Working Together to Accelerate Regulatory Submissions
“How can we submit sooner?” It’s long been the most common question a regulatory submissions team hears. Executive leaders have ambitious goals in mind for…
A start-up biotechnology research company had made significant headway in the development of a drug to improve quality and length of life for patients with terminal cancer. An established, leading pharmaceutical company recognized the tremendous potential of the drug and was interested in forming an alliance with the biotechnology company to deliver it to market. Both companies understood that it would take significant resources and time to complete drug development and failure to launch the drug would likely jeopardize the viability of the biotech and impact the pharmaceutical company’s goal of increased presence in the oncology market. Although the vision and initial alliance team had been formed, the complexity and high stakes of the product development and commercialization effort demanded expert program leadership. IPM was engaged to manage the alliance team’s efforts through the drug launch.
The Stakes
- Patient quality and length of life
- Millions of dollars invested
- Future viability of the Biotech firm
- Market share for the Pharma company
IPM’s Value
IPM recognized that project success required the coordinated efforts of a very complex project team consisting of nearly 150 executives and employees from both alliance partners and multiple functional areas including marketing, sales, manufacturing and supply chain, regulatory affairs, clinical affairs, IT, and alliance management. The team also included several third-party vendors, spread across multiple geographic locations. With this in mind, the IPM project management consultant established a project structure that enabled optimal collaboration across the entire team. IPM then led development of a comprehensive launch plan that delineated required activities, timing, resource responsibilities, communication processes, and other key program characteristics. Armed with the launch plan, IPM ensured team execution of all required activities and deliverables, monitored progress against committed timelines, and managed project communications.
Results
IPM’s dedicated onsite leadership ensured that all cross-functional activities required to execute the drug launch were conducted in a timely and predictable manner. Because the team was well prepared for product launch, drug promotion began within a week of the FDA’s approval of the New Drug Application and was available to patients shortly thereafter. Both alliance partners have praised the launch as their most successful and cite the process as the model for future drug commercialization programs. The product has since been highly successful for both alliance partners.
Service: Product Development
Industry: Life Sciences