Q: What prompted the creation of the COPD Foundation?
When the COPD Foundation was formed in 2004, Chronic Obstructive Pulmonary Disease was the fourth leading cause of death. It has since become the third leading cause of death – 12 years earlier than experts predicted. At the time of the foundation's founding, scientific, clinical, and patient leaders saw that there were big gaps in research, education, and support services for the more than 24 million individuals affected by COPD. It was clear we had to do something that would improve people's lives and one day cure this devastating disease. From the beginning, the foundation has been a true partnership between the scientific and patient communities, allowing us to engage all the stakeholder groups to support our mission.
COPD is a preventable and treatable disease. The COPD Foundation was established to speed innovations that will make treatments more effective and affordable, undertake initiatives that result in expanded services for COPD patients, and improve the lives of patients with COPD and related disorders through research and education that will lead to prevention and someday a cure for this disease.
Q: What were the challenges in COPD research that the foundation aimed to address?
With the guidance of our scientific leadership, we identified the gaps that needed to be filled in order to create an infrastructure that would support research for COPD on a meaningful level. Convening these leaders was the first step toward organizing and charting out a vision and pathway to accelerate research for COPD. Early on it was clear that despite the size of the community affected by COPD, there were challenges in identifying patients willing to participate in research and in characterizing large cohorts with the disease. It was also clear that, while there was tremendous interest in COPD, there was relatively little collaboration occurring across stakeholder groups such as academic researchers, clinical and translational researchers, government bodies, and pharmaceutical industry, and that most importantly there were no mechanisms for meaningful patient involvement in this work. The lack of infrastructure for recruitment and limited collaboration meant fewer discoveries were being translated into better treatments, and issues most important to our patient community were not rising to the top. This was unacceptable. In some cases these barriers appeared in part to be a result of the stigma around working with industry, and we felt we could challenge this stigma through good practices guided by the National Health Council and others that would result in engaging industry, not alienating them.
Q: Can you tell us a bit about the foundation's research strategies and how they help overcome the barriers you've identified?
The foundation focused early on the creation of infrastructure and platforms for collaboration to accelerate research. We needed to awake the sleeping giant that is the 24-plus million individuals with COPD in the United States, ensure they get properly diagnosed and treated, and engage them in the community and ultimately research. From the outset the large majority of COPD Foundation research expenditures have been aimed at making the money invested in research studies by other agencies and industry more efficient and effective, rather than spending more money on studies that would achieve only incremental change.
We started by forming a COPD Research Registry, which allowed patients to complete personal health questionnaires and sign up to be notified when there are opportunities to participate in clinical research. We created scientific advisory committees that promoted the cross-fertilization of ideas and sharing of resources across institutions and agencies that rarely spoke before. When the NIH funded the largest-ever study in COPD, the COPDGene Study, we created a structure that allowed private interests to provide ancillary funding, leveraging NIH's investment by vastly increasing the study's scope and depth of work. Most recently, when hurdles to faster drug development that can only be overcome through collaboration among competing companies present, we provide a neutral space for that previously unheard of collaboration to occur.
Q: What do you consider the foundation's greatest accomplishments to date?
The foundation has connected the dots among the clinical, scientific, and patient communities and have expanded the dialogue on how we can all work together to advance the understanding of COPD, improve the health outcomes of individuals with COPD, and support the development of more effective therapies. We have created several mechanisms for everyone to sit at the same table and have built bridges to the federal agencies that allow us to serve as resources for them.
We are extremely proud of the involvement we have had in the COPDGene Study, which has identified numerous phenotypes of COPD so that therapeutic development can be focused on those phenotypes, leading to a more direct impact on health outcomes in the future. To date, the Industry Advisory Committee that the foundation organizes has raised more than 4 million to support longitudinal follow-up of study subjects. The NHLBI approved funding for Phase 2 of the COPDGene Study, and there is no doubt that it will turn out to be a landmark development in how we understand and treat COPD now and into the future.
One of our greatest accomplishments to date has been the COPD Biomarkers Qualification Consortium (CBQC), created as a result of a consensus recommendation from a workshop that FDA, scientific, and industry leaders asked us to convene to address the challenge of qualifying biomarkers for COPD drug development. No one company has the data necessary to formally qualify new biomarkers, which would help accelerate the clinical trial process. The foundation organized the CBQC in 2010 and, as a result, multiple pharmaceutical companies now contribute financial support and data from their landmark clinical trials in an effort to complete the FDA qualification process for several new biomarkers. All intellectual property created from the qualification of new biomarkers will be owned by the COPD Foundation and will be made freely available to all.
Q: What are your top research goals over the next year, and what will it take to reach those goals?
At the end of 2013 we were thrilled to be selected by PCORI to create the COPD Patient Powered Research Network (PPRN) and to participate in one of the most unique and robust infrastructure building efforts for clinical effectiveness research of our time. The PPRN will catapult our efforts to focus on community engagement in 2014 and, as with all of the foundation's work, will be driven by patients and answer questions important to patients. Through the PPRN we aim to enroll at least 50,000 patients who are willing to share their information for outcomes studies and be contacted to participate in clinical research in the future.
Ultimately we have a vision of creating a mega-registry that hundreds of thousands of individuals with COPD will engage with, providing patient-reported information and medical records that will facilitate the next generation of targeted therapeutic development.
Neither are small tasks, but we have arrived at a stage where we must think big if we are to take the new knowledge about COPD and translate it into better treatments and improved health outcomes. There are considerable challenges to overcome in the PPRN and registry-building surrounding data privacy, IRB approvals, data quality, and more. To be successful we must also understand why the patient community wants to participate in research and ensure that we all create infrastructure and programming that meet their needs most importantly.
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