It has been a long journey; I founded the company and grew it into a fully integrated, pure-play, US-based company biosimilars company. Our 351(k) application was accepted by FDA for review (Adello Biologics); several more products are underway, now that we have a great team in place. There is no substitute to learning it the hard way. Over next few weeks, I am giving several talks to share my experience and also plans on how to expedite development of biosimilars. niazi@niazi.com and www.niazi.com