The Lupus and Allied Diseases Association, Inc., the Lupus Foundation of America and the Lupus Research Alliance are partnering to convene a day-long meeting to advance lupus therapy development and inform Food and Drug Administration (FDA) regulatory decision-making on new drugs for lupus.

The Lupus Patient-Focused Drug Development (PFDD) Meeting, one of the first sessions to be accepted by the FDA under the agency's externally-led PFDD meeting initiative, will be held September 25 from 10:00 a.m. to 4:00 p.m. at the College Park Marriott Hotel & Conference Center in Hyattsville, Maryland.

The meeting will enable persons with lupus to share their personal experiences of life with the disease, how it impacts them on a daily basis, their approaches to managing the condition, and what they desire most in future lupus therapies.

For more than two years, the three convening organizations have worked collaboratively to develop a high-impact agenda for the PFDD meeting. This includes two panels of persons with lupus who will share their unique experiences about life with this disease and their views on treatments to facilitate the meeting. Audience members with lupus will also have an opportunity to provide comments and respond to polling questions throughout the meeting. This direct patient perspective will allow leaders from the FDA to understand what it is like to walk in the shoes of those impacted by the disease and what the lupus community wants to see most in new therapies, including levels of risk people are willing to accept in exchange for certain benefits.

Nearly 300 people, including more than 120 people with lupus or their representatives, will attend the meeting in person, and another 300 will participate through a live webcast accessible on the Lupus PFDD Meeting website: https://lupuspfdd.org.

Staff from the FDA who will be presenting at the meeting include Dr. Janet Woodcock, Director for the Center for Drug Evaluation and Research (CDER), as well as Pujita Vaidya, also from CDER, and Dr. Nikolay Nikolov, with the Division of Pulmonary, Allergy, and Rheumatology Products. In addition, several other FDA staff and representatives from the National Institutes of Health will be at the meeting.