DURHAM, N.C., May 6, 2019 /PRNewswire/ -- Leading personalized medicine consulting firm Clarkston Consulting today announced the launch of Cell Therapy Orchestration Platform (CTOP), a proprietary, all-in-one platform for managing the complex requirements to produce and distribute gene and cell therapy treatments. The solution is built on the advanced enterprise resource planning SAP S/4HANA® software.
With recognized functional leadership and nearly 30 years of experience partnering with life sciences companies to address the industry's most pressing challenges, Clarkston has created the platform with a mindset of transformation – enabling organizations to supplement their current operational model with one supporting cell and gene therapies. For precommercial companies, Clarkston's Cell Therapy Orchestration Platform serves as a roadmap to commercialization, providing guidance to the critical components to operationalize and commercialize treatments successfully.
Leveraging S/4HANA as the digital core, CTOP allows gene and cell therapy companies secure, efficient, and seamless management of the end-to-end processes supporting the advanced treatments. For many organizations, the industry's move to personalized therapeutic models represents a unique challenge.
"Supporting the operational needs of cell and gene therapy does not fit into the current architectures of life sciences organizations. Real-time access to information and the changing variables of patients and manufacturing in a single platform are critical to realizing full operational capacities," said Clarkston Life Sciences Industry Lead Janel Firestein.
With stringent chain of custody, chain of identity, and visibility controls underpinning the platform, manufacturers maintain full supervision through the production and administration cycles. The system facilitates visibility and synchronization for internal stakeholders, including supply chain, manufacturing, quality, regulatory, IT, and commercial teams.
"The supply chains for cell and gene therapies require precise timing and traceability across many parties to provide the life-saving treatments the therapies enable. Clarkston's Cell Therapy Orchestration Platform has the tools and integration needed to provide visibility and assurance that each patient receives the treatment they need," said Chris Striffler, Supply Chain Lead at Clarkston.
CTOP also serves as a point of coordination and integration for the entire external ecosystem of partners in the personalized medicine value chain, including apheresis centers and/or clinics, providers, caregivers, patients, and more.
"The highly personalized nature of autologous therapies requires visibility and collaboration with external parties well outside the traditional norm. The coordination with clinics, patients, apheresis centers, and logistics providers starts from on-boarding and pre-screening all the way through dose administration and beyond. To successfully scale, manufacturers must facilitate this coordination with easy, secure, accurate, and seamless interactions throughout the lifecycle," notes Traigh Groover, cell therapy expert and Partner with Clarkston.
SOURCE Clarkston Consulting