Brand Activities
This category includes resource allocations associated with basic project and brand management and all that that entails prior to launch. Resources dedicated in this area are allocated to strategic items such as product positioning, pricing (if applicable), health economics, medical affairs, medical publications, managed care and reimbursement, brand and message development, product profile development, packaging, labeling, management of findings from market research and thought leader interactions, the development of promotional strategies, and other strategic branding activities.

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Market Research
This category includes resource allocations associated with the design and execution of market research and competitive intelligence studies.

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Thought Leader Development
This category includes all resource allocations associated with thought leader and opinion leader activities, such as advisory boards, KOL meetings and field-based work with national, regional, and local doctors.

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Advertising
This category includes all resource allocations associated with advertising and promotions, such as formal advertising to physicians, direct-to-consumer advertising, development of conference materials, educational posters, public relations activity, internet activity, and the range of unique promotional tasks that supports every brand.

Note one key exception to this area: advertising here does not include expenditures for sales force operations and support.

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Sales
This category includes all resource allocations associated with sales force activities dedicated to brand promotion, such as sales force training and deployment, promotional item development, compensation and samples management.

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Pre-Clinical
The period encompassing pre-clinical testing in laboratory and animal studies to assess safety, biological activity and formulations.  On average, pre-clinical testing lasts more than six years, and it precedes filing with the FDA or other regulatory body for approval to initiate human clinical trials.

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Phase I
The period in which a drug is first tested in healthy human volunteers to determine safety and dosage.

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Phase II
The period of time – usually about two years – when a drug is tested in larger numbers of patients to evaluate effectiveness and look for side effects.

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Phase III
The period encompassing large-scale clinical testing to determine efficacy and safety prior to submission for regulatory approval.

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Registration and Launch
The period beginning with submission for regulatory approval with the FDA and ending with approval for marketing and actual product launch in the United States. 

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First 12-18 Months on market
The period of time immediately following initial launch in the United States that encompasses at least one 12-month cycle

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