Lupus Groups to Host ‘Patient Voices’ Drug Development Meeting Next Spring

Lupus Groups to Host ‘Patient Voices’ Drug Development Meeting Next Spring
0
(0)

Four key Lupus advocacy groups will host a Lupus Patient-Focused Drug Development Meeting next spring called “Lupus: Patient Voices,” according to a news release.

The groups, the Alliance for Lupus Research (ALR), the Lupus Research Institute (LRI), the Lupus and Allied Diseases Association (LADA), and the Lupus Foundation of America (LFA), will lead the innovative initiative featuring panel debates to provide the U.S. Food and Drug Administration (FDA) with different viewpoints from advocates, lupus patients, and  caregivers.

The conference will follow a model previously developed by the FDA. Focus will be placed on discussing patient perspectives about lupus; reviewing the disease’s symptoms and its impacts on patients lives; and exploring patients’ views on currently available and potential future therapies.

According to organizers, the day-long event aims better inform the FDA’s decisions and oversight for development of new drugs for Lupus and assist in the review of marketing applications for new Lupus treatments.

The four Lupus associations responded to the FDA’s call for organizations to send letters of intent for the Patient Focused Drug Development (PFDD) convention.

PFDD is a new initiative from the FDA intended to bring patient perspectives into an earlier stage of product development in order to provide context for benefit-risk assessments and input to review divisions. The FDA also hopes to utilize information to help in the development of new assessment tools, study endpoints, and risk communications.

A related effort was undertaken in 2014 by the Parent Project Muscular Dystrophy (PPMD), who lobbied for passage of the Patient-Impact Assessment Act by Congress to function as a publicly accessible measurement tool for the FDA to conduct revisions of their other resources and tools focused on patient-focused drug development.

Beginning in fall 2017, the four lupus organizations will begin gathering input from patients across the country through personal stories and surveys. At that time, information regarding patient participation in the meeting will be made available.

Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
×
Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
Latest Posts
  • Benlysta
  • COVID-19 Global Rheumatology Alliance
  • RC18 on fast track
  • financing round

How useful was this post?

Click on a star to rate it!

Average rating 0 / 5. Vote count: 0

No votes so far! Be the first to rate this post.

As you found this post useful...

Follow us on social media!

We are sorry that this post was not useful for you!

Let us improve this post!

Tell us how we can improve this post?