Speaker: Ken Klein, Endpoints LLC
Getting a medicine from the lab to the pharmacy shelves is complex, expensive, time-consuming, and more often than not, unsuccessful. Ken Klein, who has been involved in drug development in many settings for over three decades, will describe the process of how drugs are developed, starting with laboratory testing, then human testing, and finally regulatory submission and approval. The emphasis will be on the succession of human clinical trials that evaluate the candidate medicine’s safety and effectiveness.
Bio:
Ken graduated from Harvard College and Harvard Medical School, and is board-certified in internal medicine and gastroenterology. After a career in academic medicine he jumped ship for the pharmaceutical industry where he was fortunate enough to have been very involved in the development of numerous medicines that eventually came to market, first in North Carolina, then in London. For four years he was the international project leader of a drug for migraine. Eventually he left big pharma and started Endpoint, LLC, which consults to small biotech and international drug companies as well as investors, government agencies, and NGOs. He has lived on Bainbridge Island for 27 years.