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DTSTART;VALUE=DATE:20230101
TZNAME:UTC
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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:20240328T104057Z
DTSTART:20230314T140000Z
LOCATION:
SEQUENCE:0
SUMMARY:PSI Pre-Clinical SIG Webinar: End-user Tool for Immunogenicity Cut-
points Calculation
UID:RFCALITEM638472192575030172
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)
\n
\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
Reg
istration for this webinar is free to both Members of PSI and Non-Members.
\nPlease \;click here \;to register.
"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."
\n Speaker \n | \n \n
Biography \n | \n
\n
| \n
\n Els Pa ttyn is educated as a bio-engineer. After obtaining her PhD\, she addition al worked 8 years as a post-doctoral researcher at the University of Ghent in the immunology research\, whereafter she took the role of scientist NA NOBODY®\; characterization at Ablynx. After obtaining a master in stati stical data analysis\, she switched to Ablynx&rsquo\; statistics team. By the acquisition of Ablynx by Sanofi in 2018\, Els joined Sanofi&rsquo\;s N on Clinical Efficacy and Safety Statistics team\, where she provides stati stical support for mainly projects in immunology research\, with focus on dose response modelling\, design of experiments and immunogenicity assessm ent. \n | \n
&nb sp\;
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