ARTICLES BY LOUIS

• 3 Questions Of Risk And Communication In A Time Of Coronavirus

  3/20/2020

  Communication with your service providers may turn out most important in getting through immediate coronavirus-induced supply-chain challenges. Outsourcing may have got you into this situation; now it may be the only thing that can get you out. 

• Beck Joins Boston Pharmaceuticals: Another Sign Of The Times

  3/18/2020

  Celgene and Shire former executive Joanne Beck joins Boston Pharmaceuticals. It's another example of where drug development is heading, and how outsourcing -- and lots of funding -- are driving programs to proof-of-concept.

• Sign It, President Trump; Don't Go There, President Xi

  3/17/2020

  If drugs are discovered as purposefully held up by China to create a supply issue in the U.S., would you ever again employ a China-based CMO? Who would have thought Outsourced Pharma readers would be front and center in presidential politics? But you are.

• U.S. Manufacturing On The Rise: Add Another CDMO To The Heartland

  3/16/2020

  Ascending U.S.-based CDMOs may exemplify a national taking back of our own supply-chain destiny. Now there’s another CDMO, Andelyn Biosciences, taking shape in Central Ohio, and targeting gene-therapy services.

• Don't Spread The Wrong Message: COVID-19 And Respect For CMOs

  3/13/2020

  The first was to be a celebration for safely, reliably, and productively keeping drug development and manufacturing supply chains running. The second is a threat to shut those supply chains down. But here’s a second irony: This new coronavirus may have provided us an opportunity of sorts. 

• A Path To Biotech For Young Women

  3/11/2020

  “I’m one of the original founders at Aristea, a start-up company here in San Diego.” One of the founders? Sara McCutchan takes the conference room by surprise, although by now we should be inured to how thoroughly younger generations are contributing to our biopharma industry.

• COVID-19 No-Fly Zone: A Year And Counting For Biopharma Supply Chains

  3/4/2020

  “Right now, the coronavirus situation is more about transportation than manufacture,” says one biopharma executive with a global supply chain. “If this continues for more than a year, then I think it'll be getting products manufactured that will really be in play.”

• Follow The Molecule: One Man's Tale Of Commercialization And Outsourcing

  3/4/2020

  This is a story of drug and personal development. It demonstrates why our industry deserves respect for its accomplishments, and recognition of the individuals who drive them. And it outlines an interesting strategy for outsourcing drug development and manufacturing.

• Six Degrees Of Frank Gupton (And Continuous Manufacturing)

  2/26/2020

  In the course of an hour, Frank Gupton mentions the highest level government officials; Janet Woodcock of CDER; Scott May of Eli Lilly; an ongoing project with DARPA; and others. They all come to the professor for help with U.S.-based manufacturing, and particularly the art of continuous manufacturing.

• Essentially Free: How A Definition Tamed The Visible Particulate Matter Debate

  2/19/2020

  In 2005, Stephen Langille was the FDA liaison to the USP Parenteral Products - Industrial Expert Committee. He and others were concerned with the number of injectable drug product batches rejected or recalled because of  “visible particulate matter.” The situation grew worse over the years. But now Langille offers advice on how you — and your CDMOs — can prevent issues from occuring.