centralizes learning content that can be easily accessed from anywhere, any time, accelerating learning and empowering employees to create a culture of transformation. It also allows employees to use different approaches to consume individualized and role-specific training.
It uses a risk-based approach to enable prioritization and mitigation of critical risks, thereby improving the outcomes. ComplianceQuest EQMS also includes solutions for:
- Document management
- Change management
- Audits and inspections
- CAPA and Root Cause Analysis
- Management review
- Complaint handling
- Supplier management
To know more about COmplianceQuest’s EQMS and Training Management Software, visit: https://www.compliancequest.com/training-management-software-system-solutions/
Request for a demo here: https://www.compliancequest.com/online-demo/