In today’s highly competitive market, effective life cycle planning could be the equalizer that offsets increasing drug development costs and revenue lost from patent expiration of successful drugs. Many biopharma companies either do not focus enough on life cycle planning or start too late. Companies that take a strategic approach to life cycle planning can identify innovative opportunities with potential to generate significant long-term value and build greater patient and prescriber loyalty to their brands.
“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.
Life Cycle Strategies Differ by Stage
A product’s current life cycle position determines the scope and types of LC strategies. For example, a drug in clinical development will have a broader set of life cycle opportunities to consider than a drug facing loss of exclusivity. Although it’s best to initiate life cycle planning early, a product at any stage of development or commercialization will benefit from life cycle planning. Here are some life cycle strategies by stage:
A broad range of innovative ideas must be explored during the early stages of drug research as this provides a longer runway to execute LC strategies and generate maximum value. Providing that the product’s mechanism of action (MOA) has been fully elucidated, a key area of focus should be identifying the lead indication and prioritizing other potential secondary indications. Strategically sequencing these indications is an important part of the process. Understanding where the molecule targets can also lead to the development of follow-on compounds which is another LC strategy.
Once the initial indication is in development, generating data that supports launch, and identifying additional indications and product enhancements (e.g., new formulations, advanced delivery systems) becomes critical to strengthen the product label and support additional promotional claims. Unearthing and evaluating approvable life cycle concepts that can help meet patient needs will generate a robust portfolio of opportunities.
The post-launch LCM efforts tend to focus more on potential label or additional product enhancements, such as efficacy data in sub-populations, delivery mechanisms or patient support programs. One of the disadvantages of initiating LCM efforts at this stage is the shorter timeframe to generate value before the product loses exclusivity. However, many companies have been successful in extending product exclusivity particularly in cases where the new indication is also linked to a new product formulation that may provide patient benefits.
Loss of Exclusivity
As a product approaches the end of patent protection or market exclusivity, the focus shifts to protecting brand value using a variety of strategies and tactics such as patient support and retention programs that are specific to each region while ensuring that patients are getting the optimal value from the product.
“Successful life cycle planning is more than a random exercise of exploring opportunities, it requires planning and execution throughout a product’s life cycle. Effective life cycle planning must align a company’s strategic objectives, product vision, and capabilities in the target disease area to maximize the long-term value of the asset”, said Subbarao Jayanthi, Managing Partner at RxC International. The absence of a consistent and replicable method for developing life cycle plans is a major gap in many organizations.
Best Practices That Ensure Successful Life Cycle Planning
There are five guiding factors critical to developing high impact life cycle strategies:
1. Accounting for product life-time value implications
Companies that investigate innovative life cycle options early in a product’s development have greater flexibility to explore the most comprehensive strategy and longer runway to execute this strategy. The best time to begin life cycle planning is in the pre-clinical stage when planning teams are assessing potential lead indications and can sequence follow-on indications. This allows the company to plan the most impactful launch and be prepared to initiate subsequent development efforts.
2. Building an evaluation framework for strategic and operational decisions
An objective, measurable, and market-tested framework helps drive more strategic and operationally successful life cycle planning decisions. This framework must incorporate standardized criteria that addresses key scientific, clinical development, regulatory, intellectual property, technical operations, and commercial factors to determine which LC concepts warrant further exploration.
3. Taking a cross-functional approach to identifying and evaluating life cycle opportunities
Developing an effective life cycle plan requires onboarding a cross-functional team. Having the right team in place with key functional representatives and timely input helps ensure more innovative and robust idea generation. Engaging key stakeholders during this process also fosters broader organizational support that is needed to successfully develop and launch these life cycle strategies.
4. Using objective and measurable criteria to prioritize opportunities
Prioritizing LCM opportunities requires the use of objective criteria and a scoring system to evaluate and rank each of the life cycle concepts. This step enables teams to see the relative attractiveness and prioritize the life cycle strategies. The criteria must also account for other factors such as alignment with corporate objectives, strategic fit, direct patient benefits and development cost.
5. Developing business cases for making investment decisions
After selecting the high priority life cycle opportunities, the cross-functional team develops business cases to gain buy-in from key stakeholders within the organization. Business cases provide deeper insight into each functional element and the investment rationale for senior management to make decisions. Once the plans are approved, the life cycle team must work with cross-functional teams to implement these opportunities.
In summary, early and effective life cycle planning is a great tool to help drive innovation and increased value into marketed and pipeline products. The strategies and best practices outlined in this paper provide a good roadmap to successful life cycle planning.
About RxC International
RxC International is a premier life sciences management consulting firm. RxC collaborates with clients to identify and develop growth opportunities. The firm leverages consulting partners and advisers to combine strategic and operational expertise to bring multiple perspectives to every engagement. The firm has deep expertise in corporate strategy, new product strategy, and commercial excellence. RxC International adheres to the following values:
Pioneering | Collaborative | Principled | Tenacious
About the Author
Nick DeSanctis is an Executive Partner at RxC International with over 25 years of leadership in the pharmaceutical industry. Nick is an expert in new product planning and driving portfolio value through portfolio management, life cycle management and therapeutic area strategy.