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At STAAR, we are dedicated to improving the lives of people diagnosed with low-grade serous ovarian cancer.
One powerful way we can achieve this is by ensuring that the FDA—the federal agency responsible for evaluating drugs in the United States—hears our stories about living with this disease and undergoing treatment By incorporating our voices, the FDA can make more informed decisions that directly impact our lives. |
We Want to Hear from YOU |
Patient-Focused Drug Development Meeting
What is a patient-focused drug development (PFDD) meeting?
One of the FDA’s missions is to protect and promote public health by evaluating the safety and effectiveness of new drugs, biologics, and devices. The FDA does not develop drugs nor conduct clinical trials. FDA does, however, play a constructive role in guiding, helping, or evaluating at some stages of the pre-clinical, translational, and clinical development work.
On October 13, 2023, from 10 am to 3 pm ET, STAAR is hosting a live and interactive virtual meeting to give the LGSOC community an opportunity to tell our stories to the FDA . In preparation for the meeting, we have worked with partners Cure our Ovarian Cancer and World Ovarian Cancer Coalition, and collected patient stories and comments and recorded some on video to be shared at the event. Other stories will be shared live at the webinar.
Please join #myLGSOCstory by sharing your experience with LGSOC now.
One of the FDA’s missions is to protect and promote public health by evaluating the safety and effectiveness of new drugs, biologics, and devices. The FDA does not develop drugs nor conduct clinical trials. FDA does, however, play a constructive role in guiding, helping, or evaluating at some stages of the pre-clinical, translational, and clinical development work.
On October 13, 2023, from 10 am to 3 pm ET, STAAR is hosting a live and interactive virtual meeting to give the LGSOC community an opportunity to tell our stories to the FDA . In preparation for the meeting, we have worked with partners Cure our Ovarian Cancer and World Ovarian Cancer Coalition, and collected patient stories and comments and recorded some on video to be shared at the event. Other stories will be shared live at the webinar.
Please join #myLGSOCstory by sharing your experience with LGSOC now.
Learn MoreListen to Larry Bauer, Sr. Regulatory Drug Expert from Hyman, Phelps & McNamara, P.C. discuss patient-focused drug development (PFDD) meetings, the history and role of the U.S. Food and Drug Administration during an PFDD, and how the LGSOC community can be involved with the PFDD meeting
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Why is the FDA Coming to this Meeting?
Patient-Focused Drug Development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation.
The PFDD initiative started in 2012 as part of FDA’s commitments under the Prescription Drug User Fee Act (PDUFA) V. After conducting FDA-led PFDD meetings, FDA recognized there are many more diseases/conditions that can be addressed beyond those that were planned and conducted by FDA.
To help expand the benefits of FDA’s PFDD initiative, in 2015, FDA announced the opportunity for externally-led (EL-PFDD) meetings. EL-PFDD meetings are planned and hosted by patient organizations, with the input of FDA staff, and use the process established by FDA-led PFDD meetings as a model.
Recognizing the value of patient perspectives, we are seeking patient stories to better inform the FDA's drug development process. That's where the PFDD comes in!
PFDD meetings follow a town hall style discussion format. The majority of the meeting is dedicated to hearing from patients and caregivers about their perspectives on their condition. Participants are asked to share their perspectives during two panels followed by open discussion.
The PFDD initiative started in 2012 as part of FDA’s commitments under the Prescription Drug User Fee Act (PDUFA) V. After conducting FDA-led PFDD meetings, FDA recognized there are many more diseases/conditions that can be addressed beyond those that were planned and conducted by FDA.
To help expand the benefits of FDA’s PFDD initiative, in 2015, FDA announced the opportunity for externally-led (EL-PFDD) meetings. EL-PFDD meetings are planned and hosted by patient organizations, with the input of FDA staff, and use the process established by FDA-led PFDD meetings as a model.
Recognizing the value of patient perspectives, we are seeking patient stories to better inform the FDA's drug development process. That's where the PFDD comes in!
PFDD meetings follow a town hall style discussion format. The majority of the meeting is dedicated to hearing from patients and caregivers about their perspectives on their condition. Participants are asked to share their perspectives during two panels followed by open discussion.
Voices of LGSOC Publication
The recording of patient perspectives will become permanent public evidence available to key stakeholders, including the FDA.
Patient input from meetings and meeting summary reports can support FDA staff:
PFDD meetings offer an opportunity to foster relationships between patient organizations and industry/medical product developers.
By sharing our perspectives, we can work towards changing the way they care for people with LGSOC.
Patient input from meetings and meeting summary reports can support FDA staff:
- In conducting benefit-risk assessments for products under review by informing the therapeutic context
- Advising drug sponsors on their development programs. Patient input can support drug development more broadly
- Identify areas of unmet need in the patient population
- Identify or develop tools that assess benefit of potential therapies
- Raise awareness and increase engagement within the patient community
PFDD meetings offer an opportunity to foster relationships between patient organizations and industry/medical product developers.
By sharing our perspectives, we can work towards changing the way they care for people with LGSOC.
What Will the PFDD Meeting Look Like?
Watch a recording of a similar PFDD meeting from the National Kidney Foundation.
Who Benefits from PFDD Meetings?
Patients: know the FDA and drug sponsors have heard their voices. Patients’ experiences are validated, reducing feelings of isolation. Hearing other patients voice their experiences and needs helps patients to better self-advocate. PFDD meetings can also help to bring new treatments to the market, which benefits patients.
FDA: gains understanding of what it’s like to live with a particular disease. The FDA becomes informed of side effects and risks patients may be willing to accept to gain a certain level of symptom relief or slowing of their disease progression. The FDA learns about patients’ needs regarding new drugs, and what their preferences are for clinical trials for their disease. PFDD meetings assist the FDA in knowing if a new drug addresses patient needs.
Patient advocacy groups: PFDD Meetings help these groups (like STAAR) identify what needs exist for patient education and advocacy. More effective advocacy increases public awareness and knowledge of the disease. In addition, these meetings help patient advocacy groups connect patients with their peers.
Pharmaceutical companies: gain insights into the major concerns of patients. This helps the companies develop treatments and design clinical trials that match patients’ needs and preferences. Drug sponsors learn which disease symptoms or treatment side effects are, or are not, tolerable by the patients. This helps the companies develop drugs that matter to patients. With knowledge gained from PFDD Meetings, pharmaceutical companies receive advice from the FDA on developing potential drugs and therefore help to advance medicines that meet patients’ needs.
FDA: gains understanding of what it’s like to live with a particular disease. The FDA becomes informed of side effects and risks patients may be willing to accept to gain a certain level of symptom relief or slowing of their disease progression. The FDA learns about patients’ needs regarding new drugs, and what their preferences are for clinical trials for their disease. PFDD meetings assist the FDA in knowing if a new drug addresses patient needs.
Patient advocacy groups: PFDD Meetings help these groups (like STAAR) identify what needs exist for patient education and advocacy. More effective advocacy increases public awareness and knowledge of the disease. In addition, these meetings help patient advocacy groups connect patients with their peers.
Pharmaceutical companies: gain insights into the major concerns of patients. This helps the companies develop treatments and design clinical trials that match patients’ needs and preferences. Drug sponsors learn which disease symptoms or treatment side effects are, or are not, tolerable by the patients. This helps the companies develop drugs that matter to patients. With knowledge gained from PFDD Meetings, pharmaceutical companies receive advice from the FDA on developing potential drugs and therefore help to advance medicines that meet patients’ needs.
What Does it Cost to Attend the Meeting?
The meeting is free and open to the public.
How Do I Register to Attend the Meeting?
Register using our registration form here.
The day of the meeting you will receive an email with a link to the meeting page that will include the livestream as well as ways to submit public comments.
The day of the meeting you will receive an email with a link to the meeting page that will include the livestream as well as ways to submit public comments.
Three Ways YOU Can Help:
- Share your LGSOC story.
- Attend the meeting on October 13th.
- Spread the word via email, social media, tell your friends, invite your healthcare providers.
Attend the MeetingThe Patient Led Drug Development meeting will include a presentation of shared stories and provide an opportunity to interact directly with the FDA, healthcare professionals, researchers, drug companies, caregivers, and fellow LGSOC patients. Registration is now open.
Mark your calendars for October 13, 2023, 10 am to 3 pm ET |
Spread the Word
Share this page with everyone you know! The more participation we get, the better informed the FDA is on providing us with the treatments we need! Spread the word via email, social media, tell your friends, invite your healthcare providers.
Thank you to the webinar sponsors and partners
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