ARTICLES BY LOUIS

• Debate On Project Management In Biopharma Gets Heated

  7/22/2016

  Forget presidential elections. We’ve got the debate we were looking for. The one on the professionalism of project management in the biopharma industry. It includes a reader’s comments that start with: “I call BS on this article.” The prosecuting paragraphs are copied below for careful dissecting. Vitriol can be valuable.

• Biomanufacturing As Seen From A North Carolina Campus

  7/14/2016

  Gary Gilleskie graduated with a Ph.D. in chemical engineering, went to work at a CMO, and became senior director for downstream manufacturing and process development. Now he’s back on campus to ensure part of his history isn't repeated: obtaining that first job in biomanufacturing without a solid background in the industry.

• Still Spouting on Sovaldi? That's A Misdiagnosis, Doc

  7/13/2016

  In a recent LA Times Op-Ed, Dr. Daniel J. Stone, internal medicine and geriatric medicine specialist in Los Angeles, lashes out at the pharmaceutical industry, and the company that appears to have cured his patient of hepatitis. He raises some interesting points, and  give him credit for laying out his argument. Unfortunately, that argument includes a misdiagnosis of the ailment.

• Silicon Valley, Meet BioPharma And Its CMOs (Please)

  7/8/2016

  The information technology titans of Silicon Valley (and beyond) should meet up with the BioPharma industry and its subterranean contract development and manufacturing organizations (CMOs). We believe this could alter the topology of drug development and manufacturing. Here’s why, and an offer to assist in the primo incontro.

• 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.