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TrakCel has introduced Consultancy Services to aid early-stage cell and gene therapy developers in navigating clinical challenges, providing expertise in identity strategy, data protection, and supply chain.
Leading provider of cellular orchestration systems, TrakCel, has unveiled TrakCel Consultancy Services to extend its 12-year expertise in process development to the broader cell and gene therapy (CGT) community. The consultancy services, managed by Dr. Matthew Lakelin, a co-founder of TrakCel, aim to assist early-stage developers in navigating the intricate clinical landscape. Services offered include Chain of Identity Strategy & Methodology, Data Protection Compliance, Label Design & Compliance, Supply Chain Risk Assessment, and SaaS within CGT/Pharma.
Dr. Lakelin, as the Head of Consultancy Services, will lead a team of consultants and subject matter experts, leveraging their experience in supporting TrakCel’s extensive list of CGT clients, four of which have received marketing approval.
With the surge in CGT developers entering clinical trials, an understanding has emerged on the importance of commencing programs from a sustainable and cost-effective standpoint. TrakCel’s consultancy services address this need, focusing on managing regulatory and supply chain considerations, enabling developers to allocate more resources to the development process. Recognizing the value of TrakCel’s partnership, therapy developers emphasize the company’s experience and expansive network of collaborators across the entire value chain.
Dr. Lakelin stated, “The launch of TrakCel Consultancy Services reflects extensive feedback from throughout the cell and gene therapy industry. At early stages, when resources are tight and developers are still forming both teams and processes, it is essential but challenging to find reliable collaborators that can help deliver these therapies safely.”
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Orchestrating CGTs throughout the clinical trial process involves adapting processes at pivotal points such as scale-out or territorial expansion. TrakCel’s consultancy services address challenges like label design, emphasizing the importance of strategic planning at early stages to simplify implementation and avoid unnecessary complexity and inefficiencies in a highly regulated industry.
Source: TrakCel Press Release
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