Keynote Speakers:

Cellular Engineering at the National Institues of Health
A Four Decade Journey Toward an Ever Advancing Frontier

Keynote Speaker: Harvey Klein, MD, National Institutes of Health, Clinical Center Senior Staff, Chief, Department of Transfusion Medicine

Harvey G. Klein, MD graduated magna cum laude from Harvard College and earned his medical degree from the Johns Hopkins School of Medicine. After an internship, residency and fellowship in hematology at Hopkins, Dr. Klein came to the National Institutes of Health in 1973, becoming chief of the Clinical Center's Department of Transfusion Medicine in 1984. He maintains his ties with Hopkins as a visiting professor in pathology and medicine. Dr. Klein is known nationally and internationally for his expertise in blood transfusion. He is widely published on such topics as blood policy, transfusion-transmitted disease, blood storage, and the impact of biotechnology on transfusion medicine. He co-authored the twelfth edition of Mollison's textbook, Blood Transfusion in Clinical Medicine, and has held editorial roles with several publications, including Blood, Transfusion, Transfusion Medicine Reviews, and the Journal of Clinical Apheresis. Dr. Klein has an extensive list of professional activities that includes serving on the Institute of Medicine Blood Safety Forum, the Secretary's Advisory Committee on Blood Safety and Availability, the WHO Committee on Biologicals Standardization, the FDA Blood Products Advisory Committee, and the UK Research Review Committee for Blood and Transplantation; chairing the US Pharmacopoeia Blood and Blood Products Committee and the American Red Cross Medical Advisory Council; and serving as president of the American Association of Blood Banks and the National Marrow Donor Program Council. 

Clinical Development, FDA Approval, and What’s Coming Next for Genetically Engineered Cellular Immunotherapies
Keynote Speaker: Bruce Levine, Ph.D., Barbara and Edward Netter Professor in Cancer Gene Therapy; University of Pennsylvania Perelman School of Medicine

Bruce L. Levine, PhD is the Barbara and Edward Netter Professor in Cancer Gene Therapy and the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. Dr. Levine has overseen the production, testing and release of 3,000 cellular products administered to >1,200 patients in clinical trials since 1996. T lymphocytes from cancer patients have been redirected with chimeric antigen receptors (CAR's) to hunt and destroy their malignancies. This therapy, developed by the CVPF and licensed by Novartis, recently became the first FDA approved gene therapy (Kymriah). Dr. Levine is co-inventor on 23 issued US patents and co-author of 140 publications with a Google Scholar citation h-index of 72. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania.

Cellular Therapy: Clinical Applications and Studies

Keynote Speaker: Enkhtsetseg (Enkhee) Purev, MD, PhD, Assistant Professor of Medicine, University of Colorado School of Medicine, Division of Hematolog

Dr. Purev has a broad understanding of biomedical research with specific training in molecular cloning, immunology, and cell biology. She obtained her Ph.D. training at Temple University and postdoctoral training at Harvard/Yale Universities. She obtained her M.D. in Mongolia and had vigorous clinical training in the Internal Medicine residency program at the University of Medicine and Dentistry of New Jersey (UMDNJ). She joined the hematology fellowship program at the National Heart, Lung, and Blood Institute in NIH. She cared for patients with large variety of hematologic disease, with particular stress on bone marrow failure patients, leukemia and bone marrow transplant. She trained with Dr. Richard W. Childs at NHLBI, one of the world leaders in translational and clinical research. Caring for patients under clinical trial protocols, she learned how to run and monitor clinical trials, and how to establish and carry collaborations with other researchers. The University of Colorado Health System is the referral center for blood cancer and bone marrow transplant in the Rocky Mountain Region with both the cGMP facility (ClinImmune Labs) required to manufacture and deliver cell-based treatments as well as the cGCP expertise (HCTU) to execute clinical trials, respectively.

IMMUNOLOGY SUMMIT | AGENDA

1:00pm:  Event Kickoff
Welcome from the NoCoBio Cluster Director, Ben Walker
Remarks from Dr. Thomas Downes, Chief Medical Officer, UCHealth Northern Colorado

Clinical Development, FDA Approval, and What’s Coming Next for Genetically Engineered Cellular Immunotherapies
Keynote Speaker: Bruce Levine, Ph.D., Barbara and Edward Netter Professor in Cancer Gene Therapy; University of Pennsylvania Perelman School of Medicine
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Since the 1990’s, we have conducted clinical trials of gene modified T cells. Chimeric antigen receptor (CAR) T cells targeting CD19 on B cells leukemias and lymphomas have induced durable complete responses in patients who are relapsed or refractory to all other available treatments.  This synthetic biology technology has now undergone global multi-center clinical trials and recently received FDA approval (Kymriah^TM, Novartis) in relapsed/refractory acute lymphoid leukemia in children and young adults.  CAR T cells targeting new targets in hematologic malignancies and in solid tumors are underway and provide demonstration that it is possible to design immunity at will for therapeutic application. The road forward for wide patient access to these uniquely personal cellular therapies depends not only on scientific progress in targeting, gene modification and cellular manipulation, but also on meeting automation, engineering, and health policy challenges.

Industry Speaker: AxImmune
Revolutionizing cancer therapy and pioneering immune activating therapies
Speaker: Patrick Bols, CEO of AxImmune

Industry Speaker: PhotonPharma, Inc.
Delivering effective and affordable immunotherapy treatments for solid organ tumors
Speaker: Raymond Goodrich, PhD, Executive Director, Infectious Disease Research Center, Office of the Vice President for Research, Professor, Department of Microbiology, Immunology and Pathology
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PhotonPharma, Inc., a new biotech startup based at the Research Innovation Center at Colorado State University and an offshoot of research work of Colorado State University Professors Dr. Raymond Goodrich and Dr. Amanda Guth, is focused on developing methods that utilize photochemical processes for the development of immune therapy applications. The basic technology of the company employs photochemical sensitizers that are activated by light of specific wavelengths to carry out chemical modifications to organisms containing nucleic acids. The modifications induced by these processes render the test article unable to replicate and hence transmit or convey disease. The specificity of the chemistry preserves the antigen profile and integrity and maintains protein structure in its native state. The inactivated cellular, bacterial, parasitic or viral agents that are treated by this process thus provide a source for antigen presentation without the potential for risk of spread of the disease.  Such preparations treated with this procedure can be used as vaccine agents or stimulants for immune system priming and recognition that foster immune response to disease causing agents in patients with existing conditions.

2:40pm:        15 Minute Break

Introduction of Enkhtsetseg (Enkhee) Purev, MD
Steven R. Schuster, MD, Medical Director, Oncology Clinical Research Northern Region
Cancer Care and Hematology, University of Colorado Health

Cellular Therapy: Clinical Applications and Studies

Keynote Speaker: Enkhtsetseg (Enkhee) Purev, MD, PhD, Assistant Professor of Medicine, University of Colorado School of Medicine, Division of Hematology

Cellular Therapy: The Advancing Frontier of Transfusion Medicine
Speaker: Harvey Klein, MD, National Institutes of Health, Clinical Center Senior Staff, Chief, Department of Transfusion Medicine
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Blood transfusion represents the first example of a cellular therapy. But the last half century has witnessed a dramatic convergence of biologic discovery and technologic advances that have redefined this concept well beyond intravenous infusions of unmanipulated blood cells.
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The National Institutes of Health (NIH) has pioneered advanced cellular therapies through its intramural programs, extramural funding, and partnering with industry. Cellular gene therapy through gene replacement, gene enhancement, and gene correction now treat a wide variety of neoplastic, infectious, and genetic disorders. Pluripotent stem cells are already in human trials.
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NIH contributions to this discipline will be discussed with emphasis on the role of the NIH intramural program and future studies and opportunities.

3:55pm: Immunology Panel 
Moderated by Terry Opgenorth, PhD. 

Panelists: 

• Steven R. Schuster, MD, Medical Director, Oncology Clinical Research Northern Region
• Enkhtsetseg (Enkhee) Purev, MD, PhD, Assistant Professor of Medicine, University of Colorado School of Medicine, Division of Hematology
• Bruce Levine, Ph.D., Barbara and Edward Netter Professor in Cancer Gene Therapy; University of Pennsylvania Perelman School of Medicine
• Harvey Klein, MD, National Institutes of Health, Clinical Center Senior Staff, Chief, Department of Transfusion Medicine
• Raymond Goodrich, Ph.D., Executive Director, Infectious Disease Research Center, Office of the Vice President for Research, Departmnet of Microbiology, Immunology and Pathology.

4:45pm: Networking begins until 6:00pm