Pharma technical development, also known as cmc (chemistry, manufacturing, and controls), is a complex multidisciplinary function critical to the successful development of any drug (see sidebar “excellence in technical development”). its purpose is to develop processes and methods for producing safe and effective medicines. The sometimes overlooked function of chemistry, manufacturing, and controls (cmc) has a rare opportunity to reimagine its role and find innovative ways to improve and accelerate drug development.
Stream listen to the article: out of the shadows: a brighter future for pharma technical development by mckinsey & company on desktop and mobile. play over 320 million tracks for free on soundcloud. Thanks for the post, broderick. good read and i like your observations over the top. from a technical development standpoint, surly the most important shift is that from small to large molecules. I am excited to share my most recent article shedding light on the future of pharma technical development. in this work, miriam fontanillo, katharina paulick, tobias silberzahn and i present perspectives on current trends shaping the industry, provide outlook for the future, and set forth five imperatives for a successful transformation which we believe is pivotal for cmc to maintain and. #innovationdrivers 2022 from mckinsey & company, sep 2022 ‘out of the shadows: a brighter future for pharma technical development’ patient benefits ….
I am excited to share my most recent article shedding light on the future of pharma technical development. in this work, miriam fontanillo, katharina paulick, tobias silberzahn and i present perspectives on current trends shaping the industry, provide outlook for the future, and set forth five imperatives for a successful transformation which we believe is pivotal for cmc to maintain and. #innovationdrivers 2022 from mckinsey & company, sep 2022 ‘out of the shadows: a brighter future for pharma technical development’ patient benefits …. It is time to rethink and rewrite the technical development operating model. based on decades of research in our cmc round table, this new article by miriam fontanillo, katharina paulick, pawel poda, and tobias silberzahn explains why technical development needs to change and set forth five imperatives for a successful transformation. The role of process development in (bio)pharma is to deliver robust processes in short timelines and at limited technical risk (and at best requiring minimal financial investment). the quality by design (qbd) paradigm is seen as a framework to keep technical risks in check, as it helps to systematically explore the process knowledge and improve.
It is time to rethink and rewrite the technical development operating model. based on decades of research in our cmc round table, this new article by miriam fontanillo, katharina paulick, pawel poda, and tobias silberzahn explains why technical development needs to change and set forth five imperatives for a successful transformation. The role of process development in (bio)pharma is to deliver robust processes in short timelines and at limited technical risk (and at best requiring minimal financial investment). the quality by design (qbd) paradigm is seen as a framework to keep technical risks in check, as it helps to systematically explore the process knowledge and improve.
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