“Driving the Future of Pharma” is the theme for next week’s fully digital 2020 ISPE Annual Meeting and Expo. The focus for the meeting is:
…on steering the future of pharmaceutical science and manufacturing toward a more global, synchronized, and quality-driven industry.
…what are some of the Life Sciences industry trends and challenges associated with taking a therapeutic entity from discovery through the commercialization pipeline? The villains of this drama will be introduced to understand why this is so difficult in our current organization with existing processes and technologies. The profile of the emerging heroes in this space then be reviewed.
She shared a sneak peek of the poster with me and it addresses why knowledge management is so hard (the villains), capabilities that are here now to help (emerging heroes), and the path forward in driving better time to market, cost-effective compliance, and manufacturing efficiency.
If you happen to visit the poster sessions, Michalle would love to discuss some of the current trends and drivers for pharmaceutical and biotech manufacturers including global supply chains, Pharma 4.0, data relevance, BioSimilars & Generics, personalized medicine, smaller market productions, manufacturing efficiency, compliance, security, single-use manufacturing, continuous manufacturing, and more. She is quite passionate about the industry goals to accelerate the pipeline and reduce the cost of quality & compliance.
One of the areas of greatest opportunity is to streamline the tech transfer process through the drug discovery lifecycle—basic research to/from development pilot plant to/from clinical trials pilot plant to/from commercial manufacturing. 97 months is typical for the move through the pipeline from clinical to approval. Traditionally knowledge is lost bidirectionally through the pipeline delaying progress and increasing costs.
Data is scattered in many places including lab results, manufacturing devices, pilot plants, drug substances, automation and engineering databases, contract manufacturing sites, supply chain, quality department, regulatory reporting, and the manufacturing plant. The issues are that there is no single version of the truth, decision making is fragmented, point-to-point information flows proliferate, and the required context often has multiple sources.
Michalle will describe some of the ways to address these challenges in several dimensions—business & organizational structure, risk management tools, standards & controls, and process knowledge management tools.
Visit the DeltaV System Life Sciences Solutions section on Emerson.com to learn more about the technologies, services and solutions to drive improved time to market and more cost-effective commercialization of products.