MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)(TOKYO:4592), a scientific leader in regenerative medicine for neurological disorders, today announced the appointment of Bijan Nejadnik, M.D., as its new Chief Medical Officer in charge of development and regulatory affairs.
Dr. Nejadnik has held many important positions, including key roles at Johnson & Johnson Services, Inc., a major pharmaceutical company, as well as pioneering clinical programs in the pharmaceutical and biotech industry, such as Jazz Pharmaceuticals, Inc., Galena Biopharma, Inc., and Eureka Therapeutics, Inc. At Johnson & Johnson, he was involved in the development of immunological and oncology therapeutics, including the development of infliximab (trade name: Remicade) used for the treatment of rheumatic and other autoimmune disorders. At Jazz Pharmaceuticals, he submitted Biologics License Applications (BLA) for multiple oncology therapeutics and obtained approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As Chief Medical Officer at Galena Biopharma, he led the research of immunotherapy for multiple cancers and research in adoptive T-cell therapy in combination with checkpoint inhibitor drugs. As Chief Medical Officer at Eureka Therapeutics, he was involved in the development of genetically modified T-cells and obtained FDA approval for several IND and launched the clinical trials. Dr. Nejadnik thus is a leading figure in clinical development, with diverse experience.
In Japan, using the conditional and term-limited authorization system for regenerative medicine products under the Revised Pharmaceutical Affairs Act, the SanBio Group is currently working toward applying for manufacturing and marketing approval of SB623 for the treatment of chronic motor deficit resulting from traumatic brain injury (TBI) during the fiscal year ending January 31, 2020 (February 1, 2019–January 31, 2020). Further, it plans to initiate a Phase 3 clinical trial of SB623 for the same indication by the end of the fiscal year ending January 31, 2020. Dr. Nejadnik will work on leading these clinical developments for obtaining approval, and in the long term, will work to promote global expansion of the Group.
Damien Bates, M.D., PhD, FRACS, MBA, who until today has served as the Group’s Chief Medical Officer and Head of Research, will continue to contribute to the global development of the regenerative cell medicine SB623 as the Group’s senior advisor.
Accepting the position of Chief Medical Officer, Dr. Nejadnik commented, “I have been involved in the development of many new pharmaceutical drugs with a view to meeting unmet medical needs that lack effective treatment. SanBio is a pioneer in drug development for patients suffering central nervous system disorders. I understand that the development of SB623 has already come close to the stage of product launch in Japan; taking advantage of my past experiences, I will do my best to bring SB623 to patients worldwide as soon as possible.”
“I am very pleased to welcome Dr. Bijan Nejadnik as SanBio’s new Chief Medical Officer,” said Keita Mori, CEO of SanBio, Co., Ltd. “In Japan, the development program for SB623 as a treatment for chronic motor deficit resulting from TBI has already advanced to a stage that we are preparing for obtaining the approval for launch under the conditional and term-limited authorization system for regenerative medicine products. Going forward, we aim to bring the product to the global market. We expect that Dr. Nejadnik will receive the baton from Dr. Damien Bates and, by drawing on his extensive experience, will make further contributions to the clinical development and submission process towards the approval of SB623.”
About SanBio, Inc. (SanBio)
SanBio is a regenerative medicine company headquartered in Tokyo and Mountain View, California, with cell-based products in various stages of research, development and clinical trials. Its proprietary cell-based investigational product, SB623, is currently in a Phase 2b clinical trial for treatment of chronic motor deficit resulting from ischemic stroke, and in a Phase 2 clinical trial for treatment of chronic motor deficit resulting from traumatic brain injury. More information about SanBio, Inc. is available at http://sanbio.com.