[NMusers] ISoP Data Standards at ACoP7

From: Radivojevic, Andrijana <andrijana.radivojevic_at_novartis.com>
Date: Thu, 20 Oct 2016 13:21:36 +0000

Population pharmacokinetic (popPK) analyses are performed regularly, and st=
and as a commonly-included component of regulatory submissions. Datasets us=
ed in such analyses are prepared and documented inconsistently, however, wi=
th varying degrees of quality, are often difficult to review (internally an=
d externally) and as such do not facilitate the development of precompetiti=
ve tools for process automation and data exploration.

A group of around 20 enthusiastic pharmacometricians and data programmers w=
as formed at the beginning of 2016 to address this situation. Sponsored by =
ISoP, the group envisions the development of common popPK data standards fo=
r interchange and analysis. Some of the benefits will include improved:

* consistency in pharmacometric datasets,

* quality (fewer errors),

* efficiency (automation of dataset preparation, facilitation of proj=
ect handover and on-boarding, enabling development of open-source tools for=
 automatic graphical exploration), and

* regulatory compliance and audit readiness (enabling development of =
open-source tools for packaging data for submission).


The group has established close links with CDISC, who have lent their exper=
tise to this initiative and will assist in its eventual integration with th=
eir system of standards. We intend to develop open-source companion tools t=
o support the automation of dataset creation and checking. Once this first =
phase is complete, we intend to expand our focus to include PK-PD datasets.


On Tuesday, October 25, 5-6:30pm, we will have an open session at ACoP 7 in=
 Bellevue. We intend to update the community on our progress and welcome an=
yone with ideas that could facilitate achieving our goal and our overall vi=
sion to move the field of Pharmacometrics forward!

For more information, do not hesitate to contact Andrijana Radivojevic<mail=
to:andrijana.radivojevic_at_novartis.com> (Novartis), or any other member of t=
he team: Justin Wilkins<mailto:justinwil_at_gmail.com> (Occams), Brian Corriga=
n<mailto:Brian.Corrigan_at_pfizer.com> (Pfizer), Ted Grasela<mailto:Ted.Grasel=
a_at_cognigencorp.com> (Cognigen), Jill Fiedler-Kelly<mailto:jill.fiedler-kell=
y_at_cognigencorp.com> (Cognigen), Murad Melhem<mailto:mmelhem_at_amgen.com> (Amg=
en), Robert Fox<mailto:robert.fox_at_astrazeneca.com> (AstraZeneca), Huan Liu<=
mailto:Huan.Liu_at_astrazeneca.com> (AstraZeneca), Jing Su<mailto:jing_su_at_merc=
k.com> (Merck), Neelima Thanneer<mailto:neelima.thanneer_at_bms.com> (BMS), Ma=
ciej J Swat<mailto:mjswat_at_ebi.ac.uk> (DDMoRE), Peter Schaefer<mailto:pschae=
fernet_at_yahoo.com> (Validated Cloud Applications), David Radtke<mailto:radtk=
e_david_b_at_lilly.com> (Eli Lilly), Henning Schmidt<mailto:henning.schmidt_at_in=
tiquan.com> (IntiQuan), Christian Rasmussen<mailto:chvr_at_novonordisk.com> (N=
ovo Nordisk), Warwick Benger<mailto:Warwick.J.Benger_at_gsk.com> (GSK), Jeff=
ry Florian<mailto:Jeffry.Florian_at_fda.hhs.gov> (FDA), Scott Pivirotto<mailto=
:scottp_at_metrumrg.com> (Metrum), Tim Bergsma<mailto:tim.bergsma_at_certara.com>=
 (Certara), Stuart Moodie<mailto:stuart.moodie_at_eightpillars.uk.com> (Eight =
Pillars), Liping Zhang<mailto:LZhang11_at_its.jnj.com> (J&J), or simply join u=
s this Tuesday!



Andrijana Radivojevic, PhD
Principal Pharmacometrics Scientist
Pharmacometrics
Novartis Pharmaceuticals Corporation
One Health Plaza, 135/108A
East Hanover, NJ 07936-1080
USA
Phone +1 862 778-1152
Mobile +1 917 714-1215
andrijana.radivojevic_at_novartis.com<mailto:andrijana.radivojevic_at_novartis.co=
m>
www.novartis.com<http://www.novartis.com/>


Received on Thu Oct 20 2016 - 09:21:36 EDT

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