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Speakers

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Kurt Griffin
Associate Professor
University of South Dakota Sanford School of Medicine

Day Two

Thursday February 27, 2020

6:00 pm | Panel Discussion: “Bridging the Valley of Death: Non-Profit Organizations as Enablers of Novel Commercial T1D Therapeutics from Research to Phase II”

Andreas Lutterotti
Head of Experimental Therapies Research
University Hospital Zurich

Andreas Lutterotti is assistant professor for "Experimental Therapy Research in Multiple Sclerosis and Other Neurological Diseases" at the University of Zurich since August 2014, as well as a senior physician at the Department of Neurology, Section Neuroimmunology and MS Research (nims), University Hospital Zurich. His core expertise is the development and implementation of experimental therapies in the field of multiple sclerosis and other autoimmune diseases. He is Co-Founder of Cellerys AG, a company developing a cell based therapy to induce immune tolerance in MS. The group has recently closed a successful phase Ib trial using myelin-peptide coupled red blood cells to induce immune tolerance in MS patients and is continuing the clinical development the approach for treatment of MS.

Day Two

Thursday February 27, 2020

11:50 am | Establish Tolerance in MS with Myelin-Peptide Coupled Red Blood Cells

Stephen Miller
Co-Founder of Cour Pharmaceuticals; Professor of Microbiology- Immunology
Northwestern University Medical School

Dr. Stephen Miller is the Judy E. Gugenheim Research Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine in Chicago.  He received his Ph.D. in 1975 from the Pennsylvania State University and did postdoctoral training at the University of Colorado Health Sciences Center before joining the faculty at Northwestern in 1981 where he currently serves as Director of the Northwestern University Interdepartmental Immunobiology Center.  Dr. Miller is internationally recognized for his research on pathogenesis and regulation of autoimmune diseases.  He has published over 415 journal articles, reviews and book chapters and has trained multiple generations of scientists. His work has significantly enhanced understanding of immune inflammatory processes underlying chronic autoimmune disease employing animal models of multiple sclerosis (MS), Type 1 diabetes (T1D) and celiac disease (CD).  His work has focused on the study of the cellular and molecular mechanisms underlying treatment of established T cell-mediated autoimmune diseases using antigen-specific immune tolerance.  His current work is geared to translating the use of antigen-linked biodegradable PLG nanoparticles for the treatment of human immune-mediated diseases including autoimmunity, allergy, protein and gene replacement therapy, and tissue/organ transplantation.

Day One

Wednesday February 26, 2020

9:30 am | From Bench to Bedside: Pre-Clinical & Clinical Results of Tolerogenic Therapy of Celiac Disease using Gliadin-Encapsulating PLG Nanoparticles

Aaron Michels
Associate Professor of Pediatrics Medicine, & Immunology, Barbara Davis Center for Diabetes, University of Colorado; Chief Scientific Officer
IM Therapeutics

Aaron Michels, MD is a physician scientist at the Barbara Davis Center for Diabetes at the University of Colorado. His research focuses on understanding the role of HLA molecules in conferring type 1 diabetes risk and protection.  He discovered that small ‘drug-like’ molecules targeted to diabetes risk HLA molecules can block self-reactive T cell responses and translated these findings from bench to bedside for a personalized disease modifying therapy. He also serves as the Chief Scientific Officer of IM Therapeutics, a biotech company spun out of the University of Colorado based upon this technology. IM Therapeutics is actively developing small molecule drugs to treat type 1 diabetes and Celiac disease.

Day One

Wednesday February 26, 2020

11:00 am | From Mechanism to Clinical Trial – Blocking Disease-Specific HLA in Type 1 Diabetes

Shahrokh Shabahang
Chief Innovation Officer
AdiTxt Therapeutics

Dr. Shahrokh Shabahang is a co-founder and Chief Innovation Officer of Aditxt.  He completed his training in Microbiology and Molecular Genetics at Loma Linda University and continued his academic research with a focus on host-pathogen interactions.  In 2005, he transitioned from academic research to industry serving as clinical director and other management roles.  For the past decade, Dr. Shabahang has focused his research on ASITs for induction of tolerance with applications to organ transplantation, autoimmunity and allergies.  He is currently leading Aditxt’s product development with a team comprising of transplant surgeons, immunologists, and regulatory and commercialization experts in collaboration with academic institutions to translate a technology platform called Apoptotic DNA Immunotherapy™ (ADi™) into clinical practice.

Day One

Wednesday February 26, 2020

2:00 pm | The Importance of Tolerance Delivery Systems in Antigen-Specific Immune Tolerance

Kei Kishimoto
Chief Scientific Officer
Selecta Biosciences

Dr. Kishimoto is the Chief Scientific Officer of Selecta Biosciences, a biotechnology company developing synthetic vaccines based on a novel self-assembling nanoparticle technology.  Prior to joining Selecta, Dr. Kishimoto was Vice President of Research at Momenta Pharmaceuticals where he led multidisciplinary teams in inflammation, oncology, and cardiovascular disease.  Previously he was Senior Director of Inflammation Research at Millennium Pharmaceuticals, where he provided the scientific leadership for four programs in clinical development, and an Associate Director of Immunology at Boehringer Ingelheim.  Dr. Kishimoto received his doctoral degree in Immunology from Harvard University and his post-doctoral training at Stanford University.

Day One

Wednesday February 26, 2020

11:30 am | Mitigation of Anti-Drug Antibodies with ImmTOR Tolerogenic Nanoparticles

David Alleva
Executive Director
Akston Biosciences

David Alleva, Ph.D., has over 20 years of experience as a scientific leader in drug discovery and development of immunotherapeutics and vaccines in several biopharmaceutical companies and has published over 30 research articles in peer-reviewed journals. He developed one of the first antigen-specific immunotherapeutic clinical candidates for T1D, an altered peptide ligand of insulin B9-23, and is currently involved with the biotech company, Akston Biosciences, focused on B cell immunotherapeutics for T1D. He also led the T1D Immunotherapeutics program at the JDRF that drove a therapeutic research and development pipeline aimed at delivering novel therapies for the prevention and treatment of T1D. This entailed creating strategies for developing innovative immunotherapies for partnering with biotechnology and pharmaceutical companies along with managing an academic research portfolio.

Day One

Wednesday February 26, 2020

7:50 am | Chair’s Opening Remarks

Day Two

Thursday February 27, 2020

6:00 pm | Panel Discussion: “Bridging the Valley of Death: Non-Profit Organizations as Enablers of Novel Commercial T1D Therapeutics from Research to Phase II”

3:30 pm | Assay Development for AKS-107, an Insulin-Fc Biologic Designed to Target Insulin-Specific B Cells in Type 1 Diabetes (T1D)

8:20 am | Chair’s Opening Remarks

Giles Benichou
Associate Professor of Surgery, Harvard Medical School, Senior Immunologist
Massachusetts General Hospital

I am a basic immunologist who received his Ph.D. degree in 1987 at the Pasteur Institute and the University of Science of Paris, France for studies of cell surface signaling by anti-MHC antibodies. I pursued a post-doctoral training in immunology under Dr. E. Sercarz’s supervision, at the University of California, Los Angeles (UCLA). Since then, my research has been focused on the mechanisms underlying the recognition of self versus non-self antigens by the immune system in autoimmune diseases, cancer and transplantation. My first series of papers showed the presence of hidden, “cryptic” determinants on autoantigens and tumor antigens that fail to induce immune self-tolerance. This finding was seminal to the research community dealing with autoimmune diseases. In 1992, I published the first article demonstrating the presence of indirect alloreactivity during the course of allotransplant rejection. Since then, the laboratories I directed at UCSF and then Harvard/MGH have been studying the roles of allorecognition pathways in the initiation and regulation of T and B cell responses in transplantation using mouse and primate models. During this period, we published the first paper demonstrating the nature and role of memory T cells in tolerance resistance in primates. I am currently pursuing basic immunology studies on immune tolerance using mouse models and pre-clinical and clinical studies in non-human primates and patients, respectively, in collaboration with transplant surgeons at MGH.

Day Two

Thursday February 27, 2020

10:50 am | Immune Tolerance Induction via Allogeneic Exosomes

Emilio Flano
Director & Head of Immunology Discovery
Merck & Co

Emilio Flano trained at St. Jude Children’s Research Hospital and at The Trudeau Institute as a T cell immunologist. He was a faculty member of the Department of Pediatrics at Ohio State University and the Center for Vaccines and Immunity at Nationwide Children’s Hospital in Columbus, OH from 2004-2014.  His work focused on understanding the molecular and cellular mechanisms of generation and maintenance of innate and adaptive immune responses during infection, inflammation and vaccination. Since 2014 he has worked in biotechnology and drug development at Genocea Biosciences, Seres Therapeutics, and Merck leading discovery and early development activities. At Merck, Emilio leads Immunology Discovery group and is responsible for building the early immunology pipeline with a focus on autoimmunity, tolerance, and inflammation.

Day One

Wednesday February 26, 2020

8:00 am | Antigen-Specific Immunotherapy Approaches for the Treatment of Autoimmune Diseases

Matthias von Herrath
Vice President
Novo Nordisk

Dr. Matthias von Herrath is committed to clinical translation of immune-based interventions in autoimmune and metabolic diseases, the latter in particular being an exciting emerging field. His expertise and main strength is working at the interface of experimental research to interpret and refine early phase I/II clinical trials in order to optimize strategies for phase 3 trials and drug approval. This comprises translation from various animal models to human interventions, optimization of immunotherapies and their relative ranking, assessment of combination therapies, development of biomarkers as primary or secondary outcomes, induction of antigen specific tolerance in autoimmunity, regulatory cells and clinical T cell assays. In order to be better able to pursue his goal of clinical translation, Dr. von Herrath accepted the position of Vice President and Head of Novo Nordisk’s diabetes R&D Center in Seattle in autumn of 2011. At Novo Nordisk, he built the diabetes translational unit, which is based on less conventional and innovative design. In addition, he took on the task of finding new treatments to diabetic kidney disease in 2017. In 2018 he moved to the CMO office as many of the interventions are now at a later developmental stage and the position allows bridging between patient needs and trial design, biomarkers and basic mechanistic insight.

Day Two

Thursday February 27, 2020

9:00 am | Exploring the Parameters by which Tolerance Induction is Determined

Martin Roland
Head - Department of Neuroimmunology & Multiple Sclerosis Research
University Hospital Zurich

Roland Martin is professor for neurology and neuroimmunology at the University Zürich and heads the Neuroimmunology and Multiple Sclerosis Research Section and MS outpatient clinic at the University Hospital Zurich. R. Martin trained in medicine, and specialized in neurology at the University Würzburg. He pursued post-doctoral fellowships in immunology, virology and neuroimmunology in Würzburg and at the Neuroimmunology Branch, National Institutes of Health (NIH), Bethesda, USA, where he worked as tenured senior investigator until 2005. Subsequently, he held professorships in Barcelona (Vall D´Hebron University Hospital), Hamburg (Director of the Institute for Neuroimmunology and Clinical MS Research, University Hamburg) and now in Zurich. The main interests of his group are disease mechanisms of multiple sclerosis (MS), cellular immunology and antigen discovery, disease mechanisms of JC polyoma virus-mediated progressive multifocal leukoencephalopathy (PML) and developing novel treatments for MS and PML besides providing care for MS patients in one of the largest MS centers in Switzerland. He and his group developed more than 10 projects from idea to early clinical proof-of-concept trials. He is a member of the Kuratorium of the Jung Foundation for Science, Hamburg, of the core faculty of the Wyss Translational Center Zurich, a cofounder of the Drug Discovery Network Zurich (DDNZ) and of the Therapy Development Accelerator (TDA) at the University Zurich. Within the antigen-specific immune tolerance space, he has been involved as PI or mentor in three proof-of-concept clinical trials of antigen-specific tolerance in MS and has worked on antigen discovery and target antigens in MS for 25 years.

Day One

Wednesday February 26, 2020

1:30 pm | Antigen Discovery as Key Prerequisite for Successful Tolerization & Vaccination Strategies in Autoimmune Diseases, Allergies & Oncology

Dolly Tyan
Professor; Emerita of Pathology
Stanford University School of Medicine

Dr. Dolly (Ness) Tyan is Professor, Emerita of Pathology in the Stanford University School of Medicine and was the clinical Director of the Histocompatiblity, Immunogenetics, and Disease Profiling Lab until she retired in February, 2019. She is past president of the American Society for Histocompatbility & Immunogenetics. She has been involved in working out the genetics of the HLA and KIR systems as well as defining HLA antibody epitopes. She began her research career investigating immune responsiveness in the mouse H-2 system, then continued research in autoimmune disease susceptibility associated with HLA, particularly the seronegative spondyloarthropathies and inflammatory bowel disease. Spurred by her clinical work in solid organ transplantation and together with a colleague, she developed the IVIG therapy for desensitization of highly HLA sensitized transplant patients and continued working on the mechanism for the entirety of her career. As director of the R&D section of the laboratory, she worked with her team on translational assay development to overcome the deficiencies of traditional assays and to better monitor response to desensitization, profile antibodies involved in rejection, and assess cellular immunity including T and B cell memory of individual patients both before and after transplant. She holds three patents with a fourth pending for these novel technologies/assays.

Day Two

Thursday February 27, 2020

3:00 pm | FlowSpot: A Single Platform Assay with Broad Versatility for Measuring Cellular & Humoral Immune Status, Responsiveness & Memory

Lawrence Steinman
Professor of Neurology, Neurological Sciences & Pediatrics
Stanford University

Steinman is Professor of Neurology, Neurological Sciences and Pediatrics at Stanford University and Chair of the Stanford Program in Immunology from 2001 to 2011. His research focuses on what provokes relapses and remissions in multiple sclerosis (MS), and on the quest for antigen specific therapy in type 1 diabetes, neuromyelitis optica and myasthenia gravis. He is taking forward a pivotal clinical trial with antigen specific tolerization therapy for type 1 diabetes. Steinman was senior author on the 1992 Nature article that led to the drug Tysabri, approved for MS and Crohn’s disease. Dr. Steinman graduated from Dartmouth College, Magna Cum Laude in Physics. His MD is from Harvard Medical School.  He was a post-doctoral fellow in chemical immunology fellow at the Weizmann Institute of Science. After neurology residency he remained on the faculty in 1980.  He has received numerous honors, including the John M. Dystel Prize in 2004, the Javits Neuroscience Investigator Award from the NINDS twice, the Charcot Prize in MS research, and the Cerami Prize in Translational Medicine. Steinman is a member of the National Academy of Sciences, and the National Academy of Medicine. Dr. Steinman cofounded several biotech companies, including Neurocrine, Atreca, Katexco, and Tolerion. He was a Director of Centocor from 1988 until its sale to Johnson and Johnson.

Day Two

Thursday February 27, 2020

12:50 pm | Antigen Specific Tolerance in Autoimmunity & in Gene Therapy

Anne De Groot
Founder, Chief Executive Officer & Chief Scientific Officer
Epivax

Annie De Groot is a Smith College graduate (1978) and medical doctor trained at the University of Chicago Pritzker School of Medicine (1983). She trained in Internal Medicine and Infectious Disease at New England Medical Center and was a research fellow at the National Institutes of Health from 1986 to 1989. She has both laboratory bench (NIH) and field experience in vaccine research and vaccination campaigns (in former Zaire, the Gambia, and Mali). Having experienced both the beauty of discovery in bench research and the thrill of improving patient lives through her field and clinical work, De Groot has worked to expand the engagement of bench scientists in clinical work, and vice versa. Following her Infectious Disease Fellowship (NEMC), De Groot joined the faculty at Brown University in 1993, where she began to develop the cutting edge computational vaccine design tools for which she is well known. In 1998, De Groot and two partners founded EpiVax, Inc. and she licensed the first versions of these computational tools to the new company. De Groot has served as CEO/CSO of EpiVax since the company’s inception. With co-founder Bill Martin, she has established EpiVax as a leading company in the field of immunoinformatics, working with a wide range of global clients and partners to improve the design of vaccines and biologics and improving human health everywhere. De Groot moved her academic affiliation from Brown University to the University of Rhode Island in 2009. She was named director of URI’s Institute for Immunology and Informatics and was subsequently awarded $13M in funding from the NIH to develop the ‘iCubed’ as a center of excellence in computational vaccinology. De Groot is the author more than 190 peer-reviewed publications in the fields of computational vaccinology, biodefense, personalized vaccines, and immunology. In September 2017, De Groot and her business partner Bill Martin launched EpiVax Oncology Inc. to focus on the emerging field of immune-oncology. EpiVax Oncology will develop personalized cancer vaccines based on the patient’s own tumor genome. Should De Groot succeed in translating these concepts to the clinic, she will have realized her lifelong dream, which is to make individually tailored vaccines that are safe, highly efficient, and accessible worldwide. De Groot has won numerous awards, including the Smith Medal in 2013, was recognized as one of the 50 most influential people in vaccinology in 2014, and named Biotech CEO of the Year at the 2016 Vaccine Industry Excellence (ViE) Awards.

Day One

Wednesday February 26, 2020

1:00 pm | Antigen Discovery for Tolerance Induction (Using Immunoinformatics)

Ben Williams
Program Officer for the Type 1 Diabetes (T1D) Program
Helmsley Charitable Trust

Dr. Ben Williams is a Program Officer for the Helmsley Charitable Trust’s Type 1 Diabetes (T1D) Program, where he oversees the drug discovery grant portfolio that identifies and invests in promising new therapies for T1D. The grant portfolio spans investments in academia and biotech, focusing on specific strategic priorities, including targeted antigen-specific immunotherapies and preventing hypoglycemia in T1D. Ben earned a PhD in Genetics from Harvard Medical School’s Biological and Biomedical Sciences Program and a Bachelor of Arts degree in Chemistry from Earlham College. He was also a postdoctoral fellow at Fred Hutchinson Cancer Research Center.

Day Two

Thursday February 27, 2020

6:00 pm | Panel Discussion: “Bridging the Valley of Death: Non-Profit Organizations as Enablers of Novel Commercial T1D Therapeutics from Research to Phase II”

Giorgio Raimondi
Associate Scientific Director for Transplant Immunology
John Hopkins School of Medicine

Giorgio Raimondi is the Associate Scientific Director for Transplant Immunology of the Vascularized and Composite Allotransplantation (VCA) Laboratory and Assistant Professor in the Department of Plastic and Reconstructive Surgery at Johns Hopkins University School of Medicine. Born and raised in Italy, he obtained his Master of Science (Advanced Studies in Immunology) through a joint course between the University of Milano-Bicocca (Milan, Italy) and the Institute Pasteur (Paris, France). He then obtained his PhD (Biotechnology – focus on immunological tolerance) at the University of Milano-Bicocca (Milan, Italy). Dr. Raimondi conducted his postdoctoral studies at the Starzl Transplantation Institute of the University of Pittsburgh School of Medicine. There he forged his expertise on T lymphocytes and regulatory T cells immunobiology with a focus on the development of new strategies of immunoregulation for solid organ transplant rejection. Dr. Raimondi joined the Hopkins family in 2013. The Transplant Immunology section of the laboratory that Dr. Raimondi directs is devoted to pushing the boundaries of immunological research by improving our understanding of the complex mechanisms of transplant rejection as well as devising novel strategies to exploit mechanisms underlying the regulation of immune responses. Dr. Raimondi truly believes that meaningful advancements in research can only derive from the smooth integration of multidisciplinary approaches. Moreover, he believes that better understanding of the intricacies of the immune system can be obtained by juxtaposing the results of investigations in tangential areas, hence the additional focus of the lab on the immunology of autoimmune diseases, type 1 diabetes in particular. It is with this philosophy that Dr. Raimondi promotes the collaborative work of laboratory fellows with experts in other areas like biomaterial scientists and bioengineers (for actuation of novel drug delivery approaches and biomimetic strategies) as well as computational modelers (to better understand the dynamics of transplant rejection and identify unanticipated points of intervention). Driven by the values of honesty and respect, Dr. Raimondi enjoys being surrounded by young curious minds, learning from them while promoting their out-of-the box thinking and nurturing their growth as inquisitive and independent scientists. You will often find Dr. Raimondi drawing his thoughts on a white board (he really loves it…).

Day Two

Thursday February 27, 2020

5:00 pm | Novel Applications of Localized Delivery of Combination Strategies for Modulation of Allo- & Auto-Reactivity

Cory Berkland
Cory Berkland Distinguished Professor, School of Pharmacy Pharmaceutical Chemistry
University of Kansas

Cory Berkland holds the Solon E. Summerfield Distinguished Professorship in the Department of Pharmaceutical Chemistry and in the Department of Chemical Engineering at The University of Kansas.  He received MS and PhD degrees from the Department of Chemical and Biomolecular Engineering at the University of Illinois in Urbana-Champaign and a BS degree in Chemical Engineering from Iowa State University in Ames.  Prof. Berkland is a co-founder of Orbis Biosciences, Savara Pharmaceuticals (NASDAQ: SVRA), Bond Biosciences, and Orion BioScience.  His lab at The University of Kansas studies pharmaceuticals and biomaterials.  In particular, the lab focuses on delivery systems for antigen-specific immunotherapies applied to autoimmune diseases.

Day One

Wednesday February 26, 2020

3:00 pm | A Review of Clinically Tested ASIT Delivery Systems & Implications for Future Design

Todd Zion
President & Chief Executive Officer
Akston Biosciences

Dr. Zion has been a leader in the field of insulin engineering for over 15 years, initially as the CEO of SmartCells, Inc. who developed the world’s first clinical glucose-responsive insulin for treating diabetes (acquired by Merck & Co.).  As co-founder and CEO of Akston Biosciences Corp., Todd is leading the development of a platform of insulin-fusion proteins to target insulin-specific B cells for the prevention of Type 1 diabetes.  Akston has assembled a consortium of non-profit, government, and private organizations to finance and develop its lead candidate (AKS-107) for clinical trials.

Day Two

Thursday February 27, 2020

6:00 pm | Panel Discussion: “Bridging the Valley of Death: Non-Profit Organizations as Enablers of Novel Commercial T1D Therapeutics from Research to Phase II”

Garth Ringheim
Director Immunology Therapeutic Area
Clarivate Analysis

Garth Ringheim received his Ph.D. from the University of California, San Diego and has 28 years of experience working in pharma and biotech in the areas of drug discovery, translational medicine, and clinical development at companies that include Clarivate Analytics, Celgene, nPharmakon, Sanofi, and DuPont de Nemours. Therapeutic areas of expertise include the inflammatory diseases lupus, rheumatoid arthritis, psoriasis, and vitiligo as well as the neuroimmunological diseases multiple sclerosis, Alzheimer’s disease, and inflammatory pain. Developing T- and B-cell therapeutics and validating their mechanisms of action has been a particular focus, encompassing research and clinical development of small molecules and biologics that modulate B- and T-cell activation, differentiation, and function. He has overseen the design and development of numerous clinical development agents for the treatment of autoimmune diseases that include the marketed drug Aubagio, T cell anergy-inducing small molecules, T cell exhaustion-inducing checkpoint inhibitor protein agonist biologics, and biologics modulating regulatory T cells. His most recent position at Clarivate Analytics involves thought leadership strategies for pursuing innovative drug target identification, development, and clinical directions in pharma and biotechnology.

Day Two

Thursday February 27, 2020

11:20 am | T Cell Anergy Induction by Pharmacological Agents Partially Restricting T Cell Activation

Curtis Ruegg
President & Chief Executive Officer
Parvus Therapeutics, Inc.

During more than 25 years in the biopharmaceutical industry, Curtis has built and managed several successful novel biologics development programs across R&D and Technical operations, from research through clinical development and commercialization. Prior to joining Parvus, Curtis was Executive Vice President, Technical Operations at Revance Therapeutics where he established and managed the product development program to support the company’s platform from pre-IND through Phase 3. Prior to Revance, Curtis led development efforts supporting commercialization of several products including Ventavis® (CoTherix), Esbriet® (Intermune) and Provenge® (Dendreon). Curtis earned his Ph.D. degree from Johns Hopkins University School of Medicine for work on retroviral mediated immunosuppression and performed research in immunology as a Cancer Research Institute Fellow at Stanford University School of Medicine.

Day One

Wednesday February 26, 2020

3:30 pm | Induction of Antigen-specific TR1 Cells & Therapeutic Outcomes in Autoimmune Models Using Navacim™ Precision Nanomedicines

Jack Ragheb
Senior Medical Fellow for Immunology in Global Patient Safety
Eli Lilly & Co.

Dr. Ragheb has been with Eli Lilly & Co. for about 3 years. He is based in Indianapolis where he serves as the Senior Medical Fellow for Immunology in Global Patient Safety and Co-Chair of the Immunogenicity/Immunosafety Working Group. He received his MD and PhD degrees from the Johns Hopkins University and is a Diplomate of the American Board of Allergy & Immunology. Formerly, he was a Senior Clinical Investigator at NIH where he conducted clinical and basic research on immune tolerance and a Chief Medical Research Officer in the Office of Biological Products at the FDA where his research group established the BLT humanized mouse model there in an effort to predict the immunogenicity of biotherapeutics. He has published in the areas of immunogenicity, immune tolerance, CD28 and CD40L regulation, retrovirology and gene therapy.

Day Two

Thursday February 27, 2020

8:30 am | Checkpoint Inhibitors: Insights into Immune Tolerance

Arpita Maiti
Executive Director & Global Head
Global Head Pfizer

As Executive Director and Global Head for Inflammation & Immunology, Emerging Science & Innovation (ES&I), Arpita leads scouting of external opportunities (Idea to Candidate) and academic collaborations for the Inflammation & Immunology (I&I) research unit and the Centers for Therapeutic Innovation (CTI), at Pfizer.  She also leads strategy and partnering efforts in the microbiome for Pfizer.  ES&I is an externally-focused scientific team of PhDs / MDs, embedded within Pfizer research groups, that identifies late-breaking, first-in-class science forming the basis of innovative therapies, and drives related collaborations that deliver value to Pfizer, its partners, and patients.  Deals for which Arpita is responsible include Evotec, Biorap, CytoReason, and an equity investment and subsequent license with AnTolRx.  Prior to Pfizer, she was Associate Director of R&D Alliance Design & Management at Vertex Pharmaceuticals.  Arpita got her start in biotech at Angiotech Pharmaceuticals, heading the Cell Biology & Drug Screening group.  She trained as an immunologist and has a PhD and MSc in Immunology from UBC and a BSc from Trinity College, UofT.  In addition to presenting at pharma innovation and microbiome conferences, she co-organized the 12th World Congress on Inflammation held in 2015, and has served on the board of the Inflammation Research Association in numerous positions, including as its President (2012-14).

Day One

Wednesday February 26, 2020

8:30 am | Translating Innovative Science to Therapies that Establish Immune Tolerance – One Pharma’s Perspective

Kristina M. Harris
Director, Biomarker & Discovery Research
Immune Tolerance Network

Kristina M. Harris, PhD is the Director of the Biomarker & Discovery Research division at the Immune Tolerance Network (ITN) in Bethesda, MD.  She serves as the scientific liaison to a network of core and specialized laboratories that design and perform cutting edge mechanistic assays under strict standard operating procedures.  Her role provides oversight to the Biomarker & Discovery Research group to harmonize assessments across trials and therapeutic areas to identify common themes associated with immune tolerance.  These assays are critical to the mission of the ITN, which is to advance the clinical application of immune tolerance by performing high quality clinical trials of emerging therapeutics integrated with mechanism-based research.  She is very satisfied working in this highly-matrixed organization, and embraces new and exciting opportunities to advance the field of immunotherapy in collaboration with key opinion leaders around the globe. Dr. Harris received her PhD in Molecular Medicine from University of Maryland School of Medicine in 2008.  She completed her post-doctoral training under the mentorship of Drs. Dean Mann, Alessio Fasano, and Alan Cross and established herself as a translational researcher of immune mechanisms in human disease.  Dr. Harris joined the ITN in 2013 to serve as the senior biologist responsible for mechanistic evaluation of the autoimmune portfolio, and served as the senior biologist for the allergy and asthma portfolio from 2014-2016.  She was promoted to Director of Biomarker & Discovery Research in 2015, and continues to oversee mechanistic evaluation of the autoimmune portfolio.

Day Two

Thursday February 27, 2020

2:00 pm | Antigen-Specific T & B Cell Profiles as Therapeutic Targets in Allergy & Autoimmune Disease

Joshua Sestak
President and Chief Executive Officer, Founder
Orion BioScience

Orion BioScience is a therapeutic development company focused on bringing their first in class ‘Soluble Antigen Array’ technology into the clinic for the treatment of autoimmune diseases such as Type-1 diabetes, neuromyelitis optica, and myasthenia gravis. Joshua Sestak co-founded Orion BioScience with technology out of the Cory Berkland Lab at the University of Kansas. To date Joshua has helped Orion secure funding through both SBIR and patient advocacy group grants, industry partnerships, angel investment, and institutional venture capitalists. Orion is currently focused on IND enabling activities for their SAgA-T1D platform as an early stage disease intervention to stop the progression of Type-1 diabetes and restore health. Joshua received his BS in Chemistry and BioChemistry from Gonzaga University, and his MS and PhD in Pharmaceutical Chemistry with a focus in Immunology from the University of Kansas. Prior to completing his graduate work at the University of Kansas, Joshua worked at Nastech Pharmaceutical as a Formulation Scientist where he developed peptide and siRNA therapeutics, as well as served as the Formulation to Clinical liaison bringing therapies through CMC activity and into the clinic. He has co-authored numerous papers as well as been named as an inventor on multiple patents, including the foundational technology for Orion. Outside of work Joshua enjoys spending time with his family of 6, golfing, and is currently training for his first full marathon.

Day Two

Thursday February 27, 2020

4:30 pm | Considerations for Dual Therapy Approaches in Autoimmune Disease

Monali Manohar
Life Science Research Scientist
Stanford University School of Medicine

Dr. Monali Manohar obtained her PhD from Indian Institute of Science. Most of her doctoral thesis work was carried out at Prof. Wolfgang Junger’s laboratory at Beth Israel Deaconess Medical Center, and was focused on purinergic signaling in human gamma delta T cells. She did her first postdoc at Brigham and Women’s Hospital under the mentorship of Prof. Clare Baecher-Allan addressing the role of specific subsets of regulatory T cells in the pathogenesis of multiple sclerosis. She then joined Prof. Kari Nadeau’s laboratory at Stanford University School of Medicine for her second postdoc in late 2013, and has continued to work with the group as a research scientist. Her work in recent years has been focused upon understanding the immune mechanism of desensitization and tolerance to food allergens through allergen-specific oral immunotherapy (OIT). Towards this goal, her group primarily employs techniques such as high dimensional mass cytometry, single-cell and bulk RNA-Seq, and ex vivo functional assays to study post-OIT immune changes in a defined cohort of food allergic study participants.

Day Two

Thursday February 27, 2020

2:30 pm | Unraveling the Mechanism of Desensitization & Tolerance through Food Allergen-Specific Oral Immunotherapy

Colin Dayan
Professor of Clinical Diabetes & Metabolism
Cardiff University School of Medicine

Colin Dayan trained in medicine at University College, Oxford, and Guy’s and Charing Cross Hospitals in London, UK before obtaining a PhD in the immunology of Graves’ Disease in Laboratory of Marc Feldmann. He then spent a year as an endocrine fellow at the Massachussetts General Hospital in Boston, USA before completing his specialist training in diabetes and endocrinology as a Lecturer in Bristol. He became a consultant senior lecturer in medicine (diabetes/endocrinology) at the University of Bristol in 1995 and Head of Clinical Research at the Henry Wellcome Laboratories for Integrative Neuroscience and Endocrinology in Bristol in 2002. In 2010, he was appointed to the Chair of Clinical Diabetes and Metabolism and Head of Section at Cardiff University School of Medicine. He served as Director of the Institute of Molecular and Experimental Medicine in 2011 – 2015. In 2017 he was appointed to the post of Professor of Endocrinology and Diabetes at the University of Bristol, UK as a joint post with Cardiff. He has a long established interest in translational research in the immunopathology of type 1 diabetes and is currently conducting early phase clinical trials in the development of antigen specific immunotherapy as well as leading multicentre phase 2 studies. He is the lead for diabetes in the Cardiff whole pancreas transplantation programme and with colleagues leads an All Wales anonymised data linkage programme for monitoring childhood type 1 diabetes. He has been part of 2 major EU FP7 programme grants in type 1 diabetes (and coordinator on one), a member of the Juvenile Diabetes Research Foundation Medical and Scientific Committee and the Welsh Diabetes Research Unit. Prof Dayan currently leads the Clinical Engagement and Training Core of the Diabetes UK funded type 1 diabetes UK immunotherapy Consortium which aims to coordinate and support combined efforts to bring immunotherapy for type 1 diabetes into clinical practice. He also chairs the UK Clinical Studies Group for the prevention, targets and therapies in type 1 diabetes and the JDRF/Diabetes UK funded Trial Outcome Markers Initiative which aims to develop a revised clinical trial endpoint in type 1 diabetes immunotherapy. In antigen specific immunotherapy, he has a particular interest in translational studies in humans in type 1 diabetes and autoimmune thyroid disease. He worked with Mark Peakman to identify T cell epitopes targeted in type 1 diabetes and conducted two studies in humans confirming safety of repeated dosing. He has since explored several approaches to promote tolerance in antigen specific therapy including the use of microneedles, topical skin pretreatment, nanoparticles and small molecule combination therapy as well as exploring novel readout approaches including fine needle lymph node sampling.  

Day One

Wednesday February 26, 2020

4:00 pm | Novel Approaches to Antigen Delivery & Immune Response Monitoring

David Wraith
Director of the Institute of Immunology & Immunotherapy
University of Birmingham

Born in Newcastle upon Tyne in 1956, David studied Biochemistry in Newcastle and London before taking a position in the Division of Immunology at the MRC National Institute for Medical Research in London. Working in the laboratory of Professor Ite Askonas, he helped discover that T lymphocytes respond to peptide fragments of antigens and designed a vaccine that would generate heterotypic immunity against influenza A viruses. In 1986, the MRC awarded David a travelling fellowship enabling him to join the laboratory of Professor Hugh McDevitt in Stanford University, USA. There he studied fundamental mechanisms of antigen recognition by CD4 T cells publishing papers on MHC binding, T cell receptor selection and the first use of peptide analogues to switch off the immune response to antigen. The Wellcome Trust awarded David a Senior Research Fellowship to establish his own laboratory at the University of Cambridge. His group revealed how autoreactive T cells escape deletion in the thymus and developed the use of peptides for immunotherapy of both allergic and autoimmune diseases. In 1995, David was appointed Head of the Department of Pathology and Microbiology at the University of Bristol where he worked for 21 years. His group continued to define mechanisms of autoimmune disease but, most importantly, developed antigen-specific immunotherapy into a safe and effective means of controlling allergic and autoimmune diseases. In 2002, he established a spinout company, Apitope International, that has since completed phase 2 clinical trials of peptide immunotherapy in Multiple Sclerosis and phase 1 trials in Graves’ hyperthyroid disease. His group relocated to the University of Birmingham in 2016 to extend their peptide therapy work to rheumatoid arthritis, type 1 diabetes and autoimmune liver diseases. In addition to running his laboratory, David is Director of the Institute of Immunology and Immunotherapy within the College of Medical and Dental Sciences.

Day One

Wednesday February 26, 2020

9:00 am | Antigen-Specific Immunotherapy for Treatment of Autoimmune Diseases

Stephan Kontos
Founder & Chief Scientific Officer
Anokion

Stephan is the Chief Scientific Officer and Founder at Anokion, driving the technology forward from our research unit in Cambridge. He received his B.Sc. in Chemical Engineering from the University of Texas at Austin and moved to the EPFL for his doctorate in Bioengineering. During his thesis work in Jeff Hubbell’s group, he co-invented and developed the liver-targeting and red blood cell tolerance technologies that led to the founding of Anokion. Following completion of his PhD in Bioengineering, Stephan further advanced several design aspects of our core technology as a post-doctoral researcher.

Day Two

Thursday February 27, 2020

9:30 am | Translational & Clinical Development of Novel, Liver Targeted Immune Tolerance Therapies for Celiac Disease & Multiple Sclerosis

Simi Ahmed
Director of Research & Lead of the Immune Therapies Program
JDRF

Simi T. Ahmed, Ph.D., is a Director of Research and lead of the Immune Therapies Program at JDRF. She is responsible for creating and implementing the vision and strategy of this program, with core emphasis on the establishment of effective disease modifying immunotherapies for T1D. Her experiences range from basic research to translational medicine, and draw from effective partnerships within the public and private sectors. Prior to joining JDRF, Dr. Ahmed completed her postdoctoral training in Dr. James E. Darnell’s laboratory at The Rockefeller University in New York. She holds a bachelor’s degree in Biophysical Chemistry from Dartmouth College and a doctorate in Immunology from the Weill Graduate School of Medical Sciences of Cornell University.

Waldo Concepcion
Professor of Surgery (Abdominal Transplantation) and of Pediatrics (Nephrology)
Stanford University Medical Center

Waldo Concepcion, MD, FACS, is a Professor of Surgery and Pediatrics ( Nephrology), Chief of Clinical Transplantation at Stanford University and Chief of Pediatric Kidney Transplantation at Lucille Packard Children’s Hospital at Stanford. Dr. Concepcion was born in Omaha, Nebraska and spent his early years of life in Panama and Costa Rica.  He graduated from Medical School from Universidad Autonoma de Guadalajara, Mexico.  Then, he proceeded to complete his General Surgery Residence at Loma Linda University Medical Center and his Transplantation Surgery Fellowship at University of Pittsburgh under the mentorship of Dr. Thomas Starzl, world leader in the field of transplantation. His area of interest is pediatric and adult transplant surgeon, and he is an expert in the field of hepatobiliary surgery and portal hypertension surgery in children and adults.  Dr. Concepcion is a member of the original team that developed the liver transplant program at California Pacific Medical Center,  where he practiced as transplant surgeon from 1988 to 1994. In 1994, Dr. Concepcion moved with his team to Stanford University.  In 1996, Dr. Concepcion was named Director of the Transplantation Institute at Loma Linda University Medical Center where he founded the Pediatric Liver Program and served as Director over the multi-organ transplant program.  Under his leadership, his program became one of the premier transplant centers in Southern California, earning the industry distinction of Center of Excellence among health care organizations.  Under his leadership, the program reported one of the highest patient and organ graft survival in Southern California. In 2005, Dr. Concepcion returned to Stanford University to become the new Chief of Clinical Transplantation and  Chief of Pediatric Kidney  Transplantation at Lucille Packard Children’s Hospital continuing in the tradition of one of the best kidney transplant programs in the world.  Dr. Concepcion has published over 100 articles and book chapters in the scientific literature and remains active in clinical research projects. His areas of interest are Quality Process in Healthcare, Clinical Outcomes research and viral complication in pediatric transplantation. Immunomodulation through Apoptotic DNA is a great interest of mine and developing strategies for clinical application in organ transplantation. Organ Regeneration by Stem Cell technology are projects important in my research work. My three daughters Zoe, Katie and Christine are the joy of my life!  

Amy Rosenberg
Director - Therapeutic Proteins & CDER
FDA

Day Two

Thursday February 27, 2020

5:30 pm | Regulatory Perspective on Combination Therapies