Louis Garguilo

ARTICLES BY LOUIS

  • 10/11/2018

    Vadim Klyushnichenko of The Scripps Research Institute works with some 10 CDMOs at any given time. He's developed methodologies for handling due diligence, project and product quality for both drug substance and drug product, and timelines and budgets. But perhaps most instructive is his management — and best practices — for handling all the analytical services his programs require through development and manufacturing at his service providers.

  • 10/4/2018

    Vadim Klyushnichenko, PhD, CSCP, VP Pharmaceutical Development and Quality, California Institute for Biomedical Research (Calibr) and The Scripps Research Institute (TSRI), excels at enumeration.

  • 10/2/2018

    I’ve reached out to biopharma companies for answers to this question: “Why does your organization outsource so much drug development and manufacturing to China?” Prompted by President Trump’s remarks on the subject on October 1st, seems like a good time to present some of those initial industry responses, and further analysis of what we are facing.

     

  • 9/28/2018

    Drug development and manufacturing outsourcing professionals from AstraZeneca, Boehringer Ingelheim, and GE Life Sciences tell us: Global playing fields are uneven, the players unequal, and the supply-chain risks imbalanced. Here are their global assessments, and strategies for coping. 

  • 9/4/2018

    Alarms have rung persistently in biopharma quarters. Have the dire warnings staved off the actual emergency? Some executives from Big Pharma whisper that the anticipated “capacity crunch” for contracting bioprocessing services has not nor appears to be materializing. A study from Industry Standard Research (ISR) seems to confirm that. Or does it? 

  • 8/24/2018

    Your supply chain – raw materials and intermediates, APIs and particularly commercial products – is at serious risk from bad actors. We are talking about falsified or stolen materials, counterfeiting, gray-market diversion, and other nefarious behaviors. How can you fight back? Supply chain experts, including from Sanofi and Biogen, offer some sound advice.

  • 8/16/2018

    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. 

  • 7/30/2018

    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.

  • 7/23/2018

    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.

  • 7/13/2018

    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.

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Louis Garguilo



Louis Garguilo is chief editor of Outsourced Pharma, and is considered a leading authority on the art and science of drug development and manufacturing outsourcing. He studied public relations and journalism at Syracuse University (and holds a Master’s in English). His widely read editorials are based on in-depth analysis and interviews with industry executives and professionals. Editorials are written in an engaging and unique style that guide readers through the macro aspects and subtle nuances of outsourcing, and working with contract development and manufacturing organizations (CDMOs). Garguilo also serves as moderator for the various Outsourced Pharma Live webinars held throughout the year.

Prior to joining Outsourced Pharma in 2014, Garguilo spent a decade at a global pharmaceutical contract research, development and manufacturing organization, leaving the industry after attaining the role of vice president, business development and marketing. Additionally, he has served under the governor of New York in the state’s economic development agency, as liaison to the pharmaceutical/biotechnology industry; as chief strategic officer for an e-learning software company; and spent most of the ‘80s and ‘90s in Japan as an educator, author, and communications consultant.