Marketing Needs, Wants, and Issues in Developing Drugs
Market competition is the only form of organization which can afford a large measure of freedom to the individual.
–Frank Hyneman Knight. From Freedom and Reform (1947).
Every individual necessarily labors to render the annual revenue of the society as great as he can. He generally indeed neither intends to promote the public interest, nor knows how much he is promoting it…. He intends only his own gain, and he is in this, as in many other cases, led by an invisible hand to promote an end which was no part of his intention…. By pursuing his own interest he frequently promotes that of the society more effectually than when he really intends to promote it. I have never known much good done by those who affected to trade for the public good.
–Adam Smith
This chapter seeks to differentiate between the necessary standards a new drug must achieve in order for the company to determine that it will launch the drug on the market and those standards that are desired in order for the drug to be medically or commercially successful. These differences are described as needs and wants.
DEFINING MARKETING (AND CUSTOMER) NEEDS AND WANTS
Marketing (and indirectly, customer) needs and wants are described in terms of a drug’s technical and clinical profile. This combined profile consists of a number of the drug’s characteristics, which are described in the package insert, and is used as the basis for the drug’s positioning and promotion. In positioning and promoting a drug, all marketers desire a profile (i.e., a series of medical and nonmedical characteristics) as close to that of the ideal drug as possible. There is an important distinction between characteristics of a drug and the claims that can be made, which are limited to what is in the product’s label, usually based on two well-controlled trials. Because this goal is virtually never achieved, it is important to establish, at the outset of a drug’s development, the profile of clinical and other characteristics that represent marketing needs (i.e., the minimally accepted profile of claims that must be achieved to keep the project alive). The profile that represents marketing wants (i.e., the desirable profile) should also be discussed and identified. The individual characteristics of both the minimally acceptable and desirable profiles should be described and quantified to the degree possible at the initiation of a project (see Chapter 50). Both sets of characteristics should be written, reviewed, and approved and periodically reviewed and modified throughout the project’s life.
Just as a set of marketing needs and wants may be listed for each drug, medical departments also have a set of needs and wants for the same drug. A set of preclinical needs and wants exists also; these are the standards against which the compound was measured before the decision was reached to test that compound in humans as a potential drug. Also, the formulation, toxicology, analytical assays, and other preclinical groups have a series of needs and wants. In all cases, needs are defined by a set of minimally acceptable criteria or standards for a number of characteristics, and wants are defined by a set of desirable criteria for the same and possibly additional characteristics. In many cases, the individual standards for evaluating characteristics may be quantified or semi-quantified. A few examples of these standards are listed in Table 95.1.
Table 95.1 Selected examples of standards used to define minimally acceptable or desirable criteria for a drug | ||||||||||||
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COMPARING MARKETING’S NEEDS AND WANTS WITH THOSE OF MEDICAL
In viewing the marketing and medical needs for a specific project (i.e., an investigational drug), there should be no quantitative differences between medical and marketing for the standards of any characteristic (e.g., duration of action). It is critical for marketing and medical to resolve any differences and to establish a single list that combines both marketing and medical needs. The same observation generally holds for marketing and medical wants. Even if there are large differences between medical and marketing wants, these should not influence the drug’s development because that progression is based on the drug achieving the minimally acceptable profile.
Differing Minimally Acceptable Standards among Countries
Marketing’s minimally acceptable standards (i.e., needs) for a specific drug may differ among countries. For example, marketing might accept a twice-a-day dosing regimen as a minimal standard in one country but require a once-a-day dosing regimen to compete successfully on the market in another country. In some situations, marketing groups might be willing to accept a lower standard than that acceptable to the company’s medical group. For example, a higher incidence of nonserious adverse events could occur with one of the company’s drugs (either during development or after marketing) compared to other drugs of the same class that are on the market. This might limit the ability to market the drug effectively in some less-developed countries but the marketing group may still wish to place it on the market in those countries. However, the marketing group would not seek to sell the drug in more-developed countries because their research showed that the higher incidence of these adverse events (versus the competition) is not acceptable. The company’s medical group might object to this proposal on the basis that they do not think it is acceptable to market the drug anywhere. This type of internal issue must be resolved within the company as soon as possible, or else it could become an unanticipated major company dilemma during the drug’s development (or marketing).
Questions to Consider about the Needs of Marketing and Medical Groups
In the process of addressing the needs of marketing and medical groups, the following questions typically are considered.
What indication(s) should each new drug be developed for? The answer will depend on the medical need for a new treatment, as well as commercial and practical considerations.
In what order should these indications be pursued? Should any of these indications be developed simultaneously or only sequentially? How should the timing be arranged if there will be an overlap (i.e., the second indication could be initiated when the first one enters Phase 3)?
What dosage forms and routes of administration should be developed?
In what order should these dosage forms and routes of administration be developed? How does this plan fit with the development of the various indications?
What comparison drugs, placebos, or treatments should be used in clinical trials? Can the same ones be used in all countries?
What patient populations, disease subtypes, disease severity, and other relevant characteristics should be chosen to study and in which order?
What countries should be pursued for conducting clinical trials?
COMPARING MARKETING PRIORITIES AND RESOURCES WITH THOSE OF MEDICAL
Priority Setting
Pharmaceutical companies are often better able to synchronize marketing and medical needs than to synchronize the priorities of the two groups. Often, the two groups will differ about the need to establish formal priorities; medical groups often see less of a need.
One of the reasons for this difference is that early- and midstage development projects change their relative priority whenever the drug’s safety or efficacy is found to be much less or much greater than anticipated and its new priority puts it ahead of another drug being developed. While all staff should know whether the priority of a drug is relatively high or low, a much more precise description of priority is not necessary because it is usually not helpful in implementing work allocations in most departments (i.e., a high-priority project in a technical department such as analytical chemistry working on an early-stage development candidate may be a relatively low priority for the company).
Resource Allocation
Even when the relative overall priorities of investigational drug projects are the same within the many research and development (R and D) and marketing groups, the resources allocated within different groups will not be the same. Resource imbalance may be manifested in a number of ways.
A relative imbalance of resources allocated by the medical (or marketing) group may exist when the entire portfolio of projects and products is considered. Some lower priority projects may, for example, be receiving a relative excess amount of resources compared to other drugs in the portfolio.
An absolute shortage of resources may be allocated to a project by only medical (or by only marketing) groups, even though the relative apportionment of resources within the portfolio is correct.
A relative imbalance of resources may exist within some of the medical groups but not within others. For example, there may be an insufficient number of data processors and statisticians to handle the data generated, or there may be an insufficient number of monitors available to handle the number of trials planned and initiated by other medical groups.
An absolute shortage of resources may exist within some medical (or marketing) groups but not within others.
A relative imbalance may exist in the types of resources available within the medical (or marketing) groups. For example, there may be insufficient head count but sufficient funds (e.g., if professional staff cannot be found or hired). The opposite situation may also occur. In addition to funds and staff, there are other types of resources where imbalances or bottlenecks could occur (e.g., equipment, facilities, raw materials). Many companies underestimate the resources they require to support their marketed products in both marketing and development (e.g., ongoing stability tests, ability to address lot failures).
The relative and absolute imbalances just listed are all examples within a medical or within a marketing group (Fig. 95.1). An entire additional series of problems could be listed for relative imbalances between medical and marketing groups. Furthermore, the type (i.e., appropriateness) and experience of staff could raise an additional series of imbalances.
Consequences of Imbalances in Resource Availability within One Group But Not the Other
The major consequences of imbalances in resource availability for projects within medical but not within marketing (or vice versa) are that one of the following will occur:
Work will be delayed within one group (i.e., either medical or marketing) but not within the other. This imbalance presumably occurs either because only one group has sufficient resources or because the priority assigned differs between the two groups. If this latter issue is a problem, then discussions should be held by managers to resolve this.
Work will be delayed within both groups because of the impact of activities conducted by one group on the other one.
Work will not be delayed within either group because that group is (a) not on the critical path to delay the overall project, (b) able to hire temporary staff to do the work, or (c) able to work late and on weekends to prevent delays.
Communicating Marketing Priorities
One means of communicating marketing priorities to medical and other groups (e.g., production) is to create a list that is periodically updated. Separate lists could be created for the following:
Marketed prescription products
Marketed over-the-counter products
Investigational prescription products
Investigational (i.e., under development) over-the-counter line extensions
Proposed projects for over-the-counter products
Possible category headings for the information to be included in tables are shown in Table 95.2. These tables should be periodically updated (e.g., every three to six months), sent to senior medical staff, and discussed informally, or formally, if necessary. Medical commitments should be received to conduct at least the most important studies to marketing.
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