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Perfect timing

Carefully planned early-phase communications can help optimise commercial success

StopwatchAlthough mergers and acquisitions have provided opportunities to cut costs in the pharmaceutical industry, analysts agree that in order to offset loss of sales to generics, companies must do better in developing and marketing innovative products.

And although often neglected in the industry, brand marketing, as opposed to simple product promotion, has demonstrated real benefits in optimising the perceived medical benefits of a product and allowing it to achieve its full commercial potential. But what are those medical benefits and how can they be crystallised and communicated appropriately in a hostile external environment? Early-phase communications can help, but what should be undertaken, and when, for optimal commercial success?

Communication planning
Central to the successful commercialisation of any brand is the development of a clear, consistent and compelling proposition. In developing that proposition, product development teams demand that communication planning:

•  ensures that communication of the product benefits (NOT features) are optimally communicated to relevant audiences

•  minimises risk by ensuring that scientific communications (NOT product claims) are accurate, consistent and supportable

•  saves time and money through efficient development of communications.

To deliver these benefits, the scope, content and nature of core communications planning must be determined. Further, to gain optimal advantage for future commercialisation, this should be done as early as possible, within certain practical constraints, and by those who really understand global pharma marketing, product development and the science, from the broadest possible communication perspective. In early-phase communication planning, the focus needs to be on building a core set of statements that capture the most important elements relevant to the product. These should cover:

•  disease area – what is the disease burden, the company's view on limitations of current therapy and where are the opportunities for intervention?

•  disease biology – what are the underlying mechanisms that cause the disease, relevant to the company's product(s)? What is the premise for pharmacological intervention?

•  product preclinical – what is the mechanism of action? What is the evidence from preclinical models that supports clinical development?

•  product clinical – what studies have been performed to date? What are the key results? What other studies are underway or planned? What other studies should be undertaken to meet commercial/marketing objectives?

•  competitors – on the basis of available, or likely, evidence, how would this product be different from, and superior to, other treatments, including competitors in development?

These statements form the basis for the product development team who can use them selectively in the development of internal or, if appropriate, external communications.

Unfortunately, in some companies, communication planning is unstructured, taking place at various stages throughout product development. Whether internally (between individuals or departments), or externally (to regulators or investigators), choices are made on what to say, and how to say it. But who determines how to present scientific product data, and is it offered in the context of the target disease?

To truly benefit the product, development teams must give communications and communication planning importance equal to that given to clinical development. Increasingly, these teams are considering developing robust communication platforms much earlier, but when is optimal?

When to act
Figure 1 lists the advantages and disadvantages of communication planning at the different stages of clinical development. As communication planning takes time and money, a balance must be struck between expenditure and likely return. This varies according to the stage of drug development and determining the most appropriate timeframe depends on several factors:

•  target market – primary care or specialist?

•  market development status – is this a well characterised market, understood by key audiences?

•  disease biology – is this established and are opportunities for intervention clear?

•  product novelty – does the product have a new mechanism of action that will require extensive explanation? Or has this been established by a first-in-class competitor?

•  'push' or 'pull' – to what extent is there latent demand for the product offering(s)?

Generally speaking, the less well characterised the market or the product, the earlier communication planning should take place.

 

Figure 1: Relative attractiveness of communication planning (by development phase)

Stage

Advantages

Disadvantages


 

Preclinical

Non-scientists engage with science interesting for analysis

Too many candidates
Insufficient data
No development team formed
? Patent protection

-

Phase I

On the radar
Can influence clinical development programme
Can influence regulatory strategy

? Too many candidates
Low perceived return
No budget for communications

+

Phase II

Strong commitment
Team commitment
TPP under development
Can save money
Can influence external communications

Too late for some products

++

Phase III

Key tollgate passed/funds released
Strong internal commitment

Too late for most products
External views already formed
Potential for conflicting messages
Internal assumptions resistant to change

-

Pre-registration

None

Serious problems with launch preparations

--

Post-launch

Correct earlier failings, inadequacies
Incorporate real world learning

Confusion (internal and external)
Potential for mistrust (external)
Cost (major!)
High risk

---

Later...

Many - but only if the core is sound

Tweaking the intangible value
Change for its own sake

-/+


Preclinical. Most companies do not release details of products in preclinical development. Therefore, the focus is on internal communication, often involving providing data to support a decision on whether or not to take the product into clinical development. Typically, communication at this stage relates to the product only and there is no data supporting unmet clinical need. So, although internal communication planning may have some merits here, the number of candidates and uncertainty over the product's future, together with the associated cost, suggest that it is too early.

Phase 1. A decision has been taken to commercialise the product and external communication becomes a reality. At this stage, details of products are often made public though investor briefings and in pipeline updates. Yet, in many cases, no real consideration has been given to how to present early information. Should the product be described by its chemical composition, its functional effect, or by the disease it is designed to treat? Who, apart from the preclinical team and the CEO or head of research, has decided what to say about the product and how to say it? So, communication planning here is a real possibility and could bring benefits.

Phase II. Unlike in phase I, where external clinical exposure is limited to strictly controlled centres, in phase II investigators will receive documentation as part of their participation in studies. This documentation often represents the first full assembly of the product 'story', but rarely includes full details on the disease area, or relevant disease biology. At this stage, many companies have fully functional development teams with expertise in marketing and communication and some will have a Target Product Profile (TPP) under development. Most importantly, at this stage, planning for phase III takes place and the team may have significant engagement with external audiences, in the form of advisory boards and other planning activities. Therefore, it is critical that the full force of communication planning takes place here as without it external audiences may form an inaccurate picture of the product, its potential benefits, and its likely place in therapy.

Phase III. This is traditionally when serious consideration is given to communication planning. Phase II results will have indicated that the company has a viable product, internal resources are usually allocated and there is an intense external focus on the product. Yet, in reality, this is usually too late. The strategic communication planning should already have taken place so that an implementation plan can begin immediately. The team should already have agreed the key messages and important descriptors to avoid adversely affecting the medical and commercial position of the product. If this has not been done:

•  assumptions will have been made by internal team members regarding the product function, performance and positioning

•  these assumptions are unlikely to be consistent, may not be fully supportable and they will rarely be optimal

•  such erroneous perspectives on the product will have been communicated externally, either through the clinical development programme, discussions with regulatory authorities or via third parties like analysts or journalists.

This could place the company in a difficult position. When agreement is finally reached on how to present the product, internal and external views may need to be challenged and, in some cases, undone. This is a time-consuming, difficult and expensive task. In addition, inconsistent, and in some cases potentially conflicting, statements may have been made about the product. This is poor risk management and may have serious consequences should safety issues emerge subsequently.

Pre-registration. There are no advantages to leaving communication planning this late. Indeed, failure to manage external communications by this stage must be seen as negligent.

Post-launch. While this is not the time for primary communication planning, real world experiences can, and should, be used for fine-tuning communication platforms previously developed.

Later... As with any product, lifecycle management is likely to cause adaptations to communications. However, what is difficult, if not impossible, is attempting to reposition the product when early-phase communications management has been inadequate.

Recommendation
Although there is no set rule, the best time for extensive communication planning appears to be early in phase II. This provides an optimum congruence of:

•  data availability (product preclinical is mostly complete and no major safety issues have emerged from phase I)

•  ability to influence perceptions (both internal and external)

•  practicality (product development team in place)

•  resources (sufficient funds likely to be available).

Benefits
Early-phase communication planning offers four main benefits:

•  a clear product proposition that places product data within the context of market need

•  reduced risk through consistent external communication

•  greater congruence within the product development team

•  savings in time and money (reduced duplication of effort by staff or agencies).

Conclusion
Early-phase communication planning is set to become a new standard operating procedure. With proven benefits, additional, earlier allocation of human and financial resources will ensure that a relevant, scientifically sound, valued picture of the product is available across all internal and external communications. Ideally completed during phase II, early-phase communications development must take its place alongside clinical development as a driver of medical and commercial value for new products.

 

Case study: oncology

With dozens of new products in development, the oncology market has exploded in size and complexity. Not only are many novel products being developed, but combination therapy is being used increasingly.

Against this background, Company X, a leader in oncology therapies, prepared a message platform for a novel product (Product Y) during clinical phase II. This contained all key messages relating to:

•  the target diseases – specific tumour types, their epidemiology and characteristics

•  the disease biology – relevant biological processes targeted with Product Y

•  Product Y nonclinical data – the scientific premise of its MoA

•  Product Y clinical data – phase I and anticipated results from the ongoing phase II.

The development of the message platform brought three important, tangible benefits:

•  congruence within the development team on how to describe the product and its target market

•  a fully defined product profile, agreed by all team members

•  a robust platform for phase III development and product positioning.

This resulted in clear and consistent use of terminology and scientific statements in internal and external communications about Product Y. Initially, some team members had to be convinced of the benefits of this method, but by the end of the project, all acknowledged its worth. Now, two years on, a major update to the message platform has confirmed the value of the original, to which new messages have been added relating to additional indications.


The Author
Paul FitzGerald
is director at Syntropy Medica

To comment on this article, email pme@pmlive.com

8th February 2011

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