OncoBay Clinical Partners with Vineti to transform access to CTx logistics
OncoBay Clinical and Vineti form strategic alliance to deliver integrated clinical trial solutions and supply chain automation for cell and gene therapies
Integrated Custom-Curated IO Clinical Trial Services and Personalized Therapy Management systems to seamlessly manage advanced therapy clinical journeys for cancer patients
TAMPA, Florida and SAN FRANCISCO, Calif. and – August 25, 2020 – OncoBay Clinical, Inc., a full-service boutique contract research organization (CRO) specializing in complex oncology programs including cellular therapy, and Vineti, a company that offers a digital platform to enable broad access to advanced therapeutics, today announced a fully integrated solution to provide advanced therapy developers with a complete suite of clinical trial systems and services.
Today, many processes and workflows for cell and gene therapy clinical trials are managed using manual processes that can hamper scale, speed, and patient safety. The OncoBay Clinical-Vineti collaboration will provide an innovative alternative truly connecting clinical operations and manufacturing.
Together, OncoBay Clinical and Vineti will implement end-to-end solutions that simplify and accelerate the clinical trial logistics process and oversight for cell therapies, gene therapies, and personalized cancer vaccines. Advanced therapy operations and supply chains are among medicine’s most complex, with operational needs and regulatory requirements that can be demanding for early-phase therapy manufacturers. OncoBay Clinical and Vineti will focus on integrated solutions that support and drive advanced therapy clinical trial operations and enable advanced therapy developers to focus on their science.
OncoBay Clinical, a wholly owned subsidiary of H. Lee Moffitt Cancer Center, leverages scientific expertise and experience when implementing oncology clinical trials, including immuno-oncology research initiatives. OncoBay Clinical’s CRO offerings provide an advanced technology infrastructure, a highly trained clinical site network, and the vast expertise of staff that integrates one of the nation’s leading cancer treatment centers to provide an innovative approach to cell and gene therapy clinical trials, which often focus on cancer. According to the Alliance for Regenerative Medicine, more than half of all advanced therapy clinical trials address oncology.
“As a CRO specializing in complex oncology programs including cellular therapies, Oncobay Clinical specializes in operational excellence and most importantly, helping our sponsors to simplify the complex as they navigate the many operational steps involved with biospecimen chain of custody”, said Krystyna Kowalczyk, President and CEO of Oncobay. “As a wholly owned subsidiary of Moffitt Cancer Center, we understand the challenges our sites are faced with and together, with Vineti, can provide the platform and operational support necessary to ensure a successful trial at a price point that is affordable.”
Personalized therapies, at any clinical phase, require a software system to manage the complex value chain associated with patient-based treatments. Vineti’s software platform will help OncoBay Clinical’s biopharmaceutical sponsors advance their clinical trial by supporting treatment locations and manufacturing sites, cell collection scheduling, logistics orchestration, manufacturing traceability, and overall visibility for each patient’s individual drug product.
“Advanced therapies require advanced software, at every clinical phase, and Vineti is honored to support them,” said Vineti CE0 and Co-founder Amy DuRoss. “We’re very excited to collaborate with OncoBay Clinical to serve their advanced therapy clinical trials and help get breakthrough treatments to cancer patients faster.”
The OncoBay Clinical-Vineti solution is available from both company’s business development teams. The new collaboration follows the news of the growth of the OncoBay Clinical Business Development team, and Vineti’s collaboration with Avobis Bio.
About OncoBay Clinical
OncoBay Clinical is a boutique contract research organization (CRO) specializing in immuno-oncology/cell therapy, offering full- service custom-curated CRO solutions for global pharmaceutical and biotech companies looking to advance their immuno-oncology product or device. As a wholly owned, for-profit subsidiary of Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integrated cell manufacturing capabilities providing true end-to-end control. Built on years of IO and cell therapy expertise, a streamlined technology framework, a highly trained site network, and a dedicated team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter and LinkedIn.
About Vineti Inc.
Vineti is the first commercial, configurable cloud-based platform to expand patient access to life-saving cell and gene therapies. Vineti was co-founded by GE and the Mayo Clinic to solve the key challenges that patients, medical providers, biopharmaceutical companies and regulators face in the delivery and commercialization of individualized therapies. Now a fully independent company, Vineti offers a digital platform of record to integrate logistics, manufacturing and clinical data for personalized therapies. The Vineti platform supports the full continuum of patient-specific therapies, including cancer vaccines and autologous and allogeneic therapies. The company is expanding rapidly, and Vineti’s Personalized Therapy Management (PTM) platform was in use in hundreds of leading medical centers worldwide in 2019, on behalf of multiple biopharmaceutical partners. In 2019, the World Economic Forum selected Vineti as a global Technology Pioneer.