Editors' Desk

  1. Top (Secret) Quality Concerns For Selecting CMOs: How Important Are Records? 9/27/2016

    Five experts go undercover to prioritize a secret top-ten list of quality topics for Pharma and Bio sponsors selecting contract development and manufacturing organizations (CMOs). After weeks of discussion, they select a venue full of drug industry sponsors and service providers to unveil their work. They aren’t aware, though, that the audience will have its own stab at the list.

  2. The Price At My CMO Isn't Right … But How Do I Know? 9/22/2016

    “What we’re doing up here is never done – focusing on that one input in public. Instead of focusing on money, you talk openly about ‘value.' Well, what is that? Or it’s all about ‘relationships.’ The industry talks partnership in public, but behind closed doors, aren’t prices and costs closing or breaking outsourcing business deals?”

  3. 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.

  4. 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.

  5. FLAG These Biopharma Outsourcing Beliefs 8/2/2016

    A few weeks away from Outsourced Pharma San Diego, we’re already into provocative discussion on outsourcing of drug development and manufacturing. Everything from the role of finance managers in CMOs; pharmacists in biopharma; Car-T and personalized medicine in development; the FDA in foreign lands; and project managers in situ. Frank Sorgi, Ph.D., President and CEO of FLAG Therapeutics, Inc., leads the charge.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.