Louis Garguilo

ARTICLES BY LOUIS

  • China Biopharma: Recognizing The Past, Recasting The Future
    China Biopharma: Recognizing The Past, Recasting The Future

    In part two of our discussion with BeiGene’s Diana Francis, VP Quality & Compliance, we turn her attention back to two concerns with China: IP theft and quality breaches. Then I’ll wrap up our overall discourse to date, with two observations on what we’ve learned this past year about China’s growing connection to the global biologics industry.

  • Straight Talk From BeiGene On Quality, Compliance, And Outsourcing
    Straight Talk From BeiGene On Quality, Compliance, And Outsourcing

    It was time within our ruminations on China to speak directly with a quality executive at a drug developer and manufacturer based there. That’s now accomplished via a discussion with Diana Francis, Vice President, Quality & Compliance, BeiGene, Ltd., a biopharma some have dubbed as a potential “Genentech of China.” Francis spoke openly about her role, BeiGene’s global strategy, and outsourcing within and from China. 

  • Not Enough Data To Utilize AI And Machine Learning In Drug Development
    Not Enough Data To Utilize AI And Machine Learning In Drug Development

    We’ve heard the calls for help: “We’re drowning in oceans of data.” But I’ve learned that those further “downstream” may end up high and dry when it comes to having sufficient data to allow drug developers and manufacturers to fully actuate artificial intelligence (AI) and machine learning (ML). Here’s what some experts had to say. 

  • Biologics In China: Market-Driven Inevitability, New Quality Start
    Biologics In China: Market-Driven Inevitability, New Quality Start

    “… the people you’ve been talking with are just not seeing all the components of the global biopharmaceutical industry — and this huge market opportunity. China will become a big player in biologics. This is only natural; there’s good reason for that.” Here’s a more positive outlook on the current situation in China, from Eric Langer, President, BioPlan Associates, Inc.

  • Service Provider Establishes U.S. Home For Smaller Drug Sponsors
    Service Provider Establishes U.S. Home For Smaller Drug Sponsors

    We ended our last editorial wondering about a regeneration of start-up service provides, after so much M&A in recent years. Will biotechs particularly have smaller service providers to help with their specific drug development and manufacturing needs? Well, there's at least one new option in town. It could be a sign of things to come.

  • 2 Reasons Your CDMOs Are Consolidating: Money & Muscle
    2 Reasons Your CDMOs Are Consolidating: Money & Muscle

    Private equity is providing the M&A fuel for CDMOs, fill-and-finish specialists, and clinical and commercial packaging partners. Big Pharma readily encourages this industry consolidation. But not everyone is on board. Two experienced financiers agree both investors and Big Pharma have their reasons for pushing consolidation, but the verdict is still out on to what degree, big is better for the industry as a whole. 

  • Country Cultures, And Global Vaccine Development And Manufacturing
    Country Cultures, And Global Vaccine Development And Manufacturing

    Often the team [for a biopharma company or NGO/donor] deciding on a grantee or production partner for vaccines does not include both: (a) someone who can predict the credibility of the candidate based on the potential for a sustainable quality system, and (b) diagnose the reliability of the company's promises.” In other words, what's needed is a process to access the culture of  drug development and manufacturing partners, particularly in developing countries …

  • 7 Reasons There Was Never Going To Be A Bioprocessing Capacity Crunch
    7 Reasons There Was Never Going To Be A Bioprocessing Capacity Crunch

    “Basically, industry perceives, reports, and expects no major capacity crunches” related to global bioprocessing needs. So concludes an editor of BioPlan Associates, Inc.’s Fifteenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (April 2018), in a response to my recent editorial saying as much. Now we have the data to back the assertions up.  

  • 10 CDMOs, 2 Cancer Therapies, And An Eye On Analytical Services
    10 CDMOs, 2 Cancer Therapies, And An Eye On Analytical Services

    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.

  • Two Cancer Therapies And Ten CDMOs
    Two Cancer Therapies And Ten CDMOs

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

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.