Louis Garguilo

ARTICLES BY LOUIS

  • Are We Comfortable With “Patent-Cliff Innovation”?
    Are We Comfortable With “Patent-Cliff Innovation”?

    Did you see where they took away the patents for the iPhone from Apple, and the patents for Toyota’s top car models? Of course you didn't — that’s ludicrous. So why is it normal to take away patents, and by extension products, from innovative drug companies? An essay on “patent cliff innovation."

  • Are You – And Your CMOs – Ready For The Second Coming Of DSCSA?
    Are You – And Your CMOs – Ready For The Second Coming Of DSCSA?

    Last year at this time we were gearing up for DSCSA’s first November deadline. The second November deadline — specific to salable returns verification — is now upon us. Reaching compliance could depend to a large extent on your CDMO and other supply-chain partners. Are they ready? Are you? Here’s some historic perspective from the Healthcare Distribution Alliance (HDA).

  • 4 Concepts For Supply Chains And Your Good Supply Practices (GSPs)
    4 Concepts For Supply Chains And Your Good Supply Practices (GSPs)

    Readers who’d like to set down and then put their Good Supply Practices (GSPs) in motion, practice the core concepts that need to surround that effort, and align both internally and externally for a more successful supply-chain experience, might want to look over this well-worth-the-wait report. 

  • HDA: “Drug Importation” A Concern For DSCSA
    HDA: “Drug Importation” A Concern For DSCSA

    I’d bet a bitcoin many readers of Outsourced Pharma know less about the Healthcare Distribution Alliance (HDA) than you should. And something else we all should recognize: Current ideas for “drug importation” into the U.S. could negate DSCSA efforts. An outcome none of us should accept.

  • No Freeze In Lyophilization Outsourcing
    No Freeze In Lyophilization Outsourcing

    Ionis Pharmaceuticals considers itself a research and development engine  – and why not, with three commercial drugs and a pipeline of 40-plus clinic-worthy drug candidates. "We don't want to be a large-scale commercial manufacturer,” explains Max Moore, Executive Director, Manufacturing & Operations.  Instead, Ionis relies on CDMOs for that work, which almost always requires lyophilization. And so might your future product development and manufacture.

  • CDMOs In An Innovative-Drug Uprising
    CDMOs In An Innovative-Drug Uprising

    The goal is to stop force-feeding patients cheaper generics, and keep them on branded-innovator drugs until a more effective one comes along. In this final of our three-part series, we look at the role of drug development and manufacturing outsourcing within this discussion. Because if we’ve learned anything, it's that all drugs are not the same.

  • Business Roundtable Reaffirms Capitalism – And The Supply Chain
    Business Roundtable Reaffirms Capitalism – And The Supply Chain

    With the hoped-for media splash accomplished, 181 CEOs, including from Bayer, BMS, J&J and Pfizer, published an updated “Statement on the Purpose of a Corporation.” They’ve committed to benefit “customers, employees, suppliers, communities and shareholders.” What’s it all about really?

  • Lyophilizing All The Way To The Biotech Bank
    Lyophilizing All The Way To The Biotech Bank

    Max Moore, Executive Director, Manufacturing & Operations, Ionis Pharmaceuticals, lays down a challenge to certain drug developers and manufacturers: Try to find a better scientific or economic outcome for bulk API production than lyophilization. He says you won’t. Not if you consider outcomes correctly. (And by the way, expect a lot more of all kinds of “lyo" in your future.)

  • CDMO-To-Hospital: A Direct Ending For Generic Shortages?
    CDMO-To-Hospital: A Direct Ending For Generic Shortages?

    Part 2 of our look at the unique business model and ambitious plans of Civica Rx.

  • Biologics Dose And API Outsourcing: A Decade of Decline?
    Biologics Dose And API Outsourcing: A Decade of Decline?

    Can it be that today, when we expect increasing demand for CDMO services, biopharmaceutical companies have decided to outsource less of their commercial production needs than in the past? Some new data provided exclusively to Outsourced Pharma by PharmSource, an organization of GlobalData Plc., seems to suggest so. But if so, why that apparent trend reversal? 

Louis Garguilo

Louis Garguilo



Louis Garguilo is chief editor and conference chair for Outsourced Pharma, and a contributing editor to Life Science Leader magazine. He studied public relations and journalism at Syracuse University (and holds a Master’s in English), and has 30+ years of international experience in business communications and development positions. Louis spent a decade at a global pharmaceutical contract research, development and manufacturing organization; served under the governor of New York in the state’s economic development agency, as liaison to the pharmaceutical/biotechnology industry; was chief strategic officer for an e-learning software company; and spent most of the ‘80s and ‘90s in Japan as an educator, author, and business communications consultant, including for the Osaka Medical Center for Cancer and Cardiovascular Diseases.