Louis Garguilo

ARTICLES BY LOUIS

  • “SOPs In Action” For Effective QA Audits Of CDMOs
    “SOPs In Action” For Effective QA Audits Of CDMOs

    There’s a lot riding on a drug sponsor’s selecting the right CDMO. Kim K. Burson, Head of Quality Assurance (QA) and Quality Control (QC) at Achaogen, has some advice for those initial audits. A critical component is the “witnessing" of standard operating procedures (SOPs) in action. Burson explains this, and also helps us separate the QC and QA functions. 

  • President Trump, Communist China, and Pharma Outsourcing
    President Trump, Communist China, and Pharma Outsourcing

    President Clinton once said to reject permanent normal trade relations with China would be a mistake of hugely historic proportions. But years later will history judge “free" trade with China "a blunder of truly historic proportions from which America will never recover”? Enter Donald Trump. Our drug industry, dependent on China, should join the public discourse.

  • “China Rx” Looking For The Truth In Biopharma Outsourcing
    “China Rx” Looking For The Truth In Biopharma Outsourcing

    Outsourced Pharma is quoted in a new book, “China Rx: Exposing the Risks of America's Dependence on China for Medicine.” Award-winning author and senior advisor at The Hastings Center, Rosemary Gibson, says drug companies rely on China to the detriment of U.S. patient safety, and we’ve ceded control of drug supply chains to Chinese CMOs, and potentially an adversarial government across the Pacific.

  • Shire’s Plasma Facility Built On Training
    Shire’s Plasma Facility Built On Training

    Parcel to the success of Shire’s state-of-the-art plasma manufacturing facility outside of Atlanta – and a behind-the-scene contributor to the news regarding the first FDA-approval there – is a second state-of-the-art facility, located across the street. That facility is a training center. Shire’s Matt Walker, EVP of Technical Operations, explains the importance of these types of training facilities to biopharma manufacturing in the U.S.

  • There’s An “I” In Biopharma Teams – But It’s Not For “Identities”
    There’s An “I” In Biopharma Teams – But It’s Not For “Identities”

    Today’s "identity splintering" is bad for biopharma teams. And since no organizational activity is more important to the overall success of drug development and manufacturing outsourcing than the formation of competent teams — at the drug owners and CDMOs — we should be particularly concerned. Here’s a discussion on this sociopolitical trend seeping into our industry.

  • The “Build Strategy” Behind Shire’s Plasma Manufacturing Center
    The “Build Strategy” Behind Shire’s Plasma Manufacturing Center

    Among other accolades, Shire is a proficient drug development and manufacturing outsourcing organization. So why is the recent excitement from Shire about a large facility “build,” instead of an external services “buy”? Matt Walker, EVP of Technical Operations, explains for Outsourced Pharma readers why Shire built its state-of-the-art plasma manufacturing facility just east of Atlanta, Georgia.

  • This CDMO Deal Significant Sign Of The Times
    This CDMO Deal Significant Sign Of The Times

    Some deals are more symbolic than others. The recent M&A announcement by PCI Synthesis and Novacap is one of those. The added significance is not lost on Ed Price. He founded PCI at the age of 29, and has been the company’s CEO and president for all 22 years of existence. “Many in the industry were surprised,” says Price. Here’s why, and what it means for the outsourcing market.

  • Contract Manufacturing: Descriptions For A Decade Of Growth
    Contract Manufacturing: Descriptions For A Decade Of Growth

    Over the next decade, global biopharma contract manufacturing (combined small and large molecule) will grow globally at an annualized rate of 4.8%, according to a new report. The Roots report is chock-full of the quantifying we rarely find in our field of drug development and manufacturing outsourcing, and includes some fundamental but interesting CMO categorization.

  • The SEC And The Risk of Biopharma Outsourcing
    The SEC And The Risk of Biopharma Outsourcing

    Two of the most widely covered biopharma-related news stories in the U.S. involve a regulatory agency, as you might expect. But that agency isn’t the FDA. It’s the SEC (United States Securities and Exchange Commission). Both the SEC and FDA are increasingly interested in evolving business models for drug development and manufacturing. For this reason: Your outsourcing is a serious and reportable risk. 

  • 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.

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.