Covington, Kentucky–(Newsfile Corp. – October 13, 2021) – CTI Clinical Trial and Consulting Services (CTI), a global, privately held, full-service contract research organization announced plans today to offer contract development and manufacturing services. CTI will launch the new initiative, focusing on offerings that will enhance cell and gene therapy capabilities.
The announcement was made during a special company presentation at the Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa.
CTI has been on the forefront of life-changing medicine for more than 20 years, working on breakthroughs from some of the earliest developments in immunosuppression to recent discoveries in regenerative medicine. As advancements in medicine trend towards personalized medicine and targeted regenerative therapies, demand for manufacturing capacity has increased, creating a manufacturing shortage.
The facility is estimated to be approximately 40,000 square feet and will initially focus on viral vector manufacturing, ideally to support emerging companies who face challenges in manufacturing priority.
“The decision to build out contract development and manufacturing capabilities was two-fold. First, we are always looking to better serve our biotechnology and biopharmaceutical sponsors and help facilitate the most seamless, efficient clinical trial process possible. Providing manufacturing services will help us better meet the needs of our clients working in the cell and gene therapy space,” explains Tim Schroeder, CEO and Chairman of CTI. “Second, and arguably more importantly, we see major challenges that could delay medical advancements and ultimately impact patient lives. If capacity maintains at current levels, manufacturing shortages have the potential to significantly delay future developments in personalized medicine and treatments and cures for disease. Our expertise and resources create a unique position for CTI to make a difference, so we’re moving forward to begin to address the challenge.”
The decision to enter into the manufacturing arena follows the company’s announcements about expanding laboratory services to support rare disease and cell & gene therapy research across all regions of the world, with a flagship lab set to open in Cincinnati, OH (covering the Americas), and with the acquisition of Dynakin Labs, we will have laboratory services to support Europe and the MEA region. Offering manufacturing, regulatory development and strategy, clinical operations, research site, laboratory, and real-world evidence services, CTI is the only global research service provider with a history of success in regenerative medicine spanning decades and the ability to support cell and gene therapy programs throughout the entire clinical development lifecycle. The company’s regenerative medicine experience includes work with more than 1,000 sites, and its current operations can support cell and gene therapy programs in any location across the globe.
“We believe cures for debilitating diseases and prevention of catastrophic illnesses are possible with advances in fields such as regenerative medicine and personalized curative therapies,” adds Lynn Fallon, President and Vice-Chair of CTI. “We are privileged to be in a leadership role for these exciting and life-changing projects, and we’re looking forward to seeing how our team’s and our partners’ work will change the medical landscape.”
CTI, now in its third decade, is one of the 20 largest CROs in the world with associates in more than 60 countries across six continents. The company was recently named the #1 CRO in the world for operational excellence at the 2021 CRO Leadership Awards, outperforming dozens of other recognized CROs from around the world. More information about CTI’s work in COVID-19 and other complex disease areas can be found at www.ctifacts.com.
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. CTI 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. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, MEA and Asia-Pacific. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations and for moving medicine forward. For more information visit www.ctifacts.com.
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