The Amyloidosis Forum – bringing together the AL amyloidosis community with FDA
ARC is excited to announce the inaugural gathering of The Amyloidosis Forum on November 12, 2019 at FDA’s White Oak Campus in Silver Spring, MD.
This is the first in a series of meetings focusing on advancing drug development in AL amyloidosis and stems from the creation of ARC’s Public Private Partnership (PPP) with the U.S. Food and Drug Administration (FDA).
The PPP, which was announced in June 2019, provides ARC with the unique opportunity to bring together the entire AL amyloidosis community – patients, caregivers, academia, industry and regulatory – at FDA to discuss the challenges and obstacles to developing treatments for AL amyloidosis. FDA is well aware of the difficulties of designing and conducting studies in AL amyloidosis, due to the heterogeneity of the population combined with the complexity of the disease and treatment pathways. It also recognizes the desperate need of patients to have therapies developed and approved for AL amyloidosis.
In addition to expert speaker presentations, there will be a number of large panels discussions consisting of a broad range of different members of the AL community, including patients and caregivers, industry representatives, statisticians, clinicians, and researchers, as well as representatives from seven different divisions of FDA. This is a unique forum for open discussion and collaboration to consider ways to break down the barriers to drug development in amyloidosis, and to develop actionable pathways for drug development and approval.
The planned outcomes from the meeting will consist of a publication and the development of a roadmap for future meetings and working groups. Subsequent meetings of the Amyloidosis Forum will go into greater depth on a variety of topics relevant to developing treatments for AL, such as biomarkers, different types of endpoints for studies, and quality of life tools and measurements.
ARC is very proud to be at the forefront of the growing movement to recognize the importance of real-life patient outcomes when considering clinical study and drug development. Improving patient outcomes is at the center of all that we do, and what drives us to push for accelerating the pace of development of new and innovative treatments to improve the quality of life for all amyloidosis patients. We are eagerly looking forward to the first Forum on November 12th at FDA.
More information can be found at www.amyloidosisforum.org