decide, within the scope of development scale clinical trials, whether there is any prospect for demonstrating incremental benefit against best competitor claims. It should also be recognized that there is always the possibility that conducting trials to document more fundamental benefits may backfire with disappointing clinical results.
4.
Life-Cycle Strategy
Life-cycle strategy is concerned with identifying optimal and coherent approaches to realizing the full value of the asset and translating these into a life-cycle management plan. Adroit life-cycle management can make a major contribution to the scale of the commercial success. The level of risk for investment at this stage is often lower and the return on investment faster than with the earlier development projects.
Life cycle management encompasses
plans to support the marketed indications:
The competitive environment continually changes and requires a continuing investment in studies to support the asset. Increasingly, this will be investment in cost effectiveness studies to retain the marketed product in formulary/reimbursement lists or gain access to these.
plans to extend indications and labeling:
Frequently there will be opportunities to expand the market by registering the drug for smaller niche indications which, of themselves, would not commercially justify development of the drug but add significant value as additional indications. In addition, there may be opportunities to optimize labeling to provide a stronger commercial platform.
plans for introducing line extensions:
The first dosage forms and the dose regimen introduced in the market may often be improved on. It may be possible to develop patented dosage forms offering improved pharmacokinetic profiles in humans and providing clinical benefit with reduced dose frequency. It may be possible to introduce more palatable dosage forms. This an area of drug development too easily dismissed as being trivial. This is naive. Convenient dose regimens offer considerable benefit to patients, particularly those on chronic therapy by enhancing compliance and minimizing disturbance to their busy daily lives. Dosing twice a day for children rather than three times a day may be particularly helpful to ensure compliance without the need for medicine to be given at school.
