Evolution of the New Model

Like other drugmakers, Amgen is seeking new markets by clinical and commercial expansion into countries where it currently has no presence. Accordingly, Amgen is using a combination of virtual operating models and strategic partnerships to launch products without increasing its bricks-and-mortar infrastructure. The main driver is not costs (although cost savings are realized) but control of operations, good governance, and patient safety. Because this is a regulated industry, what occurs in clinical trials overseas can have an impact on regulatory filings in the US and in other parts of the world. Poor data quality impacts overall results, thus delaying product approval and access of medicine to patients in need.

Implementing a global functional outsourcing model presented the company with unique challenges. In addition, Amgen's particular model had to be installed in three months to support a wave of major Phase III studies starting up across Latin America, Southeast Asia, and Central Europe, as Amgen was seeking to increase access to patients worldwide who would benefit from its novel therapies.

Hub-and-Spoke Structure

Amgen put this model into practice without overwhelming investment in human capital. A new role—Regulatory/Safety Liaison—was created at each hub, but most other positions were filled by existing staff, with expanded job descriptions. Amgen hired several new staff members, but this incremental cost was relatively minimal and quickly offset by the advantages of the new hub-and-spoke model.

The primary responsibility of the Regulatory/Safety Liaison is to manage the FSP staff and act as the conduit to relevant functions at Amgen. Leading a virtual team requires a combination of skills—strong technical grounding, effective project management, and clear communication. The manager is accountable for all regulatory/safety activities through FSPs in spoke countries, including ensuring the timeliness and quality of regulatory and safety deliverables in accordance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, and local regulations.

After selecting the best partner for each function in each region, Amgen established service agreements to fully document the working relationship and agree on performance metrics regarding safety reporting compliance, clinical trial agreement (CTA) submission and approval cycle time, and passing local validation. The agreements also included parameters for effective communication, escalation, risk management, and budget controls.