Pharmaceutical

 

Driving a product to the market safely, quickly, and cheaply is the best way for a pharmaceutical (pharma) firm to be successful. Pharmaceutical companies encounter enormous challenges during the long product-development process. Today's fast-paced competition requires efficiency in all aspects of business. The identification of risks at the right stage and an effective mitigation plan are key factors for success, both financially and technically. The complex drug-development process from lab to launch includes management of several business processes, such as technical development using quality by design, regulatory strategy, clinical studies, and supply chain. These processes are affected not only by many circumstantial factors but also by each other. The inherent uncertainties during the evolution of any of these processes require constant change in plans. If the risks associated with the uncertainties are not managed in a timely and effective manner, the complexity of the situation increases dramatically and it subsequently becomes cost prohibitive for the developing industries to move forward.

 

The pharmaceutical industry also has its own obstacles to profitability. Higher “first to market” competition in developing generic drugs, more stringent regulatory requirements, and increasing research and development (R&D) costs for innovative new drugs force the industry to restructure the strategies to reduce the internal costs. In general, it takes 10 to 15 years and researching approximately 10,000 molecules to launch one new product to the market. The activities during this period need coordination between many internal functional groups, such as R&D, regulatory, legal, finance, supply chain, sales, and marketing, as well as external partners. The efficiency in coordination between different functional groups is crucial.

 

The regulatory policies and compliance in developing a new drug are changing and becoming tighter, impacting product development, manufacturing, and registration strategies. The wait time to obtain authorization for a product launch has increased, affecting the economics of drug development. The pharma industry is under pressure to accelerate the drug-development stage to compensate for the longer wait for regulatory approval. With access to many innovative ideas, companies often try to develop many products in parallel. In this case, management often encounters hurdles in focusing on any single product. As the pharma industry learns the importance of focusing on a single product while developing multiple products in parallel, the use of project management strategies is becoming more and more popular.

 

Inherent risks in every stage of the science of developing a new product need to be managed effectively. The integration of risk management into product development is the key to reducing time and cost. As the level of information increases with multiple possible scenarios during the life cycle of product development, the decision-making process becomes more complex. In other industries, project management takes greater responsibility in managing risks and implementing the risk-mitigation plan. The pharma industry began taking advantage of this approach in the last two decades. The concepts of project management and best practices in project management continue to evolve in the pharma industry.

In the pharma industry, with added uncertainties from the process of scientific research, project management becomes more challenging. A pharmaceuticals project manager is in charge of overseeing new products and/or new iterations of existing products within their company. They manage a project from conception to completion, assembling teams, assigning tasks and determining target completion dates for the project's different stages. Project management in the pharmaceutical industry involves:

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• Scope management

• Project planning, execution, and monitoring

• Timeline and budget planning and management

• Stakeholder management

• Management of regulatory and compliance strategies

• Environmental safety

• Risk management

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