ARTICLES BY LOUIS

• Pfizer Transitions In Risk Managing Clinical API Supply

  6/30/2016

  Thomas Niemeyer leads a team for Pfizer that sources clinical API development and supply from Phase I through regulatory approval. That puts him in a transition zone when it comes to supplier risk management.

• More Biomanufacturing Workers, Less Paper Work

  6/27/2016

  Eight hundred students enrolled in biomanufacturing courses. Hundreds more trained for biopharma like Merck and CMOs like Fujifilm Diosynth. Gary Gilleskie of North Carolina State University’s Golden LEAF Biomanufacturing Training and Education Center (BTEC) believes there are plenty of workers to train. And now he’s doing it with less paper. 

• Emerging Biopharma – And Their CMOs – Crazy Like A Fox

  6/22/2016

  We’re learning of an emerging biopharma and CMO model. We’ll have to see if this evolution, of sorts, takes hold more largely throughout the industry. But then again, we’ve heard “crazy” things in the past that are proving tantalizingly accurate.

• Value Creation Redefines BioPharma Outsourcing

  6/15/2016

  Am I starting an article on biopharma outsourcing by noting Frederick Engels, co-author (with Karl Marx) of The Communist Manifesto? And asking Mary Kachinsky, VP Strategic Sourcing and Operations at FORMA Therapeutics, to participate? Well, yes, and it should be a “valuable" read.

• Sanofi-Genzyme – And CMOs – Serious About Training Project Managers

  6/13/2016

  Carol Sherako, Director Program Management at Sanofi-Genzyme, is a highly trained project manager. She humbly suggests other PMs in the biopharma industry should be, too. If biopharma is going to stick with the model of transitioning scientists from within its ranks to the status of PM, it ought to get serious about training them.

• Required Skills For Project Management At Genzyme

  6/5/2016

  “I’m not sure you want to hear my thoughts on project management in our industry.” That turns out to be the only statement Carol Sherako, Director Program Management at Sanofi-Genzyme, and I disagreed on in what became two articles of her views on the subject.

• For M&A, Shire Stays Three Dimensional With CMOs

  5/26/2016

  How do biopharmaceutical companies handle CMO and supplier relationships that stem from M&A activity? Who better to ask than Shire? The folks there know M&A and outsourcing as well as anyone in the global biopharma industry today. 

• The Creation Of Shire's Outsourcing Model

  5/20/2016

  Approaching $7 billion in annual sales, and fully reliant on outsourcing, no other biopharma today engenders more wonder at its business model than Shire. How does it all fit together? How is it managed? We learn firsthand here.

• BioMarin Gives Supplier Scorecards Failing Grades

  5/16/2016

  Isaac Young, senior director, supply chain operations, BioMarin Pharmaceutical Inc., gives a lot of today’s CMO/supplier scorecards an “F.” “Stop confusing precision with accuracy,” he says. In this article, he helps us understand how to do better, and provides an example of a scorecard that gets a passing grade.

• Trending: Supply Chain Capacity, Value Calculations, And Serialization

  5/10/2016

  “Lord knows where this leads over time, but it’s a way of forcing people to think even more strategically about their supply chain,” says Sally, our anonymous supply-chain expert, who also surreptitiously provides some important advice and a unique perspective on three key industry trends.