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DESCRIPTION:PSI Webinar\nPersonalised Medicine: Statistics for Companion Di
 agnostics\nDate for Webinar:&nbsp\;Thursday 4th&nbsp\;May. 2-3.30pm UK tim
 e\nPersonalised medicines - which are designed to treat particular groups 
 of patients - &nbsp\;are becoming increasingly prominent. In order to iden
 tify patients suitable for treatment a companion diagnostic assay is often
  needed. The Personalized Medicines Coalition (PMC) recently published an 
 article stating that 25% of NME approved by FDA in 2016 included a compani
 on diagnostic.\nThis webinar will introduce and examine some of the consid
 erations required for statisticians working in the field of companion diag
 nostics and will include information from an FDA (CDRH) speaker and perspe
 ctives/ case-studies from representatives from both a pharmaceutical compa
 ny and a diagnostic company.\n\nCLICK HERE TO VIEW THE FLYER\n\nSpeakers:\
 nMeijuan Li\, CDRH\nPeter Cooper\, Qiagen\nRachel Hodge\, AstraZeneca\nAbs
 tracts:\nMeijuan Li (CDRH)\nApplications of personalized medicine are beco
 ming increasingly prominent. A companion diagnostic assay (CDx) is often d
 esired for patient enrollment in device-drug pivotal clinical trial(s) so 
 that FDA can ensure that appropriate clinical and analytical validation st
 udies are planned and carried out for CDx. However\, such a requirement ma
 y be difficult or impractical to accomplish. A clinical trial assay (CTA) 
 instead of CDx may be used for patient enrollment in drug-device pivotal c
 linical trial(s). A supplemental agreement study of CDx and CTA will be re
 quired to bridge the clinical results from CTA to CDx. In this webinar\, w
 e will discuss statistical challenges in study design and data analysis fo
 r bridging study. Particularly\, we aimed to provide statistical methods o
 n how to estimate the drug efficacy in CDx intended use population using r
 esults from bridging study and CTA-drug pivotal clinical trial.\nPeter Coo
 per (Qiagen)\nPerspective from Diagnostic Company\n&nbsp\;\nRachel Hodge (
 Astrazeneca)\nPerspective/Case-study from Pharmaceutical Company\nTo acces
 s the recording\, please visit the Video-on-Demand Library.
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DTSTART:20170504T140000Z
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SUMMARY:Personalised Medicine: Statistics for Companion Diagnostics
UID:RFCALITEM639201513596658206
X-ALT-DESC;FMTTYPE=text/html:<p><strong>PSI Webinar<br />\n</strong><strong
 >Personalised Medicine: Statistics for Companion Diagnostics<br />\n</stro
 ng><strong>Date for Webinar:</strong>&nbsp\;Thursday 4<sup>th</sup>&nbsp\;
 May. 2-3.30pm UK time</p>\n<p>Personalised medicines - which are designed 
 to treat particular groups of patients - &nbsp\;are becoming increasingly 
 prominent. In order to identify patients suitable for treatment a companio
 n diagnostic assay is often needed. The Personalized Medicines Coalition (
 PMC) recently published an article stating that 25% of NME approved by FDA
  in 2016 included a companion diagnostic.</p>\n<p>This webinar will introd
 uce and examine some of the considerations required for statisticians work
 ing in the field of companion diagnostics and will include information fro
 m an FDA (CDRH) speaker and perspectives/ case-studies from representative
 s from both a pharmaceutical company and a diagnostic company.<br />\n<br 
 />\n<a href="https://www.psiweb.org/docs/default-source/default-document-l
 ibrary/companion-diagnostic-webinar-flyer.pdf?sfvrsn=4137d2db_0&sf_site_te
 mp=true&sf_site=00000000-0000-0000-0000-000000000000" title="Companion Dia
 gnostic Webinar Flyer">CLICK HERE TO VIEW THE FLYER</a><br />\n<br />\n<st
 rong>Speakers:</strong></p>\n<p>Meijuan Li\, CDRH<br />\nPeter Cooper\, Qi
 agen<br />\nRachel Hodge\, AstraZeneca</p>\n<p><strong>Abstracts:</strong>
 </p>\n<p>Meijuan Li (CDRH)</p>\n<p>Applications of personalized medicine a
 re becoming increasingly prominent. A companion diagnostic assay (CDx) is 
 often desired for patient enrollment in device-drug pivotal clinical trial
 (s) so that FDA can ensure that appropriate clinical and analytical valida
 tion studies are planned and carried out for CDx. However\, such a require
 ment may be difficult or impractical to accomplish. A clinical trial assay
  (CTA) instead of CDx may be used for patient enrollment in drug-device pi
 votal clinical trial(s). A supplemental agreement study of CDx and CTA wil
 l be required to bridge the clinical results from CTA to CDx. In this webi
 nar\, we will discuss statistical challenges in study design and data anal
 ysis for bridging study. Particularly\, we aimed to provide statistical me
 thods on how to estimate the drug efficacy in CDx intended use population 
 using results from bridging study and CTA-drug pivotal clinical trial.</p>
 \n<p>Peter Cooper (Qiagen)<br />\nPerspective from Diagnostic Company</p>\
 n<p>&nbsp\;<br />\nRachel Hodge (Astrazeneca)<br />\nPerspective/Case-stud
 y from Pharmaceutical Company</p>\n<p><strong>To access the recording\, pl
 ease visit the <a href="https://www.psiweb.org/vod">Video-on-Demand Librar
 y</a>.</strong></p>
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