September 25, 2017
College Park Marriott / Hyattsville, MD


What is patient-focused drug development (PFDD)?

For several years, Congress and patient advocates have been demanding that patients have a greater voice in the FDA product review process. For too long, patients were seen largely as customers or as participants in clinical trials but were rarely viewed as equal partners in this work.

This view is now changing thanks to patient-focused drug development or PFDD for short. Simply put, PFDD is a set of laws and policies that are providing opportunities for patients to be more involved in the FDA’s drug review process. The Lupus PFDD Meeting is one example of PFDD.

What is an externally-led PFDD meeting and how does it differ from an FDA-hosted meeting?

More than five years ago, the FDA committed to convene 20 to 25 meetings for patients organized around specific diseases or conditions. These meets were known as the agency’s Patient-Focused Drug Development or PFDD meetings. This program developed the prototype for the PFDD meeting and was well-received by patient groups. However, demand for these meetings far outpaced the agency’s ability to convene them, which necessitated development of another meeting route.

In late 2015, FDA developed the externally-led PFDD meeting option whereby patient communities like ours can serve as organizers. The FDA must still grant requests for such meetings and will attend these externally-led meetings, using a format similar to those used by meetings hosted by FDA.

When and where will the meeting be held?

The Lupus PFDD Meeting will be held Monday, September 25 from 10:00 a.m. to 4:00 p.m. at the College Park Marriott Hotel and Conference Center in Hyattsville, Maryland, just outside of Washington, DC. Check-in will be from 9:00-10:00 a.m. If you want to attend the meeting in person, you must register by September 12.

How will the information from the survey and meeting be used?

The organizers will develop a report containing the information from the meeting as well as the pre-meeting survey that summarizes the community’s perspective on life with this disease and what our community wants to see in new treatments for lupus. This data will inform how FDA views upus and our community, including what life with lupus is like each and every day and what we are hoping to see in the future.

How will this meeting impact our community?

The intent of the patient engagement movement is to ensure that the FDA understands the perspectives of patients impacted by a disease or condition and keeps those in mind when reviewing prospective treatments. We want and need the FDA to understand the lupus patient journey, including the many physical challenges of this disease, the limitations it places on daily activities of life, the social frustrations and the emotional pain.

Simply put, we want FDA officials to experience a day in our lives and to walk away with an understanding of what we want to see in lupus therapies and treatments. This includes giving the agency meaningful insights into the level of risks we would be willing to accept in exchange for potential benefits in treatments as well as what outcomes matter most to us. This meeting provides a unique forum to achieve this objective.

How will we know if the meeting is successful?

First and foremost, a successful PFDD meeting requires a large and diverse group of patients ready to actively participate and to share their story and perspectives. FDA officials have been clear that they want and need input from a large enough sample of people with lupus to have confidence we are capturing information on the diverse nature of lupus and its wide variety of impacts.

Beyond a well-attended and vibrant meeting, our community will summarize the findings and recommendations and have follow-up engagement with the agency to ensure the perspectives and views aired are heard and inform agency decision-making.

How can I participate?

As mentioned above, we need people with lupus to register to attend the meeting in person. A robust and diverse crowd of lupus advocates – including representatives of those with the disease – will be essential to a productive meeting. From the group of registrants, the organizers will assemble two patient panels of persons with lupus who will help kick off and drive the discussion and help frame the dialogue. These participants will have an important role to play. They will work closely with the organizers in advance of the meeting to develop the remarks they will share about their patient journey. This could include their path to diagnosis, how lupus impacts their daily life and their experiences finding treatments for the disease.

How can I join the meeting online?

The conveners are committed to ensuring the most widespread access to this meeting as possible. As such, the meeting will be streamed live providing the ability for anyone to participate. Register to participate in the webcast on this page and we will send you a link to the webcast closer to the day of the meeting.

Will financial support be available to cover travel and other expenses associated with attending the meeting?

The organizers will be selecting people to speak on panels or be active audience participants during the event based on responses to the survey. Individuals who are selected as panelists and audience participants will have their trip costs covered including travel to/from Hyattsville, hotel rooms, meals, and local travel. If you would like to be considered for a role as a panelist or audience participant, please complete the survey by July 1, 2017. You will be notified in early August if you have been selected for one of these roles.