COVINGTON, Ky. — Cincinnati Children’s Hospital Medical Center and the research service provider CTI Clinical Trial & Consulting Services in Covington have agreed to form a company that will focus on providing cell and gene therapy manufacturing services to the biotechnology and pharmaceutical industries.
“Medicine is rapidly evolving toward cell- and gene-based therapies,” said Dr. Steve Davis, president and CEO of Cincinnati Children’s. “By melding the scientific expertise of Cincinnati Children’s with the operational expertise of CTI, this joint venture will ensure that our community, region and the world have ready access to the most innovative and effective therapies.”
Tim Schroeder, CEO and chairman of CTI, said: “We anticipate advances in cell and gene therapies to bring about medical breakthroughs with the potential to not only treat, but actually cure some rare and complex diseases – including some forms of cancer.”
The joint venture will enable Cincinnati Children’s to expand on the work of its existing Translational Core Laboratory, which manufactures and tests services for cell and gene therapy clinical trials, said Hector Wong, MD, vice chair of the Department of Pediatrics at the medical center.
There is a global shortage of manufacturing capacity, which has begun to impede development of new cell and gene therapies. The industry has less than 1% of the capacity needed to support a growing volume of clinical programs, according to CTI. Fifteen cell and gene therapy products have been approved by global regulatory agencies, and the Alliance for Regenerative Medicine estimates 10 to 20 additional approvals per year by 2025.
“CTI and Cincinnati Children’s have been engaging in conversations for some time about ways to further these developments and bring new treatments to the children and adult patients looking for hope,” Schroeder said. “This joint venture is a natural evolution of our pre-existing relationship involving clinical trials, maximizing the expertise and resources of both organizations to collaborate, innovate, and facilitate scientific developments with the potential to save lives.”
The approximately $100 million investment in the joint venture will include a new clinical laboratory, which is expected to encompass 40,000 s.f. and house three dozen sterile clean rooms. The facility will have the potential to support the research of more than 30 clinical trial sponsors at a time. The specific location has yet to be determined, but the facility will be in the Cincinnati/Northern Kentucky region. The opening date is expected to be 2023.
“The joint venture will ensure that Cincinnati Children’s faculty and researchers have access to a state-of-the-art, multimodal cell and gene therapy manufacturing laboratory, which is expected to help retain and draw the best talent in the world to the medical center,” Wong said. “The facility will enhance Cincinnati Children’s ability to participate in early phase cell and gene therapy research and clinical trials, leading to improved treatments and, hopefully, cures.”
About 150 jobs are to be created by the joint venture, and the new company will build on the region’s growing status as a research hub.
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI is currently part of more than 30 active COVID-19 projects for treatment and prevention. It also offers a fully integrated multi-specialty clinical research site, as well as complete global laboratory services. Now in its third decade, it is one of the 20 largest CROs in the world with associates in more than 60 countries across six continents.
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