For Immediate Release: April 23, 2019
513-579-9911 x 12627
Challenges and Considerations in Designing and
Conducting Immuno-Oncology Clinical Research
Hear Perspectives from Medical, Central Lab and Imaging Core Lab Experts
CINCINNATI, OH – (April 23, 2019) – Join experts from Medpace’s medical department, central lab and imaging core lab in an interactive discussion aimed at addressing the challenges and considerations in designing and conducting Immuno-Oncology clinical research.
WEBINAR: Challenges and Considerations in Designing and Conducting Immuno-Oncology Clinical Research
DATE: Thursday, May 09
TIME: 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
DURATION: 60 Minutes
About the Webinar
Given the accelerating pace of immuno-oncology (I-O) clinical research, awareness of the specific challenges and considerations in designing and conducting successful trials for these new agents is critical. Medpace medical department, central lab, and imaging core lab experts discussed lessons-learned, best practices and the importance of considering the most appropriate biomarkers, safety testing, and imaging needs early in the planning process. Topics include:
- Medical and operational considerations when designing immunotherapeutic trials including:
- Carefully considering eligibility criteria
- Designing timely site communication
- Maintaining research subject calendars
- Employing standard guidelines developed for the assessment of disease response and toxicities
- Selecting appropriate biomarkers to address the interplay between the immune system and tumor:
- Tumor antigens
- Inflamed tumor markers
- Immune suppression markers
- Host environment factors
- Imaging considerations:
- Types of imaging that are useful as end-points in immuno-oncology trials
- I-O imaging-related response criteria including Response evaluation criteria in solid tumors (RECIST), irRC, irRECIST, and iRECIST
- Nuclear medicine imaging and I-O response criteria including PERCIST and Lugano
- Optimization of database structures for imaging endpoints in I-O trials including how to structure EDC and eCRF
About the Presenters
Gregory Hale, MD, Senior Medical Director, Hematology & Oncology, Medpace
Dr. Gregory Hale is a physician with over 26 years of experience in all phases of clinical development, with expertise in hematopoietic stem cell transplantation, cellular and gene therapies and immuno-oncology. 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.
El Mustapha Bahassi, PhD, Associate Director, Clinical Laboratory, Medpace
Dr. El Mustapha Bahassi is a research scientist with over 20 years of clinical and research laboratory experience. He is experienced in biomarker development and well-versed in various molecular biology techniques such as DNA cloning, PCR, protein purification, mass spectrometry, flow cytometry, mouse modeling, mammalian/bacterial cell culturing, and cell-free DNA/circulating tumor cells manipulation. He received his PhD in Molecular Biology and Biotechnology from the University of Brussels in Belgium. He then joined the University of Texas Southwestern Medical Center in Dallas as a postdoctoral fellow in Molecular Oncology. Following his training at UT Southwestern, Dr. Bahassi moved to the Department of Cancer Biology at the University of Cincinnati and later became a faculty member in the Division of Hematology/Oncology. As an independent faculty, Dr. Bahassi developed a translational line of research where he worked closely with clinical oncologists to develop new companion diagnostics using cutting-edge genomic technologies.
Jess Guarnaschelli, MD, Medical Director, Hematology & Oncology, Medpace
Dr. Jess Guarnaschelli has 15 years of experience in clinical oncology. She is board-certified in radiation oncology, with clinical experience in numerous indications including breast cancer, gynecologic cancers and other adult solid tumors. Prior to joining Medpace, she was an assistant professor at the University of Cincinnati College of Medicine. During her academic career, she focused on novel treatments and supportive care methods for patients with solid malignancies. She was the principal investigator of multiple oncology clinical trials and received numerous funding awards. She has held nationally recognized leadership positions and is a frequently invited speaker at national and international conferences. Locally, she was the moderator of the University of Cincinnati breast tumor board for four years and now remains active in boards and advisory committees focusing on women’s cancer initiatives. Dr. Guarnaschelli received her BA in Biology at Brown University and her MD from the University of Louisville School of Medicine.
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,900 people across 36 countries.