ARTICLES BY LOUIS

• 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. 

• Are We Comfortable With “Patent-Cliff Innovation”?

  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."

• Are You – And Your CMOs – Ready For The Second Coming Of DSCSA?

  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).

• 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.

• Business Roundtable Reaffirms Capitalism – And The Supply Chain

  8/23/2019

  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

  8/15/2019

  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.)

• CDMO-To-Hospital: A Direct Ending For Generic Shortages?

  8/15/2019

  Part 2 of our look at the unique business model and ambitious plans of Civica Rx.