The 2015 Arthritis Industry Forum (AIF) was held Oct. 7-8 in Washington, DC, convening stakeholders from the pharmaceutical, biotech and academic fields – along with federal agency and Capitol Hill staff – to discuss vital policy issues around arthritis. Presentations ranged from fascinating discussion about the future of identifying biomarkers on individualized treatment regimens to a profoundly moving photography collection depicting people with disabilities boldly expressing their beauty and strength.
Arthritis Foundation CEO Ann Palmer spoke about the organization’s continued growth since last year’s forum, as well as increased efficiencies and effectiveness. “My vision is that we become the Amazon.com for the arthritis community,” said Palmer, “a one-stop personalized destination for those affected by the disease to find resources, connect with their local communities, receive tailored help and get the advice they need to overcome everyday battles.”
Palmer went on to highlight several Arthritis Foundation successes, including record-breaking attendance at the Juvenile Arthritis Conference last summer and hosting a registry workshop for arthritis patient databases so that arthritis data can be studied globally.
Advocacy in action; speeding up science
Sandie Preiss, national vice president of the Foundation’s Advocacy and Access team, told attendees that the organization has successfully grown its advocacy program over the past year, including an increase in numbers of meetings and briefings with legislators. “The Arthritis Foundation’s Advocates recruited 68 new members to the Congressional Arthritis Caucus,” Preiss said, adding that almost one quarter of the members of Congress are now members of the Caucus, representing more than 127 million Americans. In addition, there has been advocacy activity supporting 159 health care bills in 46 states.
The Arthritis Foundation’s new scientific strategy was presented by Amanda Niskar, national scientific director. Dr. Niskar said the science team has implemented changes to stimulate innovative approaches, quicker results and practical application of research findings and how to bring those findings to the market. She also discussed the new request for proposals (RFP) process. “There was no exclusion criteria for who was eligible to apply for research funding,” stated Niskar. “We simply said, ‘Tell us the best way to find a cure for arthritis.’ We’re trying to find the most innovative people, ideas and approaches.”
Quality of life matters most
Marc Boutin, CEO of the National Health Council, presented information on the Prescription Drug Fee User Act and how it has changed over the years. He also elaborated on the changing Food and Drug Administration (FDA) culture and processes and how the FDA is becoming more progressive about the consideration of a patient’s needs and concerns. He said patient feedback is being incorporated into the drug development process and studies indicate that patients prefer the development of drugs that focus more on quality of life versus overall longevity. Boutin emphasized the importance of continuing to find ways to use patient-based input.
A panel moderated by Wesley Metheny of Penn Quarter Partners discussed the importance of positive and supportive relationships in securing bipartisan approval in the House and how it will continue to be important in the Senate. They also discussed the necessity of clear and accurate communications that properly portray the prevalence and impact of arthritis.
Breaking beauty out of the box
Shelly Baer discussed her life as a person living with arthritis and her consequent exploration of her own body and the bodies of other people with disabilities in an art show called “The Bold Beauty Project.” “I’m standing here today to ask that we re-examine how we look at beauty – the beauty of disability,” said Baer. “Let’s break beauty out of the box – the narrow confines of society’s unrealistic standards.” The project features people with disabilities in artistic poses that highlight their physical presence. Baer explained that her participation in the Arthritis Foundation Advocacy Summit was “transformative,” inspiring her to create the Bold Beauty Project. She said she found her voice at the Summit and offered thanks to the sponsors of that event.
Another panel, moderated by Jorge Lopez, Jr., partner and head of National Health Industry Practice at Akin Gump Strauss Hauer & Feld LLP, had a lively and engaging discussion about their experiences working with legislators. The panelists also discussed their experiences with Advocates during the legislative negotiations surrounding the enactment of the Affordable Care Act and offered best practices for engaging in legislative discussions.
Biomarkers should lead to significant breakthroughs
To close out the forum, AIF Chair Michele Oshman facilitated a discussion with Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, focusing on the FDA’s process for patient involvement in the development of drugs. “We have learned [through patient interviews] that survival isn’t the gold standard,” said Woodcock. “Living is the gold standard. And that isn’t the medical point of view. ”
She also acknowledged that due to the unanticipated volume of expedited new drug applications, the FDA is understaffed, and this issue is made worse because the Federal hiring process takes too long. Regarding the evolving role of patients, “It [patient input] is going to be more of a social science,” Woodcock noted. “We’re going to have to figure out how to collect authentic, valid and representative patient data. We know there’s a spectrum of risk tolerance. We know there’s a spectrum of disease. We know different people are different. We need to collect from the community and there are ways to do this.” She noted that this information can be gathered in partnership with partnership with patient advocacy organizations, as they are the “true patient experts”. FDA is currently working with several patient groups leading scientific programs to develop Patient Reported Outcome measures.
When asked how to improve the number and quality of true scientific breakthroughs, Woodcock indicated that breakthroughs are driven by scientific progress and, in the past, progress was very slow. She noted that with the establishment of biomarkers, breakthroughs should come more frequently and be more significant.
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