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IMPORTANT: This event spans two separate days (Sep 22 and Sep 29). The speakers listed below will be presenting on Sep 22.

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2:00 – 2:40 pm

Novel approaches to cfDNA biomarkers that do not require sequencing for mutation
Nic Dracopoli, Ph.D., Chief Scientific Officer, Delfi Diagnostics
Dr. Nicholas Dracopoli is one of the founders and is currently Chief Scientific Officer at Delfi Diagnostics. Previously he was Vice President, Head Oncology Translational Research and Oncology Diagnostics at Janssen R&D. In these roles he was responsible for biomarker discovery, development and applications for oncology products. Previously, he was Vice President of Clinical Discovery Technologies at Bristol-Myers Squibb, and prior to that spent five years in the biotechnology industry at Sequana Therapeutics. Dr Dracopoli obtained his B.Sc. and Ph.D. degrees from the University of London, and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center and the Massachusetts Institute of Technology. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center, and as a Section Chief at the National Center for Human Genome Research at the NIH before moving to the biotechnology industry. Dr Dracopoli has authored >80 scientific publications, and has extensive experience in the fields of genomics, molecular biology and cancer research.
Abstract: Early detection has great promise to reduce the overall morbidity and mortality of cancer by surgical resection and therapeutic intervention on small, localized, genetically homogeneous tumors. This presentation describes our attempts to develop a blood-based test for early cancer in asymptomatic individuals and allow for early intervention and potentially cure of cancer in some patients. Traditionally blood tests for cancer rely on detection of cancer-specific proteins or somatic mutations. While this approach is important for directing therapy and monitoring treatment response in advanced cancers, it is inadequate for early stage tumors because they release very small amounts of DNA into circulation which are simply too low for reliable detection. Here, we will describe a new approach for early detection that evaluates abnormal nucleosome packaging of DNA in cancer cells, and show how this approach can be used to identify early stage malignancies as well as identifying the tissue of origin of the cancer.

2:40 – 3:20 pm

Challenges and Strategies in LC-MS/MS Bioanalysis of PD-1 and PD-L1 as the Clinical Biomarkers in Formalin Fixed Paraffin Embedded (FFPE) Tissues for Cancer Immunotherapy Development
Naiyu Zheng, Ph.D., Senior Principal Scientist, Dept. of Translational Medicine, BMS
Dr. Naiyu Zheng is a Senior Principal Scientist in the Department of Translational Medicine at Bristol Myers Squibb (BMS). Currently, his group at BMS is responsible for LC-MS/MS or LC-HRMS based assay development and validation to quantify clinical biomarkers in support of clinical studies. In the past 18 years, Naiyu has been working at BMS in regulated LC-MS bioanalysis of drugs and biomarkers, including small and large molecules, for the assessment of toxicokinetics, pharmacokinetics and pharmacodynamics in support of IND, FIH and NDA filings for over 30 drug development programs, including three marketed anti-HCV drugs (DAKLINZA™, SUNVEPRA® and Beclabuvir). In the most recent years, Naiyu has focused on the development and implementation of immuno-affinity LC-MS protein biomarker assays for PK-PD correlation and target engagement measurement. His works related to clinical biomarker assays were recognized at BMS as a recipient of 2017 Chemistry Leadership Award. Naiyu has published 50 peer-reviewed papers/book chapters. He is a steering committee member of NJDMDG, a session chair of ASMS in 2019, and serves as a frequent reviewer for a number of peer-reviewed journals. Naiyu received his Ph.D. in Pharmaceutical Sciences from University of Rhode Island, followed by a postdoc training in Prof. Ian Blair Lab at University of Pennsylvania before joining BMS in 2002.
Abstract: Immune checkpoint proteins, such as programmed death 1 (PD-1) and its ligand, PD-L1, mediate inhibition of CD8+ effector T cells. Inhibition of the PD-1/PD-L1 interaction with therapeutic antibodies, such as Opdivo® (nivolumab) has emerged as an effective immuno-oncology treatment for several cancers. Currently, the major biomarker used to predict the response to immune checkpoint therapeutics is PD-L1, which is usually measured by immunohistochemistry (IHC) using Formalin-Fixed Paraffin-Embedded (FFPE) tissue specimens. However, IHC provides only semi-quantitative results, and it was reported that about 50% of PD-L1 IHC-positive tumors failed to respond to therapy, while about 15% of PD-L1 IHC-negative tumors did respond to the treatment. Therefore, we evaluated the feasibility of using LC-MS to quantify PD-1 and PD-L1 in FFPE tumor tissues as a complementary analytical platform to IHC. Considering the limited availability and analyte instability concerns with the fleshly frozen tissue samples, there was an increased interest in the utility of FFPE tumor tissues as alternative samples for LC-MS bioanalysis of endogenous protein biomarkers in support of translational research. However, quantitative analysis of endogenous protein, such as PD-1 and PD-L1, in FFPE tumor tissues by LC-MS/MS still poses serious challenges due to low abundance of the protein analytes with potential protein denaturation, fixation and crosslinking in FFPE tissues. This presentation will provide an overview of the methodologies we developed in the LC-MS/MS bioanalysis of endogenous protein biomarkers in FFPE tumor tissues, and discuss the challenges and opportunities associated with the LC-MS/MS bioanalysis of PD-1 and PD-L1 as clinical biomarkers in FFPE tissues for cancer immunotherapy development.

3:20 – 4:00 PM

Developing Therapeutic Materials to Redirect Cellular Chatter
Juliane Nguyen, Ph.D., Associate Professor, University of North Carolina Eshelman School of Pharmacy
Dr. Juliane Nguyen is an Associate Professor in the Division of Pharmacoengineering and Molecular Pharmaceutics, School of Pharmacy, at the University of North Carolina at Chapel Hill. Her translational research program focuses on developing next-generation protein-, RNA-, and exosome-based delivery and biochemical platforms for treating diseases such as cancer and myocardial infarction. Dr. Nguyen’s work has been recognized with the NSF CAREER Award (2018), the NY-STAR faculty award (2019), the CMBE Young Innovator Award from the Biomedical Engineering Society (2019), and the AAPS Emerging Leader Award (2019). She received her Ph.D. in Pharmaceutical Sciences from the Philipps-University of Marburg (Germany), where she was mentored by Dr. Thomas Kissel. She then trained at UCSF under Dr. Frank Szoka as a Deutsche Forschungsgemeinschaft Postdoctoral Fellow.
Abstract: An increasing number of studies report that exosomes play critical roles in intercellular communication. While exosomes are essential to maintain physiological conditions, aberrant exosomal communication can lead to the development of cancer, diabetes, and many other diseases. My lab has developed materials to redirect and modulate cellular communication mediated by exosomes for therapeutic applications. Specifically, we have identified RNA-based materials to modulate exosomal function by repackaging them with different types of cargoes. Furthermore, I will discuss how beneficial exosomal communication could be enhanced for therapeutic purposes.

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