When it comes to launching a new product, even companies with the most meticulously planned schedules can find themselves missing milestones while waiting—and waiting—for approval from a government agency.
That was the challenge for a major pharmaceutical company planning the launch of a new injectable cholesterol drug. The company was already racing the clock against a competitor with a similar product; although the new drug was ready to go, the company had to wait for final signoff by the Food and Drug Administration, which kept shifting its approval date based on the competitor’s approval date. Although the company knew it would not be first to market, it wanted to launch well before additional competitors could enter the fray.
Recognizing the need for help, the company called on Integrated Project Management Company, Inc. (IPM) to provide professional project management leadership and assist in the drug’s access marketing program, set to go live after final FDA approval.
Many Moving Parts
The program was designed to focus on access, reimbursement, and value: helping patients to get and consistently take the drug, negotiating pricing and contracts with distributors, and demonstrating to clinicians and payers that the drug is worth the price. It would involve many moving parts, including a centralized call center, nurse call center, field nurses, pharmacy education, segment marketing, a pricing/rebate plan, and a specialty pharmacy network. The program had an administrative cost of more than $80 million a year.
To coordinate all of these elements, IPM helped to ensure that the team understood the company’s vision of access support, communicated to vendors how support would be set up, and established and implemented a plan with the vendors.
Dealing with the many vendors—for the call center, nurse and copay programs, among others—proved to be one of the program’s biggest challenges. Because the company team needed to focus on other projects, management had empowered IPM to negotiate with vendors on its behalf. Some vendors had overpromised delivery and were missing their own deadlines, further threatening the drug release date. IPM was in charge of holding the vendors to their timelines and tracking the status of the deliverables to ensure all tasks would be completed by the FDA approval date.
Staying on Budget
Another challenge was staying on budget. Initially, the team lacked a solid budget management process to track purchase orders and current available funds, and monitor delivery. IPM helped the team develop processes to address this need, and realized almost immediate improvements.
The engagement required strong leadership and communication skills, especially important since each vendor and work stream was being treated as a separate project.
An essential tool for program’s success was the integrated project schedule showing all different vendors and tasks, deadlines, and how each interacted with the others. The project also required process flow diagrams to help streamline information and improve communication for vendors and other partners who were electronically sharing data.
By the time the FDA finally approved the new product—a month after its original projected date—the access marketing support team was ready to go, and the cholesterol drug was successfully launched.
Since then, the drug has realized $185 million in 2016 sales, with a projected $3 billion in annual sales by 2022.
Ongoing Involvement
But IPM’s involvement didn’t end there. The pharma company was so pleased with the outcome and the launch processes IPM developed that it kept IPM onboard to oversee the drug’s Access Reimbursement Operations (ARO) division, split off from the original team and headed by a new executive director to streamline day-to-day operations. IPM has also been charged with tracking the internal work involved with the upcoming release of clinical study data of the cholesterol drug.
The company recognized the value of project leadership from the launch and its aftermath. The process convinced management that the company needed a dedicated project manager for each product launch. The company continues to rely on IPM to engage stakeholders, meet deadlines, and keep product launches running smoothly.
Service: Product Development
Industry: Life Sciences