June 15, 2021
PRA Health Sciences Announces Partnership with Vineti
RALEIGH, NC and SAN FRANCISCO, CA, June 15, 2021 — PRA Health Sciences and Vineti, Inc., today announced a new strategic relationship to support the operational challenges associated with autologous, allogeneic, and personalized therapeutics in cell and gene therapy (CGT) clinical trials. PRA’s global reach, along with Vineti’s leading software platform, which supports small and larger multi-country studies, will provide a joint solution that includes efficiency and scalability to CGT clinical trial and product development. PRA’s unique Logistics Coordinator role and cross-functional clinical trial delivery expertise, combined with Vineti’s best-in-class workflow orchestration software known as a Personalized Therapy Management® (PTM) workflow orchestration platform, will provide end-to-end Chain-of-Custody/Identity tracking, manufacturing slot management, and patient scheduling capabilities. Vineti, a leader in commercial CGT orchestration with their flagship software solution, recently launched PTM Essentials™ , a streamlined enterprise software system tailored specifically for clinical trials.
“This partnership will leverage technology earlier into the development process than just peri-commercialization, allowing us to prepare sponsors for early single-trial benefits that will continue to pay off as studies are added,” Jim Wise, Vice President and Head of PRA’s Center for Immuno-Oncology, Cellular, & Gene Therapy, said.
PRA also has a globally established CGT courier vendor that provides delivery of specialized therapies to more than 50 countries from controlled rooms to cryogenic temperatures. The platform will be integrated with Vineti’s, as well as the shipping systems provided by major container suppliers. The courier provides world customs brokerage that can quickly move mission-critical shipments through the import process while maintaining high standards of compliance and assurance of supply.
“We know how many more patients can benefit from cell and gene therapy clinical studies, and this partnership will help these transformative therapeutics reach patients both quickly and safely,” said Vineti CEO and Co-founder Amy DuRoss. “We’re very excited and honored to collaborate with the team of true experts at PRA to provide clinical trials with operational approaches as advanced as the therapies themselves.”
Careful planning and integration development will allow the two companies to come to the stakeholder table ready to hit the ground running with sponsors —a critical step for the development of these ground-breaking therapies and accelerated approval timelines. This partnership will bring together expertise, technology solutions, and personalized therapies to make logistics management solutions accessible to more clinical trials, driving quality and efficiency.
About PRA Health Sciences
PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East and more than 19,000 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs.
Vineti offers 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, supply chain management, manufacturing, and clinical data for personalized therapies. The Vineti Personalized Therapy Management® (PTM) platform aligns and orchestrates the advanced therapy process and improves product performance overall, supporting the full continuum of patient-specific therapies, including personalized cancer vaccines and autologous and allogeneic cell and gene therapies. Vineti is currently serving patients, healthcare providers, and researchers in hundreds of leading medical centers and manufacturing centers world-wide on behalf of a growing number of biopharmaceutical partners. In 2019, the World Economic Forum honored Vineti as a World Economic Forum Technology Pioneer. Vineti is headquartered in San Francisco, California, with teams based in the Washington, D.C. area and Yerevan, Armenia. For more information, please visit vineti.com.
PRA Health Sciences
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