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

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schizophrenia and other psychosis spectrum disorders are too often misunderstood or ignored, and current treatments are outdated and can cause significant side effects.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 Nov. 2, the schizophrenia community will finally have the spotlight, as those living with the condition and their family members share 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” – offers 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 will be 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.

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

The daylong meeting will be held in the Washington, D.C., area, with a hybrid format that allows both in-person and remote participation. It will feature panel discussions among people living with schizophrenia and those who care for them, as well as polling and discussion sessions on key topics. People living with schizophrenia and their caregivers/family members will be central to both planning and participating in the event.

If you live with schizophrenia or are a caregiver and/or family member and would like to participate in a pre-meeting survey, click the button below.

Registration for the meeting will begin early this fall on this website. 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 on Nov. 2 at 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.