Editor's note: Dr. Murray Simon, President of D / R / S HealthCare Consultants and Michael Latta, Ph.D, Executive Director of YTMBA Research, are members of the Axxiom HealthCare Alliance, an association of experienced researchers committed to innovative and actionable health care marketing research.

New product / drug launch research methodology has been going through a process of evolution for a long time. Twenty-five years ago it was not uncommon for pre-launch strategy research to consist primarily of a series of focus groups with appropriate medical professionals in four or five cities with an emphasis on questions such as: What do you like about this drug? What do you dislike about it? If it were to become available tomorrow, what is the likelihood you would prescribe it? What patients would you prescribe it for? What patients would you not prescribe it for? What drugs currently in use might it replace? and (by the way) Which of these three ads do you like best?

In years gone by, many a drug was launched with little more than a qualitative attitudinal study as described above coupled with a pricing study. But given the competitive nature of today's drug market, with so many therapeutic entities competing for the physician's (and the patient's) attention and with the cost of new drug development so high, pharmaceutical clients are demanding a much greater degree of marketing guidance and predictability from their market research studies. As qualitative researchers, the onus is on us to be innovative and analytical. The days of qualifying every statement in a qualitative report with "suggests that" or "may be indicative of" coupled with a liberal assortment of "insightful" verbatims are over: most pharmaceutical clients expect qualitative research to provide analytical commitments and our relative success as researchers depends on it.

TheNP/4P Paradigm

We have been working on a highly effective research model for developing new product / drug launch strategies utilizing a pre-launch, four-phase program that begins and ends with qualitative research. The NP / 4P Paradigm represents a combination of older, proven methodologies and new ideas structured within a specific format and time frame (usually six months), resulting in a body of information that represents an opportunity for pharmaceutical companies to develop successful positioning strategies capable of maximizing:

NP / 4P Paradigm - Phase I

The lead-off research phase to determine the most effective natural positioning of a pre-launch Product X. It focuses on identifying:

The resultant output of Phase I is a natural positioning statement and supporting messages that feature the physicians' own words.

NP/4P Paradigm - Phase II

A discrete choice survey incorporating the results from Phase I to develop an accurate model of the current market and determine how well the natural positioning of Product X will fit in with particular attention paid to potential market share and cannibalization rates.

NP/4P Paradigm - Phase III

Data mining to develop database clusters of physicians who are likely to be early adopters, brand loyalists or late adopters: the discrete choice model data is used to generate specific physician profile categories for targeting purposes and developing a forecast of product uptake.

NP/4P Paradigm - Phase IV

The capstone phase, representing a final check of the combined results of the first three phases via a qualitative evaluation of the overriding natural positioning and its supporting messages.

Putting the NP / 4P Paradigm to Work

As an example, let's suppose a client calls several months before a new cherry-flavored analgesic syrup (Product X) is to be launched. This product, a combination of a non-habit-forming nighttime sleep aid and a pain reliever, is for adolescent post-surgical patients. It will be marketed in an eight-hour, time-release formulation dosed at one teaspoon every eight hours for children between the ages of six and twelve. The following is an example of the use of the NP / 4P Paradigm to develop marketing strategies in preparation for the launch of this product.

Phase I: Natural Positioning Interviews

Natural positioning requires efforts to establish a link or series of links between a product and the potential end-users. Here we are concerned with the relationships between product attributes and benefits versus end-user needs and values. In the case of therapeutic agents, attributes gain relevance because they allow the patient to achieve certain benefits (e.g., pain relief, sleep, improved healing). Individual patient benefits, in turn, become important to physicians who have a more global need for those benefits e.g., meeting the needs of an entire patient population, satisfying the Hippocratic oath of "First, do no harm."

The perceived inherent value of a drug can differ depending on the needs of specific physician types and their specialties. For example, Product X may be perceived to be of importance by pediatric surgeons because its pain reduction and sleep inducing benefits will promote faster post-surgical healing. Pediatricians, on the other hand, may see it as a means of reducing the number of call-backs that often have to be dealt with throughout the course of a busy day.

This analogous information is gathered through a qualitative interviewing technique that is similar to laddering. In laddering, the moderator first elicits attributes that are important to the physician followed by a rank ordering of those attributes. Then, by raising questions about why specific attributes are important to physicians, benefits and values are identified. Through this approach, it is possible to gain a reasonably valid understanding of how high prescribers of pediatric analgesics will position Product X in their pain relieving armamentarium.

A laddering interview for a natural positioning for Product X might proceed as follows:

The information generated by Phase II can be used for segmentation, targeting, and estimating the level of cannibalization of existing brands caused by introducing a new competitive therapeutic agent. If segmentation, targeting, and an estimation of cannibalization rates are attempted without knowledge of the natural positioning (Phase I) of Product X, the accuracy of the results of a discrete choice model survey will be highly questionable.

Phase III: Data Mining and Targeting

Pharmaceutical companies have a long history of primary research with physicians, pharmacists, and nurses. These research efforts provide valuable insights into how professionals may be influenced to use or prescribe new products by providing an understanding of how they think, feel, and react to the diagnosis and treatment of medical problems such as post-surgical pain in pediatric patients. It does not, however, provide predictive models indicating the types of physicians that are most likely to initially try and to adopt new products. Data mining, on the other hand, uses the historical prescription data that manufacturers purchase from companies such as IMS and NDC in order to support the allocation of marketing resources through better segmentation and targeting of those physicians most likely to use new products.

Data mining is directed at understanding the issues a typical set of prescription Excel spreadsheets cannot reveal through the application of advanced predictive modeling techniques. Pharmaceutical companies typically have Excel spreadsheets with thousands of individual physician records representing the Moving Annual Total (MAT) prescriptions written for products such as analgesics used to treat pain and/or induce sleep. The overall objective of this effort is to use that data to identify and profile the low hanging fruit in that particular garden in which a new product is most likely to gain trial and adoption. A secondary objective is to identify "holes" in the market i.e., those geographic or therapeutic segments where existing products have not achieved substantial penetration.

The process of data mining is very much a carefully planned search whose mission is to shed light on valuables hidden from sight . . . as opposed to a haphazard statistical ramble in the dark. That planned search must be an informed one that is guided by the natural positioning of Product X (as determined during Phase I) or it will miss the mark.

Phase IV: Final Positioning/Main Messages Testing

By the time we get to Phase IV, we have come full circle with a return to qualitative methodology (typically on the eve of launch). In this phase, we often utilize two qualitative methods: