Life Cycle Management - Kendall Life Sciences LLC
Specialized Business & Compliance Consulting Group

Life Cycle Management
 

Prescription Drug Evolution

How our team can guide you through the entire journey

Life Cycle Management

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The management of a drug’s life cycle begins with the identification of an appropriate chemical or biologic molecule or compound in the Pre-IND phase. A successful life cycle management plan prepares for challenges throughout the drug’s life cycle. However, NDA holders face many key decisions as the prescription drug product nears the end of its life cycle and is facing patent expiration and requires strong management plans for success. The goal of successful end of life management is either to extend the drug’s patent exclusivity and preserve the revenue generated by the prescription drug product, or to decrease the pace of revenue loss following patent expiration.

The Challenge

NDA holders must adopt effective life cycle management plans in order to successfully manage its prescription drug product at the end of the product’s life cycle. These life cycle management plans not only must understand the strengths and weaknesses of the prescription drug product as it nears patent expiration but also must take into consideration external factors. As the demand for more affordable healthcare continues, NDA holders must consider strategies that contemplate both the goal of successful end of life cycle management and external pressures for alternative cost-effective products.

The Strategy

KLS is well versed in the potential actions NDA holders may take to plan for patent expiration and the end of a drug’s life cycle. KLS’ experts will work with your team to develop the right life cycle management plan for your product that accounts for end of life cycle management goals and potential external pressures for alternative cost-effective products that may arise.

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Commercial Operations

This department manages some of the industry’s most high-risk areas. Our team understands that commercial initiatives are often critical for success, but the monitoring and oversight process can be difficult in practice.
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Sales & Marketing

Life sciences sales and marketing departments face a number of challenges not present in other industries. Developing effective yet risk appropriate sales and marketing strategies in the life sciences industry is often a long and difficult process.
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Regulatory & Compliance

Life sciences companies face compliance and regulatory requirements and restrictions unique to their industry.
Often times a long-term vision of the compliance/regulatory landscape is necessary to ensure that commercialization strategies
are fully achieved.
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– Partners for Success

Our team takes the time to understand each client’s unique business objectives, operations and long-term vision to successfully solve problems, avoid risk and accomplish tasks correctly the first time.