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Opening'of'the'3rd'European'Conference'on'' Whole'Slide'Imaging!
Niels!Grabe!
Harvard&Business&Review,&Dec&2012&
Opening'of'the'3 rd 'European'Conference'on'' Whole'Slide'Imaging ! - - PowerPoint PPT Presentation
Opening'of'the'3 rd 'European'Conference'on'' Whole'Slide'Imaging ! - - PowerPoint PPT Presentation
Opening'of'the'3 rd 'European'Conference'on'' Whole'Slide'Imaging ! Niels!Grabe! How!to!deal!with!transforma4ons?! Harvard&Business&Review,&Dec&2012& Scien4fic!Transformers! 450! Pubmed'WSI'Publica;ons' 400! 350! 300!
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SLIDE 3
Scien4fic!Transformers!
0! 50! 100! 150! 200! 250! 300! 350! 400! 450! 2003!2004!2005!2006!2007!2008!2009!2010!2011!2012!2013!
Pubmed'WSI'Publica;ons'
SLIDE 4
WSI!is!Transforming!
- Transforming!research!in!many!fields:!!
– Bioinforma4cs! – Biology! – Medicine! – Medical!Systems!Biology!+!Systems!Pathology!
- Transforming!biomarker!analysis!
– Clinical!studies! – Regulatory!studies! – Mul4Qdimensional!
- Transforming!HE!&!IHC!based!diagnos4cs!
- The!ques4on!is!not!if:!the!ques4on!is!how?!
- How!will!you!have!to!adapt?!!
!
- What!chances!will!emerge!for!you?!
!
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Real!Transformers!=!Companies!!!
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6
FDA on Whole Slide Imaging (=>Transforming Diagnostics)
- Microscope one component of the system
- Image acquisition, processing and display new
technology for this intended use
- Diagnostic for neoplastic disease
- WSI systems can not be considered Class I exempt
Mechanical scanner Light source SLIDE Imaging
- ptics
Digital image sensor Image Processing software Display READER IMAGE DATA FILES
Conventional
- ptical microscope
SLIDE 7
7
21 CFR 864.9 Limitations of exemptions from 510(k) (a few)
Exemption only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality
– Different fundamental scientific technology – IVD intended for use in diagnosis, monitoring
- r screening of neoplastic diseases
SLIDE 8
8
How does FDA plan to ensure the safety and effectiveness of digital pathology devices?
- Require analytical and clinical studies to
- bjectively and precisely validate performance
- Knowledge of the risks, benefits and limitations
- Standardization
- Postmarket studies
SLIDE 9
9
Summary
- FDA recognizes that the technological advances
associated with WSI make its use a reality
- WSI systems are not Class I exempt and are therefore,
subject to premarket requirements
- Current IVDs that utilize digital imaging for limited
applications are not applicable to the WSI paradigm
- Digital mammography may provide useful lessons but
does not address all of the concerns for WSI
- Our goal is to gain information about the technology in
- rder to ensure safe and effective use
SLIDE 10
!!!!!! !
COMBI'
DIGIT DIGITAL P AL PATHOLOGY PLA THOLOGY PLATFORM TFORM
Technology!Research! (Systems!Pathology)! LargeQscale!Biomarker! Quan4fica4on!in!Rou4ne!! and!Clinical!Studies! Transla4on! !Technology! LargeQScale!! Tissue!Banking!
IVD!+!WSI! WSI!
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„House“!of!Medical!Systems!Biology!
Spa4al/microscopic!! 4ssue!analysis! ! Testable!4ssues! (3D!Cell!culture)! Molecular! analysis! Clinical!! pa4ent!data! Computa4onal! mul4Qscale!modeling! What!is!Medical!Systems!Biology?!Integra4on!of!these!levels!in!a!way!closer!than! ever!before!driven!by!technology!to!generate!new!points!of!interven4on.!
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Program!change:!! Caroline!Kampf!is!ill!
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The!image!processing!badle!
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Technology!&!! Applica4on!
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Working!! Reliably!
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Coun4ng!! the!Tumor!
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Linking!Technology!
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3D!Tissue! Informa4on!
(Kai!Safferling!ill)!
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