ARTICLES BY LOUIS

• Riding With The Drug "Serializers" Of Pharma

  9/19/2016

  A recent article with GSK mentioned the assistance Pharma is receiving from external serialization vendors and partners. Like in Wild West movies, the initial decision to bring in these benevolent gunslingers — I call them serializers — is difficult. Unlike the movies, though, there’s no moral equivalence: Few pharmaceutical companies — or packaging service providers — will achieve timely serialization compliance without this outside help.

• GSK's Global Strategy For Serialization

  9/12/2016

  The biopharma industry throws around the term “serialization” as if it were some global singularity to be tamed by an equally universal, technical silver bullet. Terry Crawford, Serialization Technical Manager at GSK, quickly shoots down that type of talk.

• Waldorf Departure Drama For DCAT?

  8/20/2016

  I didn’t quite buy into the DCAT announcement regarding its departure from the Waldorf Astoria, the long-time central location for DCAT Week in New York City each spring. Call me cynical—a degree in public relations can do that – but I just couldn’t believe “checking out” of the Waldorf would be as easy as it sounded. I took this cynicism directly to Margaret Timony, Executive Director of the Drug, Chemical & Associated Technologies Association.

• Biopharma Leadership Through Troubled Waters

  8/10/2016

  At the turn of the 21st century, a rare, Houston-based biotech, busy pursuing the development of its own drugs and IP, discovers it has a sought-after talent for viral vector manufacturing. It decides to pursue contract manufacturing. This begins a tale of how devoted leadership in the midst of significant difficulties can provide a saving grace … and strengthen careers.

• Leadership Lessons From Oil Patches To Biopharma Plants

  8/8/2016

  From the oil patches of Wyoming to biomanufacturing in southern California, this is a tale of living your career, and the essence of leadership. “There’s a recurring theme of including people, taking calculated risks, learning about yourself, and being damn stubborn,” says David Enloe, President and CEO at Ajinomoto Althea, Inc. “Maybe not quite in that order.”

• Grunenthal's Technology Model For The 21st Century

  8/1/2016

  We’re entering our era of technology. It’s transferring preeminence from science to tech innovation. New players will enter; traditional biopharma will retool. Tech implementation of all hues will coalesce in the outsourcing model. Grünenthal of Aachen, Germany, is a leader in this new paradigm. Alexander Kraus, VP Product Development, Technical and Government Affairs, Grünenthal USA, Inc., explains how and why.

• 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.