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Kim Solez, MD

Images from 1991
 .
The Banff Schema
was first developed
at a meeting of pathologists,
clinicians and surgeons in Banff, Alberta, Canada,
August 2-4, 1991 and has become the worldwide
standard for the 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.) appeared in Kidney
International last year
 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
 2011 Planning for Banff Foundation begun.
 2013 Establishment of Banff Foundation for Allograft Pathology supported
by Roche Organ Transplantation Research Foundation (ROTRF).
 Given changed regulations and climate surrounding pharma support
we can never again hold the Banff meeting in a resort location.
Future meetings will have to be in regular business destination
cities. We are very grateful for the extraordinary hard work
undertaken by the Brazil organizers this year, a herculean effort!
 Vancouver for Banff 2015 in cooperation with the Canadian Society
of Transplantation.
 For 2017 and 2019 Barcelona and Pittsburgh will work if the
necessary infrastructure and background stability can be found,
otherwise Edmonton could be considered. The 2001 Banff meeting
in Edmonton was quite successful, uncomplicated.
 The many accomplishments of the Banff process can be used to
establish useful partnerships with cities, as we did with Aberdeen in
2003. Many cities offer financial incentives to groups planning
meetings.
86% Kidney clinical
6% Liver clinical
5% Kidney experimental
1% Liver experimental
Most articles are in high quality journals
with impact factor of 3.2 or higher,
one third have impact factors of 6-9.
 The Banff meeting reports and main meeting
papers have been cited over 5,000 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 2,478
times.
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.
Isolated v-lesion
Working Group
IHC Quality Assurance
Working Group
Glomerular Lesion
Working Group
Polyoma Virus Nephropathy
Working Group
Fibrosis Scoring
Working Group
Data-driven & Validated
Refinement of the
Banff Guidelines
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
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
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.
 Before 2013 we have
had none beyond
Drs. Racusen and
Solez.
 Formed Swiss
foundation legal
entity in 2013, the
Banff Foundation for
Allograft Pathology.
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.
 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
 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.
 Secretary/Treasurer
Responsible for day-to-day business/activities of the Banff Foundation
for Allograft Pathology 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 Foundation:
 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 in 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
 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
Future concepts of where
technology is taking us are
incorporated into long term
planning of Banff Process.
 Moore’s Law&Eroom’s Law ,
the technological Singularity and
exponential change, exponential
decline in # new drugs per
billion dollars R&D expenditure.
We should proactively address
the challenges of the future, not
be passive victims of events,
keep ahead of the game.
The Banff Foundation for Allograft Pathology
Must Remain Youthful and Relevant for the
Future – Must Adapt, Plan for Changes
 As the field changes and stem-cell-grown organs replace
transplantation, the organization must change with it
 Transplantation may be loosing its luster but luster of the
Banff Foundation for Allograft Pathology can remain
strong. We need to foster sense of community – consider
membership fees.
 Need more young people&women. Enhanced cooperation
with other organizations, AST, TTS, Eurotransplant.
 As an exercise in alternative realities, at Gala Dinner I
asked participants to consider the very different life of
David Crippen, my counterpart in critical care medicine.
We need to consider changes that large!
The spectacular dynamics influencing the
pace of stem generation of organs replacing
transplantation in the future.
 There were YouTube videos (now removed) suggesting
that stem cell generation of complex organs in humans
would be routine by 2020.
 The dramatic slowdown of new drug approvals (Eroom’s
Law) by the FDA suggests that the FDA is ripe for
disruptive innovation.
 However stem cell therapies may be the last area the FDA
will relax regulation in, as unproven bogus stem cell
therapies are causing widespread suffering and protection
of the general public is needed.
 The role of the pathologist/laboratory physician will
increase/expand in the coming decades and they will begin
practicing standing up!
The Banff Schema: Establishing the Worldwide Standard for Transplant Biopsy Interpretation

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The Banff Schema: Establishing the Worldwide Standard for Transplant Biopsy Interpretation

  • 3.  . The Banff Schema was first developed at a meeting of pathologists, clinicians and surgeons in Banff, Alberta, Canada, August 2-4, 1991 and has become the worldwide standard for the 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.) appeared in Kidney International last year
  • 5.
  • 6.  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  2011 Planning for Banff Foundation begun.  2013 Establishment of Banff Foundation for Allograft Pathology supported by Roche Organ Transplantation Research Foundation (ROTRF).
  • 7.  Given changed regulations and climate surrounding pharma support we can never again hold the Banff meeting in a resort location. Future meetings will have to be in regular business destination cities. We are very grateful for the extraordinary hard work undertaken by the Brazil organizers this year, a herculean effort!  Vancouver for Banff 2015 in cooperation with the Canadian Society of Transplantation.  For 2017 and 2019 Barcelona and Pittsburgh will work if the necessary infrastructure and background stability can be found, otherwise Edmonton could be considered. The 2001 Banff meeting in Edmonton was quite successful, uncomplicated.  The many accomplishments of the Banff process can be used to establish useful partnerships with cities, as we did with Aberdeen in 2003. Many cities offer financial incentives to groups planning meetings.
  • 8. 86% Kidney clinical 6% Liver clinical 5% Kidney experimental 1% Liver experimental Most articles are in high quality journals with impact factor of 3.2 or higher, one third have impact factors of 6-9.
  • 9.  The Banff meeting reports and main meeting papers have been cited over 5,000 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 2,478 times.
  • 10. 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.
  • 11. Isolated v-lesion Working Group IHC Quality Assurance Working Group Glomerular Lesion Working Group Polyoma Virus Nephropathy Working Group Fibrosis Scoring Working Group Data-driven & Validated Refinement of the Banff Guidelines 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 C4d-Negative ABMR Working Group
  • 12. 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
  • 13. 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.
  • 14.  Before 2013 we have had none beyond Drs. Racusen and Solez.  Formed Swiss foundation legal entity in 2013, the Banff Foundation for Allograft Pathology.
  • 15.
  • 16. 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.
  • 17.  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
  • 18.  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.
  • 19.  Secretary/Treasurer Responsible for day-to-day business/activities of the Banff Foundation for Allograft Pathology 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 Foundation:  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 in 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
  • 20.  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
  • 21.  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
  • 22. Future concepts of where technology is taking us are incorporated into long term planning of Banff Process.  Moore’s Law&Eroom’s Law , the technological Singularity and exponential change, exponential decline in # new drugs per billion dollars R&D expenditure. We should proactively address the challenges of the future, not be passive victims of events, keep ahead of the game.
  • 23. The Banff Foundation for Allograft Pathology Must Remain Youthful and Relevant for the Future – Must Adapt, Plan for Changes  As the field changes and stem-cell-grown organs replace transplantation, the organization must change with it  Transplantation may be loosing its luster but luster of the Banff Foundation for Allograft Pathology can remain strong. We need to foster sense of community – consider membership fees.  Need more young people&women. Enhanced cooperation with other organizations, AST, TTS, Eurotransplant.  As an exercise in alternative realities, at Gala Dinner I asked participants to consider the very different life of David Crippen, my counterpart in critical care medicine. We need to consider changes that large!
  • 24. The spectacular dynamics influencing the pace of stem generation of organs replacing transplantation in the future.  There were YouTube videos (now removed) suggesting that stem cell generation of complex organs in humans would be routine by 2020.  The dramatic slowdown of new drug approvals (Eroom’s Law) by the FDA suggests that the FDA is ripe for disruptive innovation.  However stem cell therapies may be the last area the FDA will relax regulation in, as unproven bogus stem cell therapies are causing widespread suffering and protection of the general public is needed.  The role of the pathologist/laboratory physician will increase/expand in the coming decades and they will begin practicing standing up!