Endpoint, LLC provides clients with high-quality, authoritative advice on the clinical development of medicines. Endpoint's clients include multinational pharmaceutical companies, emerging biomedical ventures, life sciences investment firms, contract research organizations, regulatory agencies and national health services.
Endpoint, LLC was started in London by Kenneth Klein, MD, a Harvard-trained physician who is board-certified in both internal medicine and gastroenterology. After a career in academic medicine Dr. Klein worked for 15 years in the pharmaceutical industry, holding various management positions with companies in the United States and Europe. He has helped bring major 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 position he led all aspects of the drug's worldwide development. This included responsibility for the design and implementation of the clinical trial program and coordination of the basic science, manufacturing, regulatory and commercial strategies.
Dr. Klein has had a direct role in the design, conduct and analysis of several hundred clinical trials in a wide variety of therapeutic areas. He has been involved in drug studies in more than thirty countries and has participated in numerous meetings with regulatory authorities and advisory panels in North America and Europe.
Special skills offered by Dr. Klein include interpreting complex preclinical and clinical data, creating novel designs for pivotal clinical trials, and devising optimal study outcome measures. A particular interest is helping pharmaceutical companies devise comprehensive development strategies early in the life cycle of their products; the driving principle is not merely to achieve rapid regulatory approval but to maximize the compound's ultimate market potential. He also has extensive experience in regulatory strategy, in- and out-licensing coordination, due diligence of drug development programs and companies, optimizing interactions between parties working on a common project, and evaluating the clinical and commercial potential of drug and device candidates.
Dr. Klein is a frequent speaker at international medical, scientific and pharmaceutical industry meetings, a referee for peer review journals, and a member of academic, governmental, and industry task forces and advisory boards. He is internationally recognized for his work on clinical trial design in the functional gastrointestinal disorders.
