Successfully optimizing co-promotional agreements relies upon governance, brand management, and performance management. Yet, despite good intentions from each party, challenges can arise in a co-promotional agreement that threaten its longevity and overall success. In our experience, preventing or overcoming challenges in existing co-promotions usually requires assistance from a third party like RxC International. Below are the nine most common challenges we have encountered during our extensive experience with co-promotion programs.
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.
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.
As the complexity and investment for successfully marketing a prescription drug or biologic rises, many companies seek to de-risk their commercialization effort by joining forces with a partner biopharma company. Co-promotions, or the formal relationship established between two companies to combine resources for a more effective promotion of a product, are becoming increasingly common in the biopharma industry. While co-promotions are structured with the right intent, these agreements require careful consideration of several key strategic and operational issues in order to achieve optimal effectiveness.
Three Key Co-Promotion Drivers
A structured approach early-on in the formation of a co-promotion agreement can significantly reduce pitfalls and difficulties later on in the process. To facilitate a successful co-promotion structure, three key co-promotion drivers must be optimized:
Governance: Structuring a Winning Co-Promotion
Brand Management: Optimizing Brand Planning and Execution
Performance Management: Ensuring Optimal Performance
Successful co-promotions have several key factors in common: they are very focused, they have shared objectives, and their team members are committed to the process and outcome.
A successful co-promotion requires the governing body to fully support the initiative and foster a culture that reflects the shared values of both companies. Governance is the key to ensuring that co-promotion teams work together effectively to provide the framework for undertaking the brand lifecycle management and performance management processes.
Brand strategic planning is a way to develop and communicate brand strategies across affiliated co-promoting companies. A well-executed brand planning process provides alignment among brand teams, clear guidance on the brand objectives (near-term vs. long-term), supporting strategies/tactics, resource allocation, performance targets, and the leads for each tactical initiative. While each company will have its own planning timetables and formats, the co-promotion should accommodate each partner’s own timeline.
To effectively oversee co-promotion, governance teams must establish objectives and supporting performance management processes to hold teams accountable. Incentives should be designed to increase accountability and drive results at every level of the co-promotion. The governing body must facilitate strategic issues, day-to-day operational challenges, mechanisms for monitoring performance, and the timely resolution of issues. Performance management must also include evaluating team effectiveness, team dynamics, and collaborative behaviors.
Achieving Optimal Performance and RxC International Assistance
The optimization of the above three key drivers ensures that supporting processes are in place, strategic brand life cycle management processes are consistent, and performance targets are clearly defined. Often, achieving successful performance outcomes requires the expert evaluation and insight of a third party. At RxC International, we have extensive experience optimizing both new and existing co-promotions.
For companies experiencing challenges in a current co-promotion arrangement, we have developed a co-promotion effectiveness diagnostic framework. The framework helps us work with companies to identify areas that need realignment and generate an action plan for co-promotion optimization. If you would like more information about RxC International’s co-promotion capabilities, if you would like to request a complimentary evaluation of your co-promotion partnership, or a copy of our latest whitepaper on this topic, please contact us today or email Frank Koos.
Gene therapies are poised to enter the US healthcare system within the next 1-2 years as viable treatment options for a variety of diseases. In response to this burgeoning opportunity, the Institute for Clinical and Economic Review (ICER) convened a policy summit and recently released a report on the potential value and challenges of gene therapy treatments, GENE THERAPY: Understanding the Science, Assessing the Evidence, and Paying for Value.
Developing Pathways for Commercial Success
The pathway to commercial success is just as vital as the pathway to regulatory approval. RxC International has drawn key insights in conversation with ICER’s white paper for the commercial entrance of gene therapies.
Value Assessment for Gene Therapies: Pricing and innovative payment mechanisms have received much attention as significant concerns for gene therapy stakeholders. A more pressing issue, however, is that gene therapies will not have the robust data generated by clinical trials. The reliance on abbreviated data sets coupled with the fact that gene therapies are not a homogenous group mean that market sizes, target populations and clinical trial evidence will vary greatly. Thus, the plan for gene therapy commercial success must be integrated with the clinical development strategy. At RxC we have modified the typical Target Product Profile into the Target Value Profile that better reflects the market dynamics of gene therapies.
Identifying partners and alliances for commercialization: Due to the complexity of gene therapy commercialization, persuading providers to use gene therapy treatments may require the resources of a partner with commercial expertise. To assist companies in identifying partners and alliances, RxC has the experience and models for forging the strategic partnerships necessary for commercial success.
RxC International Advantage
RxC International, a premier life sciences consulting firm, has created proprietary, cross-functional frameworks for aiding life sciences companies with commercialization and go-to-market strategies for new treatments. We have adapted our models to assist clients with navigating the unchartered waters of planning and commercializing gene therapies. If you are interested in keeping abreast of our expert work in the gene therapy market, please follow RxC International on Linkedin for updates.
Regulatory Dynamics: The BioPharma industry is highly regulated. The FDA is armed with strict federal legislations that are implemented to tightly regulate the drug approval procedure and subsequent commercialization of these drugs. The sole focus of FDA for such stringent regulatory measures is to offer safer and effective medicines to the consumers.
Traditional methods of drug discovery rely on in vitro and in vivo trial-and-error testing of chemical substances on cultured cells or animals, and extrapolating the observed effects to potential treatment regimens. Compounds are initially screened to narrow in on the ones that have some degree of activity. If these compounds share common chemical features, one or more pharmacophores are then developed. At this point, medicinal chemists attempt to use structure-activity relationships to improve certain features (activity against the chosen target, reduce activity against unrelated subjects) of the lead compound to make it more effective and safe.
A clinical trial or clinical study is defined as any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product, and/or to identify any adverse reactions to an investigational product, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the objective of ascertaining its safety and/or efficacy. While the major questions answered are those of clinical value in all three phases, economic end-points and strategic end-points like quality of life (QoL) are introduced during Phases II and III. It is not uncommon that these economic and strategic end-points are introduced in earlier phases as well.