Infectious Diseases in the Immunocompromised Host – A Dynamic Landscape with Challenges for Clinical Development

Join medical experts from Medpace’s Infectious Diseases and Hematology/Oncology teams in an interactive discussion of infectious diseases in the immunocompromised host—with a focus on hematologic malignancies and hematopoietic cell transplantation patients—and the unique challenges for clinical development. Key topics for discussion will include:

• New therapeutic approaches for hematologic malignancies and their impact on the immune system
• Changes in the incidence, nature, epidemiology, timing, and resistance profile of selected opportunistic infections observed with the new treatment modalities
• Identification of the growing current unmet medical needs in the field of infections in these immunocompromised hosts
• Challenges in the design and implementation of development programs aimed at addressing these emerging unmet medical needs

Recent changes in antitumor therapy and hematopoietic cell transplantation (HCT, or bone marrow transplantation) are affecting the pattern of immunosuppression previously known in this patient population. The shift from myeloablative treatment of leukemia, as well as conditioning regimen for HCT, to a more targeted or immunomodulatory approach, combined with the increasing indications and number of unconventional graft sources, are affecting a shift from depletion of the innate immune system (intense neutropenia followed by relative lymphopenia recovering within a few months), to a depletion of the specific immune system (targeting B or T cell depending on the regimen) for longer periods of time.  These changes in hemato-oncology therapeutics are leading to changes in the nature (e.g., from bacterial to viral), pathophysiology (e.g., reactivation versus or combined with primary infection), incidence of, and therapeutic approach for infections in this patient population. Furthermore,the timing of these infections is starting to shift from those defined during the meyloablative era. Following a worldwide increase in resistant bacteria, the emergence of multi-drug resistant strains has also affected hematological wards, including the HCT setting. The clinical impact of resistant bacteria is worrisome, with an increasing mortality of infections produced by these strains.

Speakers

Hervé Momméja-Marin, MD, Senior Medical Director, Infectious Diseases & Vaccines, Medpace

Dr. Hervé Momméja-Marin is an internal medicine and infectious disease specialist with over 15 years of experience in clinical research, in both the biotech and CRO industry. Herve has led multiple development programs for anti-infectives, with a particular emphasis in infections in the immunocompromised host, including orphan indications. He received his medical degree from the University Pierre et Marie Curie in Paris France.

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Anibal Calmaggi, MD, Senior Medical Director, Infectious Diseases & Vaccines, Medpace

Dr. Anibal Calmaggi is board certified in infectious diseases and has more than fifteen years of director-level clinical operations and medical affairs experience. His extensive clinical practice experience included a position as the infectious disease consultant in a bone marrow transplant unit for more than a decade. He has actively participated in National Scientific Societies as a member of the Committee of Infections in Patients with Cancer and hematopoietic Cell Transplant at the Argentinian Infectious Diseases Society of Infectology. Dr. Calmaggi is co-author of several clinical guidelines in infectious diseases, including prevention and treatment of opportunistic infection in cancer and HCT patients. Dr. Calmaggi is a regular speaker in Infectious Diseases Medical Conferences covering different aspects of infection in immunocompromised hosts. He received his medical degree from the National University of La Plata in Argentina.

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Gregory Hale, MD, Senior Medical Director, Hematology & Oncology, Medpace

Dr. Gregory Hale is an experienced physician with 24 + years of experience in all phases of clinical development with expertise in hematopoietic stem cell transplantation, cellular and gene therapies, and hematologic malignancies. Dr. Hale has served as clinical director of the Transplant and Gene Therapy Program at St. Jude Children’s Research Hospital and Medical Director of the Division of Hematology/Oncology at Johns Hopkins All Children’s Hospital.  Most recently he was Professor of Oncology at Johns Hopkins and has authored more than 200 peer-reviewed manuscripts, review articles and book chapters.  He has held leadership positions in the National Marrow Donor Program (NMDP) and the Center for International Blood and Marrow Transplant Registry (CIBMTR). He earned his medical degree from the Joan C. Edwards School of Medicine at Marshall University.  He completed his pediatrics residency at Children’s Hospital of Pittsburgh, and his pediatric hematology/oncology fellowship at St. Jude Children’s Research Hospital.

 

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