Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announces the immediate appointment of Lynn Kramer, MD, to the newly created position of chief clinical officer of Eisai Product Creation Systems.
In this role, Dr. Kramer will be responsible for the approval of protocol designs of pivotal studies to achieve timely regulatory approval of competitive labels for new products, indications and life-cycle extensions. This includes the selection of study regions and clinical sites. He also will provide oversight of the design of Proof of Concept (POC) Studies for each of Eisai's Product Creation Units.
In addition to these new responsibilities, Dr. Kramer will continue to serve as president of the Neuroscience and General Medicine Product Creation Unit, a position he has held since July 2009. In this capacity, he is responsible for overseeing the full product creation cycle from discovery through regulatory approval of innovative projects in the neuroscience and general medicine areas.
Dr. Kramer joined Eisai in 2007 as executive vice president of Global Clinical Research and was soon promoted to the additional role of COO of Eisai Medical Research. Upon the establishment of Eisai Product Creation Systems in 2009, he accepted a dual appointment as president of the Neuroscience and General Medicine Product Creation Unit and also the Scientific and Operational Clinical Support (SOCS) Core Functional Unit. He held the SOCS position until mid-2010.
Dr. Kramer is a Fellow of the American Board of Psychiatry and Neurology. He currently serves as the industry representative on the Peripheral and Central Nervous System Drugs Advisory Committee of the Food and Drug Administration and is on the Board of Directors of the American Society for Experimental NeuroTherapeutics (ASENT). Dr.
Kramer also has been appointed to the newly established Scientific Leadership Advisory Council of the Pharmaceutical Research and Manufacturers of America (PhRMA).
Dr. Kramer received his MD from Hahnemann Medical College. He completed his internship in internal medicine at the University of California at Irvine and his residency in neurology at the University of Virginia. Dr. Kramer also holds a Bachelor of Arts from Lycoming College, where he has since been named to the Board of Trustees.