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  • The Islet Foundation... A Final Push in the Cure for Diabetes
    age 10 The source of his motivation is self evident The following is a list of all the things that Encelle is doing differently from current conventional wisdom in the field of islet xenotransplantation and the benefits which the company claims Encellin XP uses m a croencapsulation not m i croencapsulation All the islets are contained within a postage stamp sized device The capsule is transplanted intramuscularly typically the shoulder muscle not in the peritoneal cavity Dr Usala claims better results because of superior vascularization and higher oxygen tension If necessary complete retrieval is simple and assured The protective layer is a stealth polymer not alginate This polymer provides no sites for the binding of proteins and is therefore invisible to the immune system Encelle has found no fibrosis following implantation in dogs rats and mice for up to a year The capsule consists of pig islets trapped in a hydrogel matrix which is wrapped in a thin polyester net which is then coated in a very thin about 1 000 angstroms coating of the stealth polymer The hydrogel is solid at room temperature liquid at body temperature During the application of the stealth polymer the hydrogel is solid and protects the islets from damage Once implanted in the body the hydrogel becomes a liquid and allows rapid transit of glucose and insulin thereby facilitating a pancreas like response time to blood glucose changes Encelle deliberately avoids purification of the islets whereas others aim for very high purity in order to assure that no acinar tissue remains The islets are maintained in a much more pancreas like environment than individual microencapsulated islets The Encelle capsule maintains the pulsatility of insulin secretion found in the pancreas In other words islets in a normal pancreas do not simply increase a steady flow of insulin in response to rising blood glucose levels Instead the secretion from the islets is coordinated to produce pulses of insulin typically 7 to 10 minutes apart The amplitude of these pulses increases in response to rising glucose but the frequency is relatively stable When insulin is secreted in pulses tissue receptors are much more sensitive to its effect Microencapsulated islets without acinar are unable to communicate with each other and synchronize their secretion pulses However by retaining the acinar the Encellin XP capsule maintains pulsatility in its insulin secretion and hence may be more effective at glucose control than a continuously modulated insulin secretion Encelle claims to be able to reach euglycemia normal blood glucose with no injected insulin with fewer than 1 000 islets per kg of body weight versus at least 10 000 islets per kg for pure islets This startling difference is attributed to the higher insulin sensitivity resulting from the pulsatility Encelle claims that their capsule creates an embryonic environment for the islets and acinar tissue As a result there may be some limited replication of islets which continues for about 60 days They prefer to wait for this replication and recovery period before

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  • The Islet Foundation... A Final Push in the Cure for Diabetes
    assures that the implants are pathogen free Dr Shane Ray manages special projects of which there is no shortage at Encelle And Marilyn Smith keeps the whole place running smoothly My apologies to anyone who has been left off the list we were so overwhelmed by what we saw we are certain to forget someone Dr Usala has had diabetes since age one After 40 years of having the disease and with a pediatric endocrinology practice of 500 children he knows first hand the science and tragedy of diabetes Dr Usala started Encelle in 1985 and personally financed the company for 5 years with money earned working evenings as an emergency room doctor Since 1991 Encelle has achieved its amazing accomplishments with less than 3 000 000 and with no support from the major diabetes funding organizations Today Encelle has reached milestones which many believe will lead soon to a means of restoring normoglycemia in people whose islets have been destroyed by diabetes The company has considerable patent protection on its unique and proprietary technologies and processes What we saw was the marriage of commitment inventiveness frugality and intellect Encelle has created a facility for the small scale manufacture of insulin producing implants At every step of the process there were examples of innovation to solve problems for which no off the shelf solutions existed Today they have a sterile product development facility with computerized process and environmental controls At Encelle we saw the steps that hopefully will translate into large scale manufacturing of implants that can restore normoglycemia In their clean room complex technicians isolated islets tested for pathogens manufactured capsules applied stealth polymer inserted islets and acinar into finished capsules and made extensive use of computers and specialized instrumentation to assure a repeatable and documented process If animal

    Original URL path: http://islet.org/19.htm (2016-04-29)
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  • The Islet Foundation... A Final Push in the Cure for Diabetes
    in the process and the people who are deciding whether we will be allowed to enjoy the benefits of islet xenotransplantation the only promising cure for diabetes that we have or whether it will be blocked by a process over which we have little control or input The following letter is from the Honourable Bill English Minister of Health for New Zealand Does anybody out there know what cultural safety

    Original URL path: http://islet.org/22.htm (2016-04-29)
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  • The Islet Foundation - Xenotransplant Ban Lifted in NZ
    Hospital One patient Michael Helyer said he understood the caution but had no regrets about being one of the world s few recipients of animal parts Up to 30 per cent of his insulin needs were produced by the pig cells after his May 1996 operation That has made his condition much easier to manage with fewer low blood sugar episodes He said insulin produced by the pig cells had since dropped but he hoped for a top up this year if the moratorium was lifted I knew there were dangers in receiving pig cells but I weighed it all up There is a lot more risk in having diabetes he said Diatranz the company managing the pig cell trials said New Zealand would stand up to the most rigorous guidelines on animal transplants The managing director David Collinson said the work could be huge for the country Diabetic patients worldwide would want to come for pig cell transplants A Ministry of Health advisor Dr Stewart Jessamine said all the risks of animal transplantation needed to be known before research continued It s very new it s very cutting edge and very controversial said Dr Jessamine There s no doubt that if you ask transplant surgeons they will tell you there s an immense shortage of transplant organs and there will never be enough for the demand I m sure they would say that it the use of animal parts is a good way forward But he said the moratorium on animal to human transplants would remain until guidelines were released They were due next month but he had heard that delays were now expected The new guidelines are tipped to include lifetime monitoring of recipients unprecedented in medicine Animals will also need to be raised in strictly sterilised conditions

    Original URL path: http://islet.org/36.htm (2016-04-29)
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  • The Islet Foundation... A Final Push in the Cure for Diabetes
    Health must consider both the cultural and scientific safety of a process or procedure At the time I had no idea what cultural safety meant but it has since emerged that there are groups strongly opposed to xenotransplantation based on their own personal beliefs regarding animal rights and human identity These groups certainly have the arguable right to deny the benefits of any medical procedure to themselves and to their children However they have no right to deny such benefits to others who do not share their beliefs A significant percentage of your population is morally opposed to abortion and yet your ministry does not ban that procedure It would be both wrong and inconsistent to allow cultural factors to deny a medical benefit to one group while affording a far more controversial benefit to another What if today s process had been applied to the discovery of insulin We should look to 1921 when Banting and Best discovered that insulin from pigs and cows could be injected into children with diabetes and save them from a horrible wasting death At the time there were voices decrying those who would inject the filthy juices of pigs and dogs into our children Had those voices prevailed tens of millions of children around the world would have died for no valid reason In the future history must not write of fearful and unscientific voices in the year 2002 that brought unwarranted suffering and death to millions Regulating xenotransplantation must not be arbitrary or discriminatory Every medical advance and procedure carries both risk and benefit When the benefit outweighs the risk we progress To deny islet xenotransplantation to people with diabetes is to ignore the profound benefits while irresponsibly exaggerating the undemonstrated risks Consider medical practices that are performed every day Normal organ transplantation carries the risk of infecting the recipient with every pathogen present in the donor including HIV Today people with AIDS are routinely treated at hospitals despite the risk of infection to medical staff and the general public These are not some purely speculative risks but real dangers that have unfortunately been demonstrated many times Yet even this public health danger does not stop us from performing organ transplants or providing medical care to people with AIDS As a society we have made the rational decision that the benefits outweigh the risks however real those risks may be Beyond the field of health care your government allows citizens to travel to ebola infested countries and return to New Zealand The public health consequences of an ebola outbreak are real and horrendous By way of example you cannot tell a mother whose child is dying of diabetes that you are banning a promising research protocol because you think there might be some risk even though you have absolutely no evidence Can you then tell that same mother that people with AIDS are being treated in public hospitals when she knows the public health risk is so real Is her child somehow

    Original URL path: http://islet.org/50.htm (2016-04-29)
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  • The Islet Foundation - JDF/NASA Conference
    tissue including neurons without infection Pig islets are a near term opportunity Insulinoma cells may offer some contribution as a source of islets These cells derive from a human malignant tumor whose dominant characteristic is that it secretes insulin and ultimately kills the patient through hypoglycemia There are major challenges in this initiative including assuring that the secretion of insulin is responsive to blood glucose and that a reliable off switch can be found to disable the malignant cell multiplication once the required islet mass has been established This cell source would appear to be long term and highly speculative Proliferated human islets and internally regenerated islets also represent longer term prospects for sourcing islets and were discussed in detail in subsequent sections In this section the role of endocrine secretions that a normal islet produces in addition to insulin were also discussed especially the potentially beneficial role of C peptide in preventing complications As was pointed out at the conference and earlier on our own forum people with type 2 diabetes often have very high insulin and C peptide levels and yet suffer the same complications The common denominator is elevated blood sugar and the cure is normoglycemia The value of partial cures treatments which do not allow complete insulin independence was discussed Some researchers felt that without complete freedom from insulin injections a technology could not be deemed a success Those living with diabetes were generally supportive of a partial cure in which the patient would be responsible for a couple of shots per day of long acting insulin to provide background coverage but the transplanted islets would provide closed loop insulin control in response to variations in food intake and activity Such a treatment would almost certainly mean near normal glycated hemoglobins and avoidance of dangerous hypoglycemic episodes For some reason people who do not have diabetes seem to imagine that taking shots is the main problem Speaking personally I find injections to be a complete non issue The real problem with this disease is the fact that all the shots and testing still result in lousy blood glucose control The restoration of even a small measure of closed loop insulin control would be an immense improvement Panel 2 Physical Barriers to Immune Rejection of Implanted Islets This section dealt with immunobarriers physical screens that block access to the foreign islets by the recipient s immune system These barriers need to offer a delicate balance of characteristics including physical strength immunocompatibility capacity to induce vascularization and selective permeability that will block large immune components while allowing smaller molecules such as oxygen glucose water and insulin to pass easily While protecting the islets the barrier material must not itself attract an inflammatory or fibrotic response from the person s immune system This is not an easy challenge but many are closing in on a materials that now appear ready or have already been used for human testing It is expected that some form of immunobarrier will be required whether the source of islets is human pigs proliferated insulinoma or engineered Our immune system is aggressive when it comes to foreign tissue and immunobarriers seem to represent the best hope for protecting the transplanted tissue while not compromising our entire immune system One of the issues that came up with almost all the researchers was the role played by small toxic molecules that can kill islets A semi permeable screen can keep out the large components of the immune system but what about very small molecules that are also toxic to the islets in particular cytokines and free radicals These molecules are actually smaller than glucose insulin and oxygen molecules and so can in theory reach the islets and damage them Some researchers felt that the barriers would not allow the normal chain of events in an immune attack to get started and so these tiny killers would not be present in the region of the capsules Others proposed more complex cell engineering solutions that would circumvent this problem It is unclear if the successes of encapsulated islets to date have actually been compromised by these very small agents or if the rate of damage would simply mean that a periodic booster would be needed to retain normoglycemia We heard presentations from several researchers who are using a range of natural materials alginate being a dominant choice a stealth polymer that is both semi permeable and presents no binding sites for adhesion of proteins synthetic polymers such as Polyethylene Glycol or PEG and a semi permeable fabric from the makers of GoreTex There is a very high degree of agreement on the characteristics that need to be achieved and on the use of immunobarrier technology as a safe and potentially effective way to protect transplanted islets There was a great deal of discussion on the different kinds of attacks that a transplanted islet would face As with any foreign tissue there would be the normal allograft or xenograft immune response but people with type 1 diabetes also may be able to again mount an autoimmune response just as they did against their original islets Since both immune attacks utilize a similar chain of events it is likely that immunobarriers will be effective in hiding the islets from both attackers There was considerable discussion as to whether xenotissue or engineered cells would attract the same autoimmune reaction as our original beta cells Even if the autoimmune response is still present and even if immunobarriers are less effective in blocking it diabetic autoimmunity seems to be a very slow process occurring over many years Perhaps autoimmunity would just be another of those slow killers of transplanted islets that would force us to consider periodic boosters to assure continuing normoglycemia As well as physical barriers to an immune attack other agents which can hopefully create tolerance of the transplanted tissue were discussed Most were in agreement that the use of existing immunosuppressants such as cyclosporin was not ethical as a means of reversing diabetes as the side effects in some people may be worse than the disease Newer agents such as Anti CD40 Ligand appear much less toxic but the early hope that a single administration would confer a lifetime of transplant tolerance seems to be under question Animal tests indicated that a repeat dose of the agent was required every few months to maintain tolerance of the transplanted tissue Another technique for inducing tolerance to human islets which involves a transplant of the donor s bone marrow along with the islets has had some encouraging outcomes in whole organ transplants with minimal adverse effects but some researchers at the conference expressed concern about triggering graft versus host disease in which the transplanted marrow creates antibodies that attack the new host In contrast the apparently benign nature and the low probability of unexpected consequences of a physical barrier held a lot of appeal for both researchers and potential recipients Panel 3 Beta Cell Growth and Differentiation Several researchers presented their work in the area of islet cell replication and regeneration falling into two distinct categories Exogenous Islet Replication Some researchers are developing growth factors as a means to force the reproduction of an ideal islet cell line external to the recipient These islets are then immunoprotected and transplanted into the recipient The appeal of this approach seems to be the ability to make consistent generations of islets when compared to the variability found in naturally occurring pig and human islets There were dramatic claims of human islet replication and we eagerly await the supporting data Endogenous Islet Replication Some researchers were looking for the precursor cells that in the embryonic state differentiate into islet cells as the pancreas forms Most agreed that duct cells within the forming pancreas are stimulated by some growth factor to become islets Therefore there may be an opportunity to stimulate the duct cells within the pancreas of a person with diabetes to differentiate into functioning islets Such islets would reside in the pancreas their normal home and would not require immunoprotection This work is very early and speculative as an effective growth factor has not been identified and some researchers questioned the ability of any growth factor to stimulate only the growth of islets and no other cell type As for the possibility of a continuing autoimmune attack on the new islets very little is known however the slowness of autoimmunity provides hope that the replication rate could outstrip autoimmune destruction and normoglycemia could be maintained over time Of all the approaches to islet replacement endogenous islet replication could theoretically come nearest to restoring normal pre diabetic conditions Panel 4 Engineering of Surrogate Beta Cells This section focused on the hope of engineering the perfect islet having all the characteristics that we want Genetic engineering technologies were presented which had the potential to allow the insertion of gene fragments into the DNA of cells and cause those cells to assume new and more useful characteristics Genetically engineered islets may represent an opportunity to create just the islet that we all want In an ideal world these islets would secrete human insulin be responsive to glucose express other proteins such as C peptide have just the right glucose setpoint present no adverse effects be available in large quantities last a lifetime and be immunocompatible without the use of immunobarriers In other words they would be just like the islets we used to have before diabetes With increasingly precise tools for inserting genetic material into cells including gene guns and adenoviruses we may converge on these ideal characteristics in the longer term Some caution was expressed about the possible creation of infectious viral material in the process of radically engineering the genome of these cells as well as the potential of viral based gene insertion to make the islets more irritating to the immune system Most researchers expected that no engineered islet could provide all the characteristics that we would consider ideal and that some form of immunobarrier would be required to protect these cells Short Term versus Long Term And so we were presented with a research landscape that included immediate prospects for testing encapsulated human islets near term opportunities for testing pig islets in immunobarriers and longer term opportunities to create the perfect replacement islet technology Taylor Wang of Vanderbilt University summarized the situation succinctly when he suggested that we need to immediately fund the near term prospects while in parallel supporting the science that may represent subsequent generations of cure In a field like this it is unlikely that the cure we first test will be the same one used in 20 years and therefore the work to develop even better and cheaper solutions must continue As an aside we must remember that the treatment for diabetes invented 75 years ago persists to this day Good job we didn t wait for something more ideal Some Personal Conclusions The following are my own conclusions based on what I heard during these two days I must emphasize that these are the personal conclusions of a lay person and I would welcome an email with suggestions or corrections from anybody Over time these conclusions can hopefully be refined to be an increasingly accurate reflection of the current state of the art in diabetes cure research and a mechanism for prioritizing future research funding As a source of islets human cadavers and pigs represent the only near term opportunity for non immunosuppressed human trials Of the two sources only pig islets offer adequate quantities to treat a meaningful number of people with diabetes With at least 2 000 human pancreases being wasted each year in the United States a program to transplant encapsulated human islets should begin immediately Although not a long term solution for diabetes we would gain priceless knowledge about islet transplantation and would improve the lives of thousands of people and their families Immunobarriers in the form of micro or macro encapsulation are a vital link in most cure technologies providing protection from the recipient s immune system regardless of the source of islets The reversal of diabetes in an otherwise healthy person generally does not warrant the use of toxic systemic immunosuppressants although there may be hope for some new short term immunotolerance agents Genetic engineering is a promising technology for providing better and cheaper future generations of transplanted islets but will not likely be part of the first generation of diabetes cure technology The first human clinical trials of pig islets should be restricted to healthy non immunosuppressed adults who understand informed consent As efficacy and safety are demonstrated in adults the age threshold can gradually be reduced A procedure that does not result in complete insulin independence is a valuable contribution If the person with diabetes still needs to use injected insulin for background coverage with the transplanted islets providing the responsive swing load at mealtimes the result will be a major improvement in glycemic control and avoidance of dangerous hypoglycemic episodes Insulin independence is not the only measure of success The risk of PERV infection when using pig islets has never been demonstrated despite millions of opportunities over hundreds of years In a rational risk benefit analysis the benefits of using pig islets overwhelm any known risk The most important cause of diabetic complications is hyperglycemia not an absence of other agents such as C peptide Therefore the restoration of normoglycemia alone will improve or normalize the health of people with diabetes The role of autoimmunity as a threat to transplanted islets is not clear and more work needs to be done However immunobarriers would appear to be effective against both an autoimmune assault and an allograft or xenograft immune assault Also autoimmune destruction is very slow and islet replacement may be able to outpace it Some Suggestions for JDFI Having had an opportunity to reflect on the information presented at this conference and to consider Emily Spitzer s request for some real ideas as to how JDFI could better direct its research dollars to the goal we all share I would like to offer some suggestions Any researcher applying for JDF funding would be asked to present a clear road map of the path from his or her current research to a cure for diabetes The research may be a component in a greater cure strategy in which case the road map would describe the other technologies which fit with this particular initiative to arrive at a cure The researcher would be asked to provide some milestones with dates that he or she expects to meet within the funded period These milestones could be specific deliverables or they could be knowledge milestones Within the first funded period and because of the non deterministic nature of research it is likely that many of these milestones will not be met However over time it would become clear which research initiatives are goal oriented and which are simply process oriented Obviously as research progresses the original milestones may become irrelevant and newer and better milestones may emerge JDF should have an opportunity to consider these new milestones as the funding is being spent JDF will place greater emphasis on evaluating research outcomes Involvement of the lay and scientific review committees will not end at the granting of funds but will continue to assure that people with diabetes are receiving value for the dollars invested This periodic review process must recognize the non linear nature of research and will emphasize value as opposed to meeting some artificial milestones Any review by JDF s scientific review panel of an application that is rejected must be accompanied by a written report as to the reasons for the rejection and this report must be made available to the applicant In many cases the supporting data for a given initiative may be open to misinterpretation and the applicant must be given a chance to understand the reasoning that went into such a decision Conversely applicants must understand that they cannot seek damages as a result of any adverse decision Any member of the grant review process who is unwilling to provide such written reasons should not be part of the process Priority must be given to research that has the ability to make a contribution in the near term A limited number of promising paths are now emerging in seeking a cure for diabetes and there is no longer justification for a shotgun approach to project selection in the hope that serendipity will deliver some unexpected advance Serendipity should be supported only at a very early stage when promising paths have not been identified and any one approach looks as good as any other We are now at a stage where the inevitable subtle shift from research to development to production is happening and a new funding strategy is clearly called for It s time to put away the shotgun and get out the rifle JDF must be able to fund promising research whether it be academic or corporate research Although academic research has been important in elucidating many basic mechanisms it is companies that are most likely to take this knowledge and create a finished product The reason an academic researcher is rewarded for publishing a company is only rewarded for a marketable product The question is often raised How can JDF give money to a for profit company The answer is easy If for example JDF wished to grant 1 million to Acme Islets it could do so in the form of an equity investment and would become a shareholder in Acme If Acme is successful JDF has not only helped create an important advance in the treatment of diabetes but it will also realize a profit as the shares rise in value If JDF s shares in Acme rise in value from 1 million to 50 million there is 49 million to invest in other promising research programs be they academic or commercial In structuring a

    Original URL path: http://islet.org/23.htm (2016-04-29)
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  • The Islet Foundation - JDF/NASA Conference
    meat packing operations of this century with each worker butchering hundreds of pigs every day PERV infection of a human being has never been a public health issue In other words there have been millions of inadvertent experiments seeking adverse clinical outcomes as a result of PERV infection on many millions of people If PERV could infect humans it would have done so by now AIDS was not caused by xenotransplantation Those opposing islet xenotransplantation frequently talk about the scourge of AIDS It is important to remember that AIDS was not caused by the transplantation of animal tissue into people The Human Immunodeficiency Virus HIV found its way into humans through existing pathways Islet xenotransplantation is not some new pathway where none existed before and to use the specter of AIDS as a bogeyman against this procedure is irresponsible scare mongering without any scientific integrity Mad Cow Disease Some opponents of xenotransplantation have cited Mad Cow Disease as an example of animal diseases infecting humans with disastrous consequences Once again the pathway through which this disease was spread was not xenotransplants but was the feeding of diseased animal protein to cows Such an infection pathway has absolutely no relevance to xenotransplants since the cost of islets is insignificant compared to their benefit and there will be no economic pressure to use diseased donors Medical science is all about risk and benefit Every medical advance and procedure carries both risk and benefit When the benefit outweighs the risk we progress To deny islet xenotransplantation to people with diabetes is to ignore the profound benefits while irresponsibly exaggerating the undemonstrated risks Consider medical practices that are performed every day Normal organ transplantation carries the risk of infecting the recipient with every pathogen present in the donor including HIV Today people with AIDS are routinely treated at hospitals despite the risk of infection to medical staff These are not some abstract theoretical risks but real dangers that have unfortunately been demonstrated many times Yet even this public health danger does not stop us from performing organ transplants or providing medical care to people with AIDS As a society we have made the rational decision that the benefits outweigh the risks however real those risks may be We should all be grateful that voices like the present xenotransplant opponents were not heeded at the introduction of blood transfusions or organ transplants or any number of other medical advances If they had been many of us would not be alive for this debate Pigs are cleaner than people As organ donors pigs are a much safer source than human cadavers Pigs can be bred in a specific pathogen free environment to optimize the safety of their tissue for transplants We have no control over the lives led by human donors or the safety of their organs after brain death There are very few viruses which can cross from pigs to humans and only pig tissue that is free of such viruses will be used Because

    Original URL path: http://islet.org/24.htm (2016-04-29)
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  • National Forum on Xenotransplantation - Ottawa - November 6-8 1997
    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 Massachusett s 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

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