Immuno-Oncology Clinical Trials: Best Practices for Clinical Development of Immunotherapies

Advances in Immuno-oncology have given oncologists and their patients reason to be encouraged—the launch of immune checkpoint inhibitors and development of other immunotherapy assets for the treatment of several difficult-to-treat diseases, including metastatic melanoma and non-small cell lung cancer, represents great progress. Novel immunotherapy agents activate the human immune response against antigens expressed on tumor cells; many immunomodulatory approaches against both clinically validated and novel targets are being tested. The industry is seeking to optimize immunotherapies based on a rapidly growing body of knowledge about tumor biology and the human immune response.

Bringing the first group of immune checkpoint inhibitors to approval and thus providing wide access for patients required overcoming a number of developmental challenges. The challenges included adjustments in trial design, efficacy endpoint assessment and safety evaluation. To enhance the possibility of success in the development of immuno-oncology drugs, biopharmaceutical sponsors need to understand the special challenges and partner with organizations that have specific expertise with the clinical development of these agents. Furthermore, the rapid pace of the changing landscape as new knowledge is developed requires a keen eye on the future of the market.

This webinar summarizes key aspects of evaluating safety and efficacy in studies of immune checkpoint inhibitors and describes operational strategies that support successful trial execution and regulatory approval. In this session, the panel will present medical and operational lessons learned from past immuno-oncology trials and an assessment of the current pipeline of immunotherapy agents and the coming market trends.

Learning Objectives

• Understand key concepts that define immuno-oncology
• Learn best practices in medical management of immune-related AE management and response criteria
• Identify considerations for operational planning and execution on immunotherapy clinical trials
• Learn about the competitive landscape and commercialization of immunotherapy assets

Speakers

Thomas Moehler, MD, PhD, Vice President, Medical & Scientific Affairs, Hematology/Oncology, inVentiv Health

Dr. Moehler has over 20 years of experience in hematology/oncology drug development. He is a board certified internist and board certified hematologist and oncologist with a wide range of clinical experience in hematology and oncology indications including supportive care. Dr. Moehler is an experienced medical monitor in global clinical studies. He has been involved in many consulting activities for Pharmaceutical and biotechnology companies in a large variety of indications and study drugs. Dr. Moehler is an expert in providing drug development plans and in strategic planning for regulatory agency submissions and presentations to regulatory agencies (e.g. FDA, India FDA, EMA). Dr. Moehler served as medical representative in planning and conduct of several phase IV and health economic projects including submissions and presentations to regulatory agencies.
Dr. Moehler has extensive experience in biomarker co-development and imaging. His experience in clinical cancer research is completed by his expertise in pre- clinical and experimental cancer research. Dr. Moehler holds an appointment as associate professor of medicine since 2004. He is scientifically successful as author or co-author on more than 100 peer-review original reports e.g. in Lancet, Blood and Clinical Cancer Research on a range of diagnostic and therapeutic research topics in cancer patients as well as preclinical models of cancer therapy. In addition, Dr. Moehler has contributed to many congress abstracts, reviews, books and book chapters on various hematology/oncology aspects.

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Cheryl Askew, PhD, Senior Director, Program Delivery, Hematology/Oncology, inVentiv Health

Dr. Askew has more than 20 years experience in research with twelve years clinical research experience. She has led numerous phase I-IV global oncology and hematology studies. Dr. Askew’s oncology experience includes solid tumors (renal, pancreatic, prostate, melanoma, lung, head and neck, and breast) as well as hematologic malignancies (chronic myelogenous leukemia, chronic lymphocytic leukemia, acute lymphoblastic leukemia, multiple myeloma, extranodal NK/T lymphoma, non-Hodgkin’s lymphoma, and Hodgkin’s lymphoma). She is published in the Journal of the American Chemical Society and has more than eight years experience in bio-inorganic chemistry research.

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Jessica Lee, PhD, Senior Engagement Manager, Campbell Alliance (an inVentiv Health Company)

Jessica Lee, PhD, is a senior engagement manager in the Commercial Strategy Practice of Campbell Alliance, the consulting business line of inVentiv Health. Her consulting expertise includes market opportunity assessments, therapeutic area growth strategies, indication and disease assessments, portfolio strategies, clinical development strategies, and launch strategies. She also has experience working across multiple therapeutic areas, including immuno-oncology, immunology, hematology, oncology, nephrology, neurology, ophthalmology, and pain management.
Before joining Campbell Alliance, Dr. Lee worked for ClearView Healthcare Partners, a boutique strategy consulting firm for Pharmaceutical and biotechnology companies. In addition to her consulting experience, she spent over ten years conducting basic and translational research, first at the University of Washington and then Johns Hopkins University. She received competitive Howard Hughes Medical Institute fellowships to support her research. Dr. Lee earned her PhD in immunology from Johns Hopkins University School of Medicine. She also holds a BS in cellular and molecular biology as well as a BA in communications from the University of Washington.

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