INNOVATION


PLANNING FOR SUCCESS


D


evelopment of a new chemical entity (NCE) drugs is characterised by uncertainty. Reduction


and management of uncertainty in drug development has a direct impact on enhancement of an NCE development programme’s value, as does the ability to progress a given candidate rapidly and steadily through the development cycle. A critical challenge to the


current practice of development is the need to proceed quickly


Stuart Levy discusses how traditional as compared with entrepreneurial approaches to chemistry, manufacturing and controls can be reconciled to navigate drug development


Stuart Levy is a principal at SGL Chemistry Consulting in the US


and economically, and to simultaneously ensure that the effort is positioned in a way that allows progress to be sustained beyond the achievement of early project milestones.


Much thought and discussion has been devoted to this topic, yet the ability to address compound attrition and maintain steady progress, resulting in both timeliness/cost control and an increase in development asset value, remains elusive. This is due in no small part


26 02 | 2018


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