{"id":49482,"date":"2022-10-11T15:01:48","date_gmt":"2022-10-11T13:01:48","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/families-of-those-living-with-a-severe-neurodevelopmental-disorder-to-provide-perspective-to-fda-to-help-expedite-new-treatments\/"},"modified":"2022-10-11T15:01:48","modified_gmt":"2022-10-11T13:01:48","slug":"families-of-those-living-with-a-severe-neurodevelopmental-disorder-to-provide-perspective-to-fda-to-help-expedite-new-treatments","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/families-of-those-living-with-a-severe-neurodevelopmental-disorder-to-provide-perspective-to-fda-to-help-expedite-new-treatments\/","title":{"rendered":"Families of Those Living with a Severe Neurodevelopmental Disorder to Provide Perspective to FDA to Help Expedite New Treatments"},"content":{"rendered":"
\n

\nThe Phelan-McDermid Syndrome Externally-Led <\/i>Patient-Focused Drug Development (EL-PFDD) meeting will be held virtually on November 8 from 10 a.m. to 3 p.m. ET<\/i>\n<\/p>\n

<\/a><\/p>\n

LOS ANGELES–(BUSINESS WIRE)–Families of loved ones living with Phelan-McDermid syndrome (PMS) will inform and educate the U.S. Food and Drug Administration (FDA) and other key stakeholders about the patient and caregiver experience <\/b>during an Externally-Led Patient-Focused Drug Development (EL-PFDD<\/a>) meeting on November 8.<\/b> The meeting is sponsored by CureSHANK<\/a>, a nonprofit organization singularly focused on accelerating the development of treatments for PMS and other disorders related to the SHANK<\/i> family of genes, and co-planned with the Phelan-McDermid Syndrome Foundation<\/a> (PMSF) a nonprofit organization with the mission to improve the quality of life of all those affected by PMS by providing family support, accelerating research, and raising awareness.\n<\/p>\n

\n\u201cThis EL-PFDD meeting is an indispensable part of CureSHANK\u2019s mission to overcome critical barriers to the development of successful treatments for PMS,\u201d said CureSHANK President Geraldine Bliss. \u201cThe more the FDA and other stakeholders understand the patient perspective, the more quickly treatments that make a difference to those in the PMS community will be brought to those living with this profoundly debilitating genetic condition.\u201d\n<\/p>\n

\nFor additional information on the EL-PFDD including access to the live discussion with the FDA on November 8, please visit: https:\/\/www.cureshank.org\/elpfdd-meeting<\/a>.\n<\/p>\n

\nCurrently, no treatments for PMS are approved by the FDA.<\/b> PMS is a rare genetic condition caused by deletions or mutations of the SHANK3<\/i> gene. Patients with PMS experience significant intellectual disability and are monitored for management of multiple devastating developmental and medical conditions, which can include epilepsy (often refractory); mood disorders (ranging from anxiety to various forms of catatonia); hypotonia; sleep disturbances; regressions or failure to retain skills; gastrointestinal dysfunction; fine and gross motor deficits; and severe expressive and receptive language deficits.\n<\/p>\n

\nPMS is also among the most common causes of autism.<\/b> Researchers estimate that it occurs in about 1% of individuals with autism and 2% of those with both autism and intellectual disability. As one of a few known monogenic (single-gene) causes of autism, PMS provides insights into the underlying biology of severe forms of autism and approaches to treating them.\n<\/p>\n

\nEL-PFDD meetings are a part of the FDA\u2019s Patient-Focused Drug Development (PFDD) program, which aims to systematically obtain the patient perspective on specific diseases and their treatments. \u201cThis meeting is exciting because it will result in a tangible record of the patient voice, which can be used as a guide for pharmaceutical companies looking to apply to the FDA to launch clinical trials,\u201d said Kate Still, PhD, Scientific Director at PMSF. \u201cThe hope is that we will see a real shift in the design of clinical trials towards focusing more on the symptoms, assessments, and challenges that matter most to families.\u201d\n<\/p>\n

\nTopics shared at EL-PFDD meetings include the symptoms patients find the most challenging; the impact of the disease on patients\u2019 daily lives; and patients\u2019 experiences with currently available treatments\u2014or struggles due to their unavailability. This input helps inform the FDA\u2019s decisions and oversight both during treatment development and during the agency\u2019s review of marketing applications.\n<\/p>\n

\nIn addition to all families impacted by PMS, other stakeholders – including medical product developers, health care providers, and federal partners – are encouraged to attend the EL-PFDD meeting on November 8.\n<\/p>\n

\n\u201cCureSHANK\u2019s Board appreciates the relationships that have helped make this EL-PFDD possible: our partnership with the Phelan-McDermid Syndrome Foundation<\/a>, as well as industry sponsorships, which to date include Jaguar Gene Therapy<\/a> and Neuren Pharmaceuticals<\/a>,\u201d added Ms. Bliss.\n<\/p>\n

\nAbout CureSHANK
\n
<\/b>CureSHANK was founded in 2019 by Geraldine Bliss, Abby Lievense and Paulina Rychenkova, each the parent of a child living with PMS. A 501(c)(3) nonprofit organization, CureSHANK identifies and funds projects that overcome critical barriers to successful drug development and coordinates scientific efforts to improve efficiency and speed in the field. The nonprofit\u2019s other projects include the CureSHANK Biomarkers and Outcome Measures Consortium<\/a>, the PMS Conceptual Model<\/a>, and the CureSHANK Real Family Stories<\/a> video series.\n<\/p>\n

\nAbout Phelan-McDermid Syndrome Foundation
\n
<\/b>The Phelan-McDermid Syndrome Foundation<\/a> (PMSF) is a 501(c)(3) nonprofit organization founded in 2002 comprised of a diverse network of directors, advisors, staff members, and community volunteers with the mission to improve the quality of life of people affected by PMS worldwide by providing family support, accelerating research, and raising awareness. Current and recent projects include an ICD-10 proposal for PMS<\/a>, funding neuropsychiatric illness research<\/a>, the CANDID consortium<\/a> on GI dysfunction, and the PMS DataHub<\/a>.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nCureSHANK<\/b>
Abby Lievense
\n
abby@cureshank.org<\/a>\n<\/p>\n

\nMedia<\/b>
Matt Wright
\n
mwright@realchemistry.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The Phelan-McDermid Syndrome Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting will be held virtually on November 8 from 10 a.m. to 3 p.m. ET LOS ANGELES–(BUSINESS WIRE)–Families of loved ones living with Phelan-McDermid syndrome (PMS) will inform and educate the U.S. Food and Drug Administration (FDA) and other key stakeholders about the patient and caregiver experience … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-49482","6":"format-standard","7":"category-industry"},"yoast_head":"\nFamilies of Those Living with a Severe Neurodevelopmental Disorder to Provide Perspective to FDA to Help Expedite New Treatments - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/families-of-those-living-with-a-severe-neurodevelopmental-disorder-to-provide-perspective-to-fda-to-help-expedite-new-treatments\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Families of Those Living with a Severe Neurodevelopmental Disorder to Provide Perspective to FDA to Help Expedite New Treatments - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"The Phelan-McDermid Syndrome Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting will be held virtually on November 8 from 10 a.m. to 3 p.m. ET LOS ANGELES–(BUSINESS WIRE)–Families of loved ones living with Phelan-McDermid syndrome (PMS) will inform and educate the U.S. Food and Drug Administration (FDA) and other key stakeholders about the patient and caregiver experience ... 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