2024年の講演者
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Edward Abrahams, PhD, President, Personalized Medicine Coalition
Edward Abrahams, Ph.D., is the President of PMC. Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services and products for the benefit of patients and the health system. It has grown from its original 18 founding members in 2004 to more than 200 today. Previously, Dr. Abrahams was the Executive Director of the Pennsylvania Biotechnology Association, where he spearheaded the successful effort that led to the Commonwealth of Pennsylvania’s investment of $200 million to commercialize biotechnology in the state. Earlier, he had been Assistant Vice President for Federal Relations at the University of Pennsylvania and held a senior administrative position at Brown University. Dr. Abrahams worked for seven years for the U.S. Congress, including as a legislative assistant to Senator Lloyd Bentsen, as an economist for the Joint Economic Committee under the chairmanship of Representative Lee Hamilton, and as a AAAS Congressional Fellow for Representative Edward J. Markey. The author of numerous essays, Dr. Abrahams serves on the editorial board of Personalized Medicine and has also taught history and public policy at Brown University and the University of Pennsylvania.
Alexey Aleshin, MD, General Manager, Oncology and Early Cancer Detection; CMO, Natera, Inc.
Dr. Alexey Aleshin has led the oncology clinical development efforts at Natera, Inc., since 2018. Prior to this, he worked on the various novel ctDNA technologies while at Stanford University. He remains a clinical adjunct faculty in the division of Hematology at Stanford, where his work focuses on novel diagnostics assays for treatment decision support in hematologic malignancies. He received a BA in Statistics from UC Berkeley and his MD/MBA degrees at UCLA. He completed his clinical training in internal medicine and hematology/oncology at Stanford University.
Michael J. Alkire, President and CEO, Premier, Inc.
Michael J. Alkire is the President and CEO of Premier. As the leader of Premier, Alkire leads the continued integration of Premier’s clinical, financial, supply chain and operational performance improvement offerings helping member hospitals and health systems provide higher quality care at a better cost. He oversees Premier’s quality, safety, labor and supply chain technology apps and data-driven collaboratives allowing alliance members to make decisions based on a combination of healthcare information. These performance improvement offerings access Premier’s comparative database, one of the nation’s largest outcomes databases. Alkire also led Premier’s efforts to address public health and safety issues from the nationwide drug shortage problem, testifying before the U.S. House of Representatives regarding Premier research on shortages and gray market price gouging. This work contributed to the president and Congress taking action to investigate and correct the problem, resulting in two pieces of bipartisan legislation. Prior to serving as President and CEO, Alkire was president of Premier Purchasing Partners, which offers group purchasing, supply chain and resource utilization services to hospitals and health systems. Premier remains among the top group purchasing organizations in the industry as the value of supplies purchased through its contracts has increased to more than $56 billion. Upon joining Premier in late 2003, Alkire worked closely with the Purchasing Partners team to develop and implement a three-year transformation plan designed to dramatically increase returns to the alliance’s shareholders while building stronger relationships with members and suppliers. Alkire is a past board member of GHX and the Healthcare Supply Chain Association. Most recently, he was recognized as one of the 100 Most Influential People in Healthcare in 2021 and 2022 by Modern Healthcare. In 2018, he was named one of the Top 25 COOs in Healthcare. In 2015, Alkire won the Gold Stevie Award for Executive of the Year and in 2014 he was recognized as a Gold Award Winner for COO of the Year by the Golden Bridge Awards. He has more than 20 years of experience in running business operations and business development organizations at Deloitte & Touche and Cap Gemini Ernst & Young. Before joining Premier, he served in a number of leadership roles at Cap Gemini, including North American responsibilities for supply chain and high-tech manufacturing. Alkire graduated magna cum laude with a Bachelor of Science from Indiana State University and a MBA from Indiana University.
Jim Almas, MD, Vice President and National Medical Director, Clinical Effectiveness, LabCorp
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).
Ashley Arthur, Vice President, Head of Market Access, GeneDx
Ashley Arthur is the Head of Market Access at GeneDX, leading a team dedicated to increasing the number of patients who can access a genetic diagnosis via testing covered by their health insurance. Ashley and her team partner closely with commercial payors, Medicaid agencies, state legislators, professional societies, patient advocacy groups, and healthcare providers to challenge the status quo in genomics and elevate the standard of care. With 15 years of experience in healthcare, Ashley previously held sales and market access positions at companies including AstraZeneca, Counsyl (now Myriad Women's Health), Invitae, and Illumina. Her unique background brings an understanding of the implementation challenges those who champion personalized medicine face. Perhaps most importantly, Ashley is a rare disease sibling with a deeply personal drive to develop solutions to make the rare disease diagnostic odyssey a thing of the past.
Mara G. Aspinall, Partner, Illumina Ventures; Professor of Practice, Arizona State University; Editor, Sensitive & Specific: The Testing Newsletter
Mara G. Aspinall is a healthcare industry leader and pioneer committed to active civic involvement. She is Managing Director of BlueStone Venture Partners, a venture capital firm investing in diagnostics, medical devices and digital health companies. Aspinall also heads Health Catalysts Group, publishing the popular Sensitive & Specific: The Testing Newsletter and the annual Health Catalysts Diagnostics Year in Review. She is the creator and chief curator of TestingCommons.com - the largest international database of COVID tests on the market and in development. Aspinall is an advisor to The Rockefeller Foundation on COVID diagnostics. She is co-author of The Rockefeller Foundation’s national reports on COVID and heads the implementation of the K-12 National Testing Action Plan. Aspinall is passionate about education on diagnostics, genomics, and personalized medicine. To that end, she co-founded the School of Biomedical Diagnostics at Arizona State University, the first school dedicated to Diagnostics as an independent discipline. Aspinall served as President and CEO of Ventana Medical Systems, now Roche Tissue Diagnostics. Previously, she was President of Genzyme Genetics and Genzyme Pharmaceuticals. Aspinall sat on the U.S. Health and Human Services Secretary’s Advisory Council on Genetics, Health & Society (SACGHS) in the Obama and Bush administrations. Aspinall is also certified in Cybersecurity Oversight from Carnegie Mellon University. Mara was named Arizona Biosciences Leader of the Year by the Arizona Bio Association and one of “100 Most Inspiring People in Life Sciences” by PharmaVOICE and one of Women Inc.’s Most Influential Corporate Board Directors. Ms. Aspinall holds an MBA from Harvard Business School and a BA from Tufts University. She is a member of the Board of Directors of Abcam plc, Castle Biosciences, DA32, OraSure Technologies, and Blue Cross Blue Shield Arizona.
Michael Astion, MD, PhD, Regional Medical Director & Professor, Laboratory Medicine and Pathology, Seattle Children's Hospital and the University of Washington
Dr. Astion is a clinical pathologist who is the Regional Medical Director, Department of Laboratories at Seattle Children’s Hospital and Professor of Laboratory Medicine and Pathology at the University of Washington. His career is divided between clinical service, teaching, and research and development. He has authored more than 20 software titles, 50 peer-reviewed papers, and 75 editorials. He is working actively, through grants and intellectual property held by the University of Washington and Seattle Children’s, with the insurance industry in the United States to create utilization management rules for clinical laboratory testing. In addition, he is the Creator and one of the Founders of PLUGS, the Patient-Centered Laboratory Utilization Guidance Service, a unique service that helps hospital-based and commercial laboratories actively increase the value of lab testing through aligning with patients and the insurance industry. Dr. Astion is a frequent speaker at professional meetings, where he lectures on issues related to laboratory stewardship and management, laboratory economics and outreach, and medical errors.
Esther Babady, PhD, D(ABMM), FIDSA, FAAM, Chief, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center
Dr. Esther Babady, PhD, is a board-certified clinical microbiologist with expertise in the molecular laboratory diagnosis of infectious diseases. She received her doctoral degree in Biochemistry and Molecular Biology and completed a post-doctoral fellowship in Clinical Microbiology both at the Mayo Clinic in Rochester, MN. She is currently the chief of the Clinical Microbiology Service, an Attending Microbiologist, and Professor in the Department of Pathology and Laboratory Medicine and the Department of Medicine (Infectious Disease Service) at Memorial Sloan Kettering Cancer Center. At a national level, she serves on several professional societies’ committees including those of the American Society for Microbiology, the Pan-American Society for Clinical Virology, and the Association for Molecular Pathology. Her research focus is on the rapid diagnosis of infectious diseases using molecular-based methods and the application of molecular methods for the surveillance and prevention of healthcare acquired infections primarily in immunocompromised cancer patients. Dr. Babady has published extensively on diagnostic molecular microbiology tests. She is a Senior Editor for Microbiology Spectrum and also serves on the editorial boards of the Journal of Clinical Virology and the Journal of Molecular Diagnostics. She is an elected fellow of the Infectious Disease Society of America and the American Academy of Microbiology.
Peter Bach, MD, CMO, Delfi Diagnostics
Health policy and payment expert, pulmonary physician, and lung cancer epidemiologist, Peter has devoted his career to repairing defects in the healthcare delivery system that impede access to high-quality cancer care and working to ameliorate healthcare’s cost crisis. His work spans seminal studies including that identification of racial gaps in lung cancer care, the development of the first lung cancer risk prediction model (the “Bach model”), lead authorship on multiple lung screening guidelines, and definitional work on pharmaceutical pricing and value. Peter previously served as Senior Adviser at the US Centers for Medicare & Medicaid Services and mentor on many National Institutes of Health K awards. He has been elected to the National Academy of Medicine, American Society for Clinical Investigation, and the Johns Hopkins Society of Scholars.
Lourdes Barrera, PhD, Executive Director, Global Medical Affairs, Merck
Dr. Lourdes Barrera is a Biomedical Researcher and Scientist with in-depth experience leveraging expertise in immunology, medical affairs, precision medicine, diagnostic solutions, and testing technologies. Dr. Barrera holds PhDs in Biological Sciences (Immunology) and in Philosophy of Science (Science Communication) and a master’s degree in Molecular Biology. Dr. Barrera has developed an outstanding career as a medical researcher in respiratory diseases (IPF, HP, COPD) and lung cancer for 20 years. First author of more than 40 scientific peer reviewed publications and multiple congress presentations and scientific talks since 2002. She has had a long-standing relationship with diagnostic and pharmaceutical companies for which she has performed training courses as well as consulting worldwide. Dr. Barrera has a wealth of experience and proven talent leveraging both biomedical expertise and business acumen to drive pharma industry-leading performance. She has held positions as Country Diagnostic Lead, Global Diagnostic Capabilities Director, Global Medical Affairs Lead for Immuno-oncology and most recently, Global Precision Medicine Senior Director at Novartis.
J. Carl Barrett, PhD, Professor, University of North Carolina
Dr. J. Carl Barrett is Vice President & Global Head of Translational Medicine, Oncology R&D at AstraZeneca Pharmaceuticals LP. His responsibility is to develop and execute biomarker strategy and translational sciences efforts to support compound development from research through early and full development in oncology. From 2005-2011, he was Global Head of Oncology Biomarkers and Imaging in Novartis Oncology Translational Medicine. Prior to joining Novartis, Dr. Barrett was the founding Director of the NCI Center for Cancer Research (CCR), which is the NCI intramural center for translation medicine and novel technologies. He also was Chief of the Laboratory of Biosystems and Cancer. Prior to joining NCI, Dr. Barrett was the Scientific Director at the National Institute of Environmental Health Sciences where his efforts focused on integrating new approaches to toxicology by utilization of molecular approaches of toxicogenomics, molecular toxicology, and the Environmental Genome Project. Dr. Barrett’s longstanding research interests focus on the discovery of the critical genetic and epigenetic changes in the cancer cell, in particular the discovery of genes involved in breast cancer (BRCA1) and in the processes of cellular senescence and cancer metastasis. He has made significant contributions to the identification of molecular defects in cancers and the role of the biosystem in the carcinogenesis process. Trained as a chemist at the College of William and Mary, Dr. Barrett received his PhD degree in Biophysical Chemistry from Johns Hopkins University. He has published over 600 research articles and reviews in leading scientific journals and books. He is a member of the Johns Hopkins University Society of Scholars, an elected member of the Ramazini Foundation, an honorary member of the Japanese Cancer Association, and a recipient of multiple NIH awards and Keynote lectures.
Anne Beaubrun, PhD, Vice President, Global Health Economics & Outcomes Research, Cepheid
Anne Beaubrun is a senior leader with extensive experience and successes in the biopharmaceutical diagnostic arena. Anne is currently the Vice President of Global Health Economics and Outcomes Research (HEOR) at Cepheid, the pioneer in molecular diagnostic technologies. Most recently, Anne was the Executive Director and Head of Global HEOR at Global Blood Therapeutics [now Pfizer post 2022 acquisition] where she built a team of HEOR professionals based in the US, Europe, and the Middle East to successfully launch therapeutics for patients with sickle cell disease. Prior to Global Blood Therapeutics, Anne joined Portola Pharmaceuticals as Executive Director and Global Head of HEOR and grew both the HEOR headquarter and field team to generate and disseminate a suite of real-world evidence studies, and economic models to support the product launches. In addition to academic and consulting positions as a health services researcher, Anne held roles with increasing responsibility at Gilead Sciences and Amgen, Inc. in both the epidemiology and health economics departments. During her career, Anne has authored over 85 congress presentations and peer reviewed publications. Anne earned a B.A. in Public Policy Studies from Duke University and a Ph.D from the University of North Carolina at Chapel Hill with a focus in pharmacoeconomics & pharmacoepidemiology.
Jonathan Beer, Senior Director, Diagnostic Sciences, Bristol Myers Squibb
Jonathan Beer joined BMS in 2023 and leads the diagnostic strategy and CDx development of multiple global investigational new drug Phase III clinical trials assays across technology and sample types to select patients for enrollment. Prior to BMS he was with Novartis for more than a decade and contributed to 7 Pre-Market Approval submissions to the US FDA for Companion Diagnostic Assays and was the lead for the CDx assay of alpelisib which was the 2nd liquid biopsy CDx approved by the FDA and only contemporaneous approval for multiple sample types in a submission. In addition to clinical support, Jonathan has led a research lab identifying new and emerging technologies, performed feasibility testing of selected platforms or vendors, and recommended assays will the highest impact exploratory biomarker data to drug development teams. Jonathan is a member of the BLOODPAC consortium and shares their mission to help improve patient outcomes through Liquid Biopsy.
Tomasz Beer, MD, FACP, Chief Medical Officer and VP, Multi-Cancer Early Detection, Exact Sciences
Dr. Beer is Chief Medical Officer & VP, Multi-Cancer Early Detection at Exact Sciences and adjunct professor of medicine at OHSU. He has held appointments as deputy director of the Knight Cancer Institute, Chief Medical Officer at OHSU’s Knight Cancer Institute Cancer Early Detection Advanced Research Center, professor at OHSU School of Medicine, head of the Prostate Cancer Research Program, and the Grover C. Bagby Endowed Chair for Prostate Cancer Research.
Paul Beresford, Vice President and General Manager, CDx, Agilent Technologies
Paul Beresford is the VP/GM of Agilent Technologies’ Companion Diagnostics (CDx) Division. CDx partners with pharmaceutical companies to identify and validate cancer biomarkers, and to develop, register and commercialize companion diagnostic tests on a global scale. As VP/GM of the CDx Division, Paul plays a critical role in delivering Agilent’s mission to improve the human condition by bringing the power of precision oncology to customers, partners, and patients.
Gregory J. Berry, PhD, Associate Professor, Pathology & Cell Biology, Columbia University Vagelos College of Physicians and Surgeons
Dr. Berry received his undergraduate degree in Biology from East Stroudsburg University in East Stroudsburg, Pennsylvania, and his PhD in Microbiology and Immunology from Pennsylvania State University College of Medicine in Hershey, Pennsylvania. He also completed a fellowship in Medical Microbiology and Public Health at University of Texas Medical Branch in Galveston, Texas. Dr. Berry is the Director of Molecular Diagnostics and an Assistant Director of Infectious Disease Diagnostics at Northwell Health Laboratories and is also the Director of Microbiology at Long Island Jewish Medical Center in New York. He is also a Diplomate of the American Board of Medical Microbiology and an Assistant Professor of Pathology and Laboratory Medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. His interests include the optimization of current methodologies and the development of new technologies for patient-centered clinical testing.
Manoj Bhasin, PhD, Associate Professor, Pediatrics and Biomedical Informatics, Emory School of Medicine; Associate Professor, Biomedical Engineering and Bioinformatics, Georgia Tech
Dr. Manoj Bhasin is an Associate Professor of Pediatrics and Biomedical Informatics at Emory School of Medicine. He also holds the position of Associate Professor of Biomedical Engineering at Georgia Tech and is an Associate Member of the Benson Henry Institute for Mind-Body Medicine. In addition, he serves as the Director of Genomics, Proteomics, Bioinformatics, and Systems Biology at Children Healthcare of Atlanta, as well as the Aflac Director of the Single Cell Biology Program at Children Healthcare of Atlanta. Dr. Bhasin is also the co-Director of the Atlanta Initiative for Single Cell Omics and Analytics, a collaborative effort involving Emory School of Medicine, Georgia Tech, and Morehouse School of Medicine. His primary focus is on the application and development of innovative analytical strategies for high-throughput transcriptional profiling, epigenomics, genotyping, proteomics, and metabolomics data. These approaches aim to enhance the molecular understanding of diseases and to identify new diagnostic, prognostic, and therapeutic biomarkers in relation to cancer and diabetes. Additionally, Dr. Bhasin's team is actively involved in the development of novel AI-based approaches for personalized cancer treatment, utilizing multidimensional data. He is at the forefront of developing computational methodologies for the systems-level integrative analysis of imaging, clinical, and single cell genome-level data. These efforts aim to identify key features that drive diseases and provide valuable insights for improved disease management.
Gabriel Bien-Willner, MD, PhD, Medical Director, MolDx, Palmetto GBA
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.
Clarisa Blattner, Senior Director, Revenue and Payor Optimization, XiFin, Inc.
Clarisa Blattner is the Senior Director of Revenue and Payor Optimization at XiFin, Inc. She serves as a subject matter expert in revenue cycle management (RCM) and payor and market strategies, focusing on achieving operational efficiencies and maximizing revenue. With over 25 years of experience in the healthcare sector, Clarisa has an extensive background in revenue cycle management, particularly within the healthcare industry. Previously, she oversaw the billing and reimbursement operations for the outsourced billing department. She cultivated and directed a large team of revenue cycle personnel to service diagnostic providers in multiple specialties. She has served in leadership roles at prominent organizations such as US Labs, Clarient, and MDxHealth. In her current role, Clarisa works closely with new and existing customers to implement and operate innovative capabilities tailored to their unique needs. Leveraging her deep knowledge of market access and payor policy, she functions as a trusted advisor, offering recommendations that maximize the utility of XiFin’s products and services to achieve revenue targets. Beyond her day-to-day responsibilities, Clarisa is committed to sharing her industry expertise through public speaking engagements and networking events. She holds a Bachelor of Science degree in Biological Sciences from the University of Southern California, as well as a certificate in Business Administration. Additionally, she is credentialed as a Certified Coding Specialist (CCS) through AHIMA and as a Certified Professional Coder (CPC) through AAPC. Clarisa’s leadership and subject matter expertise make her a pivotal asset to XiFin and its clients, helping them navigate the complexities of the modern healthcare revenue landscape.
Stacey Brown, Market Access Lead, Optum Genomics
Stacey leads Market Access for Optum Genomics, overseeing all related engagements with diagnostic company clients. Stacey has a couple decades' worth of payer relations and market access experience in the molecular diagnostic space. Prior to joining Optum, she spent many years at Myriad Genetics, in roles with increasing responsibility for securing coverage and reimbursement with regional, national, and government sponsored payers. Stacey went on to spend many years at Foundation Medicine, leading Market Access, and played a large role in the company successfully completing the FDA and CMS parallel review of the first comprehensive genomic profiling companion diagnostic assay. Stacey has also spent time at Sera Prognostics and GeneDx.
Atul Butte, PhD, Chan & Zuckerberg Distinguished Professor & Director, University of California, San Francisco
Atul Butte, MD, PhD is the Priscilla Chan and Mark Zuckerberg Distinguished Professor and inaugural Director of the Bakar Computational Health Sciences Institute (bchsi.ucsf.edu) at the University of California, San Francisco (UCSF). Dr. Butte is also the Chief Data Scientist for the entire University of California Health System (health.universityofcalifornia.edu), the eighth largest by revenue in the United States, with 20 health professional schools, 6 medical schools, 6 academic health centers, 10 hospitals, and over 1000 care delivery sites. Dr. Butte has been continually funded by NIH for 25 years, is an inventor on 24 patents, and has authored over 300 publications, with research repeatedly featured in the New York Times, Wall Street Journal, and Wired Magazine. Dr. Butte has been elected into the American Association for the Advancement of Science (AAAS), American Institute for Medical and Biological Engineering (AIMBE), American College of Medical Informatics (ACMI), and National Academy of Medicine, and in 2013, he was recognized by the Obama Administration as a White House Champion of Change in Open Science for promoting science through publicly available data. Dr. Butte is also a co-founder of three investor-backed data-driven companies: Personalis (IPO, 2019), providing medical genome sequencing services, Carmenta (acquired by Progenity, 2015), discovering diagnostics for pregnancy complications, and NuMedii, finding new uses for drugs through open molecular data. Dr. Butte trained in Computer Science at Brown University, worked as a software engineer at Apple and Microsoft, received his MD at Brown University, trained in Pediatrics and Pediatric Endocrinology at Children's Hospital Boston, then received his PhD from Harvard Medical School and MIT.
Jonathan M. Carlson, PhD, Managing Director, Microsoft Health Futures
Jonathan Carlson, PhD, is Managing Director of Microsoft Health Futures, a global multidisciplinary organization that serves as Microsoft's "moonshot" factory for Healthcare and Life Sciences. Health Futures' portfolio includes deep investments in technology areas at the forefront of biomedical computing (e.g., multi-modal generative AI, causal and experimental reasoning, and research systems) grounded in applications focused on precision diagnostics and drug discovery and development (e.g. precision radiology, genomics, real world evidence, protein design, rare disease, and immunomics). These projects have created new businesses and products for Microsoft, led to fundamental scientific discoveries and advances in AI, and resulted in first-in-class AI-based diagnostics. Jonathan trained as a biologist at Dartmouth (BA 2003), a computer scientist at the University of Washington (Phd 2009), and has published widely at the intersection of machine learning, immunology and virology.
Lon Castle, MD, Associate CMO, Precision Medicine, EviCore
Dr. Castle is responsible for the clinical performance of the Laboratory and Specialty Drug programs at eviCore healthcare, a wholly-owned subsidiary of Cigna. In addition to his decade-long experience with specialty drugs, Dr. Castle has been working in the genomic and molecular diagnostic field since 2007, both designing initiatives that support the advancement of precision medicine as well as managing programs that ensure these tests are used appropriately.
Charles Chiu, MD, PhD, Professor, Laboratory Medicine and Medicine/Infectious Diseases; Director, UCSF-Abbott Viral Diagnostics and Discovery Center; Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine
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.
Ezra Cohen, MD, CMO, Oncology, Tempus Labs, Inc.
Ezra Cohen, MD joined Tempus Labs in May 2023 as the CMO, Oncology. Dr. Cohen is a leading medical oncologist and cancer researcher. Prior to Tempus he was the Chief of the Division of Hematology-Oncology as well as the Associate Director of Clinical Science at UCSD Moores Cancer Center. Dr. Cohen obtained his medical degree from University of Toronto in 1990 and trained in internal medicine at Albert Einstein College of Medicine. Subsequently, he completed a hematology/oncology fellowship at the University of Chicago and joined the faculty there in 2002. He joined the faculty at UCSD in 2014 as full professor.
Christopher Conn, PhD, Global Director, Clinical Biomarkers & Diagnostics, Diagnostics Strategy Lead, Amgen
Christopher Conn is a Director and Diagnostics Strategy Lead in the department of Clinical Biomarkers & Diagnostics at Amgen where he is responsible for developing and implementing end-to-end diagnostic development programs spanning early to late phase clinical development. Christopher has over 15 years of cross-functional experience in the diagnostic and pharmaceutical industries from product concept development to commercialization. Christopher has led the companion diagnostic efforts for numerous programs in the biotech and pharmaceutical industries in both oncology and non-oncology therapeutic areas. Christopher has a PhD in cell and molecular biology from the University of Cincinnati College of Medicine and has completed postdoctoral training at St. Jude Children's Hospital and the University of Colorado.
Dana Connors, MSc, PMP, Director, Cancer Research Partnerships, Foundation for the National Institutes of Health
Dana E. Connors, MSc, PMP is the Director for Cancer Research Partnerships at the Foundation for the National Institutes of Health. Drawing on experience in the biotechnology industry, non-profit and federal sectors, he works with the Cancer Steering Committee to set strategy and prioritize project pipelines and 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 participation from government, industry, academia, patient-advocacy, and private sector organizations to drive international scientific collaboration in multiple disease areas. Ongoing collaborations include analytical validation and clinical utility of liquid biopsy, project opportunities around immuno-oncology biomarkers, development of clinical trial metrics, and Minimal Residual Disease in blood-based cancers.
Robert Cook, Ph.D., Senior Vice President, Research & Development, Castle Biosciences
Dr. Robert Cook currently serves as Castle Biosciences’ Sr. Vice President, Research & Development. Dr. Cook joined Castle in 2011 following a postdoctoral fellowship at Baylor College of Medicine, where he focused on the genetic regulation of rare ovarian granulosa cell tumors. Dr. Cook holds a B.S. degree in molecular biology from Temple University and completed doctoral work in biochemistry, molecular biology and cellular biology at Northwestern University. Dr. Cook is a co-inventor of several of Castle’s technologies.
Ahmet Coskun, PhD, Assistant Professor, Biomedical Engineering, Georgia Institute of Technology
Ahmet F. Coskun (faculty & lab) is currently a Bernie-Marcus Early-Career Professor and Assistant Professor of Biomedical Engineering at Georgia Institute of Technology and Emory School of Medicine. Dr. Coskun directs an interdisciplinary research team at the Single Cell Biotechnology Laboratory. His team’s research aims to study spatial biology in health and disease at the nexus of multiplex bioimaging, microfluidic biodynamics, and big data biocomputation. Using high-dimensional nanoscale imaging datasets, this interdisciplinary program addresses the fundamental challenges in immuno-engineering, cancers, and pediatric diseases. Dr. Coskun was an Instructor at Stanford University School of Medicine. Dr. Coskun received his postdoctoral training from the California Institute of Technology. He holds a Ph.D. degree from the University of California, Los Angeles. He is a recipient of the National Institutes of Health K25 Career Award (2018), the Burroughs Wellcome Fund CASI Award (2016), and the Leukemia & Lymphoma Research Fellowship (2015). His lab is currently funded by a Welcome LEAP grant (2021), Pilot grant from Lung SPORE at Winship (2021), and Georgia Tech & Emory University.
Stacey DaCosta Byfield, PhD, MPH, Vice President, Genomic Health Economics and Outcomes Research, Optum Labs
Stacey DaCosta Byfield currently leads the Genomics Health Economics and Outcomes Research (HEOR) Team supporting the Optum Genomics Evidence Engine. Her focus is on the design of HEOR studies to examine and support strategic objectives and she specializes in conducting observational research studies using administrative claims, EHR/medical record data and other data sources, including laboratory results data. Stacey joined UnitedHealth Group (UHG) in 2009 in the OptumInsight Life Sciences HEOR group where she started as a Senior Researcher focusing on oncology studies. She later served as VP, Research of the Life Sciences HEOR group before moving to Optum Labs were she led the Data Scientist team and most recently the Oncology Focus Area Research Team. Prior to joining UHG, she worked in the Department of Drug Use Policy and Pharmacoeconomics at the University of Texas M.D. Anderson Cancer Center as a Pharmacoeconomics Research Specialist. In this capacity, her main responsibilities included developing research designs to evaluate clinical, economic and humanistic outcomes of pharmaceutical products and services. She holds a PhD in Tumor Biology from Georgetown University and completed a basic science fellowship at the National Cancer Institute where her work focused on identifying targets of pharmaceutical intervention for metastatic breast cancer. Stacey also received her MPH with a concentration in clinical effectiveness from the Harvard T. H. Chan School of Public Health and has completed the Program in Cancer Outcomes Research Training (PCORT) Fellowship, a jointly sponsored program by the Massachusetts General Hospital and the Dana-Farber Harvard Cancer Center in Boston, Massachusetts.
Kevin Davies, PhD, Executive Editor, The CRISPR Journal; Author, Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing
Kevin has more than three decades’ experience in science publishing as an editor, journalist, author, and publisher. He is the founding editor of Nature Genetics and Bio-IT World magazine and also served as Editor-in-Chief of Cell Press and publisher of Chemical & Engineering News. Kevin is the author of five popular science books including Cracking the Genome, The $1,000 Genome, and an updated version of DNA: The Story of the Genetic Revolution with James D. Watson and Andrew Berry. His most recent book is Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing, published in 2020 by Pegasus Books and supported by a 2017Guggenheim Foundation Fellowship in science writing. He is the founding Executive Editor of The CRISPR Journal and is spearheading the launch of GEN Biotechnology, a new marquee peer review journal, in 2022. Kevin holds a degree in Biochemistry from Oxford University and a PhD in Human Genetics from St Mary’s Hospital Medical School, London. He carried out postdocs at MIT and Harvard Medical School before joining the editorial staff at Nature. He still clings to a British accent.
Yanxiang Deng, PhD, Assistant Professor, Pathology & Lab Medicine, University of Pennsylvania
Dr. Yanxiang Deng is an Assistant Professor of Pathology and Laboratory Medicine at the University of Pennsylvania. He obtained his Ph.D. in mechanical engineering from Rensselaer Polytechnic Institute (RPI). During his Ph.D., he developed microfluidic platforms for high-throughput single-cell mechanotyping and Intracellular delivery. Yanxiang then pursued his postdoctoral training in Biomedical Engineering at Yale University, during which he worked on developing new technologies for spatially resolved omics profiling.
Lauri Diehl, PhD, Executive Director, Research Pathology, Gilead Sciences
Lauri Diehl is Executive Director of Research Pathology at Gilead Sciences where she has worked since 2018. She is interested in harnessing the potential of computational pathology to inform the drug discovery and development processes. Her organization is actively assessing new tissue based technologies and exploring options for cross platform data integration.
Nicholas C. Dracopoli, PhD, CSO, Delfi Diagnostics
Nicholas Dracopoli, Ph.D. is Chief Scientific Officer at Delfi Diagnostics. Previously, his work focused on oncology translational science at PGDx, Janssen and Bristol Myers Squibb. Prior to joining the pharmaceutical industry, he spent five years in the biotechnology industry at Sequana Therapeutics. Nic obtained his bachelor’s degree and doctorate from the University of London and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center in New York City, NY and the Massachusetts Institute of Technology (MIT) in Cambridge, MA. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center and as a Section Chief at the National Center for Human Genome Research at the National Institutes of Health, Bethesda, MD. Nic has authored more than 70 scientific publications and has extensive experience in the fields of genomics, molecular biology and cancer research.
James Eberwine, PhD, Elmer Holmes Bobst Professor, Systems Pharmacology and Translational Therapeutics; Co-Director, Penn Program in Single Cell Biology; Co-Director, Penn Center for Subcellular Biology, University of Pennsylvania Perelman School of Medicine
Dr. Eberwine is the Elmer Holmes Bobst Professor of Systems Pharmacology and Translational Therapeutics at the University of Pennsylvania Perelman School of Medicine. His scientific interests revolve around understanding the functional role of variation in the biology of single cells in complex cellular networks. To investigate these issues, he developed methodologies that would facilitate that level of analysis, among which were, single cell PCR, linear aRNA amplification, immuno-aRNA, phototransfection, TIPeR, CHeX and APRA. Further, he coined the phrase “expression profile” to describe the relative abundances of cellular RNAs. Using these approaches, he showed that translation could occur in isolated neuronal dendrites, that RNA splicing could occur in the cytoplasm of neurons, that RNA expression profiles carry cellular phenotypic memories and produced the first single cell library and transcriptome characterization thus pioneering the field of single cell biology. Dr. Eberwine has authored over 200 manuscripts, is an inventor on over 180 patent applications and was elected to the National Academy of Inventors and the National Academy of Medicine. He originated two long running Cold Spring Harbor Summer Courses, “Advanced Techniques in Neuroscience” and “Single Cell Analyses”. He also developed the Neuroscience School for Advanced Studies course on “Single Cell Analyses”. Dr. Eberwine currently serves as a member of the NIH Multi-Council Working Group, which consults on the United States Brain Initiative while also serving as a member of the Brain Initiative Neuroethics Working Group.
Speaker Eli Glezer, PhD, CSO & Founder, Singular Genomics
Eli founded Singular Genomics in 2016 and serves as the Chief Scientific Officer. Eli’s experience includes over 20 years of building and leading multi-disciplinary R&D teams in the biotech field. Prior to Singular Genomics, Eli served as the CTO at Meso Scale Diagnostics. Eli received a Ph.D. in Applied Physics from Harvard University and BAs in Physics and Mechanical Engineering from the University of California, Berkeley.
Helmy Eltoukhy, PhD, Co-CEO, Guardant Health
Helmy Eltoukhy is the Chairman and co-CEO of the leading precision oncology company Guardant Health, which he co-founded in 2012 with Dr. AmirAli Talasaz. In 2007, Eltoukhy co-founded Avantome to commercialize semiconductor sequencing which was acquired by Illumina. While at Illumina, Eltoukhy served as senior director of Advanced Technology Research, where he developed novel chemistries, hardware, and informatics for genetic analysis systems. Eltoukhy received his PhD, MS and BS degrees in electrical engineering from Stanford University.
Ruth Etzioni, PhD, Professor, Public Health Sciences, Fred Hutch Cancer Center
Dr. Ruth Etzioni is Professor of Biostatistics at the Fred Hutch Cancer Center in the Division of Public Health Sciences where she holds the Rosalie and Harold Rea Brown Endowed Chair. Dr. Etzioni received her PhD in Statistics from Carnegie-Mellon University. She has studied the benefit-harm tradeoffs of cancer early detection for more than 25 years and serves as a member of early detection guidelines panels for the National Comprehensive Cancer Network, the American Urology Association, and the American Cancer Society. Dr Etzioni's group of biostatisticians and cancer modelers was the first to quantify the frequency of overdiagnosis in prostate cancer screening and in 2022 published a definitive study of overdiagnosis associated with breast cancer screening in the US. She is a fellow of the American Statistical Association and recipient of an NCI Outstanding Investigator Award for her research in the area of novel cancer diagnostics.
Lauren Feldman, Vice President and Head, Value, Access, and Pricing, ADVI
Lauren brings more than 14 years of precision medicine expertise to the ADVI team and her clients. She leads ADVI’s value, access, and pricing work. With a primary focus on molecular diagnostics, she develops innovative commercialization and clinical valuation strategies designed to improve access and accelerate the adoption of precision medicine tools and therapies. Lauren has extensive expertise in oncology products, advising on all aspects of reimbursement, market access, and strategic policy planning. She specializes in launch planning and execution, CPT coding, and Medicare payment policy. She is passionate about providing meaningful, integrated solutions to deliver on the value of genomics-based precision medicine. Prior to ADVI, Lauren worked at the American Medical Association where she was responsible for crafting and implementing innovative coding solutions for disruptive technologies. Prior to the AMA, Lauren worked for a start-up biotechnology company performing discovery research and began her career in academic research at Harvard Medical School and Brigham and Women’s Hospital.
Douglas Flora, MD, Executive Medical Director, Oncology Services, St. Elizabeth’s Healthcare; Editor-in-Chief, AI in Precision Oncology Journal
Dr. Doug Flora is the Executive Medical Director of Oncology Services and The Robert and Dell Ann Sathe Endowed Chair in Oncology at the St. Elizabeth Healthcare Cancer Center in Edgewood, Kentucky. Dr. Flora graduated from The Ohio State University College of Medicine in 1999. With a distinguished career spanning over two decades, he is a steadfast advocate for whole-person care and medical innovation. His leadership and vision have led to cutting-edge technology and treatment protocols and improved patient outcomes. Dr. Flora’s dedication extends beyond clinical practice. As the Editor-In-Chief for the pioneering peer-reviewed journal AI in Precision Oncology, he plays a pivotal role in medical education and research, nurturing the next generation of healthcare leaders. Dr. Flora is a Board Member of the American Cancer Society, the Association of Community Cancer Centers, and the Kentucky Society of Clinical Oncology and enjoys international travel with his family.
Thomas Fouqueau, PhD, R&D Team leader, R&D, Meridian Bioscience
Thomas Fouqueau, Ph.D. is R&D Team leader for Meridian Life Science. He obtained a Ph.D. in 2013 in Biochemistry/Molecular Biology at University of Regensburg, Germany. He later extended his Molecular Biology skills at UCL, UK, before joining Meridian. With extensive experience working with qPCR and LAMP technologies, Thomas now leads a team focused on developing innovative molecular products used by the global diagnostic industry for the development of Molecular Diagnostic devices.
John L. Fox, MD, Senior Medical Director for the Americas, Illumina, Inc.
John Fox, MD MHA, is currently the Senior Medical Director of the Americas, Market Access, for Illumina, where he is accountable for working with payers and employers to expand access to genomic testing and personalized medicine. He served as the Associate Chief Medical Officer at Priority Health, a provider-sponsored health plan with over 1,200,00 members from June 2000 through May 2019. He was responsible for medical and pharmaceutical technology assessment, use of medical resources, case management, and physician pay-for-performance programs. He was also responsible for development of new programs, including shared decision-making, digital therapeutics, advanced care planning, integrated specialty pharmacy program, surgical optimization initiatives, value-based benefit designs, and contracts, oncology medical home programs, and personalized genomic medicine initiatives. In June 2019 he became the Vice President of Clinical Transformation of Spectrum Health Systems, the parent company for Priority Health, and the Executive Medical Director for the West Michigan ACO, a clinical collaboration between Spectrum Health providers and Answer Health, the largest independent physicians organization in west Michigan.
Ben Freeberg, Founder & Managing Partner, Oncology Ventures
Ben is the Founder and Managing Partner of Oncology Ventures, a Seed-stage venture fund focused on investing into data-driven cancer start-ups. The fund is backed by strategic LPs including City of Hope and NY Cancer & Blood Specialists, alongside 40+ family offices and individuals. Prior, Ben was a Vice President at Optum Ventures and the 1st employee at Alpha Partners. Ben has also helped build a value-based cancer technology start-up (health plan partnerships and operations at Thyme Care).
Mark Gardner, MBA, Senior Vice President, Molecular Genomics and Oncology, Quest Diagnostics
Mark Gardner is Senior Vice President, Molecular Genomics and Oncology for Quest Diagnostics. In this role, Mark is responsible for driving growth in Quest’s Advanced Diagnostics offerings by providing genetic sequencing services, cancer diagnostics and working closely with all our clinical franchises. Mark joined Quest in 2022 from Corza Medical, a private equity operating company focused on surgical technologies and tools, where he served as Executive Partner, Senior Vice President and General Manager of European Commercial Operations and Biosurgery Products. Prior to that, Mark served in leadership positions at a range of companies including Thermo Fisher Scientific, Life Technologies, Invitrogen and Omniseq. He started his civilian career as a consultant with the global management consulting firm McKinsey & Company, after leaving the U.S. Navy, where he was a Lieutenant Commander. Mark earned an MBA from the Wharton School at the University of Pennsylvania, a master’s degree in national security studies from Georgetown University, and a bachelor’s degree from the U.S. Naval Academy.
Lana Garmire, PhD, Associate Professor, Computational Medicine & Bioinformatics, University of Michigan
Lana Garmire is an associate professor of Computational Medicine and Bioinformatics from University of Michigan. Her research interest includes single cell sequencing informatics and genomics; precision medicine through integration of multi-omics data types; novel modeling and computational methods for biomarker research, and population science. She has published over 100 papers/preprints in top quality journals and delivered over 90 invited talks. She is a standing member of BDMA study section at US National Institute of Health (NIH) and serves on the editorial advisory board for journals such as Genome Biology. Her work has been continuously funded by NIH. Among the awards, noticeable ones include US Presidential Early Career Scientists and Engineers (PECASE), and fellow of American Institute of Medical and Biological Engineering (AIMBE).
C. Taylor Gilliland, PhD, Senior Advisor for Innovation Programs, Office of the Director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health
C. Taylor Gilliland, Ph.D. is the Senior Advisor for Innovation Programs at the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH) where he supports the Institute in designing and implementing innovation initiatives across scientific and operational domains. Dr. Gilliland first joined NIBIB on detail in April 2020 as the policy, communications, and reporting team lead for the Rapid Acceleration of Diagnostics Technology (RADx Tech) Program that sped innovation in the development, commercialization, and implementation of COVID-19 testing technologies. Previously, Dr. Gilliland was a Senior Policy Advisor within the NIH Office of the Director providing scientific, programmatic, and policy analysis and advice across a range of biomedical research initiatives. He first came to NIH in 2014 as an AAAS Science & Technology Policy Fellow at the National Center for Advancing Translational Sciences where he was instrumental in developing the Center’s inaugural strategic plan and co-led the NIH Translational Science Training Program. Taylor received his Ph.D. in Biomedical Sciences from the University of California San Diego where he studied structure-function relationships among the chemokine family of G-protein coupled receptors, and a B.S. in Biochemistry & Molecular Biology from the University of Florida.
Alex Greninger, MD, PhD, Assistant Professor, Laboratory Medicine, University of Washington
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 a residency in clinical pathology at the University of Washington. His work generally involves genomically-informed approaches to understanding a variety of infectious diseases.
Jill Hagenkord, MD, CMO, Optum Genomics
Jill Hagenkord, MD, is the Chief Medical Officer of Optum Genomics at UnitedHealth Group. Dr. Hagenkord is a board-certified pathologist with subspecialty boards in molecular genetic pathology and an additional fellowship in pathology/oncology informatics. She specializes in the development, validation, and implementation of novel health technologies as well as coding, coverage, and reimbursement issues for novel tests. Prior to joining Optum, she was the Chief Medical Officer of several Silicon Valley genomic companies, including Invitae and 23andMe. She began her career as the Director of Molecular Pathology and Assistant Professor of Pathology at Creighton University School of Medicine.
Nicholas Halzack, MPH, Director, Health Policy, Roche Diagnostics
Nick is the Director of Health Policy at Roche Diagnostics Corporation. He believes that diagnostics are one of the most crucial elements to improving public health, and that broad access to new diagnostic technologies is based on a solid foundation of reimbursement and access policies. Prior to Roche, Nick worked on federal health policy at the American Society of Anesthesiologists and Nemours Children's Health System. He holds a M.P.H. in Health Policy from The George Washington University and a B.S. in Biological Sciences from Cornell University.
Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center
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.
Chris M. Hartshorn, PhD, Chief, Digital & Mobile Technologies Section-CTSA Program, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)
I am the Chief of the Digital & Mobile Technologies Section and member of the scientific staff of the Division of Clinical Innovation within the National Institutes of Health's (NIH) National Center for Advancing Translational Sciences (NCATS). In this role, I manage and coordinate programmatic and research activities relevant to the section. My team focuses on bringing more interventions to more people, faster. Furthermore, to enable participants from more diverse backgrounds, those whom have been traditionally medically underserved, and from rural regions of the country to be able to participate in clinical trials. We tackle challenges in the remote delivery of care, building infrastructure for the decentralization of clinical trials, and working to implement solutions for providers and their community to engage and co-design remote patient monitoring. Our vision is to move the needle from bringing patients-to-care, to bringing care-to-patients. We implement this vision by way of the Clinical & Translational Science Award (CTSA) program - the single largest program of its kind within the U.S. DHHS that supports our Nation's clinical research ecosystem and its infrastructure. Prior to joining NCATS, I served as a program director in the Division of Cancer Treatment and Diagnosis at the NIH NCI. During my tenure at NIH, I have founded, guided and managed multiple programs. Prior to joining NIH, I was a member of the research staff at the NIST for projects focused on biomedical and national security applications, as well as subsequent collaborations with the U.S. Department of Defense, U.S. Department of Justice, NIH, Merck and Pfizer.
Bethany Hills Grois, JD, MPH, Vice Chair, FDA Regulatory, DLA Piper LLP
Bethany Hills focuses her practice on life science and health care. She advises life sciences and health tech industry clients on the full range of regulatory compliance issues, bringing together FDA regulatory, healthcare regulatory and life science compliance expertise. Bethany helps her clients manage complex, multi-faceted regulatory compliance issues in product development, product launch, ongoing market compliance and defends private and government enforcement actions. She provides practical, strategic guidance for investment, strategic collaborations and long-term commercial success. Bethany has deep expertise in digital health issues and experience in artificial intelligence and software solutions in the life science and health care industry.
Dave S. B. Hoon, PhD, Director, Translational Molecular Medicine and Genome Sequencing, Saint John's Cancer Institute
Dave SB Hoon is Professor, Director of Translational Research at John Wayne Cancer Institute (JWCI), Providence Health System. He is director of Depts of Translational Molecular Medicine and Sequencing Center. Dr. Hoon was a founding member of JWCI in 1991 and has been a pioneer of molecular blood biopsies since the early nineties. He has published over 400 publications mainly on translational molecular cancer research. Has published on the utility of various types of cell-free circulating nucleic acids(cfNA) in different cancer types involving multiple clinical settings and phases of clinical trials. Over the years has developed various types of assays to assess different forms of cfNAs and their utility in early and advanced stages of solid tumor cancers. Advisor of cfNA pharmabiotechs.
Damon Hostin, Lead, Health System Market Access, Illumina, Inc.
Damon serves as Lead for Health Systems in Illumina’s Market Access department. Prior, Damon held multiple leadership positions at Catholic Health Initiatives (CHI), culminating in leading the Precision Medicine Alliance of CHI and Dignity Health (the Precision Medicine Alliance of CommonSpirit Health). Before CHI, he was clinical business leader for Complete Genomics. Earlier, he led the Life Science segment of Strategic Diagnostics’ (SDIX, now Origene) antibody and assay business, including IVD production, research tools and therapeutic candidate generation. Earlier, Hostin managed GenVis Labs, a clinical molecular diagnostic company purchased by Pfizer in 2005. As a part of the founding Team of Actinium Pharmaceuticals, he managed alliances in developing targeted oncology therapeutics. His start in genomics was as Team Leader, Sequencing at Celera Genomics, where he was published on the Human and Drosophila genomes in Science and contributed to pharmaceutical partnerships. His education includes undergraduate studies at Tulane University, Masters studies at Harvard, and certificate programs at Wharton and the NIH.
William L. Hwang, PhD, Instructor, Radiation Oncology, Massachusetts General Hospital
William L. Hwang, MD, PhD, is a principal investigator and physician-scientist at the Center for Systems Biology, Center for Cancer Research, and Department of Radiation Oncology at Massachusetts General Hospital (MGH) and Harvard Medical School (HMS) where he leads the Laboratory for Spatial and Systems Oncology, cares for patients with gastrointestinal malignancies, and serves as associate director of the Radiation Biology & Research Program. He has a long-standing interest in the immense temporal and spatial heterogeneity of biological systems and the many insights that can only be gleaned by studying systems at the level of their individual components-single molecules or cells. Dr. Hwang’s laboratory studies tumor-stromal interactions through the development and application of novel techniques in advanced microscopy, spatial and systems biology, and genetic engineering to patient-derived specimens, stromal tumoroids, and mouse models. Current project areas include mechanisms of (1) therapeutic resistance mediated by cell state plasticity and malignant-stromal interactions in the tumor microenvironment; and (2) tumor-nerve interactions, which are remarkably important in the pathogenesis of many cancers but poorly understood. His work has been honored with a Rhodes Scholarship, ASCO/CCF Young Investigator Award, Burroughs Wellcome Fund Career Award for Medical Scientists, Pancreatic Cancer Action Network Career Development Award, AACR NextGen Star, and 40 under 40 in Cancer Award - Rising Stars and Emerging Leaders.
Sanjay Juneja, MD, Hematologist & Medical Oncologist, Mary Bird Perkins Cancer Center
Dr. Sanjay Juneja is a triple board certified hematologist & medical oncologist, probably known better for his social & news media brand 'TheOncDoc’, where he educates over half a million followers on cancer concepts and the latest therapies through relatable, entertaining content. As the host of the innovative podcast 'Target: Cancer Podcast', Dr. Juneja picks the brains of a wide range of distinguished guests, from Pulitzer Prizer winners and selling authors, to celebrities and biomed entrepreneurs. Dr. Juneja has been featured on CNBC, Bloomberg, WebMD, The Washington Post; is an active international Keynote speaker, and provides content as a Contributor for Entrepreneur Magazine. In 2022 he was selected by the White House to participate on their Healthcare Leaders in Social Media Roundtable series. Dr. Juneja is a co-founder of OncoAI, OncoIndex, and Medfluencers all of which focus on democratizing optimized care in community America. He serves on the editorial board for the AI in Precision Oncology Journal, and practices alongside his wife, Dr. Lauren Juneja, in his hometown of Baton Rouge where they are proud parents of three vivacious boys.
Evan T. Keller, DVM, PhD, Professor of Urology and Pathology, School of Medicine, University of Michigan; Director, Single Cell Spatial Analysis Program
Dr. Keller is the Richard and Susan Rogel Professor of Oncology and serves as Director of the Single Cell Spatial Analysis Program (website: singlecellspatialanalysis.umich.edu), Director of Research Core Office in the Office of Vice President of Research, and Associate Director of the Rogel Cancer Center Shared Resources. Dr. Keller obtained a Doctor of Veterinary Medicine (D.V.M.) and Masters of Preventive Veterinary Medicine/Epidemiology (M.P.V.M.) degrees from the University of California, Davis and a doctorate (Ph.D.) in Developmental Biology from the University of Wisconsin, Madison. He is Board Certified in the American College of Veterinary Internal Medicine (Oncology). Dr. Keller is a Professor of Urology and Pathology at the University of Michigan. Dr. Keller has published more than 250 scientific publications. Dr. Keller’s research extends from basic through clinical studies with a focus is on crosstalk between tumor and its microenvironment.
Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium
Dr. Kessler is professor in the Department of Health Systems and Population Health, University of Washington, which he chaired from 2009 - 2015. He has over 40 years of experience in health services research, including positions at the National Institute of Mental Health, National Cancer Institute, and FDA. At NCI, he and his colleagues substantially changed the way in which cancer surveillance is performed, with the addition of the cancer supplements to the National Health Interview Survey, the SEER-Medicare data system, and the Breast Cancer Screening Consortium and the Breast Cancer Surveillance Consortium. His research record includes focused work in cancer, cancer surveillance research, and regulatory aspects of medical products. He came to UW from U.S. FDA Center for Devices and Radiological Health. His recent collaborative research focuses on patient-centered outcomes and comparative effectiveness research. He also serves as Deputy Chair of the MCED Consortium.
Sean Khozin, MD, MPH, Research Affiliate, Massachusetts Institute of Technology; Founder, Phyusion
Sean Khozin, MD, MPH is a physician-scientist and board-certified oncologist with two decades of experience in therapeutic development, drug and device regulation, and the applications of artificial intelligence and machine learning in biomedical research. He is a Research Affiliate at MIT and the founder of the advisory firm Phyusion. Dr. Khozin was previously the Global Head of Data Strategy and Data Science Innovation at Johnson & Johnson, leading a worldwide multidisciplinary team charged with the design and implementation of pioneering data science solutions to support the development of innovative new medicines and vaccines. Prior to this, he was a founding member of the US FDA’s Oncology Center of Excellence and Executive Director of Information Exchange and Data Transformation (INFORMED), the FDA’s first data science and technology incubator that he established under special federal authorities. As a uniquely entrepreneurial sandbox housed within the agency responsible for regulating nearly a third of the US economy, INFORMED played a pivotal role in shaping the US FDA’s position on real-world evidence and the use of novel data science solutions in drug discovery and clinical development. Before his tenure in the US federal government, Dr. Khozin was the cofounder of Hello Health, a TechBio venture focused on developing integrated telemedicine, point-of-care data visualization, and advanced analytical systems for optimizing patient care and clinical research. The company’s core technology offerings were first operationalized in a multidisciplinary network of clinics he had founded called SKMD. Dr. Khozin has over a decade of clinical and basic science research experience at the US National Cancer Institute and currently serves on the board of the Society for Translational Oncology and the Life Sciences Consortium of the CEO Roundtable on Cancer.
Eric Klein, MD, Distinguished Scientist, GRAIL, Inc.
Eric A. Klein, MD is a Distinguished Scientist at GRAIL. Previously he served as the Andrew C. Novick Distinguished Professor and Chair of the Glickman Urological and Kidney Institute and Lerner College of Medicine of the Cleveland Clinic, where he was also a member of the Department of Cancer Biology of the Cleveland Clinic Lerner Research Institute, the Taussig Cancer Institute, and the Genitourinary Malignancies Program in the Case Comprehensive Cancer Center. Dr. Klein’s clinical and research interests focused on prostate cancer with an emphasis on genomics and clinical trials. Most recently his work has focused on the clinical development of multicancer early detection tests. Dr. Klein was a Fellow in the Distinguished Careers Institute at Stanford University in 2022 and joined GRAIL in 2023.
Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy
Dr. Klepser received his Doctor of Pharmacy from the University of Michigan College of Pharmacy. Subsequently he completed a pharmacy practice residency at Detroit Receiving Hospital and University Health Center and a fellowship in Infectious Diseases at Hartford Hospital in Hartford, Connecticut. Dr. Klepser is currently a Professor of Pharmacy at Ferris State University since 2001. Dr. Klepser’s well-known for his work surrounding use of CLIA-waived point-of-care tests in community pharmacies and community-based antimicrobial stewardship. He has published extensively on these topics and has more than 130 peer-reviewed manuscripts to his credit. Dr. Klepser is a founder and content advisor for the “Community Pharmacy-Based Point-of-Care Testing” certificate program and Vice President of POC Consultants.
Nikolaos Kourtis, PhD, Scientist, Regeneron
Nikos Kourtis obtained his Ph.D. from the Institute of Molecular Biology and Biotechnology in Crete, Greece. He completed his postdoctoral training at NYU School of Medicine. He is currently a Principal Scientist in the Department of Immunology & Inflammation at Regeneron Pharmaceuticals where he leads a team studying the role of epigenetic rewiring of immune cells in cancer. His research has been published in top-tier journals including Nature, Nature Medicine, Nature Cancer and Nature Cell Biology. He is the recipient of the EMBO Postdoctoral Fellowship, the HFSP Postdoctoral Fellowship, the Charles Revson Senior Fellowship and the NYU Outstanding Postdoctoral Award.
Razelle Kurzrock, MD, Professor, Medicine, Associate Director, Clinical Research, Linda T. and John A. Mellowes Endowed Chair of Precision Oncology, Medical College of Wisconsin; CMO, Worldwide Innovative Network (WIN) for Personalized Cancer Therapy
Razelle Kurzrock, MD is a world-renowned physician-scientist leader in precision medicine as well as in the development of novel therapeutics in the field of oncology. She is recognized for founding, developing and chairing one of the largest Phase 1 clinical trial departments globally while at the University of Texas MD Anderson Cancer Center; the central theme of the department was a personalized medicine strategy. She is also one of the pioneering trialists of the WINTHER precision medicine trial focusing, for the first time, on transcriptomics in addition to genomics. This trial was the signature study of the WIN international consortium (Nature Medicine). During her time at the University of California San Diego Health, Dr. Kurzrock’s charge was leading the Center for Personalized Cancer Therapy as well as the Experimental Therapeutics program, and she also founded a Rare Tumor Clinic focused on precision medicine. The signature study of the center was the IPREDICT study (Nature Medicine, 2019) that gave, for the first time, individualized matched combination therapies to patients with lethal malignancies, hence resulting in improved outcomes. Dr. Kurzrock is also an entrepreneur. She is co-founder of CureMatch, and on the Board of both CureMetrix and CureMatch. Dr. Kurzrock has over 850 publications on Pubmed, an H-index of 126, and has been named to the list of most cited scientists worldwide and to the list of the 25 most important voices in Precision Medicine globally. She has four children and three dogs and lives with her husband Dr Philip Cohen, in San Diego, California.
Kathyrn Lang, Senior Vice President, Real-World Data and Analytics, Freenome
Dr Kathryn Lang is a board certified hemato-oncologist, who completed clinical training in London, UK. With a strong focus on outcomes research throughout her career and over 100 publications, Dr. Lang moved to an industry role with Pfizer in 2016 where she led global data science initiatives and developed regulatory grade observational research within Pfizer Oncology with successful filings in the US and Europe, including the first of its kind oncology drug label expansion based on real world data. She moved to her current role with Guardant Health in 2018 where she is Vice President of Outcomes and Evidence focusing on early detection of cancer and applied health economics and outcomes research. She is the lead for the Guardant Health Real World Evidence program, including Guardant Inform, the largest clinical-genomic real world database and GRECO, a novel siteless clinical trial platform that emphasizes active patient engagement. Additionally, she is the Principal Investigator of the ECLIPSE study, a prospective, multi-site, observational study evaluating the potential for blood based colorectal cancer screening.
Adrian Lee, PhD, Professor, Pharmacology & Chemical Biology, University of Pittsburgh
Dr. Adrian Lee is Professor of Pharmacology & Chemical Biology and Human Genetics at the University of Pittsburgh and UPMC Hillman Cancer Center. Dr. Lee is the Pittsburgh Foundation Chair and Director of the Institute for Precision Medicine (IPM), a joint effort by the University of Pittsburgh and UPMC to move biomedical research into personalized well-being and clinical care. The lab studies the molecular basis of breast cancer development and resistance to therapy, with the goal to improve precision medicine and outcomes for breast cancer patients.
Elyse LeeVan, MD, MPH, Program Officer, Cancer Screening Research Network, National Cancer Institute, National Institutes of Health
Elyse LeeVan is the program officer for the new Cancer Screening Research Network in the Division of Cancer Prevention at the National Cancer Institute. She received her medical degree from Case Western Reserve University. She then completed her residency in general surgery and a fellowship in colorectal surgery. Prior to joining NCI, she developed multi-national clinical trials with the Henry Jackson Foundation. She received an MPH from Johns Hopkins University with a focus in health disparities and clinical research. Since joining the Division of Cancer Prevention, Dr. LeeVan has concentrated her portfolio on Multi-Cancer Detection technologies and worked to develop a network to assess new cancer screening modalities.
Lauren Leiman, Executive Director, BLOODPAC Consortium
Lauren C. Leiman is currently the Executive Director of the Blood Profiling Atlas in Cancer (BloodPAC), a consortium focused on creating an open database for liquid biopsies to accelerate the development of safe and effective blood profiling diagnostic technologies for patient benefit. Prior to running BloodPAC, she was the Senior Director of External Partnerships at White House Cancer Moonshot Task Force during the Obama Administration. Previously, Lauren was a Senior Advisor for the Melanoma Research Alliance and Director of Philanthropy at Elysium Management LLC in New York City. From 2008-2010, Lauren worked for the Millennium Promise Alliance, where she led the major gifts fundraising effort and spent significant time in sub-Saharan Africa. Lauren was also the head of marketing and investor relations at Steel Partners, LP, an activist hedge fund investing globally. Lauren received her undergraduate degree in communications from the University of Pennsylvania's Annenberg School. She also holds an MBA in international business from the University of North Carolina's Kenan-Flagler Business School and a master's degree in public relations and corporate communications from NYU.
Jochen Lennerz, MD, PhD, Director, Center for Integrated Diagnostics, Massachusetts General Hospital; Associate Professor, Pathology, Harvard Medical School
Dr. Joe Lennerz is the Associate Chief of Pathology and the Medical Director of the Center for Integrated Diagnostics (CID) at Massachusetts General Hospital (MGH). He oversees all aspects of the clinical laboratory service that supports personalized medicine at MGH. The main aim of the CID is technology assessment and optimizing care delivery through rapid clinical integration of innovative technologies. Dr. Lennerz is board certified by the American Board of Pathology and the American Board of Medical Genetics. He completed his residency training in anatomic pathology in 2008, and a fellowship in molecular genetic pathology in 2009 at Washington University in St. Louis, MO. He was the principle investigator of the first FDA instrument precision study for the first whole slide scanning system and his interests are tissue-based biomarkers, and financial sustainability of molecular genetic diagnostics. In his free time, he loves playing at open mics.
Imanuel Lerman, MD, MSc, Professor, Electrical and Computer Engineering, Anesthesiology, University of California, San Diego
I am a passionate and driven leader in the fields of neurology, pain medicine, electrical and computer engineering, machine and deep learning. My work focuses on augmenting the clinician's aptitude to diagnose inflammation that is core to disease. I am the founder of InflammaSense, a startup that is creating a wearable device that can detect early signs of inflammation and infection (www.inflammaSense.com). I am also a Professor at the University of California, San Diego at the Jacobs School of Engineering as well as the Department of Anesthesiology and Pain Medicine, where I teach and conduct research on the neuroinflammatory mechanisms that collectively contribute to pain, inflammation, and mental health disorders (www.lerman-lab.org). At InflammaSense, I lead the development of an AI enabled EMR connected non-invasive monitor that can record and differentiate neural signals for inflammation. The device is intended to help clinicians identify patients who are at risk of developing severe complications from respiratory diseases, such as cytokine storm and sepsis. I work with talented multidisciplinary teams of life scientists, electrical and computer engineers, software engineers, machine and deep learning engineers, data scientists, statisticians and clinicians. Our teams at InflammaSense partner with government, academic and industry stakeholders to advance health care diagnostic and therapeutic systems from concept to market.
Jing Li, PhD, R&D Scientific Manager, Research and Development, Streck
Jing Li received a Ph.D. in Pharmaceutical Sciences from Wayne State University (Detroit, MI) before completing her postdoctoral training at the University of Nebraska Medical Center (Omaha, NE). For the past five years, Jing has been a part of Streck’s Research and Development department, where she currently serves as a Scientific Manager and focuses on the development of new stabilization technologies intended for liquid biopsy applications.
Yuhwa Lo, PhD, Professor, Electrical & Computer Engineering, University of California, San Diego
Yuhwa Lo received his PhD in Electrical and Computer Engineering from UC Berkeley. He is the William SC Chang Distinguished Professor of UCSD, and published over 500 peer reviewed articles in the fields of single cell technologies, biophotonics, lab-on-chip, microfluidics, and nanophotonics. He is a co-founder of NanoCellect Biomedical. He is a fellow of the IEEE and the Optical Society of America.
Arturo Loaiza-Bonilla, MD, Co-Founder & CMO, Massive Bio, Inc.
Dr. Arturo Loaiza-Bonilla, MD, MSEd, is the Co-Founder and Chief Medical Officer at Massive Bio, a global industry leader in connecting patients to clinical trials using artificial intelligence. An internationally renowned medical oncologist and researcher, Dr. Bonilla has a distinguished academic and clinical career in precision medicine oncology, immunotherapy, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr. Loaiza-Bonilla is board certified in both medical oncology and hematology and has extensive experience in the diagnosis and treatment of genomic biomarker-driven cancers and serves as enterprise Medical Director of Oncology Research at Capital Health. Dr. Loaiza-Bonilla earned a medical degree from the Universidad Nacional de Colombia in Bogota, Colombia. Following medical school, he completed an internship and residency in internal medicine at Harbor Hospital Center, Johns Hopkins Hospital in Baltimore, Maryland. Dr. Loaiza-Bonilla also completed a fellowship in hematology and oncology from the University of Miami, Miller School of Medicine in Miami, Florida. He completed his master’s degree in medical education at the University of Pennsylvania, and pursued professional certification in Artificial Intelligence in healthcare at the MIT Sloan School of Management. Before joining Capital Health, Dr. Loaiza-Bonilla was vice chairman of the Department of Medical Oncology at Cancer Treatment Centers of America in Philadelphia, Pennsylvania, as well as enterprise director of research, where he provided leadership and expertise to their oncology trial portfolio across 5 cancer centers and over 70 NCTN and industry-sponsored clinical trials. His research has been extensively published in the most prominent journals and meetings in oncology, and he has been recipient of NIH funding to advance digital health and artificial intelligence tools for cancer research. He was also assistant professor of Clinical Medicine at the University of Pennsylvania School of Medicine; and he is currently assistant professor in the Department of Medicine at Drexel University College of Medicine, both in Philadelphia. Throughout his stellar career, Dr. Loaiza-Bonilla has held numerous leadership positions such as President of the Pennsylvania Society of Oncology and Hematology and President of the Board of Directors of the Global Alliance for Patient Access. In 2018, he was recognized as Philadelphia Business Journal’s Forty Under 40, in 2019 he was bestowed the Influencers of Healthcare Award - Outstanding Healthcare Provider award by the Philadelphia Inquirer, and in 2021 he was chosen as recipient of '40 under 40 in Cancer' accolade. He has also been selected in Castle Connolly's and Philadelphia Magazine's Top Doctors listing since 2018.
Sangeetha Mahadevan, PhD, Senior Research Scientist, Gilead Sciences
As part of the Research Pathology group at Gilead Sciences, Sangeetha is involved in efforts to implement tissue-based transcriptomic profiling technologies. Working across therapeutic areas allows for opportunities to develop generalizable discovery frameworks.
Sonya Makhni, MD, Medical Director, Mayo Clinic Platform
Sonya Makhni MD, MS, MBA, is Medical Director of Mayo Clinic Platform Solutions. In this role, Dr. Makhni focuses on data systems transformation, ML operations, bias mitigation of artificial intelligence systems in healthcare, health inequity, healthcare innovation, change management, and novel models of care delivery. She is also a Senior Associate Consultant within the department of Hospital Internal Medicine at Mayo Clinic. Dr. Makhni completed her residency in Internal Medicine at the University of Michigan and her fellowship within Clinical Informatics at the University of Chicago, where she also earned a Masters of Science in Biomedical Informatics. Prior to this, she completed medical school at Icahn School of Medicine at Mount Sinai in New York, her MBA from Harvard Business School, and her undergraduate degree at MIT. Dr. Makhni is passionate about using her experiences to improve healthcare in safe, fair, and effective ways that will improve the lives of patients.
Elizabeth M. Marlowe, PhD, D(ABMM), Executive Scientific Director, Head R&D Infectious Diseases & Immunology, Quest Diagnostics
Dr. Beth Marlowe is the Executive Scientific Director and heads R&D for Quest Diagnostics Infectious Diseases and immunology. Dr Marlowe joined Quest in June of 2019. Beginning January of 2020, her team played a key role in the COVID-19 response and in 2022, the Mpox response. Previously she has worked as the Global Director of Medical Affairs for Microbiology at Roche Molecular Systems, provided laboratory leadership for over a decade within the Kaiser Permanente Regional Laboratories, and assay development for Gen-Probe (now Hologic). She is a diplomat of the American Board of Medical Microbiology, past-president for the SoCal branch of the American Society for Microbiology (ASM), served as an editor for the Clinical Microbiology Newsletter as well as the Journal of Clinical Virology. She has served as an elected member to the Council on Microbial Sciences for ASM, an appointed member of CLIAC, the federal advisory committee for CLIA to the United States HHS Secretary, and an elected member of the Board of Directors for ASM. Her research areas of interest are focused on the translation of new infectious disease diagnostics for use in evidence-based research for clinical and public health microbiology practice.
Jean-Francois Martini, PhD, Diagnostics & Translational Lead, Global Product Development - Oncology and Rare Diseases, Pfizer Inc.
Jean-Francois Martini has 20 years of biotech and pharma industry experience in pharmacology and clinical translational sciences and is author/coauthor of over 50 scientific publications. He is currently Executive Director, Translational Oncology Lead, Global Product Development-Oncology and has been at Pfizer, in La Jolla, California, since December 2011. He was previously Sr. Director, Translational Medicine, at Exelixis, So San Francisco, California, where he contributed to the approval of cobimetinib (preclinical in vivo pharmacology, partnered with Genentech) and cabozantinib (first approval in MTC) and to projects such as the alliance with Sanofi for the PI3K programs and out-licensing of esaxerenone (mineralocorticoid receptor blocker, approved in Japan for the treatment of hypertension) to Daiichi Sankyo. He completed his postdoctoral training at University of California, San Francisco, where he studied the antiangiogenic properties of fragments of Prolactin and Growth Hormone, after obtaining a PhD in Biochemistry and Molecular Biology from University of Paris XI, France. At Pfizer, he currently leads and/or supports the translational strategy for the next generation of CDK inhibitors; the Renal Cell Cancer franchise (sunitinib and axitinib); and lorlatinib (ALK/ROS1 inhibitors) in Lung Cancer. He also leads the cross functional efforts in the area of liquid biopsy/cfDNA (represents Pfizer as part of Blood Profiling Atlas-Cancer; Friends of Cancer Research), and is the Pfizer board of director representative for the WIN consortium.
John Mattison, MD, Operating Partner/Chief Medical Information Officer, Arsenal Capital Partners
My journey has evolved from systems biology to practicing medicine, to co-leading the digital transformation and virtual care initiatives at a large IDN, to healthcare data interoperability, to machine learning analytics, to investing in healthcare technology (diagnostic, therapeutic, value-based care delivery incorporating virtual care and virtual clinical trials). Along this journey, John has acquired a multifaceted lens into the co-evolution of healthcare delivery models, clinical research models, and the role of technology in support of the virtuous cycle of accelerating new discoveries and incorporating them into daily clinical practice.
Larissa May, MD, MSPH, MBA, Professor, Emergency Medicine; Director, Emergency Medicine Innovation and External Partnerships; Assistant Clinical Ventures Officer, UC Davis Health
Larissa May, MD, MSPH, MSHS - Dr. Larissa May is Professor of Emergency Medicine and Director of Emergency Department and Outpatient Antibiotic Stewardship at the University of California-Davis. She is a national expert in antibiotic stewardship in the emergency department (ED). Dr. May received her M.D. (2002), her MSPH in Public Health Microbiology and Emerging Infectious Diseases (2008), and her MSHS in Clinical and Translational Research (2013) from The George Washington University. She completed her residency training at the George Washington University in 2006t. Dr. May’s research interests center on the application of rapid molecular diagnostic assays, behavioral economics and clinical guidelines to improve antibiotic stewardship and other patient safety and quality improvement efforts in the ED and urgent care setting. Dr. May has served as an investigator on multiple federally-funded and industry-funded trials evaluating antimicrobial stewardship strategies in the ED and has published over 70 peer-reviewed articles in her field. She has also served on numerous committees and task forces focused on antibiotic stewardship, emergency preparedness, and infectious diseases surveillance for the Centers for Disease Control and Prevention, the National Institutes of Health, and professional organizations including the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America.
Geoff McCleary, Vice President, Global Connected Health, Capgemini
As the VP Global Connected Health Lead at Capgemini, I help healthcare and life sciences executives and companies turn their connected health efforts into value-driving enterprises. An executive leader with over 25 years of experience in leading digital innovation, strategy, and marketing for global clients across the health ecosystem, from pharma and biotech to providers and payers. I am passionate about using emerging technologies and data-driven insights to create meaningful experiences and outcomes for patients, consumers, and physicians. I am a frequent commentator and speaker on the impact of connected health and the future of healthcare, and a board member of the TOPP Foundation, a non-profit organization that supports type 1 diabetes research and families.
Jennifer McClure, Global Portfolio Manager, Custom Antibodies, MilliporeSigma, Diagnostics and Regulated Materials, MilliporeSigma
Jennifer McClure brings 10 years of diagnostic industry experience to the MilliporeSigma Custom Antibodies Portfolio. She has led numerous technologies and products to commercial success in the IVD space. She has a deep understanding of the design process, quality standards, and regulatory requirements that shape the industry. She leverages her experience in global innovation and R&D leadership to deliver services for dynamic customer needs.
Molly McGinniss, Senior Director, Population Genomics and Precision Medicine, Genome Medical
Molly McGinniss, MS, CGC, is Senior Director of Client and Partner Relations for Population Genomics at Genome Medical, a digital health company and specialty medical group focused on genetics and genomics. Through the Genome Medical Precision Insights team, she provides strategic consulting and support services to health care partners developing precision medicine and population genomics programs. She is a board-certified genetic counselor with extensive clinical and commercial experience. Molly began her career as a clinical genetic counselor providing prenatal, pediatric, and adult genetic counseling services. Prior to joining Genome Medical, she led global market development at Illumina for the genetic disease testing clinical segment. Molly received her B.S. in Biology from Loyola Marymount University in Los Angeles, and her M.S. in Genetic Counseling from Boston University. She currently serves as the President of the Accreditation Council for Genetic Counseling (ACGC), having served on the Board of Directors since 2017.
Steve Miller, MD, PhD, CMO, Delve Bio
Dr. Miller is a board-certified clinical pathologist with expertise in microbiology and infectious disease diagnostics. He spent over 15 years as Director of the Microbiology Laboratory at UCSF, where he specialized in development and validation of molecular diagnostic testing for pathogen detection and characterization and pioneered the implementation of metagenomic next-generation sequencing (mNGS) in the clinical laboratory. He joined Delve Bio as Chief Medical Officer to develop mNGS clinical testing in a commercial reference laboratory setting, and aims to improve access to mNGS testing for diagnosis of infections and demonstrate how this novel technology can improve patient care.
Michael Montalto, PhD, CSO, PathAI, Inc.
Dr. Montalto is currently the CSO of PathAI and has deep experience developing digital pathology diagnostic products and driving cutting-edge translational research in a large biopharmaceutical setting. In his current role he responsibility for the global product vision and execution of regulated and non-regulated product development for both Diagnostic and Biopharma segments, as well as the delivery for Biopharma Services. Prior to joining PathAI, Mike was Vice President and Head of Translational Sciences at Bristol Myers Squibb where he and his teams played key roles in the development and commercialization of IHC diagnostic tests and various other biomarker tests in support of all therapeutic areas. Prior to this, Montalto was a co-founder and executive of Omnyx, LLC, a joint venture of GE Healthcare and the University of Pittsburgh Medical Center, which was sold to Inspirata and later Fuji Film. Prior to this, Montalto was the Molecular Imaging and Diagnostics Advanced Technology Leader at General Electric, where he was a lead inventor of MultiOmyx™, a proprietary pathology-based multiplexing technology for biomarker discovery currently on the market through Danaher/Cytiva as CellDive™.Mike has served as a member of NIH study sections for in vivo molecular imaging centers, designed and led global clinical trials for the registration of digital pathology devices and served as a board member and president of the Digital Pathology Association (DPA). Under his leadership, the DPA successfully collaborated with the FDA to establish industry wide regulatory guidance and clinical trial designs for the clinical use of digital pathology devices. Dr. Montalto earned his PhD in tumor biology from Albany Medical College and received his post-doctoral training in anti-inflammatory drug discovery and whole animal physiology at Brigham and Women’s Hospital, Harvard Medical School.
Shawn Mulvaney, PhD, Health Science Administrator, Bioanalytical Sensors Portfolio, National Institute of Biomedical Imaging and Bioengineering
Dr. Mulvaney is a health science administrator working on project applied towards the design and development of biosensors and the next generation of diagnostic devices.
Ronald Myers, PhD, Professor, Division of Population Science, Medical Oncology, Thomas Jefferson University
Ronald E. Myers, DSW, PhD, FSBM is a Professor in the Division of Population Science, Department of Medical Oncology, and Director of the Center for Health Decisions at Thomas Jefferson University. Dr. Myers has been actively involved in cancer prevention and control research for almost 40 years. During this time, he has served as the Principal Investigator of numerous peer-reviewed research grants that have been funded by the National Cancer Institute, American Cancer Society, Centers for Disease Control and Prevention, Department of Defense, and the Patient Centered Outcomes Research Institute. He has published extensively in the field on patient adherence to cancer screening, physician follow-up of abnormal cancer screening test results, and shared decision making related to standard of care cancer screening, MCED test use in cancer screening, cancer treatment, and participation in cancer clinical trials. His research studies have involved health care providers and patients in numerous health systems and has engaged patients from diverse populations.
Rainer Ng, PhD, Head, Technology Development, Baebies, Inc.
Rainer Ng, Ph.D. is the Head of Technology Development at Baebies and oversees all research initiatives at the company. His teams develop enabling technologies to support the company’s product pipeline, as well as advance the capabilities of FINDER, the company's FDA-cleared multifunctional patient testing platform. Rainer has in-depth experience leading research teams to develop solutions for a range of diagnostic use cases, including pathogen detection, sepsis diagnosis, coagulation monitoring and home use devices. In addition to serving in study sections at NIH, Rainer also has had the privilege of working with research entities to develop solutions for a variety of unmet needs, including NIH, RADx, BARDA, and Carb-X.
James Nichols, PhD, DABCC, FADLM, Professor of Pathology, Microbiology, and Immunology; Medical Director, Clinical Chemistry and POCT, Vanderbilt University School of Medicine
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.
Lesley Northrop, PhD, Chief Diagnostic Officer, Everly Health
Lesley Northrop is the Chief Diagnostic Officer at Everly Health. She is a PhD-trained neuroendocrine biologist and a clinically-boarded molecular geneticist. She has spent the past 20 years working in clinical diagnostics, developing high-throughput, high-complexity diagnostic tests that meet clinical unmet need. Lesley's early training started in species survival of the giant panda and moved into developing genomic tests for humans affected with infertility, including early-detection of specific cancers through liquid biopsy detection. She has built and secured CLIA/CAP/NYS-licensure for several clinical dx labs as a licensed laboratory director and acts as a clinical translational scientist from ideation to commercial launch of diagnostic tests.
Jai Pandey, PhD, Head, Global Device Regulatory IVD/CDx and Digital Health, Sanofi
Jai Pandey currently serves as Director of Global Regulatory Strategy IVD at Bayer. Prior to joining Bayer, he worked as a Regulatory Lead at GSK for strategic and innovative precision medicine and digital health approaches. From 2017-2020, Jai was a lead IVD device reviewer at FDA/CDRH. Jai did his postdoctoral training at the Whitehead Institute of MIT. He holds a PhD in Cellular and Molecular Biology from University of South Carolina.
Alpa V. Patel, PhD, Director, Cancer Prevention Study, American Cancer Society
Dr. Alpa V. Patel earned her Bachelor of Science from the University of Florida, her Master of Public Health in Epidemiology from the Rollins School of Public Health at Emory University, and her Doctoral degree in Preventive Medicine with a concentration in Epidemiology from the Keck School of Medicine at the University of Southern California. She is the Senior Vice President of Population Science at the American Cancer Society where she oversees a team of approximately 50 research and study operations staff. These multi-disciplinary scientists use their research expertise in epidemiology and behavioral science to increase the understanding about the causes of cancer and how to improve treatment outcomes after a cancer diagnosis. She also serves as the principal investigator of the Cancer Prevention Studies (CPS) II and 3, providing strategic and operational oversight for the studies, including their biospecimen and data management. CPS-II and 3 are long-term, large-scale, epidemiologic cohort studies established by the American Cancer Society in 1982 and 2006-2013, respectively. Combined, these two cohorts include over 1.5 million participants with a variety of over 400,000 biologic samples (such as blood, buccal cells, saliva, stool, and tumor tissue), and are focused on better understanding cancer risk as well as improving outcomes and quality of life after a cancer diagnosis. Dr. Patel is a recognized leader in the development of population cohort studies and as a cancer epidemiologist, particularly related to physical activity, sedentary behavior, and obesity in relation to cancer risk and survival. She serves on the National Cancer Institute’s Board of Scientific Counselors along with several other national and international scientific advisory committees, is a Fellow of the American College of Sports Medicine, on the editorial board of several cancer-related journals. She has published approximately 250 scientific articles and book chapters, and her research has contributed significantly to national and international cancer prevention guidelines, such as the US Physical Activity Guidelines for Health and the American Cancer Society’s Nutrition and Physical Activity Guidelines for both cancer prevention and cancer survivorship.
Scott Penberthy, PhD, Managing Director, Applied AI, Google Cloud
Scott uses AI to eradicate cancer and help people live longer, healthier lives with simple habits. Cancer will soon become a manageable condition, powered by our ability to understand, debug, and repair the source code of life itself. Therapeutics also become code, customized to the individual, powered by nanoscale physics analyzed by hyperscale AI. The trick? Scott uses AI to model our lives and data as tensors, essentially high dimensional versions of cubes, trapezoids, and more. Healthy lives are paths through these shapes, where machines detect when we drift, then suggest simple actions to keep us moving forward, feeling great and staying healthy. Tensors are the ultimate equalizer, dealing with everything from your weight, resting heart rate, DNA, gut microbiome, x-rays, daily supplements, and Peloton workouts. Scott is inspired by an emergent stack for programming in human language (and Mojo!), purpose built for the AI generation, reasoning and computing with trillions of tensors in milliseconds. Tensor networks, tensor databases, tensor prompts, tensor patterns, tensor generators, and more. This is the Age of Phenomics.
Brad Perkins, MD, CMO, Karius, Inc.
Brad Perkins is a physician, scientist, and entrepreneur. He is the Chief Medical Office at Karius, Inc., a global pioneer in clinical use of microbial cell-free DNA. Previously he was the founding Chief Medical Officer for Human Longevity, Inc. (HLI) where he designed, built and operated the Health Nucleus, a leading precision medicine platform with genomics pioneer JC Venter. Brad served as EVP for Strategy and Innovation and Chief Transformation Officer at Vanguard Health Systems, a multi-state integrated health system in the run-up to its IPO with 46,000 employees and revenue of $6B+ and subsequent sale to another publicly-traded healthcare company. Brad started his career at the Centers for Disease Control and Prevention (CDC) where he led and was involved in many high profile scientific successes and investigations in the US and globally; he led the 2001 US anthrax bioterrorism investigations following 9/11. He served as the Chief Strategy and Innovation Officer at CDC. Brad has an MD and MBA, and is Board-certified in Internal Medicine. He lives and works in San Diego and Redwood City, CA.
Gary Pestano, PhD, Chief Development Officer, Biodesix, Inc.
Dr. Pestano heads the Research and Development organization at Biodesix, a leading diagnostic solutions company. He is the NYS CLEP Laboratory Director of the company’s corporate clinical testing laboratory in Colorado. His greater than 20 years of experience in laboratory and assay development for high complexity molecular diagnostics for oncology includes molecular and proteomic approaches in support of Biodesix Nodify and IQ Lung blood-based tests. Most recently his work has focused on the detection and standardization of testing for cell free nucleic acids as a part of a consortia led by the Friends of Cancer Research. As a critical part of product development Dr. Pestano has fostered innovative key collaborations with leading academic and industry partners across the globe. Prior to Biodesix, Dr. Pestano was at Ventana, a member of the Roche Group, where he led project teams in Pharma Services and in Assay Development. Dr. Pestano received his Ph.D. training at The Graduate Center, City University of New York and conducted his post-doctoral training in cancer immunology at the Dana Farber Cancer Institute, Harvard Medical School.
Jasmine Plummer, PhD, Associate Member, Developmental Neurobiology, St Jude Children's Research Hospital
Dr. Jasmine Plummer, PhD is the founding Director of the Center for Spatial Omics and member of the Comprehensive Cancer Center at St Jude’s Children’s Research Hospital. She is an Associate Professor and cross appointed in the Department of Developmental Neurobiology and the Department of Cellular and Molecular Biology. She received her PhD in Molecular and Medical Genetics at the University of Toronto, Mount Sinai Hospital. Dr. Plummer completed her post doctoral training at Children’s Hospital Los Angeles and University of Southern California and moved into a faculty role at Cedars Sinai where she became a funded PI of the Human Cell Atlas. Dr. Plummer was also co-director of the Genomics Core at Cedars Sinai which focused on generating genomic data for a variety of technologies from single cell and spatial assays to sequencing. Dr. Plummer’s lab uses a mult-iomic approach through single cell and spatial genomics to better understand the pathogenesis of neurodevelopmental disorders and cancer. Since moving to her new role, Dr. Plummer has established one of the first center’s specializing in the application of spatial technologies to a variety of disease types.
Colles Price, PhD, Principal Scientist, Takeda
Colles, an original Baltimore native, did his PhD at the University of Chicago in Cancer Biology. He also holds a Masters in Science from the University of Maryland in Biological Sciences and Masters in Science from the University of Chicago in Translational Science. He is interested in the intersection of basic research, clinical research and translational research. His interest in spatial omics started during his postdoctoral fellowship at the Dana Farber Cancer Institute/Broad Institute with his initial interest in mapping cancer with functional genomics and single cell biology. This developed into a strong passion in spatial omics and he spent two years leading the oncology team at the spatial transcriptomics company Vizgen. From there he went to Takeda to build out spatial omics within the company and use it to help develop new therapeutics and gain critical insight into cancer biology.
Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition
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.
Oscar Puig, PhD, Vice President, Translational Medicine & Diagnostics, Nucleai
Oscar Puig currently holds the position of VP Translational Medicine & Diagnostics at Nucleai, an AI-powered digital pathology and biomarker development company. Prior to joining Nucleai, Oscar held leadership positions at BeiGene, Lilly, BMS, Roche, and Merck, with a focus on biomarkers and diagnostics in oncology clinical development. Oscar holds a PhD in Molecular Biology from the University of Valencia, Spain, and carried out postdoctoral research at EMBL, Germany and UC Berkeley, USA.
Jennifer Quigley, Senior Director, Global Precision Diagnostics, Novartis
Jennifer is a diagnostic business leader with more than 23 years’ experience in the commercial specialty and clinical laboratory business where she held leadership positions in laboratory commercial sales, strategy, and program and product development at Labcorp, PathAI, Genoptix, and Miraca Life Sciences / Caris Life Sciences. Jennifer has advised, designed, launched, and promoted commercial diagnostic tests and diagnostic programs, working along the drug development - diagnostic continuum with drug development and laboratory scientists, pathologists, laboratorians, treating physicians, health system executives, and diagnostic and therapeutic partners. Jennifer has also consulted various lab companies on diagnostic commercialization strategies in the US and Europe. She joined Novartis Pharmaceuticals more than two years ago, leveraging her lab knowledge and experience to assess and establish the ideal health system environment for timely and routine testing decisions and result interpretation by physicians, thus leading to optimal therapeutic decisions. She is passionate about improving patients access to appropriate treatment through access to testing and services. Jennifer studied biology and geology at the University of Pittsburgh and completed certificate programs in strategy, leadership, and negotiation at Carnegie Mellon University Tepper School of Business. She resides in Pittsburgh, Pennsylvania with her wonderful family.
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC
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.
Rajiv Raja, PhD, Executive Director, Translational Research and Innovation, Precision Medicine, Oncology R&D, GSK
Rajiv Raja, Ph.D. is currently an Executive Director leading innovation in Precision Medicine at Glaxo SmithKline. Before joining GSK, Dr. Raja was Senior Director of Translational Medicine Oncology at AstraZeneca where he functioned as the biomarker lead for late-stage lung and bladder cancer programs as well as the Head of Translational Genomics Laboratory. In this role, Rajiv is known for his contributions to the development of ctDNA-based tumor mutational burden (TMB), molecular response (MR) and minimal residual disease (MRD) as biomarkers in solid tumors. Before joining AstraZeneca, Rajiv worked as Biomarker Lead and Head of Clinical Assays and Technologies at Genentech/Roche where he developed biomarker strategies for antibody-drug conjugate (ADC) programs and led a team of scientists and research associates in developing molecular biomarker assays and next-generation technologies for use in clinical trials in collaboration with partners such as Roche Molecular Diagnostics (RMS) and Foundation Medicine. Dr. Raja received his Ph.D. in Molecular Genetics from Oklahoma State University and post-doctoral training at University of Illinois at Urbana-Champaign. He has held positions at the University of California at San Francisco, Lawrence Livermore National Laboratory, Arcturus Biosciences and Molecular Devices and has over 60 peer-reviewed publications and clinical presentations at conferences to his credit.
Stuart C. Ray, MD, Professor of Medicine (Infectious Diseases) and Oncology, Vice Chair of Medicine for Data Integrity and Analytics, Johns Hopkins University School of Medicine
Stuart C. Ray is Professor of Medicine in the JHU School of Medicine in the Division of Infectious Diseases with a secondary appointment in Viral Oncology, Vice Chair of Medicine for Data Integrity and Analytics, Assistant Dean for Research, and Co-Chair of the Research Data Subcouncil of the JHM Data Trust. He is a faculty member of the graduate programs in Immunology, Pharmacology, and Biomedical Informatics & Data Science. Dr. Ray received his MD from Vanderbilt in 1990, then served at Johns Hopkins as resident, chief resident, fellow, and faculty since 1997. His research interest has been the interplay between the human immune system and RNA virus evolution, initially focusing on HIV then hepatitis C virus (HCV) and more recently SARS-CoV-2. His research has been influenced by computational biology; for example, his SimPlot program has been used in thousands of publications including the first publications that described the SARS-CoV-2 genome. His clinical focus is adult inpatients with infectious diseases. He has 7 patents for technologies ranging from vaccine design to point of care diagnostic device technologies. He is a Fellow of the American College of Physicians and the IDSA, and an elected member of the American Society for Clinical Investigation.
Sean Roenspie, Senior Scientist, Custom Antibodies Lead, MilliporeSigma, Diagnostics and Regulated Materials, MilliporeSigma
Sean Roenspie is an expert in molecular biology techniques including assay development, vector design, recombinant PCR methods for gene synthesis and mutagenesis, lentiviral/retroviral transduction, and recombinant protein expression. He developed a stable cell line platform and proprietary vector technology for recombinant antibody production. Sean leads multiple animal welfare projects and oversees the MilliporeSigma Custom Antibody process.
Sandra Waugh Ruggles, PhD, Director, Policy Research, Stanford Byers Center for Biodesign; President, Summit Rock Strategy
Sandra Waugh Ruggles, PhD serves as Director for Policy Research in the Stanford Byers Center for Biodesign Policy Program. She studies policy issues at the intersection of healthcare and innovation. She is also the President of Summit Rock Strategy Consulting where she specializes in leading medtech development teams through early-stage strategic innovation decisions. She holds a PhD from the University of California, San Francisco and was a Stanford Biodesign Innovation Fellow.
Hakan Sakul, PhD, Owner and President, Precision Dx Strategies, Inc.
As former VP and Head of Diagnostics, Dr. Hakan Sakul founded and led Pfizer’s Diagnostics group, with dozens of drug/diagnostics combination approvals in global markets under his leadership. During his 24-year tenure at Pfizer, Hakan also held leadership positions in Clinical Pharmacogenomics, Molecular Profiling, and Translational Oncology. One of his most significant professional accomplishments was to lead Pfizer’s flagship CDx program for Xalkori®, resulting in simultaneous FDA approvals of the drug/diagnostic combination in 2011. Prior to Pfizer, Hakan worked in the biotech industry in human genetics and statistical genetics. Hakan’s contributions to precision medicine and diagnostics have been widely recognized through both internal and external awards and frequent speaking engagements. He is a former member of the Board of The Personalized Medicine Coalition, served as a Scientific Advisory to Luminex Corp, and currently is a Board member of Progentec Diagnostics, as well as BASH Biotech. Hakan is a member of California Gov Newsom’s Precision Medicine Advisory Council. He received his BS and MSc degrees from Ankara University in Turkey, PhD in Quantitative Genetics from the University of Minnesota as a Rotary Foundation Scholar and conducted postdoctoral studies at the University of California-Davis. He has authored over 30 refereed scientific articles as well as many other publications. Hakan is keenly interested in molecular diagnostics, liquid biopsy and related medical technologies to advance Precision Medicine for the improvement of individualized healthcare.
Virginia Savova, PhD, Senior Director & Global Head, Single Cell Biology, Sanofi
Dr. Virginia Savova was trained in Cognitive Science at Johns Hopkins and MIT before joining the genomics revolution at the Broad, DFCI and the Harvard Medical School, where she developed machine learning approaches to epigenetic data, contributed to the first microfluidic single-cell protocol and led on its early clinical applications. She joined Sanofi in 2017 and established a lab combining single-cell omics and artificial intelligence to deconvolve disease and drug mechanisms at the cellular level, focusing initially on immunology. She served as the industry co-chair of Accelerated Medicine Partnership - an NIH initiative which brings together clinicians, academics and industry experts seeking to apply these technologies to a broad range of autoimmune and inflammatory diseases. She is currently the Global Head of Single-cell Biology at Sanofi, leading the application of single-cell techniques across therapeutic areas.
Howard I. Scher, MD, Head of Biomarker Development Program, Member and Attending Physician, Department of Medicine, Memorial Sloan Kettering Cancer Center
Howard I. Scher, MD, FASCO is Head of the Biomarker Development Program and Member and Attending Physician at Memorial Sloan Kettering Cancer Center (MSK); Professor of Medicine at Weill Cornell Medical College; and D. Wayne Calloway Chair in Urologic Oncology. His research focuses on the codevelopment of targeted therapies and biomarkers to guide treatment selection, improve drug evaluation, and accelerate regulatory approvals. Dr. Scher led PCWG2 and PCWG3, international efforts to standardize the design and analysis of prostate cancer trials. Translating insights into molecular and genetic prostate cancer features to the clinic, he led the development of FDA-approved Zytiga and Xtandi. Dr. Scher serves as PI of the NIH SPORE in Prostate Cancer at MSK and the Department of Defense-sponsored Prostate Cancer Clinical Trials Consortium (PCCTC), and received an AACR Team Science Award for his multidisciplinary work developing AR inhibitors. Dr. Scher was elected to the Association of American Physicians.
Brock Schroeder, PhD, Vice President, Market Access, Illumina, Inc.
Brock Schroeder is Vice President of Market Access Illumina, where he leads efforts to generate evidence of clinical and economic utility of current and emerging clinical applications of NGS to support HTA, payer coverage, and patient access to clinical genomic tools. Prior to joining Illumina in 2017, Brock led Medical Affairs at Biotheranostics. Brock’s industry experience includes multiple therapeutic areas, including oncology, rare diseases, and reproductive health. Brock has authored >25 peer-reviewed manuscripts and >50 scientific congress abstracts. He received his BA in Biology from Washington University and his PhD in Neuroscience from University of Wisconsin-Madison.
Shaoline Sheppard, Senior Data Scientist, Data Science, Scailyte
Shaoline holds a Master’s degree in Bioinformatics from the University of Lausanne. Following the completion of her degree, she worked as a Bioinformatician at EPFL for three years, where she gained invaluable experience in the field. In 2021, she joined the dynamic team at Scailyte as a Data Analyst and later on as the data science lead for the endometriosis project. In that position, she spearheaded the data science efforts leading to the discovery of molecular markers for the accurate diagnosis of Endometriosis through a qPCR assay. The assay will now be validated and deployed in clinical laboratories in the USA by HeraBiotech.
Anthony N. Sireci, MD, Senior Vice President, Clinical Biomarkers & Diagnostics Division, Loxo@Lilly
Anthony “Nino” Sireci, MD is the Senior Vice President, Diagnostics Development at Loxo Oncology at Lilly. Dr. Sireci is a board certified Clinical Pathologist and a practicing molecular pathologist. Prior to joining Loxo, he was an Assistant Professor of Pathology and Cell Biology at Columbia University and a medical director in the Laboratory of Personalized Genomic Medicine at Columbia Medical Center. He is an active member of the Association for Molecular Pathology (AMP) where he serves on the organizations’ Strategy Committee and was the former vice chair for new codes and pricing on the Economic Affairs Committee. He is also a member of the Pathology Coding Caucus in the College of American Pathologists (CAP) and the Molecular Pathology Advisory Group in the American Medical Association (AMA). Dr. Sireci received a B.A in chemistry from New York University, an MD from the Johns Hopkins University School of Medicine and a Masters in Biostatistics from the Mailman School of Public Health at Columbia University. He completed his residency training in Clinical Pathology in the New York Presbyterian Hospital-Columbia, where he also served as chief resident.
Gregory Sommer, PhD, Scientific Discipline Director, Alternative Sample Collection, Labcorp
Greg Sommer, Ph.D. serves as an R&D Director and the Scientific Discipline Director for Alternative Sample Collections at Labcorp, overseeing the design, validation, and deployment of new decentralized liquid microsample collection technologies. He joined Labcorp in 2021 following Labcorp’s acquisition of Sandstone Diagnostics, Inc. - a consumer healthcare and diagnostics technology company he co-founded in 2012. He received his Ph.D. in Mechanical Engineering from the University of Michigan in 2008, and previously served as a Staff Scientist in Biodefense Technologies at Sandia National Laboratories from 2008-2012.
Anil K. Sood, PhD, Professor and Vice Chair for Translational Research, Departments of Gynecologic Oncology and Reproductive Medicine; Co-Director, Center for RNA Interference and Non-Coding RNA, MD Anderson Cancer Center
Dr. Anil K. Sood is Professor in the Department of Gynecologic Oncology and Reproductive Medicine at the UT MD Anderson Cancer Center. He is co-director of the Center for RNA Interference and Non-Coding RNA at the M. D. Anderson Cancer Center. He is also Director of the multi-disciplinary Blanton-Davis Ovarian Cancer Research Program and co-leads the Ovarian Cancer Moonshot Program. Dr. Sood received his medical degree from the University of North Carolina, Chapel Hill. A major and consistent theme of his scientific research has been on understanding human cancer biology and converting lab discoveries into novel therapeutics. His research group has made several seminal research contributions in the fields of tumor microenvironment, nanomedicine, and neuroendocrine effects on cancer biology. Dr. Sood has received recognition for his research accomplishments including the Hunter Award, and the GCF/Claudia Cohen Research Foundation Prize for Outstanding Gynecologic Cancer Researcher. He is an elected member of the American Society for Clinical Investigation (ASCI), the American Association for the Advancement of Science (AAAS), and the Association of American Physicians (AAP). Dr. Sood was selected as an American Cancer Society Research Professor in 2017 and was elected to the National Academy of Medicine (NAM) in 2021.
Sudhir Srivastava, PhD, Chief, Cancer Biomarkers Research Group, NIH NCI
Dr. Srivastava is Senior Scientific Officer and Chief of the Cancer Biomarkers Research Group in the Division of Cancer Prevention, National Cancer Institute. He joined the National Cancer Institute in 1988. Since 1990, he has served as program director in the Division of Cancer Prevention and focused his responsibility in developing molecular approaches to cancer early detection, screening and prevention. He has conceptualized and implemented several programs to study the biology and early detection of precancer lesions, with a primary emphasis on translational research on cancer screening, early detection, risk assessment and enabling technologies including artificial intelligence (.https://prevention.cancer.gov/research-groups/cancer-biomarkers/about-cancer-biomarkers) Dr. Srivastava is an internationally recognized leader in cancer biomarker research. He is best known for his seminal contributions to improving systems approach to biomarker discovery, development and validation. In 2000, Dr. Srivastava developed and implemented a novel approach to collaborative clinical research on cancer biomarkers through the establishment of the Early Detection Research Network (EDRN; www.cancer.gov/edrn ), a flagship program at the National Cancer Institute, National Institutes of Health. Under his leadership the network has begun translating biomarkers into clinical tests (> 8 FDA approved and > 13 CLIA certified) for early detection and diagnosis, risk assessment, and prognosis. He has spearheaded the role of chemical sciences in oncology by establishing the NCI’s Alliance of Glycobiologists (www.glycomics.cancer.gov) v to study the structure-function relationship of glycans, AI for improving prediction, noninvasive technologies, such as liquid biopsy to multi-analyte, multi-cancer screening, and biomarkers in cancer detection and diagnosis of rare cancers, such as pancreas, liver and ovary. He has played a key role in conceptualizing and implementing informatics infrastructure for the EDRN in collaboration with NASA (Jet Propulsion Laboratory), a model collaboration being followed elsewhere in NIH. Dr. Srivastava is best known for his work on developing medical guidelines on the diagnosis of Hereditary Non-polyposis Colorectal Cancer (HNPCC). He played a pivotal role in the development of the Bethesda Guidelines for diagnosing HNPCC, which is in clinical practice world-wide. He has received several honors and awards and is a member of a number of scientific committees world-wide. In 1995, he was elected to the American Joint Committee on Cancer (AJCC) which is responsible for developing staging criteria for cancers for worldwide use and currently serves on the AJCC Executive Committee. He has been a visiting Professor at several medical and academic institutions and has delivered several inaugural and keynote addresses. In 2017, he was appointed as an inaugural head of the Human Proteome Organization’s External Development Initiatives (HEDI; www.hupo.org ). He has delivered lectures as a Keynote Speaker in more than 150 professional meeting and was invited in 2013 by the US Congress to speak on the early detection research programs at NCI. Currently, he is serving on the Planning Committee of the National Academies of Science to host a workshop on screening and early detection in 2020. He is founding Editor-in Chief of the journal Cancer Biomarkers) https://www.iospress.nl/journal/cancer-biomarkers) published by the IOS press and serves as Associate Editors and reviewers for several internally know journals. He has published more than 200 research papers, review articles and commentaries in peer reviewed journals. He has edited several monographs and five book: Early Detection of Cancer: Molecular Markers, published by the Futura Publishing Company in 1995 and Molecular Pathology of Cancer, published by IOS Press, Amsterdam in 1999; Informatics in Proteomics (2005) published by Francis and Taylor, New York; Translational Pathology of Early Cancer (2012), published by the IOS Press and Biomarkers in Cancer Screening and Early Detection, published by Wiley, New York, 2017. Dr. Srivastava has received numerous NCI and NIH awards for his leadership in biomarker research and received a Team Science Award for Informatics by the Jet Propulsion Laboratory, NASA for his visionary and innovative use of NASA Data System Technologies in biomedical science. In 2016, he received a Cancer Prevention Distinguished Alumni Award for his accomplishments and mentoring of fellows. Recently, he was awarded Distinguished Public Service Award (2016) by the American Pancreatology Association and a Distinguished Clinical and Translational Proteomics Award (2017) by HUPO International the Distinguished Alumni Award (2016), Cancer Prevention Fellowship Program, NCI . He was featured in Wired magazine in August 2003 for his leadership in cancer diagnostics. He has been planning and managing comprehensive extramural scientific programs for more than 26 years. In 2016, he was invited to brief the US Congress on progress made on biomarkers for cancer early detection. He has successfully managed several mission-critical goals of the National Cancer Institute at various fronts including conceptual, infrastructure, dependency linkage, and coordination among various federal, academic and private sector constituents. He has successfully developed partnerships with National Institute of Standards and Technology, DOD’s Center for Prostate Disease Research, DOE’s Pacific Northwest National Laboratory and Jet Propulsion Laboratory on shared interests. In addition, he has developed collaborations with international and non-profit foundations, such as Japan’s Agency for Medical Development and research, CR-UK, Chinese National Cancer Institute, PanCAN, Lustgarten and Kenner’s Family Research Foundation.
Eric Stahlberg, PhD, Director, Cancer Data Science Initiatives, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Rockville, Maryland, USA
Dr. Eric Stahlberg now directs cancer data science initiatives at the Frederick National Laboratory, having led and launched several initiatives at the lab. He has been instrumental in establishing the Frederick National Laboratory’s high-performance computing initiative and in assembling scientific teams across multiple, complex organizations to advance predictive oncology. Stahlberg first joined the Frederick National Laboratory in 2011 to form and direct the National Cancer Institute’s Center for Cancer Research Bioinformatics Core, which helped build intramural research collaborations between the national laboratory and the National Cancer Institute. Since then, Stahlberg has played a leadership role in many key partnerships, including a major collaboration between the National Cancer Institute and the Department of Energy. Under the Joint Design of Advanced Computing Solutions for Cancer (JDACS4C), the National Cancer Institute and Department of Energy are accelerating progress in precision oncology and computing. The collaboration is rooted in three major national initiatives; the Precision Medicine Initiative, the National Strategic Computing Initiative, and the Cancer Moonshot. He has helped lead initiatives to transform data management approaches at the lab as well as more recently leading program efforts exploring the application biomedical digital twins for cancer applications. Stahlberg has spearheaded the Frederick National Laboratory’s contributions to a number of JDACS4C projects, including ATOM and CANDLE. He helped launch the annual meeting series, Frontiers in Predictive Oncology and Computing, and co-organizes the annual Computational Approaches for Cancer and HPC Applications of Precision Medicine workshops. In 2017, he was recognized as one of FCW‘s Federal 100. Stahlberg holds a Ph.D. in computational chemistry from The Ohio State University.
Kari Stefansson, MD, PhD, CEO, deCODE genetics
Kari Stefansson MD, PhD is a founder and CEO of the Icelandic biotechnology company deCODE genetics. He pioneered the use of population genetics in the study of human diversity. The population approach he advanced in Iceland has served as a model for large scale genome projects around the world. Before founding deCODE in 1996 Dr. Stefansson was a professor of neurology, neuropathology and neuroscience at Harvard Medical School. Dr. Stefansson is an International Member of the US National Academy of Sciences, he is a member of the European Molecularbiology Organization (EMBO) and he is the recipient of the American Society of Human Genetics (ASHG) William Allan Award, the European Society of Human Genetics Award, the Anders Jahre Award, the Federation of European Biomedical Societies Sir Hans Krebs Medal, the European Heart Association Gold Medal, the World Glaucoma Association Award, the American Alzheimer’s Association’s Inge Grundke-Iqbal Award, the Wallace H. Coulter Distinguished Award, International KFJ Award from Rigshospitalet in Denmark, and the Jakobus Award. Chosen by Time magazine as one of the 100 most influential men of the year for 2007 (Time100 list for 2007), chosen 2007 by Newsweek as one of the 10 most important biologists of the 21 century, Chosen by BusinessWeek as one of the stars of Europe in 2000 at the forefront of change, on the Reuter´s/Thompson´s list of the world´s 10 most cited scientists of 2010, Clarivate Analytics 2016, 2017 and 2018 Highly Cited Researcher in molecular biology and genetics, Clarivate Analytics 2019 and 2020 Highly Cited Researcher Cross-Field.
Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories
Ester Stein is Director of Corporate Reimbursement and reports into Abbott’s Government Affairs’ office which is based in Washington DC. 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.
Andrea L. Stevens, PhD, Director, Precision Medicine Access Strategy, Janssen Pharmaceuticals, Inc.
Andrea is passionate about Precision Medicine and the role that quality testing plays in providing patients access to life changing medicines. She joined Janssen in March 2020, following 7 years in market access consulting, culminating in her appointment as Director of Value and Access at WG Group. Andrea was previously a member of the Scientific Affairs team at Quest Diagnostics Clinical Trials focused on genetic testing. Andrea holds a PhD in Transplantation Immunobiology from University College London and studied at the Anthony Nolan Research Institute.
Timothy Sweeney, PhD, Co-Founder & CEO, Inflammatix, Inc.
Tim Sweeney, MD, PhD, is co-founder and CEO of Inflammatix. Tim has extensive experience in medical practice (general & trauma surgery), bench research, and bioinformatics/machine learning. While training at Stanford he helped invent the core technology on which Inflammatix is based, is named on over a dozen patents related to medical diagnostics, and has published >100 manuscripts & abstracts. He is PI (through Inflammatix) on multiple development contracts from DARPA, BARDA, and NIH, and brought Inflammatix to recognition as the ‘Most Disruptive Technology’ at AACC in 2019, and the “Fierce 15” list in 2020.
Sarah Thibault-Sennett, PhD, Senior Director, Reimbursement Policy, American Clinical Lab Association
Sarah Thibault-Sennett joined ACLA in April 2023 as Senior Director of Reimbursement Policy. Sarah was previously the Director of Public Policy & Advocacy at the Association for Molecular Pathology (AMP). Her areas of expertise focus on coding, coverage, and reimbursement issues affecting molecular diagnostic tests. Additionally, she has a strong background in patient engagement and regulatory issues affecting molecular pathology. She has a PhD in Molecular and Cell Biology from the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD, and a background in molecular genetics and developmental biology. She moved into public policy with the goal of increasing patient access to appropriate diagnostic testing.
Eric Topol, MD, Founder and Director, Scripps Research Translational Institute; Executive Vice President and Professor, Scripps Research
Eric Topol is the Founder and Director of the Scripps Research Translational Institute, Professor, Molecular Medicine, and Executive Vice-President of Scripps Research. He has published over 1,200 peer-reviewed articles, with more than 325,000 citations, elected to the National Academy of Medicine, and is one of the top 10 most cited researchers in medicine. His principal scientific focus has been on individualized medicine using genomic, digital and A.I. tools. He authored three bestseller books on the future of medicine: The Creative Destruction of Medicine, The Patient Will See You Now, and Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again. Topol is the principal investigator to two large NIH grants, the All of Us Research Program that supports precision medicine and a Clinical and Translational Science (CTSA) Award that promotes innovation in medicine. He was the founder of a new medical school at Cleveland Clinic (Lerner College of Medicine), was commissioned by the UK to lead a review of their National Health Service, and is active clinically as a cardiologist. Additionally, Topol is Editor-in-Chief of Medscape, publishes the Substack newsletter “Ground Truths, “and maintains a strong presence on social media on Twitter (@erictopol) with over 680,000 followers.
Nam K. Tran, PhD, Professor, Pathology and Laboratory Medicine, University of California, Davis
Dr. Tran is a board-certified High Complexity Laboratory Director specializing in clinical chemistry and point-of-care testing. He holds the prominent position as Professor and Senior Director of Clinical Pathology at the UC Davis Health and Director of both the Pathology Biorepository and the new UC Davis Center for Diagnostic Innovation which he helped establish. In 2023, he also serves as Chair for the AACC Northern California Section, and Chair-Elect for the AACC Critical and Point-of-Care Testing Division. His research interest lies in acute care settings, particularly in the field of point-of-care testing, clinical chemistry, and molecular diagnostics. More recently, he has been at the forefront of incorporating artificial intelligence and machine learning into point-of-care testing-playing a significant role in the development of an automated ML software which has resulted in a UC Davis equity-owned start-up company. During the challenging period of the COVID-19 pandemic, he led the SARS-CoV-2 testing efforts at UC Davis Health where he played a role in deploying several POC emergency use-authorized COVID-19 tests, but also invented one of the first machine learning-enhanced mass spectrometry methods for identifying patients with COVID-19, showcasing his expertise in the field of in vitro diagnostic innovation.
Courtney Noah Vagnone, PhD, Vice President, Scientific Affairs, BioIVT
Courtney Noah, PhD, is BioIVT's Vice President of Scientific Affairs. She leads a team that provides solutions for BioIVT’s clients and business partners. With a broad knowledge of life science applications and a keen understanding of business strategy, Dr. Noah has successfully expanded BioIVT's portfolio and increased brand awareness. Previously, Dr. Noah served as BioIVT's head of marketing and director of research and development for the cell and gene therapy business unit. She was also a senior marketing manager for Enzo Life Sciences and a senior scientist at Pall Corporation. Dr. Noah received her PhD in Molecular and Cellular Biology from Stony Brook University, and her BS is in Food Science from Cornell University.
Pankaj Vats, PhD, Senior Bioinformatics/Genomics Scientist, NVIDIA
Pankaj Vats Sr. Bioinformatics/Genomics Scientist NVIDIA Pankaj Vats, PhD, is a highly accomplished and experienced Bioinformatics/Genomics Scientist at NVIDIA, with a passion for leveraging cutting-edge technologies to advance genomics research and precision medicine. His expertise lies in the research and development of innovative applications for the analysis of large, complex genomic datasets, utilizing NVIDIA's advanced AI, high-performance computing, and data analytics capabilities to accelerate high-accuracy genomics workflows. He operates as a distinguished expert in genomics and has contributed significantly to the scientific community with his outstanding research in the field of cancer genomics and precision medicine, where his research has significantly impacted the field.
Jithesh Veetil, PhD, Senior Program Director, Digital Health & Technology, Medical Device Innovation Consortium
Jithesh Veetil, PhD, serves as the Senior Program Director of Digital Health and Technology portfolio at the Medical Device Innovation Consortium (MDIC). His prime focus at MDIC is to aid in the development of regulatory science resources and regulatory grade tools working collaboratively with government and industry stakeholders in an effort to advance solutions that promote patient access to innovative medical technologies. Jithesh’s current portfolio at MDIC includes projects in Medical Device Cybersecurity, Medical Extended Reality (MXR), Software as/in Medical Devices (SaMD/SiMD), Computational Modeling & Simulation (CM&S), and Digital Pathology. Previously, Jithesh worked with Global Biological Standards Institute (GBSI), a Washington DC based non-profit as its Scientific Program Manager, leading the development and implementation of multiple programs on science policy, communications, and advocacy, including those related to cell line authentication, antibody validation, and reproducibility in biomedical research and development. Jithesh has extensive experience in designing and development of programs towards modernizing scientific workforce and practices by building academic-industrial-nonprofit collaboration through his work at National Institutes of Health (NIH) campus as the Lead Scientist and Program Manager for the Foundation for Advanced Education in the Sciences (FAES). Jithesh also served as the Operations Manager for Preludesys Inc., working with international clientele from medical, IT, insurance and paralegal organizations on medical/healthcare data management. Jithesh completed his PhD in Biomedical Engineering at University of Arkansas, Fayetteville, AR, followed by postdoctoral fellowship at NIH. He has published numerous peer-reviewed manuscripts, reviews and book chapters.
Jeffrey Venstrom, MD, CMO, GRAIL
Jeffrey M. Venstrom, MD, is a physician-scientist specializing in drug and diagnostic product development, with expertise in oncology, hematology, and immunology. Dr. Venstrom is currently the Chief Medical Officer at GRAIL, where he leads the medical and laboratory teams overseeing the launch and implementation of a first-in-class, blood-based multi-cancer early detection test. Prior to joining GRAIL, he served in many roles at Roche / Genentech, across early- and late-stage drug and diagnostic development, including as Senior Vice President, Head of Clinical Development and Medical Affairs at Foundation Medicine, Chief Medical Partner and VP of Medical Affairs at Genentech, and Global Head of the Hematology Biomarker Research Franchise across Roche / Genentech. Dr. Venstrom practiced Medical Oncology and led a medical research laboratory in the Department of Medicine at The University of California, San Francisco, where he was the Krishnamurthi Endowed Chair of Hematologic Malignancies. He completed his oncology clinical and cancer immunology research training at Memorial Sloan-Kettering Cancer Center in New York, his internal medicine training at The Johns Hopkins Hospital, medical and bachelor’s degrees at Vanderbilt University, and additional research training at the National Institutes of Health.
John Warren, Owner and Principal Consultant, Gettysburg Healthcare Consulting, LLC
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.
Keith Wharton, Jr, MD, PhD, Global Medical Affairs Leader - Pathology, Roche Diagnostics Solutions
In his current role with Roche Diagnostics, Keith supports digital pathology and multiplexing as part of a global medical affairs team. A licensed physician and board certified pathologist, Keith completed an MD/PhD in Molecular Biology from UCLA, a postdoctoral fellowship and pathology residency at Stanford, then served as a faculty, principal investigator, and ultimately as Associate Dean at UT Southwestern. Keith has held a variety of roles in drug and diagnostic development since joining the industry in 2009, authoring several publications, reviews, and a book on molecular histopathology and tissue biomarkers. Throughout his career he has used molecular biology, tissue staining, and microscopy to reveal molecular mechanisms in normal and diseased tissues. He is passionate about education and mentoring, and hopes to apply spatial multi-omics and artificial intelligence to create next generation pathology diagnostics.
Julie Wiedower, Director, Medical Affairs, Managed Care, Guardant Health
Julie is a certified genetic counselor and has over 11 years of experience in genetics services in a laboratory, hospital, and health plan vendor setting. She has specialized in utilization management to increase access to appropriate genetic testing across health care, achieving a savings of $500,000 from modification or cancellation of inappropriate genetic testing at one pediatric center. She has reviewed prior authorizations, crafted genomics coverage policies, and is currently the Senior Director of Medical Affairs for Managed Care for a cancer diagnostics lab specializing in liquid biopsy. Julie is pursuing her PhD in Healthcare Genetics with a focus on the attributes of the "Value of Genomic Testing." Her passion lies in speaking enthusiastically and effectively to multiple stakeholders while advocating for increased access to quality genetics care and forming partnerships between providers, institutions, health plans, and laboratories.
Stephen T. C. Wong, PhD, Chair & Professor, Houston Methodist Hospital and Weill Cornell Medical College
Stephen T.C. Wong, Ph.D., P.E., FIEEE, FAIMBE, FIAMBE, FACMI, FAMIA, FAAIA, is the John S. Dunn Sr. Presidential Distinguished Chair, the founding Chair of Systems Medicine and Bioengineering, Director of the T.T. & W.F. Chao Center for BRAIN, and Associate Director of Neal Cancer Center, Houston Methodist Hospital. He is a Professor of Radiology, Neurosciences, Pathology, and Laboratory Medicine of Cornell University. Previously he was a professor at Harvard and UCSF and held executive leadership positions with Philips Healthcare and Charles Schwab. His laboratory investigates mechanisms, diagnostic, and therapeutic of cancer and neurological disorders.
Christopher W. Woods, MD, MPH, Professor, Medicine, Global Health & Pathology, Duke University
Dr. Woods is the Executive Director of the Hubert-Yeargan Center for Global Health; Associate Director of the Center for Applied Genomics and Precision Medicine; professor in the Departments of Medicine and Pathology at Duke University; an adjunct professor in Epidemiology at the University of North Carolina at Chapel Hill School of Public Health; and an adjunct professor in the Emerging Infections Program at the Duke-National University of Singapore Graduate Medical School. Clinically, he serves as Chief of Infectious Diseases Durham VA Health System. Dr. Woods has published over 210 peer-reviewed articles and has a particular interest in the diagnostic capacity in the developing world and the epidemiology of emerging and re-emerging infectious diseases. As an infectious diseases clinician and medical microbiologist, his approach to host genomic response has been called a paradigm shift in the field of infectious disease diagnostics.
Alexander Xu, PhD, Instructor, Biomedical Sciences, Cedars Sinai Medical Center
Dr. Alexander Xu is an Instructor at Cedars-Sinai Medical Center, and the Associate Director of the Spatial Molecular Profiling Shared Resource. He is interested in the spatial biology of tumor microenvironments, with a focus on lymphoma. He is also interested in bioinformatic tools for spatial analysis and T-cell receptor sequence analysis. He received his PhD from Stanford in 2015 in Materials Science and Engineering, and did postdoctoral training at Caltech and Institute for Systems Biology. He is currently an NCATS KL2 fellow.
Paul Yager, PhD, Professor, Department of Bioengineering, University of Washington
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, the Washington State Academy of Sciences, and NAI. Specifics are at http://faculty.washington.edu/yagerp/. He is also a co-founder and CSO of UbiDX, a startup in home diagnostics and healthcare.
Shaun Yang, PhD, Associate Clinical Professor, Director, Molecular Microbiology and Pathogen Genomics Laboratory, University of California, Los Angeles
Dr. Yang is a molecular biologist and clinical microbiologist, with extensive experience in clinical microbiology, clinical virology, molecular diagnostics, microbial genomics, genomic epidemiology, antimicrobial resistance, and transplant infectious disease diagnostics. He is also a pioneer in the clinical applications of Next-generation Sequencing (NGS) in infectious diseases. Dr. Yang developed and implemented numerous cutting-edge molecular microbiological tests, and authored or coauthored over 70 peer-reviewed papers and 2 book chapters. Dr. Yang currently is an Associate Clinical Professor in the Department of Pathology and Laboratory Medicine, UCLA School of Medicine, and serves as the Associate Medical Director of the Clinical Microbiology Laboratory. Dr. Yang is also the Director of the Molecular Microbiology and Pathogen Genomics (MMPG) Laboratory, which integrates the most advanced NGS technologies with pathogen-focused bioinformatics for microbial whole-genome sequencing (WGS) and metagenomics testing, solving the unmet clinical needs in diagnosing and treating challenging infectious diseases cases. The MMPG Laboratory also performs real-time institution-level microbial genomic surveillance for outbreak investigation, emerging pathogen characterization, and AMR monitoring, providing timely and highly actionable information to guide infection prevention and treatment optimization. Dr. Yang graduated from Beijing University with a B.S degree in Biotechnology in 2001, and from the University of Southern California with a Ph.D. degree in Molecular Biology and Biochemistry in 2006. He received Clinical and Public Health Microbiology Fellowship training at UCLA (2014-2016) and became board certified by the American Board of Medical Microbiology (ABMM) in 2016. Dr. Yang's main research interests include molecular diagnostics test development and innovation, clinical applications of NGS, transplant-related infectious diseases testing, genomic epidemiology, hospital outbreak investigation, and antimicrobial resistance (AMR) mechanisms and genotypic prediction. Dr. Yang also works closely with international collaborators in the investigation and monitoring of global emerging infectious diseases and novel AMR mechanisms. He is an advocate and public speaker for vaccines, infection prevention, drug resistance and preparedness for emerging outbreaks in the community. He is also an enthusiastic educator to promote the science of microbiology and infectious diseases to the public and younger generation.
Eugene Yeo, PhD, MBA, Professor, Cellular and Molecular Medicine, University of California, San Diego; Founding Member, Institute for Genomic Medicine
Gene Yeo, PhD, MBA is a Professor of Cellular and Molecular Medicine at the University of California San Diego (UCSD), a founding member of the Institute for Genomic Medicine and member of the UCSD Stem Cell Program and Moores Cancer Center. Dr. Yeo has a BSc in Chemical Engineering and a BA in Economics from the University of Illinois, Urbana-Champaign, a Ph.D. in Computational Neuroscience from Massachusetts Institute of Technology and an MBA from the UCSD Rady School of Management. Dr. Yeo serves as Co-Director of the Bioinformatics and Systems Biology Graduate Program and Associate Director of a Genetics T32 training program at UCSD. Dr. Yeo is a computational and experimental scientist who has contributed to RNA biology and therapeutics. His primary research interest is in understanding the importance of RNA processing and the roles that RNA binding proteins (RBPs) play in development and disease. Since inception, Dr. Yeo’s lab has focused on uncovering molecular principles by which RBPs affect gene expression, how RBP-mediated post-transcriptional gene networks contribute to cellular homeostasis in stem cells and the brain, and how mutations in RBPs lead to human developmental and neurodegenerative disease. His lab pioneered computational algorithms and experimental methods in human disease-relevant systems to conduct systematic and large-scale studies. These multidisciplinary methods combine machine learning, biochemistry, molecular biology, genomics, chemistry and materials research. His lab develops methods that are systematic, robust and adoptable, such as enhanced CLIP for the purposes of large-scale mapping of protein-RNA interactions (Van Nostrand et al, Nature Methods, 2016). Gene’s lab is a major contributor of resources to study RBPs that enable hundreds of labs across many areas of bioscience, such as the world’s largest resource of RBP-specific antibodies that facilitated generation and interpretation of the most comprehensive maps of RBP-binding sites to date for hundreds of RBPs (Van Nostrand et al, Nature, 2020). They have also systematically uncovered RBPs that condense into RNA granules during stress and demonstrated strategies to leverage these for therapeutic use in neurodegeneration (Markmiller et al, Cell, 2018; Fang et al, Neuron, 2019; Wheeler et al, Nature Methods, 2020). His lab also demonstrated in vivo RNA targeting with CRISPR/Cas proteins (Nelles et al, Cell, 2016) with proof of concept in repeat expansion disorders (Batra et al, Cell, 2017; Batra et al, Nature Biomedical Engineering, 2020). Recently his lab has developed the STAMP technology (Brannan et al, Nature Methods, 2021) which is the first transcriptome-wide method for identify RNA binding protein sites and translation measurements at single-cell resolution. Work from the Yeo lab has been highlighted in Nature Methods and Nature Reviews Genetics as “Method to Watch” and featured as a top story in Discover magazine. These efforts have led to clinical programs to develop medicines for RNA-related diseases.Dr. Yeo has authored more than 200 peer-reviewed publications including invited book chapters and review articles in the areas of neurodegeneration, RNA processing, computational biology and stem cell models; and served as Editor on two books on the biology of RNA binding proteins. Gene is on the Editorial Boards of the journals Cell Reports, Cell Research and eLife, and on the Advisory Board of Review commons. Gene joined UCSD as an Assistant Professor in 2008, was promoted with tenure to Associate Professor in 2014 and to Professor in 2016. Gene was the first Crick-Jacobs Fellow at the Salk Institute (2005-2008). Other awards include the Alfred P Sloan Fellowship in recognition of his work in computational molecular biology (2011), Alpha Chi Sigma-Zeta Chapter Krug Lecturer (2016), Singapore National Research Foundation Visiting Investigatorship Award (2017), the inaugural Early Career Award from the International RNA Society (2017), the Blavatnik National Award Finalist (2018 & 2019), San Diego Xconomy Awardee for ‘Big Idea’ (2019) and Highly Cited Researcher in Cross-Field category (2019, 2020, 2021), recognizing the world’s most influential researchers of the past decade. Gene is also a Paul Allen Distinguished Investigator (2020) and received the 2021 Elisa Izaurralde Award for Innovation in Research, Teaching and Service from the RNA Society. Gene is a co-founder of biotech companies which includes Locanabio, Eclipse Bioinnovations, Enzerna, Proteona, Trotana and Circ Bio. Gene serves or had served on the scientific advisory boards of the Allen Institute of Immunology, Locanabio, Eclipse Bioinnovations, Proteona, CircBio, Aquinnah, Cell Applications, Tecan, LGC, Sardona Therapeutics, Ladder Therapeutics, Insitro, Trotana, Nooma and Ribometrix. Gene is a senior advisor to Accelerator Life Sciences Partners. Gene’s lab has current or previous support from the National Institute of Health, National Science Foundation, California Institute for Regenerative Medicine, TargetALS, ALS Foundation, Department of Defense, Myotonic Dystrophy Association, Myotonic Dystrophy Foundation, Chan-Zuckerberg Initiative, Takeda, Genentech and Roche.
Hoi-Ying Elsie Yu, PhD, System and Core Laboratory Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Health System
Dr. Elsie Yu is a Medical Laboratory Director at Geisinger Health System with a system leadership role in Clinical Chemistry, Immunology, Toxicology and Point-of-Care Testing. She is also a Clinical Associate Professor at Geisinger Commonwealth School of Medicine. In 2016, she was named “40 Under Forty Top Five” by American Society of Clinical Pathology. Outside of Geisinger, she has participated at various special project committees (e.g. CLSI, NKF and AACC committees) to promote proper laboratory utilization. Since she joined Geisinger in 2010, Geisinger has grown from a two- to nine-hospital system with over 80 clinics. During this rapid growth, she has integrated different hospitals and clinics to the Geisinger Health System through consolidation and standardization to enhance testing services. Her main interest is to improve laboratory test utilization and operational efficiency. Much of her work requires extensive collaboration with clinical providers to achieve system standardization and clinical effectiveness. Two such examples include her effort to - curb the opioid epidemic with enhanced urine drug testing program and decision support - improve ED throughput and transform cardiac care by implementing high sensitive troponin She earned her PhD in Cellular and Molecular Biology at University of Wisconsin - Madison, completed her clinical fellowship at Boston’s Children Hospital. She is board-certified by the American Board of Clinical Chemistry.
Noah Zimmerman, PhD, Vice President, Translational Science, Tempus
Noah Zimmerman is Vice President of Translational Science at Tempus, where he oversees Research & Development for the Cardiology business. Prior to joining Tempus, Dr. Zimmerman was an Assistant Professor at the Icahn School of Medicine at Mount Sinai, and director of the Health Data and Design Innovation Center. His research is aimed at improving decision-making in healthcare by developing and deploying methods to analyze large volumes of heterogeneous data. He is the author of numerous peer reviewed scientific articles, a textbook on measures for digital medicine, and a children’s blockchain board book. He received his Ph.D. from Stanford University in Biomedical Informatics and a B.S. in Computer Science and Philosophy from the University of Maryland, College Park.
Maryellen de Mars, PhD, Program Director, Clinical Diagnostics, Medical Device Innovation Consortium
Maryellen de Mars recently joined MDIC in the role of SRS Technical Project Manager. Before joining MDIC, Dr. de Mars worked at Integrated Nano-Technologies, Inc. (INT) where she led efforts towards regulatory approval and market launch of a novel molecular platform for detection of COVID-19. Prior to INT, Dr. de Mars led the business unit at ATCC focused on standards and related services supporting life science research and development. While at ATCC, she served as an industry representative in early MDIC SRS efforts to help mold and define the current project. Prior to ATCC, Dr. de Mars served as COO and VP of Clinical Operations at USDS, Inc., an independent third party evaluating the performance of molecular diagnostic tests to support regulatory, reimbursement and adoption efforts. She also served as Director, Clinical Biomarkers at Critical Path Institute (C-Path), leading collaborative efforts to evaluate and improve the utility of clinical biomarkers and optimize the pathway for development of companion diagnostics. She served as Executive Director of Genomics Services at Gene Logic, Inc. as well as Director of Gene Logic’s biorepository. Dr. de Mars led business development and marketing efforts for several product lines at Life Technologies, Inc., now ThermoFisher. Dr. de Mars holds a BA from Smith College and a PhD in virology from the University of Texas.
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