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International Workshop on Xenotransplantation
 
International Issues in Transplantation Biotechnology,
Including the Use of Non-Human Cells, Tissues and Organs
 
New York City, 18-20 March 1998
 
Jointly Sponsored by
The Organization for Economic Co-operation and Development (OECD)
and
The New York Academy of Sciences (NYAS)
 
Report by
Alastair T. Gordon
The Islet Foundation
 
This report is not intended to be a comprehensive summary of all the material covered at the International Workshop on Xenotransplantation.  Because our primary interest is in islet xenotransplantation as a means of reversing diabetes, sections relevant to that particular endeavor are emphasized, and some conclusions are drawn.  Not covered in any significant details are sections dealing with such issues as animal welfare, religious considerations, third world implications, regulatory enforcement, trade in human organs, macroeconomics, political concerns, and the use of bridge xenografts. This report is not the official record of the OECD, NYAS, nor of any organization other than The Islet Foundation, and neither the OECD nor many of the speakers were consulted in its drafting.
 
Availability of Official OECD Report
 
An OECD short article will be published in the OECD Observer be the end of July 1998.  The complete OECD report will be available by August/September 1998 on the World Wide Web.
 

Table of Contents

Introduction
Why Xenotransplantation?
The Fear of Xenotransplantation
The First Xenotransplant Trials
Dr. Joshua Lederburg, The Rockefeller University, USA Opening Remarks
Dr. Michael Oborne, OECD, Paris, France Welcome - OECD Perspectives
Dr. David Harper, Department of Health, London, UK Conference Goals and Objectives
Dr. John Wallwork, Papworth Hospital, The Need for Alternatives to Allotransplantation
Dr. Blanca Miranda, National Transplant Organization, Madrid, Spain International Issues in Transplantation
Professor Randall E. Morris, Stanford University, USA New Developments in Allo/Xenotransplantation
Dr. Jay A. Fishman, Massachusetts General Hospital, USA Xenotransplantation: Risk of Infection
Professor Dr. Frans van Knapen, Utrecht University, The Netherlands Parasitic Issues in Xenotransplantation
Dr. Jonathan P. Stoye, National Institute for Medical Research, UK Endogenous Retroviruses
Dr. Joachim Denner, Paul Ehrlich Institute, Germany Immunosuppression by Retrovirus
Dr. Jonathan Allan, Southwest Foundation for Biomedical Research, USA The Risk of Baboons as Transplant Donors
Dr. Marian Michaels, Children's Hospital of Pittsburgh, USA Xenotransplant Associated Infections: Patient Issues
Dr. Nelson A. Wivel, Institute for Human Gene Therapy, USA Lessons from Public Oversight of Gene Therapy Research
Mr. André La Prairie, Health Canada, Ottawa, Canada Public Confidence and Government Regulation
Dr. Louisa E. Chapman, CDC, USA Guidelines on the Risk of Infectious Agents during Xenotransplantation
Dr. James Whitehead, Stellar Systems, USA Development of Databases and Registries: International Issues
Dr. Jeffrey L. Platt, Duke University, USA Xenotransplantation: Historical Perspective and Future Promises
Professor Dr. Claus Hammer, Ludwig Maximillians Universität, Germany Physiology of Xenografts
Dr. David H. Sachs, Massachusetts General Hospital, USA Tolerance and Cloning Strategies
Bartha Maria Knoppers, McMaster Meighen, Canada The Ethics of Xenotransplantation
List of Workshop Speakers and Participants
 

Introduction

Xenotransplantation is an emerging medical technology that offers enormous promise for the treatment of human disease.  Today, we are witnessing the birth of a new branch of medicine, in which tissue and organs from animals will be transplanted into people to replace essential functions lost through myriad diseases.  Because of the international implications of xenotransplantation, the Organization for Economic Co-operation and Development (OECD) and the The New York Academy of Sciences (NYAS) sponsored the International Workshop on Xenotransplantation which brought together researchers, clinicians, regulators, ethicists, advocates,  legal experts, and economists to achieve a common understanding of the benefits and risks associated with xenotransplantation.

For people with diabetes, xenotransplantation may represent the only hope for a cure in the near term.  Specifically, the most promising technology today is the transplantation of insulin-producing islets from pigs into people, without the use of immunosuppressive drugs.  Therefore, any regulatory impediments to the advancement of xenotransplantation would have serious consequences for those seeking to end diabetes.  With several countries threatening to impose moratoria on xenotransplantation, it was essential that our voice be heard in an international forum where such regulatory arguments would be aired.

I am happy to report that I do not believe we will face a moratorium in most countries of the world.  It was generally recognized that the benefits of xenotransplantation are enormous, and the risks manageable.  In the United States, the Food and Drug Administration stated very clearly that it would not impose a moratorium, as such a move is unnecessary and would only drive people seeking treatment to countries where the practice was not banned.

The conference lasted for 3 days, each day packed with speakers and panels.  The following report is compiled from my notes taken at the conference, as well as informal discussions with attendees.  Since our main interest is in diabetes, the report will focus on that specific application, rather than provide comprehensive coverage of all the material presented.

Dianne Terry from London, Ontario and I were present representing the interests of the diabetic community.  At the end of the conference, Dianne gave a very pointed challenge to the researchers and regulators saying, in effect, "Now it's time for some action. By this time next year there should be some real progress, and we must not find ourselves still talking about the same things.  This is all about clinical trials, not about endless process."

Why Xenotransplantation?

Allotransplantation, the grafting of organs from human donors, has been a victim of its own success.  The transplanting of organs such as kidneys, hearts, livers, lungs, pancreases, and lungs has saved so many lives that the demand for human organs is outstripping the supply by an accelerating margin.  There were several speakers who operated the organ donation systems in their respective countries, and the message was always the same: More people are dying each year while waiting for a suitable organ donor.  All the speakers agreed that they knew of no way to significantly increase the availability of human donor organs, and that the number of deaths would grow in the coming years.

To bridge the gap between organ supply and demand, it was agreed that xenotransplantation was the only real hope.  In addition, xenotransplantation offers the possibility of treating diseases, such as diabetes and Parkinson's disease, that were hitherto not considered treatable through transplantation.

The Fear of Xenotransplantation

Xenotransplantation, like any new medical technology, comes with enormous promise and some unknowns.  The one risk identified was zoonotic infection resulting from a virus or other pathogen that crosses the species barrier and infects the human host. The remote chance of an infection that causes disease only in the new host would not necessarily create any ethical concern, since the recipient was deriving benefit from the transplant.  The ethical issue centered on the possibility that the zoonotic disease could be spread to other humans who did not derive the same benefit as the recipient.

Several speakers expressed concern about the use of non-human primates, especially baboons and monkeys, as organ donors, as well as the fact that the recipient would be heavily immunosuppressed.  At this point it was important to make the point to the audience that xenotransplantation is not a lumpen mass of science, uniform in its risk and benefit.  In fact, xenotransplantation reflects a whole spectrum of activity, ranging from pig islets without immunosuppression at the safest end of the spectrum, to baboon heart transplants with immunosuppression at the riskiest end of the spectrum.  The difference between those two extremes of xenotransplantation is greater than the difference between xenotransplantation and allotransplantation.  To regulate and practice these extremes as if they shared the same risk/benefit profile would squander a unique opportunity to safely deliver demonstrable benefit from xenografts in the near term.
 
The following table compares the extremes in xenotransplantation.  The obvious difference in risk profiles clearly demonstrates that one set of guidelines targeting the worst case will never work.
 
Safest End of 
Xenotransplantation
Spectrum
Midrange of 
Xenotransplantation
Spectrum
Riskiest End of 
Xenotransplantation
Spectrum
Disease Treated
Diabetes
Kidney Failure
Heart Failure
Organ Transplanted
Pancreatic Islets
Kidney
Heart
Donor Animal  SPF pig  SPF transgenic pig Baboon 
Immunosuppression None (Immunobarriers) Systemic (Lifelong) Systemic (Lifelong)
Graft Failure Return to insulin injections Dialysis Death
 

The First Xenotransplant Trials

Xenotransplantation is a relatively new science with great promise.  The question arises: What should the first clinical trials of xenotransplantation be?  Just as nobody started selling tickets to cross the Atlantic immediately after the Wright brothers managed 20 seconds of bumpy flight on Kitty Hawk, the first xenografts should be selected for the maximum chance of success and the minimum risk of an adverse outcome.  I had an opportunity to make the case strongly to the audience that islet xenografts were the logical first choice.  Although whole organ xenografts will provide tremendous life-saving potential, they represent a greater challenge and more unknowns that islet xenografts.  By demonstrating success and safety in the least challenging end of the xenotransplantation spectrum, both governments and the public will be more friendly to the promise of whole organ xenografts.

The following table compares islets to whole organ xenografts in terms of challenge, risk, rejection potential, efficacy, track record, compatibility, and public response.  The whole field of xenotransplantation would benefit from an early success, such as reversing diabetes.
 
Islet
Xenotransplantation
Whole Organ
Xenotransplantation
Donor Animal Specific-pathogen-free (SPF) pigs only (lowest risk of zoonotic infection). Transgenic pigs are not required. Both transgenic SPF pigs (lowest risk of zoonotic infection) and non-human primates (higher zoonotic infection risk), depending on organ. 
Immunosuppression No immunosuppression - Immunobarriers protect transplanted tissue. Recipient retains healthy immune system. Risk of infection from all sources is minimized, and adverse effects such as cancer are precluded. Systemic immunosuppression  - Higher risk of infection and adverse effects. Immunosuppression is cited as a major risk factor associated with xenografts.  The use of transgenic pigs may allow immunosuppression comparable to allografts.
Hyperacute Rejection None - Since islets do not contain endothelial cells, hyperacute rejection typical of non-human organs does not occur. Strong - Because of endothelial cells and species mismatch, whole organs will experience immediate hyperacute rejection, unless the recipient is sufficiently immunosuppressed.
Acute Vascular Rejection None - Since islets are free tissue not connected directly to the recipient's vascular system, acute vascular rejection is avoided. Strong - Organs such as hearts, liver, or kidney must be connected to recipient's vascular system, resulting in immediate destruction of the blood vessels unless the recipient is sufficiently immunosuppressed.
Physiologic Differences Minimal - Normal blood glucose range is 70-100 mg/dl for humans, 70-105 mg/dl for pigs. Pig islets would maintain a normal blood glucose setpoint in humans. Organ matching is not an issue, as it is impossible to transplant too many islets. Variable - Pigs and humans differ significantly in most physiological parameters. It is not known if these differences will lead to problems in liver, heart, kidney, or other whole organ xenografts.
Historical Efficacy Compelling - Pig insulin has been used for 77 years to control blood glucose in people with diabetes. None - There is no track record comparable to pig insulin for any animal whole organ.
Consequence of Failure Minimal - The recipient will revert to normal injected insulin therapy. Severe - Failure of a whole organ may result in death or serious illness. 
Retransplantation Minor - Injection or simple surgery to add additional islets, or to remove islets for examination. Major - Intrusive and risky surgery to retransplant in event that recipient survives graft failure.
Clinical Trials Some - Several thousand people have already been transplanted with living pig tissue, including islets, hepatic cells, neurons, and skin. In 8 years, there has been no disease manifestation. None - Other than some early failed attempts, there has been no short or long term experience with a xenografted animal organ.
Economic Impact High - Diabetes costs the US $30B/year in direct costs, and over $100B/year total costs. High - Xenografted whole organs will reduce costly organ waiting times and return patients more quickly to productive health.
Organ Demand Positive effect - Islet xenografts will reduce demand for kidney transplants, many of which are a direct consequence of diabetes. Positive effect - Organ xenografts may reduce demand for all human organs, and will meet need without costly and often lethal delays.
Organ Donation No effect - Islet xenografts will have no effect on normal organ donation, as there is no expectation today that donated organs are for curing diabetes.  Possible negative effect - Many administrators of national organ donation systems fear that conventional organ donation will diminish if people believe that animals can meet the demand for organs.
Public Message Safe - Graft failure would be a "quiet" event. Reversing diabetes would create public support for xenotransplantation in general. Risky - Failure of early whole organ xenografts and the likely death of recipients may create public antipathy for xenotransplantation in general.
 
It now appears that clinical trials of xenotransplantation will be allowed to proceed in most countries under guidelines that assure adequate record keeping, reporting of adverse events, archiving of donor and recipient biologic samples, safe and humane animal management, long-term monitoring of recipients, and other procedures intended to reduce or eliminate risks.

The following sections provide highlights from some of the speakers and panel participants.

Dr. Joshua Lederburg
Professor Emeritus
The Rockefeller University, NY, NY, USA
Opening Remarks

Dr. Michael Oborne
Deputy Director
Directorate for Science, Technology and Industry
Organization for Economic Co-operation and Development, Paris, France
Welcome - OECD Perspectives Dr. David Harper
Chief Scientist
Department of Health, London, UK
Conference Goals and Objectives Dr. John Wallwork
Department of Surgery
Papworth Hospital
Papworth Everard, UK
The Need for Alternatives to Allotransplantation Dr. Blanca Miranda
National Co-ordinator
National Transplant Organization, Madrid, Spain
International Issues in Transplantation: Urgent and Controversial Issues Professor Randall E. Morris
Director, Transplantation Immunology
Stanford University School of Medicine, Stanford, CA, USA
New Developments in Allo- and Xenotransplantation Dr. Jay A. Fishman
Infectious Disease Division
Massachusetts General Hospital, Boston, MA, USA
Xenotransplantation: Risk of Infection Professor Dr. Frans van Knapen
Faculty of Veterinary Medicine
Utrecht University, The Netherlands
Public Health Implications of Parasitic Issues in Xenotransplantation Dr. Jonathan P. Stoye
National Institute for Medical Research
London, UK
Endogenous Retroviruses:  A Potential Problem for Xenotransplantation Dr. Joachim Denner
Paul Ehrlich Institute, Germany
Immunosuppression by Retrovirus: Implications for Xenotransplantation Dr. Jonathan Allan
Department of Virology and Immunology
Southwest Foundation for Biomedical Research, TX, USA
The Risk of Using Baboons as Transplant Donors: Exogenous and Endogenous Viruses Dr. Marian Michaels
Children's Hospital of Pittsburgh, PA, USA
Xenotransplant Associated Infections: Patient Issues Dr. Nelson A. Wivel
Deputy Director
Institute for Human Gene Therapy
Hospital of the University of Pennsylvania, PA, USA
Lessons Derived from The Public Oversight of Human Gene Therapy Clinical Research Mr. André La Prairie
Policy Analyst, Therapeutic Products Directorate
Health Protection Branch, Health Canada, Ottawa, Canada
Public Confidence and Government Regulation Dr. Louisa E. Chapman
Retrovirus Disease Branch
National Center for Infectious Diseases
Center for Disease Control and Prevention (CDC), Atlanta, GA, USA
Guidelines on the Risk for Transmission of Infectious Agents during Xenotransplantation Dr. James Whitehead
Stellar Systems, Vienna, VA, USA
Development of Databases and Registries: International Issues Dr. Jeffrey L. Platt
Department of Immunology
Duke University, Durham, NC, USA
Xenotransplantation: Historical Perspective and Future Promises Professor Dr. Claus Hammer
Institute for Surgical Research
Ludwig Maximillians Universität, Munich, Germany
Physiology of Xenografts Dr. David H. Sachs
Transplantation Biology Research Center
Massachusetts General Hospital, Boston, MA, USA
Tolerance and Cloning Strategies Bartha Maria Knoppers
Medical Ethicist
McMaster Meighen, Montreal, PQ, Canada
The Ethics of Xenotransplantation
International Workshop on Xenotransplantation
  New York City, 18-20 March 1998
LIST OF SPEAKERS AND PARTICIPANTS
 

 CHAIRS
Dr. Louisa E. CHAPMAN  
Retrovirus Diseases Branch 
Division of AIDS, STD and TB Lab. Research 
National Center for Infectious Diseases 
Centers for Disease Control and Prevention 
UNITED STATES
Dr. Rachel LEVINSON 
Assistant Director 
Life Sciences 
Office of Science and Technology Policy 
UNITED STATES 
E-mail: levinson@ostp.eop.go
Dr. Mike CRUMPTON 
Deputy Chief Executive 
Imperial Cancer Research Technology 
ICRF 
UNITED KINGDOM 1
Dr. Amy P. PATTERSON 
Interim Deputy Director and Medical Offcer 
Division of Cellular and Gene Therapies 
US Food and Drug Administration 
UNITED STATES 
E-mail: pattersona@A1.cber.fda.gov
Professor Abdallah S. DAAR 
Chairman 
Department of Surgery 
College of Medicine 
Sultan Qaboos University 
SULTANATE OF OMAN 
E-mail: asdoc@gto.net.om
Dr. Jeffrey L. PLATT 
Department of Immunology 
Duke University 
DURHAM NC 27710 
UNITED STATES 
E-mail: platt00l@mc.duke.edu
Dr. David HARPER 
Chief Scientist 
Department of Health 
UNITED KINGDOM 
E-mail: dharper@doh.gov.uk
Dr. Elettra RONCHI 
Biotechnology Unit 
Directorate for Science, Technology and Industry 
OECD 
E-mail: elettra.ronchi@oecd.org 
Professor Ian KENNEDY 
Professor 
School of Public Policy 
University College London 
UNITED KINGDOM 
E-mail: i.kennedy@ucl.ac.uk
Dr. Calvin R. STILLER 
Microbiology and Immunology 
Department of Medicine 
University of Western Ontario 
CANADA 
E-mail: cstiller@cmdf.com
Dr. Joshua LEDERBERG 
President Emeritus 
The Rockefeller University 
UNITED STATES 
Email: lederberg@rockvax.rockefeller.edu
Dr. David WHITE 
Imutran Limited 
UNITED KINGDOM 
E-mail: david.white@pharma.novartis.com
 



 RAPPORTEURS
Overall Workshop Rapporteur: 
Dr. Louisa E. CHAPMAN 
Retrovirus Diseases Branch 
Division of AIDS, STD and TB Lab. Research 
National Center for Infectious Diseases 
Centers for Disease Control and Prevention 
UNITED STATES 
Day Two 
Professor Ian KENNEDY 
Professor 
School of Public Policy 
University College London 
UNITED KINGDOM 
Day One  
Dr. Mike CRUMPTON 
Deputy Chief Executive 
Imperial Cancer Research Technology 
ICRF 
UNITED KINGDOM


 PANEL CHAIRS
Panel I
Dr. Louisa E. CHAPMAN 
Retrovirus Diseases Branch 
Division of AIDS, STD and TB Lab. Research 
National Center for Infectious Diseases 
Centers for Disease Control and Prevention 
UNITED STATES 
Panel II
Dr. Amy P. PATTERSON 
Interim Deputy Director and Medical Officer 
Division of Cellular and Gene Therapies 
US Food and Drug Administration 
UNITED STATES 
Dr. Clara J. WITT 
World Health Organization (WHO) 
SWITZERLAND
Panel III
Dr. Jeffrey L. PLATT 
Department of Immunology 
Duke University 
UNITED STATES
Panel IV
Professor Abdallah S. DAAR 
Chairman 
Department of Surgery 
College of Medicine 
Sultan Qaboos University 
SULTANATE OF OMAN 
Pane1 V
Marvin MILLER 
Chair 
Committee on Xenotransplant BIO 
President and Chief Executive Officer Nextran INC 
UNITED STATES 
Dr. Calvin R. STILLER 
Microbiology and Immunology 
Department of Medicine 
University of Westem Ontario 
CANADA 


 SPEAKERS
CANADA
Dr. Renaldo N. BATTISTA 
President 
Conseil d'Evaluation des Technologies de la Sante 
Ministere de la Sante et des Services Sociaux 
201 Boul. Cremazie est 1er etage 
H2M 1L2 MONTREAL, QUEBEC
Mr. Andre LA PRAIRIE 
Policy Analyst - Blood, Tissues and Organs Project 
Policy Division 
Therapeutic Products Directorate 
Health Protection Branch, Health Canada 
LCDC Blg #6, Location code 0603C3 
Tunney's Pasture 
K1A OL2 OTTAWA, ONTARIO
Professor Bartha Maria KNOPPERS 
Universite de Montreal 
Faculte de Droit 
Centre de recherche en droit public 
C.P.6128, succursale A 
H3C3J7 MONTREAL, QUEBEC
 
FRANCE
Professeur Didier HOUSSIN 
Directeur General 
Etablissement francais des Greffes 
5, rue Lacuee 
75012 PARIS 
Dr. Jean-Paul MOATTI 
Director 
Epidemiology and Social Sciences Applied 
to Medical Innovation 
Laboratoire U379 - INSERM 
Institut Paoli Calmettes (CRLCC) 
232, Bd. de Sainte-Marguerite 
13273 MARSEILLE 
Dr. Jean JULVEZ  
Etablissement Francais des Greffes 
E.F.G. 
5 rue Lacuee 
75012 PARIS 
Professor Jean-Paul SOULILLOU 
Directeur 
Institut de Transplantation et de Recherche en Transplantation (ITERT) 
ITERT-INSERM U437 
CHU-HOTEL DIEU 
30 Bd Jean Monnet 
44093 NANTES CEDEX 1 
 
GERMANY
Dr. Joachim DENNER 
Paul-Ehrlich-Institute 
Paul-Ehrlichstrasse 51-59 
D-63225 LANGEN
Professor Dr. Claus HAMMER  
Institut für Chirurgische Forschung 
Ludwig Maximilians Universitat Munchen 
M. Marchioninistr.15 
81366 MUNICH 
 
ISRAEL
Professor Shimon SLAVIN 
Head 
Department of Bone Marrow Transplantation 
Cancer Immunotherapy & Immunobiology Research Program 
Hadassah University Hospital 
POB 12000 
91120 JERUSALEM 
 
JAPAN
Professor Kikuo NOMOTO 
Department of Immunology 
Medical Institute of Bioregulation 
Kyushu University 
Higashi-ku 
FUKUOKA
 
THE NETHERLANDS
Professor Dr. Frans VAN KNAPEN 
Vakgroep voedingsmiddelen van dierlijke oorsprong 
Universiteit Utrecht 
Faculteit Diergeneeskunde 
Postbus 80175 
3508TD UTRECHT
Dr. Eric VAN RONGEN 
Secretary 
Xenotransplantation Advisory Committee 
Health Council of The Netherlands 
P.O. Box 1236 
2280 CE RIJSWIJCK 
 
SPAIN
Dr. Blanca MIRANDA 
National Co-ordinator 
National Transplant Organisation 
Sinesio Delgado No. 6 
28029 MADRID
 
SWITZERLAND
Mr. Sergio BELLUCCI 
Swiss Science Council 
Inselgasse 1 
3003 BERN
Dr. Thomas CUENI 
Secretary General 
INTERPHARMA 
Petersgraben 35 
P.O. Box 
CH-4003 BASEL
Dr. Alberto BONDOLFI 
Ethik Zentrum Universitat Zurich 
Zollikerstrasse I 17 
8008 ZLTRICH
 
UNITED KINGDOM
Dr. David HARPER 
Chief Scientist 
Department of Health 
Skipton House, Room 537B 
80 London Road 
SEI 6LW LONDON
Dr. Jonathan P. STOYE 
National Institute for Medical Research 
The Ridgeway 
Mill Hill 
NW7lAA LONDON
Professor Norman C. NEVIN 
Head of Division of Molecular Medicine 
& Professor of Medical Genetics 
Northern Ireland Regional Genetics Centre 
Floor A, Belfast City Hospital 
Lisburn Road 
BT9 7AB BELFAST
Dr. John WALLWORK 
Department of Surgery 
Papworth Hospital 
CB38RE PAPWORTH EVERARD
 
UNITED STATES
Dr. Jonathan ALLAN 
Department of Virology and Immunology 
Southwest Foundation for Biomedical Research 
7620 NW Loop 410 at Military Drive 
Urschel Building 
SAN ANTONIO, TX 78227-5301
Dr. Jeffrey L. PLATT  
Department of Immunology 
Duke University 
401 MSRB 
Research Drive 
DURHAM, NC 27710 
Dr. Kathryn A. BAYNE 
Associate Director for Accreditation 
AAALAC-International 
11300 Rockville Pike, Suite 1211 
ROCKVILLE, MD 20852-303
Professor S.G. POST 
Center for Biomedical Ethics 
School of Medicine 
Case Western Reserve University 
10900 Euclid Avenue 
CLEVELAND, OH 44106-4976
Dr. Roger W. EVANS 
Head 
Section of Health Services Evaluation 
Department of Health Sciences Research 
Mayo Clinic 
Harwick 826 - 200 First Street, SW 
ROCHESTER, MN 55905 
Dr. David H. SACHS 
Transplantation Biology Research Center 
Massachusetts General Hospital 
MGH-East, Building 149-9019, l3th Street 
BOSTON, MA 0212
Dr. Jay A. FISHMAN 
Infectious Disease Division 
Massachusetts General Hospital 
Harvard Medical School 
55 Fruit Street 
BOSTON, MA 02114
Dr. M. Michael SWINDLE 
Professor and Chairman 
Department of Comparative Medicine 
Medical University of South Carolina 
171 Ashley Avenue 
CHARLESTON, SC 29425 
 
Dr. Gwenn MAYES 
Division of Transplantation 
HRSA 
5600 Fisher' Lane 
ROCKVILLE, MD 20852 
Dr. Nelson A. WIVEL 
Deputy Director 
Institute for Human Gene Therapy 
Room M6-40, Maloney Building 
Hospital of the University of Pennsylvania 
36th and Spruce Streets 
PHILADELPHIA, PA 19104-4283
Dr. Marian MICHAELS 
Children's Hospital of Pittsburgh 
Infectious Disease Unit 
3705 Sth Avenue 
PITTSBURGH, PA 15213
Dr. James WHITEHEAD 
Stellar Systems 
1997 Barkham Lane 
VIENNA, VA 22182
Professor Randall E. MORRIS 
Director 
Transplantation Immunology 
Stanford University School of Medicine 
Cvrb Sec. Floor North 
300 Pasteur Drive 
STANFORD, CA 94305-5407 
 
CAMEROON
Dr. Pierre EFFA 
Cameroon Bioethics Society 
B.P. 2734 
DOUALA
 
SULTANATE OF OMAN
Professor Abdallah S. DAAR 
Chairman 
Department of Surgery 
College of Medicine 
Sultan Qaboos University 
PO Box 35 
123 AL-KI-IOD


INTERNATIONAL ORGANISATIONS/INDUSTRIES
COUNCIL OF EUROPE WORLD HEALTH ORGANIZATION (WHO)
Mr. Carlos DE SOLA 
Secretary of the Steering Committee on Bioethics (CDBI) 
Council of Europe 
Secretariat General 
67075 STRASBOURG CEDEX 
FRANCE
Dr. Francois-Xavier MESLIN 
Division of Emerging and other Communicable Diseases 
Surveillance and Control (EMC) 
World Health Organisation 
20, Avenue Appia 
CH-1211 GENEVA 27 
SWITZERLAND
NOVARTIS HOST ORGANISATION (NYAS)
Dr. William O. IVERSON 
Laboratory Animal Services - Research 
Novartis Pharmaceuticals Corporation SEF/2 
556 Morris Avenue 
SUMMIT, NJ 0790I 
UNITED STATES
Dr. Rashid SHAIKH 
Director, Science & Technology Meetings 
New York Academy of Sciences 
2 East 63rd Street 
NEW YORK, NY 10021 
UNITED STATES 
Tel: (1212) 838 0230 
Fax: (1212) 838 5640 
Email: rshaikh@nyas.org
OECD SECRETARIAT
Dr. Michael OBORNE 
Deputy Director 
Directorate for Science, Technology and Industry 
OECD 
2, Rue Andre Pascal 
75775 PARIS 
FRANCE
Ms. Sonia GUIRAUD 
Biotechnology Unit 
Directorate for Science, Technology and Industry 
OECD
Dr. Tadashi HIRAKAWA 
Biotechnology Unit 
Directorate for Science, Technology and Industry 
OECD
Ms. Susan ELIE 
Biotechnology Unit 
Directorate for Science, Technology and Industry 
OECD
Dr. Elettra RONCHI 
Biotechnology Unit 
Directorate for Science, Technology and Industry 
OECD

 OTHER PARTICIPANTS
 
Austria
Dr. Marion GMACH 
Federal Chancellery
Mr. Markus PASTERK 
Federal Ministry of Science and Transport
Belgium 
Mr. George BINAME 
Comite Consultatif National Belge de Bioethique et de la Societe Belge de Transplantation
Mr. P. GIANELLO 
Chirurgie Experimentale, Universite Catholique de Louvain 
Canada
Ms. Elizabeth BARKER 
Nova Scotia Department of Health
Mr. Stephen YARROW 
Canadian Food Inspection Agency
Mr. Peter GANZ 
Health Canada 
Czech Republic  Finland 
Dr. Alana BLAZKOVA 
Ministry of Education, Youth and Sports
Mr. Bjorn EKLUND 
Helsinki University Central Hospital 
Germany 
Dr. Peter LANGE 
Federal Ministry of Education and Research 
Dr. Ralf TONJES 
Paul-Ehrlich-Institut 
Dr. Heiner NIEMANN 
Institut für Tierzucht und Tierverhalten
Ds. Marion WEHNER 
German Ministry of Research and Technology 
Greece
Dr. Spyridon B. LITSAS 
General Secretariat for Research and Technology 
Israel 
Prof. Bracha RAGER 
Ministry of Health
Dr. Alexander YUSSIM 
Rabin Medical Center
Dr. SHABTAI 
Sheba Medical Center
Italy 
Dr. Velio MACELLARI 
Laboratorio di Technologie Biomediche, Istituto Superiore di Sanita
Ms. Aurelia SARGENTINI 
Direttore del Laboratorio di Tecnologie Biomediche, Istituto Superiore di Sanita 
Dr. Carlo PINI  
Direttore del Laboratorio di Immunologia, Istituto Superiore di Sanita 
Dr. Maria TOLLIS 
Laboratorio di Medicina Veterinaria, Istituto Superiore di Sanita
Japan 
Dr. Hiroshi YOSHIKURA 
National Institute of Infectious Diseases 
The Netherlands 
Mr. Jan-Willem HARTGERINK 
Ministry of Health, Welfare and Sport 
Dr. Ingeborg STENEKER 
Ministry of Health, Welfare and Sport 
Ms. Evelien KAMPERT 
Leiden University Medical Center
Dr. Alice VAN SLIEDREGT 
Ministry of Health, Welfare and Sport 
Norway 
Dr. Kjersti SLETHOLT 
The Research Council of Norway 
Dr. Jan SVENNEVIG 
Department of Surgery, Rikshospitalet 
Portugal 
Dr. Mario CAETANO PEREIRA 
Hospital Geral Santo Antonio 
Spain 
Dr. Federico COFAN 
Hospital Clinic Barcelona 
Dr. Rafael GOTSENS 
Hospital Clinic Barcelona
Sweden 
Dr. Carl-Gustaf GROTH 
Deparhnent of Transplantation Surgery, Huddinge Hospital
Ms. Marie Omnell PERSSON 
Swedish Committee on Xenotransplantation, Departments of Health and Social Affairs 
Dr. Lars-Ake MARKE 
The Swedish Council on Technology Assessment in Health Care
Mr. Nils PERSSON  
Deparhnent of Vascular and Renal Diseases, Malmo University Hospital 
Dr. Bertil PERSSON M.D. 
Swedish National Xenotransplantation Committee, Swedish Parliament
Mr. Stefan REIMER 
The Swedish Committee on Xenotransplantation, Ministry of Health and Social Affairs
Dr. Tore SCHERSTEIN 
The Swedish Council on Technology Assessment in Health Care 
Switzerland 
Dr. Isabella BERETTA 
Swiss Federal Office of Education and Science 
Dr. Michel JEANNET 
Swiss Academy of Medical Sciences 
Dr. Karoline DORSCH-HASLER 
Swiss Expert, Commission for Biosafety
Dr. Robert RIEBEN  
Department of Cardiology, University Hospital Bern 
United Kingdom 
Dr. Rachel ARRUNDALE 
The UK Xenotransplantation Interim Regulatory Authority (UKXIRA)
Dr. Imogen EVANS 
Medical Research Council 
Dr. Christopher CLEGG 
Centre for Applied Microbiology and Research(CAMR) 
Dr. Geoffrey SCHILD 
National Institute for Biological Standards and Control (NIBSC)
Dr. Ulrich DESSELBERGER 
Public Health Laboratory Service
Dr. Glynn STACEY 
National Institute for Biological Standards and Control (NIBSC)
United States 
Dr. Eda BLOOM 
Preclinical Screening and Testing Committee, Food and Drug Administration 
Dr. Mary GROESCH 
Office of the Director, Committee on Xenotransplantation, National Institutes for Health 
Dr. Thomas L. EGGERMAN 
Center for Biologics Evaluation and Research, Food and Drug Administration 
Dr. Austine "Tina" MOULTON 
Committee on Xenotransplantation, Food and Drug Administration 
Dr. Thomas L. EGGERMAN 
Center for Biologics Evaluation and Research, Food and Drug Administration 
Dr. Stephen ROSE 
Genetics and Transplantation Branch, NIAID, National Institutes for Health 
Dr. Lily ENGSTROM 
Office of the Secretary for Planning and Evaluation, Committee on Xenotransplantation, Department of Health and Human Services 
Dr. Lana SKIRBOLL 
Director of Science Policy, Committee on Xenotransplantation, National Institutes for Health 


OTHER PARTICIPATING EXPERTS
 
Sandra DUSING, Ph.D
MA Bioservices 
Rockville, MD, USA 
Dr. Jeffery SHORT 
Rush-Presbyterian-St. Luke's Medical Center 
Chicago, IL, USA 
Mary D. ELLISON, Ph.D
United Network for Organ Sharing 
Richmond, VA, USA 
D. Dianne TERRY 
The Islet Foundation 
London,0ntario, CANADA 
Violet ESQUENAZI, Ph.D. 
University of Miami 
Miami, FL, USA
Loan T. TRAN, Pharm.D.  
Genzyme Corporation 
Cambridge, MA, USA 
J. Stephen FINK, M.D., Ph.D. 
Genzyme Corporation 
Cambridge, MA, USA
Dr. Jean-Paul CASTAIGNE  
Novartis Pharma 
Canada 
Gary GOLDENBERG  
New York & Presbyterian Hospital 
Port Chester, NY, USA 
Mr. Geoff COOK 
Novartis Pharmaceuticals 
United States 
Alastair T. GORDON  
The Islet Foundation 
Toronto, Ontario, CANADA
Dr. Philip LAKE  
Novartis Pharmaceuticals 
United States 
Julia GREENSTEIN, Ph.D.  
BioTransplant, Inc. 
Charlestown, MA, USA
Ms. Barbara FAGG  
Imutran/Novartis 
United Kingdom 
Marlon LEVY, M.D.  
Baylor University Medical Center 
Dallas, TX, USA
Ms. Anne PILLIN
Novartis Pharmaceuticals 
United Kingdom 
John LOGAN, Ph.D. 
Nextran, Inc. 
Princeton, NJ, USA 
Dr. Laurie O'ROURKE  
Novartis Pharmaceuticals 
United States 
Dr. Christopher G.A. McGREGOR  
Mayo Clinic 
Rochester, MN, USA
Dr. Kaz PARADIS  
Novartis Pharma AG 
Switzerland 
Joshua MILLER, M.D.  
University of Miami School of Medicine 
Miami, FL, USA
Dr. M. TARRES i FERRAN  
Novartis 
Barcelona, Spain 
Marvin MILLER  
Nextran Inc.Baxter International 
Princeton, NJ, USA
Ms. Lucy THOMAS  
Novartis 
United Kingdom 
Robert C. MOEN, M.D., Ph.D.  
Baxter Healthcare Corporation 
Round Lake, IL, USA
Mr. Neil WARMA  
Novartis Pharma AG 
Switzerland 
Claudy J. MULLON, Ph.D.  
Circe Biomedical 
Lexington, MA, USA 
Dr. Elizabeth ADEN  
Roche Bioscience 
United States
Zorina PITKIN  
Circe Biomedical 
Lexington, MA, USA
Dr. Debra BARKER  
F. Hoffmann La Roche 
Switzerland
Larry B. SCHOOK, Ph.D.  
University of Minnesota College of Veterinary Medicine 
St. Paul, MN, USA
 
The Xenotransplantation Debate -- Science or Superstition?
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