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Biomarker Summit

2018-04-202018-02-132017-11-27
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Day 1 - Tuesday, March 27, 2018
7:30
Continental Breakfast & Registration
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10:00
Morning Networking Break
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Oncology Biomarkers
Immuno-oncology Biomarkers
Moderator: Tony Pircher, Biocept
10:45
Biomarkers for Cancer Immunotherapy: State of the Art
 
Sandip  Patel
Sandip Patel
Assistant Professor, Cancer Immunotherapy Program
University of California, San Diego
About Speaker: Sandip Patel, MD.  Assistant Professor, Medical Oncology/Hematology, UC San Diego Moores Cancer Center Dr. Sandip Patel, MD is a medical oncologist focused on early development of novel immunotherapy, in particular early phase clinical trials of ca... Read Full Bio 
 
 
Sandip  Patel
Sandip Patel
Assistant Professor, Cancer Immunotherapy Program
University of California, San Diego
 
About Speaker:

Sandip Patel, MD.  Assistant Professor, Medical Oncology/Hematology, UC San Diego Moores Cancer Center

Dr. Sandip Patel, MD is a medical oncologist focused on early development of novel immunotherapy, in particular early phase clinical trials of cancer immunotherapy and thoracic oncology immunotherapy trials.  His research focus is on predictive biomarkers for immunotherapeutic response and generation of personalized cancer immunotherapy regimens.

He is co-leader for the Experimental Therapeutics (Phase 1) Program and Deputy Director for the Center for Precision Immunotherapy at UCSD.  He is Assistant Director of the Clinical Trials Office at UCSD Moores Cancer Center and a member of the Cancer Immunotherapy, Experimental Therapeutics (Phase 1), and Thoracic Oncology Programs.  Dr. Patel earned his medical degree at Baylor College of Medicine, while performing research at MD Anderson Cancer Center. He completed a residency in Internal Medicine at UCLA Medical Center. He completed a fellowship in Medical Oncology and Hematology at Duke University Medical Center. He is triple board-certified in internal medicine, medical oncology, and hematology and was named a “Top Doc” in the most recent San Diego Magazine Physicians of Exceptional Excellence survey.

 

 
Abstract: Dr. Sandip Patel, MD will be discussi...Read More 

Dr. Sandip Patel, MD will be discussing predictive biomarkers for immunotherapeutic response in cancer, with a focus on novel biomarker assays.  He will be focusing on the nuances in the development of PD-L1 IHC with a focus on alternative predictive biomarkers that may better determine patient response to immune checkpoint modulation.  Additionally, Dr. Patel will be discussing the next generation of cancer immunotherapeutics currently under development including cell-based approaches.

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Cardiovascular Biomarkers
Biomarkers for Heart Failure & Acute Coronary Syndrome
Moderator: J. Brent Muhlestein, University of Utah
10:45
Comparative Translational Biomarkers of Cardiac Disease
 
Jim Turk
Jim Turk
Pathologist Director
Amgen
About Speaker: Jim Turk completed BA in Biology at Washington University, St.Louis, Doctor of Veterinary Medicine (DVM) at the University of Missouri, Columbia, PhD at College of Veterinary Medicine, Washington State University Pathology residency the Washingto... Read Full Bio 
 
 
Jim Turk
Jim Turk
Pathologist Director
Amgen
 
About Speaker:

Jim Turk completed BA in Biology at Washington University, St.Louis, Doctor of Veterinary Medicine (DVM) at the University of Missouri, Columbia, PhD at College of Veterinary Medicine, Washington State University Pathology residency the Washington Animal Diagnostic Laboratory in Pullman, WA.  

Jim is certified in anatomic pathology by the American College of Veterinary Pathologists.  

Jim has received numerous teaching awards as an Associate Professor in the Department of Veterinary Pathology, School of Veterinary Medicine Pathology, Louisiana State University, Baton Rouge, & Full Professor in the Departments of Veterinary Pathobiology and Biomedical Sciences, College of Veterinary Medicine, University of Missouri, Columbia. 

Dr. Turk was Pathology Core leader for a Program Project Grant awarded by the National Heart Lung and Blood Institute using the pig as a model to study the impact of exercise on diet-induced atherosclerosis. Jim has worked at Merck, Westpoint PA, and Pfizer, St. Louis. 

Dr. Turk  is currently employed as a Pathologist Director in Comparative Biology and Safety Sciences at Amgen, Thousand Oaks, CA.

 
Abstract: ...Read More 

Cardiovascular disease is the leading cause of morbidity and mortality in the developed world.  Heart disease is the leading cause of death in the United States.   Acute and chronic myocardial damage and dysfunction are currently monitored by assay of circulating biomarkers including cardiac troponins and natriuretic peptides.  Multi-marker panels comprised of additional biomarkers may improve diagnosis, prediction of cardiovascular disease risk, and prognostication in acute coronary syndrome and heart failure.  Genomics and proteomics guide the development of biomarkers such as galectin-3, that is associated with exosomes, to include multi-marker panels.  Likewise, in addition to protein cargo, exosomes carry microRNAs that may reveal cell-specific mechanistic biomarkers of acute coronary syndrome and heart failure.

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11:10
Biomarkers for Predicting Response/Benefit for Cancer Immune Checkpoint Inhibition
 
Jaffer Ajani
Jaffer Ajani
Professor of Medicine
University of Texas MD Anderson Cancer Center
About Speaker: Dr. Jaffer A. Ajani is a Professor of Cancer Medicine at the MD Anderson Cancer Center at The University of Texas in Houston, Texas. Dr. Ajani earned his medical degree at Government Medical College in Nagpur, India and completed a residency program... Read Full Bio 
 
 
Jaffer Ajani
Jaffer Ajani
Professor of Medicine
University of Texas MD Anderson Cancer Center
 
About Speaker:

Dr. Jaffer A. Ajani is a Professor of Cancer Medicine at the MD Anderson Cancer Center at The University of Texas in Houston, Texas.

Dr. Ajani earned his medical degree at Government Medical College in Nagpur, India and completed a residency program in general surgery and orthopedics at the Government Medical College.  After completing two more residency programs in family practice and internal medicine at Altoona General Hospital, Pennsylvania State University, Altoona, Pennsylvania, and Tulane University School of Medicine, New Orleans, Louisiana, respectively, Dr. Ajani was awarded a fellowship in medical oncology at The University of Texas MD Anderson Cancer Center in Houston.

Certified in Medical Oncology by the American Board of Internal Medicine, Ajani has authored over 500 peer-reviewed articles and was cited in Good Housekeeping Magazine as being among the Best Doctors in America for GI Cancers.

Dr. Ajani is the Chair of 2 (gastric and esophageal cancers) guidelines of NCCN. He is also the lead for gastric cancer classification by AJCC8. He is the chief scientific officer of International Society of GI Oncology. He provides service to many large societies (such as ASCO, AACR, AGA, SSO, JSS, IGCC, JSMO, CSCO, and SLAGO).

 

 
Abstract: The best drug to treat cancer of many...Read More 

The best drug to treat cancer of many types is our own immune system. However, evolutionarily the immune system is tolerant of damaged cancer cells and the cancer cells recruit many normal cells to suppress the activated CD8+ T-cells. Thus, the immune system can be competent in a given patient and cancer cells can be thriving and proliferating at the same time. Nevertheless, certain cancers depending on multiple factors seem highly responsive to checkpoint inhibition. Many biomarkers have been advanced. Namely, microsatellite instability, high labeling indices of the protein PD-L-1, number of activated CD8+ cells, perforins and granzyme B transcripts, tumor mutation burden, microbiome, monocytes (CD14+CD16-HLA-DRhi) in peripheral blood, and cytokine signatures in addition to germline mutations/SNPs. However, to date, the most important biomarker of long-term benefit is microsatellite instability. In this presentation, some aspects of all these biomarkers will be covered.

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11:10
Extracellular Vesicles as Biomarkers for Cardiovascular Injury and Risk
 
John Nolan
John Nolan
President
Cellarcus Technologies
About Speaker: John Nolan is Professor at the Scintillon Institute, where his group develops new instrumentation, reagents, and assays for cytometry and single cell analysis. Recently, his group has developed quantitative and reproducible single vesicle analysis to... Read Full Bio 
 
 
John Nolan
John Nolan
President
Cellarcus Technologies
 
About Speaker:

John Nolan is Professor at the Scintillon Institute, where his group develops new instrumentation, reagents, and assays for cytometry and single cell analysis. Recently, his group has developed quantitative and reproducible single vesicle analysis tools for the study of EVs. He earned BS degrees (Biology and Chemistry) at the University of Illinois, and a PhD (Biochemistry) from Penn State. He has served as Director of the National Flow Cytometry Resource at Los Alamos National Lab, President of the International Society for Advancement of Cytometry, and serves on the editorial boards of Cytometry and Current Protocols in Cytometry.

 
Abstract: All cells release small membranous ex...Read More 

All cells release small membranous extracellular vesicles (EVs) that carry a variety of molecular cargo including lipids, proteins, and nucleic acids to nearby or distant cells. EVs mediate inter-cellular signaling and have been implicated to have roles in normal physiology and disease. Cells from the cardiovascular system including red cells, platelets, leukocytes and endothelial cells, release EVs into blood where they can be pro-coagulant, but can also carry microRNAs. A limit to progress in the field is the ability to measure individual EVs and their cargo quantitatively and reproducibly. We have developed flow cytometry-based methods to selectively count, size, and measure the cargo of EVs as small as 70 nm and bearing as few as 50 fluorescent antibodies. I will review the biogenesis, transport, and measurement of EVs, and the application of high resolution single EV analysis to identify biomarkers of cardiovascular injury and risk.

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11:35
BiTE® in Hematologic Malignancies: Lessons Learned From BLINCYTO® and Moving Forward
 
Cedric Dos Santos
Cedric Dos Santos
Principal Scientist | Heme/Onc Clinical Biomarkers and Diagnostics
Amgen
About Speaker: Cedric received his Ph.D in Oncology from the University of Toulouse, France where he studied mechanisms underlying the PI3K/Akt and mTOR pathways activation in Acute Myeloid Leukemia. He did his post-doctoral training at City of Hope, Duarte, CA wit... Read Full Bio 
 
 
Cedric Dos Santos
Cedric Dos Santos
Principal Scientist | Heme/Onc Clinical Biomarkers and Diagnostics
Amgen
 
About Speaker:

Cedric received his Ph.D in Oncology from the University of Toulouse, France where he studied mechanisms underlying the PI3K/Akt and mTOR pathways activation in Acute Myeloid Leukemia. He did his post-doctoral training at City of Hope, Duarte, CA with Dr. Ravi Bhatia and Dr. Steve Forman assessing the impact of small molecules and immunotherapy (CAR-T) on AML stem/progenitor cells maintenance and drug resistance. After his training he joined the University of Pennsylvania and continued to work on AML and immunotherapy. Cedric joined Amgen and the Clinical Biomarkers and Diagnostics group in June 2015 where he rapidly became the Therapeutic Area lead for all Immuno-Oncology programs (BiTE® and CAR-T) at Amgen within the Leukemia and Lymphoma space including the first FDA approved BiTE® Blincyto®. Cedric recently took more responsibility and he is now responsible for the Heme/Onc pipeline and Clinical Biomarker strategy at Amgen.

 
Abstract: ...Read More 

Immunotherapy, which consists of unleashing a patient’s own T cells to fight cancer, includes bi-specific antibodies, Chimeric Antigen Receptor (CAR) or adoptive cell therapy, and immune checkpoints inhibitors. This has become a major strategy for anti-cancer therapy and has dramatically improved patients’ outcomes, especially in hematologic malignancies. Blinatumomab belongs to a new class of bi-specific antibody constructs called bispecific T-cell engagers (BITEÒ) that targets both the CD3e subunit of the T cell receptor complex and the B cell differentiation marker CD19 bringing T cells from patients towards target cells. Blinatumomab is the first FDA approved BiTE® therapy for adults and pediatrics Relapsed/Refractory (R/R) B-Acute Lymphoblastic Leukemia (B-ALL). In the phase 3 TOWER clinical trial (NCT02013167) for R/R B-ALL blinatumomab monotherapy vs standard of care resulted in significantly higher complete remission (CR) / CR with partial hematologic recovery / CR with incomplete hematologic recovery (CR/CRh/CRi) rates (44% vs 25%, P < 0.001) and longer median overall survival (7.7 months vs 4.0 months; P = 0.01). I will review what we have learnt from a Biomarker standpoint in the R/R B-ALL setting with an emphasis on predictive and/or prognostic biomarkers, Pharmacodynamic, Mechanism of action and drug resistance mechanisms post BlincytoÒ treatment.

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11:35
Found in Translation: ST2 from Discover to Heart Failure Patient Management
 
James  Snider
James Snider
President
Critical Diagnostics
About Speaker: Dr. Snider received his Ph.D. in biochemistry from The University of South Carolina in 1990 and pursued postdoctoral studies in the biological response modifiers program at the NCI. Since then he has held several positions in various companies. In 20... Read Full Bio 
 
 
James  Snider
James Snider
President
Critical Diagnostics
 
About Speaker:

Dr. Snider received his Ph.D. in biochemistry from The University of South Carolina in 1990 and pursued postdoctoral studies in the biological response modifiers program at the NCI. Since then he has held several positions in various companies. In 2005 he became president of Critical Diagnostics and in that role has lead the company from formation to become a multinational corporation. He has published several papers in peer reviewed journals and has over a dozen patents.

 
Abstract: Heart failure is a serious, terminal ...Read More 

Heart failure is a serious, terminal syndrome effecting over 6 million patients and costing the healthcare system over $50 billion annually in the US alone. There is a limited set of laboratory tests routinely used to diagnose and attempt to manage heart failure patients but in many instances it is still patient management by best judgement. ST2 is a protein biomarker that was discovered in a gene expression exploration analysis to be involved in cardiac disease and to potentially have clinical value in managing patients with cardiac disease. Following this discovery Critical Diagnostics developed and validated an in vitro diagnostic assay to accurately measure ST2 and performed the necessary clinical studies to determine the clinical value proposition. This information was used to pursue and obtain regulatory approval and the test is now available in most of the world where it is used to improve care and management of patients with heart failure. Implementing a patient management program that incorporates ST2 testing improves patients quality of life and reduces hospitalization frequency and the associated costs.

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12:00
High Definition Multiplexing for Biomarker Strategies
 
Louis Levy
Louis Levy
Director Corporate & Business Development
Ultivue
About Speaker: Louis Levy began his life science career with Cepton, a strategy consulting boutique for French mid-size biotechs. As a Harvard Blavatnik Fellow, he worked on the commercialization of the Harvard technology conducive to the launch of Ultivue in 2015... Read Full Bio 
 
 
Louis Levy
Louis Levy
Director Corporate & Business Development
Ultivue
 
About Speaker:

Louis Levy began his life science career with Cepton, a strategy consulting boutique for French mid-size biotechs.

As a Harvard Blavatnik Fellow, he worked on the commercialization of the Harvard technology conducive to the launch of Ultivue in 2015. Since then, he has spearheaded corporate and business development functions.

He is a graduate from the French grande école Telecom Bretagne, with a master’s degree in engineering and from Harvard Business School, with an MBA.

 
Abstract: Biomarker discovery in immuno-oncolog...Read More 

Biomarker discovery in immuno-oncology requires the analysis of multiple protein markers (n>4) with their spatial relationships at an amenable throughput.

The scrutiny of the tumor micro-environment demands whole-slide multiplexed images featuring immune and tumor cells.

Ultivue’s InSituPlex platform fulfills this need with the data reproducibility relevant to CDx.

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12:00
Machine Learning Supported Text-Mining to Delineate Molecular Signatures in Cardiovascular Disease
 
David  Liem
David Liem
Clinical Study Coordinator
University of California Los Angeles
About Speaker: David Liem received his MD and a clinical fellowship training in cardio-thoracic surgery at the Academic Medical Center in Amsterdam in the Netherlands. Subsequently, he completed his PhD training in Experimental Cardiology at the Erasmus University ... Read Full Bio 
 
 
David  Liem
David Liem
Clinical Study Coordinator
University of California Los Angeles
 
About Speaker:

David Liem received his MD and a clinical fellowship training in cardio-thoracic surgery at the Academic Medical Center in Amsterdam in the Netherlands. Subsequently, he completed his PhD training in Experimental Cardiology at the Erasmus University in Rotterdam, the Netherlands. David Liem has had extensive experience in cardiovascular medicine and physiology. He currently serves as the Clinical Studies Coordinator at UCLA the NIH Heart BD2K Center of Excellence for Biomedical Computing at the UCLA School of Medicine. His main interest and focus are in translational medicine and Big Data science with patient care.

 
Abstract: Complex, heterogeneous textual data d...Read More 

Complex, heterogeneous textual data describing cardiovascular disease (CVD) has accumulated over the past decades, resulting in millions of publications. However, this extraordinary quantity of data is unmatched by the capacity of available analytical tools. Here, we developed a machine learning (ML) and text-mining pipeline to dissect these data and characterize protein associations in six CVDs – cerebrovascular accidents, cardiomyopathies, ischemic heart disease, arrhythmia, valvular heart disease, and congenital heart disease. We applied the Context-aware Semantic Online Analytical Processing (CaseOLAP) algorithm across 1,099,254 abstracts (published between 1995-present) and quantified the relationships of 8,325 cardiac-related proteins to these CVDs. We utilized a variety of ML tools to semantically delineate the associations of each protein to each disease category; e.g., principal component analysis and t-distributed stochastic neighbor embedding were applied to visualize divergent and convergent groups of proteins; whereas hierarchical clustering and affinity propagation were performed to cluster and characterize related proteins. Taken together, our study has uncovered distinct, hidden relationships among these proteins within the six main categories of CVDs.

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12:25
Lunch Session: Biomarkers for Precision Medicine
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Oncology Biomarkers
Circulating Tumor Cells, Microvesicles, DNA and RNA
Moderator: Jaffer Ajani, University of Texas MD Anderson Cancer Center
2:00
Utilizing Circulating Tumor Cells to Identify Predictive and Prognostic Biomarkers
 
Tony Pircher
Tony Pircher
Director of Immunochemistry
Biocept
About Speaker: Dr. Pircher joined the R&D department at Biocept Inc. in February 2001 and is currently leading the identification and validation of tumor specific markers for the enrichment and detection of rare circulating tumor cells (CTC) and development of ... Read Full Bio 
 
 
Tony Pircher
Tony Pircher
Director of Immunochemistry
Biocept
 
About Speaker:

Dr. Pircher joined the R&D department at Biocept Inc. in February 2001 and is currently leading the identification and validation of tumor specific markers for the enrichment and detection of rare circulating tumor cells (CTC) and development of predictive and/or prognostic CTC assays. He has extensive experience in developing proteomic and genomic diagnostic assays and is the inventor on several Biocept patents.

He received his Ph.D. in molecular endocrinology from the Karolinska Institute, Stockholm, mentored by Dr. Lars-Arne Haldosen and the world renowned steroid receptor scientist Dr. Jan-Ake Gustafsson. During his postdoctoral training he worked in the field of molecular hematology at the Pennsylvania State University in the highly prolific research lab of Dr. Don M Wojchowski, where he gained extensive experience in the enrichment of erythroid progenitor cells from blood, bone marrow and spleen. He acquired expertise in protein alteration, expression, detection and purification technologies, antibody production and cellular reporter systems.

 
Abstract: Major developments in the oncology sp...Read More 

Major developments in the oncology space are transforming how cancer patients are diagnosed and treated. The utility and acceptance of liquid biopsies continues to grow as increasing numbers of immunotherapies and targeted cancer treatments gain FDA approval and become the focus of new anticancer drug development programs. Traditionally, tissue biopsies are interrogated to provide physicians information on biomarker status, for example protein expression or chromosomal alterations, and to assist and guide in the development of a treatment plan. However, tissue biopsies are not always medically advisable and in some cases unavailable, limited, or inconclusively tested. Testing on liquid biopsies to identify molecular markers on enriched circulating tumor cells (CTC) from blood can fulfill a medical need in these instances and help patients qualify for treatments that can extend survival with potentially fewer side effects. Here we present Biocept’s technology to enrich various circulating tumor cell phenotypes in Biocept’s microfluidic device, in which circulating tumor cells are analyzed for various tumor markers, such as immune-oncology targets like PD-L1.

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Cardiovascular Biomarkers
Biomarkers for Metabolic Syndrome & Cardiovascular Risk
Moderator: Jim Turk, Amgen
2:00
Utilization of Biological Panomic Big Data for the Discovery and Development of Novel Biomarkers for Cardiovascular and Cardio-Metabolic Diseases
 
Szilard Voros
Szilard Voros
Founder & Chief Executive Officer
Global Genomics Group
About Speaker: Dr. Szilard Voros, MD, FACC, FSCCT, FAHA is a cardiologist, geneticist and entrepreneur. He is Founder and CEO of Global Genomics Group (“G3”), a precision-medicine-based biotechnology company, developing and commercializing diagnostic biomarkers... Read Full Bio 
 
 
Szilard Voros
Szilard Voros
Founder & Chief Executive Officer
Global Genomics Group
 
About Speaker:

Dr. Szilard Voros, MD, FACC, FSCCT, FAHA is a cardiologist, geneticist and entrepreneur. He is Founder and CEO of Global Genomics Group (“G3”), a precision-medicine-based biotechnology company, developing and commercializing diagnostic biomarkers and novel drug targets for common diseases. G3’s platform is based on the largest-ever program using DNA and RNA sequencing, proteomics, metabolomics, lipidomics and other platforms. G3 has developed a diagnostic blood test for cardiovascular disease and has identified several novel drug targets. Before G3, Voros was Chief Scientific Officer, Chief of Cardiovascular Prevention and Medical Director of Cardiovascular Imaging at Piedmont Heart Institute. He has published extensively in major scientific journals including Nature Reviews, New England Journal of Medicine, Annals of Internal Medicine, Journal of the American College of Cardiology and Circulation: Cardiovascular Genetics, etc.

 
Abstract: With the advent of advanced “om...Read More 

With the advent of advanced “omics” technologies, it has become possible to deploy large, unbiased, multi-omic (or “panomic”) strategies for the discovery and validation of diagnostic and prognostic biomarkers, as well as companion and complimentary diagnostics. Here we present two representative examples of single and multi-analyte biomarker discovery and validation from the prospective GLOBAL clinical study (NCT01738828). First, we demonstrate that out 99 commercial biomarkers measured, we were able to generate a biomarker signature that captures the biology of atherosclerosis and has high level of accuracy for the diagnosis of atherosclerotic coronary artery disease. We furthermore demonstrate that using unbiased, Bayesian network analysis, we discovered that triglyceride-rich LDL particles, as measured by LDL-TG’s, may have a causal role in atherosclerotic coronary artery disease. Second, we demonstrate that using an unbiased, mass-spectrometry-based metabolomics approach, we discovered and validated a novel, diagnostic biomarker signature for the diagnosis of atherosclerotic coronary artery disease (“knowPLAQUETM”).

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2:25
Rapid Isolation and Detection of cf-DNA and Exosome Biomarkers from Cancer Patient Blood, Plasma and Serum Samples
 
Michael Heller
Michael Heller
Professor
University of California, San Diego
About Speaker: Michael J. Heller received his Ph.D. in Biochemistry from Colorado State University in 1973. He was an NIH Postdoctoral Fellow at Northwestern University from 1973 to 1976. From 1976 to 1984 he was supervisor of the DNA Technology Group at Amoco Corp... Read Full Bio 
 
 
Michael Heller
Michael Heller
Professor
University of California, San Diego
 
About Speaker:

Michael J. Heller received his Ph.D. in Biochemistry from Colorado State University in 1973. He was an NIH Postdoctoral Fellow at Northwestern University from 1973 to 1976. From 1976 to 1984 he was supervisor of the DNA Technology Group at Amoco Corporation (Standard Oil Indiana) During that time he carried out early bioengineering and recombinant DNA work on plants, algae and photosynthetic bacteria for energy and chemical production, and he developed some of the first fluorescent resonant energy transfer (FRET) and chemiluminescent oligonucleotide probes for DNA hybridization analysis. He also oversaw Amoco’s sponsored energy and chemical research work at Cetus Corporation, which included the cloning of thermophilic enzymes. Dr. Heller was the Director of Molecular Biology at Molecular Biosystems, Inc., from 1984 to 1987.  He was a co-founder of Integrated DNA Technologies, and served as President and Chief Operating Officer from 1987 to 1989.  He was a co-found of Nanogen, and served as the Chief Technical Officer from 1993 to 2001. Nanogen carried out the successful development and commercialization of electronic DNA microarray technology for clinical diagnostic genotyping applications. Dr. Heller was a Professor (now adjunct professor) in the Departments of Nanoengineering and Bioengineering at the University California San Diego. He is also now a Distinguished Scientist at the Oregon Health & Science University (OHSU), Center for Cancer Early Detection and Research (CEDAR), in Portland, Oregon. He has recently co-founded a new company called Biological Dynamics which is developing new sample to answer cancer diagnostics technology, based on the novel dielectrophoretic (DEP) technology developed at his UCSD lab. Dr. Heller has extensive industrial experience in biotechnology, biomedical and molecular diagnostic devices and nanotechnology, with particular expertise in the areas of DNA probe diagnostics, DC and AC electrokinetic devices, DNA synthesis, FRET/fluorescent-based detection technologies and electric field assisted self-assembly of DNA nanocomponents. Dr. Heller has a respectable publication record, and has been an invited speaker to a large number of scientific conferences, which now include recent meetings on cell free nucleic acid and exosome biomarkers for cancer detection and molecular diagnostics. He also has over 55 issued US patents in the molecular diagnostics, biotechnology and nanotechnology areas.

 
Abstract: Cell free (cf) DNA and exosomal RNA a...Read More 

Cell free (cf) DNA and exosomal RNA and proteins are important biomarkers for liquid biopsy cancer diagnostics and early detection. New AC electrokinetic (ACE) microarray/chip devices (Biological Dynamics, La Jolla, CA) now allow 15-20-minute isolation of cancer related cf-DNA, exosomal RNA and protein biomarkers from 20-50ul of blood, plasma or serum. After isolation, specific fluorescent dyes are used to detect cf-DNA levels directly on the chip (in-situ). Immunofluorescent analysis can then be carried out to identify exosomal protein biomarkers. Cf-DNA and exosomal RNAs can be eluted from the ACE chip, and PCR and sequencing analysis carried out to identify the cancer-related point mutations. For glioblastoma exosomes from plasma, exosome-specific CD63 and TSG101 could be detected by immunofluorescence, and mutated EGFRvlll mRNA was detected by RT-PCR. Exosomal protein biomarker Glypican-1 and CD63 could be isolated from pancreatic cancer and colon cancer patient plasma samples and then detected on-chip by immunofluorescence. Similar results for other exosomal biomarkers have been obtained for prostate, breast, lung and TBI patient samples. ACE technology represents a powerful minimally invasive technology for cancer diagnostics that is well suited for rapid isolation of cf-DNA and exosome biomarkers. The technology is setting the stage for seamless sample to answer liquid biopsy, cancer patient therapy monitoring and for early disease detection.

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2:25
Inflammatory Biomarkers for the Treatment of Atherosclerotic Cardiovascular Disease: Is Now the Time to Begin Routine Use?
 
J. Brent  Muhlestein
J. Brent Muhlestein
Co-Director of Cardiology Research, Intermountain Medical Center and Professor of Medicine
University of Utah
About Speaker: Dr. Joseph Brent Muhlestein is Director of Cardiology Research at Intermountain Medical Center and Professor of Medicine at University of Utah in Salt Lake City, Utah. He received his BS degree in chemistry from Brigham Young University and his MD de... Read Full Bio 
 
 
J. Brent  Muhlestein
J. Brent Muhlestein
Co-Director of Cardiology Research, Intermountain Medical Center and Professor of Medicine
University of Utah
 
About Speaker:

Dr. Joseph Brent Muhlestein is Director of Cardiology Research at Intermountain Medical Center and Professor of Medicine at University of Utah in Salt Lake City, Utah. He received his BS degree in chemistry from Brigham Young University and his MD degree from the University of Utah.  He completed his residency in internal medicine and fellowships in cardiology and interventional cardiology at Duke University. In 1992, after a short stay as faculty at Duke University, he moved to Salt Lake City where he has divided his time between caring for heart patients, directing cardiovascular research and teaching medical students and residents.  Dr. Muhlestein’s research interests include new interventional technologies, cardiovascular clinical outcomes, and the evaluation of possible underlying causes of, and novel risk factors associated with, the development and progression of atherosclerosis, the major underlying cause of heart attacks.

 
Abstract: Both systemic and vascular Inflammati...Read More 

Both systemic and vascular Inflammation has long been shown to be associated with the progression and complications of atherosclerotic cardiovascular disease (ASCVD).  Although many inflammatory biomarkers have been associated with ASCVD, the most prominent one is HS-CRP.  However, because of the absence of any evidence justifying direct anti-inflammatory targeted treatment for ASCVD, the routine clinical use of HS-CRP has not yet become common.  However, with the recent publication of several clinical trials testing the clinical efficacy of a variety of targeted anti-inflammatory drugs, a resurgence of the use of inflammatory biomarkers for the management of ASCVD may be in the offing.  During this presentation, I will review prior observational data regarding inflammatory biomarkers and ASCVD, discuss the results of recent relevant clinical trials, and provide my best estimate of where the use of inflammatory biomarkers in ASCVD will go in the near future.

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2:50
A Workflow to Evaluate PD-L1 Protein Expression on Circulating Tumor Cells (CTCs) from Non-Small Cell Lung Cancer (NSCLC)
 
Elodie Sollier
Elodie Sollier
Chief Scientific Officer
Vortex Biosciences
About Speaker: Elodie is Co-Founder, Chief Scientific Officer and Vice-President Research & Development for Vortex Biosciences, heading the initiatives for the commercialization of microfluidic devices for cancer research and diagnostics. Elodie received a Phys... Read Full Bio 
 
 
Elodie Sollier
Elodie Sollier
Chief Scientific Officer
Vortex Biosciences
 
About Speaker:

Elodie is Co-Founder, Chief Scientific Officer and Vice-President Research & Development for Vortex Biosciences, heading the initiatives for the commercialization of microfluidic devices for cancer research and diagnostics. Elodie received a Physics Engineering Degree from Grenoble Institute of Technology and a PhD in Physics for Life Science from CEA LETI Minatec at Grenoble, France. Her PhD was followed by post-doctoral research in Bioengineering Department, University of California, Los Angeles, with Professor Dino Di Carlo. Her work resulted in the publication of articles in peer-reviewed journals, review papers, presentations in international conferences, and several patents including technologies licensed to Vortex Biosciences from UCLA.

Elodie’s expertise includes the development of new microfluidic devices for biological applications, focusing especially on blood sample preparation and analysis. She has been investigating different microfabrication approaches for transitioning from laboratory research to commercialization.

 
Abstract: Many tumors evade immune surveillance...Read More 

Many tumors evade immune surveillance by deploying immunosuppressive mechanisms and co-opting immune checkpoint pathways, such as PD-1/PD-L1. PD-1/PD-L1 pathway blockade is a highly promising therapy with durable antitumor responses in a variety of cancers. Challenges in advancing immunotherapies lie in patient stratification and monitoring therapy. Evaluation of PD-L1 expression is generally regarded as an inclusion criterion for clinical trials. Current methods rely on the analysis of biopsies, which are invasive and carry medical risks. Analysis of CTCs is a noninvasive alternative that may provide more representative information on the tumor(s) in real-time, and allow the monitoring of treatment effectiveness. Here, we present an integrated workflow for the analysis of PD-L1 protein expression on CTCs isolated from metastatic NSCLC patients with the Vortex Biosciences VTX-1 liquid biopsy system.

Cell lines expressing various level of PD-L1 and white blood cells from healthy donors were used to optimize the PD-L1 immunostaining assay. Several PD-L1 antibodies were titrated, and their specificity estimated with isotype controls. PD-L1 expression quantification was evaluated using two independent methods. Clinical validation was performed on blood samples collected from a cohort of NSCLC patients (stage IV) with known PD-L1 tumor status. CTCs were isolated using the VTX-1 System, immunostained, classified, and their PD-L1 expression quantified.

We have developed a PD-L1 immunofluorescent assay that shows specificity, sensitivity, and very good intra-assay repeatability. This assay was validated on CTCs isolated from a small cohort of metastatic NSCLC patients. Preliminary data shows heterogeneity in PD-L1 expression levels across CTCs from the same patient. Interestingly, among PD-L1+ CTCs, both traditional CK+/PD-L1+ and CK-/PD-L1+ cells were observed. To move toward a more automated workflow for immunostaining, imaging, and fluorescence signal analysis, methods to collect CTCs on glass slides were evaluated, with cell recovery ranging from 33 to 98%.

We demonstrated the feasibility of evaluating PD-L1 protein expression on CTCs isolated with the VTX-1. While further clinical validation is warranted, this test could represent a simple non-invasive method to help identify patients likely to respond to PD-1/PD-L1 immunotherapies. Future work will focus on compatibility of the assay with automated staining, imaging and analysis platforms.

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2:50
Artificial Intelligence/Machine Learning-driven, Multi-protein Algorithmically Scored Tests for Cardiovascular Diseases
 
Rhonda Rhyne
Rhonda Rhyne
Chief Executive Officer
Prevencio
About Speaker: Rhonda Rhyne has more than 25 years of executive medical technology research and commercialization experience and is currently CEO, Chief Translational Medicine Officer and Board Director for Prevencio, Inc., a Seattle-based company developing multi-... Read Full Bio 
 
 
Rhonda Rhyne
Rhonda Rhyne
Chief Executive Officer
Prevencio
 
About Speaker:

Rhonda Rhyne has more than 25 years of executive medical technology research and commercialization experience and is currently CEO, Chief Translational Medicine Officer and Board Director for Prevencio, Inc., a Seattle-based company developing multi-protein blood tests for obstructive heart disease; 1-year risk for myocardial infarct, stroke, and CV death; obstructive peripheral artery disease…and more. She also serves as Board Director for Aminex Therapeutics and OtoNexus Medical Technologies, both Seattle-area companies. As a medical technology industry leader, Rhonda has received multiple awards, including Ernst & Young's Entrepreneur of the Year--Medical Products, San Diego; Deloitte's Fast 50 for 50 Fastest Growing Technology and Life Science Companies in Southern California; San Diego's Business Journal's Women Who Mean Business; and Athena's Pinnacle Individual in BioSciences. Rhonda also authored the women’s leadership book, Keys to the Corner Office: Success Strategies for Women by Women (www.keytothecorneroffice.com). A portion of net proceeds is donated to OUR Rescue, a nonprofit dedicated to fighting sex trafficking. Rhonda received her Bachelor of Pharmacy from Washington State University and MBA from University of California, Los Angeles (UCLA). @rhondarhyne, www.linkedin.com/in/rhondarhyne, www.prevenciomed.com

 
Abstract: 1. Cardiovascular Disease Review: Des...Read More 

1. Cardiovascular Disease Review: Despite efforts towards better recognition of risk factors and preventive treatments, the prevalence of coronary artery disease (CAD) in the general population remains high, with nearly 1 in 5 people over age 65 affected by the diagnosis. Indeed, heart disease is the leading cause of death for both men and women, with CAD the most common affliction, killing over 370,000 people annually. As such, CAD is a public health concern, and an efficient manner for its non-invasive detection could potentially result in reduction of morbidity, mortality, and cost of this disease process.

2. Shortcomings of Current Clinical Approaches: Clinicians often utilize stress testing with or without adjunctive imaging to assist their evaluation of obstructive CAD. Drawbacks to stress testing include variable sensitivity and specificity, limitations with respect to accuracy in certain types of body habitus (including overweight/obese patients and women), as well as the need for ionizing radiation. More recently, coronary calcium assessment by computed tomography (CT), as well as CT angiography have been used to identify severe CAD; both identify CAD presence and severity independent of and substantially incremental to clinical risk scores. However, CT angiography has similar drawbacks to stress testing. Additionally, the application of imaging to large numbers of patients suspected to have CAD would not be practical. Lastly, both stress and CT imaging come with the challenge of high cost.

3. New and Highly Accurate Artificial Intelligence-driven Multi-protein Biomarker Approaches: A relatively unexplored approach for identifying significant CAD is the use of clinical and biomarker scoring systems. Accordingly, we sought to identify clinical and biomarker predictors of clinically significant CAD in an at-risk population of subjects enrolled in the Catheter Sampled Blood Archive in Cardiovascular Diseases Study undergoing coronary angiography for numerous indications. We hypothesized and validated that the addition of plasma biomarkers to known clinical risk factors increased the accuracy of predicting clinically significant CAD as well as the accuracy of 1-year risk of heart attack, stroke and cardiac death.

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3:15
Arrhythmia and Cardiotoxicity Prediction via Kinetic Image Cytometry (KIC) and hiPSC-derived Cardiomyocytes
 
Jeffrey  Price
Jeffrey Price
Chief Executive Officer
Vala Sciences
About Speaker: Jeff Price received his MD in 1985 from Loma Linda University and his PhD in bioengineering in 1990 from UCSD, where his lab created what became the IC 100 HCS instrument, first via Q3DM, which he founded in 1998, and then at Beckman Coulter, which p... Read Full Bio 
 
 
Jeffrey  Price
Jeffrey Price
Chief Executive Officer
Vala Sciences
 
About Speaker:

Jeff Price received his MD in 1985 from Loma Linda University and his PhD in bioengineering in 1990 from UCSD, where his lab created what became the IC 100 HCS instrument, first via Q3DM, which he founded in 1998, and then at Beckman Coulter, which purchased Q3DM in 2003. In 2004, he joined the Sanford-Burnham-Prebys Medical Discovery Institute (SBP) where he participated in creating the Prebys Center for Drug Discovery, one of four primary national screening centers funded by the NIH MLSCN/MLPCN program. In 2004, he also founded Vala Sciences, which in collaboration with SBP via NIH STTR funding, created and commercialized the Kinetic Image Cytometer. In 2015 he was appointed professor at The Scintillon Institute and Adjunct Professor at SBP.

 
Abstract: Scientific revolutions in stem cells,...Read More 

Scientific revolutions in stem cells, genomics, and proteomics are enabling increasingly better models of human disease-in-a-dish models amenable to high throughput drug discovery and diagnostics. Beginning in 2005, we began developing Kinetic image cytometry (KIC, single-cell video analysis) of calcium, voltage and myocyte contraction, for in vitro prediction of the effects of toxins and drugs on human tissues, including the heart, skeletal muscle, and neurons. KIC can be thought of as cell-by-cell optical electrophysiology, carried out on each of 300 cardiomyocytes or 1,000 neurons simultaneously, at a rate of about 100 fps full frame per well in microtiter plates in fully automated (high throughput discovery) mode, and up to 1500 fps ROI. As opposed to whole-well plate reader techniques and field effect readouts, KIC analyzes each cell individually, parameterizes every transient with about 30 parameters, and thus overcomes the data smearing that occurs with other technologies. The KIC also enables quantification of circuits and propagation of signals that coordinate synchronized contractions of cardiac tissue.  The presentation will focus on KIC results in cardiomyocytes that demonstrate promise for drug discovery in heart disease, and prediction of arrhythmia and cardiotoxicity side effects of candidate drugs.

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3:40
Afternoon Networking Break
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5:15
Networking Reception & Poster Session
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Day 2 - Wednesday, March 28, 2018
 
7:30
Continental Breakfast for All Attendees
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Inflammatory & Immunological Biomarkers
Biomarkers of Early Progressive Inflammatory & Immunological Diseases
Moderator: Xuemei Zhao, Merck
8:30
Biomarkers and Personalized Medicine in Rheumatoid Arthritis and Inflammatory Bowel Disease
 
Mark Curran
Mark Curran
Vice President, Immunology, Systems Pharmacology & Biomarkers
Janssen
About Speaker: Dr. Curran is currently Vice President of Immunology Systems Pharmacology and Biomarkers at Janssen Research & Development, LLC. His team is responsible for biomarker strategy, implementation, analysis and development and commercialization of com... Read Full Bio 
 
 
Mark Curran
Mark Curran
Vice President, Immunology, Systems Pharmacology & Biomarkers
Janssen
 
About Speaker:

Dr. Curran is currently Vice President of Immunology Systems Pharmacology and Biomarkers at Janssen Research & Development, LLC. His team is responsible for biomarker strategy, implementation, analysis and development and commercialization of companion diagnostics (Co-Dx) for immunology assets.

Mark’s experience in drug development includes seven years with Janssen and five years at Bristol Myers-Squibb. In addition to biomarker responsibilities he has lead clinical development and Phase 1 and 2 trials for multiple compounds in immunology. Prior to joining the pharmaceutical industry, Mark gained valuable experience in biotech and venture oriented companies with focus on genomics, diagnostics and drug discovery.

Mark earned his doctorate in human genetics at the University of Utah, has authored over 40 scientific publications and holds multiple patents. He has contributed seminal discoveries in the field of heritable cardiac arrhythmias and developed the Familion™ diagnostic test for long QT syndrome. His primary interests are discovery of novel therapeutics, implementation of molecular diagnostics for personalized medicine and evolution of Digital Health Care and Integrated Patient Care Solutions to improve the lives of patients living with auto-immune disease.

 
Abstract: Auto-Immune disease including Rheumat...Read More 

Auto-Immune disease including Rheumatoid Arthritis and Inflammatory Bowel Disease dramatically impacts quality of life for patients. Despite advances in treatment for these disorders there remains a significant unmet clinical need for new therapies, companion diagnostics and integrated treatment solutions. Our team is focused on transforming treatment of these diseases by applying Systems Pharmacology, Precision Medicine and Digital Health to create new treatment paradigms. Progress toward these objectives will be discussed.

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Neurological Biomarkers
Biomarkers for Early Identification of Neurological Disease
Moderator: Andreas Jeromin, Quanterix
8:30
Steps towards Personalized Healthcare in Alzheimer Disease and Neurodegeneration
 
Richard  Batrla-Utermann
Richard Batrla-Utermann
Medical Director
Roche
About Speaker: Global Clinical Director, Personalized Healthcare and Neurology, Roche Professional Diagnostics, Medical and Scientific Affairs, Roche Diagnostics International AG, Rotkreuz International Medical Director, Pharma Business/Global Product Strategy, Me... Read Full Bio 
 
 
Richard  Batrla-Utermann
Richard Batrla-Utermann
Medical Director
Roche
 
About Speaker:

Global Clinical Director, Personalized Healthcare and Neurology, Roche Professional Diagnostics, Medical and Scientific Affairs, Roche Diagnostics International AG, Rotkreuz

International Medical Director, Pharma Business/Global Product Strategy, Medical Affairs/Medical Marketing, F. Hoffmann-La Roche Ltd.

Global Alliance Director, Pharma Partnering, F. Hoffmann-La Roche Ltd.

Head of Scientific Business Development, mtm laboratories AG, Heidelberg

 
Abstract: For further support of clinical resea...Read More 

For further support of clinical research in neurodegenerative disorders the NeuroToll Kit, an extended portfolio of standardized prototype assays on Elecsys platform for novel exploratory CSF BM e.g. Abeta40, α- Synuclein, sTREM2 have been developed and for further 20 novel markers e.g. Neurogranin, NF-L and others will be developed at CPS and provided at the external laboratory test sites to all members of NeuroTool consortium from pharmaceutical companies and academic institutions for the evaluation of the clinical utility of novel exploratory CSF BM.

The consolidated utilization of the robust and reproducible standardized assays for the measurement of CSF samples from multiple cohorts across various studies will facilitate the collaboration and data/results sharing between academia and industry and will enable early access to novel potential CSF BM. Further it will lead to the generation of robust, trusted, multi-cohort data sets for novel exploratory CSF BM and will enable quicker decision making based on same assay and analytes for their clinical utility and their consideration by the clinical trial design. In case of demonstrated clinical utility for certain exploratory CSF BM the prototype assays could be seamless transferred to the clinical trial assay (CTA) or further developed to IVD and could be quicker implemented for patient management in clinical trials.

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8:55
Histamine-releasing Factor in Food Allergy
 
Toshiaki  Kawakami
Toshiaki Kawakami
Professor, Division of Cellular Biology
La Jolla Institute for Immunology & Allergy
About Speaker: 1978 MD, 1983 PhD from The University of Tokyo 1984-88 Postdoc at the NCI/NIH 1990 Assistant Professor, La Jolla Institute for Allergy and Immunology (LJI) 2000 Professor, LJI... Read Full Bio 
 
 
Toshiaki  Kawakami
Toshiaki Kawakami
Professor, Division of Cellular Biology
La Jolla Institute for Immunology & Allergy
 
About Speaker:

1978 MD, 1983 PhD from The University of Tokyo
1984-88 Postdoc at the NCI/NIH
1990 Assistant Professor, La Jolla Institute for Allergy and Immunology (LJI)
2000 Professor, LJI

 
Abstract: IgE molecules have a tremendous heter...Read More 

IgE molecules have a tremendous heterogeneity in their ability to influence mast cell biology. We have recently extended this line of study by showing that histamine-releasing factor (HRF) directly binds a subset of immunoglobulins (Igs) including IgE via interactions of two Ig-interacting sites within HRF with the Fab portion of Igs. Disulfide-linked HRF dimer can activate HRF-reactive IgE-sensitized mast cells.

In an IgE/FceRI/mast cell-dependent food allergy model, diarrhea and type 2 intestinal inflammation were induced by repeated ovalbumin (OVA) gavages in OVA-immunized BALB/c mice, accompanied by increased mucosal mast cell numbers and HRF dimer levels in the small intestine. Confocal microscopy revealed that orally administered HRF inhibitors that block HRF-IgE interactions preferentially target mast cells in the jejunum. Both prophylactic and therapeutic administration of HRF inhibitors reduced diarrhea incidence, intestinal inflammation, and reduced mast cell activation. Relevance of the mouse data was studied by measuring serum levels of HRF and HRF-reactive IgE and IgG before and after oral immunotherapy (OIT) of human patients allergic to hen eggs. Egg allergy patients had higher plasma levels of HRF-reactive IgE and IgG than healthy controls. Interestingly, the patients who exhibited high sensitivity to allergen within 2 weeks of allergen avoidance after 12 months of maintenance dosing, unlike those who exhibited low sensitivity, had higher HRF-reactive IgE levels than their levels one week after the OIT initiation. Similar to these human OIT results, successful OIT kept HRF-reactive IgE levels low in two mouse models of OIT. Therefore, HRF promotes diarrhea development and intestinal type 2 inflammation in food allergic mice.

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8:55
 
Arti  Gaur
Arti Gaur
Assistant Professor of Neurology
Dartmouth Geisel School of Medicine
About Speaker: Dr. Gaur is an Assistant Professor of Neurology and Member of the Norris Cotton Cancer Center at the Geisel School of Medicine, Dartmouth. She received her BS from Rochester Institute of Technology, NY; an MS from University of Rochester, NY and her ... Read Full Bio 
 
 
Arti  Gaur
Arti Gaur
Assistant Professor of Neurology
Dartmouth Geisel School of Medicine
 
About Speaker:

Dr. Gaur is an Assistant Professor of Neurology and Member of the Norris Cotton Cancer Center at the Geisel School of Medicine, Dartmouth. She received her BS from Rochester Institute of Technology, NY; an MS from University of Rochester, NY and her PhD from University of Cologne, Germany.

At Dartmouth, her group studies the molecular basis of neurological pathologies, specifically gliomas. Dr. Gaur is the Study Chair on an Alliance funded, multi-institutional, prospective clinical trial that is establishing a comprehensive panel of diagnostic and prognostic markers as well as biomarkers of tumor burden, treatment efficacy and toxicity. Furthermore in this trial her group is testing patient tumors ex vivo and establishing novel therapies to treat gliomas.  The other sites for this trial are University of Vermont Medical Center, Tufts Medical Center and Massachussets General Hospital.  Additionally, Dr. Gaur’s group is also developing innovative, in vivo wireless, nano scale devices, to measure multiple biomarkers of health that can predict and track the course of diseases, enable real-time evaluation of treatment efficacy and deliver targeted therapies in patients suffering from incurable and debilitating neurological disorders.

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9:20
Immuno-autonomics: A Concept Poised to Revolutionize the Way Payers, Patients and Clinicians View Autoimmune Diseases and Cancer
 
Andrew  Holman
Andrew Holman
Chief Executive Officer & Co-founder
Inmedix Inc and Inmedix UK Ltd
About Speaker: Andrew J. Holman, M.D., is a clinical rheumatologist, CEO and Co-founder of Inmedix, Inc. in Seattle and its subsidiary, Inmedix UK, Ltd. He established Inmedix to validate and commercialize autonomic nervous system (ANS) diagnostics and therapeutics... Read Full Bio 
 
 
Andrew  Holman
Andrew Holman
Chief Executive Officer & Co-founder
Inmedix Inc and Inmedix UK Ltd
 
About Speaker:

Andrew J. Holman, M.D., is a clinical rheumatologist, CEO and Co-founder of Inmedix, Inc. in Seattle and its subsidiary, Inmedix UK, Ltd. He established Inmedix to validate and commercialize autonomic nervous system (ANS) diagnostics and therapeutics to enhance immunosuppressive outcomes for patients with autoimmune diseases. He trained at the University of Washington (rheumatology fellowship), Presbyterian-St. Luke’s Medical Center (internal medicine residency), the University of Missouri-Columbia (M.D.) and Bowdoin College (A.B., Chemistry). Currently, he is also a Clinical Associate Professor Medicine at the University of Washington. His research identified the role of ANS assessment as a predictor of immunosuppressive treatment outcomes in patients with autoimmune diseases as well as how to enhance those outcomes through adjunctive ANS therapeutics. He discovered the role of dopamine agonists in the treatment of fibromyalgia and elucidated the dysautonomic effects of positional cervical cord compression (PC3) in humans with widespread pain.

 
Abstract: Immuno-autonomics is the interface be...Read More 

Immuno-autonomics is the interface between stress, controlled in the brain by the autonomic nervous system (ANS), and the immune system. When threatened, the ANS (fight-or-flight) enhances survival through a variety of cardiovascular mechanisms. It also activates and intensifies the immune system. And while appropriate for most, this leads to harsh consequences for patients with autoimmune diseases. Immuno-autonomic diagnostic biomarkers are the only known, actionable predictors of biologic therapeutic outcome in rheumatoid arthritis (RA). Three methods used adjunctively, including vagal nerve stimulation, have substantially enhanced traditional immunosuppressive treatment outcomes in RA. Similar studies are underway in systemic lupus erythematosus (SLE), inflammatory bowel disease (IBD) and multiple sclerosis (MS). A new health economic study, presented at the American College of Rheumatology annual meeting in November 2017, projected immuno-autonomic diagnostics and therapeutics to increase quality of life years (QALYs) by >800,000 and reduce biologic spending by $23-28 Billion over ten years in the US for RA. A coordinated immune system is also essential for cancer surveillance and successful cancer treatment. ANS state and immuno-autonomics appear to offer a potential new approach to enhance cancer therapeutics agnostically. • Define physiology and therapeutic rationale underlying immuno-autonomics. • Evaluate the clinical evidence related to immuno-autonomic diagnostic and therapeutic applications used to address autoimmune disease and cancer. • Quantify the health economic impact of immuno-autonomics on payers and the pharmaceutical industry in the near and distant future.

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9:20
Clinical Biomarkers for Alzheimer's Disease
 
Douglas Scharre
Douglas Scharre
Director, Division of Cognitive Neurology, Department of Neurology
Ohio State University, Wexner Medical Centre
About Speaker: Dr. Douglas W. Scharre is the Director, Division of Cognitive Neurology and the Medical Director of The Ohio State University Center for Cognitive and Memory Disorders. He is a clinical researcher and behavioral neurologist specializing in the diagno... Read Full Bio 
 
 
Douglas Scharre
Douglas Scharre
Director, Division of Cognitive Neurology, Department of Neurology
Ohio State University, Wexner Medical Centre
 
About Speaker:

Dr. Douglas W. Scharre is the Director, Division of Cognitive Neurology and the Medical Director of The Ohio State University Center for Cognitive and Memory Disorders. He is a clinical researcher and behavioral neurologist specializing in the diagnosis and management of cognitive issues for over 20 years. He has conducted or participated in over 140 clinical research studies in dementia and mild cognitive impairment, funded by NIH, foundations and industry, utilizing neuroimaging (anatomical and functional (resting and task-activated) MRI, PET, and SPECT), serum and cerebrospinal fluid biomarkers, cognitive biomarkers, genetic biomarkers, and cognitive, functional, and behavioral scales on dementia and control subjects. He has designed and developed both paper and digital versions of the Self-Administered Gerocognitive Examination (SAGE), a cognitive assessment instrument designed for identifying individuals in a practical way with mild cognitive impairment or early dementia from any cause and to be sensitive to changes over time. He lectures frequently on topics of dementia, Alzheimer's disease, behavioral management of dementia and other aspects of cognitive neurology. Dr. Scharre joined The Ohio State University Wexner Medical Center faculty in the Department of Neurology in 1993. Dr. Scharre is board certified in neurology and in behavioral neurology and neuropsychiatry with special interests in cognitive assessment, degenerative dementias and dementia-related behaviors.

 
Abstract: It has been over 14 years since the U...Read More 

It has been over 14 years since the U.S. FDA approved the last treatment for Alzheimer’s disease. New treatments impacting the pathophysiology of Alzheimer’s disease are best assessed by specific biomarkers. We are in great need of biomarkers that change quickly with the progression of the disease (progression prediction) to be able to determine efficacy of novel treatments in as short a time as possible so that we can focus on the most promising drugs. Biomarkers are also essential to help in the identification of the earliest stages of Alzheimer’s disease (diagnostic). Since it appears that many disease modifying treatments being tested are only effective if used in the prodromal dementia stage, we need to find biomarkers that can identify individuals very early. This presentation provides a brief overview of different types of biomarkers currently being studied and used for Alzheimer’s disease.

• Cerebrospinal fluid and serum biomarkers – pathologic proteins, synaptic function, nano-physical

• Imaging biomarkers – volumetric, PET, fMRI

• Cognitive biomarkers – diagnostic and change over time

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9:45
The Vectra DA Test for Patients with Rheumatoid Arthritis
 
Eric Sasso
Eric Sasso
Vice President, Medical & Scientific Affairs
Crescendo Bioscience
About Speaker: Dr. Sasso joined Crescendo Bioscience in 2012, where he has helped lead the Vectra medical development program to gain Medicare coverage, launch the pivotal clinical outcomes study and expand the validity and utility of Vectra DA as a predictor of ra... Read Full Bio 
 
 
Eric Sasso
Eric Sasso
Vice President, Medical & Scientific Affairs
Crescendo Bioscience
 
About Speaker:

Dr. Sasso joined Crescendo Bioscience in 2012, where he has helped lead the Vectra medical development program to gain Medicare coverage, launch the pivotal clinical outcomes study and expand the validity and utility of Vectra DA as a predictor of radiographic progression. Dr. Sasso came to Crescendo from Abbott Laboratories, where he worked in Early Immunology Clinical Development and Humira Medical Affairs. Prior to joining Abbott in 2004, he was at the University of Washington, Seattle, where he is currently an Affiliate Professor of Medicine. Dr. Sasso earned an A.B. Biochemistry degree at Harvard University, Cambridge, MA, an M.D. degree from the University of California, San Diego and has trained in internal medicine at McGill University, Montreal, rheumatology at the University of Washington, and immunology at the Virginia Mason Research Center, Seattle. He has published extensively in the fields of rheumatology, immunology and dermatology.

 
Abstract: Vectra DA is a commercially available...Read More 

Vectra DA is a commercially available multi-biomarker blood test that measures 12 serum proteins and uses a validated algorithm to measure the level of disease activity in patients with rheumatoid arthritis (RA).  Subsequent work has shown Vectra DA to be a better predictor of risk for new joint damage than conventional disease activity measures.  A new version of Vectra DA reports the score after adjusting for the effects of age, sex and adiposity.  Preliminary data show Vectra DA may also be able to predict risk for myocardial infarction or coronary heart disease.

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9:45
The Future of CNS Biomarkers
 
Andreas Jeromin
Andreas Jeromin
Scientific and Medical Advisor
Quanterix
About Speaker: Andreas Jeromin, PhD, has more than 25 years of experience in CNS clinical diagnostics and companion diagnostics and co-authors more than 150 publications. He is the founder of Atlantic Biomarkers, Inc., and currently the consulting Chief Medical Off... Read Full Bio 
 
 
Andreas Jeromin
Andreas Jeromin
Scientific and Medical Advisor
Quanterix
 
About Speaker:

Andreas Jeromin, PhD, has more than 25 years of experience in CNS clinical diagnostics and companion diagnostics and co-authors more than 150 publications. He is the founder of Atlantic Biomarkers, Inc., and currently the consulting Chief Medical Officer to Quanterix Corp.

 
Abstract: Quanterix advances in detection and q...Read More 

Quanterix advances in detection and quantitation of biomarkers has accelerated research in CNS disease and injury as well as supported  drug development.   Our work in traumatic brain injury and on diseases such as MS, ALS, Huntington’s and Alzheimer’s Disease are just a few of the areas SIMOA technology has made an impact.  The technology has been used in over 700 phase trials and continues to expand CNS, inflammation, infectious disease and other areas critical to medical research The presentation will describe the principles, underlying the technology as well highlight selected case studies. 

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10:10
Morning Networking Break
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Inflammatory & Immunological Biomarkers
Biomarkers as Surrogate Endpoints for Clinical Trials
Moderator: Calixte Monast, Janssen
10:40
Functional Relevance of Surrogate Biomarkers in Clinical Trials
 
Anuraag  Shrivastav
Anuraag Shrivastav
Associate Professor, Department of Biology
University of Winnipeg
About Speaker: Dr. Anuraag Shrivastav completed his PhD in 2002 from the Banaras Hindu University, India. He received postdoctoral fellowship from Canadian Institutes of Health Research and obtained postdoctoral training at the department of Pathology and Laborator... Read Full Bio 
 
 
Anuraag  Shrivastav
Anuraag Shrivastav
Associate Professor, Department of Biology
University of Winnipeg
 
About Speaker:

Dr. Anuraag Shrivastav completed his PhD in 2002 from the Banaras Hindu University, India. He received postdoctoral fellowship from Canadian Institutes of Health Research and obtained postdoctoral training at the department of Pathology and Laboratory Medicine and Saskatchewan Cancer Agency, University of Saskatchewan, Canada. Dr Shrivastav is a faculty member at the University of Winnipeg and adjunct member at the University of Manitoba and CancerCare Manitoba. He has published over 40 peer-reviewed articles in International journals of repute. His laboratory is engaged in studying cellular signaling mechanisms that are intricately linked to homeostasis that control cell proliferation, survival and death in cancer cells. Currently, his research group is actively pursuing scientific research to identify novel markers for CRC screening and early detection. Dr. Shrivastav is also Principal, VastCon Inc – A University of Winnipeg spinoff dedicated to developing novel biomarkers based simple prognostic/diagnostic tests.

 
Abstract: The onset and progression of cancer i...Read More 

The onset and progression of cancer is invariably associated with a downregulation in the host’s immune response regardless of the location or aetiology of the tumour. The functional alteration of immune cells in peripheral blood due to cancer progression could be monitored. Lymphocytes are the main cellular effectors of the adaptive immunity and play important role in tumorigenesis both as intrinsic and extrinsic factors. The tumor microenvironment in patients with a variety of solid tumors has revealed presence of infiltrated T cells. For example, the presence of activated CD8+ T cells within the tumor and peritumoral stroma in early stage colorectal cancer (CRC) show positive prognosis. It is becoming more evident that immunophenotype has more prognostic value than traditional staging. This also provides an opportunity to analyse peripheral blood mononuclear cells (PBMC) and/or T cells for alterations in signalling molecules due to cancer induced changes in their functions. One of the major pathways that regulate T cell functions is T cell receptor (TCR). Alteration in TCR pathway proteins could serve as prognostic, predictive and/or surrogate markers for solid tumors. I will discuss potential biomarkers that play important role in T cell function and could serve as functional surrogate markers for solid tumors in peripheral blood.

 

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Neurological Biomarkers
Monitoring Progression and Treatment Efficacy using Biomarkers
Moderator: Andreas Jeromin, Quanterix
10:40
Parkinson’s Disease Biomarkers: A Fertile Landscape for Discovery and Validation
 
Mark  Frasier
Mark Frasier
Vice President, Research Programs
Michael J. Fox Foundation
About Speaker: Dr. Frasier has been with the Michael J Fox Foundation since 2006. He earned an undergraduate degree in Biochemistry from the University of Dayton and a PhD in Pharmacology from Loyola University Chicago. He completed his postdoctoral work in the Neu... Read Full Bio 
 
 
Mark  Frasier
Mark Frasier
Vice President, Research Programs
Michael J. Fox Foundation
 
About Speaker:

Dr. Frasier has been with the Michael J Fox Foundation since 2006. He earned an undergraduate degree in Biochemistry from the University of Dayton and a PhD in Pharmacology from Loyola University Chicago. He completed his postdoctoral work in the Neuroscience Discovery Research Group at Eli Lilly, Inc., in Indianapolis, Indiana, where he worked on drug-discovery research in Parkinson's and Alzheimer's disease.

 
Abstract: Diagnosis and measurement of Parkinso...Read More 

Diagnosis and measurement of Parkinson’s disease progression relies on subjective clinical measures that are heterogeneous and suffer from inter and intra-subject variability. Objective diagnostic and progression markers would allow earlier treatment with putative disease-modifying treatments and improve clinical trial design. The Michael J Fox Foundation has developed a comprehensive strategy to support biomarker discovery, validation, and integration into clinical trials. This talk will review the current status of diagnostic and progression markers in Parkinson’s disease. It will also highlight emerging data from natural history studies that are informing clinical trial design and outcome measures. Benefits to attending the presentation include learning about Parkinson’s disease and disease outcome measures, a funder’s strategy to accelerate biomarker development, and examples of successful public-private consortia.

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11:05
Biomarkers of Extra Cellular Matrix Remodeling - Implications for Fibrosis
 
Klaus Moller
Klaus Meyer Moller
Head of Business Development
Nordic Bioscience A/S
About Speaker: ... Read Full Bio 
 
 
Klaus Moller
Klaus Meyer Moller
Head of Business Development
Nordic Bioscience A/S
 
About Speaker:
 
Abstract: The combination of a signature protei...Read More 

The combination of a signature protein and a pathology dependent protease results in the release of unique degradation fragments that have specific neo-epitopes and are thus pathology-specific. Such markers provide a novel tool for precision medicine and the assessment of treatment efficacy. A phase II study investigating the anti-fibrotic properties of Farglitazar showed no efficacy according to paired biopsy and collagen morphometry within chronic hepatitis C patients. We analysed serological PRO-C3, a marker of fibrogenesis, and found that at baseline PRO-C3 could predict which patients were likely to respond to therapy. Patients with of PRO-C3 >20.2ng/mL showed significant improvements in histological fibrosis score compared to placebo. Whereas those with PRO-C3 <20.2ng/mL showed no improvement. Additionally, Farglitazar significantly reduced the levels of PRO-C3 from baseline compared to placebo. The LITHE and RADIATE studies were phase III studies investigating the combination therapy of Tocilizumab (TCZ, 4mg/kg or 8mg/kg) and Methotrexate (MTX) within Rheumatoid Arthritis (RA) patients. Within the LITHE study, C4M was assessed at baseline and weeks 4, 16, 24 and 54. C4M was found to be associated with disease activity and radiographic progression and was dose-dependently reduced by TCZ and MTX. Within the LITHE and RADIATE studies, we investigated the change from baseline of C4M after 16 weeks of treatment and found that TCZ and MTX dose-dependently and significantly reduced the levels of C4M compared to placebo. This suggests that patients with active and progressive RA have increased remodelling of the basement membrane.

 

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11:05
Blood and Brain-Derived Neuronal Exosome Cargo in the Propogation and Progression of Neuropathology
 
Robert Rissman
Robert Rissman
Associate Professor
University of California, San Diego
About Speaker: Dr. Rissman's work at UCSD is split into several parts that are balanced relatively equally. The goal of his basic science research is to discover novel biomarkers for neurodegenerative diseases with a specific focus on blood-based biomarkers. Of pri... Read Full Bio 
 
 
Robert Rissman
Robert Rissman
Associate Professor
University of California, San Diego
 
About Speaker:

Dr. Rissman's work at UCSD is split into several parts that are balanced relatively equally. The goal of his basic science research is to discover novel biomarkers for neurodegenerative diseases with a specific focus on blood-based biomarkers. Of primary interest is the study of the biomarker utility and pathologic potential of neuronally-derived exosomes. Dr. Rissman's in vivo work is focused on the contribution of stress and changes in stress signaling intermediates in Alzheimer’s disease neuropathology and the discovery of compounds that impact the corticotropin-releasing factor system in Alzheimer's Disease.

In addition to the research program, Dr. Rissman is the Director for the Alzheimer's Disease Cooperative Study (ADCS) Biomarker Core and the Neuropathology/Brain Bank for the Alzheimer’s Disease Research Center (ADRC) at UCSD. Both cores are comprised by wet laboratories and a biospecimen banks.

Dr. Rissman is also the PI of UCSD’s Neuroplasticity of Aging Training Grant (T32) and teach graduate classes in the Neurobiology of Disease.

 
Abstract: Proteins implicated in neurodegenerat...Read More 

Proteins implicated in neurodegenerative diseases such as Alzheimer’s Disease (AD) and Dementia with Lewy Bodies (DLB) have been identified in blood encased in extracellular compartments called exosomes. Exosomes can be released from a variety of cell types, including neurons.  In this study, we performed two studies to characterize the contents and pathogenic potential of neuronal exosomes harvested from brain or blood from DLB and AD.  Exosomes extracted from brains diagnosed with AD or DLB contained aggregate-prone proteins identified in brain tissue through immunohistochemistry. Furthermore, non-diseased mouse brains injected with brain-derived exosomes from DLB or AD exhibited prominent alpha-synuclein (α-syn) and tau aggregation, respectively. Using a neuronal cell line, we also determined intracellular α aggregation of these proteins mediated by exosomes is dependent on recipient cell endocytosis. We also examined the ability of pathological proteins contained within neuronal exosomes to predict conversion of MCI to AD.  Using blood-derived neuronal exosomes from MCI and AD patients, we found levels of pT181-tau, pS396-tau, and Aβ42 were significantly higher, whereas those of neurogranin (NRGN) and the repressor element 1-silencing transcription factor (REST) were significantly lower in AD patients and patients with MCI who converting to AD compared to cognitively normal controls and stable MCI patients. These data suggest that abnormal plasma NDE levels of phospho tau, Aβ42, NRGN, and REST accurately predict conversion of MCI to AD dementia. Our data also suggest that exosomes from AD and DLB are sufficient for seeding and propagating α-syn and tau pathology in vivo

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11:30
Serum Autoantibody Markers Correlated with Clinical Response to an Anti-TNF Therapy in Patients with Rheumatoid Arthritis
 
Xuemei Zhao
Xuemei Zhao
Senior Principal Scientist
Merck
About Speaker: Xuemei Zhao obtained her Ph.D. in Chemistry at Columbia University and did her postdoctoral training at Cold Spring Harbor Laboratory.  Afterwards, Xuemei joined the Proteomics Department at Merck Research Laboratories.  Her group was responsible f... Read Full Bio 
 
 
Xuemei Zhao
Xuemei Zhao
Senior Principal Scientist
Merck
 
About Speaker:

Xuemei Zhao obtained her Ph.D. in Chemistry at Columbia University and did her postdoctoral training at Cold Spring Harbor Laboratory.  Afterwards, Xuemei joined the Proteomics Department at Merck Research Laboratories.  Her group was responsible for biochemical sample preparation for LC-MS based proteomics profiling in biomarker discovery and new target identification.  Xuemei then moved on to focus on clinical biomarker development and implementation.  Currently, Xuemei leads the immunoassay group in Translational Molecular Biomarkers to support clinical programs across all disease areas at Merck.

 
Abstract: Autoantibodies are generated by the i...Read More 

Autoantibodies are generated by the immune system to self-proteins in response to many pathological processes.  Therefore, autoantibody biomarkers allow early detection of disease prior to clinical symptoms due to the inherent amplification within the immune system.  I will discuss a case study on identification of serum autoantibody markers that correlate with clinical response of an anti-TNF therapy.  This study demonstrates the promise of serum autoantibody markers to facilitate drug development.

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11:30
Snapshot ProteomicsTM: An Epi-Proteomic Alternative to Spectrometry Applied Towards Companion Diagnostic Biomarker Discovery
 
Christian  Loch
Christian Loch
Chief Executive & Science Officer
AVMBioMed
About Speaker: Christian Loch is Chief Executive and Science Officer of AVMBioMed; and adjunct faculty in the Department of Chemistry at Villanova University where he teaches proteomics in the graduate school.  AVMBioMed is a full service proteomic CRO serving aca... Read Full Bio 
 
 
Christian  Loch
Christian Loch
Chief Executive & Science Officer
AVMBioMed
 
About Speaker:

Christian Loch is Chief Executive and Science Officer of AVMBioMed; and adjunct faculty in the Department of Chemistry at Villanova University where he teaches proteomics in the graduate school.  AVMBioMed is a full service proteomic CRO serving academics and industry alike. Our signature epi-proteomic assay called Snapshot ProteomicsTM utilizes protein microarrays to extract information about 23,000 proteins per run with >95% reproducibility from complex samples like cell lysates and human serum. Prior to AVMBioMed, Christian directed R&D at a small biotechnology company where he led teams in development of assays and reagents useful to the study of the ubiquitin proteasomal pathway.  His interest in post-translational modification began during PhD studies at the University of Virginia, where he studied epigenetics and chromosomal remodeling in yeast.  His postdoctoral studies at the Fred Hutchinson Cancer Research Center in Seattle involved using mass spectrometry and antibody microarray technologies applied towards biomarker discovery.  To better appreciate and handle the challenges of performing proteomic studies in human populations, he also obtained a Master’s in Public Health-Epidemiology from the University of Washington during this time.  He is former Fellow of both the Canary Foundation and the American Cancer Society. 

 
Abstract: Because most proteins engage multiple...Read More 

Because most proteins engage multiple molecular interactions throughout their lifecycle, even a perfectly precise drug will have unintended consequence to the cell.  Like ripples through a pond, these other proteins likewise engage different molecular interactions that will, in turn, be affected by alteration to an upstream event.  Whether the drug targets housekeepers, enzymes, receptors, or transcription factors, the full scope of effects is best viewed from an epi-proteomic perspective.  That is because these PTM-driven events precede and drive all other cellular responses including transcription, translation and degradation (which themselves can be viewed with more crude levels of analysis that miss the full scope of activity).  Of course, most drugs are not perfectly precise in their targets, making such analysis even more informative.  By identifying the off-targets, and more importantly the consequences of hitting them, our proprietary proteo-genomic analysis of the epi-proteomic changes in response to drug enables a preclinical view into the cellular effects most affected by a drug.  Such comprehensive MOA can identify opportunities for reuse of approved drugs, or to speed orphan drug approval.  Here, we will show this technique useful to novel discovery of companion diagnostic biomarkers for an investigational analgesic already in clinical trial.

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11:55
The Search for Biomarkers of Disease Severity in Crohn’s Disease
 
Calixte  Monast
Calixte Monast
Senior Scientist
Janssen R&D
About Speaker: Cal received his PhD from the University of Pennsylvania where he worked on computational and experimental analysis of signal transduction. For the last five years, Cal has worked as a computational biologist in the Immunology Biomarker department at... Read Full Bio 
 
 
Calixte  Monast
Calixte Monast
Senior Scientist
Janssen R&D
 
About Speaker:

Cal received his PhD from the University of Pennsylvania where he worked on computational and experimental analysis of signal transduction. For the last five years, Cal has worked as a computational biologist in the Immunology Biomarker department at Janssen R&D with a focus on inflammatory bowel disease. Cal's projects include identifying surrogate markers for disease severity, developing strategies for patient stratification, and executing biomarker strategies in early phase clinical studies.

 
Abstract: Clinical endpoints in Crohn’s d...Read More 

Clinical endpoints in Crohn’s disease (CD) are characterized by relatively high variability. This necessitates large late phase clinical trials and makes interpreting results from small cohorts during early development challenging. Objective biomarkers of inflammation tailored to CD are sought to support interpretation of results from CD trials, reduce the size of clinical trials, and enable directional information from early phase programs. Unfortunately, the same phenotypic variability combined with disease tissue heterogeneity has also hampered discovery and validation of reliable biomarkers. This leads to situations where clinical data and our best biomarkers disagree, raising the philosophical question: Do we believe noisy data with known drawbacks or new data with unknown drawbacks? This presentation will overview our strategy for discovering novel CD biomarkers and how we are thinking about this philosophical challenge. The presentation will include results from our work in this area and will also address the following specific questions:

• In which tissues should we search for CD biomarkers?

• How are assay platforms chosen?

• Which computational approaches are most useful?

• What do we do when clinical assessments and biomarkers disagree?

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12:20
Lunch & Round Table Session
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Round Table Session

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Keynote Panel Discussion

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4:10
Conference Concludes