PM360 JUNE 2010

LIFECYCLE MANAGEMENT

Lifecycle Management for Injectable Brands: Timing is Everything
By Kristie Zinselmeier

Effective positioning of a molecule through Lifecycle Management (LCM) strategies can maximize a company’s investment and optimize positioning relative to the competition, the primary strategic imperative for brand managers. Understanding and leveraging all facets of LCM, primarily driven by positioning within the category, provides the maximum benefit when considered early in a molecule’s development.

To successfully achieve LCM, product management teams must carefully balance the promise of LCM strategies with the fiscal challenges they pose. Every product’s competitive, environmental, and clinical issues are unique, causing LCM and the ultimate ROI to depend on a variety of factors including competition, clinical profile, region, stage in lifecycle, audience or target, and company portfolio. A critical success factor for any strategy is the timing of planning, development, and execution, which can be challenged by company priorities, outside pressures, and other important variables. Ultimately, it becomes a delicate balance between short-term marketing goals and long-term strategic plays.

UNDERSTANDING LCM PLANNING STRATEGIES
To better understand the major factors in LCM strategies for branded injectable and infused therapies, Baxter’s BioPharma Solutions business engaged a market research firm in late 2009 to conduct an in-depth, qualitative survey, including mid- to senior-level management in marketing roles at pharmaceutical and biotechnology companies of varying sizes.1

TIMING IS EVERYTHING
Survey respondents generally agreed that LCM planning most often begins in Phase III trials, just prior to commercial development. Ideally, LCM planning should begin during Phase II trials, according to two-thirds of respondents, but often these priorities are outweighed by the focus on Phase III trials and preparations for launch.

With regard to implementation, most respondents agreed that they put their plans in action after launch, as only then does a drug demonstrate its commercial viability, its potential ROI based on LCM plans, and the market demand for the product. But respondents also agreed that as the brand progresses through its lifecycle, the range of available LCM strategies narrows, since the time to design and implement large or complex programs (e.g., clinical trials) and then realize a valuable ROI shrinks as the drug approaches patent expiration. Therefore, companies with a sharp focus on potential indication expansions or enhanced packaging must begin LCM early in the product’s life.

RISKIEST APPROACHES MAY BE MOST PROFITABLE
Marketers in the survey agreed that seeking new indications is the most beneficial LCM strategy as it often opens up new markets in which the drug can compete, extends patent life, raises more awareness of the product, and encourages improved formulary placement. However, it is also the most costly and risky of the strategies as clinical trials can be lengthy and very expensive, and the results are not guaranteed to be favorable.

Packaging technologies and reformulation were also highly ranked in the survey because they help differentiate the product and improve compliance. About half of marketers said packaging technologies and reformulation are among the top three most beneficial LCM strategies, and two-thirds agreed that packaging technologies can help differentiate a product, particularly in a crowded market environment.

STRATEGIES TO IMPROVE SUCCESS
Understand How LCM Fits Into Brand Priorities Within a Global View. Survey respondents agreed that LCM is a critical component of a brand’s success and that taking a global viewpoint is important, keeping in mind that strategies should be adaptable to regional needs. Committing and prioritizing resources early in the process can translate into improved long-term outcomes.

Gain Commitment from Cross-functional Team. Lifecycle strategies cannot succeed without commitment and dedication from multi-disciplinary teams. Survey respondents noted that the core strategic team typically includes representatives from marketing, clinical, medical affairs, regulatory and legal departments. Other important cross-functional consultants throughout the process should include market research, manufacturing, business development, and finance.

Consider Partners. Given the complexities of LCM, companies may gain a competitive edge by partnering or outsourcing select elements of their strategy to help manage costs and maintain core capabilities for other existing products. Working with a partner can provide access to specific technical expertise and specialized drug delivery technologies.

REFERENCE
1. “Lifecycle Management of Injectable and Infused Drugs.” Medspan Qualitative Survey. Conducted December 2009. To see the full survey, please contact Kristie Zinselmeier at kristie_zinselmeier@baxter.com

Kristie Zinselmeier, Director of Marketing at BioPharma Solutions, Baxter Healthcare, is responsible for global marketing relating to pharmaceutical and biotech collaborations. She can be reached at kristie_zinselmeier@baxter.com