Endpoint, LLC was started in London by Kenneth Klein, MD, a Harvard-trained physician who is board-certified in both internal medicine and gastroenterology. His initial career was in academic medicine, where he served on the faculties of Oregon Health and Science University, Stanford, and the University of North Carolina. Then Dr Klein worked in the pharmaceutical industry for fifteen years, holding management positions with companies in the US and Europe.

He has helped bring numerous products from Phase I through regulatory approval and marketing. For example, for four years he was Global Project Leader for the anti-migraine drug zolmitriptan, now marketed as Zomig. In this role he led all aspects of the drug’s worldwide development. This included responsibility for the design and implementation of the clinical trials program as well as coordination of the basic science, manufacturing, regulatory and commercial strategies.

Dr Klein has had a direct role in the design, conduct, analysis and/or publication of several hundred clinical trials in a wide variety of therapeutic areas. He has been involved in drug and device studies in more than thirty countries and has participated in many meetings with advisory panels and regulatory agencies in North America and Europe.

Special skills offered by Dr Klein include interpreting complex preclinical and clinical data, creating novel designs for proof-of-concept and pivotal clinical trials, and devising optimal study outcome measures.

A particular interest is helping biotech companies devise comprehensive development strategies early in the life cycle of their products; the guiding principle is not simply to achieve rapid regulatory approval, but to maximize the product’s ultimate potential in the marketplace.

Dr Klein also has extensive experience with regulatory strategy, in- and out-licensing of products, and helping investors and potential acquirers evaluate the clinical and commercial potential of drug and device candidates.

Because of his time providing volunteer medical care in Thailand, Kenya, Uganda, and Haiti, he has particularly valued the opportunity to advise charitable health care organizations, including the Bill and Melinda Gates Foundation.

Dr Klein is a frequent speaker at international academic, medical and pharmaceutical industry meetings. He is a referee for peer review journals, and has participated in numerous academic, governmental, and industry task forces and advisory boards. He is internationally recognized for his work on clinical trial design in several therapeutic areas.

Endpoint, LLC has offices in Seattle and London.