TAMPA, Fla. – Moffitt Cancer Center announced today the launch of a first-of-its-kind contract research organization (CRO) focused on accelerating immunotherapy research. The subsidiary will 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.
Immunotherapy is an emerging area in oncology, specifically cell therapies like chimeric antigen receptor T cell (CAR T) therapy. In 2017, the American Society of Clinical Oncology named CAR T-cell therapy the advance of the year. Eighty percent of lymphoma and leukemia patients who have received CAR T therapy have benefitted from the therapy, and more than half remain in remission. Moffitt was involved in the clinical trials that led to the approval of CAR T therapy and continues to be a leader in cell therapy clinical development and delivery.
The cancer center has enrolled more than 3,000 patients in immuno-oncology studies over the last five years.
“Moffitt saw a unique opportunity; one that furthers our mission to contribute to the prevention and cure of cancer. 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,” said Thomas Sellers, Ph.D., MPH, center director and executive vice president at Moffitt.
The CRO will offer end-to-end services for pharmaceutical and biotech companies. This will include preclinical study, manufacturing, clinical trial design and oversight, as well as data management and regulatory assistance. The goal is to take a company’s drug or medical device from initial discovery to clinical testing and Food and Drug Administration approval.
“This CRO will be the premier partner for advancing immunotherapy-based clinical trials in the country. 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,” said Brian Springer, MHA, vice president and associate center director of research administration at Moffitt.
Moffitt is seeking investment and partnerships to support the wholly-owned, for-profit subsidiary. The cancer center also will be appointing a Board of Directors to oversee operations. The CRO is expected to be fully operational in 9 to 12 months.
About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 51 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999. Moffitt devotes more than 2 million square feet to research and patient care. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 6,500 team members, Moffitt has an economic impact in the state of $2.5 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter and YouTube.