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European Biopharmaceutical Review

Prepared to Launch

Lifecycle decisions are crucial to the success of new products, but often we fail to see the risks involved in the wider context. By reviewing what makes the ‘best’ product in early phases, companies can improve their later strategies.

There are three strategic opportunities inherent in the phrase ‘product lifecycle decisions’ that separate innovator companies from traditionalists. Firstly, ‘product’ is a concept built around a molecule that that should focus on a combination of features, including indication, regimen, formulation, patient type, data acquired and so on. Pharma tends to discuss ‘molecules’ when it should talk about ‘product’. Secondly, ‘lifecycle’ is a concept that, for many, means end-of-life patent management. However, as the life of a product begins in the lab, so should lifecycle options. Finally, ‘decisions’ are made possible when there is more than one option from which to choose.

Product

The product is dependent upon the variables inherent in path-to-market design, such as patient group, indication, endpoints, dose, regimen, formulation and so on. Therefore, it is helpful to maintain a view of the product as the outcome of a set of decisions that create a drug’s intrinsic properties and, in turn, the basis for the label and the resulting claims.

The challenge of traditional development has usually been summed up by the view that a molecule does what a molecule does and you cannot change it. While this is wholly true, it is not the whole truth – delivered differently, at a higher or lower dose, to different kinds of patient (whether younger, older or fitter), with different kinds of disease and degrees of severity (is an ‘obesity’ agent actually for type 2 diabetes, for example, or CV event reduction, or obesity per se) – a molecule can look like several different products. Consider Cymbalta for example, which could have launched as an (average) anti-depressant instead of one which had a pain label, or Crestor, which owns ‘atherosclerosis reduction’ as a result of a differentiated clinical plan.

The label is a summary of these product characteristics, and it is a well-understood paradigm that will evolve over time as new data are gathered and new indications are explored. However, seeing this as an active process rather than a passive, semi-directed accumulation of data – following the path of lowest technical resistance – leads to a product that is intrinsically differentiated. Setting a direction for a product can establish a framework against which development decisions can be made.

Intrinsic differentiation describes a product that does not rely on promotion to differentiate itself within the market. Extrinsic differentiation describes the creation of a perception of the product as differentiated, and either (ideally) builds on intrinsic differentiation or tries to work in its stead.

A key part of the intrinsic product is the value proposition – the demonstration of why the product is worth the price being asked. As the price of the product is a variable, it is critical that a product demonstrate a value that is higher than the price being asked. Increasingly, payers are demanding that this value has been demonstrated in the clinic versus a standard of care to show that the work of establishing comparative effectiveness has been undertaken rigorously and actively, and that the reimbursement of the product will be limited to those patients and situations where this value has been demonstrated. As an example, an agent that might work as an obesity agent will have several approaches that it could pursue to be better, each of which will have a different value proposition to prescribers and payers. Simply demonstrating the degree of average weight loss is a path already pursued (unsuccessfully, in the most part) by most entrants in this market. Each of the propositions around this wheel would have different consequences in terms of value to a payer or prescriber, but each could be evaluated differently in Phase 3.

Lifecycle

Traditionally, lifecycle management was bolted onto end-ofpatent- life, but it is increasingly becoming something that is considered in earlier phases of development. This difference is simply a case of the directed evolution of the product versus a more accidental pathway.

This separates it from the previous views of the role of the lifecycle as a way to blunt entry of generics, to one that enables the sequencing of launches. This view can then stop companies having to aim at a mass-market ‘blockbuster’ type launch to one that is appropriate for a product that knows where it wants to go. Gleevec, for example, is a blockbuster precisely because it launched into a high value space that was a perfect fi t for the drug, not despite such a highly targeted launch; later they began to develop further indications.

The answer to the question ‘how soon is too soon to begin thinking about where else the product could go?’ is usually self-evident. The industry is increasingly moving from a paradigm that was driven by the need to stock portfolios with de-risked options. Instead they are beginning to take a more ‘domino-like’ approach, where success in one indication can lead to another, rather than the older ‘multiple shots on goal’ approach that inevitably carried commercial risk. Although it is possible to launch a product that has only been studied against placebo, this presents a commercial challenge. As a platform from which to launch successive propositions, this low risk position is increasingly recognised as a mistake.

Companies are more frequently electing to launch into a high value space with good indication of commercial success, such as a niche proposition with a high value in a limited population, and then following this with a series of equally well considered moves. As in chess, a bad opening series of moves will affect the whole game, not just the fi rst moves. The commercial risk inherent in trying to launch a relatively undifferentiated product may mean that successive additions to the label seem simply like trying to close the stable door after the horse has bolted. Examples such as Elidel, Faslodex and Xenical – which launched as undifferentiated propositions versus the sometimes generic standard of care, but then tried to add in more compelling data or propositions once on market – show that it is rare that success follows failure to establish a foothold in the market. Compare this to a product like Cymbalta, which immediately established a high value proposition at launch.

In the next five to 10 years, companies will become even more aware of mitigating the commercial risk that they have historically been ignored. Until now, the industry has prioritised technical and regulatory probability of success, often to the detriment of the commercial proposition, and in some cases inevitably produced the statistic that only one in five products return on their own R&D investment. Planning lifecycle actively based on commercial and clinical parameters can mean that, as success follows success, there is a deliberate plan rather than haphazard accumulation of indications. An increasing number of companies are planning a path-to-market with a view to move through launch and beyond with cumulative evidence, and changes in formulation/regimen over time.

Decisions

Key to the concept of decision-making between alternative product lifecycles is to establish what a ‘better’ decision means. Strategy is simply the discipline and science of making improved decisions; it is a business application of game and military theory where winning counts.

Making the best decisions requires the systematic application of logic, planning and a thorough analysis of the possible outcomes and impact of the decision. IBM’s computer, Deep Blue, was able to beat the world’s best chess player by systematically working through ‘what ifs’ and ‘so whats’ for each move – plus Kasparov made a mistake with one of his early moves. However, unless the options upon which the decision is being made are exhaustive, there remains the risk that a ‘better’ decision might have been possible. To extend the chess analogy, a player with a broader playbook than her opponent can make a better decision about which ‘play’ to make in any circumstance.

Generating as many options as possible is critical to decisionmaking. Let’s presume you have several different paths your molecule could take in its approach to market, such as orphan indication, biomarker-enabled targeted population, broader lower risk population, subcutaneous formulation or oncemonthly. Although there is a lot of work in evaluating the parameters, understanding the upsides, downsides and tradeoffs of each alternative is all that is needed for gauging probable and possible futures. As an example, the cost and risks of the first launch are both calculable and the opportunity can be forecast from each approach. Adding in further options may increase the amount of effort required to support a decision, but the amount of work is finite, whereas the alternative – proceeding and then hoping to revisit at a later stage – may be impossible. As the old saying goes, ‘measure twice, cut once’. In the case of lifecycle decision-making, reversing a decision to proceed is significantly more complicated than making a full and active decision at an earlier phase.

The key, once the principal metric of what is positive is established, is to systematically eliminate sources of bias, error and uncertainty. It is important to recognise that there is no single metric that signals the ‘best’ decision in all circumstances. A low-risk path-to-market may be more attractive to one company than a high market value pathto- market, and a low investment path-to-market might be preferred to a high-risk-but-market-dominating path. Above all, it is important that path-to-market options are generated creatively or the risk remains that the market will be dominated simply by the organisation with the best molecule, rather than who made the best decision.

Conclusion

There is no clinical decision that does not have commercial consequence, and no commercial decision that does not have a clinical consideration in the pharmaceutical industry of the future. If it is not in the label, not only can most markets not make the claim, but in many cases the product is unlikely to be reimbursed. Therefore, decisions about the sequence of launches need to be taken as actively and rigorously as possible. It is clear, for example, that the terms ‘first-to-market’ and ‘best-to-market’ are not interchangeable, and they should not be treated the same. It is clear that decisions have a quality that can be improved by the presence of exhaustive, creative options and effective decision-making processes. Assessing commercial risk next to technical and regulatory risk, in addition to considerations of investment and time-to-market next to the scale of the opportunity, can lead to a strong competitive advantage.


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Mike Rea is the Principal IDEAtor at IDEA Pharma. Mike has worked in global pharma for over 20 years, and is a recognised industry leader, named in the PharmaVoice 100 Most Inspiring Individuals in Healthcare in 2011. Mike has led path-to-market strategy for over 60 pharmaceutical brands and was involved in over half of the 50 fastest growing brands in the 2005 to 2010 period. Mike authored Medical Marketing Manual: Branding Pharmaceuticals, is a thought-leader on positioning and branding, and has chaired several international conferences on pharmaceutical positioning, portfolio strategy and lifecycle management. Email: mike.rea@ideapharma.com
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