Cambridge Healthtech Institute’s 2nd Annual

Symposium: Immunology for Biotherapeutics
( 심포지엄:생물학적 제제를 위한 면역학 )

치료상 이점을 제공하는 면역계에 대한 이해와 조작


Final Agenda

9:30 am – 5:45 pm | 2019년 10월 15일(화)

Drug Discovery와 개발 분야에서 주목해야 할 동향의 다수는 면역 반응 및 조작과 제어에 관련된 것으로, 치료 대상 질병과 치료에 대한 면역 관여를 해명하는 작업도 빠르게 진행되고 있습니다. T 림프구와 B 림프구의 서브세트, 선천성 림프세포(ILC), 마크로파지, 수상세포, 사이토카인은 모두 복잡한 형태로 면역에 관여하고 있으며 이것을 조작함으로써 치료상 이점이 초래되는 반면, 이 점에 대해 충분히 이해해 두지 않으면 중대한 결과를 초래할 가능성이 있습니다. 이 심포지엄에서는 안전성에 관련된 잠재적인 문제를 놓치지 않고 면역계를 활용하여 억제인자를 극복하는 방법 등이 소개됩니다.

8:30 am Registration and Morning Coffee

면역 기구에 관한 현재의 이해

9:30 Chairperson’s Opening Remarks

Ethan M. Shevach, MD, Senior Investigator, Laboratory of Immune System Biology, National Institute of Allergy and Infectious Diseases, NIH

9:40 Keynote Presentation: Current Understanding of the Role of T Regulatory Cells and their Modulation

Shevach_EthanEthan M. Shevach, MD, Senior Investigator, Laboratory of Immune System Biology, National Institute of Allergy and Infectious Diseases, NIH

The major role of the immune system is to provide protective responses to pathogenic microorganisms. The immune system consists of several distinct cell types and each type plays a unique role. Dysregulation of the immune system can result in responses against self-antigens and in the development of autoimmune diseases. A specialized subset of T lymphocytes, termed T regulatory (Treg) cells, functions to suppress anti-self responses. Modulation of Treg function with drugs or biologics represents a major approach to the treatment of autoimmune disease.

10:10 Antigen Processing and Presentation: The Basis of T Cell Activation

Natarajan_KannanKannan Natarajan, PhD, Staff Scientist, National Institute of Allergy and Infectious Diseases, NIH

Antigen-presenting cells process protein antigens into peptides for binding by either Major Histocompatibility Class I (MHC-I) or Class II (MHC-II) molecules which are then displayed at the cell surface as peptide/MHC complexes where they are recognized by T cell receptors leading to T cell activation. Cell biological, biochemical, and structural details of these processes as we now understand them will be discussed.

10:40 The Role of the Innate Immune System and Implications for Biotherapeutics

Shih_Han-YuHan-Yu Shih, PhD, MS, Research Fellow, National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS), NIH

The field of innate lymphoid cell (ILC) biology has progressed rapidly, with appreciation of these cells’ role in immunity, barrier tissue integrity, and homeostasis. Unlike Th cells, ILCs respond to pathogens promptly without the need of antigen-specific receptor recognition. Understanding how ILCs differentiate and contribute to the immunoregulation in health and diseases is fundamentally important for the development of new strategies to treat autoimmunity, infection, and cancer.

11:10 Networking Coffee Break

11:30 Role of IgE and IgG/IgG4 in Modulating Type 1 Hypersensitivity Reactions in Human Allergic Disease

Hamilton-RobertRobert Hamilton, PhD, Professor, Medicine and Pathology, Division of Clinical Immunology and Allergy, The Johns Hopkins University School of Medicine

This presentation will overview the 4 areas of hypersensitivity: immediate-type 1-IgE-mediated, type II-antibody-dependent cytotoxicity, type III-immune-complex-mediated and delayed-type hypersensitivity. Type 1 human allergic disease will then be examined, covering its pathophysiology, current diagnostic strategies, 4 modes of disease management, and special caveats relating to food, drug, venom, and respiratory allergic disease. Finally, the new discipline of molecular allergology will be highlighted with an emphasis on 10 cross-reactive allergen families and how allergenic molecules have improved the accuracy of allergy diagnosis.

생물학적 제제를 위한 면역계의 이용

12:00 pm Applying Bispecific Technology to Modulate the Immune Response for Therapeutic Intervention

Moore_PaulPaul Moore, PhD, Vice President, Immunology and Cell Biology, Macrogenics, Inc.

Bispecific antibody-based molecules afford therapeutic opportunities not feasible with single-target antibodies or combinations. The most advanced clinical strategy in oncology exploits the ability of bispecific molecules to co-engage T cells with tumor cells resulting in tumor cell lysis and T-cell expansion. Additional approaches to leverage immune cells through bispecific targeting are being explored in oncology, autoimmunity, and infectious diseases. These approaches will be summarized in the context of molecule design and target selection.

12:30 Immunology Safety Considerations for Biotherapeutics

Dixit_RakeshRakesh Dixit, PhD, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune, Inc.

In this presentation, I shall examine the challenges of biotherapeutics impacting the immune response, and the challenges investigators face managing dose, scheduling, and satisfying the regulatory requirements. The checkpoint inhibitors used for immunotherapy have a natural role in controlling autoimmune diseases, such as Type 1 Diabetes and Lupus. Immunotherapies in general, and technologies modifying T-cell function and those involving cytokines, present dangers of autoimmune disease, cardiovascular disorders, and additional challenges, especially when used in combination.

1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:30 Session Break

2:25 Chairperson’s Remarks

Rakesh Dixit, PhD, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune, Inc.

2:30 Biopharmaceutical Product Immunogenicity: What Causes It and What are the Safety and Efficacy Consequences?

Rup_BonnieBonita (Bonnie) Rup, PhD, Biopharmaceutical Consultant, Bonnie Rup Consulting LLC

Biopharmaceuticals represent a rapidly growing class of therapeutic product, contributing significantly to advancing treatment of serious diseases, including chronic inflammatory and autoimmune diseases, genetic deficiencies, and cancer. Unfortunately, unwanted immunogenic responses against some of these products can occur, often reducing efficacy and sometimes causing safety consequences, such as hypersensitivity, immune complex disease, and autoimmune syndromes. In this talk, factors that affect the degree to which the immune system responds, and the degree to which the response affects the efficacy and safety are discussed.

3:00 Featured Presentation: Benefits and Limitations of Humanized Mouse Models for Preclinical and Immunogenicity Testing

Kristina E. Howard, DVM, PhD, Staff Fellow, Division of Drug Safety Research, FDA/CDER


3:30 Vaccines: Understanding the Mode of Action, Progress to Date, and On-Going Challenges

Lacy_MichaelMichael Lacy, PhD, Director, Nonclinical Immunology and Bioanalysis, Emergent BioSolutions

Complex immune responses result from the complexity of whole pathogen vaccines. Vaccines can be simplified to 3 general components, each of which is supplied by whole pathogens in a convenient package or can be mimicked using more defined components. Emerging safety issues may lead to purified and quantified vaccine components, such as synthetic immune stimulants and antigens, leading to more focused immunity. Formulations may preserve epitopes and control unwanted immunity. Selection of conserved epitopes may bypass rapid mutational rates of pathogens and bypass the unwanted effects of nontarget immunity.

4:00 Networking Refreshment Break

암 면역치료

4:20 Harnessing the Body’s Natural Immune Response to Fight Cancer

Forman_DaronDaron Forman, PhD, Principal Scientist, Bristol-Myers Squibb

Checkpoint inhibitor as cancer treatment has shown remarkable response rates in previously hard-to-treat cancers by redirecting the body’s own immune system to recognize and eliminate tumor cells.

Here we will discuss the current state of I-O agents in the clinic, challenges related to toxicities, biomarker approaches for patient stratification, and future directions of the field.

4:50 Adoptive T Cell Therapy

Melenhorst_JosJ. Joseph (Jos) Melenhorst, Ph.D., Director, Product Development & Correlative Sciences, Center for Cellular Immunotherapies, University of Pennsylvania

I will discuss the evolving field of adoptive T cell therapy, and compare and contrast tumor targeting efforts with allogeneic, autologous minimally manipulated to the TCR and CAR-redirected T cells. Topics to discuss are safety, efficacy, toxicity; clinical trials in hematologic and solid tumors; and future directions to enhance immunogene therapy of cancer.

5:20 Discussion

5:45 End of Symposium

6:15 Dinner Short Course Registration

6:30 pm – 9:30 pm Recommended Dinner Short Course*

SC3: Validation of ADA Assays and Cut Point Calculations

*Separate registration is required.

* 주최측 사정에 따라 사전 예고없이 프로그램이 변경될 수 있습니다.

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