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The average cost to develop a drug from the screening process to market approval
is estimated to be between 800 million and one billion USD. Approximately 75%
of the overall cost of global drug development is consumed on products that fail.
In addition, the time to market is approximately 10-12 years, with the majority of
this time spent in the clinical development phase. Despite a larger understanding
of numerous disease mechanisms, advances in technology, and regulatory initiatives,
the number of new therapeutics reaching the market has not increased substantially
over the past 10 years. Forty percent of potential lead candidates that enter
into clinical development fail in the early phases. This significantly impacts
the biotechnology sector where significant interest lies in early clinical phase
partnership strategies. Furthermore, success in phase III studies has also
decreased. Taken together, these factors have led to increased cost of development
and a lengthening of the development process. It is therefore of high utility to
employ strategic methodologies that are aimed at improving the success rate,
shorten the development times, and decrease R&D spend.
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Product Planning is critical to any organization, and a well-conceived and
comprehensive Product Development Plan can provide a detailed assessment of
your product and the most effective pathway to market or licensure.
Allphase offers expert advice on issues important to future approval or
partnership attraction for biotech products. We have expertise in providing
qualified input for the planning and execution of the appropriate non-clinical
and clinical studies. The benefit of our experience and input at these early
stages has been realized by numerous clients with significant value being added
to the project.
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