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Islet Sciences Company Highlights


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Document includes Islet Sciences’ Science, company highlights, Why The Islet Sciences Solution?, business model, existing infrastructure, etc.

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Islet Sciences Company Highlights

  1. 1. Islet Sciences COMPANY HIGHLIGHTSLed by John Steel, Chairman, Interim CEO, Chief Scientfic Officer Jonathan Lakey, Ph.D., a renowned diabetes expert and co-developer of the Edmonton Protocol and George J. Todaro, MD, Islet Sciences, Inc. is a development-stage biotechnology companywith patented and proprietary technologies focused on transplantation therapy for people with insulin-dependent diabetes.Urgent Need. Diabetes is a devastating, lifelong condition that affects people of every age, race, and nationality, includingapproximately 21 million Americans. It is the leading cause of kidney failure, blindness in adults, and amputations unrelated to injury.More than half of Americans will have diabetes or be prediabetic by 2020 at a cost to the U.S. health care system of $3.35 trillion ifcurrent trends go on unabatedProof Of Concept. Islet Sciences’ therapeutic approach builds on 2001 research breakthroughs at the University of Alberta -Edmonton. A team of Edmonton scientists led by Drs. James Shapiro and Jonathan Lakey developed methods for harvestingpancreatic islet cells and then transplanting these insulin¬producing cells to patients. The Edmonton Protocol allowed the majority ofpatients treated to become insulin-independent. However, there are two major scientific and medical challenges with the EdmontonProtocol: [1] an inadequate supply of human donor tissue; and [2] the need for continuous immunosuppressive drugs to preventrejection of the transplanted islet cells.Solution. The Companys technology comprises a proprietary microencapsulation process designed to reduce, and possibly eliminate,the need for continuous immunosuppressive drugs. In pre-clinical primate studies, subjects continued to exhibit improved glycemiccontrol over a six-month period with transient immunosuppressive therapy to prevent rejection of the transplanted insulin-producingislets.High-Profile Collaborations. The Company has several important collaborations, including the National Institutes of Health (NIH),Neostem, Diakine, University of Oxford, UK, University of Virginia, and the University of California and Progenitor Cell Therapy.Significant Business Opportunity. Islet Sciences will initially focus on diabetic patients requiring kidney transplants as a result ofend stage renal disease brought on by their diabetes. There are 100,000 new cases of end stage renal disease reported each year thatresult in approximately 16,000 kidney transplants annually. It is estimated that 40% of the transplant patients are diabetics who exhibitbetter graft and patient survival if they receive islet cells at the same time as they receive their new kidneys. In addition, of the200,000 patients currently living with kidney transplants, many could benefit from islet replacement therapy. If a total of 5,000 to7,500 patients per year from either of these groups were to receive Islet Sciences’ transplantation therapy, at an average dosing priceof $100,000, Islet Sciences’ annual revenue opportunity could be $500 million to $750 million in the US market alone.1"National Diabetes Fact Sheet, United States 2005, CDC" at www.cdc.diabetes.govBusiness Description. Islet Sciences, Inc. is a development-stage biotechnology company with patented technologies focused ontransplantation therapy for people with insulin-dependent diabetes. The Companys transplantation technology includes methods forthe culturing, isolation, maturation, and immuno-protection (microencapsulation) of islet cells. Islet Sciences’ mission includes theintroduction of commercial products with applications to cell-based replacement therapy in the healthcare marketplace. The traditionaltreatment for Type 1 diabetes involves daily "fingerstick" monitoring of blood glucose levels throughout the day, with multiple dailyinjections of insulin or its continuous infusion. This approach does not cure the disease nor its complications, and often is associatedwith poor blood glucose control, which has a long-term deleterious effect on major organs.Industry Background. According to the International Diabetes Foundation (IDF), an estimated 300 million people worldwide havediabetes, 25 million in the US alone. Over 10 million people use insulin worldwide. According to the World Health Organization(WHO), diabetes is the fourth-leading cause of death in developed countries. Worldwide, there are an estimated 3.2 million diabetes-related deaths every year. In the United States, in any given year between 1.5 and 2.0 million people suffer from insulin¬dependent,Type 1 diabetes. Between 16 million and 19 million people are estimated to have Type 2 diabetes. The cost of diabetes is enormous.According to the IDF, as much as 10% of the worlds healthcare budget is spent on diabetes-related maladies. Predominantly becauseof complications, diabetes represents over $200 billion in U.S. healthcare costs.
  2. 2. Current Therapies. Individuals suffering from insulin-dependent, Type 1 diabetes, suffer from an autoimmune disorder where theimmune system attacks and destroys insulin-producing islet cells of the pancreas. These cells are created shortly after birth and cannotrepair themselves once damaged. Patients need multiple daily injections of insulin and have to perform glucose monitoring via"fingerstick" blood sampling many times each day. Obviously, many patients fail to properly adhere to these onerous demands, andeven strict adherence does not guarantee protection from long-term complications like kidney failure, blindness, heart attack, stroke,amputations, etc. By normalizing blood glucose levels, a successful Islet Sciences product would avert the long-term complicationsmentioned above, and eliminate the need for such constant injections and monitoring. Islet Sciences’ ScienceThe Edmonton Protocol, a Proof Of ConceptA research team at the University of Alberta (that was led by Islet Sciences CSO Dr. Jonathan Lakey) managed to reverse diabetes inscores of patients by transplanting them with human pancreatic islet cells. By June 2002, the "Edmonton Protocol" had beenperformed on more than 130 patients -and 85% of the original patients remained insulin-free for one year or more following thetransplant. The Edmonton Protocol is recognized worldwide as one of the most significant advances in diabetes treatment.Hurdles Overcome By Islet Sciences’ ApproachThe Edmonton Protocol faces three major obstacles that prevent it from helping a broader group of patients with insulin-dependentdiabetes: [1] the inadequate supply of human donor tissue; [2] the need for continuous immuno-suppressive drugs to prevent rejectionof the transplanted human islet cells. Islet Sciences’ scientific approach could overcome these three obstacles; [3] the EdmontonProtocol is a difficult procedure. Islet Sciences developmental products use pathogen-free porcine islets, which are in abundantsupply. In addition, the Company encapsulates islets to minimize immune rejection and the need for immunosuppressive therapy.When successfully proven, this scientific approach may allow transplantation to become a preferred therapy for insulin¬dependentdiabetes.Islet Sciences is developing a vialed suspension of microencapsulated porcine islets for implantation into the abdominal cavity using aminimally invasive procedure. Microencapsulation involves surrounding islet cells with formulations of a highly biocompatible, ultra-pure biopolymer, called alginate, or other similar biocompatible polymers. The alginate coating allows insulin, glucose, oxygen andother nutrients to diffuse freely, while blocking antibodies and reducing the patients immune response to the implanted islet cells. IsletSciences-PTM will provide physiologic and self-regulating blood glucose control, thus reducing the need for insulin injections orinfusions and constant blood glucose monitoring. In addition, there exists an opportunity to mitigate the long-term complicationsassociated with the disease. Antibodies Blocked Alginate Coating Glucose, Oxygen and Poly-amino Acid Membrane Other Nutrients Diffuse Freely Alginate Core (liquefied) Islet Lymphocyters Blocked Insulin Diffuses Freely
  3. 3. Porcine Cells -A Mission-Critical Supply AgreementThe use of porcine-derived biologic materials is established in human therapeutics, including insulin and heart valves. FDA requiresthat porcine islets used in clinical studies for transplantation in humans come from designated pathogen free (DPF) pigs raised in aU.S. Department of Agriculture certified facility. Progenitor cell therapy is our GcMP manufacturing partner throughcommercialization and marketing. PCT has unique expertise in FDA required cell processing. ENCAPSULATED ISLET CELLSPatented TechnologiesIslet Sciences’ patent estate is focused on enabling and protecting the first commercially viable cure for Type 1 diabetes. TheCompany has delivered, and continues to develop, a wide range of intellectual property advances to meet this goal. The advancesdetail improved methods and devices for the production of viable microencapsulated cells for human transplantation. Theseinnovations cover culturing, isolation, maturation and encapsulation of pancreatic islets. Internally, Islet Sciences’ scientists havefurther refined such techniques into what we believe to be the first commercial practical transplantation treatment for diabetes.Recognizing that multiple technologies will be needed to successfully commercialize an encapsulation product, our staff activelyinvents in other vital areas, including: 1) accurate dosing of a patient via improved quantification methods of functioning islets, 2)biocompatibility advances designed to improve patient acceptance of the capsules, 3) co-encapsulation of agents to enhance isletsurvival and function, 4) modifiable alginate polymers and polyelectrolyte compositions designed to improve; molecular diffusionproperties, capsule integrity, survivability, and functionality, 5) new controlled delivery systems for varied therapeutic applications,including co-encapsulation, and, 6) innovative outer layer compositions allowing better adhesion properties and placementdependability of microcapsules.Islet Sciences believes these technologies represent state-of-the-art methods for the commercial production of vastly improvedmicroencapsulated islet cells, and thereby, the first potential transplantation therapy for diabetes patients worldwide. Finally, theuniqueness of our capsules, and their compatibility with various cell types, may expand our probable markets into transplantationopportunities beyond diabetes.Development Strategy: XenotransplantationXenotransplantation is the removal of an organ or tissue from one species of animal and transplanting it to a member of anotherspecies. For example, porcine heart valves have long been successfully implanted in humans, and this is now considered routine. IsletSciences’ studies utilize encapsulated porcine islet cells and will be the basis of the companys product, Islet Sciences-P™. Why The Islet Sciences Solution? Non-Encapsulated Human Islet Approach Porcine Islet Approach Limited Supply  Supply Not Limited; Controllable Origin and Timing Uncertain  Origin Known, Planning Possible Chronic Immunosuppression Therapies Necessary  Reduced or No Immunosuppression Required More Invasive  Minimally Invasive Islets Are Less Pure, Less Stable  Preparations of Greater Purity, Higher Quality, More Stable
  4. 4. Business ModelStrategic FocusIn capitalizing on its proprietary intellectual property, Islet Sciences has focused on three major diabetes market segments. The initial,primary emphasis is on high-risk patient populations. This includes diabetic kidney transplant patients, as well as patients with poorlycontrolled, complicated instances of Type 1 diabetes. Diabetes is the leading cause of End Stage Renal Disease, or ESRD, accountingfor an estimated 44% of new cases each year. The patient population (and prospective business opportunity) is expanding, becausethere are approximately 100,000 new cases of ESRD every year, adding up to greater than $4 billion in annual dialysis outlays.According to the National Kidney and Urologic Disease Information Clearinghouse, the relationship between diabetes and ESRD isreason enough to justify accelerated research toward new early-stage diabetes therapies. It is estimated that as many as 40% of Type 1diabetes patients develop ESRD by age 50. In the absence of adequate and timely treatment by dialysis or transplantation, thesepatients die.Diabetes and Kidney TransplantsIslet Sciences’ immediate focus will target kidney transplant recipients as a "gateway" clinical application. Uncontrolled diabetes oftenresults in severe damage to a victims kidneys. When the patient receives a kidney transplant, the same forces at work that destroyedthe original kidneys will soon start to work on the transplanted kidney(s), unless something is done to control the diabetic condition.Islet Sciences TherapyIslet Sciences’ technology involves the implantation of insulin-producing islets in the peritoneum using a minimally invasiveprocedure.Medical research indicates that there is an increase in the survival rate of diabetics with kidney transplants if they also receive apancreas transplant. Unfortunately, there is an extreme shortage of pancreas donors relative to the number of kidney transplants. In2004, for instance, there were only 1,500 pancreas transplants performed vs. more than 15,000 kidney transplants. While availablepancreas organs are in short supply, they offer an insight into the benefit of islet transplantation therapy, which would serve as avirtual proxy for pancreatic transplantation. A pancreas transplant in conjunction with a kidney transplant results in a significantlyhigher patient survival rate. However, this is not feasible because of the limited supply of donor pancreases, Islets are more available,as well as more easily administered.It is clear to many that islet transplantation therapy can help reduce the long-term complications arising from diabetes, and reducehealth-care costs. The potential advantages for targeting this market include some significant patient benefits: better diabetes control;improved quality of life; improved kidney graft survival; and improved survival. Islet Sciences management sees significant revenuepotential for Islet Sciences-PTM in the kidney transplant market. In the US market, Islet Sciences believes that Orphan status (agovernment program that rewards the development of therapies for under-treated patient populations via tax breaks, expedited FDAreviews, etc.) may be obtainable. Finally, the Company is confident that our products will be covered by health insurance, includingMedicare and private insurers. oldThe revenue potential for Islet Sciences is significant for this relatively small subset of diabetes patients. The prospective pricing iscurrently unknown, but may range between $60,000 and $120,000 per procedure, at an estimated $100,000 per dose based on currentall graft reimbursement per patient, treatment of 5,000 patients represents $500 million in annual revenue potential. The annualrevenue opportunity could be a multiple of this figure, given the large number of prospective candidates for this therapy who are in thepool of more than 150,000 living with kidney transplants. With expanded market acceptance and greater usage, an increased dosagecost could yield even higher annual revenues.
  5. 5. Beyond ESRD and kidney transplant patients, secondary indications targeted by Islet Sciences may include more typical patients withinsulin-treated Type 1 diabetes. Other potential candidates for treatment include the two to four million people who are late-stage,Type 2 insulin-dependent diabetics.Clinical ApproachThe microencapsulation of insulin-producing porcine islet tissues protects them from immune system rejection, while the use of aminimally invasive procedure to implant the insulin-producing islets into the peritoneum enhances the safety profile of human testing.Utilizing these advances, Islet Sciences has a clear, clinical strategy beginning with IAk patients and expanding into other difficult tocontrol diabetes states. Existing InfrastructureThere are currently fifteen US domiciled clinical sights and at least another twenty globally pursuing versions of the EdmontonProtocol. As outlined previously the challenges of human islet transplantation are numerous preventing any commercially viableeconomic or therapeutic opportunity.Importantly, the medical centers currently pursuing Islet transplantation would be ideal for commercialisation and efficientdistribution of Islet’s first product and patient cohort.Islet Sciences has an alliance with Progenitor Cell Therapy, a divisionof Neostem, to provide FDA required clinical grade product continuously through commercialization and marketing the typical middleman distribution and marketing function could be eliminated. There are tens of thousand of IAK patients as patients in the various domestic centers; PCT produced product could be continuously shipped to sights based on significant demand and need. The National Institutes of health, NIH -underwrites much of the science and new therapeutics application at these designated medical sights for clinical islet transplantion, and has guidance that additional grant funding will be mad available for product in the clinic for T1DiabetsCurrently the hospitals are performing human islet transplantation on an ad hoc basis based on availability proper donor situationwith out Gcmp production.Based on the anticipated IAK (?) therapeutic demand of 10,000 persons annually this would require 2 procedures daily, based on theout patient minimally available procedure per sight. ManufacturingProgenitor Cell Therapy is our GcMP manufacturing partner through commercialization and marketing. PCT has unique expertise inFDA required cell processing. Progenitor Cell Therapy (PCT) is a client-based cell therapy services company that supports thedevelopment and commercialization of cellular therapies. PCT provides cGMP-compliant cell manufacturing and consulting servicesthat address regulatory, financial, technical, process, and quality system strategies. Services include a full spectrum of support andconsulting related to process and product development, validation, due diligence evaluations, tissue collection, processing, andstorage, product manufacturing, distribution and transportation.Dr. Robert A. Preti, Ph.D. is PCTs Co-Founder, President, and Chief Scientific Officer of Progenitor Cell Therapy,, and a memberof NeoStem’s Board of Managers. He has held these positions since March 1999. Through his administrative duties, Dr. Preti hasoverseen the growth of PCT from its inception to the world’s leading commercial cell therapy company.Previous positions held by Dr. Preti include Scientific and Laboratory Director of Hackensack University Medical Centers stem cellprocessing and research laboratory and Scientific Director of the Clinical Services Division at the New York Blood Center.He is one of the countrys leading authorities on cell engineering, advanced cell and gene therapy manufacturing, testing and delivery,and regulatory aspects relating to the cell therapy and regenerative medicine industry. He has been the principal investigator for anumber of clinical trials relating to the clinical testing of cellular therapies. He is a frequently invited speaker at international andnational symposia and conferences, addressing a wide range of topics within his expertise in the clinical development programs forcellular therapies, including the business, financial, logistic, and manufacturing, product development, testing, quality, and regulatoryaspects of successful commercialization.
  6. 6. Revenue ModelAssuming that ISLT begins its initial patient population proposed in the IND and begins wider distribution into the fifteen diabetescenters and assuming a roll out of one thousand patients to, five thousand to, ten thousand and down the road, penetration into othercomplicated diabetes patients starting in 2016.And using the comparator of islet transplantation cost dynamic currently reimbursed for Pancreatitis of one hundred thousand perprocedure, the chart below indicates the potential for significant revenue growth. $2,500,000,000 $2,000,000,000 $1,500,000,000 $1,000,000,000 $500,000,000 $0 1,000 5,000 10,000 15,000 20,000 2014 2015 2016 2017 2018 Per Procedure
  7. 7. Management and Board of DirectorsGeorge J. Todaro, MDA renowned research scientist and medical doctor, Dr. Todaro co-authored the groundbreaking “Oncogene Theory” while at theNational Institute of Health (NIH) in Bethesda, Maryland in1969. The “Oncogene Theory” would became one of the foundations forfuture cancer research. In the early 90s, as scientific director at Seattle-based PathoGenesis, he developed a treatment that has savedthe lives of countless cystic fibrosis patients. And, more recently, his focus has turned to biotechnology, where he is working to findways to increase the world’s food supply. Todaro can also add to his list of accomplishments that he was elected to the NationalAcademy of Sciences, was a professor and department head at the University of Washington, holds over 20 patents, and was namedone of the Ten Outstanding Young Men of America in 1970.Joel D. PerlinJoel Perlin can be considered a veteran when it comes to the understanding and successful management of Type 1 Juvenile Diabetes.He was diagnosed with the disease in early 1965 in Southern California. His doctors at that time knew little of how to live with andsuccessfully manage the disease. Mr. Perlin determined at that time the potential benefits associated with maintaining near normalblood sugar levels to prevent complications. It was more than 20 years later this fact was established by The Diabetes Control andComplications Trial (DCCT). Mr. Perlin has participated for more than four decades in many of the technological advances includingInsulin Pump therapy since 1983, Continuous Glucose Monitoring since 2006, along with the advances achieved with current insulintherapy and continuous blood sugar finger testing. His knowledge and practice of living successfully with Type 1 Juvenile Diabeteshas long been a benefit to many other diabetics. Professionally, Mr. Perlin is a renowned numismatist and recognized expert in theinternational physical gold coin trade. Since graduating from San Diego State in1969, Mr. Perlin has combined his unique skills andknowledge with keen insight into the economic and financial factors affecting the precious metals trade. This business expertise hasresulted in highly successful and lucrative gold investment accounts for his clients who have consulted with him in financial affairs inLa Jolla, CA, for more than 40 years.John Steel, Chairman, Interim CEOMr. John Steel is the President & CEO of Islet Sciences. Mr. Steel brings over twenty years of senior management and investmentexperience in the healthcare services and biotechnology sector. In 1998, Mr. Steel founded MicroIslet, the firm that pioneered anddeveloped the technology that comprises Islet Sciences, and served as its Chairman and Chief Executive Office from September 1998to 2002. From January 1996 to December 1997, Mr. Steel was Chief Executive Officer of AKESIS Pharmaceuticals, Inc., a companythat developed a patented treatment for insulin resistance for Type II diabetes. From January 1987 to June 1990, Mr. Steel served asthe Vice President of Defined Benefit Inc., a company he founded in 1986 that provided financial services to health care professionals.After Defined Benefit Inc., Mr. Steel was an active investor and consultant within numerous areas including early-stage biotechnologyand device companies through Steel Management. Mr. Steel himself is diagnosed with Type 1 Juvenile Diabetes and is activelyinvolved in fund raising for various diabetes research-related charities. Mr. Steel has recently chaired panels regarding the future ofdiabetes for the California Insurance Commissioner. Mr. Steel is also a noted speaker on the topic of diabetes - including itsmanagement, economics, and future opportunities for improvement in therapeutic modalities. Mr. Steel received his M.B.A. degreewith an emphasis in finance from the University of Southern California and a Bachelor of Arts degree from Dartmouth College.International Scientific Advisory Board Chair - Dr. Jonathan Lakey, PhD - MSMDr. Jonathan Lakey has had a long history in cell and tissue transplantation with a focus on diabetes and islet transplantation. Hegraduated from the University of Alberta (BSc, MSc, PhD) and received postdoctoral training in Indianapolis and Seattle beforereturning to establish his research program at the University of Alberta. He is a former Director of the Comprehensive Tissue Bank.His contributions and partnership with Dr. James Shapiro led towards the improvement of islet isolation techniques and thedevelopment of the “Edmonton Protocol” for patients with Type 1 diabetes, a recognized major advancement in the treatment ofdiabetes. He has been awarded research grants and awards for diabetes and transplantation research from the Alberta HeritageFoundation for Medical Research (AHFMR), Canadian Diabetes Association and the Juvenile Diabetes Foundation International(JDFI). Dr. Lakey is widely sought after as a speaker in the field of diabetes islet transplantation and regulatory standards of cell andtissue transplantation. He has been widely published with over 250 referred scientific papers, 26 book chapters, submitted over 500scientific abstracts, and has recently published a technical book on islet isolation. Among his proudest achievements, Dr. Lakey andhis team have successfully trained over 40 islet transplant centers worldwide in replicating the Edmonton Protocol, resulting indiabetic patients being freed from exogenous insulin injections. He sits on editorial boards of several diabetes and transplantationjournals, reviews manuscripts for several journals, and has served as a Councilor for Cell Transplant Society. Currently, Dr. Lakey isthe Director of Research and Associate Professor of Surgery at the University of California, Irvine. He recently accepted the positionof Director of the Clinical Islet Program at the University of California, Irvine.Paul Johnson, MBChB MD FRCS, President, IPITA
  8. 8. Director of Oxford Islet Transplant Programme and Professor of Paediatric Surgery, University of Oxford. Dr. Johnson also currentlyserves as President of the International Pancreas and Islet Transplant Association. Paul Johnson qualified in medicine from theUniversity of Leicester and subsequently trained in General Surgery in Leicester and Derby, followed by higher surgical training inPaediatric Surgery in Oxford, Melbourne, and Great Ormond Street Hospital in London. Between 1993 and 1996 he was a ResearchFellow in the Department of Surgery at the University of Leicester, where he undertook a project on the Isolation of Human Islets ofLangerhans for Pancreatic Islet Transplantation. This led to a Doctorate of Medicine and started his ongoing interest in the field ofIslet Transplantation for reversing Type 1 Diabetes. He was awarded a Hunterian Professorship from the Royal College of Surgeons ofEngland for this research in 1998. In 2002, Mr. Johnson was appointed Director of the Islet Transplant Programme in Oxford. He iscurrently Chairman of the Research division of British Association of Paediatric Surgeons Research and Clinical EffectivenessCommittee, Founder of the UK Academic Paediatric Surgeons Group and Co-Secretary of the International Pancreas and IsletTransplantation Association. He is also Clinical Tutor at St. Edmund Hall. He has an active research group and his research interestsinclude ways of optimizing the current methods used for islet isolation with particular reference to pancreatic structure andcollagenase, and the developmental biology of the pancreas and foregut with particular relevance to the use of adult stem cells as analternative source of islet tissue for transplantation. In addition to islet transplantation, his clinical interests include the neonatal andpaediatric pancreas (endocrine and exocrine), as well as other aspects of paediatric surgical gastroenterology.Steven Paraskevas, MD PhDDr. Paraskevas is a transplant surgeon at McGill University Health Centre, specializing in pancreas and kidney transplantation.Originally from Winnipeg, Dr. Paraskevas obtained a BA in Biology at Harvard University in 1988, and obtained his MD andcompleted General Surgery Residency at McGill. During that time, he also studied mechanisms of cell death in transplanted humanislets, completing a PhD in Experimental Surgery at McGill in 2003. Based on this work, he also earned the Scientific Trainee Awardof the Canadian Diabetes Association in 1997. After residency, he completed a two-year fellowship in abdominal solid-organtransplantation at the University of Minnesota, where he was also involved in the clinical islet transplant program under Dr. BernhardHering. He returned to McGill in 2002 as Assistant Professor in Surgery, and member of the multi-organ transplant program. He iscurrently Director of the Pancreas and Islet Transplant Program and of the Human Islet Isolation Laboratory at McGill. His currentresearch focuses on mechanisms of cell survival during ischemia and the effect of metabolic and inflammatory stress on engraftmentof human islets. He is a Councillor-at-large of the Canadian Society of Transplantation and Chair of the Cell Transplant Committee ofthe American Society of Transplant Surgeons.Miguel Riella, MD, PhDDr. Riella is a graduated of Federal University of Parana in Curitiba Brazil and has undertaken his post-graduate training in the UnitedStates, first in Internal Medicine, Residency at Mount Sinai Hospital in NYC and then Research Renal Fellowship at the University ofWashington in Seattle, USA. His main interest has been in dialysis, particularly peritoneal dialysis and nutrition in uremia. Morerecently his research work has been concentrated in the relationship of inflammation, uremia, nutrition and cardiovascularcomplications. As part of his new RDH Research Center (Renal, Diabetes and Hypertension Research Center) he has recentlyestablished the Islet Cell Laboratory for cell transplant in diabetic patients. Dr. Riella has published several books in Portuguese andSpanish language in the area of Nephrology and Nutrition. He is a member of the executive committee of the International Society ofNephrology and is the Chairman of the new ISN-Interventional Nephrology Committee. He is a member of the editorial board ofseveral medical journals, is the Associate Editor of Hemodialysis International and the co-editor of the Portuguese version of KidneyInternational.Jerry L. Nadler, MDDr. Nadler is Professor and Chairman of Internal Medicine, the Harry H. Mansbach Endowed Chair in Internal Medicine and Directorof the Strelitz Diabetes Center at Eastern Virginia Medical School. Dr. Nadler is also the Scientific Founder of Diakine, a seed stagecompany developing therapies for type 1 and type 2 diabetes and related complications. Dr. Nadler is also a Pfizer Visiting Professorin Diabetes. Dr. Nadler has been a member of a Special Advisory Committee on Type I Diabetes with the director of the NationalInstitutes of Health Diabetes Institute. Dr. Nadler was also the Associate Director of the NIH-funded Diabetes EndocrinologyResearch Center at the University of Virginia. Dr. Nadler has research funding from the Juvenile Diabetes Foundation, The EllaFitzgerald Charitable Foundation and the Iacocca Foundation. He is a standing member of the ADA and NIH grant reviewcommittees.