Louis Garguilo

ARTICLES BY LOUIS

  • Biopharma And CDMOs: No Strategic Relationships In The Long Run?
    Biopharma And CDMOs: No Strategic Relationships In The Long Run?

    Biopharma companies should recognize some of the vernacular they use for negotiating drug development and manufacturing outsourcing can set CDMOs on edge. In this editorial, we talk to biopharma veterans of outsourcing about some of the "financial frictions" brought out in new models for sponsor-provider relationships.

  • End Of The Serialization Line: Aggregation By 2023
    End Of The Serialization Line: Aggregation By 2023

    The next level of FDA-mandated U.S. Serialization hasn’t received the attention heaped on phase one — item-level labeling. The FDA defines this next phase as “aggregation,” simply defined as “the process of building a relationship between unique identifiers assigned to packaging containers.” In part two of our update on serialization, we’ll look into the status and timeline to aggregation.

  • 6 Months To Serialization: A Review And Projection
    6 Months To Serialization: A Review And Projection

    It’s the six-month countdown to implementation of item-level serialization for drugs sold in the U.S. It seems a good time – “good” depending on your state of readiness – to assess our progress. Moreover, the industry needs to remain cognizant of the fact the November deadline is specific to “item-level” serialization; there’s a second phase the FDA wants completed by 2023: Full “aggregation” of product throughout the supply chain.

  • Former Kodak Park Future Super Site For Biopharma?
    Former Kodak Park Future Super Site For Biopharma?

    The last time I stepped foot on the historic Kodak campus in Rochester, NY, it was the early 2000s. Kodak was putting on a brave face, but the situation was dire. Today, what was once the largest operating business park in North America, is looking for a second chance. Those in charge of the park – now the Eastman Business Park (EBP) – think opportunities will come from biopharma and CDMOs. 

  • Artificial Intelligence Versus Human Knowledge In The Supply Chain
    Artificial Intelligence Versus Human Knowledge In The Supply Chain

    Will advancing forms of artificial intelligence (AI) help to better integrate supply-chain data to make outsourcing development and manufacturing more efficient, productive and profitable? Only if it’s a human making the decisions.

  • Big Pharma Moving The Blockchain Needle
    Big Pharma Moving The Blockchain Needle

    Susanne Somerville is founder and leader of The MediLedger Project, a biopharma-industry working group (including Abbvie, Genentech and Pfizer) for the study of blockchain implementation. She fills us in on the strong industry interest, details of the project, and what the technology could mean specifically for drug development and manufacturing outsourcing. 

  • We Weren’t Prepared For CAR-T: Lessons From An Industry Executive
    We Weren’t Prepared For CAR-T: Lessons From An Industry Executive

    Joanne Beck, Executive Vice President of Global Pharmaceutical Development and Operations,Celgene, says what has needed to be said more clearly than it has: With CAR-T, the future arrived, and we weren’t ready for it. Here’s what we missed, and where to go from here, according to Beck.

  • Hire New Biopharma Executives With Old-School Traits
    Hire New Biopharma Executives With Old-School Traits

    Times change. Industries – surely including biopharma – need to change with them. So, too, the executives leading companies through those transformations? Well, perhaps not so much. John Webber, President, GForce Life Sciences, explains …  

  • Janssen Goes From Good To Excellent Supply Chain Partners
    Janssen Goes From Good To Excellent Supply Chain Partners

    Great questions elicit enlightening answers. Especially when the first come from a wise moderator (Brendan Crowley, President, Brendan Crowley Advisors LLC), and the second a seasoned industry veteran (Remo Colarusso, Vice President, Janssen Supply Chain, Johnson & Johnson). Here’s what they had to say about drug development and manufacturing partners.

  • New U.S And Canadian Facilities Boosting Biologics Capacity
    New U.S And Canadian Facilities Boosting Biologics Capacity

    Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

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.