Empire State Drug Development

Rising high above the pavement on 34^th Street and 5^th 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.

Eighty years later, the Empire State Building is no longer the tallest building in the world, but it does remain a crowning achievement in architecture, an amazing accomplishment in the field of commercial construction, and a lasting lesson in project management. Indeed, it is a testament to successful project management, which requires disciplined planning and organization, and the ability to secure and manage resources to achieve specific goals. Contracted companies must be dependable, provide quality work, and adhere to a down-to-the-minute timetable. Effective logistics must be combined with a skilled, organized workforce.

Image courtesy of Vetter Pharma International GmbH

RISKY BUSINESS

Constructing 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.

COMMUNICATE THE BLUEPRINT

After creating the foundations of the project, communicating the blueprint effectively can avoid crises during later phases. For the contractors of the Empire State Building, enabling clear and consistent communication among 3400 workers across 60 different trades may have seemed almost impossible at first. But failure to do so would have resulted in catastrophe, if the building had exceeded its timeline and budget. Regular status checks, meetings, and reminders helped create a tangible picture of the finished deliverable for everyone, so that all effort focused in the same direction: up. Drug development projects should be no different.

A skilled project manager has to coordinate communications and is responsible for ensuring that every step of the work plan is thoroughly documented and accessible to team members. Clear channels of communication help prevent misinformation from developing and spreading, reduce risk, and promote collaborative team relationships. Regular and orchestrated conference calls and team meetings, which are then well-documented and shared, help ensure project transparency and the free flow of accurate information.

DECISIONS BIG AND SMALL

Biopharmaceutical companies of any size must define a clear decision-making process for the development project to run smoothly. Smaller firms are generally more nimble than larger organizations, but regardless of how fast or slow the process is, a common understanding of who has decision-making authority and what the turnaround times are prevents frustration. Such clear lines of authority become especially important when problems arise; quick decision-making reduces delays that can eat into precious funding.

BUILDING OUT THE PROJECT

Just as poorly constructed buildings are more likely to topple, drug products have no room for error. Project managers, whether internal or CDMO based, should have the authority to acquire and coordinate resources, request and receive cooperation from team members, and make informed decisions. The project manager must be responsible for anticipating needs, overseeing costs, identifying and addressing issues that emerge, and realizing that the project is progressing as planned.

The project manager should not just be a taskmaster; he or she should also be the chief motivator—keeping people energized and positive, especially when the pressure is on and people's nerves start to fray. A project manager who can create a trusting and collaborative environment is a major asset to the project.

CONSTRUCTING A LONG-TERM PARTNERSHIP

Many smaller biotech companies produce innovative science but may have limited experience with technical and regulatory issues. These organizations may wish to partner with a CDMO throughout the development process, starting at the preclinical stage or Phase I.

Early-stage products often hit unexpected roadblocks so biotech companies should be prepared to respond quickly by analyzing the problem, developing a solution, and then swiftly updating project specifications—all while staying within timeline and budget. The depth of experience, capacity for innovation, and flexibility of an experienced CDMO can lend vital support.

STAYING ON TIME AND IN BUDGET

Smaller biotech companies typically lack the financial resources of larger companies, so the selection of the right CDMO can make the difference between the success or failure of not only the project underway but also the company itself. A high-quality CDMO can contribute critical consulting and production support to help manage the difficult procedures and decision-making inherent in early-phase development to keep the project on target. With a well-integrated project management team, a small company can maintain its milestone schedule and budget.

CELEBRATE SUCCESS

The Empire State Building is a great example of a successful project. And while biotech project management is not entirely analogous to the creation of an iconic architectural masterpiece, it does share complexity and the need for highly skilled individuals.

A well-integrated project management plan and rigorous execution can provide a blueprint for current and future projects. The following steps are essential for success:

• Develop a plan tailored to the size and scope of each project, taking into account its unique challenges and the strengths and limitations of your team.

• Create well-defined decision-making processes—and use them.

• Consistently evaluate project progress and keep the team focused on objectives and goals.

• Take a hands-on approach throughout the project to support the team in meeting its daily schedule.

• Maintain clear channels of communication and documentation to maintain transparency, keep everyone on the same page, and engender trust.

• Anticipate and respond quickly to emerging problems and changing circumstances.

The Empire State Building celebrated its symbolic opening on March 1, 1931, when then-President Herbert Hoover pulled a switch from his office in Washington, DC, to illuminate the building for the first time. That date in history will always remain the day the most iconic building of New York was completed. Where the right plan and the right team move forward, success and celebration will follow.

PETER SOELKNER is managing director at Vetter Pharma International Gmbh, tel. +49 751.3700.3729, press@vetter-pharma.com.