A long, complex and costly process
It takes an average of 10 years or more for a new drug to go from initial research and development to the market, and an average of 6-7 years for clinical trials alone. The average cost of successfully developing a drug is estimated at $2.6 billion.
The complex drug development process from laboratory to market includes the management of several business processes, such as managing the use of quality-by-design approaches, regulatory strategy, clinical research and technology development in the supply chain. These processes are not only influenced by many environmental factors, but also influence each other. As these processes evolve, the inherent uncertainty requires constant changes to plans. Without timely and effective management of the risks associated with uncertainties, the complexity of the situation increases dramatically, and the pharmaceutical R&D industry is subsequently constrained by prohibitive costs.
In the pharmaceutical industry, project management becomes more challenging as uncertainty increases in the scientific research process. Project management in the industry includes:
- Scope management
- Project planning, execution and monitoring
- Schedule and budget planning and management
- Stakeholder management
- Regulatory policy and compliance policy Management
- Environment safety
- Risk Management
- Team management
Challenges are the foundation of these project management aspects. The interdependence of these factors adds to the complexity of project management. Products developed may be effective for the intended use, but production may require hazardous chemicals and ingredients. Any deviation from the safety plan can cause long delays to the project schedule.
While change cannot be avoided, it is reasonable that stakeholders may resist the implementation of the change, internally or externally. Creating a project environment that embraces change is key to managing stakeholders. A "no surprises" approach and open communication are important to prevent wrong information from being passed on.
Each component has its own roles and responsibilities, and interdependence is inevitable. The challenge for the project manager is to preserve this interrelationship so that the project benefits. Besides, project managers in the pharmaceutical industry face the following challenges:
- Resource constraints
- Cross-functional team management
- Institutional process
- Customer management
Under pressure to cut costs, resource constraints became a major issue in project execution. Limited resources and much-needed expertise make implementing work plans and meeting deadlines more difficult. During the product development phase, engaging cross-functional teams can be a challenging task for project managers. Team members often work on multiple projects. Team members skills in prioritizing, recognizing the importance of tasks, and communicating effectively are critical to the productivity of a matrix agency. Lack of communication between team members and between team members and their functional managers can bring chaos to the project.
Businesses are faced with ever-changing customer demands and requirements in terms of regulations, quality and safety, and updating business processes becomes a very tiring task. With outdated processes, project managers often find themselves in extremely challenging situations. Top management supports the establishment of clear business processes, which helps project managers and project teams achieve project goals.
Cultural differences within the management team and the host company and with the client are a frequent challenge for project managers. Account management adds another layer of challenges when managing projects involving cross-company collaboration and contract manufacturing facilities. Ineffective management of client needs can lead to increased scope, increased project budgets, and delays. Establishing customer expectations that align with scope early in the process helps keep customers happy. Project management is the host companys client-oriented face and vice versa. It struggles when client expectations do not match the commitments the host company offers under the agreement. Working with the client on a clear scope definition early in the project is an ideal way to avoid confusion.
In addition to supporting scope management, project planning, execution and monitoring, schedule and budget planning and management, stakeholder management, compliance management, and environmental safety management, 8Manage PM provides the following functions that are particularly important to the pharmaceutical industry:
Critical Success Factor Management:
How to measure the success of a project? Obviously, a project is successful if it is delivered on time and within budget, but projects that do not meet these criteria are not automatically classified as unsuccessful. Learning from suspended projects can create greater opportunities for companies and have a greater impact on the companies’ long-term profitability. The good news is that 8Manage PM supports the two major components of project success, technology and business.
Change and Risk Management:
Project managers focus on project success, but also need the project management softwares portfolio management capabilities to understand where the project sits in the companys portfolio. As the level of uncertainty increases, projects tend to become more complex and require certain resources on an ad hoc basis. It is important to have a plan to manage these situations. Project managers need to use the project portfolio function within the business to work closely with other project managers and learn interdependencies within projects and resource conflicts, and take appropriate measures. They need to monitor and manage the impact of changes on risk. In todays environment, change is the business norm to meet market demands. One of the primary responsibilities of a project manager is to minimize changes especially within the project scope. He or she must accept and utilize changes in other steps for project success. When it comes to successfully managing a project, project managers play an important role in facilitating multiple communication channels.
n projects where information from one functional group can influence the progress of another functional group, cross-functional group communication and collaboration are two of the most important factors in minimizing risk. Active and effective communication should be encouraged at all levels to prevent confusion and unnecessary rework.
Integrating business processes into project execution is unavoidable. In the pharmaceutical industry, business processes are not only affected by changes within an organization, but also by many external factors such as changes in regulatory, quality and safety requirements. Failure to update business processes timely will affect the success of the project. During later stages of product development, changes in regulatory requirements may result in rework or an increase in steps. Likewise, changes to environmental safety requirements may demand additional time and funding in order to take appropriate measures to avoid unnecessary risks. Changes within an organization are often made to increase corporate productivity, production efficiency and cost-effectiveness. The cascading effects of changes can have a large impact on project success. Keeping up with changes and updating business processes accordingly takes time. Transition time and lack of proper communication from top management may create confusion for a project. Open communication and strong support from top management are highly desirable in moving the project forward.