Target Health is actively involved in the Clinical Trial Transformation Initiative (CTTI). The goal of the CTTI is to optimize the clinical trial process and to eliminate the infinite number of myths common to the clinical trial and regulatory community. The CTTI mandate is to identify existing issues related to current practice, design models for improvement, and to test the new models and compare them to existing processes. Target Health will contribute its extensive experience in clinical trials and regulatory affairs and its cutting edge paperless clinical trial toolbox (21st Century technology) to the CTTI. Target Health’s proprietary clinical trial software, enables our customers to switch from paper to the the digital world and at the same time accelerate time to market, increase productivity and save money.
For more information about Target Health or any of its software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors
FDA has launched of a voluntary 2-year pilot program that would help promote the safety of drugs and active drug ingredients produced outside the US. FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot’s criteria into the US. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders. Information about the pilot appears in a Federal Register notice. The way it works is that each applicant may designate up to five drugs for selection in the pilot program. To qualify, applicants will need to meet the pilot’s criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the US. A secure supply chain will help mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received. Companies wishing to participate in the two year pilot program must meet certain criteria, including:
* For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
* The active pharmaceutical ingredients imported must be used only to make FDA approved drugs;
Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
* Applicants must show that their drug products use a secure supply chain.
For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Patients with spinal cord injuries will be first 1) ___ to receive repair cells derived from embryonic stem cells. The first ever clinical trial using stem cells derived from embryonic stem cells (ESCs) received the go-ahead, from the FDA on January 23, 2009. Geron Corporation, a company based in Menlo Park, California, hopes to mend the spines of patients paralyzed from the chest down by 2) ___ injury sites with stem cells that restore connections and repair damage. This marks the beginning of what is potentially a new chapter in medical therapeutics, one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The trial had been “on clinical hold” for years over concerns that the cells could form 3) ___, but the FDA is now satisfied that this risk is low enough to allow the trial to proceed. Ethical concerns have also dogged the trial, because obtaining the cell lines involved destruction of embryos. US president, George Bush, had prevented research using such cells for eight years. The new president, Barack Obama, promised in his inaugural address to “restore science to its rightful place”, so approval of the trial could be an early sign that he will lift all of the previous restrictions on stem-cell research, first imposed in 2001. Hundreds of trials are already under way around the world with stem cells derived from adult or 4) ___ tissue, but these cells are limited in the types of tissue they can turn into and repair. The spine repair trial could open up a new era in medicine because embryonic stem cells are the only type that generate all 200 or so 5) ___ of the body. Geron says that the main objective is to prove the cells are 6) ___, especially given the FDA’s earlier misgivings over the cancer risk. But for one year after treatment, the company will also look closely for any recovery of function and movement in the lower 7) ___ lost through the injury. In all, the patients will be monitored for 15 years. If the cells appear safe, it could open the floodgates for a host of other trials using cells originally derived from ESCs. Geron itself has developed such cells for treating heart attacks, diabetes, bone damage, arthritis, liver failure and 8) ___.
ANSWERS: 1) humans; 2) injecting; 3) tumors; 4) fetal; 5) tissues; 6) safe; 7) body; 8) cancer