On September 19, 2007, the Circulatory System Devices Panel will discuss, make recommendations and vote on a premarket approval application, sponsored by SyntheMed, Inc., for the REPEL-CV. REPEL-CV is a surgical adjuvant indicated for reducing the incidence, severity and extent of post-operative adhesion formation in patients undergoing cardiac surgery. Target Health is pleased to announce that it will attend the meeting on behalf of the sponsor. For this program, Target Health provided regulatory consulting, monitoring, data management, biostatistical and medical writing services. We prepared and submitted the PMA (including eCopy) and Target e*CRF® was used for the pivotal trial. The meeting is being held at the Hilton Washington DC North/Gaithersburg, Gaithersburg , MD.

For more information about Target Health, please contact Dr. Jules T. Mitchel. or Joyce Hays.

Researchers at the University of Sheffield in England, have developed a long-acting growth hormone. The new discovery could mean that children and adults with growth hormone 1) ___ will not have to have injections as often, reducing the need for daily treatments. Most hormones and 2) ___ have a short life and therefore require frequent injections as therapy. The new technology developed, means that scientists and clinicians are able to generate effective, long-acting hormones which promote growth over a minimum of ten days, after just one 3) ___. Cytokines are a subset of 4) ___ that enable communication between cells and the external environment, including the immune system. Cytokines hold huge potential for the treatment of disease due to their often fundamental roles in the development and progression of 5) ___. The research, published in the journal Nature Medicine, shows that the hormones are able to act for longer because of unique characteristics in the new 6) ___ created. Hormones normally circulate in blood attached to binding 7) ___ that prevent their clearance from the circulation and prolong their biological action. The new molecules, are able to bind to each other in a head-to-tail configuration, doubling their molecular mass in the 8) ___. This delays their absorption and elimination from the blood and therefore generates a hormone that will last for a longer period of time. This technology could bring significant benefit to patients. Children and adults with growth hormone deficiency have to give themselves daily injections and it is hoped that the new technology will reduce the number of times they have to do this to once every two weeks, or even once a month. The team is in the early stages of the drug 9) ___ process, and any drugs resulting from this research are several years away. The technology can also be applied to treat 10) ___ diseases such as multiple-sclerosis, cancer and metabolic diseases.


ANSWERS: 1) disorders; 2) cytokines; 3) injection; 4) hormones; 5) disease; 6) molecules; 7) proteins; 8) bloodstream; 9) development; 10) inflammatory