ARTICLES BY LOUIS
Do The Math: “Reshoring” Adds Up For Biopharma Manufacturing
“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.
Outsourcing Equilibriums And Imbalances
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.
Biopharma Supply Chains At Industry 4.0
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.
Are We Comfortable With “Patent-Cliff Innovation”?
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."
Are You – And Your CMOs – Ready For The Second Coming Of DSCSA?
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).
HDA: “Drug Importation” A Concern For DSCSA
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.
No Freeze In Lyophilization Outsourcing
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.
CDMOs In An Innovative-Drug Uprising
The goal is to stop force-feeding patients cheaper generics, and keep them on branded-innovator drugs until a more effective one comes along. In this final of our three-part series, we look at the role of drug development and manufacturing outsourcing within this discussion. Because if we’ve learned anything, it's that all drugs are not the same.
Business Roundtable Reaffirms Capitalism – And The Supply Chain
With the hoped-for media splash accomplished, 181 CEOs, including from Bayer, BMS, J&J and Pfizer, published an updated “Statement on the Purpose of a Corporation.” They’ve committed to benefit “customers, employees, suppliers, communities and shareholders.” What’s it all about really?
Lyophilizing All The Way To The Biotech Bank
Max Moore, Executive Director, Manufacturing & Operations, Ionis Pharmaceuticals, lays down a challenge to certain drug developers and manufacturers: Try to find a better scientific or economic outcome for bulk API production than lyophilization. He says you won’t. Not if you consider outcomes correctly. (And by the way, expect a lot more of all kinds of “lyo" in your future.)