Rising high above the pavement on 34th Street and 5th Avenue in New York City sits one of the greatest skyscrapers ever built. At 1453 feet, the 103-story Empire State Building is not only a magnificent architectural structure, but also a marvel of engineering especially considering that it was built in The Great Depression of the 1930s. The story behind its construction provides a valuable lesson in the power of successful project management. Scheduled to be completed in an unrealistic amount of time—a mere 18 months—it was actually completed almost five months ahead of schedule and came in under budget.
RISKY BUSINESSConstructing the Empire State Building was clearly fraught with risk. In today's high-cost, highly competitive drug development environment, where complex compounds require sophisticated technology and great expertise, small biotech companies find themselves particularly vulnerable to risk during early clinical phases, especially because most compounds fail to proceed to late stage development. Injectable products are often considered the most challenging and expensive drugs to develop, so the project management process is especially vital.
Cost and time pressures can bring small biotech firms to the breaking point; having a skilled project management team in place as early as possible is crucial for survival. Clear and efficient processes, effective paths of communication, and close collaboration with technical experts during the early clinical phases should be given top priority. And in the event of something unexpected, the team must recalibrate the project plan to keep it on track.
A small biotech company that understands the value of an integrated project-management strategy has taken a first big step in reducing a drug's time to clinic, optimizing costs, and increasing its return on investment. On the flip side, without careful project planning, the risks can quickly escalate from losing time and money to outright failure of the project resulting in serious damage to the reputation of the company or, in the worst-case scenario, complete business failure.
A strategy planned in concert with a contract development and manufacturing organization (CDMO) is often the key to properly allocating resources, creating a top-notch project management team, satisfying regulatory authorities, and advancing the compound to later-phase development.
BUILD THE FOUNDATION FIRST
The creation of an integrated project management team that will plan and form a development strategy is the strong foundation on which everything else will be built. The team's project manager has a responsibility to keep everyone's attention focused on project deliverables and deadlines and keep the project moving forward. Pulling together a group of individuals who are able and ready to solve problems from the lab to the filling line is key. By acquiring the most skilled, most experienced, and most qualified people, the project manager can often compensate for an overambitious schedule, too little money, or other project constraints.
For smaller companies, a lack of staffing and expertise to accomplish the project target means asking a CDMO to designate a project manager and create the team. The team should possess a variety of skills, including experience in packaging development, process development, quality management, supply-chain management, and regulatory affairs.