Target Health Inc. is pleased to announce the release of Target Document Version 1.3. This 21 CFR Part 11 compliant version has a bulletin board for discussions about documents and allows the administrator to recover deleted documents. Other features include eSignatures, full user and group management, document check-in and check-out, folder templates, full audit trail of changes, version controls etc. Several CROs have already licensed Target Document and are experiencing significant cost savings. Target Health is managing a 90-center clinical trial with a fully paperless Trial Master File (TMF). We have no physical TMF binders and no paper copies of documents. For an analysis of cost savings, please go to our website and read Target Document – Cost Analysis and ROI.

For more information about Target Health or any of its software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors

A Humanitarian Use Device (HUD) facilitates the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people per year in the US. To receive approval, a company must demonstrate the safety and probable benefit of the device. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting small populations. To obtain approval for an HUD, an humanitarian device exemption (HDE) application is submitted to FDA. An HDE is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.

The FDA has approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe OCD. Obsessive-Compulsive Disorder (OCD) is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Repetitive behaviors such as handwashing, counting, checking, or cleaning are often performed with the hope of preventing obsessive thoughts or making them go away. Performing these actions provides only temporary relief, but not performing them markedly increases anxiety. The Reclaim system uses a small electrical generator known as a pulse generator to create electrical stimulation that blocks abnormal nerve signals in the brain. This small battery-powered device is implanted near the abdomen or the collar bone and connected to four electrodes implanted in the brain through an insulated electric wire known as the lead. Two device systems may be implanted to stimulate both sides of the brain or one device may be implanted with two lead outputs. The approval of the human device exemption was based on a review of data from 26 patients with severe treatment resistant OCD who were treated with the device at four sites. On average, patients had a 40% reduction in their symptoms after 12 months of therapy. While all patients reported adverse events, the majority of these events ended after an adjustment was made in the amount of electrical stimulation. Patients who require electroconvulsive shock therapy should not be implanted with the Reclaim device. Other patients who should not use the device include persons who will undergo magnetic resonance imaging (MRI) or deep tissue heat treatment known as diathermy.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

A new theory has been proposed of how Alzheimer’s disease kills 1) ___ cells. It is hypothesized that a chemical mechanism that naturally prunes away unwanted brain cells during early brain development somehow gets hijacked in Alzheimer’s disease. Amyloid precursor protein (APP) which a key building block in brain 2) ___ found in Alzheimer’s disease, is the driving force behind this process. It is known that APP is a negative factor in Alzheimer’s, but it has been unclear how it participates. One theory is that somehow this self-destruction mechanism gets switched on in Alzheimer’s disease and starts killing healthy brain cells. The finding provides new clues about potential treatments for Alzheimer’s, a disease that gets worse over time and is marked by 3) ___ loss, confusion and eventually the inability to care for oneself. The researchers made the Alzheimer’s connection by accident while studying a process of nerve cell self-destruction that occurs as a part of normal embryonic development. When the brain and spinal cord are being formed, excess nerve cells are generated that have to be removed to refine the pattern of nerve cell 4) ___. They discovered a biochemical mechanism that activates when nerve cells are pruned back. A key component of this self-destruction program was none other than APP, this bad actor in Alzheimer’s disease. In Alzheimer’s disease, 5) ___ snip APP into beta amyloid pieces, which form the basis of beta amyloid plaques that are thought to be toxic. Many companies are working on drugs to remove beta amyloid from the brain, but so far have had little success in altering the course of the disease. The current theory suggests targeting APP and other components of this mechanism may help. In tests on human 6) ___ cells, the team showed it was able to interfere with the mechanism and block the degeneration of nerve cells. The researchers now plan to see if they can disrupt this mechanism in adult brain cells. The key question is, if we interfere with it, can we halt the progression of the disease?. There is no cure for Alzheimer’s, and current drugs merely delay symptoms. Alzheimer?s disease affects 5.2 million people in the US and 26 million globally.


1) brain; 2) plaques; 3) memory; 4) connections; 5) enzymes; 6) embryonic