BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 13.3//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20230101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:PSI Webinar\nPersonalised Medicine: Statistics for Companion Di agnostics\nDate for Webinar: \;Thursday 4th \;May. 2-3.30pm UK tim e\nPersonalised medicines - which are designed to treat particular groups of patients -  \;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 \;\nRachel Hodge ( Astrazeneca)\nPerspective/Case-study from Pharmaceutical Company\nTo acces s the recording\, please visit the Video-on-Demand Library. DTEND:20170504T153000Z DTSTAMP:20240329T044618Z DTSTART:20170504T140000Z LOCATION: SEQUENCE:0 SUMMARY:Personalised Medicine: Statistics for Companion Diagnostics UID:RFCALITEM638472843780167982 X-ALT-DESC;FMTTYPE=text/html:
PSI Webinar
\nPersonalised Medicine: Statistics for Companion Diagnostics
\nDate for Webinar: \;Thursday 4th \;
May. 2-3.30pm UK time
Personalised medicines - which are designed to treat particular groups of patients -  \;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.
\nThis 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.
\n
\nCLICK HERE TO VIEW THE FLYER
\n
\nSpeakers:
Meijuan Li\, CDRH
\nPeter
Cooper\, Qiagen
\nRachel Hodge\, AstraZeneca
Abstract s:
\nMeijuan Li (CDRH)
\nApplications of personalized medicine are becoming increasingly prominent. A companion diagnostic assa y (CDx) is often desired for patient enrollment in device-drug pivotal cli nical trial(s) so that FDA can ensure that appropriate clinical and analyt ical validation studies are planned and carried out for CDx. However\, suc h a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for patient enrollment in dru g-device pivotal clinical trial(s). A supplemental agreement study of CDx and CTA will be required to bridge the clinical results from CTA to CDx. I n this webinar\, we will discuss statistical challenges in study design an d data analysis for bridging study. Particularly\, we aimed to provide sta tistical methods on how to estimate the drug efficacy in CDx intended use population using results from bridging study and CTA-drug pivotal clinical trial.
\nPeter Cooper (Qiagen)
\nPerspective from Diagnostic C
ompany
 \;
\nRachel Hodge (Astrazeneca)
\nPerspectiv
e/Case-study from Pharmaceutical Company
To access the rec ording\, please visit the Video-on-De mand Library.
END:VEVENT END:VCALENDAR