The Challenges of Cancer Immunotherapy Development and Ensuring Durability of Response

Original Air Date:  Wednesday, September 2, 2020
Time:  10:00 AM EDT/4:00 PM CET

Although cancer immunotherapy has entered the treatment mainstream and holds the potential for long-term durable responses, only a minority of patients currently respond to these treatments. The translation of preclinical findings to human cancer has been limiting and preclinical researchers are being challenged to develop more predictive models. Resistance to immunotherapy is multifaceted and complex and understanding the tumor microenvironment and how to potentially modulate it is critical to achieving long term patient response.

The panel’s presentation will begin with a preclinical development segment and move into clinical development while highlighting the key inflection points where strategic considerations can move a development program to clinical success.

A panel of CATO SMS experts and a practicing oncologist will review the key challenges encountered during the development of cancer immunotherapies and offer thoughts on development strategies to ensure clinical success.

Finally, we will discuss the future of data in clinical trials – looking at synthetic control arms as stepping stones to larger applications of data. The complete actualization of data’s potential could reshape our industry and significantly ameliorate the disease burden of at-risk populations across the therapeutic spectrum.

Learning Objectives

  • What is the optimum preclinical data package (e.g., tumor models, toxicology profile) that is needed to support the rationale to transition to the first in human study?
  • What are the considerations for clinical trial design and the interplay with the selection of biomarker, subject population, and evaluable endpoints?
  • How is immune scoring being utilized as a prognostic factor in therapy decision-making and how to include scoring in study protocols?
  • What are the evolving novel targets in the current pipeline, and which therapies are implementing cutting-edge development strategies?



Denis R. Miller, MD
Adjunct Clinical Professor of Pediatrics, Division of Medicine, University of Utah Medical School
Clinical Oncology-Hematology Consultant to CATO SMS

Dr. Denis Miller began his education at Cornell and post-doctoral training at Boston Children’s Hospital. He led divisions at the University of Rochester, Cornell, Memorial Sloan Kettering Cancer Center, and Northwestern. His major area of clinical and laboratory research was initially in inherited abnormalities of red blood cell hemoglobin, membrane, and metabolism. Major contributions scientifically during this “academic” period included identifying new ongenital hemolytic anemias including a defect in the RBC membrane associated with stomatocytosis and the first kinetic aberration in RBC pyruvate kinase (PK) deficiency. Dr. Miller expanded his focus to hematopoietic malignancies, including leukemia and lymphoma and maintained interest and involvement in congenital hemolytic anemias. He served as Vice Chairman of Childrens Cancer Group (now Childres Oncology Group) and directed the Group’s acute lymphoblastic leukemia (ALL) Bone Marrow Reference Laboratory.


Inka Pawlitzky, PhD
Director Oncology Drug Development Affairs

Inka Pawlitzky has over 12 years of oncology translational and drug development experience, and heads the Oncology Drug Development Affairs team at CATO SMS. An immunologist by training (PhD Tufts Medical School, Boston), she completed postdoctoral fellowships (Max-Planck Institute for Immunobiology and Epigenetics and Netherlands Cancer Institute) investigating the regulation of DNA rearrangements and pluripotency mechanisms in tumorigenesis. As senior scientist at Leica Biosystems she gained expertise in companion diagnostics. Since 2017, Inka is responsible for providing expert consultancy services for innovative new cancer therapies in terms of drug and clinical development planning and regulatory strategies, with particular emphasis on emerging immunotherapies.


Jack Snyder, MD, JD, PhD
Assistant Managing Director

Jack Snyder, BS, MD (Northwestern), JD (Georgetown), PhD (MCV), MFS (GeoWash), MPH-MBA-MSIS (Johns Hopkins) currently directs the Washington office of CATOSMS, serves on the Board of Directors of the American Board of Toxicology, holds a New York Certificate of Qualification to direct clinical laboratories, maintains board-certifications in Addiction Medicine, Medical Toxicology, General Toxicology, Clinical Informatics, Occupational Medicine, General Preventive Medicine, Pathology (Anatomic, Clinical & Chemical), Chemistry (Toxicological & Clinical), Quality Assurance & Utilization Review, Legal Medicine, Public Health, and Regulatory Affairs (US, Europe, Canada, Global), and has been certified as a Project Management Professional, Physician Investigator, Physician Executive, and Medical Review Officer.

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