ARTICLES BY LOUIS

• Message To Senator Warren From CDMOs: Rethink Education

  11/20/2019

  It’s been a season of discontent over political plans for drug pricing, health care, and the biopharma industry. However, a CEO of a CDMO isn’t thinking particularly about pharma- and healthcare-related proposals. It’s education that’s on his mind — and finding skilled workers locally.

• Farm To Pharma: Outsourcing Lessons From Back Home

  11/15/2019

  Growing up on a farm in Idaho, Marty Hughes of Cidara Therapeutics learned this about quality: If you can afford old equipment, you can afford new equipment. Here’s what he means, and some other of his down-home aphorisms to improve your outsourcing activities.

• Manufacturing In The U.S.: “I Cried When I Saw The Demise”

  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.

• Biogen's “Virtual” Plant Manager Goes To Switzerland

  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.

• Do The Math: “Reshoring” Adds Up For Biopharma Manufacturing

  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. 

• Outsourcing Equilibriums And Imbalances

  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. 

• Biopharma Supply Chains At Industry 4.0

  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. 

• HDA: “Drug Importation” A Concern For DSCSA

  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.

• No Freeze In Lyophilization Outsourcing

  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.

• CDMOs In An Innovative-Drug Uprising

  8/26/2019

  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.