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invention possible (current and expected) should be assessed including both prophylactic approaches, surgical intervention and drug intervention. The outcomes of intervention and their problems should be considered. This holistic approach takes time (generally this analysis will reveal important information gaps, a need to collect information, and a need to secure external expertise to help understand the treatment context), but its reward is a TPP of substance and not a jump to conclusion profile that simply adds 5 percent to an efficacy parameter of what may be an irrelevant competitive product. One benefit for a company in focusing on selected franchise disease areas is that good information bases and good understanding of specific diseases should already be in place with strong links to health care professionals who understand patient needs in these diseases. |
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3.
Target Product ProfileA Hypothetical Case Study: PRIONIX |
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Usually it is not an easy task for project teams to draft a TPP. The types of issues encountered can best be illustrated in a hypothetical application. A new development candidate has been created for the following TPP analysis. Experts in rheumatic disease are asked to exercise leniency in their scientific scrutiny of the development support data which follows. |
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PRIONIX is a novel compound that has advanced to development as an antirheumatic drug based on beguiling science not fully understood at a molecular level! It was shown that PRIONIX binds tightly in vitro to a small protein discovered in the joint fluid of patients with rheumatoid arthritis. Binding resulted in reduced cartilage degradation in a human in vitro joint explant system. Evidence from several clinical research studies demonstrated that the protein was a very potent proinflammatory factor and one whose concentration was a reproducible marker of active joint inflammation. Some animal work was done which highlighted limited bioavailability for PRIONIX: oral and IV studies established acceptable acute toxicity and demonstrated no significant issues in pharmacological safety studies. A decision was taken to develop PRIONIX. |
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The project team drafted the TPP. The key components of the TPP were addressed in defining the indication(s), the dose regimen, the required efficacy, acceptable safety, and tolerability profile. The maximum intended cost of goods was defined, and the time frame to market launch was projected. |
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Key competitor compounds in development and in the market were reviewed to ensure that the minimum criteria were adequate. The market dynamics in the period following launch were considered in detail to highlight events that could have a significant impact on prescribing the medication. |
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