The Emory Personalized Immunotherapy Center Core (EPIC CPC) is located within the premises of Emory University Hospital Blood Bank. We have refurbished a clinical-grade, fully equipped, high sterility isolation facility. It is designed as an enabling infrastructure to support early phase clinical trials of cell-based therapies where processing of human cell and tissue is required as part of a FDA-sponsored biopharmaceutical study. The facility is to be manned by a team of highly qualified personnel dedicated to the successful implementation and prosecution of personalized cellular medicine clinical trials. The purpose of this designated Core facility is to directly support investigator-driven Phase I cell therapy clinical trials at Emory with an emphasis on novel therapies considered to be first-in-human, first-in-Georgia and first-in-child. As a Core facility, EPIC provides a unique resource to the Emory community in assisting the translation of cellular therapies from the bench side to the clinic. The facility possesses all the necessary infrastructure to manufacture cellular therapies under FDA approved good manufacturing practices (FDA cGMP Phase I guidance July 2008) and can supply investigators with cellular material and specialized growth medias to foster the clinical development of novel personalized therapies. This facility was designed to be nimble and adaptable and should be able to support the manufacturing needs of most small enabling cell therapy clinical trials. The highly qualified (HQ) personnel employed to operate EPIC can als act as resources to assist clinicians and researchers in developing robust translational data to support applications to Emory IRB and INDs to FDA. In addition, these HQ persons will provide scientific input on trial design, regulatory oversight and assist in product development issues related to scale up, release criteria, potency and sterility testing.
EPIC Mission Statement:
We wish to render accessible to the patient community cutting edge, innovative cellular pharmaceuticals and biotherapies for treatment of human catastrophic illnesses. The clinical translation mandate is inclusive and we will promote development of technologies from Institutional scientists as well as partnership development of technologies from sister biomedical institutions, academic networks, biotechnology firms and pharmaceutical industry.
EPIC Programmatic Objectives:
We are engaging in impactful first-in-human studies. The program is translational in principle and motivation. This entails that a critically important deliverable is to engage in meaningful, impactful, innovative first-in-human clinical trials testing scientifically exciting ideas and technologies developed at Emory. Through our efforts at team building, we have been able to identify and assemble Emory working groups seeking to develop the platforms of cell and biological immunotherapy. These core teams serve as the basis of a developing EPIC program and would allow for future integration of emerging technologies and platforms arising from the scholarly activities of basic science Departments at Emory and beyond. The use of cell technologies for cancer therapy will be developed including the use of fusokines, Dendritic Cells and B-cells for suppression of Graft versus Host Disease complicated allogeneic marrow transplantation, and the use of personalized dendritic cells for cancer immunotherapy. Other clinical applications include the use of personalized cell therapy for life-threatening AUTOIMMUNE DISASE such as Crohn’s disease and Multiple Sclerosis as well as chronic infectious diseases such as HIV, hepatitis C and drug resistant Tuberculosis.