Alopecia Areata Treatment Development Program
In 2010, NAAF launched the Alopecia Areata Treatment Development Program with one vision: a world without alopecia areata. The Treatment Development Program drives efficiency and improves research by bringing together scientists, doctors, government agencies, other patient advocacy organizations, industry, and the patient community to accelerate the discovery and development of safe and effective treatments.
NAAF is serving as the catalyst for alopecia areata research, leveraging valuable assets to form meaningful partnerships and moving promising research initiatives forward at record speed to bring treatments from bench to bedside.
Over the last six years, NAAF has hosted five research summits to distill the latest science and chart the path of the next most critical, high-leverage research investments. The focus is now on mining promising targets from basic research discoveries – especially in immunology, forming partnerships with industry to test FDA-approved treatments that act on these targets, and investing in the research infrastructure to pave the way for clinical trials.
A list of promising targets has been developed by researchers and clinicians based on the groundbreaking discovery of eight genes that contribute to alopecia areata, one of which has a possible role in the onset of the disease. These genes were also found to be associated with other autoimmune diseases, including rheumatoid arthritis, type 1 diabetes and celiac disease; all autoimmune diseases with pre-existing treatments.
BUILDING THE INFRASTRUCTURE
The Alopecia Areata Registry, Biobank & Clinical Trials Network (Regstry) is the largest collection of alopecia areata data and DNA samples in the world. NAAF serves as the trusted custodian of this centralized database and store of well-characterized samples, available to investigators studying the disease and pharmaceutical companies developing treatments.
This powerful resource provides an instant network to alert and recruit patients for clinical trials. We are committed to continue its management and funding so we can easily link clinical-trial–ready sites to the patient community, facilitating study enrollment and feedback.
A close relationship with the patient community allows us to easily promote patient involvement in research studies and clinical trials vital to bringing safe and effective treatments to market. We are able to quickly fill studies through many outreach avenues, including: social media; website; mail and email to our database; and the Registry.
We are committed to continue its management and funding so we can easily link clinical-trial–ready sites to the patient community, facilitating study enrollment and feedback.
PAVING THE WAY FOR FDA APPROVAL
NAAF has been working closely with the U.S. Food & Drug Administration (FDA) to ensure that a safe, effective treatment for alopecia areata will obtain swift approval.
We have developed a Uniform Clinical Trials Protocol with defined clinical endpoints, statistical analyses, safety procedures and vendor charters that meet FDA requirements. This protocol utilizes a risk-based management approach for clinical trials to improve quality, safety and efficiency while reducing costs.
Companies can simply plug in specific product data and receive an expedited review enabling studies to move rapidly from concept to completion.
We coordinated alopecia areata prevalence and incidence studies to help quantify the scope of the problem, which is vital to commercial partners and the FDA when a treatment is evaluated.
Recent incidence studies found a cumulative lifetime incidence of 2.1%, translating to 6.5 million people in the United States and 146 million worldwide who have, had or will develop alopecia areata at some point in their lives.
We have funded Quality of Life Studies to objectively demonstrate the burden of alopecia areata, also essential for treatment evaluation.
The FDA nominated alopecia areata as one of few disease areas that has been be selected for the next round of targeted assistance through their Patient-Focused Drug Development initiative to enhance regulatory assessment.
ADVOCATING FOR INSURANCE COVERAGE
We continue to advocate for increased federal investment and favorable health insurance coverage for alopecia areata and all autoimmune diseases to make certain treatments will be accessible and affordable for all patients. We are working with the Centers for Medicare & Medicaid Services (CMS) to ensure that, once an effective treatment is discovered, it will be reimbursed.