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CPF Wins Place in Genetic Alliance Pilot Initiative to Advance Patient-Focused Drug Development

Coalition for Pulmonary Fibrosis logo

CULVER CITY, CALIF., Nov. 5, 2013 (GLOBE NEWSWIRE) -- The Coalition for Pulmonary Fibrosis (CPF) has been chosen to represent Idiopathic Pulmonary Fibrosis (IPF) patients in a new pilot initiative that will help insure patients are heard in U.S. Food and Drug Administration (FDA) drug development decisions through a technology called "Platform for Engaging Everyone Responsibly" (PEER).

In an effort to help more patients have a voice in the FDA process, Genetic Alliance and the Pharmaceutical Research and Manufacturers of America (PhRMA) developed an 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).

"We are pleased to be given this opportunity to make sure that not only are IPF patient voices heard in the FDA drug development process, but we will be able to provide a tool to our patients to make it simple for them to do so," said Mishka Michon, CEO of the Coalition for Pulmonary Fibrosis. "Since IPF has no FDA approved therapies, it is critical the FDA understand the patient community's perspective."

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. The CPF's patient community along with the other two disease communities will pilot a crowd-sourcing, technology-enabled approach to gathering input from a diverse set of patients on key benefit-risk questions.

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 earlier this year 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 announced plans to hold the IPF workshop in March 2014.

Background on IPF:

IPF is progressive and causes deadly scarring in the lungs that renders the patient breathless and debilitated. Unlike breast cancer PF has no FDA approved therapies and no cure. 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 27,000 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.

CONTACT: Teresa Barnes Coalition for Pulmonary Fibrosis tbarnes@coalitionforpf.org 303-521-4080

Source:Coalition for Pulmonary Fibrosis(CPF)