Immuno-Oncology Xchange West Coast 2019
Immune Biomarkers
- What emerging predictive biomarkers have the potential to be disruptive in the current clinical setting?
- Will less invasive biomarkers (e.g. ctDNA, other blood-based biomarkers) overtake and displace tumor tissue-based predictive biomarkers in the I-O clinical space?
- What challenges do you see with multiple biomarkers being utilized in the I-O clinical space? Is there a role to use multiple biomarkers even in monotherapy treatment?
- Beyond predictive biomarkers for anti-PD1 monotherapy, what is the strategy to predict response to combination therapies? Will multiple biomarkers be necessary to appropriately identify patients most likely to benefit from various combination therapies?
- What is the relative role for assessing exploratory/mechanistic biomarkers in a clinical trial vs. primary, formal biomarkers on a regulatory path to CoDx development (e.g. patient segmentation listed on the label)?
Executive Director, Profiling & Expression, Translational Medicine
Merck
Terri McClanahan is currently the Executive Director of the Profiling & Expression group in Translational Medicine at Merck Research Laboratories. Her group combines multiple molecular, cellular and tissue-based approaches to interrogate disease mechanisms, working closely with discovery biologists and drug development teams to provide mechanistic data, disease association and biomarkers of drug response. She oversees and integrates the work of several key areas utilizing multiple tissue-based methodologies including histopathology, flow cytometry, cell sorting and molecular profiling, to support projects spanning from the earliest novel discovery projects to IND-enabling mechanistic studies, tissue, cell type and disease tissue expression profiling, and translational biomarker discovery, with a specific emphasis on immune regulation and immune-oncology.
- Monitoring changes in patient cancer in realtime
- Patient comfort and ease of frequent diagnosis through liquid biopsies
- Technical challenges in isolation of exosomal vesicles
- Challenges in validation, identification of function and profile
- Confluence of advanced analytical methods such as multiplexed proteomics, sequencing, PCR, cell-based assays and other method
Chief Executive Officer
MD Bioscience
Eddie Moradian received his PhD in biotechnology from the Swiss Federal Institute in Zurich, Switzerland. Since 1987, he has been a founder or co-founder of a series of companies in the biotechnological, pharmaceutical and diagnostic industries with presence in Europe, US and Israel. At MD Biosciences, he leads a global group of companies founded in 1991, each individually focused on drug development, preclinical contract research services and CLIA clinical biomarker diagnostic development and analysis services.
- How to design tangible and effective biomarker testing plans – Schedule of assessment, sample collection scheme, and sample types – Platform and vendor selection
- How to properly control sample quality and pre-analytical factors
– Sample collection methods and sample quality
– Challenges in operations and communication - Challenges of analyzing biomarker testing data – Resources for bioinformatics
– Integration of clinical data
Director, Clinical Biomarkers
Calithera Biosciences
Yu Liang is the Director of Clinical Biomarkers at Calithera Biosciences with over 17 years of technical expertise and strategic leadership from both academic and industry in application of genomic and genetic profiling for biomarker discovery, development of real-time PCR assays for research and IVD, and implementation of biomarker programs to support all phases of drug development pipelines. Yu currently is focusing on targeting arginase and glutaminase, and in combination with immune checkpoint inhibitors. He managed biomarker portfolios of Ibrutinib at Pharmacyclics. Prior to that, he led development and applications of most TaqMan small RNA assays at Applied Biosystems and Life Technologies.
- Autologous vs allogenic – what, who and how? Applications, manufacturing, and personalization of cellular and genetic therapeutics
- Cost management – what does the industry look like in 5 years? 10 years?
- Blurring lines – how do the “engineering” challenges of cell and gene therapies compete with the clinical challenges? Which is greater?
Vice President, Business Development
Synthego
Jason Steiner is the VP of Business Development at Synthego and directs strategy and technical partnerships that leverage Synthego’s platform technologies in genome engineering, machine learning, and automation engineering to accelerate life science research and discovery applications. Prior to Synthego, Jason spent several years in the clinical genomics space commercializing liquid biopsy technologies and applications in both reproductive genetics and oncology. Jason holds a doctoral degree in Biotechnology and Biomedical Engineering from the University of California, San Diego where his research focused on the development of nanoparticle delivery systems for therapeutic and diagnostic payloads to tumors.
