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Kim Solez

    Images from 1991
.




The Banff Schema
was first developed
 by a group of pathologists,
    nephrologists, and transplant surgeons at a
        meeting in Banff Canada August 2-4, 1991..
          It has continued to evolve through meetings every
              two years and has become the worldwide standard for
                 interpretation of transplant biopsies.
 A moderated self-organizing group to define and
  standardize organ allograft biopsy interpretation
 Aim is to promote international uniformity in
  reporting allograft pathology, which is necessary for
  research, clinical trials, and standardized patient
  management
 International and inter-disciplinary process with
  meetings every 2 years
 Mini-review “The Banff Classification Revisited”
  (Solez, K. and Racusen, L.C.) will be appearing in
  Kidney International later this year.
                                                   Singularity
                                                   Course
   In 1990 all standard textbooks were inaccurate in
    interpretation of kidney transplant biopsies
    ◦ Suggesting, for example, that arteritis meant that the
      kidney was doomed and antirejection treatment should
      be abandoned
   It became imperative for the field to correct this
    and standardize interpretation




                                                           Singularity
                                                           Course
•   Began in kidney (Solez
    et al. 1993), and was
    then extended to liver,
    pancreas, composite
    tissue grafts etc.
    Meetings also consider
    heart, lung, small bowel.
•   Uses semi-quantitative
    lesion scoring 0-3+ and
    diagnostic categories.
 Normal
 Antibody-mediated rejection,

 Borderline changes: ‘Suspicious’ for acute cellular

  rejection
 T-cell-mediated rejection (may coincide with

  categories 2 and 5 and 6)
 Sclerosis, interstitial fibrosis, and tubular atrophy,

  no evidence of any specific etiology
 Other changes not considered to be due to

  rejection
   Transplant glomerulitis - g
   Chronic transplant glomerulopathy - cg
   Interstitial Inflammation - i (ti)
   Interstitial fibrosis - ci
   Tubulitis - t
   Tubular atrophy - ct
   Vasculitis, intimal arteritis - v
   Fibrous intimal thickening - cv
   Arteriolar hyaline thickening - ah (aah)
   Mesangial matrix increase - mm
   Peritubular capillary cell accumulation - ptc   Singularity
                                                    Course
   Genome Canada
    transplant transcriptome project.

           Affymetrix GeneChip® probe array.
           Image courtesy of Affymetrix.




   Traditional pathology techniques.
   1991 First Conference
   1993 First Kidney International publication
   1995 Integration with CADI
   1997 Integration with CCTT classification
   1999 Second KI paper. Clinical practice guidelines. Implantation biopsies,
    microwave.
   2001 Classification of antibody-mediated rejection
    ◦ Regulatory agencies participating
   2003 Genomics focus, ptc cell accumulation scoring
   2005 Gene chip analysis. Elimination of CAN, identification of chronic
    antibody-mediated rejection.
   2007 First meeting far from a town called “Banff” – La Coruna, Spain.
   2009 Working groups. Meeting in Banff, Alberta, Canada for last time until
    2015!


                                                                            Singularity
                                                                            Course
86% Kidney clinical
6% Liver clinical        Most articles are in high quality journals
5% Kidney experimental   with impact factor of 3.2 or higher,
1% Liver experimental    one third have impact factors of 6-9.
  The Banff meeting reports and main meeting
  papers have been cited 4,312 times in the
  medical literature.
 The 1999 paper The Banff 97 Working
  Classification of Renal Allograft Pathology
  Kidney International 55(2):713-23, 1999 by
  Racusen, Solez, and Colvin et al. is a citation
  classic in the field having been cited 1,764
  times.

                                              Singularity
                                              Course
 Classification begun at 1991 Banff meeting has
  become the worldwide standard, and the
  consensus process has now extended to all solid
  organs. Future meetings are planned every two
  years through 2019.
 Standardization principles now being extended
  from biopsy reporting to tissue typing, imaging, all
  the other elements in transplant care.
 Classification used in clinical trials, and by the
  FDA, mandatory evaluation for drug approvals.


                                                    Singularity
                                                    Course
Banff Working Groups:
 Addressing unmet needs in a data-driven, evidence based approach
             Sis et al. 2009 Banff Meeting Report, Am J Transplant. 2010 Mar;10(3):464-71


                                     Isolated v-lesion
                                      Working Group


 Fibrosis Scoring                                                      IHC Quality Assurance
  Working Group                                                           Working Group



                                  Data-driven & Validated
                                    Refinement of the
                                     Banff Guidelines



Glomerular Lesion                                                      Polyoma Virus Nephropathy
 Working Group                                                               Working Group


                                  C4d-Negative ABMR
                                    Working Group
 Isolated V lesion – Banu Sis and Ed Kraus
 Fibrosis scoring – Robert Colvin
 Polyoma virus staging – Volker Nickeleit
 Glomerular lesion scoring – Mark Haas
 Molecular pathology – Phil Halloran
 Quality assurance IHC – Michael Mengel
 C4d neg. Ab-Mediated Rejection – Banu Sis
 History&Impact of Banff Process – Kim Solez


                                          Singularity
                                          Course
 1.Defining appropriate thresholds for
 microvascular injury and for DSA that provide
 an optimal balance of specificity and sensitivity
 for ABMR, noting that none of these
 morphologic changes are specific and that not
 all patients with DSA have ABMR.
 2. Defining "C4d-negative". There is some
 evidence that focal C4d is often (though less so
 than diffuse C4d) associated with DSA and
 microvascular injury.

                                             Singularity
                                             Course
 3.
  Defining acute versus chronic/active Ab-
 mediated rejection.

 4.Defining the significance of intimal arteritis
 (in the absence of necrosis) as histologic
 evidence for Ab-mediated rejection.




                                                Singularity
                                                Course
Includes analysis of physician facilitation of consensus discussions, seen most recently in
Bob Colvin’s C4d discussions and in Michael Mengel’s organization of Banff Working Groups.
 Also includes analysis of future trends and developments.
 Future concepts of where
  technology is taking us are
  incorporated into long term
  planning of Banff Process.

 Will be part of 2013 meeting in
  Brazil.
•   Until now we have
    had none beyond Drs.
    Racusen and Solez.
•   Will form Swiss
    foundation legal entity
    in 2012, to enable us
    to enter into formal
    relationships with
    other organizations
    we cannot do now.
   To lead development and dissemination of the
    international Banff Classification of Allograft
    Pathology and to facilitate multidisciplinary,
    collaborative research to enhance its scientific
    basis and clinical utility to improve the care of
    transplant patients.




                                                        Singularity
                                                        Course
   Facilitation of knowledge generation and translation in
    transplantation pathology with the ultimate aim to
    improve patient outcome
   Maintaining the Banff spirit of a multinational,
    multidisciplinary consensus group
   Fundraising
   Guidance and financial support for Working Group
    activities
   Guidance and financial support for Banff meetings
    activities



                                                              Singularity
                                                              Course
   Responsible for annual reports of the Foundation and adherence to
    Swiss law
   Fiduciary responsibility for foundation funds
   Final responsibility for selection and content of Banff meetings
   Support and guide Working Group activities
   External representation of the Banff process: fundraising, policy
    papers, set up, content, and maintenance of a Banff website
   Bidirectional communication to membership of the Banff community
   Composition:
    ◦ The BOD consists of 6-9 members, including the Chair.
    ◦ Members are selected by majority vote of the BOD and serve for a 3 year
      term, renewable once. Terms are staggered (3 selected each year).
    ◦ The Chair and Secretary/Treasurer are selected by a majority vote of the
      BOD and serve for a 3 year term, renewable once.
    ◦ Vacancies filled by majority vote of BOD.

                                                                          Singularity
                                                                          Course
Secretary/Treasurer
    ◦ Responsible for day-to-day business/activities of the Banff Foundation
      and annual reporting
    ◦ Is a member of the board and regularly reports to the other board
      members
    ◦ Prepares annual budget and projections
    ◦ Monitors expenses
    ◦ Works closely with the administrative team
Flow and handling of funds through the
   A foundation should generate funding from whatever sources over its
    lifetime, to fulfil its purpose; which in this case would be to run Banff
    meetings and to foster advances organ transplantation
   Therefore the recommendation is to run any money e.g. from a
    pharmaceutical company into the Swiss Foundation, which then will at
    the Board of Trustees instruction transferred to a trusted organising
    committee, e.g. a University or Society account from local Banff meeting
    organizers , or Banff working group leaders for supporting their activities
   Organization of meetings together with local organizers
   Organization of cross-organ plenary sessions
   Program finalization according to input from Organ
    Steering committees
   Selection of speakers and moderators
   Support and coordination of preparation of meeting
    reports
   Terms of references:
    ◦ Appointed by the BOD
    ◦ terms of membership four years (i.e. two meetings), renewable
      through majority vote of the board




                                                                  Singularity
                                                                  Course
   Should engage pathologists and clinicians as well as
    representative from major geographic regions (e.g.
    North America, South America, Europe, Asia, Africa,
    Australia)
   Fund raising for the meetings and consensus work
    should also be scope for the organ steering committee
    members
   Organization of organ specific sessions: selection of
    topics and speakers
   Preparation of organ specific meeting reports
   Terms of reference:
    ◦ Leadership appointed by the board of directors for four years (i.e.
      two meetings), renewable through majority vote of the board
    ◦ Otherwise self-organized


                                                                      Singularity
                                                                      Course
Kim Solez Banff and Beyond presentation for Tx Update meeting in Ahmedabad, India

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Kim Solez shortened slide set for opening reception Pittsburgh Banff meeting
Kim Solez shortened slide set for opening reception Pittsburgh Banff meetingKim Solez shortened slide set for opening reception Pittsburgh Banff meeting
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Kim Solez Banff and Beyond presentation for Tx Update meeting in Ahmedabad, India

  • 2. Images from 1991
  • 3. . The Banff Schema was first developed by a group of pathologists, nephrologists, and transplant surgeons at a meeting in Banff Canada August 2-4, 1991.. It has continued to evolve through meetings every two years and has become the worldwide standard for interpretation of transplant biopsies.
  • 4.  A moderated self-organizing group to define and standardize organ allograft biopsy interpretation  Aim is to promote international uniformity in reporting allograft pathology, which is necessary for research, clinical trials, and standardized patient management  International and inter-disciplinary process with meetings every 2 years  Mini-review “The Banff Classification Revisited” (Solez, K. and Racusen, L.C.) will be appearing in Kidney International later this year. Singularity Course
  • 5. In 1990 all standard textbooks were inaccurate in interpretation of kidney transplant biopsies ◦ Suggesting, for example, that arteritis meant that the kidney was doomed and antirejection treatment should be abandoned  It became imperative for the field to correct this and standardize interpretation Singularity Course
  • 6. Began in kidney (Solez et al. 1993), and was then extended to liver, pancreas, composite tissue grafts etc. Meetings also consider heart, lung, small bowel. • Uses semi-quantitative lesion scoring 0-3+ and diagnostic categories.
  • 7.  Normal  Antibody-mediated rejection,  Borderline changes: ‘Suspicious’ for acute cellular rejection  T-cell-mediated rejection (may coincide with categories 2 and 5 and 6)  Sclerosis, interstitial fibrosis, and tubular atrophy, no evidence of any specific etiology  Other changes not considered to be due to rejection
  • 8. Transplant glomerulitis - g  Chronic transplant glomerulopathy - cg  Interstitial Inflammation - i (ti)  Interstitial fibrosis - ci  Tubulitis - t  Tubular atrophy - ct  Vasculitis, intimal arteritis - v  Fibrous intimal thickening - cv  Arteriolar hyaline thickening - ah (aah)  Mesangial matrix increase - mm  Peritubular capillary cell accumulation - ptc Singularity Course
  • 9. Genome Canada transplant transcriptome project. Affymetrix GeneChip® probe array. Image courtesy of Affymetrix.  Traditional pathology techniques.
  • 10.
  • 11. 1991 First Conference  1993 First Kidney International publication  1995 Integration with CADI  1997 Integration with CCTT classification  1999 Second KI paper. Clinical practice guidelines. Implantation biopsies, microwave.  2001 Classification of antibody-mediated rejection ◦ Regulatory agencies participating  2003 Genomics focus, ptc cell accumulation scoring  2005 Gene chip analysis. Elimination of CAN, identification of chronic antibody-mediated rejection.  2007 First meeting far from a town called “Banff” – La Coruna, Spain.  2009 Working groups. Meeting in Banff, Alberta, Canada for last time until 2015! Singularity Course
  • 12. 86% Kidney clinical 6% Liver clinical Most articles are in high quality journals 5% Kidney experimental with impact factor of 3.2 or higher, 1% Liver experimental one third have impact factors of 6-9.
  • 13.  The Banff meeting reports and main meeting papers have been cited 4,312 times in the medical literature.  The 1999 paper The Banff 97 Working Classification of Renal Allograft Pathology Kidney International 55(2):713-23, 1999 by Racusen, Solez, and Colvin et al. is a citation classic in the field having been cited 1,764 times. Singularity Course
  • 14.  Classification begun at 1991 Banff meeting has become the worldwide standard, and the consensus process has now extended to all solid organs. Future meetings are planned every two years through 2019.  Standardization principles now being extended from biopsy reporting to tissue typing, imaging, all the other elements in transplant care.  Classification used in clinical trials, and by the FDA, mandatory evaluation for drug approvals. Singularity Course
  • 15. Banff Working Groups: Addressing unmet needs in a data-driven, evidence based approach Sis et al. 2009 Banff Meeting Report, Am J Transplant. 2010 Mar;10(3):464-71 Isolated v-lesion Working Group Fibrosis Scoring IHC Quality Assurance Working Group Working Group Data-driven & Validated Refinement of the Banff Guidelines Glomerular Lesion Polyoma Virus Nephropathy Working Group Working Group C4d-Negative ABMR Working Group
  • 16.  Isolated V lesion – Banu Sis and Ed Kraus  Fibrosis scoring – Robert Colvin  Polyoma virus staging – Volker Nickeleit  Glomerular lesion scoring – Mark Haas  Molecular pathology – Phil Halloran  Quality assurance IHC – Michael Mengel  C4d neg. Ab-Mediated Rejection – Banu Sis  History&Impact of Banff Process – Kim Solez Singularity Course
  • 17.  1.Defining appropriate thresholds for microvascular injury and for DSA that provide an optimal balance of specificity and sensitivity for ABMR, noting that none of these morphologic changes are specific and that not all patients with DSA have ABMR.  2. Defining "C4d-negative". There is some evidence that focal C4d is often (though less so than diffuse C4d) associated with DSA and microvascular injury. Singularity Course
  • 18.  3. Defining acute versus chronic/active Ab- mediated rejection.  4.Defining the significance of intimal arteritis (in the absence of necrosis) as histologic evidence for Ab-mediated rejection. Singularity Course
  • 19. Includes analysis of physician facilitation of consensus discussions, seen most recently in Bob Colvin’s C4d discussions and in Michael Mengel’s organization of Banff Working Groups. Also includes analysis of future trends and developments.
  • 20.  Future concepts of where technology is taking us are incorporated into long term planning of Banff Process.  Will be part of 2013 meeting in Brazil.
  • 21. Until now we have had none beyond Drs. Racusen and Solez. • Will form Swiss foundation legal entity in 2012, to enable us to enter into formal relationships with other organizations we cannot do now.
  • 22.
  • 23. To lead development and dissemination of the international Banff Classification of Allograft Pathology and to facilitate multidisciplinary, collaborative research to enhance its scientific basis and clinical utility to improve the care of transplant patients. Singularity Course
  • 24. Facilitation of knowledge generation and translation in transplantation pathology with the ultimate aim to improve patient outcome  Maintaining the Banff spirit of a multinational, multidisciplinary consensus group  Fundraising  Guidance and financial support for Working Group activities  Guidance and financial support for Banff meetings activities Singularity Course
  • 25. Responsible for annual reports of the Foundation and adherence to Swiss law  Fiduciary responsibility for foundation funds  Final responsibility for selection and content of Banff meetings  Support and guide Working Group activities  External representation of the Banff process: fundraising, policy papers, set up, content, and maintenance of a Banff website  Bidirectional communication to membership of the Banff community  Composition: ◦ The BOD consists of 6-9 members, including the Chair. ◦ Members are selected by majority vote of the BOD and serve for a 3 year term, renewable once. Terms are staggered (3 selected each year). ◦ The Chair and Secretary/Treasurer are selected by a majority vote of the BOD and serve for a 3 year term, renewable once. ◦ Vacancies filled by majority vote of BOD. Singularity Course
  • 26. Secretary/Treasurer ◦ Responsible for day-to-day business/activities of the Banff Foundation and annual reporting ◦ Is a member of the board and regularly reports to the other board members ◦ Prepares annual budget and projections ◦ Monitors expenses ◦ Works closely with the administrative team Flow and handling of funds through the  A foundation should generate funding from whatever sources over its lifetime, to fulfil its purpose; which in this case would be to run Banff meetings and to foster advances organ transplantation  Therefore the recommendation is to run any money e.g. from a pharmaceutical company into the Swiss Foundation, which then will at the Board of Trustees instruction transferred to a trusted organising committee, e.g. a University or Society account from local Banff meeting organizers , or Banff working group leaders for supporting their activities
  • 27. Organization of meetings together with local organizers  Organization of cross-organ plenary sessions  Program finalization according to input from Organ Steering committees  Selection of speakers and moderators  Support and coordination of preparation of meeting reports  Terms of references: ◦ Appointed by the BOD ◦ terms of membership four years (i.e. two meetings), renewable through majority vote of the board Singularity Course
  • 28. Should engage pathologists and clinicians as well as representative from major geographic regions (e.g. North America, South America, Europe, Asia, Africa, Australia)  Fund raising for the meetings and consensus work should also be scope for the organ steering committee members  Organization of organ specific sessions: selection of topics and speakers  Preparation of organ specific meeting reports  Terms of reference: ◦ Leadership appointed by the board of directors for four years (i.e. two meetings), renewable through majority vote of the board ◦ Otherwise self-organized Singularity Course