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Scientific

CompetitiveIntelligence:

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Patrick]. Bryant, Thomas E Krol, andJames C. Coleman

Marion Merrell Dow

Scientific competitive intelligence (CI) is the monitoring of competitors’ research and product pipelines. It is a spe- cialized type of technical CI. In the pharmaceutical industry, as in some other indus- tries, there is a lengthy developmental cycle for a given product, often more than 12 years. The cycle starts with the discovery of a new chemical entity. It ends with Food and Drug Administration (FDA) approval for marketing the product in the U.S. The compound will go through testing in animals

testing in humans (phases 1-3) follow-

ing approval of an Investigational New Drug (IND) filing of a New Drug Application (NDA) to the FDA, and fi- nally review by the FDA. The NDA is a compilation of all pertinent preclinical and clinical data obtained during the drug’s developmental cycle. To construct a company’s pipeline, view these devel- opmental cycles as a timeline with the company’s com- pounds placed at appropriate locations (see Figure 1). This pipeline can be divided into two sections: research and product, depending on whether a compound has been committed to go into human testing. Scientific CI is the monitoring of these research and product pipelines. The model shown in Figure 2 illustrates the differences between scientific CI and business CI. This basic model describes the organization of randomly dis- tributed data as the formation of information. Analysis of this information provides intelligence, information which has been analyzed so that decisions can be made fiom it.

(preclinical phase),

Two points illustrate the Werences between scientific and business CI. First, the type of data being organized are fiom scientific versus business sources. Once this scientific information is analyzed, it becomes scientific CI. The sec- ond point involves the educational background and expe- rience of the analyst who organizes and analyzes the data and information. With scientific CI, the most qualified person has a strong scientific background and some addi- tional experience in research and development (R&D). Clients for scientific CI span a broad spectrum across the company. In addition to R&D, they include upper manage- ment, strategc development groups, and various commer- cial groups. This article concentrates on how scientific CI assists the R&D decisionmakmgand phg processes. Scientific CI’s impact on R&D decisionmaking and planning processes is multifactorial and involves several groups throughout the organization.Withm the pharma- ceutical industry these groups include:

0

Discovery scientists

0

Discovery research management

0

Development scientists

0

Development management

0

Regulatory

Table 1 summarizes examples of how scientific CI has impacted these various groups at Marion Merrell Dow.

OiscoverqScientists

Scientific CI helps

tion to target drug dxovery efforts. Ths is done by iden- tifvlng competitors’ targets, timing, and results. By know- ing the competitors’ research strategies,more informed decisions can be made to work in the same area or to pur- sue different targets. In addition, confirmation for the po- tential of the dwovery scientists’ target can be helped by monitoring the competitors’ findings in a particular area. One question that is constantly asked is whether there is a better target to focus on. Scientific CI can also assist in identifiing potential collaborations for the discovery

discovery scientists idenG the direc-

t Research Pipeline

Discovery

I Product Pipeline

Figure1.

Scientificcompetifiveintelligence.

+ scientist.

Launch

DiscoverqResearchManagement

Discovery research management select and develop strate- gies for lead compounds (compounds for which resources

Competitive Intelligence Review, Vol. 5(2) 48-50

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(1994)

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I-* Intelligence developmentalscientist, identlfjringand monitoring of competitors is crucial to development management

Analyze

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strategies. Key questions, such as “Have competitors dis- continued development, or have they accelerated devel- opment?” can be answered with scientific CI. Identlfylng other approaches in development, espe- cially non-drug approaches, can help development man- agement determine how the use of their drug will be af- fected by the competition. They can then make modificationsin strategies to deal with future competi- tion. Also, monitoring how the competition is develop- ing products can provide alternative approaches for their own product. Other future indications are often identified by moni- toring the competition’sdevelopmentalprograms. Scien- tific CI can assist in this continuous monitoring.

Regulatory

The regulatory group within a pharmaceutical company is the liaison with the FDA. Regulatory is responsible for the submission strategies. Scientific CI can help here by closely monitoring the competition’sactivity at the FDA. Monitoring the review time of a competitor’s similar product can help prehct the time to market for your product. This can also help marketing estimate launch time. The FDA advisory panel consists of thought leaders who act as consultants to the FDA. Monitoring the re- sults of the FDA advisory panel’s review of a competitor’s sirmlar product can identift issues that your company may face when its compound is presented to this panel. When known ahead of time, strategies can be implemented to minimize the impact associated with such issues. Identifjmg a competitor’s submitted drug data package can help determine ifyour submission is adequate for FDA approval. This includes identikng which trials were submitted and the specific design and patient numbers in- volved with each trial. Finally, monitoring the labeling negotiation process between the FDA and a competitor’s similar product can help predict how it will influence and affect your label- ing. This in turn wdl assist the marketing group to posi- tion your product.

Organize

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Competitive intelligence.

are committed to prepare them for human testing). Sci- entific CI can identify similar competitor compounds, their stage of research, and their positive or negative at- tributes. More informed decisions can then be made as to which compounds hscovery research management should choose as lead compounds. Discovery research management decisions take into ac- count the competitiveness of a particular lead compound, even at ths early stage of development. It is critical for them to be aware of any superior approaches being pur- sued by the competition. Thls includes ideas still in early research. Scientific CI can provide the insight into many of these questions.

UevelopmentScientists

Scientific CI can help developmentalscientists create a clinical program plan for a particular compound sched- uled for human testing. Critical competitors, those com- petitor products that may have the greatest negative im- pact on your product’s market potential, can be identified and monitored on a continuous basis. Subsequent analysis often provides valuable, ongoing intelligence that allows the development scientist to make adjustments in the clinical plan over time. Especially important is determin- ing if a critical competitor is having developmental diffi- culties and why. Identifiing a competitor’s potential advantages over your product and evaluating how to overcome this advan- tage helps the development scientist modie study proto- cols for that strategy. Monitoring the critical competitors also provides insight into potential new indications (and therefore markets) one should pursue to maximize the profits fiom a single product.

UevelopmentManagement

development

of all products within the product pipeline. They use sci- entific CI to create developmental strategies. As with the

Development management coordinates the

Conclusion

Scientific CI monitors competitors’research and product pipelines. It dlfferentiates itself fiom Business CI by the type of data it uses and the expertise of its analysts. Scien- tific CI can cross over many different levels of an organi-

1 A60Group

Table1.

Scientgc CI Impact

ScientificElImpactinIndentiflling:

Discovery

0

Competitor targets

scientist

0

Competitor timing

0

Competitor results

0

The confirmation of the research target

O

Potential collaboration

Discovery

O

Simdar competitor compounds

research

0

Competitor timing

management

0

Competitor compound’s attributes

0

Better approaches

Development

0

Critical competitors

scientist

O

Competitor development difficulties

0

Competitor advantages

O

Other indications

Development

0

And monitoring critical competitor advancement

management

0

Other approaches in development

0

Alternate development strategies

0

Other future inchcations

Regulatory

0

Timing for competitors review process

0

Competitor’s FDA advisory panel results

0

Competitor’s data package submitted to FDA

0

Competitor’s labeling

zation. Our experience with the R&D organization illus- trates hs concept. Scientific CI can be used by individu- als fi-ombench level dscovery scientists all the way to the head of R&D to affect the decisionmaking and planning process.

References

Bryant, F?J., Krol, T. E, and Coleman, J. C. (March 31-April 2, 1993) “Scientific CI: A Tool for R&D Decision Making,” presented at the 8th Annual International Conference of the Society of CI Professionals,Los Angeles, CA.

Krol, T. F., Coleman, J. C., and Bryant, P. J. (1993) “Consul-

tant Evaluation for Scientific CI in the Pharmaceutical Indus-

try,” CompetitiveIntelligenceReview, 3:43-46.

Rbouttheluthors

Patrick]. Bryant, PharmD, is Manager; Thomas E Krol, PharmD, is Senior Analyst; and James C. Coleman, PhD, is Analyst in the Global Scient$c Competitive Intelligence Group at Marion Merrell Dow Inc. All have comefrom previous positions in Research and Development. Correspondenceshould be addressed to Pat Bryant, Marion Menell Dow Inc., PO. Box 8480, Kansas City, MO 64114-0480; El: 816-966-

3153.