Session Abstract – PMWC 2022 Silicon Valley


The analysis of blood for circulating tumor cells (CTC), circulating tumor DNA (ctDNA), extracellular vesicles, or more recently, tumor-educated platelets has opened new avenues for cancer diagnostics, including early detection of tumors, improved risk assessment and staging, as well as early detection of relapse to improve patient care. The track will introduce the up-to-date technologies used in liquid biopsy and review the clinical utilities in cancer screening, detection of minimal residual diseases, selection of molecular-targeted drugs, as well as monitoring of treatment responsiveness.

Sessions:

  • Early Cancer Detection- Status quo, Technical and Clinical Challenges, and the Future (PANEL)
    Session Chair: Jimmy Lin, Freenome
    - Nicholas Dracopoli, delfi Diagnostics
    - Ash Alizadeh, Stanford
    - Amir Ali Talasaz, Guardant Health
    - Matt Franklin, Exact Sciences
  • How is Liquid Biopsy Changing the Testing Paradigm for Oncology Patients? (PANEL)
    Session Chair: Rebecca Brandes, Agilent
    - Kenna Anderes, Mirati
    - Kate Knobil, Agilent
  • The Emerging Role of ctDNA for Molecular Residual Disease (MRD) Assessment and Recurrence Monitoring
    - Alexey Aleshin, Natera
  • Liquid Biopsy for Screening, Diagnosis, Prognosis and Therapy Guidance
    Session Chair: Sam Salman, miR Scientific
    - Matt Franklin, Exact Sciences
  • The Advantages of Exosomes as a Liquid Biopsy Based Markers
    Session Chair: Johan Skog, Exosome Diagnostics
    - Jamil Azzi, Harvard
    - Dolores Di Vizio, Cedars-Sinai Medical Center
  • The Current Regulatory Landscape of Liquid Biopsy In Oncology
    Session Chair: Deepshikha Bhandari, Grail Bio
    - Seema Singh Bhan, Exact Sciences
    - Ryan Woodhouse, Foundation Medicine
  • Showcase
    - Samuel Levy, Bluestar Genomics
    - Richard Chen, Personalis

 Session Chair Profile

M.D., Ph.D., Chief Scientific Officer, Freenome

Biography
Jimmy Lin, MD, Ph.D., MHS was the Chief Scientific Officer (CSO), Oncology at Natera (NASDAQ: NTRA), where he lead the development of new diagnostic technologies for cancer. Dr. Lin is also a 2016 Senior TED Fellow and Founder & President of Rare Genomics Institute, the world's first platform to enable any community to leverage cutting- edge biotechnology to advance understanding of any rare disease. Previously, Dr. Lin led the ClinOmics program in the Genetics Branch of the National Cancer Institute (NIH/NCI). Before this, he led the computational analysis of the first-ever exome sequencing studies of cancer at Johns Hopkins and was a research instructor at Washington University in St. Louis. He has numerous publications in Science, Nature, Cell, Nature Genetics, and Nature Biotechnology, and has been featured in Forbes, Bloomberg, Wall Street Journal, New York Times, Washington Post, BBC, TIME, and the Huffington Post.


 Session Chair Profile

M.D., M.B.A., VP, Medical Affairs, Oncology, Natera

Biography
Dr. Alexey Aleshin has led the oncology clinical development efforts at Natera, Inc. since 2018. Prior to this, he worked on the various novel ctDNA technologies while at Stanford University. He remains a clinical adjunct faculty in the division of Hematology at Stanford, where his work focuses on novel diagnostics assays for treatment decision support in hematologic malignancies. He received a B.A. in Statistics from UC Berkeley and his M.D./M.B.A. degrees at UCLA. He completed his clinical training in internal medicine and hematology/oncology at Stanford University.

Talk
The Emerging Role of ctDNA for Molecular Residual Disease (MRD) Assessment and Recurrence Monitoring
In this session we will take a closer look at the expanding role of ctDNA for molecular residual disease assessment (MRD) and treatment response monitoring in patients with solid tumors and how these assays may be integrated into clinical practice to improve patient management.


 Session Chair Profile

Oncology Market Development - Companion Diagnostics, Agilent Technologies

Biography
Rebecca Brandes is a member of the Companion Diagnostics (CDx) Division specializing in Oncology Market Development at Agilent. This team is charged with the objective to help with the education and consultation on advanced genomic technologies for use in CDx including expertise in genomic technologies, clinical laboratory workflows, current testing methodologies and paradigms and genetics and oncology. Joining Agilent in 2014 with 18 years of expertise gained from leadership roles, her background includes CLIA-CAP lab operations, developing and submitting products for regulation, developing integrated workflows for routine testing and business development for companion diagnostics with an emphasis on Oncology. She holds degrees from High Point University in Biology, Biochemistry and Anthropology and a master's in Molecular Genetics from Wake Forest University. Prior to joining QIAGEN, Asuragen, Affymetrix, Stanford’s StartX not-for-profit accelerator and Agilent to lead their marketing organizations, Rebecca spent several years running a high-throughput, CAP/CLIA clinical molecular oncology laboratory.


 Session Chair Profile

Chairman and CEO, ImpactNRS and Chairman, CEO, miR Scientific

Biography
Co-founder, Chairman & CEO of Impact NRS LLC, a global innovation enterprise, and its subsidiary, miR Scientific, LLC. A physics scholar who has dedicated his career to develop and manage complex systems innovations, Sam is regarded as a visionary driven to affect global impact. He is an accomplished world class leader focused on science and its commercial applications for resolving key challenges facing humanity on a global scale. A champion of public/private partnerships, he is a member of the Board of Trustees and Board of Selectors of the Multiplying Good. Sam attended the American University of Paris and Macalester College.


 Session Chair Profile

Ph.D., Chief Scientific Officer, Exosome Diagnostics

Biography
Johan Skog is a renowned, well-published thought leader in exosome science having pioneered breakthrough discoveries about exosomes and other microvesicles and their vital role as cell messengers and disease proliferators. While at Massachusetts General Hospital/Harvard Medical School, Dr. Skog discovered that tumor-derived mutations can be detected in exosome RNA from serum and other biofluids, findings which were published in Nature Cell Biology in 2008. Additionally, he demonstrated that exosomes serve to deliver messages to other cells, inducing changes favorable to the proliferation of cancer. At Exosome Diagnostics, Dr. Skog continues to pioneer critical advancements in diagnostics and expand the field of exosome biology. Dr. Skog’s research background includes virology, gene therapy, brain tumors, RNA and biomarker discovery, and he is an inventor on several patents. Dr. Skog earned his Master of Biomedical Sciences and Doctorate at Umeå University, Sweden.

Talk
The Advantages of Exosomes (EV’s) as a Liquid Biopsy Based Marker


 Session Chair Profile

Vice President, Regulatory Affairs, GRAIL, LLC

Biography
Deepshikha started her career in orthopedic device marketing in Japan. Thereafter she transitioned to marketing cardiovascular devices and subsequently moved to the US to lead regulatory teams in developing and implementing global regulatory strategies for cardiovascular/endovascular stents, Companion Diagnostic assays, Digital health solutions and NGS tests. At GRAIL her focus is on delivering on the mission – Finding Cancer Early, When it can Be Cured.


 Speaker Profile

Ph.D., Chief Scientific Officer, Delfi Diagnostics

Biography
Nicholas Dracopoli joined Delfi Diagnostics as CSO in 2019. 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.


 Speaker Profile

M.D., Ph.D., Assistant Professor of Medicine (Oncology), Stanford

Biography
The major focus of Dr. Alizadeh’s research group is to attain a better understanding of the initiation, maintenance, and progression of lymphoid tumors, and their response to existing and novel therapies toward improving current treatment strategies. In this effort, they employ tools from functional genomics, computational biology, molecular genetics, and mouse models. They hope to apply this knowledge towards the design of clinical trials in the treatment of patients with lymphoma, leukemia, and myeloma.


 Speaker Profile

Ph.D., Co-Founder & Co-CEO, Guardant Health

Biography
AmirAli Talasaz currently serves as co-founder and co-CEO of Guardant Health, a leading precision oncology company. AmirAli is an entrepreneur in the rare genomics and clinical diagnostics fields. Prior to co-founding Guardant Health, he was Senior Director of Diagnostics Research at Illumina and led the efforts for emerging clinical applications of next-generation genomic analysis. During that time, he developed different genomic technologies suitable for clinical applications. Before Illumina, he founded Auriphex Biosciences, which focused on purification and genetic analysis of circulating tumor cells for cancer management. The technology was acquired by Illumina in 2009. During his academic years, he led the Technology Development group at Stanford Genome Technology Center. AmirAli received his PhD in electrical engineering and MSc in management science from Stanford University.


 Speaker Profile

General Manager, Precision Oncology, Exact Sciences

Biography
Matt Franklin is the General Manager of Precision Oncology for Exact Sciences. Prior to joining Exact Sciences, Matt served as the Chief Commercial Officer for Thrive Earlier Detection, where was responsible for defining the go-to-market strategy for their multi-cancer early detection assay, CancerSEEK. Prior to his role with Thrive, Matt was the Chief Business Officer for ArcherDX, a growth-stage molecular diagnostics company, and also served as the Senior Vice President of Global Marketing and Clinical Product Strategy at Foundation Medicine where he led the global launch of the company’s first liquid biopsy offering and the first FDA-approved, CMS-covered, comprehensive genomic profiling companion diagnostic test.


 Speaker Profile

Ph.D., RAC, Vice President Translational Medicine & Companion Diagnostics, Mirati Therapeutics

Biography
Dr. Anderes has worked in a variety of roles that were initially the precursors to today’s Precision Medicine including a number of senior executive/scientific advisory positions at pharmaceutical, biotech and medical device companies. Dr. Anderes acquired very broad, interdisciplinary technical, regulatory and business skills, with an extensive knowledgebase in clinical research, and vitro diagnostic device development. Achievements range from lead identification of new molecular entities to characterization of clinical development candidates for several distinct first in class molecular targeted agents to treat cancer. In parallel to drug discovery/development activities, Dr. Anderes has lead equally diverse biomarker and companion diagnostic projects from biological validation to clinical trial assay development to regulatory approval roadmaps across multiple platform technologies. She has been involved in the development of state of the art liquid biopsy approaches to evaluate clinical utility of CTCs and ctDNA.


 Speaker Profile

M.D., Associate Professor of Medicine, Harvard Medical School

Biography
Jamil R. Azzi is an Associate Professor of Medicine at Harvard Medical School. He is the medical director of the vascularized composite allo-transplantation (VCA) and the associate director of the kidney and pancreas transplant at Brigham and Women’s Hospital. Dr. Azzi is a physician scientist who is leading a NIH funded laboratory that focuses on understanding the immune-regulatory arm of the immune system in transplantation, autoimmunity and cancer with the goal of developing more targeted and safer therapeutic strategies. Currently, a major focus of his research is CD4 and CD8 regulatory T cells and their activation induced cell death in addition to engineering cell therapies. Dr. Azzi’s laboratory is also exploring multiple genomics and proteomics approaches to develop biomarkers that noninvasively detect rejection in kidney transplant recipients and measure the immune function of immunosuppressed patients.

Talk
Beyond Concept to Clinical Application in Kidney Diseases
The traditional biomarkers currently used to monitor a kidney allograft for rejection or autoimmune mediated kidney diseases are late markers of injury and they lack sensitivity and specificity. Biopsies on the other hand, are invasive and costly. Urinary exosomes, tiny vesicles released into the urine that carry parent cells’ proteins and nucleic acids, reflect the biologic function of the parent cells within the kidney, including immune cells. Their stability in urine makes them a potentially powerful tool for liquid biopsy and a noninvasive diagnostic biomarker for kidney-transplant rejection. This talk will describe the current efforts to develop urinary exosomes-based biomarkers to detect allograft kidney rejection and other kidney related diseases.


 Speaker Profile

M.D., Ph.D., Professor, Cedars-Sinai Medical Center

Biography
Dolores Di Vizio is a molecular pathologist, and a molecular and cell biologist, with 20 years of experience on urological cancer. Currently she is a Professor at Cedars-Sinai Medical Center. She published over 115 peer-reviewed manuscripts, including in high impact journals (Cancer Cell, Cell, Cancer Research, Nat Med, Nat Cell Biol,) and made important contributions to cancer research in a number of areas. Her work has been cited over 16,000 times and her H-index is 56. The Di Vizio lab is funded by the NIH and the DoD including by a NIH/NCI program for rigor and reproducibility in extracellular vesicle research to identify circulating biomarkers of cancer. One of the main effort in the lab is to develop new methodologies based on identification and characterization of heterogenous populations of cancer-derived extracellular vesicles in the plasma of patients with cancer. She serves as senior board member of the International Society of Extracellular Vesicles (ISEV) and is an associate editor for the Journal of Extracellular Vesicles.

Talk
Development of Liquid Biopsy Platforms Using Cancer-Derived Extracellular Vesicles
Cancer cell-derived Extracellular Vesicles (EVs) are attractive candidates for liquid biopsy because they contain protein, RNA, DNA, lipids and metabolites, including molecules that are functionally relevant to cancer progression or that are involved in therapeutic response. New approaches are being implemented combining new technologies with gold standard methodologies for EV purification and characterization.


 Speaker Profile

Director, Regulatory Affairs, Foundation Medicine

Biography
Ryan specializes in regulatory strategy in oncology. He has developed and executed regulatory strategy to support the development and launch of multiple innovative liquid biopsy IVD products including the first FDA-approved liquid biopsy assay for oncology. Prior to regulatory affairs, Ryan worked in development and studied as a biomedical engineer.


 Speaker Profile

M.D., Chief Medical Officer, Agilent Technologies

Biography
Dr. Kate Knobil joined Agilent in April 2021 as the company’s first Chief Medical Officer and is helping to expand Agilent’s leadership in precision medicine and the development of novel therapeutics to improve patient outcomes. Kate has more than 20 years of experience in clinical development and medical affairs while serving in global strategic leadership roles. Prior to joining Agilent, Kate was CMO and head of R&D at Kaleido Biosciences, applying her pharmaceutical experience to help translate the promise of the microbiome into solutions for patients. Prior to Kaleido, Kate served in a variety of leadership roles at GlaxoSmithKline, including head of late-stage clinical development in China, head of value evidence and outcomes, and CMO.


 Speaker Profile

M.D., Senior Vice President R&D and Chief Medical Officer, Personalis

Biography
Dr. Chen joined Personalis in November 2011 as Chief Scientific Officer, and was promoted to Senior Vice President R&D, and Chief Medical Officer in 2021. A physician scientist, Dr. Chen has extensive expertise in systems biology, translational genomics, knowledge engineering, and scientific product development. Dr. Chen has co-founded and served on the board of several companies, including Ingenuity Systems, where he led the development of systems biology approaches to genomic data analysis for scientific discovery. Dr. Chen has also served on the clinical faculty at Stanford University School of Medicine where he led process and technology innovation for improved health care delivery. Dr. Chen received a BS in Computer Science from Stanford, and a MD from Stanford University School of Medicine. He also received a MS in biomedical informatics from Stanford. He completed his Chief Residency and Dermatology Specialty Training at Stanford and is board certified.

Talk
NeXT Personal: The Next Generation in MRD Testing for Solid Tumors


 Speaker Profile

Senior Vice President, Public Policy and External Affairs, Thrive Earlier Detection

Biography
Prior to joining Thrive, she was vice president, head of public policy for Foundation Medicine, where she was responsible for developing, advocating and executing company positions before Congress and the U.S. Food and Drug Administration (FDA), including the landmark parallel review decision by the FDA and Centers for Medicare and Medicaid Services (CMS) on next generation sequencing for Foundation Medicine’s flagship product. Before that, she spent time outside of the industry, as senior counsel to Senator Arlen Specter, where she was lead policy and strategic advisor for issues related to tax, banking, healthcare and finance. Prior to that, she was lead counsel to the Senate Judiciary Committee, providing policy analysis and strategic counsel to both Chairman Specter and Republican and Democrat senators on the Committee.


 Speaker Profile

Ph.D., CEO and CSO, Bluestar Genomics

Biography
Dr. Samuel Levy has extensive background and experience in the application of genomic methods for the development of molecular diagnostic tests. Early work on the human genome project (Celera) and sequencing individual human genomes (J. Craig Venter Institute) established broad methodologies widely employed in genomic analysis. At Scripps Research Institute he worked on defining cardiovascular disease characteristics using patient derived stem cell. At Genomic Health, he led the development of methods for identifying mutational signatures from patient blood samples. Using patient derived tumor models, he established experimental methods and analytic approaches for the single cell analysis of tumor response to novel small molecule therapeutics (Quanticel Pharmaceuticals).