CULVER CITY, Calif., June 24, 2014 (GLOBE NEWSWIRE) -- The Coalition for Pulmonary Fibrosis (CPF) launched a pilot program with the Genetic Alliance to insure patients, their caregivers and families are heard by the U.S. Food & Drug Administration.
The CPF's patient community, along with the other two disease communities, is piloting the crowd-sourcing, technology-enabled approach to gathering input from a diverse set of patients on key benefit-risk questions.
In November, Genetic Alliance chose the CPF to represent Idiopathic Pulmonary Fibrosis (IPF) patients in the initiative through a technology called "Platform for Engaging Everyone Responsibly" (PEER). http://www.coalitionforpf.org/peer-portal/
"The timing couldn't be better to launch this platform. As it reviews possible first drugs for the indication of IPF later this year, the FDA will need to better understand these patients, their experiences, and the level of their willingness to accept risk," said Mishka Michon, CEO of the Coalition for Pulmonary Fibrosis. "When the FDA first reviewed a drug for IPF in 2010, neither patients or the FDA had the benefit of anything like this."
"We are pleased to be launching this program pilot with the CPF," said Sharon Terry, the President & CEO of Genetic Alliance. "The IPF patient community is especially important as the FDA reviews potential therapies and makes decisions that will impact their lives and the lives of their families."
Not only will the software allow patients and their families and caregivers to provide input on critical questions, the program will also allow the input of families and caregivers of deceased patients. Since the majority of IPF patients die within three years of diagnosis, it is often difficult to ascertain the full spectrum of the patient experience until after the patient is gone. Also, with the virtually 100 percent mortality in the disease, the CPF and Genetic Alliance believed the families and caregivers of deceased patients could provide a unique understanding of benefit-risk that is valuable to share with the FDA.
Genetic Alliance and the Pharmaceutical Research and Manufacturers of America (PhRMA) developed the initiative to explore the use of a technology-enabled, crowd-sourcing approach to patient engagement as a complement to ongoing patient-focused drug development efforts under the Prescription Drug User Fee Act (PDUFA V).
Background on Genetic Alliance Choice to include the CPF for IPF: After issuing a Request for Proposals, Genetic Alliance chose advocacy organizations representing three disease areas that will be the focus of FDA patient-focused drug development public meetings in 2014 and 2015: sickle cell disease, IPF and Irritable Bowel Syndrome.
Background on FDA decision to include IPF in its Patient-Focused Drug Development Efforts: IPF was chosen to be a disease focus of the FDA in 2013 when the agency announced 20 diseases for which it will hold public meetings to better understand the patient experience and patient perspective on drug development including a patients' willingness to accept risk with treatments. The CPF and more than 3,000 of its members sent letters to the FDA last year asking that IPF be included in the FDA list of diseases, since it was not included in the draft list posted by FDA in the fall of 2013. The FDA has not yet announced a date for the IPF workshop but it is expected to take place later this year.
Background on IPF: IPF is progressive and causes deadly scarring in the lungs that renders the patient breathless and debilitated. PF has no FDA approved therapies and no cure and claims as many lives each year as breast cancer. Scientists don't know yet what causes the disease that affects 200,000 Americans. The average lifespan, post diagnosis, is less than three years.
To learn more about PF, visit www.coalitionforpf.org .
About Pulmonary Fibrosis (PF): Pulmonary Fibrosis (PF) is a lung disorder characterized by a progressive scarring – known as fibrosis – and deterioration of the lungs, which slowly robs its victims of their ability to breathe. Approximately 200,000 Americans suffer from PF, and there is currently no known cause or cure. An estimated 48,000 new cases are diagnosed each year. PF is difficult to diagnose and an estimated two-thirds of patients die within five years of diagnosis. Sometimes PF can be linked to a particular cause, such as certain environmental exposures, chemotherapy or radiation therapy, residual infection, or autoimmune diseases such as scleroderma or rheumatoid arthritis. However, in many instances, no known cause can be established. When this is the case, it is called idiopathic pulmonary fibrosis (IPF).
About the CPF: The CPF is a 501(c)(3) nonprofit organization, founded in 2001 to accelerate research efforts leading to a cure for pulmonary fibrosis (PF), while educating, supporting, and advocating for the community of patients, families, and medical professionals fighting this disease. The CPF funds promising research into new approaches to treat and cure PF; provides patients and families with comprehensive education materials, resources, and hope; serves as a voice for national advocacy of PF issues; and works to improve awareness of PF in the medical community as well as the general public. The 'PF's nonprofit partners include many of the most respected medical centers and healthcare organizations in the U.S. With more than 28,000 members nationwide, the CPF is the largest nonprofit organization in the U.S. dedicated to advocating for those with PF. For more information please visit www.coalitionforpf.org or call (888) 222-8541.
Teresa Barnes Coalition for Pulmonary Fibrosis 303-521-4080
