CMC: A ‘Secret Sauce’ of Biotech Success

By, Arthur Tzianabos, CEO of Lifordi, as part of the From The Trenches feature of LifeSciVC

I often hear biotech leaders refer to their company’s technology and approach in terms of the “secret sauce” or “how the sausage gets made.”  I have probably used these phrases myself over the years.  But here is an interesting question…I wonder how often these words are said with the company’s Chemistry, Manufacturing and Controls (CMC) in mind?

CMC is usually on the critical path and increasingly a major cause of Complete Response Letters (CRLs). Of the >270 CRLs released by the FDA in recent months, more than 50% of the rejections…