Previously, Cory explained how the concept of the “Rx Factor” could be taken as a metaphor for the pharmaceutical industry. In this second part, the concept of the need for market research to be done better and earlier in a product’s life cycle will be developed and we will explore how robust market research has a key role to play. We left off with the cost of entry into crowded market places being questioned.
Cory Inglis 
17 Jun, 2008
The Rx Factor – Will the brand become a Michelle McManus, or a Leona Lewis? (Part 2)
Last month we began to explore the presentation that Nicola Stephens and I delivered at this year’s BHBIA meeting. In this second part the concept of the need for market research to be done better and earlier in a product’s life cycle will be developed and we will explore how robust market research has a key role to play. We left off with the cost of entry into crowded market places being questioned.
Pop Svengali Simon Fuller wrestled with this very point. In the early - mid 90’s the pop market was saturated with boy bands and solo artists, what wasn’t available was a girl band, complete with a girl for every girl whether they be extolling the virtues of being Sporty, Scary, Baby, Posh, or in the pre Catherine Tate Days, making it acceptable to be Ginger. Personally, I thank the Spice Girls for that.
Their product profile although in retrospect simple, was planned, focussed and based upon effective insight into the market. To paraphrase the Spice Girls “if you can work out how to manufacture a product that a young girl wants, what she really, really wants…you will be successful”. The Spice Girls came to market with the right content or data, the right marketing that resonated to their target audiences, all of which was based upon effective research.
Once phase III is started, in effect, the product, if the endpoints are met, is more or less fixed. Assumptions made here will define whether or not the data is acceptable in the future. Whether this be persuasive to prescribers, or acceptable to supply side customers
The first key question is:
Will there be a commercially viable market for this product given a launch in 5-7 years time and a desired sales peak in 12-15 years time, so 5-8 years post launch?
This is a crucial decision... given the amount of investment that will be required to bring the drug to market and requires that we understand the future competitive environment in which the product is likely to be launched, that we understand both the underlying dynamics that are likely to shape the developing market and whether or not we can re-shape the market to our advantage.
Sounds complicated, however, if the answer to this first question is yes, or even a qualified yes, - so yes, the product is commercially viable for launch and could achieve a desired sales number - then the next key question should be:
What is required of this product in terms of clinical data to support a successful marketing effort and maximise its potential in this future scenario?
Again this is a vital question.
The market of the future may look very different from how it looks today; this is in both global and local individual markets. Attitudes and behaviours may have changed substantially; new treatment guidelines or approaches may have been adopted and new products and line extensions may have been launched.
Pity then the brand manager who has been asked to launch a new brand using clinical data based on out of date assumptions or by comparison to the product which has already been superseded by the current ‘gold standard’ – or, now more importantly, with insufficient market access information.
In parallel we need to ask ourselves at this stage:
What can we do to prepare the market in order to maximise this opportunity?
Here we should recognise that pharmaceutical companies will have, or can create existing relationships with customers, providing a great opportunity to build on and develop these through investigator meetings, clinical trial programmes, advisory boards and other forms of medical education, but that this process needs to be well defined with clear goals and a commercial orientation. This last point is where some clinical teams in the past have been remiss.
Next we need to ask:
How should we ‘brand’ the product, to ensure that its future identity is created and protected, meaning that we begin to shape its identity with appropriate values and imagery that are designed to maximise its potential.
Why is it important to do this so early on?
Firstly because trying to develop the Global Branding after or towards the end of phase III affords very little time and tends to lead to compromise and perhaps error in the attempt to achieve launch deadlines.
Most importantly is that the direction has already been set through the Phase III programme
Creating the branding at this stage also allows us to generate Brand Equity from a very early stage, so that by launch, our customers, (Physicians, Payors and possibly Patients) feel more confident in our brand and are therefore more willing to adopt it with greater speed and to greater depth.
Finally as researchers we should also ask:
How can we help brand teams, including marketing, clinical and medical personnel, to generate deeper insight and better assumptions into the market, based on the research conducted and supplementing their inherent knowledge of the brand, the therapy area and marketing or medical issues?
This is important because judgements about the brands strategy (and its viability) should never be made by research alone or indeed just by clinical, medical or marketing.
But needs to be made by a team, a cohesive team, that has both the understanding and the responsibility to do so with insight and intelligence.
Mystic Meg should not work alone.
There are at least five ways in which market research can play a central role in this key process. For the purposes of this article we shall focus upon two of these five principles
Firstly -
Requirements for phase III trials
One of the great failures of the pharmaceutical industry is in the creation of clinical trial results in which lack future value to marketing and sales because of its lack of vision. This can be because the trial end points are inappropriate, because the comparator is outdated or because the wrong things have been measured.
Benchmarking a drug’s impact on a specific marker may be enough to get a licence. But in a market where other drugs are showing direct impacts on clinical measures or outcomes prescribed in either on or off label scenarios this may simply not be sufficient enough from a marketing perspective to capitalise upon the opportunity presented in a specific market.
In our fourth hurdle environment – whereby cost effectiveness must also be proven, not having this data may spell commercial disaster for a product. Although a licence may be granted usage may not follow because of environmental restrictions in that market.
A negative NICE appraisal for example.
We appreciate that there are often many, many constraints imposed upon clinical trials that prevent a drug having ideal data at launch for individual markets. This is largely because of the length of time required to develop results, data derived from trial conception to eventual publication in peer reviewed journals which become the referenced source for campaign and promotion. (Mortality or morbidity data for example). However, there are nevertheless many cases where simple changes in expertly crafted trial design would have produced more effective marketing friendly data.
Crucial here is the ability to be able to understand a therapy area and the products that operate within it both now and in the future in order to identify the issues that drive decision making and will drive decision making in the future.
Attitudes, beliefs and behaviours of Prescribers, Payors, and Patients all need breaking down in order to understand what will truly leverage the market both now and at time points in the future
Therefore we need to use ‘therapy area deconstruction’ research in order to inform the clinical trial decision making process. This insight may be the difference between a product that is perceptually successful, yet commercially a failure. The difference between a thumbs up, and a thumbs down.
It is important to state here that phase III trials are often developed via advisory boards or investigator meetings, here, bias and interest often skew unbiased insight and although investigator meetings are crucial, gaining an understanding of how non-KOL, - jobbing prescribers, payors and patient perceptions and requirements are viewed may be more important to a drugs commercial uptake.
The second area for discussion is that of helping brand teams in achieving greater understanding making more informed choices. In many respects, understanding is the ‘holy grail’ of marketing. The greater the understanding, the greater the probability that appropriate decisions will be made and that brands will achieve their market potential.
However, whilst the role of the pharmaceutical researcher is to establish how target respondents behave (or might in the future), how they think and feel (or might in the future) and what needs and motivations they have (or might have in the future) it is not to generate understanding from these in isolation.
This process should be a team process. More often the creation of understanding and true insight is a shared activity where success is dependent upon opening minds and unlocking creativity within a team of people sharing a common purpose of not just getting a product registered, but achieving its commercial potential
What researchers do have is access to a range of tools designed to unlock latent creativity and the experience to adapt the use of those tools to brand development situations.
The use of creative and enabling approaches (developed from cognitive psychology, psychotherapy and NLP) and the use of techniques within ‘Brand Development Workshops’ allows the extended brand team to generate, and to take ownership of the understanding which will eventually form the foundations of successful brands and compelling clinical and marketing strategies.
At this stage the traditional and familiar approach of a Target product profile, should therefore be adapted to a Target Product Profile with Access to the market being at the front of mind.
Registration is not the sole aim. Usage lies alongside.
So often phase III clinical trial decisions can be or are taken globally.
So therefore is it the responsibility of the UK, as a healthcare market that is leading the way in reducing access to products? That we should demonstrate to other markets how they should approach this problem proactively and maturely?
It is clear that the concept of “increasing hurdles” to using brands is a key issue and will stay a key issue. Market access is one of these hurdles. However the other hurdles are also increasing in their requirements
A recent report by Datamonitor highlights one factor that is responsible for the decreasing number of novel compounds approved each year, namely the increasing pressure that the industry is facing over drug safety. This has been fuelled by several recent high-profile withdrawals and black-box warnings.
In particular, there has been a recent change in the balance of power between companies and the US Food and Drug Administration, which has been given the strength to impose on pharmaceutical companies additional safety studies both prior to and more significantly for commercial and medical teams post-approval.
This shift in power has the potential to increase development costs, reduce market penetration and impact approval rates but “may actually be beneficial for certain drugs that would not be otherwise approved”.
In order to collect the right data it will be pivotal that pharma companies understand the requirements of all of the regulatory hurdles. By incorporating robust market research in parallel with traditional advisory boards and investigator meetings this will ensure that drugs are developed right first time.
What all of this indicates is that there are many research requirements that occur before and around Phase III of the pre-launch period.
Identifying and addressing these early and robustly, and inputting into the trial process will increase the competitive advantage of the product proposition at launch
It is also evident that for market research to truly deliver against these needs, research has to be treated as part of the ‘inner circle’;
Without having all possible information at their disposal and without being fully integrated as a strategic partner in marketing, clinical and medical, research would not be in a position to contribute fully to the decision making process
Its ability to contribute to better insights will be lost in the passing of time; the time for the maximum value of research may have passed.
Within pharmaceuticals it is clear that in having an understanding of the demands of regulatory processes and supply side customers via early, effective market research we can enable a product’s pivotal trials to be planned and developed at an early time point so that when companies move to complete the regulatory submission and evidence files they will be compelling and persuasive from both a regulatory and a commercial access perspective.
This article has highlighted benefits for the company, the physician and the patient and how market research within the UK should play a central role in leading this process amongst global development teams ensuring that market research is conducted better and earlier and with the products being designed to clear the hardest hurdles.
The brand is then destined to become a Leona Lewis or a Will Young, rather than launching and then floundering commercially.
Your response:
Login to respond to this article: