Landmark Externally-Led Patient-Focused Drug Development Meeting on Schizophrenia Showcases Urgent Need for New & Better Treatments

November 2 from 10 a.m. to 3 p.m. ET

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People living with schizophrenia and other psychosis spectrum disorders are too often misunderstood or ignored, and current treatments are outdated and can cause significant side effects. On November 2, 2022, the schizophrenia community finally had the spotlight, as those living with the condition and their family members shared their treatment needs and concerns with drug developers and FDA staff.

The Externally-Led Patient Focused Drug Development (PFDD) meeting – “Reimagine Schizophrenia: Transforming How We Are Treated, Function and Thrive” – offered the chance to make what matters to those living with the neurobiological brain disease a higher priority in drug development and the FDA review process.

The meeting was co-hosted by the Schizophrenia & Psychosis Action Alliance, the American Foundation for Suicide Prevention, Mental Health America, the National Alliance on Mental Illness, and the National Council for Mental Wellbeing.

Voice of the Patient Report

The U.S. Food and Drug Administration created the PFDD program in 2012 to collect information about the patient perspective on drug development – specifically, what people living with a disease consider to be meaningful treatment benefits and how they want to be involved in the drug-development process.

While current treatments for schizophrenia can help control symptoms, most have significant side effects, such as weight gain and tardive dyskinesia, a condition that causes involuntary facial and other muscle spasms. Fortunately, many new treatments are in development, making it more critical than ever that we tell drug developers and regulators what we need from new treatments: what benefits we expect, and what risks we may be willing to tolerate if we can achieve those benefits.

This is our time – our opportunity to advocate for new and better treatments that will improve how we feel, function, and thrive.

Meeting Agenda & Content

This meeting will take place in a virtual format to maximize inclusion of all who want to participate. It will feature two panels of people who live with schizophrenia, as well as polling and discussion sessions on key topics, featuring those living with schizophrenia and those who care for them. People living with schizophrenia as well as their caregivers and family members will be central to both planning and participating in the event.

Click the button below to take a pre-meeting survey that provides people with schizophrenia and their caregivers the chance to share their insights about living with this serious brain disease. The survey is an important opportunity in the PFDD process for our community to speak out—to help the FDA, drug developers and healthcare providers better understand how schizophrenia affects our lives and what we need from treatments to allow us to thrive.

This survey also offers the chance to serve as a meeting panelist. Both people living with schizophrenia and their caregivers are eligible to volunteer; we will choose some of our panelists from among those express interest and complete the survey.

Meeting Agenda

The event live stream link will be available on this page closer to the meeting date. An agenda with the discussion topics and panelists will be posted closer to the meeting date.

Millions of people around the world live with schizophrenia and many do not receive effective treatment and support. This gap is caused by the complexities of the condition as well as by social stigma, health system limitations, discrimination, and poor reimbursement for treatment. The resulting cost to society in the United States is estimated at $281.6 billion each year.

Please join us Wednesday, November 2 at 10 a.m. ET for this important milestone on our path to transform the experience of living with schizophrenia.

PFDD Meeting

The meeting was held in a virtual format to maximize inclusion of all who wanted to participate. It featured two panels of people who live with schizophrenia, as well as polling and discussion sessions on key topics, featuring those living with schizophrenia and those who care for them.

The event live stream link will be available on this page closer to the meeting date. An agenda with the discussion topics and panelists will be posted closer to the meeting date.

Please join us Wednesday, November 2 at 10 a.m. ET for this important milestone on our path to transform the experience of living with schizophrenia.

Meeting Goals

To enhance FDA and treatment developers’ understanding of the challenges of living with schizophrenia and aspects of the disease people with schizophrenia and caregivers would most like to see addressed by treatments and support.

To provide a voice to people with a wide variety of experiences with schizophrenia, including those in harder-to-reach populations such as those who have struggled with homelessness or incarceration, and to equitably engage communities of color.

To inform FDA reviews of patient perspectives on upcoming therapies for schizophrenia by providing insights on the treatment outcomes that matter most to people with schizophrenia and their caregivers – especially in terms of expected benefits and tolerance for specific risks.

To begin to shift the paradigm for how schizophrenia is viewed and treated by our health systems, law enforcement, and society.

Submit Your Comments

There’s still time to submit your comments and stories about your experiences with schizophrenia and its treatments for inclusion in our Voice of the Patient Report. The VOP report will be submitted to FDA and posted publicly online one to two months after the meeting. The agency uses the VOP and testimonials and discussions from the EL-PFDD meeting “to inform decisions and oversight” throughout the drug-development process and during its review of drug-marketing applications.

Session 1: “Disease Symptoms and Daily Impacts”

Of all the symptoms of schizophrenia, which have the most significant impact on you or your loved one’s daily life?

Are there specific activities that you or your loved one cannot do because of schizophrenia?

How does schizophrenia affect you or your loved one on best and on worst days? Describe your best days and your worst days.

How have your schizophrenia symptoms changed over time?

Have you ever experienced loss of a job, homelessness, been the victim of a crime, or been arrested/jailed as a result of your schizophrenia symptoms? Describe your experience.

What worries you most about your schizophrenia?

Session 2: “Current and Future Treatments”

What are you currently doing to treat your schizophrenia and how well does that treatment work? (Or how is your loved one treating his/her schizophrenia?)

How well does your current treatment regimen treat the most significant symptoms of your disease?

What are the most significant downsides to your current treatment(s) and how do they affect your daily life?

Have you ever stopped taking a medication prescribed to treat your schizophrenia? If so, why?

What factors do you take into account when considering a new treatment for your schizophrenia?

Outside of cost and/or insurance coverage, have you experienced challenges in accessing prescription medicines for schizophrenia? Describe your experience.

Assuming there is no complete cure for your condition, what specific things would you look for in an ideal treatment for your condition?