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National Forum on Xenotransplantation:
Clinical, Ethical and Regulatory Issues

November 6-8, 1997
Ottawa, Canada

Sponsored by
Therapeutic Products Program
Health Canada

Excerpts from the Official Report

 

PURPOSE OF THE FORUM

The Canadian government, through its Health Canada ministry, is taking a pro-active and constructive role in the emerging field of xenotransplantation.  Unlike some national governments, who are reacting out of fear and ignorance, the Canadian government has established major initiatives to assure that no person is denied the life-saving potential of xenotransplantation, while safeguarding both the patient and society in general.  On November 7-8, 1997, Health Canada organized the National Forum on Xenotransplantation:
Clinical, Ethical and Regulatory Issues in Ottawa, inviting people from the medical, scientific, regulatory, and ethics communities to pool their expertise and passion in understanding the opportunities and issues surrounding xenotransplantation.

For people with diabetes, xenotransplantation of pig islets may be our best and safest hope for restoring normal blood sugar control and health.  Immunoprotected islets, like other cell transplants and unlike whole organ transplants, hold the potential of graft survival with no immunosuppression, the major risk factor associated with xenografts.

Following is a summary of this exciting event.

Forum Purpose:

To present information and initiate discussion on the risks, benefits and ethics of xenotransplantation; to identify key regulatory issues; and to define areas where research and new information is required.

Forum Objectives:

1. To present information and promote discussion on the risks and benefits of xenotransplantation.

2. To identify areas where information on xenotransplantation is lacking and research is needed.

3. To examine the ethical and scientific issues raised by xenotransplantation, including:

             a) the use and source of animals and their potential genetic modification
             b) the transmission of known and unknown pathogens to the transplanted patient and community

4. To consider ethical and societal issues in the regulation of xenotransplantation, including:

             a) principles and practice guidelines for clinical trials
             b) a risk management/regulatory framework that coordinates the establishment of standards,
                 oversight and surveillance methods
             c) responsibilities of federal agencies, health care providers, industry and the community
                 in addressing research, clinical and policy issues

5. To solicit comments and make recommendations concerning:
             a) a draft standard for xenotransplantation
             b) a national registry for patients of xenotransplantation
             c) establishment of a national ethics committee
             d) international harmonization

THE MAJOR QUESTIONS




Workshop A - 1  Immunology    3:00 pm Friday November 7th

Chair Dr. Uri Galili, Department of Microbiology and Immunology,
Allegheny University of the Health Sciences, Philadelphia, Pennsylvania

Rapporteur Dr. Bhagirath Singh, Department of Microbiology and Immunology,
University of Western Ontario, London, Ontario

1. SOURCE MATERIAL:

-What cells, tissues or organs offer the best prospects for immunological success (i.e. transgenic/non-transgenic isolated or encapsulated cells, solid organs, bone marrow, etc.)?

2. IMMUNE SUPPRESSION AND MODULATION (consider separate responses for organs and cells):

- Which immune modulation strategies are most effective? What risks are associated with them? For what type of xenotransplantation would they be most appropriate?

- What are the limits of acceptable immunosuppression? Which types of xenotransplants would require the least immunosuppression?

- How should recipients of short-term bridging xenotransplants be treated once the xenograft is removed?

- Could tolerance to the xenograft be induced?

- Could vaccines be developed to prevent xenozoonotic infection or disease? (See also Xenozoonoses workshop.)

3. ANIMALS:

-What animal models are most appropriate for xenotransplantation into humans? If an appropriate model exists, should it be a requirement for pre-clinical studies?

- What evidence from pre-clinical studies should there be before limited human trials can proceed? (See also Clinical Trials workshop.)


Workshop A - 2    Xenozoonoses   3:00 pm Friday November 7th

Chair Dr. Louisa Chapman, Centers for Disease Control and Prevention, Atlanta, Georgia

Rapporteur Dr. Harvey Artsob, Head, Zoonotic Diseases, Laboratory Centre for Disease Control, Health Canada, Ottawa, Ontario

1. REDUCING RISK:

- Can we determine a graded risk scale for zoonoses based on different types of xenotransplants (i.e. cells, tissues, organs)?

- Should some animal sources be excluded (particular animals, or particular tissues)?

- Would short-term bridge transplants be significantly safer than long-term transplants?

- Can the breeding, selection and screening of animals reduce infectious disease risks to acceptable levels?

- Could vaccines be developed to prevent xenozoonotic infection or disease? (See also Immunology workshop.)

2. PREVENTING WORST CASE SCENARIOS:

- What science/research can be done to define and quantify the risks that (a) recombination of endogenous retroviruses may occur in xenotransplant recipients; and (b) if this occurs, such viruses may cause disease which may be transmissible to others?

3. PUBLIC HEALTH:

- Which has the potential to be a greater risk to public health -- endogenous or exogenous viral zoonoses?

- Why does xenotransplantation present any greater risk to public health than other animal-human contact (eg. farmers, slaughterhouse workers, butchers)?

- At the present time, is it safe to proceed with limited clinical trials?


Workshop A - 3    Use and Care of Animals  3:00 pm Friday November 7th

Chair Dr. Donald Casebolt, Atlantic Veterinary College, University of Prince Edward Island, Charlottetown, Prince Edward Island

Rapporteur Dr. Francine Lord, Canadian Food Inspection Agency, Agriculture Canada, Ottawa, Ontario

1. USE OF ANIMALS:

- Does using animals for xenotransplantation differ from using them for medical research, or as a food source?

- If xenotransplantation proceeds, how can the number of animals be minimized (including animals involved in development of transgenics)?

- Is genetic modification of animals legitimate if it puts them at increased risk of disease? Is increased risk of disease likely to occur?

2. CARE OF ANIMALS:

- What new considerations are introduced into animal care by transgenic and cloning technologies, as these may be applied to xeno sourced animals?

- What level of animal seclusion is needed to maintain a disease-free environment for potential donors? Is this compatible with current animal care standards?

3. REGULATIONS:

- Who within Canada has the responsibility to regulate appropriate care and use of animals for xenotransplantation?

- Should there be a National Animal Care Committee? Should public consultation be incorporated?

- Is there a need for internationally accepted regulations/standards?

- Should there be an international registry of transgenic strains?


Workshop A - 4    Patient Ethics   3:00 pm Friday November 7th

Chair Dr. John Dossetor, Director, Bioethics Centre, University of Alberta, Edmonton, Alberta

Rapporteur Mr. Michael Hudson, General Counsel, Canadian Blood Secretariat, Health Canada, Ottawa, Ontario

1. PATIENT CONSENT:

- Given all the implications of xenotransplantation (i.e. scientific, ethical, public health), what constitutes a truly informed consent?

- What is the minimum information that must be presented and understood for a patient to make an informed decision?

- Should informed consent extend to a spouse or other close contacts?

- Is lifetime surveillance acceptable or feasible?

- Should various lifestyle restrictions be recommended in early trials, eg. regarding blood donation, unprotected sexual contact?

2. PATIENT SELECTION:

- Should some patient groups be excluded from initial trials, for example because of age, sex, ability to comply?

- Should there be minimum benefit criteria for the patient?


Workshop B - 1  Surveillance and Patient Registries  11:00 am Sat Nov 8

Chair Dr. Jay Fishman, Transplant Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts

Rapporteur Dr. Robert Kauffman, Vice-President Clinical Affairs, BioTransplant Inc., Charlestown, Massachusetts

1. REGISTRIES - ORGANIZATION AND ADMINISTRATION:

- Should xenotransplantation registries be part of existing solid organ and/or tissue registries? Should they be operated by industry or government?

- Is a central monitoring agency needed for xenotransplantation? If so, who should pay?

- Should all public health agencies have open access to patient registries and patient records?

- Should/could the xenotransplantation registry be linked internationally? Should/could the registry be used for other means?

- How can adverse event reporting be brought into surveillance systems? What kind of access should companies have?

- Who keeps the samples? How often is sampling and testing done? Who should be responsible for doing the testing?

2. PATIENT ISSUES:

- Should close relatives and contacts be monitored? Is this feasible?

- How anonymous and yet ‘identifying’ should registry data be?

- How can we ensure lifetime surveillance?


Workshop B - 2   Clinical Trials  11:00 am Saturday November 8th

Chair Dr. David Grant, London Health Science Centre, London, Ontario

Rapporteur Dr. Francis Rolleston, Medical Research Council, Ottawa, Ontario

1. PATIENTS AND TESTING:

- How long should the assessment period be after initial clinical trials, before proceeding with larger trials? Who should determine this? What questions need to be answered?

- How should the issue of "xenotransplantation tourism" be addressed? Should initial trials exclude foreign nationals?

- There are no comprehensive screening tests for xeno sourced animals. How much emphasis should be placed on the ability to test and screen for infectious agents?

- What evidence from pre-clinical studies should there be before limited human trials proceed? (See also Immunology workshop.)

2. FACILITIES:

- Can existing transplant facilities perform xenotransplants, or are specialized facilities and staff required before trials can proceed?

3. ECONOMICS:

- Should cost-benefit considerations be different for xenotransplantation than for allotransplantation?


Workshop B - 3   Ethics Review Boards  11:00 am Saturday November 8th

Chair Dr. Henry Dinsdale, President, National Council on Bioethics and Human Research, Kingston, Ontario

Rapporteur Ms. Ann Bourke, Policy and Consultation Branch, Health Canada, Ottawa, Ontario

1. COMPOSITION:

- Does a local Institutional Review Board (IRB) have the necessary expertise to review proposed xenotransplant trials?

- Should an IRB have access to broader expertise (eg. a National Advisory Board, or ad hoc members) for reviewing xenotransplantation trials?

2. RESPONSIBILITIES:

- How can an IRB balance patient benefits vs. community risks?

- Should there be a National Advisory Board? If so, who should be on it and how should it be supported?


Workshop B - 4  Standards and Screening   11:00 am Saturday November 8th

Chair Dr. Jim Wright, Dalhousie University, Halifax, Nova Scotia

Rapporteur Dr. William Freeland, Medical Devices Bureau, Therapeutic Products Programme, Health Canada, Ottawa, Ontario

1. STANDARDS:

- How can standards be written that encompass a variety of tissue types and source animals (primate and porcine, solid organs, tissues, encapsulated cells, etc.)?

- Should the standards address the scaling of risk (eg. the immunosuppressed patient vs. the non-suppressed, vascularized organs vs. cells, etc.)?

- Is a standards based approach to regulation appropriate for xenotransplantation?

- Should extra precautions be taken by staff and caregivers who handle xenograft specimens?

2. SCREENING:

- What should be done if a recipient tests positive? (eg. Notify all participants in the trial? Stop the trial? Begin anti-retroviral therapy for the patient? Increase surveillance?)

- What tests are now available for xenozoonoses? Are they sufficient for the potential endogenous and exogenous retroviruses?

- How long should monitoring continue? At what intervals?

 PLENARY SESSION ABSTRACTS

Plenary Session I: Overview

XENOTRANSPLANTATION:
ETHICS AT THE HUMAN/-ANIMAL/-GENE/-MACHINE INTERFACE

Dr. Margaret Somerville,
McGill Centre for Medicine
Ethics & Law, Montreal, Quebec

Abstract

Xenotransplantation raises profound ethical issues, which means that ethical concerns and analysis must be embedded in the research and development of this technology. These issues are not ones that can be addressed adequately just by scientists, physicians, ethicists or ethics committees. They require public debate by an informed public. Indeed, it is an ethical requirement that the public be fully involved in the development of Canadian public policy on xenotransplantation.

We must first ask whether xenotransplantation is intrinsically acceptable, that is, is it inherently right or wrong? This raises ethical questions in two areas: First, the ethics of the use of animals as a source of organs for human transplantation, in particular, our treatment of these animals in order to make them suitable as organ donors and the ethics of modifying the genome of animals to include human genes. Second, are the risks of xenotransplantation, especially possible unknown risks, of such a nature and seriousness that we ought not to run them? The major risk usually considered in this context is that of the transfer of an animal virus across the species barrier to humans with potentially tragic results, not simply for the person who received the organ, but for other people, including possibly the community at large who could subsequently be infected by this virus. This means that we must balance, not only harms, risks and benefits to potential individual xenotransplant recipients, but also harms to them in not having access to these transplants and risks to the community in allowing them, in deciding whether xenotransplantation is intrinsically acceptable.

If we decide that, in principle, xenotransplantation is ethically acceptable, we must then examine the ethical issues raised by research, development and use of this technology, in particular, the ethics of human subject research; the ethics of the allocation of scarce health care resources, including opportunity costs in both research and health care; and the ethics of access to xenotransplantation.

Finally, and at the broadest and deepest level, we need to consider the impact that the advent of xenotransplantation technology will have on our societal paradigm, that collection of attitudes, values, myths, beliefs, symbols - the "shared story"- that we buy into in order to form society and which we use to give meaning to our individual and collective lives. For instance, does this take us yet one more step away from an integrated theory of personal identity - seeing ourselves as unique, indivisible human beings - and further along the line of a modular theory of human identity - that we are simply a series of interchangeable parts, and these parts can now include animal parts - and a "gene machine" view of human life? Or could the "miracle" that this technology makes possible deepen our sense of awe and wonder about ourselves, our world, and life in general?


Plenary Session I: Overview

Scope of Xenotransplantation

Dr. Calvin Stiller, Professor of Medicine
University of Western Ontario, London, Ontario

Abstract

Xenotransplantation has been a dream of both scientists and practitioners to solve the problem of organ availability in order to save human lives. The biological and social hurdles have not been overcome, but plausible strategies are now available with the imminent application in humans of the first clinical trials. A combination of vision and pragmatism is required in order to meet the growing human need without ignoring the serious down sides that might occur. A review of the opportunities and obstacles, with a description of benchmarks to be achieved will be presented.


Plenary Session I: Overview

Overview of the Need for Xenotransplantation in Canada

Dr. Gary Levy, Director, Multi-Organ Transplants
Toronto Hospital, Toronto, Ontario

Abstract

Transplantation is now recognized as the most effective treatment for patients with end stage organ failure. The short term results of transplantation using allografts from humans are excellent with one year patient and graft survival rates approaching 80-90% and five year survival rates of 70-80%. However, the success of transplantation has brought with it the problem of obtaining an adequate supply of human organs. As the indication for transplantation continues to grow, the shortage of organ donors has emerged as the major barrier to transplantation. Currently, greater than 52,000 people are waiting for organ transplantation in the United States and over 2,800 people are waiting in Canada. In 1996, in Canada, 1551 transplants were performed and thus, there is a severe discrepancy between the number of candidate recipients and number of donors available for transplantation at the present time. Furthermore, the overall number of solid organ transplants has declined steadily, at a rate of 1% per year between 1988 and 1994. Thus, nearly 4% of kidney patients awaiting transplantation will die, whereas the mortality among prospective heart or liver graft recipients is approximately 8% and 11% respectively. Additionally, those patients who are waiting a replacement renal allograft can anticipate a median wait time of greater than 2 years, whereas patients awaiting replacement of liver allograft now wait 6 months to one year. Although a number of attempts have been made to improve organ donation rates, it is clear that allotransplantation will never solve the problem of donor shortage. Thus, a solution to the shortage of human organ donors is the development of xenotransplantation, the transplantation of organs from animal species into humans.


Plenary Session I: Overview

Report of the Expert Working Group on Xenotransplantation Standards

Dr. Michael Gross,
Chair for Xenotransplantation Expert Working Group
Queen Elizabeth II Hospital, Halifax, Nova Scotia

Abstract

A uniquely Canadian initiative brought together all interested parties; governments, federal and provincial, patients, surgeons and other interested parties, to address the issue of transplantation of organs and tissues.

The National Consensus Conference on the Safety of Organs and Tissues for Transplantation was sponsored by Health Canada, Therapeutic Products Directorate in 1995. An expert working group was established and the standards for the transplantation and tissues were developed in 1997 and will become incorporated as national standards for Canada.

A Xenotransplantation Expert Working Group was struck to explore the potential of drafting guidelines in a similar manner for xenotransplantation. It rapidly became apparent to the members of the group that the issues surrounding xenotransplantation are broad, not well focused and open to much debate. As such, the committee felt that all of the issues needed to be explored in a forum that allows for free exchange of information, free debate, open exploration of ethical concerns and an attempt to inform the public of these issues.

This xenotransplantation forum should be seen as an opportunity for experts, interested parties and the public to explore these many issues, address this safety, the potential benefits and disadvantages and the way that new technology should be monitored and applied, the ethics of human and animal interactions and co-dependencies.

There are no hidden agendas. We have very rough drafts of guidelines that are not meant to restrict or influence this debate. The role of the Xenotransplantation Expert Working Group is to listen, to advise, to take notes and to produce recommendations based upon your input in this meeting. We will endeavour to communicate all recommendations back to participants and the general public at large.

Our goal is to set in process a program that will maintain Canada’s pre-eminent role in the care of its citizens, while exercising due diligence to protect those who are more dependent on us.


Plenary Session II: International Perspectives Panel

The U.S. Approach to Xenotransplantation

Dr. Amy Patterson, Cellular and Gene Therapies,
Office of Therapeutics Research and Review,
Centre for Biologics Evaluation and Research, US PHS,
Bethesda, Maryland

Abstract

A fundamental public health dilemma in xenotransplantation is how to balance the potential clinical promise with the problem of potential transmission of infectious agents to both individual patients and to the population at large. Within the U.S. Department of Health and Human Services, the Public Health Service (PHS) agencies, including the National Institutes of Health (NIH), Centres for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA), are working together to address the public health issues raised by xenotransplantation. Lessons learned in human allotransplantation, gene therapy and human cell and tissue therapy are being applied in the development of public health policy in xenotransplantation; these will be briefly discussed during the presentation. The draft PHS Guideline on Infectious Disease Issues in Xenotransplantation, published in September 1996, is a visible public statement of current U.S. PHS perspectives. The draft Guideline foreshadowed additional tools, currently under development, to address public health issues raised by xenotransplantation. Other components of what may be viewed as a matrix of public health tools will be presented and include: Department of Health and Human Services Committee on Xenotransplantation, a Pilot National Xenotransplantation Registry Database, biologic specimen archive(s), regulatory oversight, and possibly a national xenotransplantation advisory body and other continuing venues for public discussion and public accountability in xenotransplantation.


Plenary Session II: International Perspectives Panel

The U.K. approach to Xenotransplantation

Dr. Lucy Thomas, Director of Regulatory Affairs,
Novartis/Imutran, Cambridge, England

Abstract

The UK Government commenced work on xenotransplantation when it established the Advisory Group on the Ethics of xenotransplantation, under the Chairmanship of Professor Ian Kennedy. Their report, Animal Tissue into Humans, was published in January 1997. Its main recommendations were that xenotransplantation could be acceptable provided that certain criteria were met and that there should be some national committee to oversee developments. However, the main conclusion was that key pre-conditions of safety and efficacy had not yet been demonstrated and that it was not therefore appropriate to allow xenotransplantation in humans, nor is it appropriate to use primates as organ donors.

In response to this report, the Government established the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) to regulate the development and implementation of xenotransplantation, as they believed that existing legislation on medicines and medical devices was not adequate to cover all xenotransplant therapies.

Proposals for xenotransplantation may be submitted to the UKXIRA, which will advise on whether they are acceptable. Proposals must also be considered by Research Ethics Committees and comply with other relevant legislation on genetically modified organisms and the use of animals in scientific procedures.


Plenary Session II: International Perspectives Panel

Need for International Harmonization

Dr. Clara Witt, World Health Organization,
Geneva, Switzerland

Abstract

Research and development in xenotransplantation technology is occurring at a very rapid rate. If its implementation becomes a reality, it may serve to alleviate the chronic shortfall in human organ donations. Also, its potential for application as a treatment modality for diseases with no other effective therapeutic intervention, such as for Parkinson’s disease, or for which xenotransplantation could offer additional therapeutic approaches, such as Diabetes mellitus, is being investigated. Xenotransplantation also carries with it a risk for the transmission of animal-origin infectious agents - xenozoonoses. The potential of xenozoonotic infections and disease is not solely a community or national issue. In today’s shrinking world, it is an international issue. While the development of the technology is occurring in the developed world, its usage, if proven possible, will occur over a wide geographic distribution. Therefore, the development of effective and realistic national approaches to xenozoonotic disease prevention and control requires international coordination and cooperation, and it requires the input from a variety of social, cultural and religious perspectives. The WHO believes that the harmonization of national approaches to addressing the issues surrounding xenozoonotic disease prevention and control can contribute to the safe and effective implementation of this new and exciting technology internationally.


Plenary Session II: International Perspectives Panel

Review of International Policies on Consent and Human Clinical Trials for Xenotransplantation

Professor Bartha Maria Knoppers, Faculté de Droit, CRDP,
University of Montréal, Montréal, Québec

Abstract

A comparative international review of official policy statements on xenotransplantation will reveal both common and different positions on: ethical concerns, safety issues, patient perspectives and personal and social effects. Even guidelines that do not purport to cover ethical, legal and social issues offer information on possible directions. The reports of the: Biotechnology Unit of the OECD 1996 Institute of Medicine, Washington, 1996 Nuffield Council on Bioethics, U.K., 1996 and the Advisory Group on the Ethics of Xenotransplantation, U.K. 1997, will serve as the basis for this comparison.


Plenary Session II: International Perspectives Panel

Canadian Regulatory Approach to Transplantation

Dr. Keith Bailey, Director, Bureau of Biologics and Radiopharmaceuticals
Therapeutic Products Directorate, Ottawa, Ontario

Abstract

Transplantation science has developed rapidly during the past several years. To keep pace with rapid change in this field, an appropriate regulatory approach to issues of safety, efficacy, quality and supply is essential. As a commitment to promoting safety, Health Canada organized a National Consensus Conference on Safety of Organs and Tissues for Transplantation in October 1995. There has been a continuous consultation process since that time. An Expert Working Group developed a draft Canadian General Standard (CGS) on Safety which was widely distributed for public comment in September 1996. Subsequent activities of organ/tissue specific expert sub-groups have led to proposed tissue- and organ-specific standards, using the CGS as a template. Xenotransplantation has been included among the subset standards being developed.

The regulatory framework environment to be developed is standards-based, designed to be responsive to future requirements in many emerging areas including somatic cell, gene, blood and transplantation therapy. The pillars of this new approach are consensus building, transparency, staged and consistent stakeholder involvement, flexibility and rapid regulatory response. It is proposed that standards will be accredited as National Standards of Canada and referenced in Regulations. Continuous input and feedback from client and stakeholder groups is an integral part of the Therapeutic Products Directorate’s refreshed approach to regulation.


Plenary Session III: Scientific, Medical and Ethical Issues

Risk of Zoonoses

Dr. Lorne Babiuk, Veterinary Infectious Disease Organization
University of Saskatchewan, Saskatoon, Saskatchewan

Abstract

Viruses have evolved various methods of interacting with their hosts, ranging from acute infections to persistence. These persistent infections are often difficult to detect and therefore can serve as a source of infection to naive individuals. Furthermore, since viruses are so adaptable, evolutionary pressures can alter the host range of viruses resulting in new emerging diseases. Thus, what was not normally a zoonotic virus may rapidly adapt to replicate in a new host, especially if the host is immunosuppressed. Thus, the risk of assisting virus evolution and emergence of new diseases may be enhanced in such individuals. These factors must all be taken into consideration in xenotransplantation. Examples of accidental and natural transmission of viruses to humans will be described.


Plenary Session III: Scientific, Medical and Ethical Issues

Porcine Endogenous Retroviruses (PERVs)

Dr. Robin Weiss, Institute of Cancer Research
London, England

Abstract

Certain C-type retroviruses released from pig cells can replicate in human cells in culture. We have characterized two distinct porcine retrovirus isolates with human cell tropism. While most of their genome sequences are highly similar they possess distinct gp70 sequences in the env gene. Retroviral vectors constructed with the porcine env genes indicate that the two viruses recognize distinct receptors on human cells. Using our specific probes, each retrovirus is found to be endogenous with numerous genomes in porcine DNA of diverse breeds, showing some polymorphism. This means that it will be difficult to eradicate them. These retroviruses are sensitive to inactivation by human complement when released from pig cells but become resistant upon passage in human cells. Complement sensitivity of enveloped viruses occurs by the same mechanism as hyperacute rejection of xenografts.

1. Patience, C., Takeuchi, Y. and Weiss, R. A. (1997). Infection of human cells by an endogenous retrovirus of pigs. Nature Medicine, 3; 282-286. 2. LeTissier, P., Stoye, J. P., Takeuchi, Y., Patience, C. and Weiss, R. A. (1997). Nature, 389; 681-682.

Plenary Session III: Scientific, Medical and Ethical Issues

Immunological Hurdles to Xenotransplantation

Dr. Fritz H. Bach, Harvard Medical School
Boston, Massachusetts

Abstract

Transplantation of a pig organ into a human (xenotransplantation) leads to additional forms of rejection as compared with those that we have been dealing with in allotransplantation (transplantation of an organ from one human to another) . The pig organ evokes an inflammatory response in a primate recipient (non-human primates are used as a pre-clinical model for transplantation to humans) that leads to hyperacute rejection (HAR) of the organ in just minutes to one or two hours. Even when we overcome HAR, the xenograft is rejected by a process called delayed xenograft rejection (DXR), which is an inflammatory response involving changes in the endothelial cells (EC) lining the blood vessels of the pig organ. Lastly, we expect that if both HAR and DXR can be overcome, we shall see a reaction quite similar to the T lymphocyte mediated rejection of an allograft.

HAR has been overcome by inhibiting either one of the two factors in the recipient that together precipitate HAR. The primary approach that has been taken is to inhibit recipient complement, which if not inhibited acts on the EC of the organ graft and leads to rejection. Since the molecules in the pig EC that inhibit pig complement do not function to inhibit human complement (a molecular incompatibility), my colleague Dr. Gus Dalmasso and I showed that if one expresses the human inhibitors of complement on the pig EC surface, one can prevent the action of the human complement on those cells. As such, several companies have now produced "transgenic pigs" (pigs that express a human gene) expressing the human inhibitor of complement. The organs from these pigs when given to primates that are immunosuppressed, are not rejected hyperacutely.

With regard to DXR, less progress has been made. However, promising approaches are being developed that may contribute therapeutically to overcome DXR. These potential therapeutic approaches in part involve further genetic engineering of the EC. These include expressing certain molecules such as thrombomodulin and ATPDase (CD39) on the EC to help prevent thrombosis (platelet aggregation and pro-coagulation) and also expressing genes within the EC that prevent EC activation, which if allowed to occur will lead to an inflammatory response that will in turn lead to rejection. Rendering the EC (the first-encountered or most prone cell type of the pig xenograft ) resistant to immune and pro-inflammatory processes may be a key element in the survival of the xenograft. This approach focuses on the importance of the defense or resistance of the xenograft rather than the type or level of immune attack.

It is also likely that immunosuppressive agents can be found that will help overcome DXR. One must be very careful however, not to have the immunosuppressive therapy be toxic to the patient, as is very likely the case with immunosuppressive therapies tested to date. Genetic engineering has the likely advantage of suppressing a given rejection factor locally in the organ and thus being less toxic than an immunosuppressive agent given orally or by vein.

The T lymphocyte response that is the cause of rejection of an allografted organ, and which is the target of most immunosuppressive agents currently being used, will almost certainly occur in some form in xenograft rejection. There is controversy whether the immunosuppressive agents that we currently have will suffice to suppress the xenograft rejection response.

A likely reason why the xenograft rejection response is so strong is the existence of other molecular incompatibilities in which the molecules associated with EC and others do not adequately function on the human system. The reactions are intended in part to avoid the very factors that seem to cause xenograft rejection. As such, some of the major regulatory systems that prevent pro-coagulation and thus blood clotting do not function across this species barrier.

More work needs to be done regarding the inflammatory responses, and understanding the physiological significance of molecular incompatibilities at the human blood / pig EC barrier.

I believe that there is good reason to be optimistic that we shall reach the point of clinical trials of organ xenotransplantation. Yet, I do not think we are ready to have such trials. The findings often presented about weeks of survival of a transgenic pig heart that expresses a human inhibitor of complement in immunosuppressed, non-human primates, while quite dramatic, must be tempered by several facts. First, in order to achieve such survival, very heavy immunosuppression has been used; levels that may not be applicable in humans. Second, these findings have been with heterotopically placed hearts (hearts transplanted in a position in the body where they do not have to work to pump blood and keep the recipient alive). When transplanted orthotopically and asked to do work the survival is not nearly as impressive. Third, the results of various of these studies have not been published, making evaluation of them very difficult.

Nonetheless, I find the progress that has been made in the last few years in both our understanding and in devising of therapeutic approaches very encouraging. It is just that it seems to me that we have additional problems that need solution before clinical activity is begun.


Plenary Session III: Scientific, Medical and Ethical Issues

Ethical Use of Animals for Medical Treatment

Dr. Gilly Griffin, Canadian Council on Animal Care
Ottawa,Ontario

Abstract

The Canadian Council on Animal Care (CCAC) is the national agency responsible for the oversight of the care and use of animals used for research, teaching and testing in Canada. The keystone of the oversight afforded by the CCAC rests at the local Animal Care Committee (ACC) level. These ACCs are established at each institution which uses experimental animals, according to Terms of Reference laid down by the CCAC and are responsible for providing ethical review of any proposed animal-based study. ACCs are asked to adhere to the CCAC guidelines on: animal use protocol review in making their ethical judgements. ACCs must attempt to reconcile public demands for medical, scientific and economic progress with demands for reduction in animal use, pain and suffering. The cost in terms of animal welfare and integrity must be measured against the expectation of a proportional contribution to the understanding of fundamental biological principles, or to the improvement of human or animal health or welfare. ACCs are also responsible for ensuring that animals receive proper housing, husbandry and veterinary care and that any procedures are carried out by qualified personnel according to Standard Operating Procedures or best practices.


Plenary Session IV: Clinical Trials and Surveillance

Clinical Trials in Xenotransplantation

Dr. Daniel Salomon, Director of Transplantation Research
Scripps Research Institute, La Jolla, California

Abstract

Clinical trials in xenotransplantation are already underway. The best examples are fetal pig neural cell transplantation to patients with severe Parkinson's disease and the extracorporeal perfusion of pig hepatocytes to rescue patients with acute liver failure. Thus, the need for regulatory bodies to establish working guidelines for clinical trials is based on a very real and present challenge. That process requires a clear idea of the problems this new field must overcome for clinical trials to be successful.

One of the first questions will be what donor species should be used for a given clinical trial. Therefore, I will describe some of the options such as heart, kidney and liver transplantation in the context of donor selection, specifically pig vs. non-human primate. How and based on what kind of parameters, will we decide when a given set of experiments based in the laboratory warrants the initiation of a clinical trial? Three general issues must be considered: 1) Who is in the best position to evaluate or validate this process: the investigator, a company, the local institutional review boards, the local animal use committees or a more central authority of experts at the federal level? 2) How will we integrate concerns over patient-centered efforts with possible public health implications? In other words, a patient at high risk of dying will have a very different view of risks in xenotransplantation than the public. 3) What is an appropriate expectation for success to justify a clinical trial and how do clinical trial designs and scope impact on issues of informed consent, potential conflicts of interest and safe advancement of the field?

Once we decide to go forward with conduct of a clinical trial, how do we insure the best management of resources, the safety and the efficacy? What are the responsibilities of the various participants: investigator, physician colleagues, vested biotechnology companies, large pharmaceutical industry backers, local institutional reviewers, federal regulatory bodies as well as patients and patient families? Should we have central registry, how closely should this be tracked, what should be done if a problem is identified and in a practical world, who should pay for this work?

In the final analysis, the tremendous potential of xenotransplantation must be respected and all our efforts designed to facilitate this development. Thus, any guidelines or regulations established must be considered in the context of protecting and enhancing the conduct of clinical trials, necessary to bring xenotransplantation into practice. That goal will require a delicate balance protecting the interests of the patients and the public while remaining flexible enough to permit the innovation absolutely required for success in a new endeavour.


PLENARY SESSION IV: Clinical Trials and Surveillance

Patient Registries in Disease Surveillance

Dr. Maura Ricketts, Laboratory Centre for Disease Control,
Health Canada, Ottawa, Ontario

Abstract

Surveillance systems for the detection of pathogens resulting from xenotransplantation must be designed for their purpose: the detection of novel infectious disease or the detection of novel infections in the recipients of xenotransplants. To do this, they must be capable of detection of previously unrecognized pathogens, capable of rapid detection, reporting and response, and they must monitor populations of people over long time periods. Such a system will need to be networked to other surveillance systems, be public health oriented, have secure long-term funding and be able to accurately follow every recipient over the long term. Participation of clinicians, patients, biotechnology companies and health care provider organizations in such surveillance must be compulsory until xenotransplantation can be demonstrated to be safe from novel infectious disease for both the individual recipients and the general public.


PLENARY SESSION IV: Clinical Trials and Surveillance

Proposed Methods for Patient Surveillance

Dr. Khazal Paradis, Clinical Research
Novartis Pharma Limited
Basel, Switzerland

Abstract

One of the major safety concerns that has been raised regarding xenotransplantation is the potential for transmission of zoonoses from the donor animal. The risk to the patient could be considered to be part of the general individual risk of undergoing a transplant, along with the risks of over immunosuppression, a non-functioning graft and the potential of lymphoma for example. The concern is primarily one of public health, if a zoonotic infection were to establish itself in the recipient and if that could be transmitted to the contacts of the xenograft recipient. Close monitoring of the recipient for life is therefore probably necessary, until such time as the inherent risks of the procedure are better known. Pre-transplant counselling will be essential. Contacts of the recipient, defined as being at risk of contact with the recipient’s bodily fluids should probably have baseline samples archived, as well as samples drawn whenever a mucosal barrier is broken. Prior to entering any xenotransplant trials, Novartis is conducting a study looking at the potential for transmission of the porcine endogenous retrovirus (PoERV) in patients who have been in intimate contact with porcine tissue (islet cell transplants, extracorporeal liver or hepatocyte perfusion, skin grafts, extracorporeal splenic perfusion etc). The PoERV agent may not be the only potentially infectious agent involved and monitoring will be required for the detection of new, previously undetected agents. Novartis proposes to establish a system for patient surveillance composed of 3 parts: 1) a database for all relevant information on the organ donor animal including health status and test results, 2) a registry to follow all patients containing safety relevant information, contact numbers, inventory of samples and test results, intimate contacts and health care personnel, which will be linked to the donor; and finally, 3) an archiving facility for all retention samples from donor animals and patients. This system would be at the disposition of health authorities in each country, act as a tool for analysis of xenotransplant results and assure a common, worldwide standard of health surveillance for all patients included in Novartis trials.


PLENARY SESSION IV: Clinical Trials and Surveillance

Initial Experience in Clinical Trial Surveillance

E. Michael Egan,
Senior Vice President, Corporate Development
Diacrin, Incorporated

Abstract

Over two years ago Diacrin, Inc. initiated clinical trials using porcine fetal ventral mesencephalon cells for treatment of Parkinson’s disease. As part of this phase 1 clinical trial, 12 patients were transplanted. Safety and preliminary efficacy data are being generated. In addition, 12 patients have been entered into a phase 1 program using porcine fetal lateral ganglionic eminence cells for the treatment of Huntington’s disease. These trials will be discussed along with the qualification of the cells for transplantation . This effort includes the screening of animals for porcine infectious diseases which would be of concern. Once screened, the animals are maintained in a Biomedical Animal Facility (BAF) to maintain their health status, additional viral screens are conducted during this period. After artificial insemination, intact uteruses are harvested from donor pregnant pigs at specific gestational ages. Fetuses are collected and cells isolated under GMP conditions. Cells are implanted using standard stereotactic techniques. Extensive follow-up testing is done on final product as well as on the patient samples, including the testing for porcine endogenous retrovirus (PERV) in peripheral blood monocyte cells (PBMC). Samples of patient PBMCs, up to two years post transplantation, which were tested for PERV have been shown to be negative.


Plenary Session IV: Clinical Trials and Surveillance

US PHS National Xenotransplantation Registry Database Pilot Study

Ms. Tina Moulton, Division of Cellular and Gene Therapy
Office of Therapeutics Research and Review
Centre for Biologics Evaluation and Research, US PHS
Bethesda, Maryland

Abstract

The US-PHS National Xenotransplantation Registry Database is a proposed national data collection system that will systematically collect data from all clinical centres conducting clinical trials in xenotransplantation and all biomedical animal facilities supplying animals/xenografts for clinical use. A pilot study to test and implement this database has been initiated (fall 1997). The most immediate purpose for this registry database will be to provide the means for rapid recognition, accurate assessment and appropriate response for identification of any infectious agents or other adverse clinical events that are associated with xenotransplantation and which may have public health consequences. If adverse transplant-associated events are identified in recipients of xenografts, a national registry database could be used to: (1) identify and notify other patients that have received similar xenografts; (2) identify close contacts of the recipients; (3) locate stored serum or tissues from patient and individual source animal for laboratory testing; (4) link patients by cause of death as indicated on death certificates and (5) locate source animal and herd health records. Data quality and the use of an internationally recognized medical terminology and controlled vocabulary will be used to facilitate any future international collaborations, the sharing of data or possible linkages to other databases.


Plenary Session IV: Clinical Trial and Surveillance

Porcine Fetal Neural cells for Treatment of Parkinson’s
and Huntington’s Disease

E. Michael Egan,
Senior Vice President, Corporate Development
Diacrin, Incorporated

Abstract

Over two years ago Diacrin, Inc. initiated clinical trials using porcine fetal ventral mesencephalon cells for treatment of Parkinson’s disease. As part of this phase 1 clinical trial, 12 patients were transplanted. Safety and preliminary efficacy data are being generated. In addition, 12 patients have been entered into a phase 1 program using porcine fetal lateral ganglionic eminence cells for the treatment of Huntington’s disease. These trials will be discussed along with the qualification of the cells for transplantation . This effort includes the screening of animals for porcine infectious diseases which would be of concern. Once screened, the animals are maintained in a Biomedical Animal Facility (BAF) to maintain their health status, additional viral screens are conducted during this period. After artificial insemination, intact uteruses are harvested from donor pregnant pigs at specific gestational ages. Fetuses are collected and cells isolated under GMP conditions. Cells are implanted using standard stereotactic techniques. Extensive follow-up testing is done on final product as well as on the patient samples, including the testing for porcine endogenous retrovirus (PERV) in peripheral blood monocyte cells (PBMC). Samples of patient PBMCs, up to two years post transplantation, which were tested for PERV have been shown to be negative.

 SPEAKER, CHAIR & CO-CHAIR BIOGRAPHIES

Dr. Lorne Babiuk

Director, Veterinary Infectious Disease Organization (VIDO)
University of Saskatchewan, Saskatoon, Saskatchewan

Lorne Babiuk, a Saskatchewan native, obtained his B.SA., M.Sc. and D.Sc. degree at the University of Saskatchewan and a Ph.D. from the University of British Columbia. He was appointed as Professor of Veterinary Microbiology at the Western College of Veterinary Medicine in 1973, Associate Director (Science) of the Veterinary Infectious Disease Organization in 1984 and Director of VIDO in 1993. Dr. Babiuk also serves on numerous national and international committees in setting scientific policies, in addition to being active in the scientific community.

For the past 23 years Dr. Babiuk has focused his research activities on understanding how viruses and bacteria cause disease and how animals respond to infection. During this time, he has assembled and trained a group of researchers in biotechnology and immunology to help identify protective proteins of disease-causing organisms and to determine ways to enhance the immune response of animals using cytokines. As part of these activities his group at VIDO produced and licensed the world's first engineered vaccine for any animal species, when they developed Pasteurella leukotoxin to control respiratory disease in cattle. Subsequently, they developed additional subunit vaccines for use in pigs and cattle. In addition, the VIDO group is developing live-vectored vaccines for poultry and other livestock. These research achievements have been published in over 300 peer reviewed manuscripts and 63 review articles and lead to 7 patents awarded and 5 patents pending.

Dr. Babiuk has been instrumental in transferring technology from the research laboratory to industry. As a result, VIDO has a number of industry interactions with multi-national companies as well as having played a pivotal role in spinning off a local company, BIOSTAR Incorporated. Biostar Inc. raised over 10 million dollars in private funds to develop technologies originating at VIDO. In recognition of this University /Industry interaction he was awarded the Xerox Canada Forum Award in 1993.


Dr. Fritz H. Bach

Harvard Medical School
Boston, Massachusetts

Fritz Bach, born in Vienna, Austria, received his A.B. degree from Harvard College and his M.D. from Harvard Medical School. After a residency in internal medicine at New York University, he joined the Laboratory of Genetics at the University of Wisconsin, Madison in 1965. He was promoted to Full Professor in 1973, and in the following year took on Directorship of the newly-established Immunobiology Research Center at that University. Dr. Bach was awarded Full Professorship at Harvard medical School in December 1994 and Lewis Thomas Professorship in November 1995.

In 1979, Dr. Bach moved to the University of Minnesota, Minneapolis, as Professor of Laboratory Medicine, Pathology and Surgery and to function as the Director of the Immunobiology Research Center. As of July 1, 1992, Dr. Bach became Director of the Sandoz Center for Immunobiology at Harvard Medical School. He also directs a Laboratory of Transplantation Biology at the Vienna International Research Cooperation Center in Vienna, Austria.

In 1964, Dr. Bach published a paper in Science, one of more than 500 in his bibliography, in which he described a method, the mixed leukocyte culture (MLC), for testing tissue compatibility between donors and recipients for organ transplantation. This test has served not only as a major approach to determine compatibility of donor and recipient for transplantation, but also became the basic experimental method for studying the response of one of the two principle types of immune cells, the T lymphocytes. Dr. Bach used this method to make several key observations in cellular immunology. He used genetic studies with the MLC to help define HLA, the major histocompatibility complex in humans, which plays such an important role in determining the fate of a graft and in controlling immune responses. He performed, based on testing compatibility in MLC, one of the first two successful, matched bone marrow transplants ever done, and did compatibility testing for the second. He made the all-important observation that there are different classes of antigens associated with HLA that perform different function in regulating the immune response. He also devised a number of additional tests, based on the MLC, that were key elements in the evolution of transplantation biology and basic Immunology.

All during this time, Dr. Bach has played a leading role in the field of transplantation immunology. He has written a large number of the major reviews in various aspects of the field and is one of the most sought-after lecturers at national and international meetings. During the last three years, Dr. Bach has again turned his attention to the area of xenotransplantation, and has played a major role in revitalizing that field with his suggestion that it is activation of endothelial cells of the donor organ that is the fundamental event leading to vascular rejection in that situation, his proposing of an overall model for the basis of rejection by primates of xenografts from a species such as pig, and his view of the future.

Dr. Bach has received numerous honors during his career. These include election as Foreign Member of the Royal Dutch Academy of Sciences, the Emilio Trabucchi Medal, election as an Honorary Member of the American Society of Transplant Surgeons, as well as Distinguished Achievement Awards from Modern Medicine, the Milwaukee Academy of Medicine and The American Red Cross.


Dr. Keith Bailey

Director, Bureau of Biologics and Radiopharmaceuticals
Therapeutic Products Directorate
Ottawa, Ontario

Keith Bailey studied chemistry at St. Catherine's College, Oxford, and received his D.Phil. in the chemistry of natural products. He conducted post-doctoral research work and taught chemistry at the University of Oxford for two years, and at Trent University, Ontario, from 1967-1969.

He joined the research laboratories of the then Food and Drugs Directorate as a Research Scientist in 1969. His early studies of the chemistry and forensic characterization of hallucinogenic substances developed into general interests in pharmacology and toxicology of drugs, on which he published over fifty original articles. Progressing to Section Head and Division Chief, he was appointed Director of the Bureau of Drug Research in 1984 and moved to the Bureau of Biologics and Radiopharmaceuticals, as Director in 1994.

Dr. Bailey is a Fellow of the Chemical Institute of Canada. He is Canada's Member-at-Large to the United States Pharmacopeial Convention and has served on various international task forces and committees for the OECD, PAHO, and WHO.

His hobbies include gardening his one acre in the Ottawa suburbs, theater and singing— he belongs to several choral and operatic groups in the Ottawa area.


Dr. Donald Casebolt

Atlantic Veterinary College
Charlottetown, Prince Edward Island




Donald B. Casebolt received his Bachelor of Science Animal Science in 1979, Doctor of Veterinary Medicine in 1983, and Master of Preventive Veterinary Medicine in 1984 from the University of California at Davis. He completed postdoctoral training in laboratory animal medicine and comparative pathology in 1987 at the University of Alabama at Birmingham. He is board certified by the American College of Laboratory Animal Medicine. From 1987 to 1993, Dr. Casebolt was Assistant Professor in the Department of Comparative Medicine and Associate Director of the Animal Resources Program at the University of Alabama at Birmingham. Since 1993, he has been Assistant Professor in the Department of Pathology and Microbiology and Director of Animal Resources at the University of Prince Edward Island.


Dr. Louisa Chapman

Centers for Disease Control & Prevention
Atlanta, Georgia

Louisa Chapman received a BA degree from Macalister College, St. Paul, Minnesota in 1975 and MSPH and MD degrees from the School of Public Health (1977) and the School of Medicine (1982), respectively, University of North Carolina, Chapel Hill. She is board certified in Internal Medicine and Infectious Diseases. Dr. Chapman has worked with a variety of zoonotic viruses during a decade as a viral epidemiologist at the United States Centers for Disease Control in Atlanta, Georgia. She is currently the medical epidemiologist in the HIV/Retrovirus Diseases Branch, Division of AIDS, STD, and TB Laboratory Research, National Center for Infectious Diseases, CDC and heads the CDC Xenotransplantation Working Group.


 Dr. Henry Dinsdale

President, National Council for Bioethics in Human Research
Kingston General Hospital, Kingston, Ontario



Henry Dinsdale is a neurologist and Professor Emeritus (Medicine), Queen’s University. A graduate of the Faculty of Medicine of Queen’s University, he undertook clinical and research training in neurology at the Maudsley and National Hospital, Queen Square, London and the Harvard Neurological Institute, Boston City Hospital. He returned to Queen’s University where he was professor and Head of the Department of Medicine from 1983-1993. Dr. Dinsdale’s main research interests and publications have been in the area of cerebrovascular disease and blood-brain barrier permeability.

Dr. Dinsdale has been a member of numerous national and international organizations representing his profession and speciality. He was a founding member and currently is President of the National Council on Bioethics in Human Research. He was member of Council and Vice-President of the Medical Research Council of Canada. He is immediate Past-President of the Royal College of Physicians and Surgeons of Canada. He is Chair of the Health and Public Policy Committee of the Royal College.


Dr. John Dossetor

Director, Bioethics Center
University of Alberta
Edmonton, Alberta

Born in India in 1925 of Australian parents, John Dossetor was educated in England’s Marlborough College, Wiltshire and entered Oxford University as an Open Scholar in Natural Science in 1943 to study medicine. After 3 years in Oxford, he completed an Honors degree in Physiology before moving in 1947 to St. Bartholomew's Hospital and obtaining medical degrees from Oxford and London Universities in 1950.

Dr. Dossetor’s postgraduate clinical residency training in London during the next 5 years was interrupted for two years of National Service in the Royal Army Medical Corps. He returned to London for residency training at the Royal Post-Graduate Medical School, Hammersmith and at St. Bartholomew's Hospital and obtained the MRCP (UK) in 1955 before moving to McGill University (Royal Victoria Hospital). After years as a teaching fellow and then Chief Resident in Medicine at Royal Victoria Hospital (1956-1957), Dr. Dossetor was awarded a Canada Life Insurance Research Fellowship to do research in circadian rhythms of electrolyte excretion and renal function, leading to a Ph.D. at McGill (1961) in Experimental Medicine. This experience was followed by a post-doctorate fellowship of the U.S. Public Health Service at New York University Medical School, Bellevue Hospital.

In 1961, Dr. Dossetor was appointed Director, Renal and Urologic Research, Royal Victoria Hospital, Montreal and in charge of the renal service, with responsibility for dialysis and the medical aspects of renal transplantation. It is noteworthy that in the mid-sixties the Royal Victoria series of cadaver-donor transplants was the second largest such series in the world. In 1963, he was elected Fellow of the American College of Physicians. Between 1961-1969 immunological aspects of renal transplantation became the principle research field and in 1968, while at McGill, he was appointed Career Investigator of the Medical Research Council of Canada, an appointment in which he remained active to 1989. Dr. Dossetor is recognized as co-founder of the Kidney Foundation of Canada and founding member of the Canadian Society of Nephrology, the Canadian Society of Immunology and the Canadian Transplantation Society.

In 1969, Dr. Dossetor was appointed Professor of Medicine, University of Alberta and Director of the Division of Nephrology and Immunology, Department of Medicine. In 1970, he was appointed Chair and Co-Director (with Dr. Erwin Diener) of a research group in transplantation established by MRC, Canada, at the University of Alberta. He conducted studies in HLA immunogenetics, with two groups of Inuit in the Arctic and many hutterite communities in Alberta, as well as in immunologic monitoring of kidney transplant recipients. He was elected to Fellowship of the Royal College of Opticians, London, UK, in 1982.

In 1985 his interest in medical ethics precipitated a career change into bioethics after a sabbatical year spent in medical ethics at UCSF, San Francisco, the Bioethics Center in Montreal and the Hasting's Center, New World . As Director of the joint-faculties Bioethics Project at the University of Alberta and the University of Alberta hospitals, he was responsible for bioethics teaching at the undergraduate level, ethics seminars for residents and nurses and a graduate course in healthcare ethics. The Bioethics Project evolved in 1990 into the Division of Biomedical Ethics and in 1993 into the Bioethics Center. Dr Dossetor is Past President of the Canadian Bioethics Society of which he is also a founding member. He was appointed Professor Emeritus of the University of Alberta in January, 1992 and Chair of the University of Alberta Hospitals Ethics Committee from 1992-1995 and has remained an active committee member. He served as Director of the Division of Bioethics and Bioethics Center from 1990-1996. He has over 250 publications and has co-authored 5 books. In 1992, he was awarded the 125th Canadian Confederation Commemorative Medal for work with the Kidney Foundation of Canada and on January 4, 1995, he was appointed an Officer of the Order of Canada for his achievements in the fields of medicine and bioethics. He remains active as the first nominee to the Chair in Bioethics, Faculty of Medicine and is a key consultant in the field of ethics for the Center and the Provincial Health Ethics Network, of which he is Vice-Chair and C.E.O.


Mr. E. Michael Egan

Senior Vice President, Corporate Development
Diacrin Incorporated

E. Michael Egan has been Senior Vice President, Corporate Development of Diacrin, Inc. since June 1993. Mr. Egan joined Diacrin from Repligen, where he was employed from 1983-1993 and since 1989 had been Vice President of Business Development. He was also a member of the Board of Directors of Repligen clinical Partners, L.P. and the Secretary/Treasurer of Repligen Sandoz Research Corporation. Mr. Egan’s previous positions at Repligen include director of Business Development and Manager of Business Development. Prior to joining Repligen in 1983, Mr. Egan was a laboratory supervisor at Dana Farber Cancer Institute, Division of Medicine. He received a B.S. in Biology from Boston College and a Certificate of Special Studies in Administration and Management from Harvard University in 1986.


Dr. Jay Fishman

Transplant Infectious Diseases
Massachusetts General Hospital
Boston, Massachusetts

Jay A. Fishman, M.D., F.A.C.P., is Associate Visiting Physician in Infectious Diseases at Massachusetts General Hospital, Boston, Massachusett, and Assistant Professor of Medicine at Harvard Medical School. Dr. Fishman is on the staff of the Infectious Disease (Medicine) and Transplantation (Surgery) Units and is the Clinical Director of the Transplantation Infectious Disease Program at the Massachusetts General Hospital. He received a B.A./B.S. (Biology/lmmunology) from the University of Pennsylvania and the M.D. from the Johns Hopkins University School of Medicine. He completed a residency in Internal Medicine and fellowships in Infectious Diseases and Molecular Biology and Genetics at the Massachusetts General Hospital and at Harvard Medical School. He received additional training in molecular parasitology at the MacArthur Center for Molecular Parasitology at Yale University. He is on the senior scientific staff of the Shriners' Burns Institute (Boston Unit) and Visiting Scientist at the Massachusetts Institute of Technology. He is a consultant to BioTransplant, Incorporated and Diacrin, Incorporated for issues concerning infectious diseases related to the development of swine as xenograft source species. He has served on the United States FDA, Advisory Committee on Xenotransplantation.

Dr. Fishman's laboratory research has focused on studies of the pathogenesis of infection in the immunocompromised host. On-going projects include investigation of the molecular biology of Pneumocystis carinii, viral infections in xenotransplantation and the role of cytokines in pulmonary infection. His clinical research interests are focused on the prevention of infection in solid organ and bone marrow transplant recipients and in other immunocompromised individuals.


Dr. Uri Galili

Allegheny University of the Health Sciences
Philadelphia, Pennsylvania



Uri Galili pursued graduate studies at Hebrew University, Jerusalem, Israel, obtaining an M.S. in Immunology in 1973 and subsequently a Ph.D. in Immunology in 1977. Dr. Galili continued on a Post Doctoral Fellowship in the Department of Tumor Biology, Karolinska Institute, Stockholm until 1979. From 1979-1984, he worked as Assistant Research Immunologist, leading histology and immunology, at the Hadassah University Hospital, Department of Hematology, Jerusalem, Israel. Subsequently, he traveled to University of California, San Francisco where he worked from 1984-1987 as Assistant Research Immunologist in the Cancer Research Institute. Dr. Galili was appointed as Associate Professor in the Department of Anatomy, University of California, teaching histology and cell biology from 1988-1990. His teaching responsibilities were further expanded at the University of California, from 1989 to 1990, to histology and immunology in the Department of Laboratory Medicine and his specialization in teaching continued there after his appointment as Professor in Residence, from 1990-1991. Since February 1991, Dr. Galili has pursued teaching immunology, microbiology and molecular biology as Professor in the Department of Microbiology and Immunology, Allegheny University of the Health Sciences.



 
 

Dr. Peter Ganz

A/Manager, Blood and Tissues Division
Bureau of Biologics and Radiopharmaceuticals
Therapeutic Products Directorate, Ottawa, Ontario

Peter Ganz received both his bachelors (biochemistry, magna cum laude) and doctoral degrees (protein and nucleic acid biochemistry) in Toronto. As a Leukemia Society of America Post-Doctoral Fellow, Dr. Ganz trained in the area of molecular biology (virology) at Harvard Medical School and the University of Toronto. Before moving to Health Canada, he served as Research Director at the Ottawa Blood Center, CRCS. He is well known in Canada for his research in expression of blood factors in transgenic plant systems and in the area of vascular cell biology. Dr. Ganz moved to Health Canada in 1996 and is currently the Acting Manager of the Blood and Tissues Division of the Bureau of Biologics and Radiopharmaceuticals. In his current position, he serves as the Chair of the Department’s Tissues and Organs Working Group, as well as the Chair of the Interdepartmental Special Working Group on Xenotransplantation. He is also the Executive Secretary of the Therapeutic Products Directorate Expert Working Group-Xenotransplantation. Dr. Ganz holds a cross appointment in the Department of Biochemistry, Faculty of Medicine, University of Ottawa.


Dr. David Grant

Liver Transplantation
University Hospital
London, Ontario

David Grant is a Professor in the Department of Surgery at the University of Western Ontario. His research interests include xenotransplantation, small bowel transplantation and tolerance induction for transplantation. Dr. Grant is a member of the Editorial Board for Transplantation and Clinical Transplantation and the Director of the International Intestinal Transplant Registry. Dr. Grant has been recognized by receiving the Medal in Surgery, awarded by the Canadian Royal College of Surgery and the Hames IV Travelling Scholarship.


Dr. Paul Greig

Director, G.I. Transplantation, University of Toronto
Toronto General Hospital, Toronto, Ontario




Paul D. Greig is an Associate Professor, Department of Surgery, University of Toronto and Director of the G.I. Transplant Program. He is an hepatobiliary/pancreatic and liver transplant surgeon at the Toronto Hospital. Dr. Greig is the President and Chief of the Board of Directors of the Canadian Organ Replacement Registry (CORR). He has also served as the President of the Canadian Transplantation Society and with Mr. LaPrairie, was the Co-Chair of Organ Sharing Canada. He, in part, authored the document "Safety of Human Organ and Tissue Transplantation in Canada" and currently serves on the Expert Working Group advising Health Canada in developing the Canadian General Standard for Organ and Tissue Transplantation. He is the Chair of the Subcommittee to the Expert Working Group, on Standards for Perfusable Organs and is also a member of the Subcommittee on Standards for Xenotransplantation.


Dr. Gilly Griffin

Canadian Council on Animal Care
Ottawa, Ontario

Gilly Griffin, Ph.D., is the information officer for the Canadian Council on Animal Care (CCAC). The CCAC is the primary agency setting guidelines for and assessing the quality of institutional animal care and use programs in Canadian science. Since its inception in 1968, it has continuously developed and refined the terms of reference which guide the composition and function of institutional animal care committees and has been the dominant factor in assuring Canadians that high ethical standards are met for animals used in research, teaching and testing. Dr Griffin holds a Ph.D. in physiology and has worked in both medical and agricultural research. She is also the Executive Director of the Canadian Centre for Alternatives to the Use of Animals in Research, based in the Faculty of Health Sciences, University of Ottawa and an Associate Editor of the journal Alternatives to Laboratory Animals (ATLA).


Dr. Michael Gross

Expert Working Group Chair for Xenotransplantation
Queen Elizabeth II Hospital, Halifax, Nova Scotia



Michael Gross is an Associate Professor of Surgery at Dalhousie University in Halifax, Nova Scotia. Dr. Gross is the Medical Director of one of the largest tissue banks in Canada and is keenly interested in the transplantation of tissues. He has served as the Chair of the Tissue Subcommittee of the Canadian Standards Committee for Organ and Tissue Transplantation. He is also Chair of the Xenotransplantation Subcommittee. As an orthopaedic surgeon, he brings to the conference an understanding of the huge need and potential benefit of transplantation of tissues, both allograft and potentially, xenograft. He is also acutely aware of the need for transplantation from the patients’ perspective and the potential benefits that can accrue. He is committed to a consensus process whereby appropriate standards and guidelines can be developed that will respect the desires of the patient and the well-being of those involved in the transplantation process.


Professor Bartha Maria Knoppers

Faculté de Droit, CRDP
University of Montréal, Montréal, Québec

Bartha Maria Knoppers, Ph.D. (Sorbonne, Paris I) is Ful1 Professor at the Faculty of Law, Université de Montréal, Senior Researcher at the Center for Public Law Research (C.R.D.P.) and Counsel to the law firm McMaster Meighen. She is a graduate of McMaster University (B.A.), University of Alberta (M.A.), McGill University (LL.B., B.C.L) and Cambridge University, U.K, (D.L.S.) and was admitted to the Bar of Quebec in 1985.

Professor Knoppers serves as an expert to committees of the World Health organization (WHO), Geneva and of the National Institutes of Health (NIH), Washington. She is currently Chair of the International Ethics Committee of the Human Genome Organization (HUGO), member of the International Bioethics Committee of the United Nations Educational, Scientific and Cultural Organization (UNESCO) and Co-Director of the Institute for Population Studies (REP). As a consultant to the Ministry of Industry, Ottawa, she was recently appointed to the Standing Committee on Ethics of the Medical Research Council of Canada (MRC).

She was a member of the Central Management Committee of the Canadian Genome Analysis and Technology Program (CGAT), where she also chaired the Medical, Ethics, Law and Social Issues Committee (l992-l995). She is past Commissioner of the Royal Commission of New Reproductive Technologies (1991-1994) and was both past-president of the Canadian Bioethics Society and past Vice President of the National Council on Bioethics in Human Research. She was named Visiting Heritage Scientist by the Alberta Medical Research Heritage Fund (l993-1995) and she co-chaired the Quebec Bar Committee on the Representation of Children in 1993-1995. In 1995, she became Chair of the Social Issues Committee of the American Society of Human Genetics. In September 1996, she chaired the Organizing Committee of the First International Conference on DNA Sampling, Human Genetic Research: Ethical, Legal and Policy Aspcris, held in Montreal and was also named the ‘Scientist of the Year’ by the CBC French radio network. Finally, in 1997, she received the Medal of the Bar of Quebec.


 Dr. Gary Levy

Director, Multi-Organ Transplants
Toronto Hospital, Toronto, Ontario

Gary Levy graduated from medical school at the University of Toronto in 1973. He completed his training in hepatology at the University of Toronto in 1978 and undertook postdoctoral training in immunology at the Scripps Clinic and Research Foundation from 1978-1981. Dr. Levy founded and became the Medical Director of the Liver Transplant Unit in 1987 at the Toronto Hospital and University of Toronto. In 1991, he organized and co-founded the Multi Organ Transplant Unit at the Toronto Hospital and University of Toronto.

Dr. Levy is currently a Full Professor in the Departments of Medicine and Surgery, Director of Gastroenterology at the University of Toronto and Director of the Multi Organ transplant Unit at the Toronto Hospital and University of Toronto.

He has organized and now heads a research group of 11 principle investigators which is focused on studying cellular and molecular mechanisms of inflammation. His research, funded by the Medical Research Council of Canada and the National Institutes of Health has focused on immune-mediated mechanisms of organ injury due to viruses, alloantigens, and xenoantigens. He has published over 200 original articles and 20 books and book chapters. Dr. Levy has played a leading role in the development of the new cyclosporine microemulsion, Neoral and has demonstrated its usefulness and its efficacy in the setting of liver transplantation

He has received a number of honors including election to the American Society for Clinical Investigation, the Goldie Prize in Medicine, the Canadian Association of Gastroenterology Visiting Research Professorship and the University of Toronto, Department of Medicine Research Award for Outstanding Contributions to Research. He is a member of the following editorial boards: Transplantation Science, Liver Transplantation and Surgery and Current Opinion in Organ Transplantation.


Ms. Susan McCabe

Transplant Recipient
Toronto, Ontario

Susan McCabe obtained an undergraduate degree in History at York University and subsequently obtained a Law degree from the University of Windsor. She was called to the Ontario Bar at Osgoode Hall in 1984. Ms. McCabe was past CEO and Chair of the Board of the Canadian Liver Foundation. She is currently serving on the executive committee as Director for Regional Development and as President of Corbrook Enterprises, a provincially funded vocational rehabilitation agency. She has contributed as past speaker and guest panelist on legal ethical issues concerning transplantation at International Association of Nurses and is a member of Health Canada's Expert Working Group formed to provide safety standards for the transplantation of tissues and organs. Ms. McCabe was a recent recipient of Health Canada's Volunteer Achievement Award Certificate of Merit, recognizing individuals who improve the health and safety of Canadians on a national basis.



 
 

Mr. Dann Michols

Director General
Therapeutic Products Directorate
Ottawa, Ontario

Dann Michols is currently head of Health Canada's Therapeutic Products Directorate. Mr. Michols came to the Department of Health on assignment as Assistant Deputy Minister, National Pharmaceutical Strategy. His responsibilities were to facilitate federal/provincial initiatives in the area of national pharmaceutical policy and regulation and to coordinate the results into a comprehensive and cohesive pharmaceutical policy for Canada.

In January, 1993, Mr. Michols assumed the additional responsibility for the management of Canada's drug review agency and for the implementation of the Gagnon Report recommendations and other similar exercises leading to a renewed Drugs Programme. On January 1, 1997, Health Canada's responsibilities for drug regulation and medical device regulation were merged and the new Therapeutic Products Directorate was created.

Prior to his work with the Department, Mr. Michols was Director of Operations for the federal Royal Commission on New Reproductive Technologies, responsible for the development and management of all consultation, communication, coordination, and policy analysis activities.

Mr. Michols has had a twenty-seven year career in the Canadian Public Service, the last twelve years at the level of Assistant Deputy Minister. He has served as a senior management advisor to UNESCO in Paris and as Assistant Secretary General of the National Museums Corporation of Canada during the period when new facilities for the Canadian Museum of Civilization, the National Gallery of Canada, and the National Aviation Museum were built.

Born in Calgary, Dann Michols has an MBA from the Harvard Graduate School of Business Administration and a Bachelor of Commerce (Honours) from the University of Calgary.


Ms. Tina Moulton

Division of Cellular and Gene Therapy
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research, US PHS
Bethesda, Maryland






Tina Moulton is the Alternate Project Officer for th United States Food and Drug Administration (FDA) Contract Task Order for the US-PHS National Xenotransplantation Registry Database (NXRD) Pilot Study and a Consumer Safety Officer in the Division of Cellular and Gene Therapies (DCGT), Office of Therapeutic Research and Review, Center for Biologics Evaluation and Research, FDA, US Public Health Service. She is responsible for overseeing the administration of the NXRD Pilot Study Contract Task Order and she serves as the DCGT liaison responsible for the coordination of xenotransplantation projects.


Dr. Khazal Paradis

Medical Expert, Clinical Research,
Novartis Pharma Limited, Basel, Switzerland

Khazal Paradis received his M.D. degree from McGill University and followed this with a fellowship in pediatric gastroenterology, pediatric hepatology and liver immunology in Montreal, Paris and Minneapolis. Dr. Paradis served as Director of the Pediatric Liver Transplant Program in Montreal, until he joined Novartis Pharma Ltd. in January 1996. He is currently globally responsible for the clinical development of xenotransplantation with Novartis Pharma Ltd. and is located in Basel, Switzerland.


Dr. Amy Patterson

Cellular and Gene Therapies
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research, US PHS,
Bethesda, Maryland

Amy P. Patterson, M.D. is Team Leader and Interim Deputy Director of the Division of Cellular and Gene Therapies and Medical Officer in the Division of Clinical Trial Design and Analysis at the Center for Biologics Evaluation and Research, FDA. Dr. Patterson is responsible for reviewing both product manufacturing and clinical trial designs in the field of xenotransplantation and in gene and cell/tissue-based therapies for endocrine disorders and in-born errors of metabolism. She serves as the FDA liaison to the Department of Health and Human Services Committee, responsible for the coordinated development of US Public Health Service perspectives on xenotransplantation. Dr. Patterson received her degrees from Harvard University and Albert Einstein College of Medicine. She completed residency training in internal medicine at the New York Hospital-Cornell Medical Center and Memorial Sloan Kettering Cancer Center and later served as the Assistant Chief Resident in the Department of Internal Medicine at the New York Hospital-Cornell Medical Center. She completed post-doctoral clinical and basic science research fellowships in both pediatric and adult endocrinology and metabolism at the National Institutes of Health, where she is currently an active clinical staff physician.


Maura N. Ricketts, MD, MDSc, FRCPC

Laboratory Centre for Disease Control (LCDC)
Health Canada, Ottawa, Ontario

Maura Ricketts joined Health Canada in 1985 as Head of the National AIDS Case Reporting Surveillance System, LCDC. Deciding to continue her career in LCDC, Dr. Ricketts accepted the appointment as Medical Specialist in the Division of Blood-borne Pathogens, Bureau of Infectious Diseases. The Division of Blood-borne Pathogens is responsible for the risk identification, determination and management, which include surveillance, investigation, policy development and setting national standards.

Dr. Ricketts’ current responsibilities are multi-faceted, including consultant for blood-borne pathogens; principle investigator for a both a case control study of CJD and surveillance system for CJD in Canada; country co-investigator for the European Community BIOMED project on surveillance of CJD in the European Union; Canadian principle investigator for the paediatric surveillance for CJD and consultant for infection control practices for prion diseases.


Ms. Frances Rodenburg

Executive Director, Canadian Federation of Humane Societies
Ottawa, Ontario

Frances Rodenburg graduated from the University of Guelph in 1977 with a B.A. in political studies. She joined the staff of the Canadian Federation of Humane Societies in 1982 and became Executive Director in 1992. She works with the Federation's committees on a wide scope of animal welfare issues, including the use of animals in research, animals in food production and the status of animals in law.

Ms. Rodenburg is a community member of a local animal care committee, a CFHS representative to the Canadian Council on Animal Care and a member of the Board of Directors of the Canadian Centre for Alternatives to Animals in Research. She is also Secretary to the Canada Expert Committee on Farm Animal Welfare and Behaviour and an ex officio member of the Canadian Veterinary Medical Association's Animal Welfare Committee.


Dr. Daniel Salomon

Director of Transplantation Research
Scripps Research Institute
La Jolla, California

Daniel Salomon is an Assistant Member of the Scripps Research Institute, Departments of Molecular and Experimental Medicine and Immunology. Dr. Salomon is the Director of Transplantation Research and Medical Director of the Kidney Transplant Program. He is also an adjunct Associate Professor of Medicine, University of California, San Diego. His education includes Northwestern University (Chemistry, 1973) and Stritch-Loyola School of Medicine (MD, 1976). He did his internship, residency and was Chief Medical Resident at Cedars-Sinai Medical Center, University. Nephrology and Transplantation Immunology fellowships were done at the Brigham and Women's Hospital, Harvard Medical School (1980 to 1984). In 1984 he was appointed the Medical Director of the Kidney Transplant Program at the University of Florida and the Heart Transplant Program in 1985.

In 1990, he moved to the Laboratory of Immunology at the NIH to concentrate on basic laboratory work in molecular immunology. These studies have continued since 1993 at the Scripps Research Institute, specifically on mechanisms of human T cell selection in the thymus and human islet cell development and transplantation. In tandem, Dr. Salomon has been active in the design and conduct of clinical trials in transplantation. These include work with the NIH Cooperative Clinical Trials of bone marrow and peripheral blood stem cells in tolerance induction. Dr. Salomon is a Special Government Employee for the US FDA and has served as an advisor in the development of the US Public Health Service guidelines for xenotransplantation. He serves on the Executive Council of the American Society of Transplant Physicians, the Executive Board of CenterSpan , an internet project for education and research in transplantation and on the Editorial Boards of Transplantation and the Journal of Heart and Lung Transplantation.


Dr. Margaret Somerville

McGill Centre for Medicine
Ethics & Law, Montréal, Québec

Margaret Somerville holds professorships in both the Faculty of Law and the Faculty of Medicine at McGill University, Montreal. She is Gale Professor of Law, as such, she is the first woman in Canada to hold a named Chair in Law, and the Founding Director of the McGill Centre for Medicine, Ethics and Law. She plays an active role in the world-wide development of bioethics and the study of the wider legal and ethical aspects of medicine and science.

Professor Somerville has a background in science as well as in law. She graduated, with distinction, in Pharmacy from the University of Adelaide (1963); in Law, with First Class Honours and the University Medal, from the University of Sydney (1973); and was awarded a Doctorate in Civil Law by McGill University (1978). She has received honorary doctorates in Law from the University of Windsor, Ontario (1992), Macquarie University, Sydney, Australia (1993) and St. Francis Xavier University, Antigonish, Nova Scotia (1996). She was elected a Fellow of the Royal Society of Canada in 1991. She is the recipient of many honours and awards, including the Distinguished Service Award of the American Society of Law and Medicine (1985), the Pax Orbis ex Jure Gold Medal of the World Jurist Association for support and dedication to the cause of world peace through law (1985) and the Order of Australia (1989), awarded in recognition of her international contribution to law and bioethics.

Professor Somerville has an extensive national and international publishing and speaking record. She has wide experience in communicating with large audiences, especially television and radio audiences on topics that raise complex legal and ethical problems for society. She is regularly and frequently involved in such work in Canada and abroad.

Professor Somerville is a consultant to governments and non-governmental bodies, especially regarding public policy. In particular, she has consulted to the Global Programme on AIDS of the World Health Organization, the United Nations Human Rights Secretariat in Geneva, and law reform commissions in Canada and Australia and has been a speaker (including keynote) at UNESCO conferences in Paris. She was the founding Chairperson of the National Research Council of Canada Ethics Committee, and has served on many editorial boards, advisory boards and boards of directors including the Canadian Centre for Ethics in Sport and the American Society of Law, Medicine and Ethics. She is also active in the clinical sphere, serving on clinical and research ethics committees and consulting for McGill University Teaching Hospitals. Her work in the broad field of medicine, ethics and law has included research, speaking engagements and consultation on issues related to euthanasia, pain relief, genetics, reproductive technology, biotechnology, ecosystem health, aging populations, quality of life, human rights in medicine and health care, the pharmaceutical industry, public health, health care systems, medical malpractice, human medical research, AIDS, abortion and the allocation of medical resources.


Dr. Calvin Stiller

Chief, Multi-Organ Transplant Service
University Hospital, London, Ontario

Calvin Stiller obtained his medical degree at the University of Saskatchewan in 1965 and his F.R.C.P. (c) in 1970 following post-graduate studies in London and Edmonton. Dr. Stiller is a professor at the Department of Medicine, University of Western Ontario and Vice Chair of the Board at the John P. Roberts Research Institute. He was founder of and is a member of the Multi-Organ Transplant Service at University Hospital in London. Dr. Stiller is also co-founder and Chair of Canadian Medical Discoveries Fund and the Canadian Science and Technology Growth Fund, in addition to being a member of the Order of Canada.

He has served on the Council and Executive of the Medical Research Council and in several capacities in charitable organizations, co-founding the Alan Thicke Centre for Juvenile Diabetes Research, the J. Allyn Taylor International Prize in Medicine and the Canadian Medical Hall of Fame.


Ms. Lucy Thomas

Director, Regulatory Affairs
Imutran Limited, Douglas House
Cambridge, England

Lucy Thomas worked for several years in a toxicology research laboratory in the Biochemistry and Metabolism Department. She moved into Regulatory Affairs in the pharmaceuticals industry in 1986 working for Wyeth-Ayerst UK and Sterling-Winthrop UK before joining Sandoz UK in 1991. She first became involved in the xenotransplantation project in 1996, when Sandoz acquired Imutran, and was appointed the Director of Regulatory Affairs at Imutran Ltd., in 1997.


Dr. Robin Weiss

Institute of Cancer Research
London, England

Robin Weiss is Professor of Viral Oncology at the Institute of Cancer Research, London. Dr. Weiss has spent a significant part of his career studying retroviruses, starting with the discovery of endogenous retroviruses, in birds, 30 years ago. He first demonstrated that CD4 is the primary binding receptor for HIV and he pioneered studies of neutralizing antibody responses in patients infected with HTLV and HIV. Earlier this year, his research group reported a new exogenous human retrovirus , HRV-5. They have also extensively studied endogenous (inherited) retroviruses in several host species, including humans.


Dr. Clara Witt

World Health Organization (WHO)
Geneva, Switzerland

Clara Witt obtained both her B.A. (1972) and M.A. (1975) in International Relations, at John Hopkins University. She subsequently studied Veterinary Medicine at the University of Pennsylvania and obtained a V.M.D. in 1981. Dr. Witt pursued studies at John Hopkins University under a Comparative Medicine Internship (1982), in Small Animal Medicine and Surgery at the Animal Medical Center and later a Post Doctoral Fellowship (1989) in Immunology and Infectious Diseases. Dr. Witt’s board certification includes Diplomate, American College of Veterinary Preventive Medicine (1991) and Diplomate, American College of Laboratory Animal Medicine, (1989).

Dr. Witt was Chief, Laboratory Animal Medicine Section, Office of Laboratory Animal Science (OLAS) at the National Cancer Institute, Bethesda, Maryland from February 1989 to September 1995. Under the general guidance of the Director, OLAS, she was responsible for the activities and direction of the Laboratory Animal Medicine Section, one of three Office sections administering the NCI intramural animal care and use program. She also was responsible for integration of Section activities with those of other sections to assure appropriate and coordinated husbandry and animal care activities.

Since November 1995, Dr. Witt has provided expertise, leadership and guidance in zoonotic and infectious disease prevention and control and laboratory animal medicine and science matters to senior World Health Organization, Headquarters, Geneva, Switzerland and International Agency for Research on Cancer, Lyon, France, policy and programmatic staffs.


Dr. Jim Wright, Jr.

Professor of Pathology
Dalhousie University,
Halifax, Nova Scotia

James R. Wright, Jr. is a pediatric/perinatal pathologist at the Izaak Walton Killam/Grace Health Centre and a Professor of Pathology and an Associate Professor of Surgery at Dalhousie University, Faculty of Medicine, both in Halifax, Nova Scotia. Dr. Wright received a M.D. and a Ph.D. in Experimental Pathology, a M.A. in Medical History, and a B.Sc. in Zoology from the Ohio State University in Columbus, Ohio. He completed a residency in Anatomical Pathology and a NIH sponsored postdoctoral fellowship in Experimental Diabetes with Dr. Paul E. Lacy, both at Washington University School of Medicine in St. Lolls. This was followed by fellowship training in Pediatric and Perinatal Pathology at the IWK Children's Hospital and Grace Maternity Hospital in Halifax. Dr. Wright has published extensively on experimental diabetes and pancreatic islet transplantation.

 XENOTRANSPLANTATION ORGANIZING COMMITTEE MEMBERS




Ms. Chantal Clermont
Coordinator/Secretariat
Blood & Tissues Division
Bureau of Biologics & Radiopharmaceuticals
Health Canada
Therapeutic Products Directorate
Tunney’s Pasture - 0603C3
Ottawa, Ontario K1A 0L2
Tel.: 613-954-5582
Fax: 613-941-5841
E-mail: chantal_clermont@inet.hwc.ca

Dr. Peter Ganz (Chair)
A/Manager, Blood & Tissues Division
Bureau of Biologics & Radiopharmaceuticals
Therapeutic Products Directorate
Health Canada
Tunney’s Pasture - 0603C3
Ottawa, Ontario K1A 0L2
Tel.: 613-952-0237
Fax: 613-941-5841
E-mail: peter_ganz@inet.hwc.ca

Dr. Malle Jurima-Romet
Research Scientist
Bureau of Biologics & Radiopharmaceuticals
Therapeutic Products Directorate
Health Canada
Banting Research Centre
Tunney’s Pasture - 2201C
Ottawa, Ontario K1A 0L2
Tel.: (613) 957-9026
Fax.: (613) 941-8933
E-mail: malle_jurima-romet@inet.hwc.ca

Dr. Marian Laderoute
Biologist, Blood & Tissues Division
Bureau of Biologics & Radiopharmaceuticals
Health Canada
Therapeutic Products Directorate
Tunney's Pasture - 0603C3
Ottawa, Ontario K1A 0L2
Tel.: 613- 952-7162
Fax.: 613- 941-5841
E-mail: marian_laderoute@inet.hwc.ca
Mr. André La Prairie
Policy Analyst, Policy Division
Policy & Communications Division
Therapeutic Products Directorate
Health Protection Branch
Health Canada
Tunney’s Pasture - 0702B2
Ottawa, Ontario K1A 0L2
Tel.: 613-941-5513
Fax: 613-952-6397
E-mail: andre_la_prairie@inet.hwc.ca

Dr. Anthony Ridgway
A/Manager, Biotherapeutics Division
Bureau of Biologics & Radiopharmaceuticals
Health Canada
Therapeutic Products Directorate
Tunney’s Pasture - 0603C1
Ottawa, Ontario K1A 0L2
Tel.: 613-952-3605
Fax: 613-941-5841
E-mail: anthony_ridgway@inet.hwc.ca

Dr. Eilleen Tackaberry
Research Scientist
Bureau of Biologics & Radiopharmaceuticals
Therapeutic Products Directorate
Health Canada
Banting Research Centre
Tunney’s Pasture - 2201C
Ottawa, Ontario K1A 0L2
Tel.: (613) 952-6820
Fax.: (613) 941-8933
E-mail: eilleen_tackaberry@inet.hwc.ca

Dr. Kwok-Him Yeung
Biologist, Blood & Tissues Division
Bureau of Biologics & Radiopharmaceuticals
Health Canada
Therapeutic Products Directorate
Tunney’s Pasture - 0603C3
Ottawa, Ontario K1A 0L2
Tel.: 613-954-5821
Fax: 613-941-5841
E-mail: kwok_him_yeung@inet.hwc.ca

XENOTRANSPLANTATION SPECIAL WORKING GROUP MEMBERS




Mr. Dennis Brodie
A\Manager, Policy Division
Bureau of Drug Policy and Coordination
Therapeutic Products Directorate
Health Canada
Tunney's Pasture - 0702B2
Ottawa, Ontario K1A 0L2
Tel.: 613- 941-5515
Fax.: 613- 952-6397
E-mail: dennis_brodie@inet.hwc.ca

Dr. William Freeland
Chief, Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Main Statistical Canada Building
Tunney's Pasture - 0301H1
Ottawa, Ontario K1A 0L2
Tel.: 613-954-0298
Fax.: 613-941-4726
E-mail: wfreeland@em.agr.ca

Dr. Peter Ganz (Chair)
A/Manager, Blood & Tissues Division
Bureau of Biologics & Radiopharmaceuticals
Therapeutic Products Directorate
Health Canada
Tunney’s Pasture - 0603C3
Ottawa, Ontario K1A 0L2
Tel.: 613-952-0237
Fax: 613-941-5841
E-mail: peter_ganz@inet.hwc.ca

Dr. Claude Gardell
Vaccines Division
Bureau of Biologics & Radiopharmaceuticals
Therapeutic Products Directorate
Tunney’s Pasture - 0603C2
Ottawa, Ontario K1A 0L2
Tel.: 613-952-3605
Fax: 613-941-5841
E-mail: claude_gardell@inet.hwc.ca
Dr. Margaret Kenny
Canadian Food Inspection Agency
Animal and Plant Health Directorate
59 Camelot Drive
Nepean, Ontario
K1A 0Y9
Tel.: 613-952-8000
Fax: 613-228-6604
E-mail: mkenny@em.agr.ca

Mr. André La Prairie
Policy Analyst, Policy Division
Policy & Communications Division
Therapeutic Products Directorate
Health Canada
Tunney’s Pasture - 0702B2
Ottawa, Ontario K1A 0L2
Tel.: 613-941-5513
Fax: 613-952-6397
E-mail: andre_la_prairie@inet.hwc.ca

Dr. Francine Lord
Canadian Food Inspection Agency
Animal and Plant Health Directorate
59 Camelot Drive
Nepean, Ontario
K1A 0Y9
Tel.: 613-225-2342 ext. 4624
Fax.: 613-228-6630
E-mail: flord@em.agr.ca

Mr. Claude Lesage
Legal Services
Health Canada
Tunney’s Pasture - 0902D
Ottawa, Ontario
K1A 0K9
Tel: 613-952-4159
Fax: 613-957-1327
E-mail: claude_s_lesage@inet.hwc.ca
 

Dr. Maura Ricketts
Chief, Blood Borne Pathogens Division
Laboratory Centre for Disease Control
Health Canada
Tunney’s Pasture - 0603E1
Ottawa, Ontario K1A 0L2
Tel.: 613-952-6633
Fax.: 613- 952-6668
E-mail: maura_ricketts@inet.hwc.ca

Dr. Anthony Ridgway
A/Manager, Biotherapeutics Division
Bureau of Biologics & Radiopharmaceuticals
Therapeutic Products Directorate
Tunney’s Pasture - 0603C1
Ottawa, Ontario
K1A 0L2
Tel.: 613-952-3605
Fax: 613-941-5841
E-mail: anthony_ridgway@inet.hwc.ca

Dr. Francis Rolleston
Medical Research Council
Holland Cross, 5th Floor, Tower B
1600 Scott Street
Ottawa, Ontario K1A 0W9
Tel.: 613-954-1801
Fax.: 613-954-6653
E-mail: frollest@hpb.hwc.ca

Dr. Eilleen Tackaberry
Research Scientist
Bureau of Biologics & Radiopharmaceuticals
Therapeutic Products Directorate
Health Canada
Banting Research Centre
Tunney’s Pasture - 2201C
Ottawa, Ontario K1A 0L2
Tel.: (613) 952-6820
Fax.: (613) 941-8933
E-mail: eilleen_tackaberry@inet.hwc.ca

Dr. Steven Yarrow
Canadian Food Inspection Agency
Animal and Plant Health Directorate
59 Camelot Drive
Nepean, Ontario
K1A 0Y9
Tel.: 613-225-2342 ext. 4107
Fax: 613-228-6604
E-mail: syarrow@em.agr.ca

FORUM CO-CHAIRS AND EXPERT ADVISORS




Dr. Michael Gross (Forum Co-Chair)
Associate Professor
Dalhousie University
Room #4879, New Halifax Infirmary
QEII Hospital
1796 Summer Street
Halifax, Nova Scotia B3H 3A7
Tel.: 902-473-6811
Fax: 902-473-2042

Dr. Lorne Babiuk
Director, Veterinary Infectious Disease Organization
University of Saskatchewan
120 Veterinary Road
Saskatoon, Saskatchewan S7N 5E3
Tel.: 306-966-7465
Fax: 306-966-7478
email: babiuk@sask.usask.ca

Dr. Donald Casebolt
Atlantic Veterinary College
University of Prince Edward Island
550 University Avenue
Charlottetown, Prince Edward Island
C1A 4P3
Tel.: 902-566-0668
Fax: 902-566-0851
email: dcasebolt@upei.ca

Dr. John Dossetor
Director, Bioethics Centre
University of Alberta
222 ANR, 8220 - 11420 University Avenue
Edmonton, Alberta T6G 2J3
Tel.: 403-492-6676
Fax: 403-492-0673
email: john.dossetor@ualberta.ca

Dr. Margaret Somerville (Forum Co-Chair)
McGill Centre for Medicine,
Ethics and Law
McGill University
3690 Peel Street
Montréal, Québec
H3A 1W9
Tel.: (514) 398-7401
Fax.: (514) 398-4668
E-mail: somerv_m@falaw.lan.mcgill.ca

Dr. David Grant
London Health Sciences Centre-
University Campus
339 Windermere Road
London, Ontario N6A 5A5
Tel.: 519-663-2926
Fax: 519-663-3858
email: dgrant@julian.uwo.ca

Dr. Paul Greig
Director, G.I. Transplantation
University of Toronto
621 University Avenue
Toronto General Hospital
Toronto, Ontario M5G 2C4
Tel.: 416-340-4252
Fax: 416-340 3492
email: pdgreig@compuserve.com

Dr. Gilly Griffin
Canadian Council on Animal Care
315-350 Albert Street
Ottawa, Ontario K1R 1B1
Tel.: 613-238-4031
Fax: 613-238-2837
email: ggriffin@bart.ccac.ca

Professor Bartha Maria Knoppers
Faculté de Droit
University of Montreal
Pavillon Maximilien-Caron
3101 chemin de la Tour
Montréal, Québéc H3C 3J7
Tel.: 514-343-6714
Fax: 514-343-7508
email: knoppers@droit.umontreal.ca

Dr. Arvind Koshal
Director & Clinical Professor of
Cardiothoracic Surgery
3H2-14 Walter McKenzie Centre
University of Alberta
Edmonton, Alberta T6G 2B7
Tel.: 403-492-8058
Fax: 403-492-8617
email: akoshal@gpu.srv.ualberta.ca

Dr. Gary Levy
Director, Multi-Organ Transplantation
The Toronto Hospital
621 University Avenue
Toronto, Ontario M5G 2C4
Tel.: 416-340-5166
Fax: 416-340-3492
email: fg12@msn.com

Dr. Tom Marrie
Dalhousie University
ACC 5014
Victoria General Hospital
1278 Tower Road
Halifax, Nova Scotia B3H 2Y9
Tel.: 902-473-5553
Fax: 902-473-7394
email: tmarrie@is.dal.ca

Dr. Jim Wright
Professor of Pathology
Dalhousie University
IWK - Grace Health Centre
5850 University Avenue
Halifax, Nova Scotia B3J 3G9
Tel.: 902-428-8185
Fax: 902-428-3215
email: jwright@iwkgrace.ns.ca


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