iSyPeM2 - Nano-Tera 2016

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    Administration and monitoring of medical treatments

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    Intelligent Systems for Personalized MedicineISyPeM II

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    Intelligent Systems for Personalized MedicineISyPeM II

    dministration and monitoring of medical treatments

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    Intelligent Systems for Personalized MedicineISyPeM II

    dministration and monitoring of medical treatments

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    s o medical treatment or which monitoring is highly critical

    IV ANTIBIOTIC

    I!!"NO"##$%IV%

    &$"'

    CANC%$ TA$'%T%&T(%$A#I%

    time after dose (hrs)

       I  m

      a   t   i  n   i   b  e  x  p  o  s  u  r  e

       (  n  g   /  m   l   )

    #atient

    Courtesy of N. Widmer 

    Syva Rapidest!

    "nly#ualitative$%rugconcentrationneeds to be&uanti'ed it

    *+, accuracyfor %M

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    )

    Towards distri*+ted *ioanalytic

    IV ANTIBIOTIC

    I!!"NO"##$%IV%

    &$"'

    CANC%$ TA$'%T%&T(%$A#I% iSA- Abbott

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    Physiological parameters, DNA

    analysis

    s o medical treatment or which monitoring is highly critical

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    Reduce volume samplesMonitoring of treatmentis often needed inneborn and cild care

    .ompact- a4ordableanalytical systems

    Measurement performed atte M%integrated it decisions+pport sotware

    Interaction andInteroperability

    5ater data for decisionon dosage and enricpopulation data

    ,

    6I".37MI.A/A8A9I.A .3A7857S

    6I".37MI.A/A8A9I.A .3A7857S

    %AA I87RPR7AI"8 A8% MA8A57M78 .3A7857S

    Intelligent Systems for Personalized MedicineISyPeM II

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    Affordability of the analytical system

    Meet the microsample challenge

    -

    Abbott :Arcitect ci;0M SeguraM 5eiser

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    Affordability of the analytical system

    Meet the microsample challenge

    0

    Abbott :Arcitect ci;0M SeguraM 5eiser

    Iy#e! II demonstratoro0cost?ully integrated6ased on 3ig sensitive ?PIA@or1s on capillaries

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    Microsample analytics in capillaries

    #lasma e1traction rom whole

    *lood 

     9ield outperforms any passive on0cip

    metod reported to date2 7xtractionfrom eection2

    ttpB//dbs0system2c

    Renaud ab

    2

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    3#IA o To*ramycin perormed in glass

    microcapillaries+ared glass capillary

    ttpB//dbs0system2c

    5// 6m

    = < C D ; *= *<

    =2*C=

    =2*D=

    =2*;=

    =2

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    Lack of availability of ligands for drug

    molecules

    77

          "   6   R   A   M   9

       .   I   8

       I   M   A      I   8   I   6

          A   .   R   "      I   M   H   S

    • %rugs are small molecules

    •  ey can ave very di4erent solubility andbiocemical and metabolic caracteristics

    • In vivo raised antibody against drugs avepoor anities and in some case are notavailable at all

    @e develop in vitro approaces for teselection of ligands for di4erent classes

    of drugs

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    In vitro selection of aptamers

          "   6   R   A   M   9

       .   I   8

    5uiducci ab

    %8A aptamers canbe obtained in afe steps tat arebetter or e&ual toexisting R8A

    aptamers

    ?unctional in serumand proved onpatient samples-meeting te clinical

    range

    Speci'citydemonstrated

    Metod can be

    applied to di4erentdrugs

    .lin2 Parmac2

     

    : CCTTACCTA''T'TA': )8)8 :''AAT''ATCCACATC:

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    Measuring Tobramycin concentration

    from serum on a palm-sized devices

    5uiducci ab

          "   6   R   A   M   9

       .   I   8

    52 et al2 Analytical .emistry- April

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    In vitro selection of antibodies

          A   .   R   "      I   M   H   S

    3einis a

    ?irst in vitroselection ofantibodiesagainst

     acrolimus everperformed

     o approaceddeployed tocompetition

    assay

    Peptidemacrocycles0

    based approacfor assays

     >0M Segura

    74.2 3einis- 6icyclic peptide page display- *=t Peptide erapeutics Symposium-

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    D T INT!"!T TI#N

    ND M N $MNT

    7)

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    Drug decision support system

    developed by I%y"eM II partners

    %iv2 .lin2 Parmac2

     9ann oma

    8o in use at

    .3HK andconnected itM"IS database

    argelyoutperformingany existingsupport systems

    Kalidation and.linical trials inprogress forcerti'cation andcommercialization

    ?I grant for start0up creationBttpB//2fondation0't2c

    ab Innovation Aard- ausanne

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    Meta-analysis approaches to build

    population pharmacokinetics models

    %iv2 .lin2 Parmac2

    Br J Clin Pharmacol. 20!

    No"#$%&'()0*0+0

    .onsolidation of

    population studies for %M

    Statistical combinationof independentpopulation studies

       I   M   A      I   8

       I   6

       7   ?   A   K   I   R

       7   8   L

       A   M   I   8   "   5      9   .   "   S   I   %   7   S

    7-

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    "&" approach for data storage

    #+*lishD+*scri*e

    ## Networ; 

    Contri*+tor$&B

    Contri*+tor$&B

    &Bmetadata

     

    &B

    E+eryD%1change

    &ata

    uple+center 

    Negotiate

    Initiator

    A7

    Cryptographic

    !od+le

    Anonymi>ation!od+le

    $&B

    8o centralizedsystem fordata storage

    .ontributorscan sareteir data andgetanonymized

    data from teoters

    :Multi0Agent System for %ynamic %ataAggregation in Medical Researc A2%ubovits1aya- K2 Hrovi- I2 6arba- O2Aberer- M2 I2 Scumacer- in preparation%ubovits1aya- A2 Privacy PreservingInteroperability for PersonalizedMedicine- inB Siss Medical Informatics-Siss Society for Medical Informatics-

    Sitzerland-

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    #utput and outlook

    ore tan *+ peer revieed papers publised (only ISyPeM II)

    irst demonstrator is functional

    I on going it a Parma company (%ebioparm International)

    terest in te diagnostics 'eld

    72

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    Therapeutic Drug Monitoring Today

    Abbott :Arcitect ci;

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    'ioanalytical systems for diagnostics

    and monitoring

    Syva Rapidest!

    EMIT (Enyme mu!ti"!ied

    immunoassay te#hni$ue)

    iSA- Abbott

    .lonitStMicroelectronicscobas! ab0in0a

    tube

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    ysiological parameters- %8A analysis 7R %rug of abuse tests

    "nly #ualitative$%rug concentrationneeds to be &uanti'edit *+, accuracy for %M

    5

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    )

    I% " M bli d b d

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    I%y"eM( nabling drug-based

    therapeutic drug monitoring(

    iSA- AbbottAccu0.e1 productlines2Roce %iagnostics

    3and0eld

    ysiological parameters- %8A analysis

    I%y"eM integrated

    approach to TDM

    e3ealtstandards

    %atasecurity

    .artridge

    it stablereagents

    o samplevolume

    Supported

    Interpretationfor nonspecialists

    At te clinicand outside

    .lonitStMicroelectronicscobas! ab0in0a

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    I%y"eM II) #b*ectives

    %e&e!o" and demonstrate the feasi'i!ity of  in vitro selection te#hni$ues to identify suita'!e

    "ro'es for dru mo!e#u!es

     A#hie&e microvolume "ro#essin and ana!ysis

    %e&e!o" no&e! compact and full!inte"rated assas "ro&in their • Sta'i!ity of mo!e#u!es in #om"!e matri and in "resen#e of sam"!e treatment

    reaents• S"e#ifi#ity

    •  A##ura#y

    E$ui" !o#a! #!ini#a! institutions and se!e#ted #a'inets *ith #ertified decision support

    sstems for dru dosae• Lare!y out"erformin eistin too!s for usa'i!ity and &a!ue of e!a'oration

    a""roa#hes em"!oyed+• Conne#ted *ith !o#a! data'ases, se#ure and #onne#ted in a PP net*or to enri#h

    "harma#oineti# data'ases

    %evelop a top0benc stand0alone proof0of0conceptdemonstrator for in vitro &uantitative analysis of terapeutic

    drug from ole blood2 e consortium is no focusing on antibiotics andimmunosuppressant drugs2

    "ur metodology

    -

    M t t i i t i ti f

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    Measurement system) miniaturization of

    the assay

       .   )  c  m

    / cm

    +orescence #olari>ation Imm+noassay

          "   6   R   A   M

       9   .   I   8

    .ompetitive assay(ig sensitivity)

    %esigned for lovolumes (focalized)

    ?unctional on ells-tested on capillariesand paper

    Renaud ab

     >0M SeguraM2 PfeiferM2 5eiser

    0

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    "rogress of demonstrator 

    IntegratedPartially integrated8ot integrated 2

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    'A+, " slides

    5/

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    EImatini*G

    Therape+tic dr+g monitoring (%M) forimatinib as been suggested to impro?eeGcacy- assess compliance- and e?al+atedr+g:dr+g interactionseng et al., herapeutic Drug -onitoring. !&()%'+*$,/eruary 202.

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    #$%& for tacrolimus 'DM(urrent status and ne)t steps

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    enrico accastelli@epf

    5otta K- 6uclin - .sa1a .- @idmer 82 Systematic revie of populationparmaco1inetic analyses

    Po"u!ation P. Meta-ana!ysis of Imatini'

    P+

    P+

    P