Articles by Louis Garguilo

81. Don't Overlook Intangible Metrics When Evaluating A CMO 3/1/2016

    Something Denise McDade of Capricor Therapeutics said during a session at Outsourced Pharma West in San Diego last year stuck in my mind: “Metrics are fundamentally important in measuring and managing any relationship, but there’s a paradox when it comes to outsourcing.”

82. White- And Blue-Collar Leadership In Pharma Outsourcing 3/1/2016

    What do biotechnology and pharmaceutical sponsors want most from their contract development and manufacturing service providers? Today that answer might be summed up as: “White- and Blue-Collar Leadership.” Allow me to explain.

83. Did You Hear The One About The Supply Chain Infrastructure? 3/1/2016

    Building a reliable supply chain infrastructure; technology transfer challenges; scale-downs and scale-ups; CMO realities vs. pharma requirements; biotechs, startups, and virtual business models and their financing; small and large molecule strategies; global or domestic outsourcing; measuring everything that moves and breathes; risk mitigation and risk-sharing assessments ... we are a serious lot, with a lot on our minds.

84. Who's Got The Best Tech Transfer Protocols? 3/1/2016

    An exasperated pharma veteran publically voiced a widely shared concern via an open question: “Our industry’s been engaged in tech transfer for some 30 years, so why haven’t we gotten really good at it?”

85. Reliability Rooms And Supply Chains At Janssen 3/1/2016

    Remo Colarusso, VP, manufacturing and technical operations at Janssen (pharmaceutical companies of Johnson & Johnson), knows what you measure is as important as how you measure, and cross-functional review of the results can be as essential as the results themselves. He also knows that nowadays, Janssen appears in good shape in all four of these quadrants.

86. 5 Comments On Choosing A Global CMO 3/1/2016

    I’m amazed that today’s biotechs and drug developers are still questioning whether they should search globally for a CMO. But, since this is a difficult business decision for many companies, I decided to compile the following (edited) excerpts from a panel discussion at last year’s Outsourced Pharma West conference in San Diego, which I believe could help.

87. A Process Validation – Of Self And Service 3/1/2016

    Our industry is science-driven and technical, and we are overall a society of specialists. No one can understand in detail all that makes up the development, manufacturing, and commercialization of a specific drug.

88. Ah, To Be A Project Manager In 2016! 3/1/2016

    This is the reality that 2016 has wrought: Big Pharma is continuing to organize for enhanced utilization of external partners and supply chains. More business models — biotechs, startups, virtuals – rely on outsourcing. CROs/CMOs are reacting to these client changes with their new service models, technologies and facilities, and M&As.

89. 5 Myths Of Strategic Execution (That You May Hold) : Part 2 1/7/2016

    We continue our investigation into the myths of strategic execution and companywide performance. Spoiler alert: A third of middle managers believe factions exist within the C-suite and executives focus on their own agendas. Hopefully, this too is only a myth.

90. 5 Myths Of Strategic Execution (That You May Hold) 1/6/2016

    A lot of what you know about executing on your business strategies may be wrong. Sorry to have to break it to you so suddenly.  

    But that’s the building conclusion from studies summarized in, “The defining management ideas of the year from Harvard Business Review (2016).”