2018 Program
The continued development of “noninvasive” methods to detect and monitor disease has led to an unprecedented time in biomolecular medicine.
1) Recent scientific findings have determined biofluids consist of circulating tumor cells (CTCs), cell-free nucleic acid (cfNA), or extracellular vesicles (EVs) from multiple tissues within the body.
2) Rapid development of highly sensitive and
accurate analytical genomic technologies have allowed analysis of the role of these biomolecules.
3) Researchers are empowered to analyze the role of these biomolecules in health, disease and treatment response leading to targeted therapies.
4) However, there still remains insecurity associated with biofluid-based DNA/RNA analytical methods, which must be solved before liquid biopsies can be implemented for broader routine applications.
At The Liquid Biopsy Summit, experts present and consider process and technology refinements that can enable molecular liquid biopsies to become a fulcrum in the future of precision medicine.
Final Agenda
Wednesday, June 20
9:30 am Morning Coffee and Short Course Registration
10:00 am - 1:00 pm Pre-Conference Lunch Short Course
SC1: Innovative Technologies for Imaging CTC Phenotype, Drug Response and Metastasis
1:00 - 1:30 Lunch Provided for Short Course Participants
1:30 - 4:30 Pre-Conference Lunch Short Course
SC2: Making the Most of Clinical Samples: Understanding the Methods of Standardized Blood Collection, Handling, and Processing to Optimize Circulating Biomarker Analysis
4:00 Main Conference Registration
4:45 Organizer’s Welcome
Mary Ann Brown, Executive Director, Conferences, Cambridge Healthtech Institute
4:50 Chairperson’s Opening Remarks
Jamie Platt, PhD, MB(ASCP), Founder & Managing Director, BRIDGenomics, LLC
5:00 KEYNOTE PRESENTATION: Liquid Biopsy and Its Clinical Impact
Oanh Dang, PhD, Founder and Principal Consultant, Akamai Strategies, Inc.
Liquid biopsy is making its way into the clinic. An overview on the current state of liquid biopsy, what it is and the technologies that are enabling it will be presented. Current applications in NIPT, organ transplant rejection and oncology demonstrate
both the potentials and the pitfalls of this emerging technology. Finally, future areas where we will see the impact of liquid biopsies in the clinic will be discussed.
5:45 PANEL DISCUSSION: Enhancing the Science and Clinical Utility of Liquid Biopsies
All agree that the potential of liquid biopsies will allow for detection of disease faster, diagnosis of disease earlier, and tracking of disease progression and treatment response more efficiently. This panel discusses progress in:
- Collection, preservation, and storage of biosamples
- Advances in detection technologies
- Determining reference materials and standards
- Developing safe and effective blood profiling diagnostics
- Creating an open database of liquid biopsy results
Moderator:
Jamie Platt, PhD, MB(ASCP), Founder & Managing Director, BRIDGenomics, LLC
Panelists:
Oanh Dang, PhD, Founder and Principal Consultant, Akamai Strategies, Inc.
Lauren C. Leiman, MS, MBA, Executive Director, Blood Profiling Atlas in Cancer (BloodPAC)
Phoebe Loh, Global Product Manager PreAnalytiX, Sample Technologies, QIAGEN
Robert T. McCormack, PhD, Independent Consultant; formerly Head, Biomarker Strategy, Disease Interception, R&D, Janssen Pharmaceuticals
6:30 Welcome Reception in the Exhibit Hall with Poster Viewing
7:30 Close of Day
Thursday, June 21
8:15 am Morning Coffee
8:40 Chairperson’s Remarks
Robert T. McCormack, PhD, Independent Consultant; formerly Head, Biomarker Strategy, Disease Interception, R&D, Janssen Pharmaceuticals
8:45 BloodPAC: Establishing Standards to Accelerate Development and Approval of Liquid Biopsy Technology
Lauren C. Leiman, MS, MBA, Executive Director, Blood Profiling Atlas in Cancer (BloodPAC)
The Blood Profiling Atlas in Cancer (BloodPAC) looks to improve outcomes for patients with cancer through a collaborative infrastructure that enables the sharing of information between stakeholders in industry, academia and regulatory agencies. The
goals of BloodPAC are: to aggregate, make freely available, and harmonize for further analysis: i) data from CTC, ctDNA, proteins including tumor associated autoantibodies, and exosome assays; ii) associated clinical data; and iii) sample collection,
preparation and handling protocols.
9:20 An Update on the Development of NIST Circulating Cell-Free Tumor DNA Reference Materials
Hua-Jun He, PhD, Research Biologist, Material Measurement Laboratory, NIST
NIST, in collaboration with the Early Detection Research Network (EDRN), is developing reference materials for ctDNA. The proof of concept using synthetic DNA spiked into fragmented human background DNA has been demonstrated. The candidate reference
materials have been developed and characterized, and the cancer biomarker variants have been quantified by digital PCR assays and through different NGS approaches. The ctDNA reference materials would improve the reliability and confidence of the
measurement for cell-free DNA biomarkers that show great promise for cancer detection.
9:55 Standardized Improved Pre-Analytical Workflows: The Key to Good Quality Samples for Reliable Diagnostics and Research
Phoebe Loh, Global Product Manager PreAnalytiX, Sample Technologies, QIAGEN
Cellular biomolecule profiles can change significantly during sample collection, transport, storage, archiving and processing. This can make the outcome from diagnostics or research unreliable because the subsequent analytical test will not determine
the situation in the patient but an artificial bioanalyte profile generated during the pre-analytical workflow. The EU FP7 SPIDIA consortium could achieve significant progress by developing new pre-analytical workflow technologies and by generating
evidence for developing new standard documents. The European Committee CEN/TC 140 “In vitro Diagnostic Medical Devices” has released first 9 Technical Specification documents to standardize pre-analytical workflows for different blood,
other body fluids and tissue-based molecular applications. They are currently under further development to International Standards within the ISO/Technical Committee 212 “Clinical Laboratory Testing and In Vitro Diagnostic Test Systems”.
10:30 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 Using Samples & Standards to Overcome Challenges in Validation Planning
Jamie Platt, PhD, MB(ASCP), Founder & Managing Director, BRIDGenomics, LLC
11:35 FEATURED PRESENTATION: A Public-Private, Pre-Competitive Consortium to Develop ctDNA Reference Materials: A Method for the Madness
Robert T. McCormack, PhD, Independent Consultant; formerly Head, Biomarker Strategy, Disease Interception,
R&D, Janssen Pharmaceuticals
Testing for driver and resistance mutations using cell-free circulating tumor DNA (ctDNA) is poised to be the primary enabler of precision medicine. The complexity of the biomarker, reagents, and technologies used to generate results have led to discordance
between sites testing the same patient sample. To expedite acceptance of ctDNA testing, our consortium has implemented a project to develop well-validated reference materials to add confidence in ctDNA results interpretation. Such performance
information will help expedite acceptance of ctDNA testing for patient care among all stakeholders.
12:20 pm Enjoy Lunch on Your Own
2:00 Chairperson’s Remarks
Richard J. Cote, MD, FRCPath, FCAP, Professor and Joseph R. Coulter Jr. Chair, Department of Pathology & Laboratory Medicine, University of Miami Miller School of Medicine
2:05 Rapid Analysis of Drug Responses in Live Patient CTCs Using Microfluidic Cell Tethering
Stuart S. Martin, PhD, Professor of Physiology, Marlene and Stewart Greenebaum NCI Comprehensive Cancer Center,
University of Maryland School of Medicine
We have developed a microfluidic cell tethering device that secures CTCs for imaging and drug testing, while preserving the cytoskeletal dynamics of non-adherent cells. Using this tethering device, we can test the drug responses of patient tumor cells
in less than one hour. Combined with emerging technologies that isolate live CTCs, microfluidic cell tethering provides a platform to rapidly test patient tumor cells and optimize treatments that reduce metastatic potential.
2:35 Droplet Biopsy Microarrays Based on Nanosurfaces: A New Method to Detect and Isolate Invasive Circulating Tumor Cells Based on Negative Selection
Balaji Panchapakesan, PhD, Associate Professor, Mechanical Engineering, Worcester Polytechnic
Institute
We present a new method to isolate circulating tumor cells based on negative selection with high rate of recovery and high purity. The droplet biopsy chip with nanosurfaces enables easier isolation of CTCs with depletion of contaminating leukocytes.
This is a new paradigm in isolation of CTC and to capture invasive CTCs that do not express any biomarkers.
3:05 Sponsored Presentation (Opportunity Available)
3:35 Refreshment Break in the Exhibit Hall with Poster Viewing
4:15 Noninvasive Liquid Biopsies: Culturing Cancer Cells from Urine and Blood CTCs for Precision Medicine
Xuefeng Liu, MD, Professor, Pathology, Georgetown University
We discuss: 1) culturing cancer cells from the urine of bladder cancer patients or circulating tumor cells (CTCs) from blood using conditional reprogramming (CR) technique, 2) characterization of CR cells at cellular and genetic levels, 3) therapeutic
response of urine CR cells and tumor CR cells. This rapid, efficient and noninvasive method for generating cultures of bladder cancer cells and CTCs can be used potentially for high-throughput drug screening, predicting patient clinical responses,
and for monitoring tumor initiation and recurrence.
4:45 Liquid Biopsy Testing Using 2PG’s MoM
Trevor J. Morin, PhD, CSO, Two Pore Guys, Inc.
2PG developed a handheld diagnostic device that allows the detection of any molecule of interest, including nucleic acids, proteins, metabolites, drugs, and small molecules. The technology employs solid-state nanopores that allow single molecule counting
using purely electrical sensing, obviating the need for optics, chemistries, or electrochemical sensors. This presentation demonstrates how 2PG used the device to quantitate circulating tumor DNA from cancer positive clinical blood samples.
5:15 FEATURED PRESENTATION: Capture, Interrogation, Imaging, Automated Analysis and Culture of CTC: Strategies for the Development of a Transformative Tool to Understand Cancer
Richard J. Cote, MD, FRCPath, FCAP, Professor and Joseph R. Coulter Jr. Chair, Department of Pathology &
Laboratory Medicine, University of Miami Miller School of Medicine
Circulating tumor cells (CTCs) are important clinical biomarkers for cancer diagnosis, prognosis and target identification. Recently, we have described the presence of circulating Cancer Associated Fibroblasts (cCAF), which may have great importance.
We discuss integrated platforms for capture and novel imaging of CTC/cCAF, efforts to automate the analysis of CTC/cCAF images, and live CTC capture, which could lead to expansion, propagation, and creation of an important new biospecimen
for cancer discovery.
6:00 Close of Day
Friday, June 22
8:00 am Breakfast Breakout Discussion Groups
Chew over continental breakfast and provocative discussion topics with your peers. These are moderated discussions with brainstorming and interactive problem-solving, allowing conference participants from diverse backgrounds to exchange ideas
and experiences and develop future collaborations around a focused topic.
CTC Capture, Interrogation, and Culture
Moderator: Richard J. Cote, MD, FRCPath, FCAP, Professor and Joseph R. Coulter Jr. Chair, Department of Pathology
& Laboratory Medicine, University of Miami Miller School of Medicine
- Live CTC capture
- CTC and circulating tumor microenvironment cells (cCAF)
- Novel image capture and analysis of CTC/cCAF
- Conditions for expansion and propagation of CTC
Challenges in ctDNA Biomarker Measurements in Liquid Biopsy
Moderator: Hua-Jun He, PhD, Research Biologist, Material Measurement Laboratory, NIST
- Variables in pre-analytical processing such as collection, handling, storage, extraction methods
- Various characterization of cfDNA methods such as DNA quantitation, size determination, et al.
- Various technologies, assay validation and comparison
- You see it, is it real? Ideal commutable reference material needs for ctDNA biomarker measurements in liquid biopsy
Identifying and Characterizing Different Cell Types in Liquid Biopsies
Moderator: 
James Hicks, PhD, Professor, Department of Biological Sciences, University of Southern California
- How do CTC isolation methods affect the range of cell types observed?
- Are vimentin positive cells an indication of EMT?
- What can we learn from genomic profiling of CTCs identified by protein markers?
- What is the role of CTC clusters in disease?
- Are CTCs active agents of metastasis? Or moribund cells from decaying tumors? Does it matter?
The Utility of Exosomal Protein and PTM Analysis in Liquid Biopsy
Moderator: 
Anton Iliuk, PhD, President and CTO, Tymora Analytical Operations
- New frontiers in protein biomarker discovery
- Capturing/isolating proteins from complex biofluids
- Analysis of post-translational modifications as a part of liquid biopsy
- Combination of protein detection with ctDNA for improved disease diagnosis
- The promise of exosomes and other extracellular vesicles
9:15 Chairperson’s Remarks
James Hicks, PhD, Professor, Department of Biological Sciences, University of Southern California
9:20 Validation of a Microbial Cell-Free DNA Sequencing Test for Infectious Disease
Timothy Blauwkamp, PhD, CSO and Co-Founder, Karius, Inc.
Microbial cell-free DNA sequencing offers great potential to noninvasively identify a wide range of pathogens, but a number of challenges associated with such comprehensive testing must be addressed. We share our experience developing and
validating a next-generation sequencing test that identifies and quantifies microbial cfDNA in plasma from 1,250 clinically relevant pathogens. Particular attention will be paid to the novel strategies and experiments that we employed
to characterize performance across such a broad range of pathogens throughout the validation studies.
9:50 Validation of Aqueous Humor cfDNA as a Predictor of Tumor Response in Retinoblastoma
Jesse Berry, MD, Assistant Professor, Ophthalmology, University of Southern California
Retinoblastoma is a pediatric intraocular cancer initiated by a mutation in the RB1 tumor suppressor gene. Investigating the RB1 pathway has provided insight into the genetic mechanism of tumorigenesis for virtually all human cancers. However,
leveraging this knowledge for retinoblastoma patients has been elusive because we cannot safely biopsy retinoblastoma for risk of extraocular spread. Thus, we cannot correlate the genetic and genomic changes in the tumor with clinical
outcomes such as successful therapeutic response which allows for the eye to be saved, versus aggressive, recurrent disease that requires the eye to ultimately be removed. We recently demonstrated that we can overcome this barrier to biopsy
through an innovative 'surrogate tumor biopsy' for retinoblastoma using the aqueous humor as a liquid biopsy. We demonstrated that tumor-derived DNA is present in the aqueous humor and it is feasible to evaluate for chromosomal copy number
alterations that corroborate those seen in the tumor.
10:20 Coffee Break in the Exhibit Hall with Last Chance for Poster Viewing
11:00 EV Phosphoproteomics as the New Source of Biomarkers for Disease Diagnostics
Anton Iliuk, PhD, President and CTO, Tymora Analytical Operations
Recent discoveries in the field of extracellular vesicles (EVs) show promise in circumventing the problems plaguing current liquid biopsy methods, while retaining all the potential benefits. The vast majority of current EV studies, however,
focus on microRNA and DNA, with virtually nothing reported on their phosphoproteomes. As phosphorylation is a major player in cancer and other disease progression, EV phosphoproteins offer enormous potential as indicators of cellular states
and for in vitro disease diagnosis.
11:30 FEATURED PRESENTATION: Tumor-Derived Exosome Detection
Lydia Sohn, PhD, Professor, Mechanical Engineering, University of California, Berkeley
12:15 pm Session Break
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:00 Session Break
1:30 Chairperson’s Remarks
Rebecca (Becky) Suttmann, MS, Senior Scientific Researcher, formerly Genentech, Oncology Biomarkers
1:35 FEATURED PRESENTATION: Circulating Tumor DNA Methylation Markers for Diagnosis and Prognosis of Hepatocellular Carcinoma
Kang Zhang, MD, PhD, Professor, Human Genetics and Nano-Engineering; Founding Director, Institute for Genomic
Medicine, University of California, San Diego
An effective blood-based method for the diagnosis and prognosis of hepatocellular carcinoma (HCC) has not yet been developed. Circulating tumor DNA (ctDNA) carrying cancer-specific genetic and epigenetic aberrations may enable a noninvasive
“liquid biopsy” for diagnosis and monitoring of cancer. Here, we identified an HCC-specific methylation marker by comparing HCC tissue and normal blood leukocytes and showed that methylation profiles of HCC tumor DNA and matched
plasma ctDNA are highly correlated. Using cfDNA samples from a large cohort of 1098 HCC patients and 835 normal controls, we constructed a diagnostic prediction model with high diagnostic specificity and sensitivity and was highly correlated
with tumor burden, treatment response, and stage. Additionally, we constructed a prognostic prediction model that effectively predicted prognosis and survival. Together, these findings demonstrate in a large clinical cohort the utility
of ctDNA methylation markers in the diagnosis, surveillance, and prognosis of HCC.
2:15 Can ctDNA Complement Mammography to Improve Breast Cancer Diagnosis?
Margaret Van Meter, MD, Director, Breast Oncology, Intermountain Healthcare
Using the recently launched CREST study as a framework for discussion, I review existing data on the prognostic and predictive value of ctDNA in breast cancer and discuss the rationale for exploring its use in the screening setting. I address
analytic issues related to use of ctDNA in breast cancer screening as well as in the setting of known breast cancer.
2:45 Real-Time Application of ctDNA Testing for Patients with Gastrointestinal Malignancies
Pashtoon M. Kasi, MD, Assistant Professor, Oncology, College of Medicine, Mayo Clinic
3:15 Detecting DNA Methylation Patterns in Patient Plasma to Improve Cancer Diagnostics
Brendan Miller, Research Fellow, National Human Genome Research Institute, National Institutes of
Health
We designed a technique that can detect rare methylated DNA fragments in plasma indicative of a tumor for a fraction of the cost, in less time, and using less material than current sequencing approaches and applied this on small amounts of
plasma from patients with ovarian cancer. We correctly classified 65% of the samples as being positive for cancer using our threshold based on the background found in healthy individuals.
3:45 Real-World Results of Liquid Biopsy in Advanced/Metastatic Solid Tumors and Potential “Clinical Actionability”
Glen J. Weiss, MD, MBA, Director, Phase I Clinical Research, Beth Israel Deaconess Medical Center
Plasma-based next-generation sequencing (NGS) of circulating cell-free DNA (cfDNA) and cfRNA is a minimally invasive technique available in the clinic, also known as a “liquid biopsy”. When tumor tissue is exhausted, a new tumor
biopsy is contraindicated, and/or there has been intervening targeted therapy, a liquid biopsy may serve a unique niche. Here we report initial liquid biopsy results from patients with advanced/metastatic solid tumors and review results
for potential “clinical actionability”. This lecture will highlight some of the current data on biomarkers being used and evaluated for treatment selection and monitoring along with cost implications.
4:15 Conference Wrap-Up
Mary Ann Brown, Executive Director, Conferences, Cambridge Healthtech Institute
4:30 Close of Conference