Pharmaceutical Packaging Editorial
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The SEC And The Risk of Biopharma Outsourcing
6/29/2018
Two of the most widely covered biopharma-related news stories in the U.S. involve a regulatory agency, as you might expect. But that agency isn’t the FDA. It’s the SEC (United States Securities and Exchange Commission). Both the SEC and FDA are increasingly interested in evolving business models for drug development and manufacturing. For this reason: Your outsourcing is a serious and reportable risk.
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Biopharma And CDMOs: No Strategic Relationships In The Long Run?
6/22/2018
Biopharma companies should recognize some of the vernacular they use for negotiating drug development and manufacturing outsourcing can set CDMOs on edge. In this editorial, we talk to biopharma veterans of outsourcing about some of the "financial frictions" brought out in new models for sponsor-provider relationships.
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6 Months To Serialization: A Review And Projection
6/8/2018
It’s the six-month countdown to implementation of item-level serialization for drugs sold in the U.S. It seems a good time – “good” depending on your state of readiness – to assess our progress. Moreover, the industry needs to remain cognizant of the fact the November deadline is specific to “item-level” serialization; there’s a second phase the FDA wants completed by 2023: Full “aggregation” of product throughout the supply chain.
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Former Kodak Park Future Super Site For Biopharma?
5/30/2018
The last time I stepped foot on the historic Kodak campus in Rochester, NY, it was the early 2000s. Kodak was putting on a brave face, but the situation was dire. Today, what was once the largest operating business park in North America, is looking for a second chance. Those in charge of the park – now the Eastman Business Park (EBP) – think opportunities will come from biopharma and CDMOs.
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Artificial Intelligence Versus Human Knowledge In The Supply Chain
5/17/2018
Will advancing forms of artificial intelligence (AI) help to better integrate supply-chain data to make outsourcing development and manufacturing more efficient, productive and profitable? Only if it’s a human making the decisions.
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Hire New Biopharma Executives With Old-School Traits
4/26/2018
Times change. Industries – surely including biopharma – need to change with them. So, too, the executives leading companies through those transformations? Well, perhaps not so much. John Webber, President, GForce Life Sciences, explains …
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New U.S And Canadian Facilities Boosting Biologics Capacity
4/13/2018
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
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Biopharma Outsourcing Will Overcome Tariff Troubles
4/6/2018
Why has the biopharma industry insisted upon dual (or triple) sourcing for materials? Why does Big Pharma perform outsized due diligence on offshore CDMOs and CMOs? Why do we focus on costs of all materials and supply? One reason is so we can calmly weather uncertainties such as the current tariff troubles between the U.S. and China.
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6 Challenges For BioPharma Packaging
4/2/2018
Whether it’s innovative product-development; the need to operate globally; dealing with aging and unhealthy populations; stopping counterfeiting and theft; or facing un-harmonized serialization … biopharma packaging has its challenges.
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A View Of Biopharma From Pfizer’s Building 41
3/20/2018
This is the story of a man and a building, and their tracing of decades — and hints of the future — at Pfizer, and indeed the entire biopharma industry.