PRA Health Sciences and Vineti., are joining together to solve the operational and logistical challenges associated with autologous, allogeneic, and personalized cancer vaccine therapeutics in clinical trials. This exciting partnership will merge PRA’s unique Logistics Coordinator role and cross-functional clinical trial delivery expertise with Vineti’s Personalized Therapy Management® (PTM) platform, the best-in-class orchestration software solution that provides end-to-end Chain-of-Custody and Chain of Identity tracking.
Vineti provides the first commercial, configurable cloud-based platform to expand patient access to life-saving cell and gene therapies. PRA is a global leader in cell and gene therapy (CGT) clinical trial and product development. Given PRA’s extensive experience, expertise, and global reach, the potential for this partnership is endless when it comes to creating life-saving solutions.
“Leveraging PRA’s expertise together with Vineti’s unique configurable digital platform creates a perfect outsourcing solution that connects all stakeholders, providing consistent, real-time information necessary for sponsors in the autologous, allogeneic, and personalized medicine space,” said Jim Wise, Vice President and Head of PRA’s Center for Immuno-Oncology, Cellular, & Gene Therapy.
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. Vineti is a leader in the cell and gene therapies supply chain orchestration, operations, and data management with their flagship PTM® enterprise software system. Vineti also recently launched its new PTM Essentials™ solution, a streamlined version tailored specifically for clinical trials. Regulators expect a high degree of documentation demonstrating that sponsors have achieved compliance with Chain of Custody, Chain of Identity, and Chain of Condition for each patient-specific drug product. PTM® solves that challenge.
“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.”
“Clinical trials, especially in early phase development, often start with a Logistics Coordinator that uses highly manual processes and tracking which are not sustainable or scalable,” said Wise. “As development platforms grow, orchestrating communications and maintaining compliance with documentation can prove challenging and inefficient. This partnership will bring proven technology solutions earlier into the development process and set up sponsors for early single-trial benefits that also payoff later as more studies and assets are added.”
The partnership agreement between PRA and Vineti will take much of the planning and integration development time off of the critical path for study execution. This means that sponsors doing CGT studies can be ready to hit the ground running, which is critical for the development of these ground-breaking therapies and accelerated approval timelines often seen in this space.
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 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 Personalized Therapy Management® platform (PTM) aligns and orchestrates the cell and gene therapy process and improves product performance overall. The Vineti platform supports the full continuum of patient-specific therapies, including cancer vaccines and autologous and allogeneic cell therapies. The platform can also be harnessed for drug products requiring companion diagnostics or REMS programs. 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 offices in Bethesda, Maryland and Yerevan, Armenia. Biopharmaceutical developers, potential technology partners, patients, and clinicians can learn more about the Vineti PTM platform at www.vineti.com.Want to learn more about the PRA-Vineti solution?