The new consultancy offering will help therapy developers progress through the complex clinical environment, with services including chain of identity strategy and methodology, data protection compliance, label design and compliance, supply chain risk assessment and SaaS within CGT and pharma.
TrakCel Consultancy Services will be managed by co-founder Matthew Lakelin, who brings experience in client processes and supply chain, product and roadmap development, regulatory landscape and more.
“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,” said Lakelin.
“It is increasingly necessary for companies to strategically build digital solutions and plans for scale-out and commercialization into the earliest stages of development. Whether at set-up, clinical inflection points or anywhere between, TrakCel is uniquely positioned to tap into the collective experience and deliver, based on our work over the last decade.”
In his role as head of consultancy services, Lakelin will manage a team of consultants and subject matter experts who have likewise supported TrakCel’s list of CGT clients through their clinical journeys, including four that cleared marketing approval.
Through the rapid increase in CGT developers entering clinical trials, an understanding has crystallized around the need to start programs from a sustainable and cost-effective position.
This includes a new emphasis on managing regulatory and supply chain considerations, allowing a greater share of resources to remain dedicated to development.
TrakCel is currently supporting over 25 CGTs at every step of clinical development and has seen many of them progress through multiple stages to commercialization.