Louis Garguilo
ARTICLES BY LOUIS
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11/7/2019
Tara Caiano, Virtual Plant Manager, Biogen is a young-woman professional. We featured her a few weeks ago, just after she had relocated from Biogen’s Boston location to manage an external supply-chain partner in Switzerland. She also spoke to me about some of her personal experiences.
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11/1/2019
Returning manufacturing to the U.S. from overseas is a personal crusade for Harry Moser. He has remedial prescriptions for accomplishing this, and some surprising thoughts on the U.S. President. "If we let China continue to grow as fast as they have, we're toast,” he says. But much of our problem is self-inflicted.
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10/25/2019
Tara Caiano of Biogen packed up her belongings from her Boston-area homestead to resettle in Switzerland. This “virtual plant manager” was turning the virtual into the physical, you might say, a key concept and role within Biogen’s evolving supply-chain management strategy.
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10/21/2019
“Our mission is to bring back five million manufacturing jobs. That would balance the goods trade deficit in the U.S.,” says Harry Moser, founder of the Reshoring Initiative. “That deficit is about $800 billion per year. To make that amount of product would take about five million people — a 40% increase in US manufacturing.” Pharma, says Moser, should play a role.
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10/1/2019
When it comes to outsourcing drug development and manufacturing, while some areas may be reaching a "saturation point" of sorts – a point where a higher percentage of outsourcing can or will not be attained – other areas are in need of a vital ramp up just to keep up.
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9/24/2019
Have we moved the needle closer to “Biopharma 4.0,” and improved supply chains? Here’s what industry veterans were thinking the beginning of the year. One thing is certain: Pharma and Biotech have different ideas on what happens next.
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9/20/2019
Did you see where they took away the patents for the iPhone from Apple, and the patents for Toyota’s top car models? Of course you didn't — that’s ludicrous. So why is it normal to take away patents, and by extension products, from innovative drug companies? An essay on “patent cliff innovation."
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9/16/2019
Last year at this time we were gearing up for DSCSA’s first November deadline. The second November deadline — specific to salable returns verification — is now upon us. Reaching compliance could depend to a large extent on your CDMO and other supply-chain partners. Are they ready? Are you? Here’s some historic perspective from the Healthcare Distribution Alliance (HDA).
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9/6/2019
I’d bet a bitcoin many readers of Outsourced Pharma know less about the Healthcare Distribution Alliance (HDA) than you should. And something else we all should recognize: Current ideas for “drug importation” into the U.S. could negate DSCSA efforts. An outcome none of us should accept.
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8/30/2019
Ionis Pharmaceuticals considers itself a research and development engine – and why not, with three commercial drugs and a pipeline of 40-plus clinic-worthy drug candidates. "We don't want to be a large-scale commercial manufacturer,” explains Max Moore, Executive Director, Manufacturing & Operations. Instead, Ionis relies on CDMOs for that work, which almost always requires lyophilization. And so might your future product development and manufacture.