Outsourced Pharma

Executives say what began with the COVID-19 outbreak, and now the red flags raised over the state of the overall economy, feel like an inseparable supply-chain and outsourcing challenge. The unfortunate amalgam is expected to continue throughout 2023. outsourcedpharma.com/doc/recession-…

The EU's revised GMP Annex 1 requires a facility-specific, formally documented strategy. The span of oversight has shifted & CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency. outsourcedpharma.com/doc/cdmos-and-…

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats Report” to our readers. outsourcedpharma.com/doc/december-c…

While people don’t always think about the choreography of good scientific teamwork, some factors should be considered, and skills that can be developed to increase a drug discovery team’s overall effectiveness and the chance of success. By @BonumTx outsourcedpharma.com/doc/tips-for-s…

The time devoted to R&D tends to erode the patent exclusivity period attached to a drug or biological product. Contractual agreements must spell out ownership of discoveries and data uncovered during the outsourced development process. By @WithersLLP outsourcedpharma.com/doc/outsourcin…

“We have to change the team from doing drug development internally and internal research projects to those who are now client-centric and serving the pharmaceutical industry.” What we learn when sponsors become CDMOs. Featuring Tim Scott, @px_austin outsourcedpharma.com/doc/when-drug-…

Executives say what began with the COVID-19 outbreak, and now the red flags raised over the state of the overall economy, feel like an inseparable supply-chain and outsourcing challenge. The unfortunate amalgam is expected to continue throughout 2023. outsourcedpharma.com/doc/recession-…

Tim Scott traces the arc of spray drying from its advent to today’s advanced amorphous dispersion technology. Now he's back at it again, pushing the technology to even higher levels of accessibility and productivity. #spraydrying #smallmolecules outsourcedpharma.com/doc/prince-of-…

The EU's revised GMP Annex 1 requires a facility-specific, formally documented strategy. The span of oversight has shifted & CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency. outsourcedpharma.com/doc/cdmos-and-…

Organizations across life sciences face a data storage dilemma: balancing the need to store and potentially monetize mushrooming amounts of data while managing IT budgets and limiting the total cost of ownership. By @EY_Parthenon #datastorage #data outsourcedpharma.com/doc/how-to-clo…

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats Report” to our readers. outsourcedpharma.com/doc/december-c…

The time devoted to R&D tends to erode the patent exclusivity period attached to a drug or biological product. Contractual agreements must spell out ownership of discoveries and data uncovered during the outsourced development process. By @WithersLLP outsourcedpharma.com/doc/outsourcin…

This article looks at the needs and challenges biotech organizations face during the manufacture of therapies, how they can reduce cost, and how establishing — or not establishing — partnerships with CDMOs can help get their therapies to patients faster. outsourcedpharma.com/doc/cdmo-partn…

Those who follow this kind of news jumped on Novo Nordisk and Catalent for what is a significant supply-chain challenge that came to light at the turn of the New Year. Now we this up, but from a different perspective. #supplychain #NovoNordisk #CDMO outsourcedpharma.com/doc/a-new-year…

While people don’t always think about the choreography of good scientific teamwork, some factors should be considered, and skills that can be developed to increase a drug discovery team’s overall effectiveness and the chance of success. By @BonumTx outsourcedpharma.com/doc/tips-for-s…

“We have to change the team from doing drug development internally and internal research projects to those who are now client-centric and serving the pharmaceutical industry.” What we learn when sponsors become CDMOs. Featuring Tim Scott, @px_austin outsourcedpharma.com/doc/when-drug-…

Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed. By @Deloitte outsourcedpharma.com/doc/steps-to-e…

Executives say what began with the COVID-19 outbreak, and now the red flags raised over the state of the overall economy, feel like an inseparable supply-chain and outsourcing challenge. The unfortunate amalgam is expected to continue throughout 2023. outsourcedpharma.com/doc/recession-…

Each month, Outsourced Pharma works with PharmSource, part of @globaldataplc to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. outsourcedpharma.com/doc/november-c…

Interestingly, a report from The @ASGCTherapy and @Pharma_Intell speaks volumes about outsourcing without ever mentioning the word. #ATMP #cellandgenetherapy #mRNA #outsourcing #CDMO outsourcedpharma.com/doc/atmp-repor…