Mastering Oncology Immunotherapy Clinical Trials:
The Smaller BioPharmaceutical Perspective
About this webinar
This complimentary webinar explores challenges smaller companies should consider when embarking on immunotherapy studies.
The reality of leveraging a patient’s immune system to disrupt cancer through immunotherapy is compelling. Standards of care are shifting, and drug developers are eager to leverage new technologies. Small to mid-sized biopharma companies play significant roles in innovating and adapting drug designs to create new immunotherapies, and often require outsourcing support to manage clinical investigations.
In this webinar, we’ll explore five areas of focus for smaller companies to understand in order to fully leverage the potential of immunotherapy candidates – and get it right the first time.
- Protocol design and endpoint selection
- Retaining the right patients
- Dose-escalation strategies and measuring response
- Reactions
- Patient Education
Learning Objectives
- Learn what to include in a well-written protocol to ensure successful recruitment and data collection, as well as guidance for investigators and site staff new to immunotherapy trials.
- Understand how to select measurable endpoints and when to consider pharmacodynamic (PD) endpoints for bioequivalence studies.
- Gain an understanding of dosing and patient response challenges unique to immunotherapy trials, including dose-escalation, irRC versus RECIST, and pseudo disease progression.
- Recognize the distinct challenges smaller companies face when embarking on immunotherapy studies.
Who should attend
- VPs/Directors of Clinical Operations / Outsourcing / Procurement / Project Management / Study Management
- Immuno-oncology/Oncology division leaders
- Data Managers
- Medical Monitors
- Medical Advisors
Featured Speakers
Andrew Zupnick, Ph.D.
Dr. Andrew Zupnick is the head of strategy for the Oncology Division at Novella Clinical. Focused exclusively in oncology research for more than 15 years, Dr. Zupnick provides strategic guidance to the oncology business development and operational teams as well as consultative and account oversight for oncology customers. Additional roles at Novella include development of custom, protocol-centric solutions for new oncology projects, training to internal staff on drug mechanisms and industry trends, and the pursuit of new initiatives for the Oncology Division, including its recent sub-specialty focus in immuno-oncology. Dr. Zupnick holds a Ph.D. in biological sciences, cell & molecular biology with a focus in oncology (mechanisms of the tumor suppressor p53) from Columbia University and pursued his undergraduate research in biology and biomedical engineering at the Massachusetts Institute of Technology.
Julia Lawrence, D.O.
Dr. Julia Lawrence is a board-certified medical oncologist with 18 years of experience in clinical oncology and cancer research. She was a program director for the National Cancer Institute for three years where she worked on biomarkers for drug development. She has worked in the private sector for clinical practice and then 13 years in academia at Louisiana State University and Wake Forest University. Dr. Lawrence has conducted clinical trials in the treatment of breast cancer and cooperated on clinical trials for colorectal, lung cancer and prostate cancer. She also developed clinical trials to monitor and prevent the late effects of cancer treatment to the cardiovascular, central nervous system and hematologic system. Dr. Lawrence earned her D.O. from New York College of Osteopathic Medicine and completed undergraduate studies in psycho-biology at New York University.
Partner for this event
Novella
Novella Clinical, a Quintiles company, is a full-service clinical research organization specializing in oncology clinical trials for small and mid-sized sponsors. Novella’s dedicated oncology division is comprised of more than 500 oncology clinical trial specialists across all functional areas. Headquartered in Research Triangle Park, NC, and with active oncology work in 45 countries, Novella Clinical provides the experience and insight to bring oncology drugs to market on time and on budget. Learn more at www.novellaclinical.com/oncology.
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