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issues. First, if acute anti-inflammatory activity was demonstrated would the product be taken to the market as quickly as possible or would the company, first determine if there were DMARD activity before launching and delay filing by 18 months. It was realized that a business analysis involving assessment of costs, project commercial returns, time, and probabilities was needed. |
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A second issue was the need for acute anti-inflammatory/analgesic cover if PRIONIX possessed only slow onset of DMARD activity. Lack of adverse drug interaction with NSAIDs was considered an important need because comedication with this class could be envisaged. Whether this was a must was felt to depend on the clinical benefit offered by the DMARD and, specifically, if it arrested disease (or, perhaps, limited very slow sub-symptomatic creep). Patients dosed early in the disease with PRIONIX might accept temporary mild symptomatic discomfort because they could not take NSAIDs if they knew that their disease would be reliably controlled within a known reasonable time frame. |
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The types of issues revealed in the PRIONIX TPP example are common in drug development. In many therapeutic areas, there are a hierarchy of clinical benefits that, potentially, can be offered to the patient [2]. The options require careful analysis to select an integrated strategy for first registration and launch and subsequent development. Separating musts and wants and grappling with trade-offs of individual attributes is a challenging exercise [4]. The minimum product profile often gives a product less attractive than the team believes can be delivered and much less attractive than the commercial group would like delivered. The definition of the minimum TPP, however, focuses minds to link product performance to investment justification and leads to sharper checkpoint criteria for project termination. Careful analysis is needed, when multiple indications are options for a drug, to ensure that the best overall integrated strategy is selected. |
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It makes much sense to interrogate the potential product opportunity by defining the TPP in the discovery phase. First, it may become apparent through technical interrogation of the TPP that the indication being considered is not viable and the program should be closed (or not initiated). Secondly, TPP may profoundly influence the discovery biological studies undertaken and the selection criteria chosen for development. Discovery support activities may be identified to facilitate development of a novel asset. These could include establishing marker assays to support early clinical pharmacodynamic studies. |
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4.
Selection Criteria for Further Development |
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The minimum TPP created in the development plan should be used to define the checkpoints and Go/No Go criteria for the indication. The criteria |
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