Moffitt Cancer Center has formed a contract research organization to accelerate the institution’s immunotherapy research.
The subsidiary, which was announced Oct. 3, is intended to provide a one-stop-shop for pharmaceutical and biotech companies to accelerate their immuno-oncology and cell therapy research through collaborative clinical trial support and administration.
“There are currently no other immunotherapy clinical research organizations in the United States. We can provide a much needed service that will bring new immunotherapies to patients more quickly,” Moffit’s Center Director and Executive Vice President at Moffitt, Thomas Sellers, said in a statement.
Moffitt is seeking investment and partnerships to support the wholly-owned, for-profit subsidiary. The cancer center will appoint a board of directors to oversee operations. The CRO is expected to be fully operational in nine to 12 months.
The cancer center has enrolled more than 3,000 patients in immuno-oncology studies over the past five years. The center was involved in clinical trials that led to the approval of CAR T-cell therapy.
The new CRO will offer services that include preclinical study, manufacturing, clinical trial design and oversight, data management and regulatory assistance. The goal is to take a company’s drug or medical device from initial discovery to clinical testing and FDA approval.
“We have a facility certified in Good Manufacturing Practice, a system for ensuring that products are consistently produced and controlled according to quality standards, that is producing these therapies and will establish a network of partners to facilitate multi-center clinical trials,” Brian Springer, Moffit’s vice president and associate center director of research administration, said in a statement.
