2020 Archived Content
OVERVIEW | DOWNLOAD BROCHURE | PLENARY SESSION | BREAKOUT DISCUSSIONS | SPEAKER BIOGRAPHIES | ATTENDEES

Speaker Biographies

Neeraj Adya

Genmab US Inc

Head

Neeraj Adya has over 20 years of experience in the In Vitro Diagnostics (IVD) industry. He is currently the Head of Diagnostics at Genmab, where he leads the diagnostic strategy and development for all assets. Prior to Genmab, Neeraj spent four years as the Pharmacodiagnostic Lead at Bristol-Myers Squibb and 16 years developing diagnostic products at Abbott Labs. Neeraj received his PhD in Molecular Biology from Case Western Reserve University followed by Post-Doctoral research at the National Institutes of Health.

Catherine Alix-Panabières

University Institute of Clinical Research (IURC)

Head of the Human Rare Circulating Cells Laboratory (LCCRH)

Dr Catherine Alix-Panabières received her PhD degree at the Institute of Virology, University Louis Pasteur, in Strasbourg (France) and did a postdoctoral research in the Department of Immuno-Virology of the University Medical Centre of Montpellier, France. Dr Alix-Panabières optimizes new techniques of enrichment and detection of viable disseminating tumor cells in patients with solid tumors. She has authored or co-authored 25 scientific publications in this field during the last 5 years including 9 book chapters.

James P Almas

LabCorp

VP & Natl Medical Dir Clinical Effectiveness

Dr. Almas had years of service as a lab director of large non-profit hospitals. He has worked as a consultant to BCBS-affiliates. Dr. Almas also worked as a Medical Officer at CMS in the Coverage and Analysis Group (CAG) and, before joining LabCorp in 2018, served as the Medical Director of the MolDX Program (at PalmettoGBA).

Edward Argenta

Defense Threat Reduction Agcy

Science & Technology Mgr

Mr. Edward Argenta – Serves as a Science and Technology Manager for the United States of America Defense Threat Reduction Agency(DTRA) – Chemical and Biological Defense Program managing application and platform development for the Digital Battle Space division. Specifically, Mr. Argenta’s portfolio consists of non-invasive host –based physiological monitoring and human exposure efforts with the goal of developing subclinical threat agnostic detection capabilities after biological agent exposures as well near real-time threat agnostic detection of chemical agent exposure. Mr. Argenta’s educational background is in Meteorology and has applied the knowledge of ingesting continuous real-time data and producing a prediction of future state in support of physiological algorithm development and disease spread via epidemiological spread models. Previously, Mr. Argenta provided developmental test and evaluation of chemical and biological sensors/platforms/equipment for the United States Army specifically performing hazard prediction modeling and simulation of chemical and biological simulants. Mr. Argenta has participated in numerous agent dispersion field experiments including dense gas, inert tracers, and benign biological materials and has used data from these experiments in model validation and verification efforts. As a contractor for DTRA, Mr. Argenta supported a 24/7 operational technical reachback cell providing expert analysis to requests for information on chemical, biological, nuclear, radiation, and explosive (CBRNE) topics. These requests would vary between long-term research and developmental projects to real-world emergency response events.

Esther Babady

Memorial Sloan Kettering Cancer Ctr

Dir

Esther Babady, PhD, D(ABMM), FIDSA is the Medical Director of the Clinical Microbiology Service at Memorial Sloan Kettering Cancer Center. She received her PhD Biochemistry and Molecular Biology and completed a post-doctoral fellowship in Clinical Microbiology both at the Mayo Clinic in Rochester, MN. Her research interests include rapid, molecular diagnosis of infectious diseases in immunocompromised hosts. She has published several peer-reviewed manuscripts, book chapters and reviews on molecular diagnostics tests.

Jonathan Baden

Bristol Myers Squibb Co

Dir Pharmacodiagnostics & Precision Medicine

Jonathan Baden is a Director, Pharmacodiagnostics in the Bristol-Myers Squibb Translational Medicine organization. He joined BMS in September 2017 and supports evaluation, strategy, development and execution of the companion/complementary biomarker diagnostic programs for BMS that enhance value of the pharmaceutical product profiles. Jon leads a PDx matrix subteam to execute upon solid tumor and liquid biopsy NGS related strategies pertaining to patient selection (TMB/HRD) and disease monitoring (ctDNA). He provides strategic direction to business development led searches, evaluations and transactions for diagnostic partnering. In addition, Jon coordinates activities between the Development, Commercial teams and external diagnostic partners and is responsible for delivery of diagnostic partner critical milestones. Prior to joining BMS, Jon led diagnostic strategies aligned with therapeutic disease areas for the development of stand-alone and companion diagnostic at Janssen Pharmaceuticals and J&J subsidiaries. Jon led matrix teams both internally and with external partners for the management, execution and resolution of assay process for all stages of the product development life cycle. Jon has expertise in oncology disease states (prostate, bladder, lung, breast, and colorectal cancers), autoimmune diseases (Crohn’s and lupus) and infectious diseases (HIV, HCV, IFV, RSV, Ebola) and managed an exploratory NGS team and a late stage development team accountability for products on a fully integrated MDx platform. Jon received his MS degree in Microbiology from the University of Rochester School of Medicine and Dentistry working and also holds a BSc degree in Biotechnology from the Rochester Institute of Technology.

Holger Becker

microfluidic ChipShop GmbH

Founder & CSO

Dr. Holger Becker is co-founder and CSO of microfluidic ChipShop GmbH. He obtained physics degrees from the University of Western Australia/Perth and the University of Heidelberg. He started to work on miniaturized systems for chemical analysis during his Ph.D. thesis at Heidelberg University, where he obtained his Ph.D. in 1995. Between 1995 and 1997 he was a Research Associate at Imperial College with Prof. Andreas Manz. In 1998, he joined Jenoptik Mikrotechnik GmbH. Since then, he founded and led several companies in the field of microsystem technologies in medicine and the life sciences. He was nominated for the German Founders Prize in 2004. He led the Industry Group of the German Physical Society between 2004 and 2009, was co-chair of MicroTAS 2013, and is the current chair of the SPIE ‘‘Microfluidics, BioMEMS and Medical Microsystems’’ conference. He serves on the Editorial Board of “Lab-on-a-Chip” as well as acting as a regular reviewer of project proposals on a national and international level.

Gabriel A Bien-Willner

Palmetto GBA LLC

Medical Dir MolDX & CMO

Dr. Bien-Willner is the Medical Director of the MolDX program at Palmetto GBA, a Medicare Administrative Contractor (MAC). MolDX seeks to understand the molecular testing landscape to implement payer controls, coverage, and to set policy for affiliated MACs, which currently cover 28 states. He is a leader in the Precision Medicine space and practices as a Board-certified Anatomic Pathologist and Molecular Genetic Pathologist. Throughout his career, he has been active in research, development, and advancement of molecular diagnostic services, specifically next generation sequencing. He has worked closely with clinicians to develop clear clinical diagnostic and treatment pathways directing Precision Medicine programs for community cancer centers. Dr. Bien-Willner received his MD and PhD degrees from Baylor College of Medicine, with a PhD in Human Molecular Genetics. He completed his residency, fellowship, and attained a faculty appointment at Washington University in St. Louis prior to leadership roles in laboratory and biotech companies before joining Palmetto GBA.

Matthew J Binnicker

Mayo Clinic

Director of Clinical Virology

Dr. Matt Binnicker is the Director of Clinical Virology and Vice Chair of Practice in the Department of Laboratory Medicine and Pathology at Mayo Clinic. Dr. Binnicker is a Professor of Laboratory Medicine and Pathology and the President of the Pan American Society for Clinical Virology. Dr. Binnicker’s clinical and research interests focus on the development of rapid molecular tests for the diagnosis of respiratory infections. In addition, his work centers on the utilization of next-generation sequencing for the detection of mutations associated with antiviral resistance in the transplant population.

William Blake

Sherlock Biosciences

CTO

William Blake is the chief technology officer of Sherlock Biosciences. Dr. Blake has built and led interdisciplinary teams in biotechnology research and development spanning the fields of synthetic biology, diagnostics, biomanufacturing, and cell engineering. Most recently, Dr. Blake led technical development and translational strategy for in vitro diagnostic technologies at the Wyss Institute at Harvard University. Prior to that, Dr. Blake was on the founding team of GreenLight Biosciences where he led the development of novel synthetic biology technologies and scientific partnership strategy as vice president of research and development. Dr. Blake holds a Ph.D. in bioinformatics and an M.S. in biomedical engineering from Boston University, and earned his B.S. in biomedical engineering from The Johns Hopkins University.

Tim Blauwkamp

Karius

CSO

Tim Blauwkamp is the Chief Scientific Officer and co-founder of Karius. Prior to Karius, he led research and lab operations for the long-reads DNA sequencing startup Moleculo, until its acquisition by Illumina. Tim received his PhD in Biochemistry from the University of Michigan for studies of gene transcription networks in bacteria.  He completed his postdoctoral research at Stanford University which focused on signaling mechanisms that influence early development and stem cell biology.

Alexander Borowsky

University of California, Davis

Associate Professor

No bio available.

Bryan Bothwell

Qorvo Biotechnologies

Director of Strategy and Business Development

Bryan Bothwell is Qorvo’s Director of Strategy and Business Development - with responsibility for new market, technology and customer development worldwide.  He received undergraduate degrees in Biology/ Biochemistry, and Masters degrees in Electrical Engineering and Business Administration.

Danielle Bradnan

Lux Research Inc

Research Assoc

Dani is a Digital Health and Wellness Research Associate at Lux Research with deep expertise in digital therapeutics, digital biomarkers, and FemTech. Prior to her time at Lux, Dani worked as an Environmental Group Manager for a water treatment company, surveying and developing treatment plans for waterborne pathogen outbreaks in healthcare facilities across the United States. Dani graduated with a Masters Degree in biology from the University of Louisiana at Lafayette.

Sara Brenner

U.S. Food & Drug Administration

Associate Director for Medical Affairs; CMO

No bio available.

Susan M Butler-Wu

Univ of Southern California

Assoc Prof & Dir Medical Microbiology

Dr. Butler-Wu is the Director of Clinical Microbiology at LAC+USC Medical Center and an Associate Professor in the Department of Pathology at Keck School of Medicine of USC in Los Angeles, California. She is a Diplomate of the American Board of Microbiology, a member of the Editorial Board for the Journal of Clinical Microbiology and is active in committee work for the American Society of Microbiology and the Clinical Laboratory Standards Institute. Dr. Butler-Wu’s research interests include rapid diagnostics for the detection of infection and antimicrobial resistance.

Joseph M Campos

Childrens Natl Health System

Dir Microbiology Lab

Joseph M. Campos, Ph.D., D(ABMM), FAAM, is the Director of the Microbiology Laboratory, the Infectious Diseases Molecular Diagnostics Laboratory and the Section of Laboratory Informatics at Children's National Health System. Dr. Campos has published more than 130 peer-reviewed journal articles and book chapters during his career. He has delivered more than 550 invited lectures globally on microbiology, virology, infectious disease diagnostics, laboratory informatics and quality improvement.

Cesar Martin Castro

Massachusetts General Hospital/Harvard Medical School

Director, Cancer Program

Dr. Castro is Director of the Cancer Program at the Massachusetts General Hospital (MGH) Center for Systems Biology, Assistant Professor of Medicine at Harvard Medical School, and Attending Physician at the MGH Cancer Center. As a Regent’s Scholar, Dr. Castro attended the University of California - Berkeley leading to receipt of both Bachelor’s and Master’s degrees. He attained his Medical Degree from the University of California, San Francisco where he also pursued Internal Medicine residency training. Dr. Castro completed a combined Adult Medical Oncology fellowship at the MGH and the Dana-Farber Cancer Institute in Boston. During this period, he also received a Master’s in Medical Sciences from Harvard Medical School. Dr. Castro is a translational oncologist with experience developing and harnessing nanotechnology and molecular imaging platforms for cancer purposes. His work takes a “less is more” approach — to generate robust cancer analyses using scant amounts of specimens including liquid biopsies. Dr. Castro’s research has included funding from the National Institutes of Health, Department of Defense, V Foundation for Cancer Research, Lustgarten Foundation for Pancreatic Cancer Research, and Ovarian Cancer Research Fund.

Helen Cha Roberts

Seegene Technologies Inc.

No bio available.

Maude Champagne

Illumina Inc

Associate-Director

Maude Champagne is a genomic healthcare value expert and go-to-market strategist who works in the diagnostic industry to successfully commercialize companion diagnostics globally. Maude believes that personalized medicine is at a tipping point where genomic profiling access and reimbursement will trigger standard-of-care adoption of targeted therapies, that will change healthcare practices in oncology and beyond. She is committed to supporting that transition, while establishing a fair value for the diagnostic technology. Maude’s experience includes creating the global go-to-market strategy for a dozen of CDx at various stages in regulatory approval and successfully launched 6 FDA-approved assays, leading along the commercial continuum from sales to product management, from marketing to market access.

Richard Chasen Spero

Redbud Labs, Inc.

CEO

Chief Executive Officer is a co-founder of Redbud Labs. Since stepping into the CEO role in 2015, Redbud Labs launched its category-defining microfluidic components, MXR and STR. Under Dr. Spero’s leadership, Redbud has established its RTP manufacturing operations and attracted more than $9 million in funding. Previously, Dr. Spero served as Redbud’s Vice President of Product Development. He received his PhD and MS in Physics at the University of North Carolina at Chapel Hill, and his BS in Physics at Middlebury College.

Charles Y Chiu

Univ of California San Francisco

Prof

Charles Chiu, MD, PhD is Professor of Laboratory Medicine and Medicine, Division of Infectious Diseases at University of California, San Francisco, Director of the UCSF-Abbott Viral Diagnostics and Discovery Center (VDDC), and Associate Director of the UCSF Clinical Microbiology Laboratory. Chiu currently heads a translational research laboratory focused on next-generation sequencing assay development for infectious disease diagnostics, discovery and investigation of emerging pathogens, including Borrelia burgdorferi (Lyme disease), Ebola virus, enterovirus D68, and Zika virus, and clinical/public health applications of new diagnostic technologies such as nanopore sequencing. He is also actively developing RNA sequencing approaches to detect and identify diagnostic profiles of the body’s response to infection. His work is supported by funding from the National Institutes of Health (NIH), Abbott Laboratories, Department of Defense, NASA/Translational Research Institute, philanthropic grants (Charles and Helen Schwab and Steven and Alexandra Cohen Foundations), and the California Initiative to Advance Precision Medicine. Dr. Chiu has authored more than 80 peer-reviewed publications, holds over 15 patents and patent applications, and serves on the scientific advisory boards for Therabio, Inc., and Mammoth Biosciences, Inc.

Jason H Christiansen

Boundless Bio Inc

CTO

Jason Christiansen, Chief Technology Officer for Boundless Bio has served in multiple positions leading the development of new technologies and strategies for their research and diagnostic use. He has served as Head of Assay Development at Roche Sequencing Solutions, providing leadership in initiatives around oncology testing, Dx development, NIPT testing and platform development. Prior to Roche, Jason was VP of Diagnostics at Ignyta, where he led CDx development efforts including an in-house CLIA laboratory and molecular testing R&D group working both internally and externally to drive molecular testing in support of a global clinical trial for entrectinib. Prior to Ignyta, Jason served in multiple senior positions developing new platforms and technologies in NGS, digital pathology and molecular testing so that they could be brought into the clinical laboratory for patient testing and to support drug development.

Dana Connors

Foundation for the National Institutes of Health (NIH)

Senior Scientific Project Manager

Dana E. Connors, MSc, PMP is the Scientific Project Manager for the Cancer portfolio of the Biomarkers Consortium at the Foundation for the National Institutes of Health. He manages the activities of project teams and working groups to facilitate the advancement and execution of innovative cancer research and biomarker development. In his work with public-private biomedical research partnerships, he engages international participation from government, industry, academia, patient-advocacy and private sector organizations. Dana uses his perspective to influence creativity and production, drive international scientific collaboration, and help others make the leap from project manager to impact leader.

Elliot Cowan

Partners in Diagnostics LLC

Principal

Dr. Elliot Cowan is Principal and Founder of Partners in Diagnostics, LLC, providing consulting on the regulation of in vitro diagnostics to IVD manufacturers, as well as to international public health agencies, procurement organizations, regulatory harmonization efforts, governmental bodies, and philanthropic foundations. This followed a 20-year career at the US Food and Drug Administration, where he was responsible for leading the regulation of all blood donor screening tests and retroviral diagnostics used in the US, including the first over-the-counter HIV test system, approved in 2012. Elliot was also a member of the Laboratory Technical Working Group for the President’s Emergency Plan for AIDS Relief (PEPFAR), providing technical assistance for laboratory quality assurance issues in PEPFAR focus countries, and advised the World Health Organization on the development and restructuring of its Prequalification of Diagnostics Programme. Elliot received a BA from Williams College and a PhD in Biology and Biomedical Sciences from Washington University in St. Louis.

Emily D Crawford

Chan Zuckerberg Biohub

Scientist II

No bio available.

Mark E Curran

Janssen R&D LLC

VP Immunology Data Sciences

Dr. Curran is Global Head of Immunology Data Sciences and core member of the Immunology Therapeutic Area senior leadership team. Mark has accumulated over 25 years of experience in drug development spanning biotech and big pharma. He is a Janssen veteran of over ten years and is currently leading the Immunology data science organization with responsibilities spanning data management and engineering to implementation of cutting-edge, real-world evidence strategies. Prior positions include leading target discovery, biomarkers and diagnostics, and compound development teams at multiple companies and performing experimental medicine, Phase 1, and 2a/2b clinical trials for multiple compounds in immunology. Prior to joining big pharma, Mark gained valuable experience in biotech and venture capital working with start-up companies having focus on genetics, genomics, target discovery and validation, personalized medicine, companion diagnostics and early drug development. Mark earned his doctorate in Human Genetics at the University of Utah and BS/MS degrees in biology from Worcester Polytechnic Institute. He has co-authored over 60 peer reviewed scientific publications and holds multiple patents. He has contributed seminal discoveries in the field of predictive medicine, genetics of heritable cardiac arrhythmias and developed the Familion™ genetic diagnostic test for long QT syndrome. His primary interests are discovery of novel therapeutics, implementation of molecular diagnostics for personalized medicine and evolution of Data Sciences, Digital Health Care and Integrated Patient Care Solutions to improve the lives of all patients living with auto-immune disease.

Matthew Davis

Gritstone Oncology

Associate Director

Matt Davis serves as the Associate Director of Molecular Biology and Sequencing, responsible for biomarker development and neo-antigen discovery and selection. Dr. Davis joined Gritstone in 2015 at its inception and has driven various research and development projects supporting Gritstone’s clinical programs - GRANITE and SLATE. Prior to joining Gritstone Oncology, Dr. Davis was a post-doctoral researcher at Warp Drive Bio and has held research positions at Dana Farber Cancer Institute (DFCI) and the Broad Institute. He holds a PhD in Genetics from Yale University.

Jennifer Dien Bard

Childrens Hospital Los Angeles

Dir Clinical Microbiology Lab

Dr. Jennifer Dien Bard, is the director of the clinical microbiology and virology laboratories at Children’s Hospital Los Angeles (CHLA) and Associate Professor of Pathology with Clinical Scholar designation at the University of Southern California Keck School of Medicine. Dr. Dien Bard’s research interests include studying the application of rapid diagnostics in the clinical setting to determine clinical utility. She has authored more than 70 scientific peered-reviewed publications and is a frequent speaker on the topics of rapid diagnostics such as syndromic testing. Dr. Dien Bard serves as a member of the professional development committee for ASM and economic affairs committee for AMP and is on the Editorial board of the Journal of Clinical Microbiology.

Christopher D Doern

Virginia Commonwealth Univ

Assoc Prof

Director of Clinical Microbiology at VCU Health System and the Medical College of Virginia in Richmond, VA. I am an Associate Professor of Pathology and Pediatrics. Conducted undergraduate and graduate studies at Wake Forest University in Winston-Salem, NC. Completed a fellowship in Medical and Public Health Microbiology at Washington University in St. Louis in 2010 and am board certified by the American Board of Medical Microbiology (ABMM).

Shivang Doshi

Boston Healthcare

Executive Director

Shivang Doshi has worked with a variety of pharmaceutical and diagnostics clients on issues related to market access, evidence development and reimbursement strategies of novel diagnostic technologies. His specific areas of expertise include value-based molecular assays, companion diagnostics, and informatics tools that support the delivery of precision medicine.

Robert C Duncan

FDA CBER

Principal Investigator

Robert Duncan, PhD is a senior investigator and reviewer at the US FDA Center for Biologics Evaluation and Research (CBER). His broad experience includes over 25 years of research encompassing virology, bacteriology, parasitology, cell biology and new technology for pathogen detection. He has published over 50 peer reviewed papers in these fields. He is an internationally recognized expert in the area of blood donor screening for protozoan parasites having chaired FDA committees for product license review, written FDA policy documents and served on World Health Organization standards committees. In his current research program, he has evaluated advanced technology platforms for multiplex detection of pathogens in blood including a custom Life Technology Corporation OpenArray®, an Affymetrix GeneChip® based resequencing microarray and Laser Induced Breakdown Spectroscopy and is applying the resequencing microarray approach to Ebola Virus monitoring. The next step in his research program is application of the Oxford Nanopore Technologies MinION Next Generation Sequencing device to pathogen detection and identification.

Laura Esserman

University of California San Francisco Medical Center

Professor

Dr. Laura Esserman is Professor of Surgery and Radiology at the University of California, San Francisco (UCSF) and director of the UCSF Breast Care Clinic. Her work in breast cancer spans the spectrum from basic science to public policy issues, and the impact of both on the delivery of clinical care. Dr. Esserman is recognized as a thought leader in cancer screening and over-diagnosis, as well as innovative clinical trial design. She led the creation of the University of California-wide Athena Breast Health Network, a learning system designed to integrate clinical care and research as it follows 150,000 women from screening through treatment and outcomes. The Athena Network launched the PCORI-funded Wisdom Study, which tests a personalized approach to breast cancer screening in 100,000 women. She is also a leader of the innovative I-SPY TRIAL model, designed to accelerate the identification and approval of effective new agents for women with high risk breast cancers.

Corinne Fantz

Roche

Director

Corinne is a Director of Medical and Scientific Affairs for Point of Care Testing at Roche Diagnostics in the US. Corinne is responsible for post market studies of POC devices and networking with key opinion leaders in the field to bring the US perspective into our global development of new products. She has more than 25 years of experience in Laboratory Medicine. Corinne received her Ph.D. in biochemistry from the University of South Carolina and completed a postdoctoral fellowship in clinical chemistry at Washington University in St. Louis. Corinne supports the profession by participating as an active member of the American Association for Clinical Chemistry (AACC), ACLPS, and CLSI. She is currently a board member and Treasurer of AACC.

Joseph V Ferrara

Boston Healthcare Associates Inc

President & CEO

Joe has over 20 years of experience in life sciences consulting, working with biopharmaceutical, medical device, diagnostics, and health care IT clients in market and business development strategy. He leads the global consulting team with practice areas in reimbursement and pricing, health economics, market analysis, and M&A. Joe completed undergraduate studies at the University of Cincinnati and received his master’s degree from Harvard University.

Alejandro Francisco-Cruz

The University of Texas MD Anderson Cancer Center

Postdoctoral Researcher

Immunopathologist, M.D. Ph.D.; Post-doctoral Researcher at The University of Texas MD Anderson Cancer Center, Houston. Leading the scientific development of Mass Spectrometry-Immunohistochemistry (MS-IHC) Lab in the department of Translational Molecular Pathology, under the mentorship of Dr. Ignacio Wistuba, Division Head ad interim, Division of Pathology/Lab Medicine. The MS-IHC lab includes the most important platforms for immunoprofiling in tissue sections, Imaging Mass Cytometry (IMC) by Hyperion Image System, and Multiplexed Ion Beam Imaging (MIBI) by MIBIscope I system. Currently in charge of the validation of antibodies conjugated with ion metals for MS-IHC platforms and the development of immune-oncology panels for the characterization of immune contexture in tumor tissues, quantification of immune-cell phenotypes cellularity, and the geospatial organization of tumor infiltrating immune cells in relationship with clinical outcomes, prognosis and predictive markers for carcinoma relapse, survival, and sensitivity to immunotherapy, mainly with Non-Small Cell Lung Carcinoma cases. In addition, we are characterizing Tertiary Lymphoid Structures in early stages of NSCLC; and collaboration efforts for immunoprofiling of intraepithelial lymphocytes in Lynch syndrome, etc.

Charlotte Gaydos

Johns Hopkins University

Professor

Charlotte A. Gaydos, DrPH, MPH, MS, is a professor in the Division of Infectious Diseases of the Johns Hopkins University School of Medicine. She has joint appointments in emergency medicine and in epidemiology at the Johns Hopkins Bloomberg School of Public Health. She directs the Center for Point-of-Care Tests for Sexually Transmitted Infections. Dr. Gaydos conducted multiple FDA clinical trials for diagnostics for STIs. Dr. Gaydos has extensive laboratory experience in the development and evaluation of molecular amplification testing techniques, as well as epidemiology expertise. Dr. Gaydos has performed original research developing DNA amplification tests for Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae, and Mycoplasma genitalium. She has published >525 manuscripts, 29 book chapters, and presented >700 abstracts and oral presentations. Dr. Gaydos received her MS from West Virginia University and her MPH and DrPH from Johns Hopkins Bloomberg School of Public Health.

Tad George

RARECYTE, INC

Sr. VP

Tad has over 15 years of startup experience dedicated to creating scientific markets for novel instrumentation platforms that span basic research, drug discovery, and clinical applications. Prior to joining RareCyte, Tad has held similar positions at Biodesy, Inc. and DVS Sciences, and was Director of Biology at Amnis Corporation.

Paul Gerrard

MolDx Palmetto

CMO & Director

Paul Gerrard, MD, is a physiatrist who works with Palmetto GBA's other Contractor Medical Directors. Prior to coming to Palmetto GBA, he worked in both an academic practice and a solo private practice providing both inpatient and outpatient care. He has published articles on functional status measurement and post-acute care outcomes and co-authored a book on scientific computing. He has an interest in post-acute care and using data to improve payment accuracy and patient outcomes.

Harry Glorikian

New Ventures Funds

General Partner

Harry Glorikian is an influential global business expert with more than three decades of experience building successful ventures in North America, Europe, Asia and the rest of the world. Harry is well known for achievements in life sciences, healthcare, healthcare IT and the convergence of these areas. He is a sought-after speaker, frequently quoted in the media, and regularly asked to assess, influence, and be part of innovative concepts and trends. He holds four US patents in telecommunications, and has others pending. He recently served as an Entrepreneur In Residence to GE Ventures – New Business Creation Group. He serves on the board of GeneNews Ltd. (a molecular diagnostic company). He also serves on the advisory board of Nucelis (a gene-editing industrial biotech company), Evidation Health (a digital health startup launched with support from GE Ventures), and several other companies. He is also a co-founder and an advisory board member of DrawBridge Health (a revolutionary diagnostics startup launched with support from GE Ventures). Previously he co-founded and held the position of managing director and head of consulting services for Scientia Advisors, a company that became the go-to provider of strategic advice and implementation services for next-generation healthcare and life science innovators and Global 25 market leaders. Scientia Advisors was acquired by Precision for Medicine in November of 2012. Among his other professional roles, Mr. Glorikian served as senior manager for global business development at PE Applied Biosystems, founded X-Cell Laboratories, managed global sales at Signet Laboratories and held various roles at BioGenex Laboratories. Mr. Glorikian holds an MBA from Boston University and a bachelor's degree from San Francisco State University. Harry has addressed the National Institutes of Health, Molecular Medicine Tri-Conference, World Theranostics Congress and other audiences, worldwide. He has authored numerous articles for industry publications, appeared on CBS Evening News and been quoted regularly by Dow Jones, The Boston Globe, BioWorld Today, Los Angeles Times, London Independent, Medical Device Daily, Science Magazine, Genetic Engineering News and many other media outlets.

Alex Greninger

Univ of Washington

Assistant Professor

Alex Greninger is an assistant professor of laboratory medicine and associate director of the clinical virology laboratory at the University of Washington. He received a BS and MS in Biological Sciences and a BA in International Relations from Stanford University, an MPhil in Epidemiology at Cambridge University, and his MD and PhD from the University of California San Francisco, followed by residency in clinical pathology at the University of Washington. His work generally involves genomically-informed approaches to understanding a variety of infectious diseases.

Kimberley Gutierrez

Stilla Technologies

Senior Field Application Scientist

Kimberley received her PhD in Microbiology from the University of Washington in Seattle where she studied angiogenesis induced by latent Kaposi’s Sarcoma Herpesvirus infection. She completed a postdoc in Immunology investigating necroptotic programmed cell death and activation of the proinflammatory response. She previously held positions at Exiqon and Qiagen as a miRNA application specialist and NGS field application scientist before joining Stilla Technologies, Inc. 

Samir Hanash

University of Texas MD Anderson Cancer Center

Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research

Dr. Hanash was recruited to MD Anderson Cancer Center in 2011 to lead the Red and Charline McCombs Institute for Cancer Early Detection and Treatment. He was previously program head for Molecular Diagnosis at the Fred Hutchinson Cancer Research Center. Dr. Hanash’s interest and expertise are in the field of cancer diagnostics and the development of blood-based cancer biomarkers for risk assessment and cancer early detection. He is the inaugural president of the International Human Proteome Organization dedicated to the study of the human proteome, and a founder of the US Human Proteome Organization. Dr. Hanash’s approaches to meet the challenge of developing markers that signal the presence of cancer at an early stage to allow detection and effective treatment have included a rigorous painstaking in-depth quantitative profiling of the various types of molecules in the blood to find those that are released early either from the cancer cells or from the host response to the developing cancer. The work emphasizes the need for rigor in experimental design, in data collection and statistical analysis and in developing a mechanistic understanding of the relationship between the identified cancer markers and the developing cancer. This work has sparked innovation in experimental design and statistical analysis of biomarker data aimed at minimizing biases in discovery studies through prospective sample collections that relate most directly to the intended clinical application(s) and at reducing the false discovery rate through integration of data from multiple sources to increase confidence in the significance of the markers.

Glen Hansen

Seegene Technologies Inc.

No bio available.

David P Harding

Exact Sciences

Senior Vice President

David joined Exact Sciences in 2017 and leads the Strategy and Business Development function with a focus on long-range strategy and M&A/partnership activities. Prior to Exact Sciences, David was Chief Commercial Officer at T2 Biosystems (infectious diseases) and Chief Commercial Officer of OvaScience (women's health). David held a variety of roles over an 11-year period at Hologic/Cytyc (women's health) including Group Vice President and General Manager, Women’s Health, SVP International, and SVP & GM Interventional Breast Solutions. Prior to Hologic's acquisition of Cytyc, David was President International and VP Marketing. Before his entry into the medical device and diagnostics arena, David had a 10-year career as a strategy consultant at McKinsey & Company where he was an associate and principal. David has an MBA degree from the Wharton School of the University of Pennsylvania and a BS in Aerospace Engineering from the University of Southern California.

Marc Hartstein

Health Policy Alternatives Inc

Principal

Marc joined HPA after 26 years with the Centers for Medicare and Medicaid Services (CMS). Marc held several management and staff positions during his time at CMS, most recently as the director of the Hospital and Ambulatory Policy Group. At CMS, Marc was central to the development of the Medicare Severity DRGs, the 2 midnight rule, Medicare policy for off-campus hospital outpatient departments, the misvalued code initiative, and regulations to implement Medicare’s new clinical laboratory fee schedule among other policies. Marc’s experience not only gives him detailed knowledge of the workings of the executive branch of government, he also has worked extensively with the legislative branch. He has assisted in the drafting of legislation, working with the Congressional Committees that have subject matter jurisdiction over Medicare. Marc has a master’s degree in public policy from the University of Minnesota’s Hubert H. Humphrey Institute of Public Affairs and a bachelor’s degree in political science and economics from the University of Vermont.

Jason C Heikenfeld

Univ of Cincinnati

Prof

Jason Heikenfeld is Assoc. VP of Operations at the Univ. of Cincinnati Office of Innovation. He also directs the Novel Devices Laboratory, an internationally leading research lab in miniminally invasive biosensing technology. Dr. Heikenfeld is a serial entrepreneur who has already accumulated the most patents and licensees of any faculty member in the history of the Univ. of Cincinnati. In addition to his scholarly work, during his teaching years Prof. Heikenfeld was the highest-rated STEM educator at the University of Cincinnati.

Mark D Hiatt

Guardant Health Inc

VP Medical Affairs

Mark Hiatt, currently vice president for a precision oncology company, has served as the chief medical executive for a multi-state Blues plan and a national medical benefits manager, and department leader and board member for a regional health system. Dr. Hiatt completed a fellowship in cardiovascular imaging at Stanford University, residency in radiology and master’s in Health Evaluation Sciences at the University of Virginia, and MD and MBA with academic distinction at Wake Forest University. He is the Chair of the Greater Salt Lake Chapter of the American Red Cross.

Fred R Hirsch

Icahn School of Medicine at Mount Sinai

Lowe & Price Prof of Medicine & Exec Dir

Fred R. Hirsch MD, PhD, is currently the Executive Director at the Center for Thoracic Oncology at Mount Sinai Health Systems. He also serves as a Professor of Medicine at the Icahn School of Medicine, as well as an Associate Director of the Tisch Cancer Institute. Prior to this arrival at MSHS, Dr. Hirsch was a Professor of Pathology at the University of Colorado for 18 years and CEO to the International Association for the Study of Lung Cancer for 5 years. He has been the recipient of awards and honors, including the IASLC Mary Matthews Award for Translational Research in Lung Cancer in 2007; the Japanese Lung Cancer Society Merit Award in 2010; the Addario Foundation Lecture Award in 2015; the Joe Lowe, and Louis Price Endowed Chair in Cancer Research at the Icahn School of Medicine in 2018, and the Wuan Ki Hong Lectureship Award in 2019. Dr. Hirsch has contributed to over 400 publications in peer reviewed journals. He continues to lead research efforts as well as new research in various laboratories in the study of lung cancer.

Zach Hochstetler

American Medical Association

Dir CPT Editorial & Regulatory Svcs

Zach Hochstetler is the Director of CPT Editorial and Regulatory Affairs in the American Medical Association’s Health Solutions unit. Zach’s work focuses on several key areas, including: leading and setting strategic direction for the CPT Editorial Panel and directing the communication of health care policies, through identification and resolution of national payment and reporting problems. He is also the Secretary of the CPT Editorial Panel, ensuring that the process remains open and transparent. Zach has over 10 years of experience working on physician payment and policy issues. He spent seven years working in the Physician Payment and Policy unit of the American Medical Association, primarily tasked with managing the data acquisition and maintenance processes for the AMA RUC.

John Hornberger

Acumen, LLC & Stanford University

Senior Clinical Research & Adjunct Clinical Professor

Dr. Hornberger is Senior Clinical Researcher at Acumen LLC and Adjunct Clinical Professor of Medicine at Stanford University School of Medicine. His research focuses on the assessment – clinical outcomes & ethical/economic implications – of novel health technologies and heathcare services. He has been Principal Investigator for clinical trials, clinical registries and large databases; his research applies state-of-the-art methods in biostatistics (Bayesian), epidemiology, clinical trial design, meta-analysis, and decision analysis. He has published on technologies for cancer, diabetes, rheumatic diseases, mental health, infectious diseases (HIV, hepatitis, and herpes zoster), care for the poor and underserved, and others. He has published seminal papers on the evaluation of genomic assays, clinical utility studies, and on the cost-effectiveness of new technologies. His research is published in leading clinical and policy journals (e.g. Journal of the National Cancer Institute, Annals of Internal Medicine, JAMA) and his work is cited in international appraisals of new cancer technologies, such as the UK National Institute of Clinical Excellence and the Canadian Coordinating Office for Health Technology Assessment.

Susan Hsiao

Columbia University Medical Center

Assistant Professor

Susan Hsiao is Assistant Professor of Pathology and Cell Biology at Columbia University Medical Center and Director of Bioinformatics in the Laboratory of Personalized Genomic Medicine. She received her MD/PhD from New York University School of Medicine and trained in anatomic pathology and molecular genetic pathology at Columbia University Medical Center and University of Pittsburgh Medical Center.

Arash Jamshidi

GRAIL Inc

VP, Bioinformatics and Data Science

Arash Jamshidi, PhD, is Vice President of Data Sciences and scientific co-founder at GRAIL, leading the research and development of Machine Learning and AI, Computational Biology, Bioinformatics, and core cell free nucleic acid biomarker technologies that have enabled GRAIL’s mission of early detection. Prior to GRAIL, Arash was Associate Director of Research at Illumina where he led the development of technologies for integrated next generation sequencing platforms, massively parallel single cell transcriptomics, and cell-free nucleic acid technologies for clinical applications. Arash holds a BS from Simon Fraser University in Electrical Engineering and MS and PhD in Electrical Engineering and Computer Sciences from UC Berkeley.

Mark Jelley

OrbiMed Advisors, LLC

Managing Director

Mark R. Jelley is a Managing Director focused on healthcare royalty and structured finance investments. Prior to joining OrbiMed, he was an Associate in investment banking at UBS focused on leveraged finance transactions. Prior to UBS, Mr. Jelley was an analyst at Macquarie Capital, focused on principal investments. Mr. Jelley holds a BS in Chemistry and Biology from Duke University.

Joe Jiang

ACROBiosystems

Product Manager

Dr. Yinan Jiang is an expert on structural studies of protein complexes involved in virus-host interaction. His research focuses on elucidating the molecular mechanism of virus cell entry and viral immune evasion, including coronaviruses and influenza viruses. He has published research papers in high-profile journals such as Cell Research and Protein Cell.

Dr. Jiang is in charge of developing SARS-CoV-2 antigen proteins and kits for research use at ACROBiosystems.

Pawan Jolly

Harvard University

Senior Scientist

Pawan Jolly is a Senior scientist with biotechnology development expertise focusing specifically on biosensor development. Pawan has a PhD in Electronic and Electrical Engineering from University of Bath, UK, Masters in biomedical engineering from FH Aachen, Germany and a Bachelors in Biotechnology from Amity University, India. Pawan has been working in the area of chemo- and bio-sensors for over a decade, gaining understanding in the real-world needs and challenges for the commercialization of electrochemical biosensors. Pawan joined the Wyss Institute at Harvard to address the technical challenge of sensor surface fouling for the development of electrochemical sensors as a part of project Abbie. Pawan’s main interest is to translate the current electrochemical platform technology at the Wyss to commercialized products. Pawan’s current research area includes biosensors detecting very small analytes e.g. histamine, organ-on-chip technology, DNA as a memory storage technology, microencapsulation and phage display screening. Pawan Jolly has published more than 25 papers in the span of 4 years during his PhD studies and has experience working on multiple patent applications. Pawan is also leading the Point-of-Service working group at the MGB Center of COVID Innovation to address the current Covid-19 diagnostics unmet need.

Julie Khani

American Clinical Lab Association

President

Julie Khani is president of the American Clinical Laboratory Association (ACLA). Khani leads ACLA’s efforts to advance public policies that promote innovation and protect and enhance patient access to life-improving and life-saving diagnostics. ACLA members represent the diversity of the clinical laboratory industry and include national, regional, specialty, hospital, ESRD, anatomic pathology, skilled nursing facility and academic medical center laboratories. Ms. Khani is recognized as an effective leader, consensus builder, and advocate. Prior to joining ACLA, she served in senior roles at the National Association of Chain Drug Stores (NACDS). Previously, Khani served as legislative manager at Ford Motor Company, where she was responsible for health and labor issues and the company’s political action committee. Before joining Ford Motor Company, Ms. Khani was associate director, government relations at Planned Parenthood Pennsylvania Advocates, where she managed several successful statewide campaigns on health and welfare issues. She holds a Bachelor of Arts from New York University and a Master of Public Administration from George Washington University.

Ritesh Khullar

Foundation Medicine Inc

CCO

Tesh Khullar joined the Foundation Medicine team in January of 2020 to help leverage his 20+ years of experience in the oncology marketplace to help continue to drive forward the company’s mission to enhance the personalized patient experience to those battling cancer. He currently serves as the Chief Commerical Officer responsible for all the Sales and Operations functions.

Roger D. Klein

OmniSeq

Chief Medical Officer

Roger D. Klein, MD, JD, is a board-certified molecular pathologist who has served as medical director of molecular oncology and at several academic institutions, most recently the Cleveland Clinic. In addition, he has served as a medical, strategic, and regulatory consultant in the biotechnology, clinical laboratory, diagnostics, and medical devices industries. A leading figure in the field, Dr. Klein has advised the Departments of Health & Human Services, Food and Drug Administration, the Centers for Medicare & Medicaid Services, and the Centers for Disease Control and Prevention, and has held leadership roles on and participated in numerous professional society committees at the Association for Molecular Pathology, the College of American Pathologists, the American Society of Clinical Oncology, the Clinical Laboratory Standards Institute, and the American Medical Association. Dr. Klein has over 50 peer-reviewed articles and book chapters. He completed medical school and an internship at Case Western Reserve Medical School, residency and fellowships at Yale Medical School, and a fellowship at Mayo Clinic. He earned his law degree at Yale Law School.

Eric Q Konnick

University of Washington

Assistant Professor& Associate Director

Dr. Konnick is an Assistant Professor, Associate Director of the Genetics and Solid Tumors Laboratory, and Director of Genetics Preanalytical Services within the Department of Laboratory Medicine and Pathology at the University of Washington Medical Center in Seattle. Dr. Konnick is board certified in Molecular, Anatomic, and Clinical pathology. He is vice chair of the Association for Molecular Pathology's (AMP) Professional Relations Committee and the College of American Pathologists (CAP) Genomic Medicine Committee. He has over 20 years of clinical laboratory experience and 8 years of experience in regulatory matters.

Gerald Kost

University of California, Davis

Director

No bio available.

Colleen S Kraft

Emory Univ Hospital

Assoc Prof

Colleen S. Kraft, MD, is an Associate professor in the Department of Medicine Division of Infectious Diseases as well as an Associate professor in the Department of Pathology (primary appointment) at Emory University School of Medicine. She is Associate Chief Medical Officer at Emory University Hospital

Peter Kuhn

University of Southern California

Director, USC Michelson CSI-Cancer; Dean’s Professor of Biological Sciences; Professor of Biological Sciences, Medicine

Peter Kuhn is a scientist and entrepreneur with a career long commitment in personalized medicine and individualized patient care. He is focused on the redesign of cancer care. Kuhn’s research team in physics oncology has discovered new ways of how cancer spreads to the human body and is using those breakthroughs to impact patient care. Dr. Kuhn is the Dean’s Professor of Biological Sciences and Professor of Medicine and Engineering at USC, a founding member of the Michelson Center for Convergent Biosciences, a co-founder of The USC Michelson Center for Convergent Bioscience Bridge Institute and director of the Southern California Physics Oncology Center. Dr. Kuhn is a physicist who trained initially at the Julius Maximilians Universität Würzburg, Germany, before receiving his Masters in Physics at the University of Albany, Albany, NY in 1993 and his PhD in 1995. He then moved to Stanford University where he later joined the faculties of Medicine and Accelerator Physics. From 2002 to 2014, he established a translational science program at The Scripps Research Institute in La Jolla, CA bringing together over forty scientists from basic, engineering and medical sciences to work on understanding the spread of cancer in the human body. He has published over 200 peer-reviewed scientific articles and patents as a result of his research. He founded Epic Sciences, Inc. in 2009 to develop cancer diagnostic products. Today Epic Sciences is a premier partner to most pharmaceutical and biotech companies in the development of precision companion diagnostics for cancer care.

Erin Lahti

MilliporeSigma

Mark Landers

Guardant Health

Vice President BioPharma Business Development

No bio available.

Jordan S Laser

Northwell Health

Medical Dir

Dr. Jordan Laser is the Medical Director for the Pathology and Laboratory Medicine at the Long Island Jewish Medical Campus of Northwell Health based in New York. Dr. Laser received his bachelor of science in biochemistry at the University of Michigan, medical degree from Tel Aviv University, and anatomic/clinical pathology residency training at New York University Medical Center. Following his residency, Dr. Laser completed a fellowship in molecular genetic pathology at the Mount Sinai Hospital. Dr. Laser actively practices and is board certified in anatomic, clinical and molecular genetic pathology as well as clinical informatics. Dr. Laser has additional roles in the Health System and Department of Pathology and Laboratory Medicine. Specifically he is the Associate Medical Director, Core Laboratories and Medical Director, Division of Near Patient Testing. Dr. Laser is an associate professor at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. Dr. Laser is an active member of two national professional societies. He is currently the chair of the professional relations committee for the Association for Molecular Pathology and the vice chair of the personalized healthcare committee for the College of American Pathologists.

Tiffani Lash

National Institutes of Health

Program Director

Dr. Tiffani Bailey Lash serves as a Program Director/Health Scientist Administrator at the National Institutes of Health. She manages the research portfolios for the Biosensors, Platform Technologies, and mHealth programs at the National Institute of Biomedical Imaging and Bioengineering (NIBIB). Dr. Lash is also the Program Director for the NIBIB Point of Care Technologies Research Network, consisting of three centers charged with developing point-of-care diagnostic technologies through collaborative efforts that merge scientific and technological capabilities with clinical need. Prior to her current position, Dr. Lash worked within the NIH’s science policy administration. During that time, she worked at the National Institute of General Medical Sciences and National Heart Lung and Blood Institute, as well as the NIH Office of the Director. Dr. Lash has been selected as a science policy fellow for both the American Association for the Advancement of Science (AAAS) and the National Academy of Engineering. She also has a background in small business innovation and intellectual property. Dr. Lash earned her Ph.D. in Physical Chemistry from North Carolina State University via a collaboration between the Departments of Chemistry and Chemical and Biomolecular Engineering. Her interdisciplinary research interests include microfluidics, biopolymers with controlled molecular architecture, and biosensor technologies.

Nathan A Ledeboer

Medical College of Wisconsin

Prof & Vice Chair

Nathan A. Ledeboer, Ph.D., D(ABMM), F(AAM) received his Ph.D. Degree in Microbiology from the University of Iowa in 2005. Following two years of fellowship training in clinical and public health microbiology at Washington University School of Medicine in Saint Louis, MO, he joined the faculty of the Department of Pathology at the Medical College of Wisconsin in Milwaukee, WI. He is currently a Professor and Vice Chair of Pathology and Medical Director of Microbiology, Molecular Diagnostics, reference services, and laboratory client services at Froedtert Hospital and Wisconsin Diagnostic Laboratories in Milwaukee, WI. His research endeavors, particularly in the area developing diagnostic tools for infectious diseases, have led to numerous publications in peer-reviewed journals and more than 100 funded research projects. Dr. Ledeboer is also a senior editor for the Journal of Clinical Microbiology.

Hakho Lee

Massachusetts General Hospital

Associate Professor and Hostetter MGH Scholar

Dr. Lee has extensive experience in nanomaterials, biophysics, microfluidics, and electrical engineering. His research focuses on developing novel biomedical sensors for clinical applications. Dr. Lee’s group also pioneered new analytical technologies for EV characterization, including nPLEX (nanoplasmonic exosome), iMEX (integrated magneto-electrochemical exosome), iMER (integrated magnetic exosomal RNA), and SEA (single EV analysis).

Eunice Y Lee

Merck

Exec Dir

Eunice Lee is currently Executive Director for Companion Diagnostics and In Vitro Diagnostics in the Global Regulatory Affairs group at Merck. She leads the regulatory companion diagnostics (CDx) team that provides strategic and operational guidance to support the oncology portfolio. Before joining Merck, Eunice spent nearly 8 years at the FDA. Her tenure included experience in the Center for Devices and Radiological Health as Chief of the Molecular Pathology and Cytology Branch (MPCB) and a Senior Scientific Reviewer in the Office of In Vitro Diagnostics and Radiological Health; and in the Office of the Commissioner as a Senior Advisor in the Office of Combination Products. Eunice earned an A.B. in biology and physics from Bryn Mawr College and a Ph.D. in biology from MIT. She completed a post-doctoral fellowship at Stanford University and, prior to the FDA, was a Scientist at the National Cancer Institute at NIH.

Christina C Lingham

Cambridge Healthtech Institute

Exec Dir Conferences

No bio available.

Yun Liu

Google LLC

Senior Research Scientist

Yun is a senior research scientist on the Google Health Research and Innovation team in Palo Alto, California. In this role he focuses on developing and validating machine learning for medical imaging across multiple fields: pathology, ophthalmology, radiology, and dermatology. Yun completed his PhD at Harvard-MIT Health Sciences and Technology, where he worked on predictive risk modeling using biomedical signals, medical text, and billing codes. He has previously also worked on predictive modeling for nucleic acid sequences and protein structures. Yun completed a BS in Molecular and Cellular Biology and Computer Science at Johns Hopkins University.

G. Mike Makrigiorgos

Dana Farber Cancer Institute

Director, Medical Physics & Biophysics & Professor

Dr. Makrigiorgos is a Professor of Radiation Oncology and Director of the Medical Physics & Biophysics division at Dana Farber Cancer Institute and Brigham and Women’s Hospitals, Harvard Medical School. He also directs the DNA technology laboratory and the radiation pre-clinical facility. His research interests include the development of novel DNA technologies for molecular diagnostics in Oncology and the identification of circulating cancer biomarkers. He is the inventor of several PCR-based techniques for molecular diagnostics, including COLD-PCR and NaME-PrO technologies. He is a Member of the Editorial Board of Clinical Chemistry and has published over 150 articles, reviews and book chapters.

Hannah Mamuszka

Alva10

Founder & CEO

Hannah Mamuszka is the Founder and CEO of Alva10, a consultancy that focuses on bringing diagnostics to the forefront of Precision Medicine by partnering with payers and diagnostic developers to create a new value-based healthcare model. Ms. Mamuszka has spent 20 years in biotech and diagnostics, with extensive experience in both drug and diagnostic development, validation, and commercialization. Prior to founding Alva10, Ms. Mamuszka was VP of Business Development at Exosome Diagnostics, where she led some of the earliest deals in the liquid biopsy diagnostic space. Earlier in her career, she was Global Director for Pharma Services at Exiqon A/S (now QIAGEN) and worked as a scientist on the NDA for Bortezmib (Velcade) at Millennium Pharmaceuticals (now Takeda). She regularly speaks on issues regarding advancement of technology in healthcare, is a Board of Directors for Bionano Genomics (BGNO) and writes a column on the value of diagnostics for the Journal of Precision Medicine.

Sohrab Mansouri

Instrumentation Lab, A Werfen Co

Staff Scientist

Dr. Sohrab Mansouri is a member of Advanced Technology Development Group at Instrumentation Laboratory. He brings over 40 years of experience in the design, development and implementation of chemical, biological and optical sensors for in-vitro and in-vivo diagnostics. He has spent the past 30 years advancing blood testing technologies at the point-of-care and is responsible for the development of the Intelligent Quality Management for enhancing and automating quality control processes in the GEM line of blood gas analyzers. He has written over 50 publications in the field and authored/coauthored 15 patents for enhancing quality control, automating error detection capabilities, improving electrochemical sensor performance and stabilizing liquid reagents in sealed bags. Dr. Mansouri holds a PhD in Chemical Engineering from the University of Michigan.

Charles Mathews

ClearView Healthcare Partners

Principal

Charles Mathews has been a life science strategy consultant for 15+ years. He leads the Medtech practice at ClearView Healthcare Partners. He combines expertise in commercialization and reimbursement market access with a strong understanding of the scientific and technical aspects of innovative products. He often plays a key role in helping multi-national innovators determine the value of a potential M&A transaction and advises early stage start-ups.

Bradon R McDonald

Translational Genomics Research Institute (TGen)

Computational Scientist

Dr. Bradon R. McDonald is a computational scientist in the Murtaza Lab at the Translational Genomics Research Institute (TGen) in Phoenix, AZ. His current work focuses on the development of non-invasive treatment monitoring tools for cancer patients using circulating tumor DNA. Before his position at TGen, he received a PhD in Microbiology from the University of Wisconsin-Madison where he studied lateral gene transfer and evolutionary genomics in antibiotic producing bacteria.

Veronica Miller

Forum for Collaborative Research

Executive Director

Dr. Veronica Miller is the Executive Director of the Forum for Collaborative Research, and Professor (Adjunct) at University of California Berkeley School of Public Health. She is a leading expert in regulatory science, engaging stakeholders from both sides of the Atlantic to resolve and advance regulatory science and policy to advance the development of therapeutics and diagnostics in areas of unmet medical need. She led the expansion of the Forum’s collaborative model in HIV to 6 new disease areas: HCV, HBV, CMV, NASH, PSC and Rare Diseases. As a Professor, Miller teaches a graduate-level course she developed on FDA and drug development, based on case studies from the Forum’s rich history in facilitating drug development, and the online course: Regulatory Science, Drug Development and Public Health. She mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers. She joined the Forum for Collaborative Research in 2001 after having directed the interdisciplinary HIV Research Group at the HIV Outpatient Clinic of the JW Goethe University in Frankfurt, Germany. Together with Joep Lange, she co-founded and chaired the Euro-Guidelines Group on HIV Drug Resistance, the first pan-European group established for the purpose of assuring a common standard-of-care for patients in all European states. Dr. Miller obtained a PhD in Immunology from the University of Manitoba, Canada. Miller served on numerous industry and government advisory boards throughout her career, publishing over 100 peer-reviewed publications on HIV treatment strategies, and regulatory strategies for HIV and the other disease areas in the Forum’s portfolio.

Tom Miller

GreyBird Ventures, LLC

Founder & Managing Partner

Tom Miller is a global healthcare industry leader and an experienced and visionary CEO. He graduated from the University of Massachusetts at Lowell and then received a Masters degree in Medical Physics from the Harvard University/MIT Health Sciences and Technology Program. Tom initially pursued an academic career, working at Los Alamos National Laboratory, the Swiss Institute for Nuclear Research (now the Paul Scherer Institute), Brookhaven National Laboratory, and the Massachusetts General Hospital. Tom then joined Siemens Medical Systems where, after 9 years, he became the first non-German CEO of a German factory and business unit. He left Siemens after 15 years to become CEO of the global medical operations of Carl Zeiss. After completing a successful turnaround, he joined Analogic Corporation as CEO. After three years and a doubling of the stock price, Tom left to help establish and become CEO of LightLab Imaging, a leader in the field of cardiovascular optical coherence tomography. Subsequently, after a profitable sale of LightLab to a Japanese company, Tom re-joined Siemens, where he became a member of the operating board and CEO of the Customer Solutions Division of Siemens Healthcare, responsible for 26,000 employees in over 130 countries. Tom is a frequent speaker on healthcare technology and business at such venues as the National Press Club, the National Library of Medicine, the National Institute of Health, and the American Hospital Association. He was selected by the diagnostic imaging industry to provide Congressional testimony to the House Health Sub-Committee in June of 2009 and to speak on breast cancer technology at the European Parliament in 2012. Sponsored by the American Hospital Association, Tom gave the keynote speech on Sustainable Healthcare and Precision Medicine at the Health Executive Forum in Arizona in 2013; he also gave a keynote speech at the 2013 Arab Health meeting in Dubai on the same topic. In addition, Tom gave the 2013 commencement address at the India Institute of Technology in Roorkee, and keynote addresses to the Chinese Private Hospital Association in 2014 in Wuhan, the Innovation for Health Conference in 2015 in Amsterdam, the 2015 TiE Leapfrog Conference in Bangalore, and the 2016 World Executive Healthcare Forum in Montreal. Tom Serves on the Board of Atlas 5D and Chairs the Board of Ceres Nanosciences and Hummingbird Diagnostics.

Norman Moore

Abbott Labs

Dir Scientific Affairs

Dr. Moore received his Bachelor's Degree from Dartmouth and his PhD in microbiology from the University of New Hampshire. He has eight US and 39 non US patents in the field of infectious disease diagnostics along with numerous publications and presentations. He has sat on medical committees such as the point-of-care groups for the College of American Pathology and the Clinical Laboratory Standards Institute and helps write guidelines/best practices for additional groups. At this time, he is the global director of scientific affairs for the Rapid Diagnostic division of Abbott Laboratories. He received the Volwiler Fellowship Award for lifetime achievement in science in 2019

Carl Morrison

Roswell Park Cancer Institute

Sr VP

Dr. Carl D. Morrison joined the faculty of Roswell Park Comprehensive Cancer Center in January 2007, and is currently the Senior Vice President of Scientific Development and Integrative Medicine; Director of the Pathology Resource Network; Clinical Chief, Department of Pathology & Laboratory Medicine; Director, Division of Molecular Pathology, and Professor of Oncology. Prior to coming to Roswell Park, Dr. Morrison spent five years as faculty at The Ohio State University Medical Center after completing his residency there in Anatomic Pathology. Dr. Morrison is a board-certified pathologist with a Certificate of Qualification in Oncology in NYS who has an interest in both clinical and research areas. As Senior Vice President of Scientific Development and Integrative Medicine, Dr. Morrison supports the development of new core capabilities and technology platforms in order to conduct highly integrative research across both the basic sciences and clinical care. Dr. Morrison continues to lead the Pathology Resource Network (PRN) at Roswell Park. The overall goal of the PRN is to facilitate access to human biospecimens for IRB-approved investigators with an emphasis on translational efforts. The services offered are quite diverse and serve a unique link between the research and clinical arena. Dr. Morrison started and previously directed the Clinical Data Network (CDN) at Roswell Park. The CDN is the organization of clinical data for research purposes utilizing a federated database approach. The primary goal of the CDN is the promotion of translational research at Roswell Park in a non-human subject research setting.

Shawn P Mulvaney

U.S. Naval Research Laboratory

Section Head Surface Nanoscience and Sensor Technology Section

Dr. Mulvaney works in surface, materials, and analytical chemistry applied towards the design and development of biosensors and the next generation of diagnostic devices.

Jeanne Mumford

Johns Hopkins Hospital

Manager

Jeanne Mumford is the Pathology Manager for Point of Care Testing for Johns Hopkins Medicine, including 2 academic hospitals, 3 community hospitals and around 60+ ambulatory physician offices. She obtained a BS in Medical Technology in 2000. Over the last 20 years, she has worked in various roles in laboratory medicine, including transfusion medicine, immunology, special chemistry and laboratory management. Jeanne offers years of experience in regulatory oversight, quality assurance projects and laboratory inspection preparedness and planning. She was part of the team responsible for building the laboratory piece and implementing a universal EMR for Johns Hopkins Medicine. Her team of point of care coordinators work closely with providers across the enterprise to support patients’ needs by engaging, educating and evaluating our clinical testing personnel.

Sunitha Nagrath

University of Michigan

Associate Professor

Dr. Sunitha Nagrath is an Associate Professor of Chemical Engineering at University of Michigan. Dr. Nagrath did her Bachelor’s degree in Chemical Engineering from Sri Venkateswara University College of Engineering, Tirupathi, India. She received her Ph.D. in 2004 from Rensselaer Polytechnic Institute, Troy, NY in Mechanical Engineering. She did her postdoctoral work (2004-2008) at Harvard Medical/Massachusetts General Hospital, Boston, MA. She later worked as an instructor/junior faculty at Harvard Medical School. Dr. Nagrath is the leading scientist who designed the MEMS based technology, “CTC-Chip” for the sensitive isolation of circulating tumor cells (CTCs) from the blood of cancer patients. Her work challenged and changed the then-current paradigm of CTC isolation and concurrently increased the relevance of CTCs in cancer research, thereby accelerating the pace of CTC research. She joined University of Michigan in 2010, where she established her laboratory focused on engineering innovative microfluidic devices and nanomaterials for implementing personalized precision medicine via liquid biopsy. Dr. Nagrath’s major focus of research is on understanding cell trafficking in cancer through isolation, characterization and study of circulating cells and exosomes in peripheral blood of cancer patients. Dr. Nagrath co-directs the Single Cell Analysis Core of Rogel Cancer Center at UMICH, where Dr. Nagrath and her laboratory provides innovative microfluidic tools for handling cells at single cell resolution.

Valerie L Ng

Alameda Health System

Chair of Laboratory Medicine & Pathology, and Director of Transfusion Services

Valerie Ng, MD, PhD is Professor Emeritus in the Department of Laboratory Medicine, UCSF, and is currently Chair, Laboratory Medicine and Pathology, and Laboratory Director of the Clinical Laboratories of Alameda Health System. She completed undergraduate work at UC Berkeley, PhD in molecular virology at UT Houston, medical school at the UT Dallas Southwestern Medical School, residency training at UCSF and was a faculty member in the Department of Laboratory Medicine at UCSF from 1987-2005 before joining Alameda Health System. She has served on the Board of Directors for the Clinical and Laboratory Standards Institute and the external advisory board for the University of Georgia College of Pharmacy. She is the Chair of the Laboratory Medicine Editorial Review group for Doody Enterprises, a member of the California Hospital Association's Hospital Laboratory Workforce Initiative (HLWI), a member and currently Chair of the CDC's Clinical Laboratory Improvement Amendments Committee (CLIAC), a member of the CARB-X Scientific Advisory Board, an ad hoc external reviewer for the Moore Inventors Fellows Program of the Gordon & Betty Moore Foundation, and remains a consultant for the Hematology and Microbiology Devices Panel in the FDA Center for Devices and Radiological Health.

James Nichols

Vanderbilt University School of Medicine

Professor of Pathology, Microbiology and Immunology, and Medical Director

James H. Nichols, PhD, DABCC, FACB is a Professor of Pathology, Microbiology, and Immunology, Medical Director of Clinical Chemistry and Point-of-Care Testing at the Vanderbilt University Medical Center. Dr. Nichols received his BA in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete a Master’s and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign. Jim was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions. Jim later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA and was a Professor of Pathology at Tufts University School of Medicine. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology.

Frederick S Nolte

Medical Univ of South Carolina

Dir Clinical Labs & Prof

Frederick (Rick) S. Nolte, Ph.D. is currently Professor and Vice Chair for Laboratory Medicine in the Department of Pathology and Laboratory Medicine, and Medical Director of Clinical Laboratories and Molecular Pathology at the Medical University of South Carolina. He is a Diplomate of the American Board of Medical Microbiology and a Fellow of the American Academy of Microbiology. Dr. Nolte completed his B.S. degree in biology at the University of Cincinnati and his Ph.D. in medical microbiology at the Ohio State University. Dr. Nolte completed a postdoctoral fellowship in public health and medical laboratory microbiology at the University of Rochester. He is active and held positions of responsibility in ASM, AMP, CLSI, IDSA, ASCP, AACC, and CAP. He has authored numerous book chapters, practice guidelines, and more than 100 peer-reviewed publications in the areas of clinical microbiology and molecular diagnostics. He has served on the scientific advisory boards and provided consulting services to many early stage and established diagnostic companies and commercial reference laboratories. In addition, he has experience with FDA clinical trial work and served as a member and consultant to the CDRH FDA Microbiology Devices Panel and on several NIH and CDC advisory panels.

Kara O'Brien

Novartis

Senior Director, Precision Medicine Strategy

Kara is currently Sr. Director Precision Medicine at Novartis Oncology where she is supporting precision medicine needs across the solid tumor portfolio. Prior to joining Novartis, Kara was Executive Director, Global Commercial Diagnostics at Bayer where she was responsible for the development of the overall commercial diagnostics strategy including collaboration with diagnostic partners, development of marketing initiatives and supporting global markets with diagnostic launch readiness for the launch of VITRAKVI the first tumor agnostic therapy approved in the EU. Prior to joining Bayer Kara spent 12 years at Roche Diagnostic in a variety of Global & US Marketing positions & US Sales. She has deep experience in oncology diagnostics and companion diagnostics with experience launching multiple companion diagnostic products both within pharma and dia organizations. Kara’s early career started in dermatopathology research.

Kaylyn M Oshaben

AltraTech Ltd

Synthetic Biology Specialist

Kaylyn Oshaben received her Ph.D. in chemistry from the University of Pittsburgh studying peptide-based biomaterials. She completed a postdoctoral fellowship in the NIDDK at the NIH where she worked on the development of microfluidic diagnostics utilizing peptide nucleic acids and gold nanoparticles. After collaborating on several projects with Altratech during her postdoc, she joined the team full time in 2019.

Shaun O’Neil

Lucid Diagnostics

Chief Commercial Officer

Shaun M. O’Neil has served as the Chief Commercial Officer for PAVmed Inc (Nasdaq: PAVM) and Lucid Diagnostics since 2018. As PAVmed and Lucid Dx’s Chief Commercial Officer he is responsible for the planning and execution of both sales and marketing activities for the U.S., Europe, South America, and Asia. His responsibilities include the development of PAVmed and Lucid Dx’s strategic partnerships, commercial payer strategy, distribution channels, creation of growth strategies and successful business solutions for branding and positioning of the product lines as well as organize, develop, and grow the sales organization. Shaun works closely with, surgeons, clinicians, laboratories, medical device manufacturers and distributors, technology business managers, as well as research and development partners around the globe. With a solid track record of sales and marketing leadership, and product and business development expertise in both startup and established companies, including a particularly strong track record in growing sales and increasing market share for innovative medical devices. Since 2011, Mr. O’Neil has held various sales and marketing leadership positions with AngioDynamics (Nasdaq: ANGO), a leading provider of innovative medical devices used by interventional radiologists, interventional cardiologists, surgeons, and other physicians for the minimally-invasive diagnosis and treatment of cancer and peripheral vascular disease. He was responsible for multiple product launches and was a perennial recipient of sales and performance awards. Prior to AngioDynamics, he served in various sales, marketing and engineering roles at aycan Medical Systems, a privately-held medical imaging company. Mr. O’Neil received a B.S. in Business Administration with a focus in management information systems from Alfred University and an M.B.A. from the Rochester Institute of Technology.

Nickolas Papadopoulos

Johns Hopkins University

Professor, Oncology & Pathology, Director of Translational Genetics

Dr. Nickolas Papadopoulos is a professor of oncology and pathology at the Johns Hopkins University School of Medicine. His research focuses on cancer biology, genetics and diagnostics. Dr. Papadopoulos is internationally known as a co-discoverer of the genetic basis of the predisposition to hereditary nonpolyposis colon cancer (HNPCC), one of the most common hereditary forms of cancer, earlier in his career. He was part of the interdisciplinary team that was first to sequence all of the protein coding genes, determine genetic alterations and construct expression profiles of four common tumor types. Later he was involved in the identification of genetic alterations that drive tumorigenesis in multiple tumor types. His noteworthy discoveries include the identification of novel mutations in chromatin remodeling genes in ovarian clear cell carcinomas and pancreatic neuroendocrine tumors. Dr. Papadopoulos received his BS from Aristotelion University of Thessaloniki in Greece. He earned his MS in biology at the University of Houston and his PhD in biomedical sciences at the University of Texas Health Science Center at Houston. He completed a Fogerty Fellowship at the National Institute on Aging and a postdoctoral fellowship in oncology at the Johns Hopkins University School of Medicine. Dr. Papadopoulos joined the Johns Hopkins faculty in 2005.

Abhijit A Patel

Yale University School of Medicine

Associate Professor

Abhi Patel’s research group at Yale University is working to develop and clinically validate novel cancer diagnostics-based on analysis of tumor-derived DNA fragments in blood. His lab has developed technologies that permit ultrasensitive detection of cancer-specific DNA signatures in blood, with the ultimate goal of enabling early cancer detection and prediction of treatment efficacy. He is an Associate Professor in the Department of Therapeutic Radiology at the Yale School of Medicine. He completed residency training in radiation oncology at Harvard University, medical internship at Memorial Sloan-Kettering Cancer Center, and obtained his MD and PhD degrees at Yale University. His scientific background is in the field of nucleic acid biochemistry, having performed his PhD and postdoctoral training with Drs. Joan Steitz and Jack Szostak. As a physician-scientist, he also maintains an active clinical radiation oncology practice.

Reena Philip

FDA CDER

Supervisory Biologist

No bio available.

Daryl Pritchard

Personalized Medicine Coalition

Senior Vice President

Daryl Pritchard, PhD, is the Senior Vice President of Science Policy at the Personalized Medicine Coalition (PMC), where he leads PMC’s efforts to increase awareness and understanding of personalized medicine; identify and address barriers to the adoption of personalized medicine into the health care system; and develop and promote appropriate clinical, health care infrastructure, regulatory, and payment policies. Before coming to PMC, Dr. Pritchard served as the Director of Policy Research at the National Pharmaceutical Council (NPC). Prior to joining NPC, he served as the Director of Research Programs Advocacy and Personalized Medicine at the Biotechnology Industry Organization (BIO). Dr. Pritchard received his PhD and master’s degree in genetics from the George Washington University, and completed a post-doctoral research fellowship at the Children’s National Medical Center. He was awarded the first American Society of Human Genetics (ASHG)/National Human Genome Research Institute (NHGRI) Fellowship in Genetics and Public Policy, where he worked as a health legislative assistant in the House of Representatives.

Bruce Quinn

Bruce Quinn Associates LLC

Principal

Bruce Quinn, MD, PhD, is a professional strategy consultant helping innovative companies achieve their goals under U.S. federal health policies. His consulting practice, with offices in Los Angeles and San Francisco, works with leading genomic, medical technology, and biopharma companies. Originally trained as a neuropathologist, earlier in his career he held tenure-track faculty positions at NYU Medical School and the Northwestern University School of Medicine. As a physician executive, he has held positions with Accenture’s healthcare strategies practice, the Medicare program, and with health policy groups in two law and lobbying firms. Recent publications have included articles on defining clinical utility for diagnostic tests and a review of the emerging digital genomics industry. In addition, his blog, www.DiscoveriesInHealthPolicy.com, covers innovative health care policy developments and receives over 100,000 hits per year. The website for Dr. Quinn’s firm is www.brucequinn.com.

Kenneth H Rand

University of Florida

Professor

My research interests have focused on the evaluation of new technologies in the clinical microbiology and virology laboratories, specifically rapid multiplex respiratory, blood, gastrointestinal and positive blood culture pathogen detection and identification, as well as the use of mass spectroscopy for the identification of common bacteria. My clinical training is in Internal Medicine with subspecialty certification in Infectious Diseases (both at Stanford University Hospital), an area I still actively practice. With American Board of Pathology - Special Certification in Medical Microbiology and over 30 years as Medical Director of the UFHealth Shands Hospital Clinical Microbiology and Virology laboratories, I have experienced multiple aspects of the evolving field and have a great deal of experience in the evaluation and implementation of new, rapid technologies. Our research has shown over and again the improvement in real world patient outcomes such as reduced hospital length of stay, when rapid methodologies are implemented in the laboratory.

Asaf Rotem

Dana-Farber Cancer Institute

Associate Director

Dr. Rotem is the Associate Director of the Center for Cancer Genomics. Dr. Rotem was the head of the Innovation Laboratory at the Center for Cancer Precision Medicine at Dana-Farber Cancer Institute. Under his leadership, the laboratory focused on innovative technologies aiming to study genomics, resistance, and vulnerability of tumors derived from individual patients. The research conducted there helped develop the single-cell RNA sequencing approach and technology that allowed the testing of several anti-cancer drugs on patient-derived tumor cells to match the best drug to an individual. Practicing these technologies, Dr. Rotem found genes that contribute to cancer, and drugs that might target cancer cells in a specific manner. Dr. Rotem is a consultant to companies and serves on a scientific advisory board. He completed his graduate studies at the Weizmann Institute of Science and the Technion in Israel and was a Postdoctoral Fellow and an Instructor at Harvard Medical School.

Wendy S Rubinstein

FDA CDRH

Director

Wendy Rubinstein, MD, PhD, FACP, FACMG is Director of Personalized Medicine at FDA in the Center for Devices and Radiological Health. Dr. Rubinstein is a board-certified clinical geneticist and clinical molecular geneticist who directed academic cancer genetics programs for 15 years at three NCI-designated Comprehensive Cancer Centers. From 2011 to 2017 she was a Senior Scientist at the National Institutes of Health where she launched and directed the NIH Genetic Testing Registry (GTR) and ultimately served as Chief of Medical Genetics and Human Variation at the National Center for Biotechnology Information, hosting flagship information resources including ClinVar, dbSNP, dbGaP, GeneReviews, and GTR. Subsequently, Dr. Rubinstein was Deputy Medical Director of CancerLinQ, the American Society of Clinical Oncology’s real-world data platform aimed at improving the quality of care for patients with cancer. An NIH Medical Scientist Training Program scholarship awardee, Dr. Rubinstein earned her MD and PhD degrees at the Mount Sinai School of Medicine. She has authored publications on gene discovery (SDHD), variant interpretation, pharmacogenomics, genetic risk modifiers, clinical practice guidelines, and health information technology.

Jelani Sanaa

US Department of Health & Human Services

Clinical Lab Scientist

Jelani Sanaa started in the clinical laboratory while serving in the Army as a Medical Laboratory Technician 20 years ago. She has worked in various areas of the clinical laboratory in both military and civilian facilities during her career. Recently she served as the Technical Supervisor for Clinical Microscopy at Walter Reed National Military Medical Center providing technical oversight for all areas of Hematology, Routine and Special Coagulation, Semen Analysis, Urinalysis, Bone Marrow processing and Flow Cytometry. Prior to CMS, Jelani was the Technical Supervisor for the Armed Services Blood Bank for the National Capital Region. She also served as the Interim Training Coordinator, Interim Quality Assurance Coordinator and the Interim Director and oversaw the largest military blood-donor operation, which included a manufacturing laboratory, two apheresis collection sites, and a mobile operations team that travelled throughout Maryland, Virginia, Washington DC, Pennsylvania, and Delaware. She supervised approximately 40 personnel comprised of military and civilian staff of various disciplines. Jelani holds an Undergraduate degree in Clinical Laboratory Science from the University of Cincinnati and a Master’s Degree in Health Science Regulatory Affairs from George Washington University. In addition to being ASCP certified as a Medical Laboratory Scientist (MLS), she holds certifications as both a Specialist in Blood Banking (SBB) and Specialist in Hematology (SH). At CMS she is assigned to the CLIA program in the Center for Clinical Standards and Quality where she is a part of the validation, outreach, PT referral, enforcement, lab registry, EUA (emergency use authorization), hematology and blood bank teams. She is also responsible for maintaining the division’s historical records and files and most recently began serving on the AABB (formerly American Association of Blood Banks) Standards Committee for Cellular Therapy.

Danielle Scelfo

Hologic Inc

Senior Director, Health Policy & Reimbursement

No bio available.

Robert Schlaberg, MD, PhD, MPH

IDbyDNA

Co-Founder, Chief Medical Officer

Robert Schlaberg is a co-founder and Chief Medical Officer of IDbyDNA, as well as Assistant Professor of Pathology at the University of Utah School of Medicine. Robert received Medical degrees from the Julius-Maximilians-University in Wuerzburg, Germany and a Masters of Public Health from Columbia University where he also trained in clinical pathology and served as Chief Clinical Pathology Resident. Robert is a board-certified Clinical Pathologist and Medical Microbiologist.

Robert Schlaberg, MD, PhD, MPH

IDbyDNA

Co-Founder, Chief Medical Officer

Robert Schlaberg is a co-founder and Chief Medical Officer of IDbyDNA, as well as Assistant Professor of Pathology at the University of Utah School of Medicine. Robert received Medical degrees from the Julius-Maximilians-University in Wuerzburg, Germany and a Masters of Public Health from Columbia University where he also trained in clinical pathology and served as Chief Clinical Pathology Resident. Robert is a board-certified Clinical Pathologist and Medical Microbiologist.

Julie Schneider

FDA/OCE

Associate Director for Research Strategy and Partnerships, Oncology Center of Excellence, FDA

Julie Schneider, Ph.D. is Associate Director for Research Strategy and Partnerships at the FDA Oncology Center of Excellence (OCE). In this role, she oversees the OCE Scientific Collaborative, which supports applied research activities addressing topics identified during regulatory review of oncology products. She previously ran the HHS Entrepreneurs-in-Residence Program within the HHS IDEA Lab and worked in several roles at the National Cancer Institute (NCI) focused on developing new research funding opportunities. Julie initially joined the NCI as an AAAS Science and Technology Policy Fellow and obtained her doctoral degree in genetics from the University of Oxford and her bachelor’s degree in biology from Yale.

Charudutt Shah

BioMérieux

Director of Marketing

Charudutt Shah is the Director of Marketing for BioFire products at bioMérieux S.A. based in corporate headquarters in Lyon, France since May 2016. Charudutt is responsible for commercial marketing in Europe, Middle East and Africa (EMEA). In his role, he oversees the launch of new syndromic infectious disease panels and instruments that rapidly identify pathogens. A major focus of his efforts is in developing go to market strategies, driving clinician awareness, market access and bringing innovative testing solutions to various healthcare ecosystems to improve patient care. He has spent over a decade in commercial roles within the Diagnostic Industry developing marketing strategies, creating distribution partnerships, addressing customer requirements, leading product innovation and introducing new products to the market. Charudutt is a graduate of the University of Toronto and holds both a Bachelor’s of Applied Science and Engineering degree as well as a Master’s of Biotechnology and Management degree. He is an active member of the Association for Molecular Pathology (AMP) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID).

Jennifer Shen

ORIC Pharmaceuticals

Director

Jennifer is currently the Director of Regulatory Affairs at ORIC, a clinical-stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. At ORIC, Jennifer leads global regulatory strategies and submissions for ORIC’s development programs. Prior to ORIC, Jennifer was at Ignyta where she led the companion diagnostic regulatory activities and supported entrectinib’s filing. After the Ignyta acquisition by Roche, Jennifer continued to be responsible for entrectinib pre-NDA meetings, USPI labeling, and CDx partner activities, as part of the joint Ignyta-Roche filing team. Jennifer joined Ignyta from FDA, first at CDER for 2 years then at CDRH for another 4 years. While at CDER, Jennifer was a reviewer for oncology programs with direct experience in the areas of CMC, pharm/tox and clinical pharmacology. At CDRH, Jennifer was the lead reviewer for numerous in vitro diagnostic devices in oncology, including multiple companion diagnostic PMA approvals. Jennifer received her PhD in molecular biology and endocrinology from the University of California, San Francisco and completed a postdoctoral fellowship at the National Cancer Institute in NIH.

Patricia J Simner

Johns Hopkins Univ

Assoc Prof

Trish Simner, Ph.D., D(ABMM), is an Associate Professor of Pathology at The Johns Hopkins University and the Director of the Medical Bacteriology and Infectious Disease Sequencing Laboratories at The Johns Hopkins Medical Institutions. Her research focuses on understanding the epidemiology and molecular mechanisms of resistance of Gram-negative bacteria, in particular those harboring ß-lactamase enzymes. She is also interested in novel diagnostic tools for infectious diseases and is actively involved in validating metagenomic next-generation sequencing as a diagnostic tool.

Daniel Simon

Guardant Health

Senior Vice President

Daniel Simon is responsible for leading Guardant’s partnerships with biopharmaceutical companies. Daniel brings more than fifteen years of experience in the life sciences industry across business development, strategy, and operations. Previously, Daniel served in roles at MyoKardia, Onyx Pharmaceuticals, McKinsey & Company, and Genentech. He holds an MBA from the University of Pennsylvania's Wharton School and an MA Hons. in Natural Sciences from the University of Cambridge.

Christopher Smith

University of Cambridge

Senior Research Associate

I am currently working as senior research associate in Dr. Nitzan Rosenfeld's lab at the CRUK Cambridge Institute. We are studying the use of circulating cell-free DNA (cfDNA) as a potential diagnostic, predictive and prognostic biomarker for various cancers. Various studies (including a series of hallmark studies released by Nitzan Rosenfeld and colleagues) have shown the potential for this material for tracking disease (response to therapy, evolution of clonal populations, etc). I am currently involved in efforts to utilise current technologies with cfDNA - particularly the application of whole exome- and genome-sequencing to patient samples. The hope is that these new technologies might complement the techniques already optimised and used in cfDNA analysis (e.g. Tam-Seq), providing a broad and unbiased view of the genomic landscape of a tumour, overcoming confounding biases of clonal heterogeneity, and allowing longitudinal profiling for treatment response studies. In particular I am studying the levels and potential clinical utility of ctDNA in renal cancers.

John J Sninsky

Translational Medicine and Science

Independent Consultant

Following a doctorate in Biology and postdoctoral training in Genetics, John had an academic faculty position before garnering experience in small and enterprise CLIA laboratories and IVD companies. Teams he worked with were responsible for the transition of innovative technologies and biomarker development from research-grade to clinical-grade diagnostic tests that were reimbursed and widely adopted. John advises commercial diagnostic development in Precision Medicine and lectures in diagnostic regulatory science.

Lydia L. Sohn

University of California, Berkeley

Chancellor’s Professor

Lydia L. Sohn received her AB (Chemistry and Physics, 1988), MS (Physics, 1990), and PhD (Physics, 1992) from Harvard University. She was an NSF/NATO postdoc at Delft University of Technology and a postdoc at AT&T Bell Laboratories (1993-1995). Sohn was an Assistant Professor of Physics at Princeton University prior to joining the Mechanical Engineering Dept. at UC Berkeley in 2003. In addition to being Professor of Mechanical Engineering, Sohn is a core-member of the UC San Francisco-UC Berkeley Graduate Program in Bioengineering. Her work focuses on developing quantitative techniques to probe single cells. Sohn has received numerous awards including the NSF CAREER, Army of Research Young Investigator Award, DuPont Young Professor Award, and a Bakar Fellowship. In 2010, Sohn received the prestigious W. M. Keck Foundation Medical Research award to develop a label-free method for screening and sorting rare cells. In 2014, Sohn’s developed label-free method—Node-Pore Sensing (NPS)—was named one of five “Revolutionary Platform Technologies for Advancing Life Sciences Research” in a competition sponsored by 6 major foundations (W. M. Keck Foundation, Gordon & Betty Moore Foundation, Kavli Foundation, Burroughs-Wellcome Fund, John Templeton Foundation, and Research Corporation) and was honored at the White House Office of Science and Technology Policy for this award. Currently, Sohn serves on the Executive Committee of the UCSF-UCB Graduate Program in Bioengineering and is the Chair of UC Berkeley’s Institutional Biosafety Committee. She continues to serve on the Scientific Advisory Board of the Boulder School for Condensed Matter & Materials Physics. Sohn is a Fellow of the American Institute for Medical and Biological Engineering and is a Chancellor’s Professor at UC Berkeley.

Lynn Sorbara

National Cancer Institute (NCI), NIH

Program Director

Dr. Lynn Sorbara earned her PhD from Albert Einstein College of Medicine in 1986. Her thesis research was in the areas of the mechanism of action of the drug, Taxol, and of multidrug resistance. After postdoctoral fellowships at the Rockefeller University and the Mount Sinai College of Medicine in Manhattan, she came to the NIH as a Senior Staff Fellow in the Diabetes Branch of NIDDK. From 1996 to 2007, she was the Technical Supervisor and Clinical Staff Scientist for the Molecular Diagnostics Unit of the Laboratory of Pathology at NCI. In this role, she was responsible for the development, validation, and quality assurance for all of the diagnostic tests performed in this College of American Pathologists and CLIA certified laboratory. Since 2007, she has been a Program Director for the Cancer Biomarkers Research Group in the Division of Cancer Prevention of NCI. Dr. Sorbara oversees and manages cooperative agreement grants for the Biomarker Reference Laboratories and is the co-coordinator of the Lung Collaborative Group for the Early Detection Research Network. She is the program leader for the NCI Consortium for Liquid Biopsy in Early Cancer Assessment, as well as a Program Representative for the Innovative Molecular Technologies Analysis and the SBIR Programs. She has a strong interest in developing Standard Operating Procedures for biomarker discovery/validation, and diagnostic assay development. Her grant portfolio includes biomarkers for early detection of hematopoietic malignancies, lung and upper aerodigestive cancers, new technologies and diagnostics tools for cancer research.

Rachel R Spurbeck

Battelle Memorial Institute

Principal Research Scientist

Dr. Spurbeck is an experienced molecular microbiologist and geneticist, with over 15 years of relevant experience, including development of a co-culture system for studying interactions between an incoming pathogen, the host, and components of the microbiota; project design and technical direction of epigenetic signature analysis, molecular diagnostics, transcriptome, viromics, and bacterial metagenomics projects. At Battelle, she has worked as the Principal Investigator for various programs involving epigenetic signature identification, metagenomics, diagnostic assay development, or application feasibility assessments for state-of-the-art long read sequencing devices. She has hands on experience developing and executing methods and workflows for leading commercialized DNA sequencing platforms. Developed methods have been deployed for detection of genetic, epigenetic, and expression profiling of bacterial and human genomes, transcriptomics, and viral and bacterial metagenomics. Dr. Spurbeck has published over 18 peer reviewed manuscripts, book chapters and review articles. She currently is working on developing methods to utilize epigenetic marks for diagnostics.

Ester Stein

Abbott Labs

Dir Corp Reimbursement

Ester Stein is Director of Corporate Reimbursement and reports into Abbott’s Government Affairs’ office which is based in Washington DC. Ester has been employed at Abbott since 2003. Ester is highly knowledgeable in diagnostic reimbursement strategies for traditional diagnostics, molecular and point of care. In her capacity, she has spearheaded efforts to ensure that there is appropriate coverage, coding and payment by public and private insurers for Abbott products in the United States. Ester has also been involved in healthcare economics in the area of oncology, specifically breast and bladder cancer. She Chaired AdvaMed’s Payment Work Group and serves on the AMP Economic Affairs Committee. Ester earned her M.B.A. from Loyola University of Chicago.

Mark D Stewart

Friends of Cancer Research

VP Science Policy

Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, DC that drives collaboration and has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. Mark leads the development and implementation of the organization’s research and policy agenda as well as conducts research to inform ongoing policy discussions. Mark establishes unique partnerships to help develop innovative, evidence-based policy proposals and consensus-driven solutions to address challenges and accelerate cancer drug development. He regularly participates in policy discussions and meetings throughout the year to help catalyze meaningful change for oncology healthcare. His research and policy interests focus on medical product development, clinical trial designs and data generation, and patient focused drug development.

Katie Streicher

MedImmune

Assoc Dir

No bio available.

Sharief Taraman

CHOC Childrens Hospital Orange County

Chief

Dr. Sharief Taraman, M.D. is dual board-certified in Neurology with special qualifications in Child Neurology from the American Board of Psychiatry and Neurology and Clinical Informatics from the American Board of Preventive Medicine. He is the Division Chief of Pediatric Neurology for the CHOC Children’s Specialists Pediatric Subspecialty Faculty and Associate Clinical Professor at UC Irvine School of Medicine. Dr. Taraman is the Chief Medical Officer of Cognoa, a pediatric behavioral health company that has received two FDA Breakthrough Device designations for its first two prescription digital devices designed to improve the standard of care for the early treatment of behavioral health conditions.

Matthew Tucker

Highmark Health

Director

No bio available.

Christine Vietz

Foundation Medicine Inc

Sr VP

Dr. Vietz is Senior Vice President, Head of Product Development, at Foundation Medicine, Inc. She currently has accountability for Assay Development, Companion Diagnostic Development Operations, Biometrics and Biomarker Development and Regulatory Affairs. She was previously head of Regulatory Affairs and Quality Assurance at Foundation Medicine, and lead PMA submissions for Foundation Medicine’s FoundationOne CDx and FoundationFocus CDxBRCA LOH assays. The FoundationFocus assay was the first FDA-approved NGS assay for companion diagnostic use, and FoundationOne CDx PMA received Breakthrough Device Designation and was the first NGS assay approved for all solid tumors. Dr. Vietz has over 18 years of industry experience in assay development and clinical diagnostics and has served in a variety of functional roles throughout her career.

David R. Walt

Harvard University

HHMI Professor; Hansjörg Wyss Professor of Biologically Inspired Engineering, Harvard Medical School; Professor of Pathology, Department of Pathology-Brigham and Women’s Hospital; Core Faculty

David R. Walt is the Hansjörg Wyss Professor of Bioinspired Engineering at Harvard Medical School and Professor of Pathology at Harvard Medical School and Brigham and Women’s Hospital, is a Core Faculty Member of the Wyss Institute at Harvard University and is a Howard Hughes Medical Institute Professor. Previously, he was University Professor at Tufts University. His laboratory pioneered the development of microwell arrays, which revolutionized the field of genetic analysis. Dr. Walt’s laboratory also introduced the idea of digital protein detection by developing a high throughput technology for performing single molecule analysis. Dr. Walt is the Scientific Founder of Illumina Inc., Quanterix Corp., and has co-founded several other life sciences startups including Ultivue, Inc., Arbor Biotechnologies, Sherlock Biosciences, and Vizgen, Inc. He has received numerous national and international awards and honors for his fundamental and applied work in the field of optical microwell arrays and single molecules. He is a member of the National Academy of Engineering, the National Academy of Medicine, a Fellow of the American Academy of Arts and Sciences, a Fellow of the American Institute for Medical and Biological Engineering, a Fellow of the National Academy of Inventors, and is inducted in the U.S. National Inventors Hall of Fame.

Nils Walter

University of Michigan

Francis S. Collins Collegiate Professor of Chemistry, Biophysics & Biological Chemistry; Founding Director, Single Molecule Analysis in Real-Time (SMART) Center; Founding Co-Director of the Center for RNA Biomedicine

Nils G. Walter, Dr. Ing., is the Francis S. Collins Collegiate Professor of Chemistry, Biophysics, and Biological Chemistry at the University of Michigan, Ann Arbor. Research in the Nils Walter Lab focuses on non-coding RNA through the lens of single molecule techniques. He is the Founding Director of the Single Molecule Analysis in real-Time (SMART) Center at Michigan. In addition, Walter is the Founding Co-Director for the University of Michigan Center for RNA Biomedicine whose mission is to enrich the university’s intellectual and training environment around RNA Biomedicine. He is currently the Co-Director of the Microfluidics in Biomedical Sciences Training Program and an Associate Director for the Michigan Post-baccalaureate Research Education Program (PREP).

Roland B Walter

Fred Hutchinson Cancer Research Center

Associate Professor

My research is focused on acute myeloid leukemia (AML). I am particularly interested in improving antibody-based therapies for this hematological malignancy, both by optimizing the efficacy and safety profile of existing therapeutics as well as through the preclinical and early clinical development of novel antigen-directed immunotherapies. As recent examples of latter efforts, my lab has contributed to candidate drug identification and preclinical development of 5 novel agents that have subsequently advanced to clinical testing (SGN-CD33A, SGN-CD123A, AMG 330, AMV-564, and APVO436). A major area of focus of our research lies in the delineation of the mechanisms of action and resistance that are relevant for antibody-based AML therapeutics and the rational development of combination therapies that can overcome drug resistance. Many of my studies conducted over the last 15+ years have aimed to optimize use of CD33-targeted and, more recently, CD123-targeted therapies. In clinical studies, I conduct trials testing novel treatments and innovative care approaches for AML patients. Furthermore, in collaborative research, I use large patient datasets to develop and improve diagnostic and prognostic tools for people with AML, with studies centered around measurable (‘minimal’) residual disease being a major work focus.

Ping Wang

Univ of Pennsylvania

Assoc Prof & Dir Clinical Chemistry

Ping Wang, PhD, D(ABCC), FAACC is Professor of Pathology and Laboratory Medicine at University of Pennsylvania, and Chief of Clinical Chemistry and Director of Core Laboratory at Hospital of University of Pennsylvania. Dr. Wang oversees the clinical operation of a 10-million tests/year core lab and 3-million tests/year point-of-care testing. Dr. Wang conducts research in Precision Medicine and novel diagnostics development, including point-of-care testing technologies and devices. She is Principle Investigator on many NIH and industry funded projects, holds many patents and publishes and speaks extensively on these topics.

John F Warren

Gettysburg Healthcare Consultants

Owner

Warren has spent nearly 30 years in the healthcare sector with 22 years at the Centers for Medicare & Medicaid Services (CMS) and more than 7 years as a consultant to clients in the healthcare sector. While at CMS, Warren directed the staff responsible for establishing Medicare payment policy for physician services and non-physician services, including physician and non-physician office services, clinical diagnostic laboratory, Part B drugs, RHC/FQHC andambulance services. As an industry consultant, Warren assisted clients in the clinical diagnostic laboratory, pharmaceutical, and physician specialty spaces to navigate the complex legal and regulatory environment surrounding the Medicare and Medicaid programs. He often served as liaison between CMS staff and clients, facilitating discussions about policies and payment rates, securing favorable outcomes for his clients.

Drew Watson

CellMax Life

SVP, Biostattistics and Clinical Development

Drew is an expert advisor in the application of biostatistics, machine learning, and computational biology approaches to therapeutic and molecular diagnostic clinical product development. Drew has founded multiple software and molecular diagnostic companies and served as a senior executive and advisor to companies including Genomic Health, Adaptive Biotechnologies, Incyte Genomics, Cellworks, Invitae, Syntex, Chiron, CellMax Life, Bio-Ai Health, Hewlett-Packard, Dow Chemical, Novation Biosciences, and Nephrosant. Drew is recognized for his contributions to the development of Oncotype DX – a widely adopted molecular diagnostic test for individual breast cancer recurrence risk and chemotherapy benefit assessment. He has published extensively in the area of biostatistics, oncology and genomics, and is a holder of multiple key US patents in genomics, algorithm development, and personalized medicine. Drew holds a BS in Statistics from California State University East Bay, an MS in Computational Statistics from Stanford University, an MBA in Strategic Management from Golden State University, and a PhD in Biostatistics from University of California Los Angeles (UCLA).

Andrea L Webber

Merck & Co Inc

Principal Scientist

Andrea Webber received her PhD in molecular biology from Princeton University and went on to a postdoctoral fellowship at the University of Pennsylvania School of Medicine before joining Merck & Co., Inc. Over the course of her pharmaceutical career, she has worked in biomarker discovery and development in support of both Discovery and Clinical Research. Currently, she is Assistant Head of Clinical Biomarkers in Merck’s Translational Oncology department, providing a key link between the Translational Sciences and Merck’s Clinical Development teams. The Translational Oncology Biomarkers Team supports early- and late-stage development and leverages multiple assays and platforms to inform on Keytruda mono and combination therapies. Specifically, Dr Webber leads the biomarker strategy for multiple product development teams including Melanoma, Head and Neck, and Liver cancers.

Joe Wiencek

University of Virginia School of Medicine

Medical Director

Dr. Wiencek is a board-certified clinical chemist at the University of Virginia School of Medicine where he serves as the Medical Director of Point of Care Testing, Associate Director of Clinical Chemistry and Co-Director of the UVA ComACC accredited clinical chemistry fellowship program. Dr. Wiencek received his PhD in clinical-bioanalytical chemistry at Cleveland State University – the only doctoral program in the United States with a core focus on clinical chemistry. He also completed clinical chemistry and laboratory medicine training through an internship in the Clinical Biochemistry Laboratory at the Cleveland Clinic’s Pathology and Laboratory Medicine Institute and a two-year ComACC accredited clinical chemistry fellowship at Vanderbilt University. His research interests are in preanalytical variation in laboratory testing, diagnostic stewardship and medical education. And, lastly, he has been recognized through numerous awards for his excellence in teaching clinical chemistry and laboratory medicine.

Huntington F Willard

Genome Medical, Inc.

CSO & Senior Vice President

Hunt has deep experience in genetics and genomics leadership in academia, health care and industry, building teams that span research, education and clinical care. Prior to joining Genome Medical, Dr. Willard was most recently Director and Principal of Geisinger National Precision Health in Maryland and Pennsylvania, with a focus on design and implementation of large-scale clinical and research programs in genomics and population health. Dr. Willard is the author or co-author of more than 350 scientific publications and is co-editor of the Genomic and Precision Medicine book series and a longtime co-author of the textbook Genetics in Medicine. A former President of the American Society of Human Genetics, he is an elected member of the National Academy of Medicine and the National Academy of Sciences.

David TW Wong

UCLA School of Dentistry

Associate Dean of Research

David T.W. Wong DMD, DMSc is Felix & Mildred Yip Distinguished Professor, Associate Dean of Research and Director of the Oral/Head and Neck Oncology Research Center at UCLA. He is a fellow of the American Association for the Advancement of Sciences (AAAS), past member of the ADA Council of Scientific Affairs and the past president of American Association of Dental Research (AADR). He is current chair of the NCI Liquid Biopsy Consortium

Lawrence J Worden

IVD Logix LLC

Principal

Larry has over 40 years of experience in the diagnostics industry. He is the Principal and Founder of IVD Logix and also co-founded Market Diagnostics International, where he developed the IVD Insights and IVD Labfile syndicated databases on in vitro diagnostic testing. Prior to that, he was a senior consultant and co-founder at CaseBauer & Associates, an international business development and research firm exclusively focused on in vitro diagnostics. He has held senior legislative/regulatory affairs and market research positions with Becton Dickinson and Company, AdvaMed, and IMS Health (now IQVia). He is the most recent Past President of the Diagnostics Marketing Association and currently serves on the editorial advisory board of Clinical Omics and the programming advisory board of the Cambridge Healthtech Institute.

Yun (Sunny) Wu

University at Buffalo, The State University of New York

Associate Professor

Dr. Yun Wu is an Associate Professor in the Department of Biomedical Engineering at the State University of New York at Buffalo. She received her Ph.D. from the Department of Chemical and Biomolecular Engineering at the Ohio State University in 2009. After completion of her degree, she received her postdoc training in the NSF Nanoscale Science and Engineering Center at the Ohio State University. Dr. Wu’s research interest focuses on the development of multifunctional nanoparticles based nanomedicine and in vitro diagnostic assays for cancer imaging, therapy and early detection. She has published >50 peer-reviewed papers. Her research has been supported by National Cancer Institute, National Institute of Biomedical Imaging and Bioengineering, National Science Foundation, Food and Drug Administration, American Lung Association and Cancer Research Institute.

Paul Yager

University of Washington

Professor

Paul Yager, PhD, is a professor in the Department of Bioengineering at the University of Washington. After 7 years at the Naval Research Laboratory, he joined the University of Washington in 1987, and served as department chair from 2007 to 2013. Initially working on self-organizing lipid microstructure and optically-based biomedical sensors, since 1992 his lab has explored the fundamentals of microfluidics, and applications thereof in analysis of biological fluids for point-of-care medical diagnostics in the developed and developing worlds. Since 2005, Yager has worked toward rapid low-cost sensitive pathogen identification with support from the Bill & Melinda Gates Foundation, NIH, NSF, DARPA and DTRA. Today, his lab focuses on developing two-dimensional porous (paper) networks for ultra-low-cost point-of-care pathogen identification, including home NAAT tests for HIV virus, SARS-CoV-2, and other respiratory pathogens. Yager is a Fellow of AIMBE and the Washington State Academy of Sciences. Specifics are at http://faculty.washington.edu/yagerp/.

Jiahui Yang

Sino Biological Inc

R&D Director

Dr. Jiahui Yang received her PhD from Tufts University. She joined Sino Biological Inc. since 2010 and currently is the Director of R&D department. She has 10-year recombinant protein and antibody development and optimization experience. She and her team have successfully produced >3000 recombinant proteins and >5000 antibodies.

Renee Yura

Pfizer Inc

Dir & Lead

Renee Yura is currently a Director of Diagnostics at Pfizer where she leads implementation of diagnostic strategy in internal medicine, inflammation and immunity, and rare disease. She has more than ten years of experience in companion and complementary diagnostic assay development. Prior to joining Pfizer, Renee was at Celgene Precision Medicine where she established and oversaw both an internal lab as well as external diagnostic development activities to support multiple disease areas including hematological malignancies, inflammatory disease programs, and solid tumor indications. Prior to Celgene, she developed and executed companion diagnostic and translational biomarker strategies at Novartis, supporting several oncology compounds in breast and lung cancer. Prior to Novartis, Renee focused on infectious disease targets, leading immunoassay and molecular diagnostic assay development teams at Ortho Clinical and Janssen Diagnostics within the Johnson & Johnson family of companies. Renee received her PhD in Cell and Molecular Biology from the Pennsylvania State University College of Medicine in Hershey Pennsylvania.

Nancy Zhang

Bristol Myers Squibb

Assoc Dir Pharmacodiagnostics

Nancy Zhang, Associate Director, Pharmacodiagnostics in the Bristol-Myers Squibb Translational Medicine organization. Nancy joined BMS in September 2018, supports evaluation, strategy, development, and execution of companion/complementary biomarker programs across multiple therapeutic areas. She leads matrix teams of gene expression profiling and ctDNA for MRD and disease monitoring in solid tumors. Prior to joining BMS, Nancy was companion/complimentary diagnostic lead at Amgen Translational Medicine organization. Prior to Amgen Nancy was the development team lead at Dako, an Agilent Technologies Company, where she was the main contributor to the patent for Combined Positive Score (CPS) for evaluation of PD-L1 in solid tumors.