1. THE EVISTA PROJECT
6. WHY PATENT PROTECTION IS ESSENTIAL ?
Drug development and approval ? high cost and long development time
It covered the therapeutic molecule itself as well as the process, in which molecule was manufactured.
Offered the research-based pharmaceutical companies the protection to recoup their R&D investments and generate returns
13. In January 1995, Watanabe announced the formation of a heavyweight team to develop raloxifene under the name Evista.
In November 1993, senior management and key middle managers decided their commercialization strategy for Evista
to seek approval for the label indication of “prevention”
14. defined as increasing or preserving bone density
preventing the occurrence of new osteoporosis fractures
Need to add 2-3 years to the approval process, because long term studies are required
The patient group has to be much larger
The necessary bone density and fracture data simply took more time to generate
15. On December 9,1997 FDA approved Evista for the prevention of osteoporosis in post-menopausal women.
The Evista strategy had worked
at least 18 months had been saved compared to Lilly’s conventional development process
was able to successfully coordinate clinical trials of 12000 patients on a worldwide basis
16. The Evista team’s IT group accomplishment :
had been leverage to provide worldwide remote- patient data entry, significantly increasing the speed and accuracy of data acquisition.
constructed a worldwide database so that regulatory experts around the world could access information and access regulatory questions quickly and easily.
19. MAIN QUESTION . . . .
20. FOR YOUR ATTENTION