Clinical Target Product Profiling is the method used for relative
comparison of the investigational drug with the current standard and emerging therapies on key evaluation parameters of
efficacy, safety, delivery and dosing for the targeted indication. A
weighted average score relative to the SOC helps position the
investigational drug and serves as the basis for estimating the patient
share and price.
Drug has promising revenue potential but what about expenses?
Estimating the revenue potential of the drug is only half the story. It is equally important to accurately estimate the developmental expenses.
Clinical trial expenses constitute the majority (~75-80%) of the total developmental expenses. Clinical Development Plan (CDP) with details of planned trials needs to be carved out to estimate clinical trial expenses. The clinical trial expenses are then allocated across the ‘initialization’, ‘study’ and ‘close out’ phases of the trial to accurately reflect the spends.
Non-clinical studies should be carefully planned in accordance with the regulatory requirement of the intended country. Cost estimations are based on the number and type of studies that will be needed.
Other expenses such as manufacturing, regulatory, selling, general and administrative and pharmacovigilance expenses also need to be estimated accurately for the investigational drug.
Drug has promising revenue potential but what about expenses?
Estimating the revenue potential of the drug is only half the story. It is equally important to accurately estimate the developmental expenses.
Clinical trial expenses constitute the majority (~75-80%) of the total developmental expenses. Clinical Development Plan (CDP) with details of planned trials needs to be carved out to estimate clinical trial expenses. The clinical trial expenses are then allocated across the ‘initialization’, ‘study’ and ‘close out’ phases of the trial to accurately reflect the spends.
Non-clinical studies should be carefully planned in accordance with the regulatory requirement of the intended country. Cost estimations are based on the number and type of studies that will be needed.
Other expenses such as manufacturing, regulatory, selling, general and administrative and pharmacovigilance expenses also need to be estimated accurately for the investigational drug.
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