Category: FDA

The Amyloidosis Forum, a public-private partnership initiated between the Amyloidosis Research Consortium and FDA, was highlighted recently during FDA Rare Disease Day Virtual Public Meeting on March 4th as an exemplary model to enhance product development using a public-private partnership approach.

Launched in 2019, the Amyloidosis Forum brings together the entire amyloidosis community- from patients to academia, regulators, industry, and other related research fields to, partner on key initiatives that are designed to bridge gaps in regulatory science and ultimately help improve upon and speed up how quickly we can bring new, safe, and efficacious drugs to the hands of patients with amyloidosis

Cardiologist Preston Dunnmon, formerly an FDA clinical team leader, noted that the Amyloidosis Forum was “born from the combination of profound medical need, fascinating science, and the frustrated energy of multiple stakeholders.”

The Amyloidosis Forum has included senior FDA staff from all involved divisions, including cardiology, nephrology, neurology, gastroenterology, hematology, and clinical outcomes assessment and statistics, and included people from the UK’s MHRA, as well as amyloidosis experts and other key stakeholders across the field.

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