Alfonso Iorio on behalf of the working group DISCLOSURES Financial conflicts of interests McMaster University has received funds for research and service agreements from Bayer Baxalta ID: 932800
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Slide1
Working group on Pharmacokinetics and Population Pharmacokinetics of factor concentrates
Alfonso Iorio, on behalf of the working group
Slide2DISCLOSURES
Financial conflicts of interestsMcMaster University has received funds for research and service agreements
from Bayer, Baxalta, Biogen, NovoNordisk
,
Octapharma
, and Pfizer.
Non-financial (intellectual) conflicts
PI for the WAPPS project (
www.wapps-hemo.org
)
No mention of unlicensed products
Slide3WORKING GROUP
Core membersA Iorio, V Blanchette, P Collins, K Fischer, J
Blatny, E NeufeldAdditional membersD
Lillicrap
, D Hart, M
Makris
PK and
PopPK
consultants
A
Edginton
, S
Ito
Slide4Previous SSC Communications
The design and analysis of half-life and recoverystudies for factor VIII and factor IX.
Factor VIII/Factor IX Scientific and Standardization Committee of the International Society for Thrombosis and Haemostasis.
Morfini
M, Lee M,
Messori
A.
Thromb
Haemost
. 1991 Sep 2;66(3):384-6.
Slide5Previous SSC Communications
Scientific and Standardization Committee CommunicationThe Design and Analysis of Pharmacokinetic Studies of
Coagulation FactorsOn behalf of the Subcommittee on Factor VIII and Factor IX of the Scientific and
Standardization Committee
of the International Society on Thrombosis and
Haemostasis
M. Lee, M.
Morfini
, S. Schulman, J.
Ingerslev
and
the Factor VIII/Factor
IX Scientific
and Standardization Committee of
the ISTH
Posted on the ISTH SSC on March 21, 2001
Slide6Previous SSCCommunications
… the approaches recommended here are primarily intended for clinical trials of
factor concentrates that are being compared to other, similar preparations.
…
studies
on individual patients
for diagnostic or therapeutic purposes
may
not necessarily
be relevant
to what is discussed
here.
Slide7Previous SSCCommunications
Slide8AIMS: Primary
PK and PopPK estimates of factor concentrates:
ReportingInterpretationAssessment in clinical practiceStudy design for “real world/PM”
PopPK
assessment
Slide9AIMS: SecondaryPK
and PopPK estimation:During registration phaseTo compare different molecules
Choice of time points….
Slide10PROCESSHow (and whether) to best involve:
Pharmaceutical companies PK/PopPK experts
FDA / EMA PK/PopPK expertsAuthors
of
PK/
PopPK
published papers
Patient representatives
Slide11PROGRESS
2 conference calls1 panel surveyBi-monthly conference callsReview of the existing literature
Review of regulators guidanceDraft recommendations on primary goals
Slide12Questions time
Thank you for attentionSlides posted on:
http://hemophilia.mcmaster.ca/resources