“Given the challenges to consistently innovate in drug research and the clinical risks associated with drug development, it’s imperative for biopharma companies to maximize the value of every product by institutionalizing an effective life cycle management approach”, said Nick DeSanctis, Executive Partner at RxC International, a life sciences management consulting firm in New Jersey.
Understanding the critical success factors of Life Cycle Management (LCM) planning helps pharmaceutical companies avoid common life cycle pitfalls that can lead to sub-optimal life cycle plans or ineffective implementations. Companies that don’t optimize the life cycle management process and develop innovative strategies to meet the demands of today’s pharmaceutical landscape generally experience lower returns than their more proactive counterparts.
This post is the first in a series that distills RxC International’s robust experience in LCM strategy into best practices. Please subscribe at our LCM Resource Center to receive future posts.
Companies must implement effective Life Cycle Management (LCM) strategies to build more value into products while they are still in development. LCM includes identifying and prioritizing multiple potential indications and formulations while strategically planning their development and launch timing and sequence. Competitive companies must also direct sufficient resources to a strong LCM process for their pipeline and marketed products.
Implementing an effective LCM process is critical to:
- Meeting burgeoning R&D expenses
- Off-setting impact of generic erosion on key brands
- Combating encroaching competition
- Maximizing product value from launch to loss of exclusivity
Winning in Life Cycle Management: Having the Right Team
Developing innovative life cycle plans and ensuring their technical success requires a cross-functional approach across clinical, commercial, medical, manufacturing, and regulatory areas. Regional participation in this approach is also important. In addition to assessing concept feasibility, cross-functional participation also increases key stakeholder engagement and ensures broad organizational support during the development and launch of critical LCM strategies.
When to Start LCM: Timing is Everything
The goal of LCM is to maximize a product’s value through its entire life cycle. LCM planning, then, should start during the pre-clinical phase when the organization is in the process of selecting the lead indication. During this time a designated LCM team can identify potential indications based on the product’s mechanism of action as well as assess clinical and regulatory feasibility before completing and prioritizing commercial valuations. This process enables the company to best determine the lead indication as well as strategically plan the launch timing of follow-on indications or formulations.
If a product’s life cycle has passed pre-IND timing, the next best time to begin LCM planning is when proof of concept has been achieved in phase 2 for the lead indication. This provides greater assurance that there’s a path forward for the product, freeing the company to focus resources on identifying LCM strategies and initiating early planning to realize the most value over the product’s life cycle.
The justification for developing LCM strategies prior to approval and ideally early in development is clear. Research has indicated that sales trajectories are often established within the first 12 weeks of launch. The chart below illustrates the significant increase in revenue generated with early LCM planning compared with more traditional LCM planning approaches.
The Critical Role of a Third-Party Partnership for Successful LCM
Biopharma companies that embrace the importance of effective LCM planning and recognize the value it injects into their product portfolio often rely upon an experienced third-party partner for assistance with developing and implementing LCM plans. RxC International has significant expertise in LCM and has successfully worked with clients to optimize their existing LCM processes or to create and implement best practice LCM processes. We have also partnered with clients to develop product-specific LCM plans to ensure that full product potential is realized.
For a complimentary evaluation of your LCM process or a specific product LCM plan, please contact us or email Frank Koos, Head of Business Development. To be notified of future releases of LCM information, please subscribe on our website.