Alopecia Areata Treatment Development Program
NAAF launched the Treatment Development Program (TDP) with one vision: a world without alopecia areata. The TDP 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 to benefit the 145 million people worldwide who have, had or will develop alopecia areata in their lifetime.
Since 1985, based on targeted research aims set forth during our biennial researh summits, NAAF has awarded 185 research grants totaling $5.14 million. Of that, 38 grants totaling $1.65 million were directed to the line of inquiry that led to early stage clinical trials with drugs targeting the JAK immune pathways showing promising hair regrowth in alopecia areata for the first time ever. NAAF-funded research has also provided seed grants for over $10 million in alopecia areata research funding from the National Institutes of Health and has promoted over $20 million in government research funding in basic hair biology and related hair research.
NAAF has awarded 178 research grants totaling $4.4 million. Of that, 38 grants totaling $1.65 million were directed to the line of inquiry that led to early stage clinical trials with drugs targeting the JAK immune pathways showing promising hair regrowth in alopecia areata for the first time ever.
Bringing drugs from discovery to market approval takes an average of 15 years and costs over $1 billion. However, NAAF’s strategic investment of $1.65 million to support the development of a mouse model, the creation of a registry, and the initiation of immunogenetic studies, have shortened that timeline considerably. If the investigative trajectory that we now find so promising proves safe and durable, we could reasonably expect to see a treatment on the market for alopecia areata as early as 2020.
Strategically Driving Research
In 1988, NAAF began funding early genetic research studies in alopecia areata. NAAF awarded the first of 10 immunogenetic grants in 1989. In 1992, NAAF supported development of an alopecia areata mouse model with the earliest of 14 grants. NAAF's early support of Dr. Angela Christiano’s genetic studies (the first of 12 grants) in 1997, followed by the formation of the Alopecia Areata Registry, Biobank and Clinical Trials Network (Registry) in partnership with the National Institutes of Health* in 2001, proved instrumental in bringing about the groundbreaking 2010 Genome-Wide Association Study (GWAS) published in Nature.
Further genetic research has helped unravel underlying immunologic mechanisms that contribute to alopecia areata and identify important immune pathways that could be targeted with drugs approved by the Food and Drug Administration (FDA) for the treatment of other diseases. In 2014, NAAF advisors and grantees, Drs. Angela Christiano, Raphael Clynes and Julian Mackay-Wiggan, found that an FDA-approved drug for the treatment of myelofibrosis (a bone marrow cancer) produced near to complete hair regrowth in several patients with alopecia areata. Their exciting preliminary findings published in Nature Medicine represented a pivotal moment for alopecia areata research and treatment development.
This triumph is the result of a long history of Genome Wide Association Studies conducted by Dr. Christiano and supported by NAAF. Drs. Christiano, Clynes, Mackay-Wiggan and other members of the Columbia University team are active participants in NAAF research summits aimed to advance alopecia areata research and the development of safe, effective, affordable treatments. Without quick and easy access to well-characterized samples through the Registry – and the strategic framework of the TDP and associated research summits – these breakthroughs would never have been realized in only a few short years.
Treatment Development Program Action Plan
TDP drives efficiency and improves research progress by (1) conducting research summits that bring together scientists, physicians, government agencies, industry, and the patient community to discuss exciting new discoveries, identify innovative opportunities and prioritize the most critical, high-leverage research investments; (2) ensuring longevity of the Registry, a powerful resource of centralized data and samples for investigators studying the disease (3) facilitating future regulatory approval and coverage with the development of a standardized clinical trials protocol, coordination of prevalence, incidence and quality of life studies, advocacy efforts on Capitol Hill, and ongoing initiatives to incorporate the voice of the patient in research, including the creation of a patient-reported outcomes consortium to develop a single, consensus-defined, patient-reported outcomes instrument that can be shared across industry partners; and (4) providing critical seed and bridge funding to nurture high-caliber, independent researchers with an enduring focus on research relevant to alopecia areata.
TDP strategically funds highly meritorious grants to advance research in every phase, including (1) basic research to identify environmental triggers, genetic determinants, and disease processes offering leads for a cure or prevention (2) translational and clinical studies to bring treatment discoveries from the lab to patients, offering high-impact results and immediate benefits and (3) research to quantify and qualify biological, psychosocial and economic impacts ensuring swift regulatory approval and insurance reimbursement for potential treatments.
Over the next three years, NAAF seeks to increase key TDP investments to ensure continuation of rapid research progress and support future studies necessary to attain (1) a safe, effective and durable treatment profile, (2) FDA approval, and (3) health insurance coverage.
Your participation in the Treatment Development Program is an investment in aggressive, results-driven research!
For information about how you can support the Treatment Development Program, contact Maureen Smith, Chief Development Strategist at 415-472-3780.
For information about Treatment Development Program research activities and investigator resources, contact Abby Ellison, Associate Program Director & Research Coordinator at 415-472-3780.