A comprehensive Life Cycle Management (LCM) process is essential to developing pharmaceutical life cycle plans that deliver maximum value over the life of pipeline and marketed products. Ensuring that the life cycle process is objectively and consistently executed enables organizations to fully explore all potential concepts, foster collaborative thinking, and uncover more innovative opportunities. Life sciences companies with multiple products across several therapeutic areas can benefit from a consistent approach that allows management to make effective comparisons across the organizational portfolio and allocate resources accordingly.
Components of a Comprehensive LCM Process
RxC International, which has successfully developed and integrated LCM processes for a variety of life sciences companies, has identified five components that are critical to a successful LCM process for biopharmaceutical products.
1. Thorough Idea Generation and Opportunity Identification
An important success factor in generating ideas is to engage key functions and regions to think broadly about value enhancing life cycle strategies, which may vary depending upon the life cycle stage of the product; these strategies can include but are not limited to:
- New Drug Indications
- Improved Dosing Options
- Packaging Alternatives
- Authorized Generics
- Rx-to-OTC Switching
- Data-driven Initiatives
Preparation is critical to ensure that ideas will generate incremental value. At a minimum, this can include competitive intelligence as well as key market insights on unmet needs, trends, and emerging science.
2. Consistent and Objective Evaluation Framework
Potential opportunities must be objectively evaluated before taking the next step to prioritize and select the most attractive strategies for implementation. This requires establishing an evaluation framework using measurable criteria that are important to the organization. Criteria are often segmented into scientific rationale, commercial rationale, and strategic rationale. Some examples of each category are provided below:
- Currently available scientific evidence
- Clinical feasibility
- Regulatory pathway
- Addressable patient population
- Competitive landscape
- Unmet need level
- Fit with core competencies
- Aligned with organizational goals
- Potential synergies
Along with identifying important categories, the framework must allow for weighting the categories to identify which are most important. This also enables scenario analysis to be performed across all potential life cycle opportunities.
3. Comprehensive Research and Data Collection
Once the core criteria have been identified and agreed to by key stakeholders, extensive research and data collection will help inform and qualify each opportunity across these criteria. Often this requires a combination of secondary research using scientific publications, syndicated reports, or clinical trial databases and interviews with key opinion leaders/high prescribing physicians.
4. Opportunity Evaluations and Prioritization
The evaluation process requires key stakeholders to assign a scoring system and a weighting for each criterion based on its relative importance to the organization. This type of indexing assigns a value for each criterion based on the evidence collected during the research stage. The total scores, which include scientific, commercial, and strategic values for each of the opportunities, are generated to create a prioritized list of life cycle opportunities.
5. Management Plan Approval and Organizational Implementation
The life cycle committee responsible for the process provides a final decision on the selection of life cycle strategies based on the prioritization process and knowledge of available resources to support implementation.
To successfully implement life cycle strategies, team members from the appropriate functions (i.e. marketing, R&D, manufacturing, process engineering, regulatory, etc.) must ensure that the necessary resources have been allocated and implementation is included in their operating plan. This is especially important when it comes to resource allocation where an inconsistent, siloed process results in inequitable funding from product to product.
The Value-Add of External Partnerships for Developing Effective LCM Processes
Biopharma companies that maximize a product’s life cycle often contract third-party help when developing LCM plans. An experienced outside partner can ensure there is a consistent LCM process in place for all products in order to avoid value-eroding pitfalls and successfully develop and implement optimal plans. Outside leadership also helps avoid the perception of functional over-reach, ensures broader organization alignment, and better integrates cross-functional input from multiple departments and stakeholders.
RxC International, a premier life sciences consulting firm, has developed proprietary frameworks and analytical tools addressing each of these 5 process steps for evaluating potential LCM opportunities. We have helped clients successfully develop LCM processes, implement plans for all stages of the product life cycle, and create a competitive edge. 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, visit our Life Cycle Management Resource Center.
About the Authors
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, target value profile development, and therapeutic area strategy.
Subbarao Jayanthi, Managing Partner of RxC International, has over 20 years of strategic consulting and operational experience in the life sciences sector. His areas of expertise include corporate strategy, life cycle management, and M&A.