Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials

By Karen Ivester, inSeption Group

The establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes. Unsurprisingly, collaboration is the key to fast, effective standardization.

Even acknowledging that many elements of cell therapy development cannot be standardized (limiting the scope of this effort to a more manageable level), the list of stakeholders whose expertise would be required to inform a standardization effort is staggering: sponsors, regulatory agencies, principal investigators (PIs) and sites, apheresis equipment vendors, patient advocacy groups, nonprofit organizations, grassroots organizations, and payors, as well as CDMO personnel and laboratory personnel — just to name a few.

This assemblage of expertise, combined with mapping each patient journey and patient cell journey, will improve development timelines and standard of care. Creating every possible efficiency also serves to keep the price of these products affordable. This industry is too massive, its work too important, for collaborations of this kind not to occur. In fact, many such projects are already underway. What’s missing is an initiative to formalize this coordination and apply it toward guidelines and standardization.