Biography
Dr. Lou is a Program Director in the Small Business Innovation Research Development Center at the National Cancer Institute. She manages SBIR & STTR awards, as well as actively engages in developing targeted solicitations, guiding small businesses to develop applications and facilitating interaction between awardees and potential investors and partners. Dr. Lou has over 15 years experience in research and product development for diagnosis and drug development. Prior to joining NCI she held a variety of scientific and management positions in pharmaceutical and biotech companies, including Johnson & Johnson, LumiCyte, Applied Biosystems (now part of Thermo Fisher Scientific corporation) and diaDexus. Dr. Lou received her PhD degree in Molecular & Cellular Pharmacology from University of Miami and completed her postdoctoral training at Stanford University.

Biography
Dr. Yao has led Univfy from founding through stages of technology invention and commercialization. She is now leading the team to scale Univfy’s business. Dr. Yao has over 20 years of experience in clinical and scientific research in reproductive medicine. Prior to founding Univfy, she was on the faculty at Stanford University, where she led NIH-funded fertility and embryo genetics research and developed the Univfy technology with the academic founding team. Dr. Yao graduated from medical school at the University of Toronto and completed her obstetrics and gynecology residency training at McGill University. She received her clinical subspecialty training in reproductive endocrinology and infertility at Brigham and Women’s Hospital at Harvard University. Dr. Yao received multiple research awards for her fertility research work, including pre-implantation embryo development, the role of stem cell genes in the embryo, and uterine receptivity at implantation.

Clinical Dx Showcase:
Univfy
Univfy is dedicated to helping individuals and couples realize their dream of becoming parents. We are IVF and fertility analytics experts passionate about providing you with the tools to choose IVF with greater confidence, success, and cost-success transparency.

An AI Platform to Improve IVF Access and Patients’ Experience Across Diverse Demographics
Univfy is dedicated to helping individuals and couples realize their dream of becoming parents. We are IVF and AI experts passionate about providing you with the tools to choose IVF with greater confidence, success, and cost-success transparency.

Biography
Jeremy Norris is a Co-Founder and CEO of Frontier Diagnostics, a clinical diagnostics company developing next-generation molecular assays for tissue pathology. Frontier Diagnostics proprietary diagnostic platform utilizes mass spectrometry to measure protein signature from tissue sections, while maintaining spatial registration with anatomical features. Dr. Norris has worked in both academic and industry with an emphasis in mass spectrometry and separation science. His work has resulted in the successful launch of numerous commercial products and services. Dr. Norris obtained a Ph.D. in Chemistry from Vanderbilt University where he is currently Associate Professor of Biochemistry & Chemistry and Managing Director of the Mass Spectrometry Research Center.

Clinical Dx Showcase:
Frontier Diagnostics, LLC
Frontier Diagnostics, LLC was founded to discover, develop, and commercialize innovative tissue-based diagnostics that improve patient care.

MelanoMap: Molecular Diagnosis Of Ambiguous Skin Lesions
MelanoMap is a protein based, molecular diagnostic developed on a novel Imaging Mass Spectrometry platform, a technology that combines the spatial information of microscopy with the unparalleled molecular specificity and sensitivity of mass spectrometry.

Biography
Mr. Richardson’s company is focused on preventing trial-and-error cancer treatments by using predictive analytics to recommend treatment regimens that avoid drug resistance. His team has developed technology for mapping tumors that creates spatial (in-situ) and multi-omic data to form comprehensive, network-level understanding of tumors. Richardson’s team started development of the technology in 2016 and has since optimized its use for clinical patient samples and demonstrated novel screening methods in breast cancer patients with industry partners. Mr. Richardson and his team have received multiple awards and recognitions for their work, including the Flinn Foundation’s Bioscience Entrepreneurship Award, an Arizona Bioscience Award for Rapid Commercialization, Best Oncology-Focused Precision Medicine Company, and named one of Arizona’s Top 12 to Watch in Business for 2019. They have also won several National Science Foundation and National Cancer Institute grants to continue development of their technology.

Clinical Dx Showcase:
bioSyntagma
Data-driven biotech company addressing cancer drug resistance through novel tissue analysis and predictive analytics.

Tackling Drug Resistance: Spatial Mapping And AI
Drug resistance and patient stratification are critical obstacles to personalized medicine. bioSyntagma presents a platform for mapping patient tumors (spatial + multi-omic) paired with Artificial Intelligence for interpreting system-level environmental biomarkers to predict response and recommend combination treatments.

Biography
Dr. Andrew Wang is a physician scientist at University of North Carolina whose research has been focused on clinical translation of nanotechnologies for cancer management. He is Director of Clinical Translational Research in the Department of Radiation Oncology and co-Director of the T32 Carolina Cancer Nanomedicine Training Program. He holds adjunct positions in the Department of Urology, Department of Biomedical Engineering, and the Molecular Therapeutics Program in the School of Pharmacy. Dr. Wang obtained his MD from the Harvard-MIT Health Sciences Technology program and completed clinical oncology training in the Harvard Radiation Oncology Program. During residency, Dr. Wang completed a postdoctoral Fellowship under the dual mentorship of Prof. Robert Langer at MIT and Dr. Farokhzad at BWH. Dr. Wang has been collaborating with Dr. Hong on the clinical translation of CapioCyte™ CTC technology for 6 years. Their collaboration resulted in exciting clinical data leading to the formation of Capio Biosciences.

Clinical Dx Showcase:
Capio Biosciences
Capio Biosciences is a biotech start-up focused on delivering high-value oncology diagnostics to help inform patient care and improve outcomes. We are currently developing an advanced liquid biopsy platform for the capture of circulating tumor cells that delivers ultra-high sensitivity.

CapioCyte™ Liquid Biopsy Cancer Biomarker Development
Circulating tumor cell (CTC) holds high potential as an important cancer biomarker and liquid biopsy solution. However, clinical adoption of CTC assays has been hindered due to low sensitivity. Our company has developed a highly sensitive CTC assay—CapioCyte™. We have obtained exciting clinical data demonstrating CapioCyte’s potential in impacting cancer management.

Biography
Professor Noam Shomron is passionate about using basic science to advance better healthcare. Prof Shomron heads the Genomic Intelligence Research Laboratory at the Faculty of Medicine at Tel Aviv University, after training at MIT. He leads a multidisciplinary team of scientists: biologists, physicians, computer scientists and bioinformaticians. The team develops computational methods for parsing molecular and big-data in the bio-medical field using Artificial Intelligence, successfully publishing more than 150 scientific papers and applying for more than 30 patents. Shomron’s aim is to deepen our understanding of diseases at an early stage, in order to translate information into clinical reality. Shomron is also the Editor of ‘Deep Sequencing Data Analysis’ (Springer); Director of ‘Rare-Genomics’ Israel (NPO); Academic Director of ‘ScienceAbroad’ (NPO); and, Co-founder and Chief Scientific Officer (CSO) of Variantyx which provides clinical interpretation of whole genome sequences.

Clinical Dx Showcase:
Variantyx
Variantyx provides end-to-end Whole Genome Sequencing services based on the Genomics Intelligence bioinformatics platform.

Variantyx’s Genomic Intelligence For Whole Genome Sequencing
Variantyx presents a unique approach for Whole Genome Sequencing analysis based on its Genomic Intelligence platform. Variantyx's mission is to deliver comprehensive, cost-effective genomic testing to patients, physicians, hospitals and commercial labs.

Biography
Prior to founding Travera, Dr. Reid was the founding Chairman, President and CEO of Complete Genomics (NASDAQ:GNOM), a leading developer of whole human genome DNA sequencing technologies and services. He was also Executive Chairman of Genos Research, a consumer genomics company he spun off from Complete Genomics. Prior to Complete Genomics he founded two enterprise software companies: Eloquent (NASDAQ:ELOQ), an internet video company, and Verity (NASDAQ:VRTY), an enterprise search engine company. Dr. Reid is on the Visiting Committee of the Biological Engineering Department at the Massachusetts Institute of Technology (MIT), a member of the MIT Corporation Development Committee, and an advisor to Warburg Pincus. He earned a S.B. in Physics from MIT, an MBA from the Harvard Business School, and a Ph.D. in Management Science and Engineering from Stanford University.

Clinical Dx Showcase:
Travera
Travera is developing the first universal therapy-directing biomarker for personalized medicine for cancer.

A New Approach To Personalized Medicine For Cancer
Travera has developed a new technology for identifying effective cancer drugs and drug combinations for cancer patients. Our approach uses a new measurement device invented at MIT that weighs single cells with sub-picogram accuracy, enabling us to directly measure the response of cancer cells to cancer drugs.

Biography
Dr. Sweeney cofounded Inflammatix following his clinical training as a surgeon at Stanford, where he was frequently frustrated with the lack of tools to determine which of his post-operative patients had infections and required antibiotics or evaluation for sepsis. He subsequently pursued post-doctoral research in biomedical informatics and, along with Inflammatix’s cofounder, Dr. Purvesh Khatri, developed the proprietary technology that powers the company’s tests, including its first test, HostDx Sepsis. Beyond his work at Inflammatix, Dr. Sweeney continues to actively give back to the community as a mentor to new startups in Stanford’s StartXMed program, as an editorial board member of Critical Care Medicine, and as a frequent ad-hoc peer reviewer for manuscripts in sepsis, bioinformatics, and machine learning.

Clinical Dx Showcase:
Inflammatix
Inflammatix is a novel molecular diagnostics company focused on bringing advanced host-response diagnostics to the point of care in a rapid, small device. Its flagship test, HostDx Sepsis, is focused on diagnosing acute infection, but the company also has a deep diagnostics pipeline in acute infections and inflammatory disease based on the same computational techniques.

HostDx Diagnostics: Precision Medicine At The Point Of Care
Inflammatix’s HostDx(TM) tests combine advanced machine learning and computational biology to ‘read’ the immune response to create actionable insights that fit into rapid workflows. The company's novel device can measure dozens of novel markers in <30 minutes.

Biography
Dr. Romeo oversees Research & Development, Manufacturing, and Regulatory activities at Drawbridge Health. She joined the company in late 2017, bringing her expertise and a wealth of experience in diagnostic test development for CLIA-certified, CAP-accredited commercial laboratories and medical device companies focused on in vitro diagnostic (IVD) test development. Prior to joining Drawbridge Health, Dr. Romeo served as VP of Research and Development at Gensignia Life Sciences, IVD Development Manager at Pathway Genomics, Associate Director of Operations at HistoRx and Principal Scientist at Genoptix. Dr. Romeo completed a post-doctoral fellowship at the Scripps Research Institute in La Jolla, CA and received her PhD in Biochemistry and Human Physiology from the University Zurich in Switzerland. She received her MS in Molecular Biology from the University of Insubria, Italy.

Clinical Dx Showcase:
Drawbridge Health, Inc.
Drawbridge Health exists for one overarching reason: to give everyone, everywhere access to the powerful health information within their own bodies. We are starting by reinventing the blood draw experience.

Blood Draw, Reimagined
Drawbridge Health has designed and developed the OneDraw™ A1C Test System, a blood collection device that is nearly painless, convenient, and easy-to-use, enabling the collection, stabilization, and transport of capillary blood samples to the laboratory for testing of HbA1c.

Biography
Andrew Garazha is a Co-Founder and CEO of Oncobox, a cancer research company developing next-generation tests for companion diagnostics. Oncobox team has developed a proprietary AI platform that utilizes RNAseq to measure gene expression patterns and predict drug response for targeted and immunotherapy drugs. The most recent clinical trial has shown that Oncobox method can double the response rate to therapy even for advanced cancer patients. Andrew has worked in both academia and industry with an emphasis on molecular genetics and bioinformatics. His work has resulted in multiple peer-reviewed publications, incl. PNAS, Nature Leukemia, Seminars in Oncology and the successful launch of several products. Andrew has graduated from the Moscow Institute of Physics and Technology (Master’s and Ph.D. programs), studied and worked at the California Institute of Technology.

Clinical Dx Showcase:
Oncobox
Oncobox is a cancer diagnostics company with true clinical data and unique algorithms. Backed by a multidisciplinary team, 30 publications in 2 years and Y Combinator recognition.

AI-Guided Development Of Novel Companion Diagnostics
Employing gene expression data intensified by AI allows designing affordable and powerful all-in-one test (incl. TMB, infiltration, IHC, and targets activation), applicable for drug selection or signature for a specific drug. Oncobox clinical trial (n=238) recorded an increase of up to 55% response-rate (vs. 30%, RECIST) for advanced cancer patients (NCT03724097).

Biography
Aurelija Vaitkuviene specializes in ultrasound diagnostics, colposcopy, oncology, Obstetrics and Gynaecology. Since 1987 initiative of lasers application in medicine, 1989 Wensky Medical Laser centre (Chicago). Since 2013 affiliated senior researcher and leader of Biomedical diagnostics group. Founding member of IALMS (Florence). Earlier Head of Biomedical & Information Technologies Department, Vilnius University Institute Applied Research, President of IPTA, President of ISLSM. Principal investigator of many international and local clinical trials.

Clinical Dx Showcase:
Vilnius University
Vilnius University established in 1579, VU Institute of Applied Research-in 1992/ Institute of Photonics and Nanosciences - 2018.

Fluorescence Diagnostics For Pesonalized Medicine
Innate fluorescence provide molecular digital information specific for person and disease. Personalized by gender, age, sample optical properties, spectra could be accurately classified according to histology evaluation. 355 nm laser nanosecond pulses were applied for fluorescence excitation in waste human specimen.

Biography
Dr. Libermann is an internationally recognized translational investigator with a strong track record in precision medicine, biomarker discovery and translational studies of immunological diseases and cancer. Dr. Libermann’s lab is focused on applying multi-omics approaches to identify proteins or genes that may be exploited as biomarkers or targets for therapeutic intervention, starting with his seminal discovery of EGF receptor gene amplifications in glioblastomas. Dr. Libermann has been at the forefront of the next generation of proteomics and plays a central role in driving biomarker discovery to the next level. Libermann’s group used SOMAscan, a modified aptamer-based high multiplex immunoassay platform, to discover and validate diagnostic, predictive, and prognostic biomarkers for various diseases. Using the latest in machine learning, Libermann’s group has developed predictor models for applications in disease diagnosis, prediction of therapeutic response, monitoring of disease progression, and outcome prediction. Dr. Libermann received his PhD in Immunology in 1986 from the Weizmann Institute of Science and Technology, Rehovot.

Clinical Dx Showcases:
Harvard
Beth Israel Deaconess Medical Center (BIDMC), an affiliated teaching hospital of Harvard Medical School, brings together academic medical centers and teaching hospitals in a shared mission to advance the science and practice of medicine through groundbreaking research and education.

Next Generation Proteomics Driving Precision Medicine
Proteomics has emerged as the next frontier in precision medicine. I will present applications of the latest, cutting edge proteomics tools such as SOMAscan for disease biomarker discovery and how machine learning enables development of high accuracy predictor models.

Biography
Tom Schoenherr comes to Ambry with more than 20 years of experience in the molecular diagnostics space, most recently as the CCO of Omada Health where he was responsible for driving business growth and increasing market share. He also served in similar roles at Counsyl, Quest Diagnostics, Siemens Healthcare, and Abbott Diagnostics. As Ambry’s Chief Commercial Officer, Tom is responsible for the execution of Ambry’s go-to-market strategy and oversees all commercial functions including service, support, sales, marketing, business development, managed care and genetic specialists. Tom earned his BS from Michigan State University and completed his Executive Business Development Program from the University of Notre Dame.

Clinical Dx Showcase:
Ambry Genetics
Since 1999, our mission has remained focused on understanding disease better so cures can come faster. Through our ongoing research, we give health care providers clearer information so they can accurately guide patient care.

Accelerating Precision Medicine Solutions Through Multi-Disciplinary Platforms

Biography
Dr. MacDonald currently leads ChromaCode’s Data Science and Operations efforts. He is an experienced engineer and manager in the life sciences industry focused on data science, product engineering and process development. He is interested in using modern data science and machine learning approaches to complement tried-and-true industry standard methods for robust design like Design for Six Sigma. His PhD training was in Bioengineering, where he did computational neuroscience work modeling inter-cellular signaling mechanisms in neuro-glial networks at UC San Diego. At Illumina, he was an engineering manager responsible for product engineering and process development for consumables across several major platforms including HiSeqX, helping enable the $1000 genome. He developed numerous tools to monitor and understand the real time performance of worldwide sequencing runs in the cloud and drive continuous product improvement.

Clinical DX Showcase:
ChromaCode, Inc.
ChromaCode is redefining molecular testing through data science by increasing the information content of existing PCR and dPCR tests by 10x, enabling complex precision medicine tests on existing simple, robust technology.

10x Your Diagnostic Tool With Information Theory
We encode more information into existing diagnostic technologies (PCR) using novel data-science and informatics methods. This approach can revolutionize currently existing, stable diagnostic methods as it enables direct translation of complex applications onto existing diagnostics infrastructure.

Biography
Dr Meller’s lab at MSM is currently focused in the application of blood transcriptome profiling as a point-of care diagnostic for neurological and neurodegenerative disorders. He has published on molecular mechanisms of acquired resilience in neuronal tissues. He published the first blood RNA-seq study in minority population following stroke, and concussion in a military population. He currently collaborates with researchers at Emory University, Georgia Institute of Technology and the Grady memorial hospital. Dr Meller’s research has been funded by the NIH (NIMHD and NINDS) and AHA. Dr Meller received his D.Phil. in Clinical Pharmacology from the University of Oxford (U.K.) and his BSc from the University of Bristol (U.K.).

Clinical Dx Showcase:
Morehouse School of Medicine
Morehouse School of Medicines mission is to improve the health and well-being of individuals and communities, increase the diversity of the health professional and scientific workforce, and address primary health care through programs in education, research, and service.

Blood Transcriptome Profiling As A Point-Of-Care Diagnostic
Our studies of blood RNA profiling provide highly accurate stroke diagnosis, determines stroke subtype, offer powerful prediction of outcome. Further studies in concussion, and Alzheimer’s disease showing the utility and flexibility of this approach.

Biography
Dr. Woodward has led research and development projects in transplant diagnostics and gene expression discovery for over 20 years. Most recently at CareDx he was responsible for the bioinformatics, biostatistics, and laboratory teams that developed and validated AlloSure, an application of cell-free DNA to solid organ transplantation. Earlier in his career, he initiated biomarker discovery efforts with BioCardia and XDx and subsequently led the laboratory development of AlloMap, a gene expression test that has become an integral component of precise patient care in heart transplantation. During a post-doctoral fellowship at the Gladstone Institutes, Dr. Woodward developed unique methods for analysis of gene regulation in vivo to study atherosclerosis. Dr. Woodward earned his Ph.D. in physiology at the University of Missouri-Columbia with study of the coordinate regulation of gene expression in response to steroids.

Clinical Dx Showcase:
CareDx
CareDx is committed to improving transplant patient outcomes by providing innovative and intelligent solutions through the entire patient journey.

Multi-Modality Testing for Precision In Transplantation
CareDx multi-modality transplant surveillance solutions quantify graft injury and recipient immune quiescence while predicting long-term outcomes. Validation across long-term multi-center studies and registries provide physicians with reliable data to stratify individual patients in the context of real-world clinical use.

Biography
Dr. Zhang received his BS degree in biochemistry from Peking University in 1985. He went to the graduate school in the US under the CUSBEA program in 1986 and received his PhD degree in molecular biology from The University of Texas Graduate School of Biomedical Sciences. Dr. Zhang joined the faculty of The University of Texas M. D. Anderson Cancer Center in 1994 and rose to the rank of Full Professor in Pathology and Cancer Biology in 2006. Dr. Zhang served as the director of M. D. Anderson Cancer Center’s Cancer Genomics Core Laboratory since 1999. Dr. Zhang co-directed a Genome Data Analysis Center (GDAC) under the Cancer Genome Atlas (TCGA). Dr. Zhang is also the Director of the NFCR’s Center for Systems Informatics. In 2016, Dr. Zhang joined the Wake Forest Baptist Comprehensive Cancer Center to become the inaugural Hanes and Willis Family Professor in Cancer and the Director of the Center for Cancer Genomics and Precision Oncology. Dr. Zhang is also the Leader of the Cancer Genetics and Metabolism Program in the NCI-funded CCSG for the Wake Forest Baptist Comprehensive Cancer Center. Dr. Zhang has published more than 350 peer-reviewed papers. Dr. Zhang’s research has been supported by numerous grants from NCI/NIH, DOD, and several foundations including National Foundation for Cancer Research (NFCR), Goldhirsh Foundation, James S. McDonald Foundation, and Shriver Initiatives for Sarcoma. Dr. Zhang is a well sought after reviewer for federal funding agencies and he has reviewed more than 320 NIH grants. Dr. Zhang serves on the AACR’s China committee. Dr. Zhang is also the Chairman of the Board of Directors, US Chinese Anti-Cancer Association.

Talk
The Era Of Precision Medicine: Improved Diagnosis, Treatment, And Monitoring
As a key member of national consortium in precision medicine (PMEC and GENIE), the Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) has developed NGS clinical programs using both tumor gene panel and liquid biopsy test. Bioinformatics analysis has identified bi-omarkers which are critical for pathophysiology, etiology, response to immunotherapy, and can-cer health disparities. Results from our liquid biopsy studies led us to propose a new cancer staging system that incorporates the circulating mutation signature (TNMB system).

Biography
Dr. John Simmons joined Personal Genome Diagnostics (PGDx) in January 2016 and served as the Manager of Translational Science & Diagnostics. In his current role, John focuses broadly on scientific strategy and diagnostics partnerships with pharma/biotech. Previously, John was at the National Cancer Institute where his research focused on identifying novel therapeutic strategies for multiple myeloma through chemical genomic approaches with a particular focus on drug combinations. He received his Bachelors in Biology with honors from American University and PhD in Tumor Biology from Georgetown University as part of the NIH Graduate Partnership Program. As a post-doctoral fellow, he received the Multiple Myeloma Research Foundation (MMRF) Research Fellow award to support his work in developing systems-level approaches for drug combination identification and prioritization.

Biography
Sungwon Lim is a bioengineer/entrepreneur with 20 years of collective experiences in academia, pharmaceutical companies, and biotech industries. He co-founded ImpriMed, Inc. with a strong motivation to innovate a way to help cancer patients who need an effective treatment ‘today', by optimizing and personalizing drug treatment options that are currently available in our medical cabinet. His team is building a comparative oncology platform to develop and prove new cell-based, functional precision medicine technologies in the veterinary oncology space first, at a significantly higher speed with by far more comprehensive data compared to the human oncology space, and then translate the collected database into human cancer care. Sungwon graduated Stanford University with Ph.D. degree in Bioengineering, and has M.S. in Translational Medicine at U.C. Berkeley and U.C. San Francisco, and B.S. in Chemical Engineering at Korea Advanced Institute of Science and Technology.

Clinical Dx Showcase:
ImpriMed
ImpriMed provides a personalized drug testing service designed for pets with cancer.

From Dog To Human: Precision Medicine For Comparative Oncology
ImpriMed develops functional precision medicine technologies to help veterinary oncologists find out the most effective treatment options for individual cancer patients by building up a patient-derived database for pet cancer treatment, which can be eventually translated into human cancer care.

Biography
Dr. Ofer Sharon is a physician and entrepreneur with over 17 years of experience in the oncology drug development industry. Sharon is dedicated to overcoming one of the major obstacles in clinical oncology today – resistance to therapy and his team at OncoHost develop personalized strategies to maximize the success of cancer therapy by identifying host-driven pro-tumorigenic biological processes associated with therapy resistance and tumor spread. Sharon and his team are developing the first of-its-kind proteomic profiling platform for the early prediction of cancer treatment responsiveness in patients, as well as for the discovery of new targets to overcome treatment resistance. Sharon previously served as a Chief Medical Officer and New Technologies Scout in companies such as Roche, Merck and AstraZeneca, and co-founded several healthcare companies.

Clinical Dx Showcase:
OncoHost
OncoHost is the global leader in host response profiling, developing personalized strategies to maximize the success of cancer therapy. OncoHost utilizes proprietary proteomic analysis, enabling personalized oncological treatment strategies with improved outcomes and reduced side effects.

Host Response Profiling for Immunotherapy Response Prediction
A major obstacle in clinical oncology is resistance to therapy. Host response profiling and proprietary proteomic analysis improves our understanding of how cancer treatment can influence tumor progression, better identifying which treatments or drug combinations may result in improved outcomes.

Biography
Dr Michelle Perugini is an academic, entrepreneur, and an internationally renowned expert in digital health, medical research, and advanced AI technologies. Dr Perugini has a PhD in Medicine and was a stem cell biologist for a decade. Michelle was also the founder of the global technology company ISD Analytics, leading the commercialisation of its award-winning predictive analytics product Simulait, ISD was acquired by Ernst and Young {EY) in 2015. Dr Perugini is now the Co-Founder and CEO of Presagen, an AI company that connects clinics globally to build scalable AI medical products. Presagen co-creates scalable AI products with clinics while preserving data privacy and sharing the commercial value. Presagen’s first product is Life Whisperer that uses AI to assist clinicians to select viable embryos in IVF to improve outcomes for couples wanting to have children. International clinical studies have shown that Life Whisperer is 30% more accurate than visual selection of embryos by skilled embryologists.

Biography
Dr. Ruben Bonilla-Guerrero's interests include clinical pharmacology and genetics with a focus on pharmacogenomics. At Admera Health he is responsible for the clinical content of genomic-based assays and leading the medical affairs team. Dr. Ruben Bonilla-Guerrero obtained his medical degree from the Universidad Veracruzana in Mexico. From there, he moved to the Mayo Clinic in Rochester Minnesota where he completed his training in Clinical Pharmacology and Clinical Biochemical Genetics, spending 14 years focusing on research and clinical laboratory medicine. Prior to joining Admera Health, Dr. Bonilla-Guerrero spent over nine years at Quest Diagnostics in both Laboratory Director and Medical Directors roles. Dr. Bonilla-Guerrero is board certified in Clinical Biochemical Genetics by the American Board of Clinical Pharmacology and American Board of Medical Genetics (ABMG) and in Molecular Biology by the American Society of Clinical Pathology (ASCP).

Clinical Dx Showcase:
Admera Health
Admera Health is a CLIA-certified and CAP-accredited advanced molecular diagnostics company focusing on Advancing Precision Medicine Beyond Diagnostics. Its flagship product is PGxOne™ Plus test, a comprehensive pharmacogenomics (PGx) test.

Pharmacogenomics: An Introduction To Proper Clinical Adoption
The use of Pharmacogenomics to help predict drug response is becoming more widespread. However, it is not always being used in a way that will maximize patient outcomes the way Admera Health’s PGxOne™ Plus does.

Biography
As Chief Scientific Officer, Dr. Boysen is leading the technical and clinical development of SomicsMed’s proprietary Pyrophophorolysis Activated Polymerization assays for mutation detection using cfDNA from liquid biopsies. She has over twenty years of industry expertise developing technologies and software in genomics, bioinformatics, immunotherapies, drug discovery, and diagnostics. She recently launched a laboratory implementing microfluidic chip technologies from Caltech for the development of TCR-T cell-based immunotherapies and has previously managed QIAGEN’s consulting business in the US for their advanced genomics bioinformatics programs. She has spearheaded products and projects making integrated software solutions for sequence and microarray analysis, incl. analysis of Cancer Gene Panels, Exome, WGS, RNASeq, HLA, IG/TCR and mitochondrial data, as well as made pathogen typing and forensics applications. Dr. Boysen obtained her Ph.D from Caltech in the lab of Leroy Hood, where she developed DNA sequencing technologies for the human genome project, while sequencing the T cell receptor loci in human and mouse. She got her Cand. Scient from Univ. of Copenhagen in Denmark.

Clinical Dx Showcase:
SomicsMed
SomicsMed is a diagnostic service laboratory focused on screening and early detection of cancer-associated mutations using cfDNA from liquid biopsies.

Ultrasensitive And Selective Mutation Detection Using PAP Technology
As we strive to save lives by earliest detection of cancer, we are employing our patented technology, Pyrophophorolysis Activated Polymerization, to enable selective detection of minuscule amounts, down to one mutant template, of ctDNA in a background of wild-type cfDNA from liquid biopsies.

Biography
Dr. Esplin is board-certified in clinical genetics and internal medicine. Prior to joining Invitae, he practiced clinical genetics at Kaiser Permanente's San Francisco Medical Center. Dr. Esplin completed the medical scientist training program at the University of Texas Southwestern completing his M.D. with a Ph.D. in genetics (emphasis in cancer genetics). After his internal medicine residency at UT Southwestern, he was appointed assistant professor of the University of Texas Southwestern Department of Internal Medicine. Dr. Esplin completed his clinical fellowship training in medical genetics and postdoctoral fellowship in genetics and genomics under Mike Snyder at Stanford, during which time he was supported by an award from the Tashia and John Morgridge Endowed Postdoctoral Fellowship program and by the National Institutes of Health-funded Stanford Clinical and Translational Science Award.

Clinical Dx Showcase:
Invitae
Invitae’s mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people.

Precision Therapy Through Combined Germline And Tumor Genetic Testing
Germline genetic testing combined with somatic tumor sequencing identifies precision therapies and clinical trials for patients with cancer that would be missed by tumor-only sequencing.

Biography
Dr. Cohn leads translational research initiatives at Celmatix, a precision health company advancing the fields of reproductive medicine and fertility at the intersection of big data and genomics. Her work is focused on using Reproductive Atlas, a multi-omic initiative that integrates diverse data sets that have been evaluated and curated by reproductive experts, for real-world evidence and therapeutic discovery in reproductive health. She holds dual B.S. degrees in Chemical Engineering and Biology from MIT and a Ph.D. in Cancer Biology from the Gerstner Sloan-Kettering Graduate School of Biomedical Science.

Clinical Dx Showcase:
Celmatix Inc.
Celmatix uses big data analytics and genomics to improve fertility treatments and pave the way for proactive fertility management.

Biography
Raj Krishnan, PhD, has pioneered using AC Electrokinetics to directly isolate blood-based nanoparticles. This foundational technology powers Biological Dynamics’ novel isolation platform, Verita™. Since founding Biological Dynamics in 2010, Krishnan has led the company’s efforts to incorporate these unique capabilities into accessible cancer diagnostics to support better care. The company is developing a portfolio of novel oncology products to enable early detection and monitoring in multiple settings – from cancer centers to physician’s offices to patient’s homes.

Clinical Dx Showcase:
Biological Dynamics, Inc
Biological Dynamics is developing novel oncology molecular diagnostic systems for laboratory and point-of-care applications. The company’s technology excels at isolating nanoparticles - such as DNA, RNA, and exosomes - from unprocessed blood-based samples, driving a radically simplified workflow.

Isolation Matters: Oncology, Neuroscience and TB Biomarkers
Biological Dynamics is developing a novel lab-on-a-chip platform, Verita™, that offers a simplified workflow for isolation of blood-based circulating nanoparticles. Raj Krishnan, CEO, will share insights on applications of the technology in oncology, TB and neuroscience.

Biography
Antony Newton is Vice President, Business Development at Inivata. At Inivata he is leading new development and commercialization of Inivata’s technology platform for pharmaceutical applications. Prior to Inivata Newton led early commercialization at Personal Genome Diagnostics (PGDx) followed by advisory roles at Natera and Mission Bio. His previous experience includes commercial roles at GE Healthcare, Sigma-Aldrich and Genzyme. Newton has an MS in Applied Immunology from Brunel University London and a PG Dip in business from Anglia Ruskin University, Cambridge, UK.

Clinical Dx Showcase:
Inivata
Inivata is a leader in liquid biopsy. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late-stage cancer development programs.

The Critical Importance Of Sensitivity In Liquid Biopsy
• All liquid biopsy approaches are not the same – how does the design of approach affect the outcome?
• Why is sensitivity important?
• Liquid biopsies in the continuum of clinical research
• Building a portfolio of MRD assays

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

Clinical Dx Showcase:
Exosome Diagnostics
Exosome Diagnostics, a leader in developing liquid biopsy-based diagnostics, is the first and only company that can simultaneously isolate and analyze exosomal RNA and cfDNA in a single step to achieve highest sensitivity for detecting rare mutations. ExosomeDx empowers the world’s leading biopharma companies in exploring this unique technology.

Exosomes: Small Vesicles with Big Opportunities
Exosomes are small double lipid membrane vesicles that are secreted from all cells. Exosomes encapsulate a portion of the parent cell cytoplasm and are shed into various biofluids, such as blood, CSF, and urine. They are a source of cellular protein, DNA and RNA and are promising for profiling all stages of disease management, from disease detection to stratification for therapeutics.

Biography
My laboratory investigates how oncogenes initiate and sustain tumorigenesis. I have developed model systems whereby I can conditionally activate oncogenes in normal human and mouse cells in tissue culture or in specific tissues of transgenic mice. In particular, using the tetracycline regulatory system, I have generated a conditional model system for MYC-induced tumors. I have shown that cancers caused by the conditional over-expression of the MYC proto-oncogene regress with its inactivation. Thus, even though cancer is a multi-step process, the inactivation of one oncogene can be sufficient to induce tumor regression.

Clinical Dx Showcase:
Stanford School of Medicine
Stanford Medicine integrates a premier medical school with world-class hospitals to advance human health.

Nanoscale Measurements To Monitor And Predict Therapeutic Efficacy Of Cancer Therapies
The real-time measurement of therapeutic activity would enable both the more rapid clinical development of cancer therapies as well as enable human patients to receive the most effective therapies. We describe emerging nanotechnologies that provide the ability to make direct measurements in the actual oncoprotein targets of therapeutics enabling real-time assessment of their activity in human clinical specimens. Serial measurements of specific oncoproteins and their activation state will enable precision treatment of cancer patients.

Biography
Dr. Magliocco is an internationally recognized leader in precision oncology who has over 30 years experience in tissue pathology, research, molecular diagnostics, and digital image analysis. He was previously chair of Pathology at the Moffitt Cancer Center and Medical Director of the Morsani Advanced Diagnostics Laboratories.Most recently he has founded Protean BioDiagnostics, a new company focused on accelerating the deployment of precision oncology to under serviced cancer patients using multiomics and an advanced data integration approach. He has published over 200 research articles, holds numerous patents, and is a frequent invited speaker to international diagnostic technology meetings. His research focus is the development of clinically useful diagnostic tools to support precision oncology using multiomic technology platforms, digital image analysis, and AI approaches.

Clinical Dx Showcase:
Protean BioDiagnostics
Protean BioDiagnostics is a new start-up focused on accelerating the deployment of precision oncology to under-serviced patients using Oncology MAPS a unique integrated multi-omic and data-centric approach.

Protean BioDiagnostics: A Disruptive Approach To Accelerate Access To Precision Oncology
Protean BioDiagnostics utilizes a patient-centric, integrated, multi-omic, big data approach to accelerate the deployment of precision oncology to community cancer patients. The disruptive and collaborative approach creates a novel platform that not only delivers diagnostic services but provides unique research and development opportunities.

Biography
Dr. Femida Gwadry‐Sridhar is the Founder and CEO of Pulse Infoframe Inc. She has her PhD in Health Research Methodology, Health Economics, McMaster University. She is a pharmacist, clinical epidemiologist and methodologist with over 25 years of experience in clinical trials, disease registries, knowledge translation, health analytics and patient reported outcome measures. Pulse Infoframe has developed healthieTM.Pulse implements appropriate governance in advance of building multi-stakeholder collaborative networks of pharmaceutical companies, researchers and patients and enables stakeholder access to clinical trials, input on trial design, new treatment development, and accelerated research.

Clinical Dx Showcase:
Pulse Infoframe Inc.
Deployed globally and focused on cancer and rare disease, Pulse Infoframe (Pulse) is a real-world evidence health informatics and analytics company that has created a technology and services platform empowering a consortia of stakeholders - including patients, advocates, caregivers, physicians, researchers, pharmaceutical & medical device companies.

Unlocking the Power of AI - Real-World Evidence Informing Precision Medicine
Evidenced-based approaches to investigating new therapies are the cornerstone of advancing clinical practice. Given the advances in genotyping and molecular profiling there are greater opportunities to understand the biology of a disease. However, part of the consideration when implementing new therapies is an understanding of the impact of the treatment in patients who are not part of a clinical trial in order to understand how treatment can adversely or positively affect patient safety, outcomes, performance measures and costs. The primary obstacles to realizing the benefits of new treatments and achieving reduced variation post-approval, center around the limited availability of real-world data.

Biography
John is a biotechnology translational medicine consultant with a comprehensive and deep understanding of the development and application of pioneering molecular procedures to the translation of research-grade biomarker assays into clinical-grade clinically adopted diagnostic tests. John oversaw the translation of an early stage research Next Generation sequencing test to a US government reimbursed and now widely adopted Laboratory Developed CLIA-CAP test for transplanted kidney rejection. He advises commercial translation efforts at Stanford University (SPARK) and University of California in San Francisco (CATALYST).

Clinical Dx Showcase:
Molecular Stethoscope
Molecular Stethoscope is a seed-stage biotechnology company developing precision healthcare integrated solutions based on its proprietary circulating cell-free mRNA (cf-mRNA) technology platform. We are combining novel cf-mRNA technologies with next-generation sequencing, clinical information, and machine learning to dynamically monitor the health of patients with precision - without organ biopsies. In the near-term, we aspire to become the partner of choice for pharmaceutical companies looking to develop the right therapies, for the right patients, at the right time by deploying our cf-mRNA/information technology platform to increase our partners’ probability of technical success at all stages of their R&D process. Our long-term focus is to develop and commercialize a cf-mRNA/clinical information integrated solution for the early detection, diagnosis and therapy-response monitoring of chronic diseases in multiple organ systems within precision healthcare starting with the liver (e.g., Nonalcoholic Steatohepatitis - NASH) and the central nervous system (e.g., Alzheimer’s Disease and Multiple Sclerosis).

Cell-free mRNA: Realizing The Potential For Clinical Translation
This talk will focus on a novel clinical information technology, digital platform solution that Molecular Stethoscope is developing based on a powerful new analyte in peripheral blood: circulating cell-free mRNA. Human proof-of-concept studies in NASH, Transplant Oncology and Neurodegeneration will be presented, highlighting potential applications in clinical practice and in Pharmaceutical R&D to increase the probability of technical success.

Biography
Ronnie Andrews joined OncoCyte as CEO in July 2019. Prior to this, Ronnie was the founder and principal of the Bethesda Group LLC, a boutique consulting group focused on helping small and mid-stage diagnostic companies move emerging diagnostic content and platforms into the marketplace. Ronnie has close to 30 years of experience in the US Clinical and Molecular Diagnostics industry. He served as the President of the Genetic Science Division for Thermo Fisher Scientific until December 2014. Prior to this Ronnie held a number of other high-profile executive roles including CEO of Clarient, a public company on the NASDAQ which was sold to General Electric Healthcare in 2010.