BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Date: \;Tuesday 14th March 2023\nTime: \;14:00-14:45 GM T | 15:00-15:45 CET\nSpeaker: \;Els Pattyn \;(Sanofi)\n\nWho is th is event intended for? \;Any statisticians working in the Pharmaceutic al industry.\nWhat is the benefit of attending? \;Attendees will have the opportunity to see an example of JMP development for regulatory compli ant calculation of immunogenicity cut-point.\nRegistration\nRegistration f or this webinar is free to both Members of PSI and Non-Members.\nPlease&nb sp\;click here \;to register.\nOverview\n"Immunogenicity represents a significant hurdle for the development of all biotherapeutics and biosimil ars as it can affect both efficacy and safety of the treatment. Over the l ast decade industry and regulators succeeded in standardizing a tiered scr eening/confirmatory/titer testing approach for anti-drug antibodies (ADAs) . Unlike assays to determine the concentration of biopharmaceuticals\, ADA assays are semi-quantitative in nature\, and therefore requiring error pr one and complex statistical approaches for positivity cut-points at each t ier of the testing paradigm.\n\nTo get around these hurdles\, a solution h as been created within Sanofi by the development of a fully-automated and validated script using the JMP statistical software. This script follows a pre-determined decision tree based on the latest recommendations from ind ustry guidance\, white papers and scientific best-practice. It is designed for both binding and neutralizing antibody methods used to support non-cl inical and clinical studies in regulated environments (GLP/GcLP). The user -friendly interface allows application by any bioanalytical scientist with out requiring deep statistical knowledge.\n\nThe script allows end-users t o easily select the appropriate decision trees applicable for the specific needs of a given type of assay or study. The application accepts Excel fi les to upload assay response data and then makes outcome-dependent decisio ns based on best-practices for the chosen method and context. For example\ , the script will select the most appropriate normalization/transformation \, apply adapted effects included in the mixed-effects model based on the study-design\, optionally calculate analyst-specific cut-points in case of significant analyst-specific differences and adapt down-stream analysis i n cases where no second-tier confirmatory data is available.\n\nThe valida ted version of this purpose-built statistical tool\, named ImmunoStat Simp le\, allows immunogenicity cut-points to be calculated quickly and efficie ntly in a standardized way across multiple sites in a global organization\ , and the automated reporting is suitable for regulatory submissions. The successful implementation of this automated JMP script demonstrates how di gital tools and automation can improve the efficiency and capabilities of modern bioanalytical laboratories."\nSpeaker details\n\n\n\n \n \n \n Speaker\n \n \n Biography\n \n \n \n \n \n Els Pattyn\n \n \n Els Patt yn is educated as a bio-engineer. After obtaining her PhD\, she additional worked 8 years as a post-doctoral researcher at the University of Ghent i n the immunology research\, whereafter she took the role of scientist NANO BODY®\; characterization at Ablynx. After obtaining a master in statist ical data analysis\, she switched to Ablynx&rsquo\; statistics team. By th e acquisition of Ablynx by Sanofi in 2018\, Els joined Sanofi&rsquo\;s Non Clinical Efficacy and Safety Statistics team\, where she provides statist ical support for mainly projects in immunology research\, with focus on do se response modelling\, design of experiments and immunogenicity assessmen t.\n \n \n \n\n \; DTEND:20230314T144500Z DTSTAMP:20260422T145519Z DTSTART:20230314T140000Z LOCATION: SEQUENCE:0 SUMMARY:PSI Pre-Clinical SIG Webinar: End-user Tool for Immunogenicity Cut- points Calculation UID:RFCALITEM639124665191925021 X-ALT-DESC;FMTTYPE=text/html:Date: \;Tuesday 14th Marc h 2023
\nTime: \;14:00-14:45 GMT | 15:00-15:45 C ET
\nSpeaker: \;Els Pattyn \;(Sanofi)
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\nWho is this event intended for? \;A ny statisticians working in the Pharmaceutical industry.
\nWh at is the benefit of attending? \;Attendees will have the opp ortunity to see an example of JMP development for regulatory compliant cal culation of immunogenicity cut-point.
\n

Registration

\n

Reg istration for this webinar is free to both Members of PSI and Non-Members.
\nPlease \;click here \;to register.

\n

Overv iew

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"Immunogenicity represents a significant hurdle for the devel opment of all biotherapeutics and biosimilars as it can affect both effica cy and safety of the treatment. Over the last decade industry and regulato rs succeeded in standardizing a tiered screening/confirmatory/titer testin g approach for anti-drug antibodies (ADAs). Unlike assays to determine the concentration of biopharmaceuticals\, ADA assays are semi-quantitative in nature\, and therefore requiring error prone and complex statistical appr oaches for positivity cut-points at each tier of the testing paradigm.
\n
\nTo get around these hurdles\, a solution has been created with in Sanofi by the development of a fully-automated and validated script usi ng the JMP statistical software. This script follows a pre-determined deci sion tree based on the latest recommendations from industry guidance\, whi te papers and scientific best-practice. It is designed for both binding an d neutralizing antibody methods used to support non-clinical and clinical studies in regulated environments (GLP/GcLP). The user-friendly interface allows application by any bioanalytical scientist without requiring deep s tatistical knowledge.
\n
\nThe script allows end-users to easily select the appropriate decision trees applicable for the specific needs o f a given type of assay or study. The application accepts Excel files to u pload assay response data and then makes outcome-dependent decisions based on best-practices for the chosen method and context. For example\, the sc ript will select the most appropriate normalization/transformation\, apply adapted effects included in the mixed-effects model based on the study-de sign\, optionally calculate analyst-specific cut-points in case of signifi cant analyst-specific differences and adapt down-stream analysis in cases where no second-tier confirmatory data is available.
\n
\nThe va lidated version of this purpose-built statistical tool\, named ImmunoStat Simple\, allows immunogenicity cut-points to be calculated quickly and eff iciently in a standardized way across multiple sites in a global organizat ion\, and the automated reporting is suitable for regulatory submissions. The successful implementation of this automated JMP script demonstrates ho w digital tools and automation can improve the efficiency and capabilities of modern bioanalytical laboratories."

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Speaker details

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Speaker

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Biography

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Elsedit
\n Els Pattyn

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Els Pat tyn is educated as a bio-engineer. After obtaining her PhD\, she additiona l worked 8 years as a post-doctoral researcher at the University of Ghent in the immunology research\, whereafter she took the role of scientist NAN OBODY®\; characterization at Ablynx. After obtaining a master in statis tical data analysis\, she switched to Ablynx&rsquo\; statistics team. By t he acquisition of Ablynx by Sanofi in 2018\, Els joined Sanofi&rsquo\;s No n Clinical Efficacy and Safety Statistics team\, where she provides statis tical support for mainly projects in immunology research\, with focus on d ose response modelling\, design of experiments and immunogenicity assessme nt.

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