Finding Your Way; Making Sense of the “Must Do’s” in Early Pipeline Asset Development

Most pharma managers have little experience in deciding what the essentials are in preparing an early asset molecule for launch. Although a molecule may be too new or too far from launch to have a generic or brand name, it is not too early to start thinking about market preparation. Companies are realizing that to create a true “valuceutical” that delivers a positive outcome safely with good economic value, they must begin planning much earlier in the development process and align certain key activities. These activities will form the backbone of future go-to-market plans and will also uncover issues and gaps that can be addressed to create a robust, well-tested platform upon which a launch program can be based. They will also help avoid many of the pitfalls, lost opportunities, and blind alleys that can be caused by delayed planning, and which are hard to fix toward the end of the process, without the luxury of time.

The must-do activities ideally should be initiated before phase 3 programs begin, even before registration trials are designed, so they can be tweaked to maximize market opportunities. In our experience the activities fall into 4 simple categories: evidence; messaging; advice and endorsement; and tactical and channel planning. Sounds simple, right? Not quite. Each of these categories has a myriad of layers and complexities. Within each, parsing activities into what is essential to do first and what can wait facilitates a manageable sequential approach to early market planning, one that can be a guide to marketers and medical affairs professionals facing the “where should we begin?” conundrum.

Preclinical and clinical data is of course a must-have. However, the real essential is having the data sets on which the clinical profile of a molecule is based be easily available, organized, and most important, published in peer-reviewed literature as part of the scientific and clinical public record. Too often, in the world of company mergers, clinical plan delays, and rotation of key personnel, essential data are forgotten and never see the light of day, making the support of later clinical evidence, messages, and claims difficult. Also important to establishing a comprehensive evidence record is making sure trials are completed on time, to provide essential proof-of-concept data. A good way to ensure this is to maximize research center and patient recruitment to a trial — often difficult in a competitive environment with many trials vying for a limited center and patient pool. In long-term trials, patient retention is just as crucial as initial recruitment to preserve a study’s statistical power and speed the trial to its endpoint.

Clinical evidence underpins a sound scientific and clinical rationale for a pharma product. The clinical evidence needs to be used to answer the unmet needs expressed by HCPs, while being presented in a narrative that is relevant across multiple target audiences and geographies. The best way to approach this is to understand the current mindset of potential product users and map out the sequential beliefs and attitudes that will lead them to understand the true value of a brand. Not only do we do this, but we also identify behaviors and information that must be introduced and challenged for HCPs to move along this continuum — their thought journey. These elements define an educational curriculum that will support a brand, and, when organized into a logical narrative, will form the unifying and synchronizing blueprint for prelaunch communications. Utilized broadly, this blueprint can ensure synchronous and meaningful communications across multiple channels from investor relations, PR, publications, and early disease awareness through early branded communications.

Advice from experts is also essential, whether it is therapeutic expertise to help coalesce unmet needs, trialists to help design robust studies, or from other specialists (for example, to steer the development of plans in reimbursement). Building advocates that can represent the evidence (with full disclosure) supporting a new molecule in the most credible way across interested audiences is taking this one step further. In the past, most advice and advocacy-building activities were centered around advisory boards; now, however, online tools are being used to gather opinions and thoughts from a broader audience efficiently and quickly, with clear records of the interactions retained to maintain transparency.

With a clear message plan and foundation for advocacy in place, clearly understanding which channels will be used to communicate and educate HCPs and other constituents is the final molecule essential. It is important to define and quantify the mix of digital, print, and live communications to meet the needs and habits of each target audience, and to understand the lead times for each of these (which can be significant) so that crucial educational and brand information reaches the desired targets at the optimal time via the optimal media channels.



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One Comment

  1. Jack J Florio
    Posted May 10, 2012 at 4:56 pm | Permalink

    Great graphic for Brand Leaders to consider to make sure ll bases are covered early.
    I can see a number of places where new tools in Social Media Analytics and Engagement could be quite valuable.
    Jack J Florio
    Chief Business Officer