Appendix A
Workshop Agenda
UNDERSTANDING THE ROLE OF THE IMMUNE SYSTEM
IN IMPROVING TISSUE REGENERATION: A WORKSHOP
November 2–3, 2021
Virtual Workshop
TIMELINE
November 2, 2021: 11:30 a.m.–4:30 p.m. ET
November 3, 2021: 12:00–4:00 p.m. ET
DAY 1: NOVEMBER 2, 2021
| 11:30 a.m. ET | Welcome from the Forum Co-Chairs |
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TIM COETZEE, Forum Co-Chair Chief Advocacy, Services, and Science Officer National Multiple Sclerosis Society |
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KATHY TSOKAS, Forum Co-Chair Vice President Regulatory, Quality, Risk Management and Drug Safety Janssen Inc. Canada |
| 11:40 a.m. | Introduction and Charge to the Workshop Speakers and Participants |
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NADYA LUMELSKY, Workshop Planning Committee Co-Chair Chief, Integrative Biology and Infectious Diseases Branch Program Director, Tissue Engineering and Regenerative Medicine Research Program National Institute of Dental and Craniofacial Research (NIDCR) National Institutes of Health (NIH) |
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KIMBERLEE POTTER, Workshop Planning Committee Co-Chair Scientific Program Manager Biomedical Laboratory R&D Service Office of Research & Development Department of Veterans Affairs |
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| 11:50 a.m. | Keynote: Tissue Homeostasis, Inflammation, and Repair |
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RUSLAN MEDZHITOV Sterling Professor of Immunobiology Yale School of Medicine Investigator, Howard Hughes Medical Institute |
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| 12:10 p.m. | Comment from the Patient Perspective |
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SHERILYN GEORFE-CLINTON Leader Multiple Sclerosis: You Are Not Alone (M.S. Y.A.N.A) |
SESSION I. LESSONS LEARNED ON IMMUNE TOLERANCE AND GRAFT ACCEPTANCE
Moderator: Sohel Talib, California Institute for Regenerative Medicine
Session Objectives
- Discuss the current state of knowledge about immune tolerance mechanisms and what lessons have been learned from other areas of research, including: transplant immunology, cancer immunotherapy, maternal–fetal interface, and the microbiome.
| 12:20 p.m. | Lessons Learned from Transplant Immunology |
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MEFAN SYKES Michael J. Friedlander Professor of Medicine and Professor of Microbiology & Immunology and Surgical Sciences (in Surgery) Director, Columbia Center for Translational Immunology Columbia University |
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| 12:35 p.m. | Microbiome and Immune Tolerance—If We Can’t Live without It, How Best to Live with It? Lessons Learned from Allogeneic Hematopoietic Cell Transplantation |
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ROBERT JENQ Deputy Department Chair, Genomic Medicine Associate Professor, Genomic Medicine Associate Professor, Stem Cell Transplantation MD Anderson Cancer Center |
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| 12:50 p.m. | Q&A with the Speakers and Participants |
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Additional Panelist RUSLAN MEDZHITOV Sterling Professor of Immunobiology Yale School of Medicine Investigator, Howard Hughes Medical Institute |
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| 1:25 p.m. | Break |
SESSION II. ENGINEERING OF ALLOGENEIC DONOR CELLS FOR ACCEPTANCE BY THE HOST’S IMMUNE SYSTEM
Moderator: Rachel Salzman, American Society of Gene & Cell Therapy
Session Objectives
- Explore recent advances in engineering of allogeneic donor cells for acceptance by the host’s immune system (e.g., gene editing approaches, immune silent, universal donor cells).
| 2:00 p.m. | Protecting Transplanted Cells from Immune Rejection Is the Key to Unlocking the Potential of Regenerative Medicine |
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SONJA SCHREPFER Head of Hypoimmune Platform Sana Biotechnology Adjunct Professor, Department of Surgery University of California, San Francisco |
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| 2:15 p.m. | Challenges to Using Mesenchymal Stem Cells in Immunomodulatory Therapies |
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KATARINA LE BLANC Professor of Clinical Stem Cell Research Karolinska Institute |
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| 2:30 p.m. | Off-the-Shelf Engineered iPSC-Derived NK and T Cells for the Treatment of Cancer |
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BOB VALAMEHR Chief Research and Development Officer Fate Therapeutics |
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| 2:45 p.m. | Q&A with the Speakers and Participants |
SESSION III. ENDOGENOUS REGENERATION AND THE ROLE OF THE LOCAL ENVIRONMENT IN REPAIR
Moderator: Steven Becker, National Cancer Institute
Session Objectives
- Examine what “proper healing” looks like at the level of the local environment, and discuss relevant research gaps.
- Consider the effects of aging, gender, and other variables and pathological changes on the local environment, endogenous repair, and wound healing.
| 3:10 p.m. | Reversing Aging: Proinflammatory Metabolite Prostaglandin E2 Augments Muscle Regeneration |
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HELEN BLAU The Donald E. and Delia B. Baxter Foundation Professor Director, Baxter Laboratory for Stem Cell Biology Professor, by Courtesy, of Psychiatry and Behavioral Sciences Stanford University |
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| 3:25 p.m. | Biomaterials for Modeling Immune Mediation in Wound Healing |
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ERIKA MOORE Rhines Rising Star Larry Hench Assistant Professor Department of Materials Science and Engineering University of Florida |
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| 3:40 p.m. | Endogenous Pro-Resolution and Pro-Regenerative Mechanisms in the Periodontal Tissue |
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GEORFE HAJISHENFALLIS Thomas W. Evans Centennial Professor Department of Basic and Translational Sciences University of Pennsylvania |
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| 3:55 p.m. | Q&A with the Speakers and Participants |
| 4:20 p.m. | Reflections on Day 1 and Preview of Day 2 |
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NADYA LUMELSKY, Workshop Planning Committee Co-Chair Chief, Integrative Biology and Infectious Diseases Branch Program Director, Tissue Engineering and Regenerative Medicine Research Program National Institute of Dental and Craniofacial Research (NIDCR) National Institutes of Health (NIH) |
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KIMBERLEE POTTER, Workshop Planning Committee Co-Chair Scientific Program Manager Biomedical Laboratory R&D Service Office of Research & Development Department of Veterans Affairs |
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| 4:30 p.m. | Adjourn Workshop Day 1 |
DAY 2: NOVEMBER 3, 2021
| 12:00 p.m. ET | Welcome and Overview of Day 2 |
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NADYA LUMELSKY, Workshop Planning Committee Co-Chair Chief, Integrative Biology and Infectious Diseases Branch Program Director, Tissue Engineering and Regenerative Medicine Research Program National Institute of Dental and Craniofacial Research (NIDCR) National Institutes of Health (NIH) |
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KIMBERLEE POTTER, Workshop Planning Committee Co-Chair Scientific Program Manager Biomedical Laboratory R&D Service Office of Research & Development Department of Veterans Affairs |
SESSION IV. MODULATING THE HOST IMMUNE SYSTEM TO CREATE A PRO-REGENERATION ENVIRONMENT
Moderator: Candace Kerr, National Institute on Aging
Session Objectives
- Discuss the goal(s) of host immune modulation and consider what the correct molecular targets are for creating a pro-regenerative environment.
- Examine recent research advances of the role of innate and adaptive immunity in cell engraftment and endogenous tissue regeneration, and approaches for immunomodulation of the structure and function of stem cell niches for goals of tissue regeneration.
| 12:10 p.m. | Cellular Senescence, Senolytics, and Organ Regeneration and Transplantation |
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JAMES KIRKLAND Director, Robert and Arlene Kogod Center on Aging Noaber Foundation Professor of Aging Research Mayo Clinic |
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| 12:25 p.m. | Mapping the Immune and Tissue Environment in Healing and Non-Healing Wounds |
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JENNIFER ELISSEEFF Jules Stein Professor, Biomedical Engineering Morton Goldberg Professor, Ophthalmology Professor, Materials Science & Engineering, Chemical and Biomolecular Engineering Director, Translational Tissue Engineering Center Johns Hopkins University |
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| 12:40 p.m. | Resolution of Acute Inflammation Stimulates Tissue Regeneration |
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CHARLES SERHAN Endowed Distinguished Scientist & Director of the Center for Experimental Therapeutics and Reperfusion Injury Brigham Women’s Hospital Professor of Anaesthesia Harvard Medical School |
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| 12:55 p.m. | Q&A with the Speakers and Participants |
| 1:20 p.m. | Break |
SESSION V. DEVELOPING TOOLS AND PRECLINICAL MODELS FOR MONITORING AND OPTIMIZING THE HOST’S PRO-REGENERATIVE ENVIRONMENT
Moderator: Sadik Kassim, Vor Biopharma
Session Objectives
- Explore recent advances in monitoring and imaging of the immune system as well as the potential implications of these new approaches for clinical translation of regenerative medicines.
- Discuss challenges and opportunities with regard to preclinical models for studying the immune system involvement in response to regenerative medicine.
| 1:40 p.m. | Tools for Immune Profiling and Monitoring |
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GARRY NOLAN Rachford and Carlota Harris Professor Department of Pathology Stanford University |
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| 1:55 p.m. | Engineered Immunity as a Model for Regenerative Medicine |
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MICHEL SADELAIN Stephen and Barbara Friedman Chair Director, Center for Cell Engineering Memorial Sloan Kettering Cancer Center |
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| 2:10 p.m. | Basic Immunology to Guide Regenerative Therapeutic Design |
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KAITLYN SADTLER Earl Stadtman Tenure-Track Investigator Chief of Section on Immunoengineering National Institute of Biomedical Imaging and Bioengineering |
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| 2:25 p.m. | Q&A with the Speakers and Participants |
| 2:50 p.m. | Break |
SESSION VI. FINAL PANEL: WHAT ARE SOME POSSIBILITIES TO HARNESS THE IMMUNE SYSTEM TO IMPROVE OUTCOMES FOR PATIENTS?
Session Objectives
- Explore areas of clinical therapeutic need amenable to being clinical trial candidates that could demonstrate not only proof of principle of a specific therapeutic for a clinical indication but also ways to address the immune system’s role in improving tissue regeneration.
| 3:05 p.m. | Panel Discussion |
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Moderator: Richard McFarland, Advanced Regenerative Manufacturing Institute |
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| Speakers: | |
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SHERILYN GEORFE-CLINTON Leader Multiple Sclerosis: You Are Not Alone (M.S. Y.A.N.A) THOMAS WYNN Vice President, Discovery Pfizer EDWARD BOTCHWEY Associate Professor Department of Biomedical Engineering Georgia Tech SONJA SCHREPFER Head of Hypoimmune Platform Sana Biotechnology Adjunct Professor, Department of Surgery University of California, San Francisco |
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DANIELLE BROOKS Biologist Office of Tissues and Advanced Therapies Division of Clinical Evaluation and Pharmacology/Toxicology Center for Biologics Evaluation and Research Food and Drug Administration JENNIFER ELISSEEFF Jules Stein Professor, Biomedical Engineering Morton Goldberg Professor, Ophthalmology Professor, Materials Science & Engineering, Chemical and Biomolecular Engineering Director, Translational Tissue Engineering Center Johns Hopkins University |
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| 3:35 p.m. | Summary of Key Points from Discussion |
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RICHARD MCFARLAND Chief Regulatory Officer Advanced Regenerative Manufacturing Institute |
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| 3:45 p.m. | Reflections from the Workshop and Final Comments |
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NADYA LUMELSKY, Workshop Planning Committee Co-Chair Chief, Integrative Biology and Infectious Diseases Branch Program Director, Tissue Engineering and Regenerative Medicine Research Program National Institute of Dental and Craniofacial Research (NIDCR) National Institutes of Health (NIH) |
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KIMBERLEE POTTER, Workshop Planning Committee Co-Chair Scientific Program Manager Biomedical Laboratory R&D Service Office of Research & Development Department of Veterans Affairs |
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| 4:00 p.m. | Adjourn Workshop Day 2 |
