ARTICLES BY BRIAN JAMES

  • Pharmaceutical Manufacturer
    Choosing The Right Partner For High Potency API Manufacturing
    3/27/2018

    For companies that decide to outsource high-potency active pharmaceutical ingredients (HPAPI) manufacturing, it is critically important to understand what goes into the process of manufacturing highly potent compounds. This article outlines some of the key considerations for HPAPI manufacturing and CDMO selection.

  • research collaboration
    Selecting A CDMO: Strategies To Ensure A Successful Partnership
    11/14/2017

    The story is a common one. Your organization has just acquired a new asset and you are responsible for finding the custom development and manufacturing organization (CDMO) that is going to take you all the way to commercialization. The hard part is over, right?  If only it were that simple.

  • Gears-Dollar-Signs
    Anticipating Manufacturing Costs — And Improving Process Development
    8/1/2017

    No matter the type of organization you are in — from big pharma to virtual, small molecule to biologics, active ingredient to drug product — it is important to understand the cost structure of your program.

Brian-James-Rondaxe

Brian James

Brian James, Ph.D., MBA, is the SVP of operations at Rondaxe, a pharmaceutical CMC consulting and software firm. Brian oversees project management, API synthesis design, and API/formulation sourcing support to Rondaxe clients. He manages and oversees projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. Prior to joining Rondaxe, he was with Bristol-Myers Squibb, where he honed his skills and expertise in API synthesis and sourcing strategies. Brian received his Ph.D. in chemistry from University of California and his MBA from Le Moyne College, and performed his post-doctoral fellowship at Colorado State University.