{"id":912,"date":"2018-05-18T07:06:33","date_gmt":"2018-05-18T07:06:33","guid":{"rendered":"http:\/\/demo.ovathemes.com\/eventador\/?page_id=912"},"modified":"2023-09-23T15:15:22","modified_gmt":"2023-09-23T15:15:22","slug":"meeting-overview","status":"publish","type":"page","link":"https:\/\/pcoschallenge.org\/pcos-pfdd\/meeting-overview\/","title":{"rendered":"Meeting Information"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row equal_height=&#8221;yes&#8221;][vc_column][vc_empty_space height=&#8221;10px&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1683669320374{padding-bottom: 30px !important;}&#8221;][vc_column offset=&#8221;vc_col-lg-9 vc_col-md-8&#8243;][vc_column_text]<\/p>\n<h3 style=\"color: #545454; text-align: center; line-height: 1.2;\">Polycystic Ovary Syndrome<br \/>\nExternally-Led Patient-Focused<br \/>\nDrug Development Meeting<br \/>\nPresented by<\/h3>\n<p>[\/vc_column_text][vc_single_image source=&#8221;external_link&#8221; external_img_size=&#8221;262&#215;164&#8243; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1695116338526{padding-top: -20px !important;padding-bottom: 30px !important;}&#8221; custom_src=&#8221;https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-content\/uploads\/2023\/04\/pcos-logo.webp&#8221;]<div class=\"about-txt m-bottom-40 p-right-30 teal-links\">\n\t\t\t\t<\/p>\n<h3 style=\"margin-top: 0px; padding-top: 0px;\">About the Meeting Organizer<\/h3>\n<p>The PCOS Externally-Led Patient-Focused Drug-Development Meeting (PCOS EL-PFDD Meeting) was organized by PCOS Challenge: The National Polycystic Ovary Syndrome Association. Serving nearly 60,000 members, PCOS Challenge is the largest PCOS patient advocacy organization globally. PCOS Challenge is the leading organization advancing PCOS health policy at the federal and state level, patient-centered research and patient-focused drug development and treatment efforts. PCOS Challenge provides support to industry partners at every stage of development, from initial discovery and preclinical phases to post-FDA approval and outcome assessment.<\/p>\n<h3>PCOS EL-PFDD Meeting Background<\/h3>\n<p>Despite affecting up to 15% of women and a $15 billion annual economic burden in the U.S. alone, polycystic ovary syndrome (PCOS) has yet to see any treatments specifically for the disorder approved by the U.S. Food and Drug Administration (FDA). To address this critical gap in care, PCOS Challenge: The National Polycystic Ovary Syndrome Association has organized the PCOS EL-PFDD Meeting as a listening session for the FDA, product developers, clinicians, and academic researchers to hear directly from individuals with PCOS about the health effects and daily impacts of the condition, their treatment goals, and their decision factors when seeking out or selecting a treatment.<\/p>\n<p>The PCOS EL-PFDD meeting is being conducted as a parallel effort to the <strong><a class=\"editor-rtfLink\" href=\"https:\/\/www.fda.gov\/industry\/prescription-drug-user-fee-amendments\/externally-led-patient-focused-drug-development-meetings\" target=\"_blank\" rel=\"noopener\">FDA\u2019s PFDD initiative<\/a><\/strong> to more systematically gather patients\u2019 perspectives on their conditions and available therapies to treat their conditions. The input from EL-PFDD meetings can inform the FDA\u2019s oversight during drug development and marketing application reviews.<\/p>\n<h3>Who Should Attend the PCOS EL-PFDD meeting?<\/h3>\n<p>The PCOS EL-PFDD meeting will be attended by PCOS patients, FDA and other regulatory\/federal agency representatives, medical product developers, academic researchers, clinicians and healthcare professionals specializing in PCOS.\n\t\t\t<\/div>[\/vc_column][vc_column offset=&#8221;vc_col-lg-3 vc_col-md-4&#8243;]<div class=\"about-info \">\t\t\t\t\t\t\n\t\t\t\t\t<h5>When<\/h5>\n\t\t\t\t\t<span>FRIDAY, NOVEMBER 3, 2023<\/span><span>10:00 AM &#8211; 2:30 PM EST<\/span>\n\t\t\t\t<\/div><div class=\"about-info \">\t\t\t\t\t\t\n\t\t\t\t\t<h5>Where<\/h5>\n\t\t\t\t\t<span>RIGGS ALUMNI CENTERCOLLEGE PARK,<\/span><span>MARYLAND<\/span><\/p>\n<p>\n\t\t\t\t<\/div><a href=\"https:\/\/pcoschallenge.org\/pcos-pfdd\/register\/\" target=\"_self\" class=\"btn btn-medium btn-tra-white m-right-20 \">Register Now<\/a>[vc_column_text css=&#8221;.vc_custom_1695062910620{padding-top: 20px !important;padding-bottom: 20px !important;}&#8221;]<strong>Attend In-Person or Remotely<\/strong>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]<div class=\"templatera_shortcode\"><style type=\"text\/css\" data-type=\"vc_shortcodes-custom-css\">.vc_custom_1683662017372{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-bottom: 30px !important;background-color: #0aa2a0 !important;}.vc_custom_1683662024904{margin-top: 0px !important;padding-top: 0px !important;}.vc_custom_1684022780389{margin-top: 0px !important;}.vc_custom_1683746489933{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;padding-bottom: 0px !important;background-position: center !important;background-repeat: no-repeat !important;background-size: contain !important;border-left-color: #ffffff !important;border-left-style: solid !important;border-right-color: #ffffff !important;border-right-style: solid !important;border-top-color: #ffffff !important;border-top-style: solid !important;border-bottom-color: #ffffff !important;border-bottom-style: solid !important;border-radius: 15px !important;}.vc_custom_1683746482438{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #ffffff !important;border-left-style: solid !important;border-right-color: #ffffff !important;border-right-style: solid !important;border-top-color: #ffffff !important;border-top-style: solid !important;border-bottom-color: #ffffff !important;border-bottom-style: solid !important;border-radius: 15px !important;}.vc_custom_1683746495100{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #ffffff !important;border-left-style: solid !important;border-right-color: #ffffff !important;border-right-style: solid !important;border-top-color: #ffffff !important;border-top-style: solid !important;border-bottom-color: #ffffff !important;border-bottom-style: solid !important;border-radius: 15px !important;}<\/style><div data-vc-full-width=\"true\" data-vc-full-width-init=\"false\" class=\"vc_row wpb_row vc_row-fluid bg-lightgrey wide-100 vc_custom_1683662017372 vc_row-has-fill\"><div class=\"text-center wpb_column vc_column_container vc_col-sm-12\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"vc_row wpb_row vc_inner vc_row-fluid\"><div class=\"wpb_column vc_column_container vc_col-sm-12\"><div class=\"vc_column-inner vc_custom_1683662024904\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element  vc_custom_1684022780389 white-color\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<h2 style=\"text-align: center;\">MEETING GOALS<\/h2>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div><div class=\"vc_row wpb_row vc_inner vc_row-fluid equal-height vc_column-gap-20 vc_row-o-equal-height vc_row-flex\"><div class=\"wpb_column vc_column_container vc_col-sm-4 vc_col-has-fill\"><div class=\"vc_column-inner vc_custom_1683746489933\"><div class=\"wpb_wrapper\"><div class=\"vc_empty_space\"   style=\"height: 25px\"><span class=\"vc_empty_space_inner\"><\/span><\/div><div class=\"vc_icon_element vc_icon_element-outer vc_icon_element-align-center\"><div class=\"vc_icon_element-inner vc_icon_element-color-white vc_icon_element-size-xl vc_icon_element-style- vc_icon_element-background-color-grey\" ><span class=\"vc_icon_element-icon far fa-lightbulb\" ><\/span><\/div><\/div><h4 style=\"color: #ffffff;text-align: center;font-family:Montserrat;font-weight:700;font-style:normal\" class=\"vc_custom_heading\" >UNDERSTANDING<\/h4>\n\t<div class=\"wpb_text_column wpb_content_element  white-color\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<p style=\"text-align: left;\"><strong>To provide the FDA, medical product developers, the scientific community, and other stakeholders with a greater understanding<\/strong> of the experiences, perspectives, needs, and priorities of PCOS patients to support the development of FDA-approved treatments for PCOS.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-4 vc_col-has-fill\"><div class=\"vc_column-inner vc_custom_1683746482438\"><div class=\"wpb_wrapper\"><div class=\"vc_empty_space\"   style=\"height: 25px\"><span class=\"vc_empty_space_inner\"><\/span><\/div><div class=\"vc_icon_element vc_icon_element-outer vc_icon_element-align-center\"><div class=\"vc_icon_element-inner vc_icon_element-color-white vc_icon_element-size-xl vc_icon_element-style- vc_icon_element-background-color-grey\" ><span class=\"vc_icon_element-icon far fa-comments\" ><\/span><\/div><\/div><h4 style=\"color: #ffffff;text-align: center;font-family:Montserrat;font-weight:700;font-style:normal\" class=\"vc_custom_heading\" >CLARITY<\/h4>\n\t<div class=\"wpb_text_column wpb_content_element  white-color\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<p style=\"text-align: left;\"><strong>Listen to patient voices<\/strong> <strong>as they describe the impact of living with PCOS <\/strong>to identify their priorities and goals for PCOS management and their experiences with current options for PCOS symptom management.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-4 vc_col-has-fill\"><div class=\"vc_column-inner vc_custom_1683746495100\"><div class=\"wpb_wrapper\"><div class=\"vc_empty_space\"   style=\"height: 25px\"><span class=\"vc_empty_space_inner\"><\/span><\/div><div class=\"vc_icon_element vc_icon_element-outer vc_icon_element-align-center\"><div class=\"vc_icon_element-inner vc_icon_element-color-white vc_icon_element-size-xl vc_icon_element-style- vc_icon_element-background-color-grey\" ><span class=\"vc_icon_element-icon far fa-copy\" ><\/span><\/div><\/div><h4 style=\"color: #ffffff;text-align: center;font-family:Montserrat;font-weight:700;font-style:normal\" class=\"vc_custom_heading\" >ACTIONABLE INSIGHTS<\/h4>\n\t<div class=\"wpb_text_column wpb_content_element  white-color\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<p style=\"text-align: left;\"><strong>Consider endpoints and biomarkers for drug development trials and compare these with patient experiences<\/strong> to determine the clinical effectiveness of proposed treatments and align them with patient priorities.<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"vc_row-full-width vc_clearfix\"><\/div><\/div>[\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1683669451843{background-color: #f5f5f5 !important;}&#8221; el_id=&#8221;who-benefits&#8221;][vc_column][vc_column_text]<\/p>\n<h2 style=\"text-align: center;\">Who Will Benefit from the PCOS EL-PFDD Meeting?<\/h2>\n<p>[\/vc_column_text][vc_row_inner equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1683750247647{margin-top: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}&#8221;][vc_column_inner width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1684355806523{padding-top: 10px !important;padding-right: 50px !important;padding-left: 50px !important;background-color: #0aa2a0 !important;}&#8221;][vc_single_image image=&#8221;1956&#8243; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1683750389346{margin-bottom: 0px !important;padding-bottom: 0px !important;}&#8221;][vc_column_text el_class=&#8221;white-color circle-bullets who-benefits&#8221; css=&#8221;.vc_custom_1695056722645{margin-top: 0px !important;padding-top: 0px !important;}&#8221;]<\/p>\n<h3 style=\"text-align: center;\">Patients and Caregivers<\/h3>\n<p><strong>The PCOS EL-PFDD Meeting offers patients the opportunity to:<\/strong><\/p>\n<ul>\n<li>Help shape and accelerate the development of new PCOS-focused treatments.<\/li>\n<li><span data-preserver-spaces=\"true\">Have their voices heard, directly informing the FDA and other stakeholders about the daily impacts and health effects of living with PCOS.<\/span><\/li>\n<li>Share their perspectives on the effectiveness of existing treatment and management options.<\/li>\n<li>Highlight their unmet needs and priorities for new treatments.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1684355824155{padding-top: 10px !important;padding-right: 50px !important;padding-left: 50px !important;background-color: #545454 !important;}&#8221;][vc_single_image image=&#8221;1961&#8243; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1695059629358{margin-bottom: 0px !important;}&#8221;][vc_column_text el_class=&#8221;white-color circle-bullets who-benefits&#8221; css=&#8221;.vc_custom_1695059667059{padding-top: -20px !important;}&#8221;]<\/p>\n<h3 style=\"text-align: center;\">U.S. Food and Drug Administration (FDA)<\/h3>\n<p><strong>The PCOS EL-PFDD Meeting and summary reports can aid FDA staff in:<\/strong><\/p>\n<ul>\n<li>Acquiring patient insights for more informed benefit-risk evaluations of drugs, biologics, and devices under review.<\/li>\n<li>Advising drug sponsors on their development programs.<\/li>\n<li>Obtaining first-hand patient accounts of medication side effects, providing a nuanced understanding that can enhance post-market safety monitoring.<\/li>\n<li>Understanding what patients feel is lacking in current treatment options.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1683750238389{margin-top: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}&#8221;][vc_column_inner width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1684355834042{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-right: 50px !important;padding-bottom: 0px !important;padding-left: 60px !important;background-color: #545454 !important;}&#8221;][vc_single_image image=&#8221;1963&#8243; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1683750810916{margin-bottom: 0px !important;padding-bottom: 0px !important;}&#8221;][vc_column_text el_class=&#8221;white-color circle-bullets who-benefits&#8221;]<\/p>\n<h3 style=\"text-align: center;\">Industry and Pharmaceutical Companies<\/h3>\n<p><strong>The PCOS EL-PFDD Meeting can help industry:<\/strong><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> Gain an in-depth understanding of patients&#8217; experiences, symptom burden, and treatment history.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> Learn the multiple factors influencing patients&#8217; treatment choices and trial participation.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> Identify unmet needs in PCOS care to drive more effective drug development.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> Obtain insights to design patient-centered clinical trials tailored to better meet the needs and priorities of PCOS patients.<\/span><\/li>\n<li>Foster important relationships needed for success in developing new PCOS therapies, diagnostics and devices. Patient and other stakeholder engagement is essential at all stages, ranging from initial discovery and preclinical phases to post-FDA approval and outcome assessment.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1684355844511{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 0px !important;padding-right: 50px !important;padding-bottom: 0px !important;padding-left: 50px !important;background-color: #0aa2a0 !important;}&#8221;][vc_single_image image=&#8221;3120&#8243; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1695065226966{margin-bottom: 0px !important;padding-bottom: 0px !important;}&#8221;][vc_column_text el_class=&#8221;white-color circle-bullets who-benefits&#8221; css=&#8221;.vc_custom_1695062897650{margin-top: 0px !important;padding-top: 0px !important;}&#8221;]<\/p>\n<h3 style=\"text-align: center;\">Researchers and Clinicians<\/h3>\n<p><strong>The PCOS EL-PFDD Meeting can help researchers and clinicians:<\/strong><\/p>\n<ul>\n<li>Better understand the lived experience of PCOS patients, enriching the context for clinical decisions and research directions.<\/li>\n<li>Gain insights from patients&#8217; perspectives about the effectiveness, side effects, and other drawbacks of current treatment options, informing both research aims and clinical practice.<\/li>\n<li>Identify new research questions or gaps in existing knowledge, serving as a catalyst for innovative studies that can address unmet needs in PCOS care.<\/li>\n<li>Incorporate patient feedback to improve research and clinical processes and design.<\/li>\n<li>Enhance patient-provider communication by learning what information is most valuable to patients, improving patient satisfaction and treatment plan adherence.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=&#8221;30px&#8221;][\/vc_column][\/vc_row][vc_row][vc_column]<div class=\"templatera_shortcode\"><style type=\"text\/css\" data-type=\"vc_shortcodes-custom-css\">.vc_custom_1684358161612{margin-top: 0px !important;margin-right: 0px !important;margin-bottom: 0px !important;margin-left: 0px !important;padding-top: 20px !important;padding-right: 0px !important;padding-bottom: 60px !important;padding-left: 0px !important;background-color: rgba(0,0,0,0.84) !important;*background-color: rgb(0,0,0) !important;}<\/style><div data-vc-full-width=\"true\" data-vc-full-width-init=\"false\" data-vc-parallax=\"1.5\" data-vc-parallax-image=\"https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-content\/uploads\/2023\/04\/pcos-challenge-members-transparent.png\" class=\"vc_row wpb_row vc_row-fluid cta-center vc_custom_1684358161612 vc_row-has-fill vc_row-o-content-middle vc_row-flex vc_general vc_parallax vc_parallax-content-moving\"><div class=\"wpb_column vc_column_container vc_col-sm-12\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element  white-color cta\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<h2>PCOS PFDD MEETING - Register Now<\/h2>\n<p>Join us as we help shape and accelerate the future of treatment for polycystic ovary syndrome (PCOS).<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<a href=\"https:\/\/pcoschallenge.org\/pcos-pfdd\/register\/\" target=\"_self\" class=\"btn btn-medium btn-tra-white m-right-20 \">Register Now<\/a><a href=\"https:\/\/pcoschallenge.org\/pcos-pfdd\/survey\/\" target=\"_self\" class=\"btn btn-medium btn-tra-white m-right-20 btn-purple\">Take the Survey<\/a>\r\n<a href=\"https:\/\/pcoschallenge.org\/pcos-pfdd\/comment\/\" target=\"_self\" class=\"btn btn-medium btn-tra-white m-right-20 \">Leave a Comment<\/a>\r\n<\/div><\/div><\/div><\/div><div class=\"vc_row-full-width vc_clearfix\"><\/div><\/div>[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"Polycystic Ovary Syndrome Externally-Led Patient-Focused Drug Development Meeting Presented by About the Meeting Organizer The PCOS Externally-Led Patient-Focused Drug-Development Meeting (PCOS EL-PFDD Meeting) was organized by PCOS Challenge: The National Polycystic Ovary Syndrome Association. Serving nearly 60,000 members, PCOS Challenge is the largest PCOS patient advocacy organization globally. PCOS Challenge is the leading organization advancing [...]","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/home_template.php","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-912","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-json\/wp\/v2\/pages\/912","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-json\/wp\/v2\/comments?post=912"}],"version-history":[{"count":157,"href":"https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-json\/wp\/v2\/pages\/912\/revisions"}],"predecessor-version":[{"id":3129,"href":"https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-json\/wp\/v2\/pages\/912\/revisions\/3129"}],"wp:attachment":[{"href":"https:\/\/pcoschallenge.org\/pcos-pfdd\/wp-json\/wp\/v2\/media?parent=912"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}