Dendreon Taps Oracle to Boost eClinical Trial Capabilities

Seattle-based biotech company Dendreon partnered with Oracle to help it manage the manufacture and distribution of patient-specific cancer treatments in its clinical trials, document regulatory compliance and ensure the security of patient edata, a company executive told PIR last week. Dendreon develops therapeutics that harness the immune system to fight cancer.

After a three-month search that included a look at five vendors, Oracle won in part because its solution was workable out-of-the-box with very little customization, Dendreon Vice President of IT Linda Staley said.

The Oracle E-business Suite, including Order Management, Process Manufacturing and Advanced Supply Chain Planning, will help Dendreon streamline logistics and manufacturing processes and ensure that its active immunotherapy product candidate, Provenge (sipuleucel-T), is processed efficiently and cost-effectively, Oracle said in an Aug. 7 release.

Provenge is a first-in-class product currently under investigation. Dendreon plans to submit an application to the FDA later this year to obtain approval to market Provenge.

Part 11 Compliance Help

Leveraging Oracle’s technology will help Dendreon with 21 CFR Part 11 compliance and “promoting a chain of identity” for its products, Staley said. The company was driven equally by regulatory and business case issues when it sought the new technology, she added. “Regulatory compliance plays a big part” in their thinking, she said.

Staley stressed that it is important that Dendreon know exactly where each patient-specific treatment is in the supply chain at any given time to ensure quality and prompt delivery. The Oracle E-Business Suite enables such visibility, she added.

Down the line, Dendreon plans to leverage the Oracle technology for esignatures and barcodes, Staley said. “Being able to track electronically the receipt and shipment of a batch” is critical to the company, she added. “It is important to have that visibility.”

The Oracle system has the ability to document the entire procurement, manufacturing and distribution process, providing important edata required for compliance with FDA regulations, including Part 11. It will help Dendreon secure patient privacy and enable creation of a secure chain from order placement through manufacturing to patient billing.

“In planning our commercial strategy, we recognized the need to automate to meet our expanding business and regulatory requirements,” Staley added.

Dendreon has also implemented Oracle Financials and Oracle iProcurement to create an integrated and secure financial management system that enables real-time visibility of critical business data and automated purchasing processes.