ARTICLES BY BRIAN JAMES
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![Avoiding Mistakes]( "Lessons Learned From A CMC Risk Management Mishap")
Lessons Learned From A CMC Risk Management Mishap6/4/2020How can pharma and biotech companies establish controls to minimize deviations? What are the critical considerations that should be addressed early on — before issues develop? The short answer: a thorough risk assessment with a focus on CMC. An illustrative example of a company that failed to heed this admonition follows.
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![Pharmaceutical Manufacturer]( "Choosing The Right Partner For High Potency API Manufacturing")
Choosing The Right Partner For High Potency API Manufacturing3/27/2018For 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.
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![research collaboration]( "Selecting A CDMO: Strategies To Ensure A Successful Partnership")
Selecting A CDMO: Strategies To Ensure A Successful Partnership11/14/2017The 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.
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![Gears-Dollar-Signs]( "Anticipating Manufacturing Costs — And Improving Process Development")
Anticipating Manufacturing Costs — And Improving Process Development8/1/2017No 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
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.