BETHESDA, MD and COLUMBUS, OH
Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit drug development affiliate of the Cystic Fibrosis Foundation, announced today that it has selected Columbus Children's Hospital's Cystic Fibrosis (CF) Care Center to be part of the Therapeutics Development Network (TDN). The TDN is a network of health care institutions accredited by CFFT to conduct clinical trials of possible new treatments for CF. Columbus Children's Hospital's CF Care Center was one of the top applicants for inclusion in the TDN based on expertise, ability and facilities.
The CF Foundation's TDN, composed of eight original centers, was created in 1998 to capitalize on the increasing wealth of information uncovered by scientists about the basic defect in CF and to give CF patients access to clinical trials in cutting edge medicine traditionally available only to larger disease populations. By establishing specialized clinical centers, researchers can seize opportunities to intervene in the disease process through promising new CF treatments. The CF Foundation has taken a unique approach to drug development and through this network, now has infrastructure in place to expedite the time it takes to bring a new CF drug to market and at a significantly lower cost. Traditional drug development takes 10-15 years and approximately $800 million, but with the Therapeutics Development Network model, the CF Foundation has set its goal at seven to nine years and less than $100 million.
The principal investigators at Columbus Children's Hospital CF Foundation TDN Center are Karen S. McCoy, M.D., director of the Division of Pediatric Pulmonology and director of the CF Care Center, and John S. Heintz, M.D., director of the adult CF program at Columbus Children's Hospital.
"Columbus Children's Hospital has a long-standing commitment to providing both excellent care to people with CF and to conducting outstanding CF research. The leadership displayed by the CF team in patient care, drug development and core clinical research over the past several years is the primary reason behind their inclusion in the TDN," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation and CFFT. "We are confident that by becoming part of the TDN, Dr. McCoy, Dr. Heintz and their team will be able to increase their involvement in the fight against CF and will play an integral role in moving CF drug discovery from the test tube to the bedside in a safe and expeditious manner."
Columbus Children's Hospital will receive up to $108,000 per year over the next five years with the opportunity for renewal after the initial five-year period. This money will help the center establish the facilities, personnel and infrastructure necessary to conduct CF clinical trials. To select the new centers, the CF Foundation appointed a committee consisting of representatives from the academic medical community, the pharmaceutical industry and from the CF Foundation itself. The basis for selection included numbers of CF patients in the affiliated care center, expertise of personnel in clinical research, specialty facilities and university/hospital commitment to CF clinical research.
The CF Care Center at Columbus Children's Hospital regularly cares for more than 350 children and adults with CF. Information regarding these patients is entered into a secure database, which allows at-a-glance assessment of inclusion and exclusion criteria when recruiting for clinical trials. As a TDN center, Columbus Children's Hospital will participate in the development of novel assessment tools, as well as identifying patient participants for clinical trials, completing and documenting study procedures and complying with protocol and regulatory guidelines.
The Columbus team has outstanding laboratory capabilities that will specifically aid in evaluating the responses to CF interventions. For example, they have research quality bronchoscopy expertise, pulmonary physiology assessment proficiency (including for infants) and experience with highly sensitive, specialized radiographic techniques. These techniques include stop-ventilation high-resolution computed tomography of the chest, which allows visualization of very minor airway inflammatory changes.
In fact, Columbus Children's Hospital is ranked eighth in the nation among freestanding children's hospitals for receipt of research dollars from the National Institutes of Health. Columbus Children's Pediatric Clinical Trials International, in conjunction with the Division of Pediatric Pulmonology, already has participated in several important multi-center, TDN-sponsored projects.
"Our commitment to CF research extends beyond our staff and includes our patients who actively seek participation in research protocols," said McCoy. "In our new role as a member of the CF Foundation's TDN, we have the opportunity to use our resources to become an even greater force in CF research - to help improve care and realize a cure. We are extremely pleased and excited about the opportunity to be a part of this important initiative."
CF is a genetic disease that affects approximately 30,000 people in the United States. A defective gene causes the body to produce an abnormally thick, sticky mucus. This abnormal mucus leads to chronic and life-threatening lung-infections and impairs digestion. When the CF Foundation was created in 1955, few children lived to attend elementary school. Today, because of research and care supported by the CF Foundation with money raised from donations by individuals, corporations and foundations, the median age of survival for a person with CF is now 33.4 years.