Gene Therapy and Autologous Stem Cell Experience
Encorium has extensive experience in integrating consulting and operational services for the most complex clinical development programs for drugs and biologics including Gene & Stem Cell Therapy
Encorium has experience in the following indications:
- Infectious Disease and Oncology
– HIV (autologous T cells)
– Chronic myelogenous leukemia (autologous T cells)
– Relapsed refractory non-Hodgkin’s lymphoma (autologous T cells)
– Advanced mesothelioma (recombinant adenovirus)
– Advanced CNS malignancy (recombinant adenovirus)
– GeneTherapy: adenovirus containing myobacterium tuberculosis antigen
- Cardiovascular
– SERCA2a gene transfer/therapy in patients with advanced heart failure
– Autologous stem cell transfer in patients with advanced heart failure
- “First-of-its-kind” partnership with the University of Pennsylvania to assist in meeting FDA standards for Good Clinical Practices (GCPs) in Gene Therapy studies.
– Assistance in generation of institutional GCPs and Good Manufacturing Practices (GMPs)
– Clinical monitoring of research studies
– Quality assurance and auditing
– Development of internal review procedures and SOPs to ensure compliance with federal standards
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