演講嘉賓

With over 20 years in device and IVD reimbursement policy, Charlie is an expert in US federal health policy and reimbursement, with a focus on fee-for-service Medicare payment policy and related processes for in vitro diagnostics and devices. Currently, she leads US and OUS public policy and reimbursement initiatives for Beckman Coulter Diagnostics, a Danaher company. Since 2016, Charlie has held similar roles across various Danaher Diagnostics Operating Companies. Before joining Danaher, she spent nearly 15 years at Roche Diagnostics Corporation, focusing on US health policy and reimbursement strategies. Charlie's overarching career objectives remain dedicated to ensuring patients and clinicians have access to essential clinical diagnostic laboratory tests and medical devices.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Arshad is a founder of Zaylan Associates, a strategy consulting practice specializing life sciences and healthcare as well as digital innovation. Arshad’s experience in life sciences spans across the entire continuum of life sciences from early research, translational, clinical trials, , commercial and patient/physician engagement including technologies such as genomics, proteomics, cell biology, imaging and novel digital approaches. He has led the incorporation of novel AI techniques such as Consilience.ai into his strategy consulting practice. This novel AI approach is the only peer reviewed technique that has been pressure tested to predict the direction of science. Arshad started his career as an Analyst with Boston Consulting Group back in the 90s and founded several strategy consulting including Scientia Advisors which was a specialized strategy consulting group focused on life sciences which got acquired by Precision Medicine Group. Arshad served as the Vice President of Strategy and Business Development at Danaher where he and his team developed the strategy and business case for transformative acquisitions such as Pall Corporation which enabled Danaher’s entry into Bioprocessing. He has led Oncology Solutions for Philips as well as Digital Solutions including Cell & Gene Therapy Solutions at Avantor. He led several digital initiatives as a consultant to the Disruptive Technologies group at Novartis Oncology. During his consulting career, he has advised multinationals as well as startups in Pharmaceuticals, Life Sciences Tools, Diagnostics, Medtech, and Digital Health Informatics sectors, including but not limited to Danaher, Novartis, Philips, Avantor, Dow Chemicals, Pfizer, Astrazeneca, Sigma-Aldrich, Qiagen and numerous other companies. Arshad holds a BS in Electrical Engineering and Computer Science from the University of Illinois and an MBA in Finance and Business Strategy from the University of Chicago.

• Liquid Biopsy for Disease Management

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.

• Early Cancer Surveillance

Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). For over 25 years, Friends has created unique scientific partnerships, accelerated policy change, and supported groundbreaking research to deliver new therapies to patients quickly and safely. As a key thought leader on issues related to the U.S. Food and Drug Administration, healthcare, and regulatory policy, he is regularly published in prestigious medical journals and policy publications and has contributed his expertise to the legislative process on multiple occasions. Recent Friends initiatives include the establishment of the Breakthrough Therapies designation, innovative research consortia to enhance biomarker development, and the launch of a unique cross-sector partnership to accelerate clinical trial conduct and rapidly assess if a patient’s treatment is working. Jeff received his Ph.D. in cell and molecular biology from Georgetown University and holds a Bachelor of Science in Biology from Bowling Green State University.

• Clinical Biomarkers and Companion Diagnostics
• Liquid Biopsy for Disease Management

Megan Anderson Brooks, President at Innovation Policy Solutions LLC, lobbies and consults on a broad range of health and science policy issues. Leveraging her expertise as a researcher in the field of neuroscience for over ten years, she specializes in implementing federal policy solutions that help create, advance, and result in the adoption of technological innovations. She previously served as Vice President at CRD Associates, and additionally, advocated on behalf of the neuroscience research community while at the Society for Neuroscience. During an Eagleton Institute of Politics awarded fellowship placement at the New Jersey Department of Health, she partnered with colleagues in the development of a successful CDC-awarded program to prevent and control chronic disease in the state. Megan holds a Ph.D. in neuroscience from Rutgers University.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Niaz Banaei is a Professor of Pathology and Medicine at Stanford University School of Medicine and is the Medical Director of the Clinical Microbiology Laboratory at Stanford Health Care.  His research interests include development, assessment, and improvement of infectious diseases diagnostics.

• Advanced Diagnostics for Infectious Disease

Jared Bauer is passionate about improving global health and is driving patient-centered solutions. He currently serves as the CEO of Seek Labs, which he co-founded in 2016. His career in the med tech industry includes acquiring BurnFree Products in 2012 where he expanded distribution to 58 countries and successfully exited in 2016. Beyond his leadership at Seek Labs, Jared is a champion of Utah’s life sciences ecosystem. He serves as Chairman of the Board for BioHive, a collective of life sciences companies, healthcare systems, and academic institutions working to position Utah as a leader in healthcare innovation. As one of BioHive’s original co-founders, he remains committed to fostering collaboration and ensuring groundbreaking technologies reach the patients who need them most. Jared’s dedication extends beyond the industry-he is also a trustee of The Oliver Fund, a non-profit he co-founded with his wife, Sarah, in honor of their son.

• Enabling Point-of-Care Diagnostics

Dr. Tomasz (Tom) Beer serves as Chief Medical Officer for Multi-Cancer Early Detection at Exact Sciences Corporation since August 2022. Dr. Beer also serves as Adjunct Professor of Medicine at the OHSU Knight Cancer Institute, where he sees men with prostate cancer. Until August 2022, Dr. Beer was the Grover C. Bagby Endowed Chair for Prostate Cancer Research at the OHSU Knight Cancer Institute, where he led the Prostate Cancer Research Program, encompassing basic research, translational research, clinical trials of novel therapeutic strategies in prostate cancer, and studies aimed at enhancing cancer survivorship. He has authored or co-authored more than 280 peer reviewed articles, including investigations of targeted therapies and immunotherapies in prostate cancer, among them vitamin D receptor agonists, androgen receptor antagonists, PSMA targeted radiopharmaceuticals, clustering targeting agents as well as cancer vaccines, CTLA-4 and PD-1 inhibitors, and others. He led the global randomized trial of enzalutamide vs. placebo that demonstrated substantial improvements in overall and progression-free survival as well as quality of life and served as the basis for a global change in the standard of care for advanced prostate cancer. Dr. Beer also served as Deputy Director of the OHSU Knight Cancer institute, and NCI designated Comprehensive Cancer Center and Chief Medical Officer for the Center for Early Detection Advanced Research (CEDAR) within the Knight where he worked closely with a diverse leadership team to speed advances in the early detection of lethal cancers. At CEDAR, Dr. Beer fostered collaborations between clinicians, engineers, and cancer biologists to advance discoveries in early detection of cancer and lead clinical trials of multi-omic blood-based cancer early detection tests.

• Early Cancer Surveillance

Dr. Aaron BenComo is the Chief Medical Officer at Phronetik®, a leading biomedical research organization dedicated to advancing precision medicine and population health through genomics, biotechnology, and data science. With a deep commitment to addressing health disparities in underserved communities, Dr. BenComo spearheads initiatives that translate cutting-edge research into actionable solutions. A physician by training, Dr. BenComo transitioned from clinical practice to impactful roles in pharma, biotech, and healthcare innovation after the Covid-19 pandemic. His diverse experience spans clinical research, strategy, regulatory affairs, and strategic partnerships. Dr. BenComo has a dynamic background in finance, and holds additional degrees in philosophy, biochemistry and medicine.

• Enabling Point-of-Care Diagnostics

Anna Bergamaschi, Vice President of Product Development at ClearNote Health, has over a decade of experience in next-generation sequencing assay workflows. She is passionate about leveraging emerging technologies for greater diagnostic sensitivity, specificity, and cost-effectiveness and she oversees the design, development and launch of liquid biopsy-based epigenomic and genomic NGS tests for the early detection of cancers. She also leads clinical development efforts of large clinical trials with the goal of bringing precision medicine to areas of unmet need such as pancreatic cancer.

• Early Cancer Surveillance

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.

• Liquid Biopsy for Disease Management

Tara Burke joined AdvaMed in 2022 and currently serves as Vice President of Payment and Healthcare Delivery Policy. Previously, she served as Senior Director of Public Policy and Advocacy at the Association for Molecular Pathology, where she focused on the regulatory and reimbursement issues affecting molecular diagnostics. Dr. Burke has over a decade of biomedical research experience specializing in biochemistry, molecular genetics, and epigenetics. After receiving her BS in Molecular Biology from Vanderbilt University and a PhD in Biochemistry and Molecular Genetics from The University of Virginia, she completed a postdoctoral fellowship at The National Institute of Child Health and Human Development (NICHD) at the NIH. Her training and research in molecular genetics showed her the hope and promise that genetics can bring to improving human health, and she is proud to be able to work towards the realization of this goal.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

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

• Advanced Diagnostics for Infectious Disease

Sheldon Campbell M.D., Ph.D. is Professor of Laboratory Medicine at Yale School of Medicine and Acting Chief, Pathology and Laboratory Medicine, for the VA Connecticut Healthcare System. He completed his M.D. and Ph.D. degrees at Baylor College of Medicine in Houston, and did residency and fellowship in Laboratory Medicine at the Yale School of Medicine. He is board certified in Clinical Pathology and Medical Microbiology by the American Board of Pathology. Dr. Campbell is director of microbiology, chemistry, and point-of-care testing for VA Connecticut. In his 32 years of practice, he has served on the Point of Care, Microbiology, and Checklist committees for the College of American Pathologists, and as Division C Chair and on the Professional Practice and Laboratory Practices committees for the American Society for Microbiology. Dr. Campbell’s research interests include education of pathology residents and medical students, point-of-care testing, mycobacterial diagnostics, and laboratory utilization.

• Enabling Point-of-Care Diagnostics

Bruce Carlson is Publisher of Eye On IVD, LLC, a newsletter and market research service for in vitro diagnostic market watchers. Thousands of subscribers receive Eye On IVD's analysis and commentary on the complex market of in vitro diagnostics. Previously, Bruce worked at Kalorama Information as Publisher and at Scientific American and WebMD.

• Enabling Point-of-Care Diagnostics

No bio available.

• Liquid Biopsy for Disease Management

Dr. Chien is currently an assistant professor of pediatrics at the Aflac Cancer and Blood Disorders Center, Emory University School of Medicine. He attended medical school at Thomas Jefferson University, completed his pediatrics residency at Inova Children's Hospital, and then moved to Atlanta, Georgia, for a fellowship in Hematology/Oncology. Following his fellowship, Dr. Chien pursued an additional year of focused training in neuro-oncology. He also earned a Master of Science in Biomedical Informatics from Emory University Laney Graduate School's Department of Computer Science. Dr. Chien holds a faculty appointment at Emory University, where he treats patients with CNS tumors. His research focuses on leveraging bulk, single-cell, and spatial RNA sequencing to investigate the biological mechanisms behind pediatric brain tumor metastasis and treatment resistance.

• Clinical Biomarkers and Companion Diagnostics

Dr. Costa has successfully led multi-disciplinary R&D teams from small biotech entities to large corporate globally-directed organizations, with leadership roles in the development and commercialization of multiple genomic systems, platforms, and assays. Key responsibilities at Exact Sciences include leadership of product development programs for blood collection devices, and assay development of NGS-based assessments in cancer for molecular residual disease and therapy selection. Dr. Costa has a B.S. in Genetics from University of California, Davis and a Ph.D. in Immunology from Stanford University with research in gene therapy applications for treatment of disease. Dr. Costa has over 50 peer-reviewed publications in molecular biology, immunology, and genomics.

• Liquid Biopsy for Disease Management

Frank acts as a technical expert in the life sciences practice of BroadBranch Advisors. Frank holds a PhD in Biochemistry from Virginia Tech, and completed post-doctoral research at the University of Maryland and NIH focusing on infectious diseases. Frank has supported clients across a wide range of life science and diagnostics topics over 5 years as a consultant in the space, including significant expertise in drug discovery, bioprocessing, and clinical diagnostics.

• Enabling Point-of-Care Diagnostics

Dr. Dallas received his PhD in Medical Microbiology from Texas Tech University Health Sciences Center, in Lubbock, TX. He is certified by the American Board of Medical Microbiology. He serves as Microbiology Laboratory Director for three San Antonio, TX health systems: University Hospital, the Multi-specialty Research Hospital, and San Antonio Metro Health. He teaches pathology residents, infectious disease fellows, pharmacy students and fellows, medical students, and medical laboratory sciences students. He has served on ASM, ASCP, and CLSI committees and has authored scientific publications and book chapters and presented at numerous microbiology and pathology conferences.

• Advanced Diagnostics for Infectious Disease

Dr. Jennifer Dien Bard, is the director of the clinical microbiology and virology laboratories at Children’s Hospital Los Angeles (CHLA) and Professor of Pathology with Clinical Scholar designation at the University of Southern California Keck School of Medicine. Dr. Dien Bard’s research interests include studying the application of rapid diagnostics in the clinical setting to determine clinical utility. She has authored more than 80 scientific peer-reviewed publications and is a frequent speaker on the topics of molecular diagnostics.

• Advanced Diagnostics for Infectious Disease

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.

• Liquid Biopsy for Disease Management

Dr. Thomas Durant is an Assistant Professor of Laboratory Medicine and Biomedical Informatics and Data Science at the Yale School of Medicine. He is the Medical Director of Chemical Pathology and Laboratory Informatics at Yale-New Haven Hospital and the Associate Director for the ACGME Chemical Pathology Fellowship. Dr. Durant's research embodies a practical approach, concentrating on quality care initiatives, laboratory outcomes, statistics, machine learning, and artificial intelligence applications in pathology and clinical laboratory medicine. His primary research interests lie in clinical informatics and the innovative use of data management technology to extract valuable insights into laboratory quality and overall operations for enhanced patient care. Among his ongoing projects are investigations into stream processing of interface data for automated sample identification for subsequent biobanking, as well as machine learning endeavors such as the utilization of 'very deep' convolutional neural networks for the automated classification of digital images obtained in clinical laboratories, graph neural networks, and quantum machine learning.

• Advanced Diagnostics for Infectious Disease

Dr. Eagle is currently Chief Medical Officer of Guardant Health, Inc. Previously Dr. Eagle served as Vice President of Medical Affairs Oncology for Genentech. Prior to Genentech, Dr. Eagle has held several senior leadership positions in the U.S. and internationally over his 19-year career at Pfizer including global head of the Oncology Medical and Outcomes Group. Dr. Eagle attended medical school at the University of New South Wales in Sydney, Australia and completed his specialist training in clinical hematooncology and hematology Pathology in Australia before moving to the US.

• Early Cancer Surveillance

William is an R&D Team Leader for the Life Science division of Meridian Bioscience and has over 9 years of experience in developing molecular assays for clinical use. He earned his PhD in molecular microbiology in 2019, investigating C. difficile pathogenesis at Royal Holloway, University of London, UK. Subsequently, he held the position of Senior Scientist at Sporegen Ltd, leading diverse research projects rooted in recombinant spore technology. In his current role at Meridian, he is responsible for spearheading the creation of cutting-edge molecular products for the global diagnostic industry.

• Enabling Point-of-Care Diagnostics

Laura Geller is an Emmy, Gracie, Murrow, Associated Press and Telly winning investigative journalist for CBS News. Laura’s work as a national investigative producer in the CBS Innovation Lab has impacted lives across the country. Over the course of 20 years in journalism, her stories have prompted changes and new legislation on a local, state, and national level. In fact, Laura’s investigations have resulted in positive changes in every market in which she’s worked. Before joining the CBS Innovation Lab, Laura worked on Capitol Hill, reporting and producing stories about the impact of the political process on people’s every day lives. Laura moved to Washington to join the investigative team at WUSA9. There, her award-winning work changed multiple laws and led to the creation of new ones. Laura’s investigations focused on the military and military families, technology, health, and politics. Prior to joining WUSA9, Laura investigated issues at WVEC-TV in Norfolk, Virginia, and NBC12 in Richmond, Virginia. She began her career in Tallahassee reporting on every branch of Florida state government. Laura is a military spouse and mom to a spunky little girl. She was born and raised in New York (Go Yanks!) and graduated from the Medill School of Journalism at Northwestern University.

• Clinical Biomarkers and Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Enabling Point-of-Care Diagnostics

Dr. Jonathan Genzen is a professor at the University of Utah Department of Pathology and serves as Chief Medical Officer and Senior Director of Government Affairs at ARUP Laboratories, a not-for-profit enterprise of the University of Utah. He previously served as ARUP’s Chief Operations Officer. Dr. Genzen is a medical director in ARUP’s chemistry division and is medical director of ARUP’s laboratory automation team. His clinical and research focus is on automated clinical chemistry, quality improvement initiatives, and the impact of laboratory regulatory proposals on patient care.

• Clinical Biomarkers and Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Enabling Point-of-Care Diagnostics

Professor Ginocchio is the Chief Medical and Scientific Officer of VedaBio, a San Diego based Molecular Diagnostics Developer. Prior positions include Chief, Senior Medical Director, Division of Infectious Disease Diagnostics, Pathology and Laboratory Medicine, Professor of Medicine, Northwell Health, NY, Chief Scientific and Medical Officer at Quotient Swiss, and Senior VP of Global Medical Affairs at bioMérieux/BioFire. Her responsibilities have included a broad scope of Medical Affairs activities, investigator-initiated research programs, medical training, Clinical Affairs and Regulatory Affairs. She has received numerous awards, served as an expert consultant for international and national health agencies and remains active in Editorial Boards and professional societies. She has over 125 publications and has been an invited speaker at more than 300 international and national conferences. She has been the principal investigator for 75 industry and pharmaceutical clinical trials that include 50 studies of IVDs for US FDA clearance.

• Advanced Diagnostics for Infectious Disease

Hilary Gee Goeckner, MSW is director of state and local campaigns for the American Cancer Society Cancer Action Network (ACS CAN), the advocacy affiliate of the American Cancer Society. In this role she leads work with ACS CAN staff and coalition partners across the country to improve access to comprehensive biomarker testing, clinical trials, fertility preservation and other health care access issues. Prior to this role, Hilary served as the Kansas government relations director for ACS CAN, leading statewide advocacy efforts promoting evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem. Before joining ACS CAN, Hilary served as director of health policy at Kansas Action for Children. She holds a bachelor’s degree in anthropology and global health from Williams College and a master’s degree in social work from Boston College. She lives in San Diego with her husband and two children.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Dr. Guha has been working at the Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (US FDA) since 2012. He graduated from University of Maryland, College Park, with a PhD degree in Mechanical Engineering. His interests include microfluidics, airborne pandemics, pediatrics, and laboratory research driven by patient input. He also is the Program coordinator for the recently created Microfluidics Program within CDRH's Office of Science Engineering Laboratories. In that role his goal is to foster more collaboration with external organizations to facilitate innovation in microfluidics based medical devices.

• Enabling Point-of-Care 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.

• Enabling Point-of-Care Diagnostics

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.

• Early Cancer Surveillance

Dr. Hua-Jun He is a research biologist and the cancer biomarker team leader at the National Institute of Standards and Technology (NIST). His research at NIST primarily focuses on the metrology of cancer biomarkers through the development of standards/reference materials (RMs), methods development and validation, and interlaboratory testing to establish measurement assurance in cancer detection and clinical laboratories. Dr. He’s group has developed NIST Standard Reference Material (SRM) 2373: Genomic DNA Standards for HER2 Measurements; NIST RM 8366: EGFR and MET Gene Copy Number Standards for Cancer Measurements; and the soon-to-be-released Research Grade Test Material (RGTM) 10268: Lentiviral Vector Integration Copy Number (VCN) Standard. Currently, Dr. He is working on the development of RMs and methods for liquid biopsy, such as circulating cell-free tumor DNA (ctDNA), cfDNA methylation, and extracellular vesicles. Additionally, Dr. He is working on the development of next-generation NIST cell-based RMs, such as immortalized broadly consented and fully characterized human cancer and matched normal cell lines for cancer biomarker measurements, as well as engineered clonal Chimeric Antigen Receptor (CAR) VCN cell lines for cell and gene therapy standardization. Other research interests include developing, adopting, and validating emerging technologies for fast, sensitive, specific, and accurate cancer biomarker measurements.

• Liquid Biopsy for Disease Management

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

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

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.

• Clinical Biomarkers and Companion Diagnostics

Dr. Yun-Fu Hu, RAC, ASQ CQA President/CEO, Encore Biotech, LLC Dr. Yun-Fu Hu has over 25 years of experience spanning the FDA, diagnostics, and pharmaceutical industries. He spent over a decade at the FDA where he last served as the Deputy Director of the Division of Molecular Genetics and Pathology, and played a pivotal role in policy development for a broad range of molecular diagnostics such as early cancer detection, tumor profiling, MRD and companion diagnostics. After more than 4 years of service as the Chief Medical Officer at Genetron Health, a precision oncology biotech company in China, Dr. Hu founded Encore Biotech, a consulting firm that provides strategic and technical guidance for clients in their development of groundbreaking medical devices and precision medicines. Prior to joining FDA, Dr. Hu has more than ten years of product development experience in diagnostic and pharmaceutical industries, including GlaxoSmithKline, Becton Dickinson, Metabolon.

• Clinical Biomarkers and Companion Diagnostics

Dr. Shuguang Huang spent the first 15 years of his career working at Eli Lilly, Pfizer, and a cancer diagnostic company called Precision Therapeutics. He co-founded the statistics consulting company Stat4ward (www.stat4ward.com), which works with pharmaceutical and medical device companies, supporting CDx and IVD/LDT product development. He has rich experience in PMA and 510k submissions, and he is actively involved in CLSI guideline developments.

• Clinical Biomarkers and Companion Diagnostics

Chris Karlovich is Associate Director of the Molecular Characterization (MoCha) Laboratory at the Frederick National Laboratory for Cancer Research (FNLCR). The mission of MoCha is to develop genomic assays in support of research and clinical studies sponsored by the National Cancer Institute. In this capacity, MoCha has played a key role in several NCI precision medicine initiatives including NCI-MATCH, NCI-COG Pediatric MATCH and MPACT. Technologies either implemented or under validation at MoCha include whole exome sequencing, RNA-Seq, single cell genomics, and TSO500 ctDNA for liquid biopsies. Prior to coming to FNLCR Dr. Karlovich was at Clovis Oncology, where he provided scientific and operational oversight over molecular diagnostics and companion diagnostic development for rociletinib, a mutant-selective inhibitor of EGFR. Dr. Karlovich also spent nine years at Roche Molecular Diagnostics in biomarker discovery and in vitro diagnostic (IVD) test development.

• Liquid Biopsy for Disease Management

Jonathan Katchmore has over 20 years of experience in the diagnostic/BioPharma industry. He currently serves as the Associate Vice President of Commercial Diagnostic Strategy at Lilly where he leads strategy and execution of all external commercial initiatives in the precision medicine space. His work is focused on broadening education, improving testing utilization and creating access for patients in the community. Prior to joining Lilly, Jonathan spent 6 years at Foundation Medicine where he launched Next Generation Sequencing into the market.

• Clinical Biomarkers and Companion Diagnostics

Joan Kegerize joined the American Clinical Laboratory Association (ACLA) in January 2019 as Vice President, Reimbursement and Scientific Affairs, working closely with ACLA members on coding, coverage, reimbursement, and health interoperability issues for laboratory and pathology services. She has a background in legal and reimbursement analysis most recently prior to ACLA at GMBI, where she worked with healthcare stakeholders across the industry on a range of coding, auditing and reimbursement issues for new and existing laboratory/pathology procedures. She also worked with clients to direct and implement reimbursement strategies for the Medicare and Medicaid programs as well as commercial/private payers. She began her career as a genetic counselor at Magee Women’s Hospital in Pittsburgh. She holds a Master of Science in Human Genetics from the University of Pittsburgh, and a Juris Doctor degree from New York Law School and is a licensed attorney in New Jersey. She holds certifications from the American Academy of Professional Coders as a Certified Professional Coder and a Certified Professional Medical Auditor.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Shirin Khambata Ford, PhD, is currently Founder and Principal of Precision Medesign LLC. Her work involves providing strategic and operational consulting for personalized healthcare across Clinical Development and Medical Affairs by partnering with Diagnostics companies, AI Biotech Companies, Academic institutions and Biopharma. Dr. Khambata Ford is a globally recognized expert in Oncology Precision Medicine and Companion Diagnostics, having led many key high impact activities that helped the efforts of many companies to improve lives of cancer patients over the past 22 years. Highlights include the discovery and establishment of the KRAS mutation biomarker for cetuximab in mCRC, the establishment of a brand-new biomarker, i.e., PD-L1 testing in 80 countries globally for pembrolizumab, and more recently having led a group that enabled the approval of the first Her2 Low IHC Companion Diagnostic for Trastuzumab deruxtecan (Enhertu) in breast cancer, and the first Her2 mutation tissue and liquid based Companion Diagnostics for Trastuzumab deruxtecan in NSCLC. At Daiichi Sankyo, Dr. Khambata Ford established and served as the Global Head for the Companion Diagnostics department responsible for the end-to-end strategic oversight for Companion Diagnostics development and associated regulatory approvals. Prior to this she was the Global Head of Biomarkers and Diagnostics in Oncology Global Medical Affairs at Merck and led a team that was responsible for leading activities to support biomarker testing for Keytruda and all oncology assets pre-, at and post-launch globally. Dr. Khambata Ford also previously served as Global Head Correlative Sciences, Oncology Global Development, Novartis. She led a group focused on clinical biomarker development and translational research for twenty late-stage development programs. Prior to this she was a Senior Biomarker Experimental Medicine Leader at Roche where she led biomarker work for early development oncology programs. She was previously Director of Oncology Biomarkers at Bristol-Myers Squibb where she led a group responsible for the discovery, validation, and implementation of clinical biomarkers for the late-stage portfolio. Her key accomplishments include being the lead researcher on the team that discovered that EGFR ligand expression and KRas mutation status are predictive of benefit from cetuximab in metastatic colorectal cancer. Her research has led to numerous publications in journals such as the New England Journal of Medicine, Journal of Clinical Oncology, British Journal of Cancer, JAMA, over 65 presentations at oncology conferences (e.g., American Society of Clinical Oncology, American Association for Cancer Research, European Society for Medical Oncology), and three patents.

• Clinical Biomarkers and Companion Diagnostics

Daniel Kim, PhD is an Assistant Professor at the University of California Santa Cruz, an Associate Member of the Stanford Canary Center, and a Research Scholar of the American Cancer Society. Dr. Kim also serves as Co-Chair of the International Society for Extracellular Vesicles (ISEV) RNA Task Force, Co-Chair of the National Institutes of Health (NIH) Liquid Biopsy Special Interest Group, and Chair of Media & Communications for the RNA Society. His laboratory develops RNA liquid biopsy technologies for precision health and early cancer detection. Dr. Kim’s research has been featured in Newsweek, Scientific American, and by the Director of the National Institutes of Health and has been recognized by awards from the Damon Runyon Cancer Research Foundation and the National Academy of Sciences.

• Early Cancer Surveillance

From 1998-2009 Dr. Klausner was a Deputy Health Officer, Director of STD Prevention and Control Services at the San Francisco Department of Public Health, member of the UCSF School of Medicine faculty in the Divisions of AIDS and Infectious Diseases and Attending Physician at San Francisco General Hospital. While in San Francisco Dr. Klausner helped identify key factors associated with the increased spread of HIV and STDs and implemented multiple novel public health prevention programs. He helped create the St. James Infirmary, the first occupational health and safety clinic for sex workers and Magnet, a community-based peer-run sexual health clinic for gay men. From 2009-2011 Dr. Klausner was Branch Chief for HIV and TB at the Centers for Disease Control in Pretoria, South Africa, helping lead the South African PEPFAR program for care and treatment.

• Advanced Diagnostics for Infectious Disease

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.

• Early Cancer Surveillance

Jochen Kohlhaas is the Founder and Chief Executive Officer of Hummingbird Diagnostics GmbH. He has over 25 years of experience in executive positions at manufacturing companies and dynamic early-stage biotechs, where he has developed business strategies, driven revenue growth, and led teams to deliver successful outcomes for investors. Before founding Hummingbird, he was a partner at the German venture capital firm Techno Start and served as Chief Financial Officer at febit group and several other companies. Jochen holds a master’s degree in economics from the University of Bayreuth and started his career in financing and controlling.

• Early Cancer Surveillance

Dr. Konnick is an Associate Professor, Associate Director of the Genetics and Solid Tumors Laboratory, and Director of Genetics Preanalytical Services within the Department of Laboratory Medicine and Pathology at the University of Washington Medical Center in Seattle. Dr. Konnick is board certified in Molecular, Anatomic, and Clinical pathology. He is vice chair of the Association for Molecular Pathology's (AMP) Professional Relations Committee and the College of American Pathologists (CAP) Genomic Medicine Committee. He has over 20 years of clinical laboratory experience and more than 10 years of experience in regulatory matters.

• Clinical Biomarkers and Companion Diagnostics

Chadd K. Kraus, DO, DrPH, CPE, FACEP is Vice Chair, Research, for the Department of Emergency and Hospital Medicine (DOEHM) at Lehigh Valley Health Network (LVHN), Professor at the University of South Florida (USF) Morsani College of Medicine and Clinical Professor of Emergency Medicine at the Philadelphia College of Osteopathic Medicine (PCOM). Dr. Kraus is a member of the Board of Directors of the American College of Emergency Physicians (ACEP). A practicing emergency physician, Dr. Kraus is part of the LVHN DOEHM Executive Leadership team and at the Network level serves on the Institutional Review Board (IRB) and the Workplace Violence Prevention Workgroup. He is Co-Medical Director of the City of Allentown Bureau of Health Volunteer Medical Reserve Corps (AVMRC) and Director for the USF-LVHN SELECT Capstone Course. Dr. Kraus has expertise in clinical and policy topics at the intersection of emergency care and population health, including point-of-care diagnostic tests, rural healthcare delivery, behavioral health, sepsis and infectious diseases, substance use disorders, clinical ethics, workforce, Medicaid reimbursement, neurologic emergencies, and emergency preparedness and response. He has provided testimony to the Pennsylvania General Assembly and Pennsylvania’s U.S. Congressional delegation and has been an invited expert for regional and national media outlets including NPR, PBS, ABC, NBC, and FOX affiliates.

• Advanced Diagnostics for Infectious Disease

No bio available.

• Clinical Biomarkers and Companion Diagnostics

Dr. Sarah Kurley oversees molecular diagnostics evidence quality review for Optum Evidence Engine. Sarah has garnered extensive experience in molecular oncology, test development and validation, and evidence generation for product commercialization during her 20+-year career in biomedical research. She is the author of numerous scientific publications in the field of oncology and is the co-inventor of several precision medicine tools. Sarah received her BA in biological sciences from Northwestern University, where she graduated with honors. She obtained her PhD in cancer biology from Vanderbilt University and completed a postdoctoral fellowship at Baylor College of Medicine.

• Liquid Biopsy for Disease Management

I believe that the best solutions are grounded in the healthcare realities at both population and patient decision levels. When a company’s regulatory approved product/service takes both into account, it has a real chance of gaining market acceptance. Over the past decade I have helped healthcare, diagnostic, life science and medical device companies develop their business plans, technologies and products/services including AI to secure funding, prepare for commercialization and expand their customer bases. My background and experience partner the science and technologies of healthcare with strategy, marketing and business development that I utilize to help clients develop business solutions.

• Enabling Point-of-Care Diagnostics

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

• Advanced Diagnostics for Infectious Disease

Liam Lee is the Senior Director of Medical Diagnostics within US Medical Affairs for Oncology at AstraZeneca. In this role, he leads a team of inspired medical directors to shape and deliver innovative strategies to optimize patient care via timely, accurate, and guideline-concordant biomarker testing for every eligible patient. Specifically, Liam and his team relies on internal and external partnerships focused on enhanced education, engagements, and evidence generations to eliminate various gaps preventing effective biomarker testing. Liam has focused on oncology diagnostics throughout his career, holding a B.S. in Clinical Molecular Genetics from UT MD Anderson Cancer Center (MDACC) and a Ph.D. in Pathology from the University of Cambridge; currently also serving as an adjunct, teaching faculty in the Molecular Diagnostics Program at MDACC while maintaining board certification from American Society of Clinical Pathology.

• Clinical Biomarkers and Companion Diagnostics

Jennifer Leib founded Innovation Policy Solutions, a government relations firm specializing in genomics and precision medicine policy. Some of her accomplishments include leading the advocacy effort in support of the plaintiffs in the Supreme Court’s unanimous decision in the Association for Molecular Pathology vs. Myriad Genetics Inc. that invalidated gene patents, serving on the Executive Committee of the Coalition for Genetic Fairness which successfully advocated for passage of the Genetic Information Nondiscrimination Act, and more recently, assisting companies with navigating the evolving regulatory and reimbursement landscape for diagnostic testing for SARS-Cov-2. Previously, Jennifer co-founded another consulting firm, HealthFutures, which was acquired by CRD Associates in 2009. Board certified in genetic counseling, she also worked at the National Institutes of Health, the Senate Committee on Health, Education, Labor and Pensions, and in the biotechnology industry.

• Clinical Biomarkers and Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Enabling Point-of-Care Diagnostics

Dr. Sharon Liang is the Executive Director, Head of Precision Medicine and Digital Health in Global Regulatory Science at Bristol Myers Squibb. Dr. Liang takes on the lead role for global regulatory strategy and execution for Precision Medicine and Digital Health products across the BMS portfolio. Dr. Liang is a Human Genetics expert with 15 years of experience in Regulatory Affairs and medical device product development. Her experience includes the Health Authority (FDA and EU) communications, CLIA/CAP regulations, Quality Management System Regulation, and clinical lab operations. Before joining BMS, Sharon held the position of site head at Burning Rock Dx and VP Regulatory and Quality Affairs where she oversaw operations, quality and regulatory in companion diagnostic and clinical trial assay (CTA) services in clinical trials. She also served as the Senior Director Regulatory Affairs at GRAIL, Inc. from 2019 to 2021, leading the FDA PMA and Q-submissions for Multi Cancer Early Detection (MCED) test. Prior to joining GRAIL, Sharon was a senior reviewer and team leader at Center for Devices and Radiological Health (CDRH) at FDA. She developed guidance and articulated medical device policies, including companion diagnostics, direct-to-consumer tests, Next-generation- sequencing (NGS), bioinformatics pipelines for NGS data, Precision Medicine, targeted therapy, and cancer screening. Dr. Liang’s contributions also encompassed initiating projects in digital health and Case for Quality at CDRH. She is recognized as an expert in the regulatory submissions for medical devices, including PMA, 510(k), 513(g), Q-submissions, as well as IND,NDA,BLA for companion diagnostics devices in Precision Oncology. Additionally, she was a member of the FDA steering committee for the Precision Medicine Initiative (PMI) leading the bioinformatics working group. Sharon received her Ph.D. in Human Genetics and M.S. in Applied Statistics at Vanderbilt University, followed by a postdoctoral cancer research fellowship at National Cancer Institute and was a commissioner’s fellow at FDA. She also holds a M.D. from China Tianjin Medical University.

• Clinical Biomarkers and Companion Diagnostics

C. Jimmy Lin, MD, PhD, MHS, is the the Chief Scientific Officer (CSO) at Freenome, working on early diagnosis of cancers. Previously, he was the CSO, Oncology at Natera (NASDAQ: NTRA), where he led the development of new diagnostic technologies for cancer. Dr. Lin is also a 2016 Senior TED Fellow and Founder & President of Rare Genomics Institute, the world's first platform to enable any community to leverage cutting-edge biotechnology to advance understanding of any rare disease. Previously, Dr. Lin led the ClinOmics program in the Genetics Branch of the National Cancer Institute (NIH/NCI). Prior to this, he led the computational analysis of the first ever exome sequencing studies of cancer at Johns Hopkins and was a research instructor at Washington University in St. Louis. He has numerous publications in Science, Nature, Cell, Nature Genetics, and Nature Biotechnology, and has been featured in Forbes, Bloomberg, Wall Street Journal, New York Times, Washington Post, BBC, TIME, and the Huffington Post.

• Early Cancer Surveillance

No bio available.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Thakshila Liyanage, Ph.D., is the Founder and CEO of Early is Good, a life sciences company developing multiomic tests for early cancer detection. She earned her Ph.D. in Analytical Chemistry from Purdue University and has expertise in nanotechnology and molecular diagnostics. At EIG, she leads the development of a proprietary Multiomic Integration Platform, designed to overcome the challenge of integrating DNA, RNA, proteins, and metabolites into a single, highly sensitive, and cost-effective diagnostic solution. Under her leadership, EIG has secured multiple patents and established key partnerships, including a collaboration with Mayo Clinic to develop non-invasive multiomic tests for bladder and prostate cancer.

• Early Cancer Surveillance

Michael J. Loeffelholz, Ph.D., D(ABMM) is Vice President, Scientific Affairs at Cepheid. He received a Ph.D. in microbiology from Ohio University, Athens, OH in 1987. After completing a post-doctoral fellowship in medical and public health microbiology at the University of Rochester in 1990, he was a Senior Scientist at Roche Molecular Systems from 1990-1995. From 1995-2008 Dr. Loeffelholz held leadership positions in public health laboratories and private reference laboratories. From 2008-2018 he held the rank of Associate Professor, then Full Professor, with tenure, in the Department of Pathology at University of Texas Medical Branch, and Medical Director of the Clinical Microbiology Laboratory. Dr. Loeffelholz joined Cepheid in 2018. He served as a member of the Board of Scientific Counselors to the U.S. Centers for Disease Control and Prevention (CDC) from 2015 to 2022. Dr. Loeffelholz previously served as associate editor of the Journal of Clinical Microbiology. He is currently a member of the Board of Directors of the Clinical and Laboratory Standards Institute (CLSI) and advisor to the CLSI Expert Panel on Point-of-Care Testing. He has authored over 100 research and review papers and book chapters.

• Advanced Diagnostics for Infectious Disease

Philip Ma is the Chief Executive Officer and Founder for PrognomiQ. Previously, he was Chief Business Officer, President, and Founder of Seer. Prior to this, he was Vice President for Digital Health Technologies and Data Sciences at Biogen, a group that he established to discover insights and create value for Biogen and its patients. Before joining Biogen, Philip was Senior Partner at McKinsey & Company, where he served global leaders in the pharmaceutical and biotech sectors, leading the West Coast Healthcare Practice and global Personalized Medicine practice for the Firm. Philip was a macromolecular crystallographer in the lab of Dr. Carl O. Pabo at Massachusetts Institute of Technology, where he received his Ph.D. in Biology. Philip also has degrees in Biochemistry (A.B. from Harvard College) and in Economics (MPhil from Oxford University, where he was a Rhodes Scholar).

• Early Cancer Surveillance

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.

• Enabling Point-of-Care Diagnostics

Mark Massaro is a Managing Director and Analyst providing research coverage of the Life Science and Diagnostic Tools sector for BTIG, a global mid-market investment banking firm. Prior to joining BTIG, he served as the Chief Financial Officer at ArcherDX, Inc., an oncology diagnostics and pharmaceutical services company, which was acquired by Invitae Corporation. Previously, Mr. Massaro was a Managing Director and Senior Equity Research Analyst within Diagnostics and Life Science Tools at Canaccord Genuity, where he spent more than eight years focused on high-growth, precision medicine and next-generation sequencing companies, as well as molecular and point-of-care diagnostics, reference labs, and animal health. He was named a “Rising Star” in Institutional Investor’s All America Survey for life science and diagnostics tools in October 2016. Earlier in his career, Mr. Massaro was an Associate Equity Analyst within Healthcare Services at Avondale Partners and held corporate finance and financial reporting roles at Dell EMC and Fidelity Investments. He earned an MBA from Babson College and a BA in economics and Spanish from the University of Massachusetts - Amherst.

• Early Cancer Surveillance

No bio available.

• Clinical Biomarkers and Companion Diagnostics

Ellen T. Matloff, MS, CGC is a certified genetic counselor and the CEO of My Gene Counsel, a digital health company that makes it possible for stakeholders to scale safe, equitable genetic testing solutions for patients and clinicians. Matloff founded the Yale Cancer Genetic Counseling program, served as its director and a faculty member at Yale School of Medicine for 18 years, and was an individual plaintiff in the 2013 SCOTUS BRCA gene patent case. She serves as the Forbes.com contributor on genetic counseling, genetic testing, and digital health.

• Clinical Biomarkers and Companion Diagnostics

Dr. Dawn Mattoon is the Chief Executive Officer at Mercy BioAnalytics. She brings 20 years of experience in the biotechnology industry. She has held leadership positions in R&D, Strategy, and General Management for leading companies including Invitrogen, Life Technologies, Thermo Fisher, and Cell Signaling Technology. Before joining Mercy, Dr. Mattoon served as the Senior Vice President for Clinical Diagnostics at Quanterix, where she led the development and commercialization of the company’s first two FDA-authorized diagnostic tests for COVID-19 and received Breakthrough Device designations from the FDA for diagnostic tests in Alzheimer’s Disease and Multiple Sclerosis. Dr. Mattoon completed her Ph.D. and postdoctoral fellowship at Yale University with a focus on mechanisms of cell signaling in cancer.

• Early Cancer Surveillance

Abby is an experienced leader in bringing together science, technology, teams, and product development processes to launch complex diagnostic assay systems that make an impact in the field of oncology. For close to two decades, she has led R&D teams across the continuum from the earliest phases of research and technology transfer, through regulatory submission and approval of products focused on improving the lives of patients with cancer. These technologies include global launches of immunohistochemistry (IHC)-based assays used to select patients for various targeted therapies (companion diagnostics) and instrument and systems development at Roche; next generation sequencing (NGS)-based panels and associated bioinformatics software for molecular profiling of tumor tissue and liquid biopsies at PGDx; and multi-omic assays with machine learning (ML) for the early detection of cancer signals in the blood from otherwise healthy individuals (MCED) at Exact Sciences. Abby specializes in leading diverse, cross-functional teams to also include manufacturing scale-up, clinical validation, and on-market support. Abby is passionate about helping teams to build capabilities in R&D, manufacturing, data science, and bioinformatics/software engineering and seeing teams achieve shared goals. She is currently CSO at AOA Dx, a start-up women's health company in Denver, CO, focused on developing assays for the earlier detection of ovarian cancer.

• Early Cancer Surveillance

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

• Enabling Point-of-Care Diagnostics

Jeanne Mumford is a Manager for Point-of-Care Testing (POCT) for Johns Hopkins Medicine. She has 24 years of experience in laboratory regulatory oversight, quality assurance and inspection preparedness, with 14 of those years spent in managing POCT. Jeanne participates in many professional organizations including the Critical and POCT Division of ADLM (formally AACC) and the CLSI Expert Panel for POCT. Jeanne is the president of the KEYPOCC POCT coordinators group. She consults with vendors on product development and instrument connectivity and serves her community at home through her philanthropic endeavors with the United Way of Central Maryland.

• Enabling Point-of-Care Diagnostics

Bill’s father was diagnosed with ALS when he was 18 years old. Bill and his family were concerned because his grandfather had also died of ALS. The physicians told the family that there was no genetic connection and that the two ALS cases were really just bad luck. The family believed this for more than 35 years. In July of 2020, his brother was diagnosed with ALS and genetic testing found that he was a C9orf72 expansion carrier. Bill also was tested and found to carry the C9 expansion. He has experienced discrimination by insurance companies as a result of his genetic status.

• Clinical Biomarkers and Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Enabling Point-of-Care Diagnostics

As the CEO of Vital Biosciences, Vasu Nadella oversees the vision and strategic direction of the company. Prior to starting Vital, he co-founded a machine-learning based personalization start-up which was acquired in 2018. Inovia Capital recruited Vasu where he was an entrepreneur-in-residence, focused on supporting founders in healthcare, artificial intelligence, and life sciences. In 2019, Vasu co-founded Vital. He leads a team of scientists, engineers, and diagnostics executives building the next-generation of tools and services that will enable the future of care.

• Advanced Diagnostics for Infectious Disease

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.

• Enabling Point-of-Care Diagnostics

Dr. Odegaard is currently the Vice President of Product at Guardant Health, Inc. He trained in surgical and molecular pathology (MD) and immunology and physiology (PhD) at Stanford University, where he also served on the consulting faculty for 6 years, and at the University of California San Francisco for 3 years.

• Liquid Biopsy for Disease Management

Dr. Osborn is the Director of Microbiology at Keck Medical Center of USC and an Assistant Professor of Clinical Pathology at Keck School of Medicine of USC in Los Angeles, California. His research interests include applications of machine learning in clinical microbiology, reducing the turnaround time of infectious disease diagnostics, next generation sequencing, and diagnostic stewardship. Dr. Osborn is a Diplomate of the American Board of Medical Microbiology.

• Advanced Diagnostics for Infectious Disease

Dr. Matthew Owens, Lead Scientist at BioCaptiva, specializes in biomedical sciences and polymer chemistry. He earned a first-class Biomedical Sciences degree from Edinburgh Napier University and an MRes in Neuroscience from the University of Edinburgh. His research focuses on developing polymer technology to capture circulating cell-free DNA for improved cancer diagnosis. Previously, he was a research associate in the Bradley Group at the University of Edinburgh. Matt is the co-inventor of BIOCAPTIVA’s msX polymer technology.

• Liquid Biopsy for Disease Management

Vamsee K. Pamula is Founder and President of Baebies, which pioneered a multifunctional diagnostic platform with a mission to deliver any diagnostic test, anywhere, and to everyone. He is currently interested in the development of inexpensive and accessible diagnostics products. Prior to this, he was founder and CTO of Advanced Liquid Logic Inc (sold to Illumina). He serves as a principal investigator on several projects funded by the NIH, served as a peer reviewer for many journals and funding agencies, has given numerous talks on digital microfluidics, has published over 100 articles, authored 5 book chapters and a book, and has over 420 issued and pending patent applications worldwide. He has a PhD in electrical and computer engineering from Duke University.

• Advanced Diagnostics for Infectious Disease

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.

• Clinical Biomarkers and Companion Diagnostics

Dr. Krupa Paranjpe is a distinguished leader in oncology with expertise in global stakeholder engagement, medical affairs strategy, and clinical innovation. She has played a pivotal role in shaping collaborative strategies that address health system barriers, evolve oncology endpoints, and advance diagnostic approaches such as minimal residual disease (MRD) testing. With a strong focus on improving patient outcomes, Dr. Paranjpe drives initiatives that bridge clinical research, diagnostics, and real-world application. Her experience spans impactful programs such as the OncoCollective Initiative, where she has championed innovative solutions to meet the unmet needs in cancer care. Dr. Paranjpe earned her Doctor of Pharmacy (Pharm.D.) degree and has since built a career dedicated to addressing critical challenges in oncology through collaboration and innovation.

• Liquid Biopsy for Disease Management

Dr. Robin Patel graduated from Princeton University with a BA in Chemistry and from McGill University with an MD. She completed a residency in Internal Medicine and fellowships in Infectious Diseases and Microbiology at Mayo Clinic. She is the Elizabeth P. and Robert E. Allen Professor of Individualized Medicine, Professor of Medicine, Professor of Microbiology, Director of the Infectious Diseases Research Laboratory, and Co-Director of the Clinical Bacteriology Laboratory at Mayo Clinic. Dr. Patel is a Fellow of American Academy of Microbiology, Past President of the American Society for Microbiology, and course director for the Mayo Clinic Alix School of Medicine microbiology course. Her research focuses on clinical bacteriology diagnostic testing, antimicrobial resistance, and microbial biofilms.

• Advanced Diagnostics for Infectious Disease

Tej Patel is the Co-Founder and CEO of Fluxergy. Tej oversees various aspects of Fluxergy’s strategy, marketing, and technical development. With a passion for combining engineering and healthcare solutions, Tej has led Fluxergy's growth from a startup concept to a global leader in diagnostic testing technology. Before founding Fluxergy, Tej gained extensive experience in aerospace and sensor technology at MagCanica, where he managed high-profile projects for clients such as the U.S. Navy and Mercedes-Benz F1. His technical expertise and innovative mindset have earned him recognition as a leader at the intersection of healthcare and engineering. Tej holds dual bachelor's degrees in Aerospace Engineering and Applied Mathematics and a master’s degree in Aerospace Engineering with a specialization in fluid dynamics from the University of California, San Diego. His academic and professional background continues to fuel his mission to create accessible, accurate, and scalable diagnostic solutions for healthcare providers worldwide.

• Advanced Diagnostics for Infectious Disease

Jennifer Pollack brings over 15 years of legislative and political experience to her position as Director, Access Policy for the Alzheimer’s Association and Alzheimer’s Impact Movement (AIM). In this capacity, she works to develop federal policies for AIM and the Association related to access to treatment, diagnostics and care. Prior to joining the Association, Jennifer worked at a trade association where she advocated on behalf of medical group practices. Previously, Jennifer served as a Legislative Assistant in the House of Representatives for two members of Congress. She has a BA from The George Washington University and a JD from the Catholic University of America, Columbus School of Law.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Marianna Polonsky is a seasoned leader in reimbursement and market access strategy, specializing in healthcare diagnostics and precision medicine. With deep expertise in both startup environments and established organizations, she excels at navigating the complexities of the U.S. healthcare payer system, aligning commercial strategies with coverage, reimbursement, and revenue objectives. With over 20 years of experience in oncology, autoimmune, and other chronic disease areas, Marianna helps startup diagnostic companies incorporate market access considerations early in product development. This ensures strong product-market fit and supports sustainable market entry. Marianna has developed innovative reimbursement strategies for precision medicine products and has successfully commercially launched 10+ novel technologies. By bridging the needs of the healthcare space through novel concept development and disruptive synergies, this approach integrates the full spectrum of business, science, and patient care, helping companies address the challenges of treating complex patients and driving reimbursable innovation in the healthcare industry.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Dr. Pratt is the past President of Association for Molecular Pathology. Dr. Pratt continues to serve on the Centers for Disease Control and Prevention (CDC) GeT-RM program for reference materials for Molecular Genetics, the National Academy of Medicine’s Roundtable on Genomics and Precision Health, and the American Medical Association’s (AMA) Current Procedural Terminology (CPT) Advisory committee. Dr. Pratt graduated with a Ph.D. in Medical and Molecular Genetics from Indiana University School of Medicine. Her fellowship training was in Ph.D. Medical and Clinical Molecular Genetics at Henry Ford Hospital, Detroit MI.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

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.

• Clinical Biomarkers and Companion Diagnostics

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.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

As VP, Regulatory Affairs at GRAIL, I help bring to market the inventions, ingenuity and innovations of our scientists, clinicians and engineers to detect cancer early. My previous roles include leading Precision Medicine Regulatory at GSK, and Global Regulatory Lead at Foundation Medicine. From 2007-13 at the US FDA CDRH, I led the FDA- CMS Parallel Review pilot project, served as Policy Advisor to the Office of Center Director CDRH and as Legislative Analyst in the Office of Commissioner on issues pertaining to Device Law, FDASIA and User Fees. Following FDA, I was appointed to CMS Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). I have consulted for device/Dx clients on regulatory and payor strategy, value and evidence at Avalere Health and through my company DxDevice Strategies LLC. I have over two decades in genomics/bioinformatics, diagnostics and regulatory and have worked in academia, biotech, government, consulting and in big pharma. I have a PhD in Molecular Biology from UNC-Chapel Hill, with post-doctoral training at St. Jude Children's Research Hospital.

• Clinical Biomarkers and Companion Diagnostics

Dr. Rashidi combines his passion for patient care, research and education with his unique training in bioinformatics and machine learning (ML) to create innovative new tools (i.e. MILO, STNG, Pitt-GPT, etc.) and resources (Hematology Outlines, Cleveland Clinic's AI course, etc.) that improve clinical practice, research and education. His experience in AI/ML dates back to his graduate years at UCSD which subsequently allowed him to serve as the principal author and editor of several popular bioinformatics textbooks. This background has also enabled him to develop various novel AI-ML platforms. He is currently the Associate Dean of AI in Medicine, Professor & Endowed Chair of Lombardi-Shinozuka Experimental Pathology Research at the University of Pittsburgh School of Medicine, Executive Director of CPACE (Computational Pathology & AI Center of Excellence; a UPitt/UPMC joint venture) and the Executive Vice Chair of the Computational Pathology Division at UPMC. He is also Adjunct Professor of Engineering at the Carnegie Mellon University. Before joining U Pitt / UPMC, he served as the founding director of Cleveland Clinic’s PLMI Center for AI and Data Science & Vice Chair of Technology Innovation & Computational Pathology, and before that he served as the Director of AI for University of California Davis Medical Center and Professor & Vice chair of informatics, leading a large number of AI studies with numerous collaborators from various prominent institutions. These experiences and studies have also led to the invention of numerous products (most recent of which being the on-prem LLM framework Pitt-GPT) & several filed patents/established products (e.g. the University of California IP MILO: Machine Intelligence Learning Optimizer, the proprietary Automated ML platform & it’s suite of 6 complimentary separate unique Data Science and Statistics Apps & Cleveland Clinic’s new automated synthetic data generator and Validation platform STNG, Synthetic Tabular Neural Generator) along with a large number of manuscripts in which he serves as corresponding author. These products have also been licensed to several industry and academic institutions & serving as a powerful suite of data science tools for a large number of clinical, quality, research and educational projects while also starting to help optimize and expedite data access needs for all investigators. In addition to the above, Dr. Rashidi is also a practicing physician (board certified hematopathologist) and a well-known educator with numerous teaching awards who has created some of the AppStore’s most popular hematology Apps along with Cleveland Clinic’s most recent AI-ML course (launched Cleveland Clinic wide in Jan 2024). He is also the co-founder and senior editor of HematologyOutlines, a very popular digital hematology atlas that is used internationally and endorsed by the American Society of Clinical Pathology. Dr. Rashidi’s efforts in the AI-ML & digital space are internationally recognized, as evidenced by his continuous invited talks at prominent conferences & institutions, his various journal AI/ML editorial & reviewer roles, his multitude of key invited review articles & his continued national committee roles within this space.

• Enabling Point-of-Care Diagnostics

Cassie Ricci joined Roche Diagnostics in 2022 and currently leads the organization's Alliance Development Program within the Access & Government Affairs team. In her role, Cassie is responsible for establishing and growing relationships with patient advocacy and stakeholder organizations to advance the value of diagnostics and patient outcomes. In addition to leading Alliance, Cassie is a key contributor to Roche Diagnostics' federal legislative and public policy priorities. Prior to joining Roche Diagnostics, Cassie held roles at GE HealthCare and Deloitte and has over a decade of health policy expertise within the medical imaging and diagnostics industries.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Jessica L. Roberts is a Professor of Law, Artificial Intelligence, Machine Learning and Data Science at Emory University School of Law. She specializes in the legal and ethical issues related to genetics and other emerging health technologies, disability rights, and antidiscrimination law. Her work has been funded by the National Institutes of Health and the Greenwall Foundation. Professor Roberts was named a 2018 Greenwall Faculty Scholar in Bioethics. Prior to Emory Law, Roberts was the director of the Health Law & Policy Institute and the Leonard H. Childs Professor in Law at the University of Houston Law Center and a professor of medicine (by courtesy) at the University of Houston College of Medicine. During her time at UH, she received the university-wide Teaching Excellence Award and the Provost's Certificate of Excellence. A noted expert on diverse issues of health law, Roberts has been interviewed by several leading media outlets, including the New York Times, US News, the Washington Post, National Public Radio, and BBC World Service.

• Clinical Biomarkers and Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Enabling Point-of-Care Diagnostics

Tanner Rothstein is a Senior Developer in the Translation Research, Innovation, and Test Development Office within the Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, MN. In his current role, he develops molecular based tests, including those using next-generation sequencing and PCR, for the Division of Clinical Microbiology, focusing on detection and antimicrobial resistance prediction of pathogenic microorganisms.

• Advanced Diagnostics for Infectious Disease

Mike Ryan advises clients on the legal, regulatory, and reimbursement issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products, and drugs. He guides clients by evaluating and implementing strategies to optimize coding, coverage, and payment for novel technologies. Michael also helps innovative companies identify and navigate applicable FDA regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products.

• Enabling Point-of-Care Diagnostics

Lisa Schlager is a recognized patient advocacy leader in the cancer community. As Vice President of Public Policy for FORCE, she spearheads the organization’s legislative and regulatory policy efforts, advocating for the unique needs of the high-risk, hereditary cancer community. Well-versed in healthcare and genetic privacy laws, Schlager is the point person on national guidelines and advocacy issues impacting people with or at risk of hereditary cancers due to BRCA, Lynch syndrome or other genetic mutations. She possesses expert knowledge on policies affecting individuals at increased risk of cancer, insurance coverage of genetic, screening and preventive services, and targeted treatments for those diagnosed with cancer. Ms. Schlager holds leadership positions with several cancer and healthcare initiatives in the government, nonprofit, and private sectors. She represents FORCE and the hereditary cancer community as an expert speaker at conferences, events, and in the media.

• Clinical Biomarkers and Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Enabling Point-of-Care Diagnostics

I am a passionate and results-driven systems biomedicine specialist with expertise in utilizing cutting-edge higher dimensional data analysis techniques to unlock insights and drive innovation in the field of healthcare. As a founder and CEO of Xgenera, I am committed to leveraging my skills and knowledge to revolutionise the way we approach cancer diagnostics. With a strong background in systems biology and a deep understanding of complex biological networks, I excel in integrating diverse datasets and extracting meaningful patterns and relationships. My proficiency in advanced analytical tools and algorithms allows me to uncover novel insights and identify hidden biomarkers, contributing to the development of precision diagnostics and personalised medicine. Throughout my career, I have been at the forefront of designing and implementing data-driven strategies that bridge the gap between cutting-edge research and practical applications. As a thought leader and innovator in the field, I am actively engaged in interdisciplinary collaborations, staying abreast of the latest advancements in systems biomedicine, molecular biology, and other areas within science. I thrive on complex challenges and am driven by the opportunity to make a tangible impact of the lives of patients and the broader healthcare ecosystem.

• Early Cancer Surveillance

Khosrow Shotorbani is the CEO and founder of Lab 2.0 Strategic Services, LLC. He is a member of the board, President, CEO of Project Santa Fe Foundation, advocating for Clinical Lab 2.0 movement. Mr. Shotorbani was instrumental in the creation of Project Santa Fe-a initiative with like-minded executives-helping to drive new frontiers that will define future economic valuation and placement of diagnostic services and practice of laboratory Medicine. As the former President and Chief Executive Officer at TriCore Reference Laboratories, Mr. Shotorbani oversaw the corporate direction and strategy of TriCore, focusing on leadership, culture and innovation, as well as operations, growth, and the financial health of the company. He led TriCore’s initiatives based on the premise to improve health outcomes, population health and lower overall costs of delivery by predictive utilization of laboratory data. Before joining TriCore in 2014, Mr. Shotorbani served as Senior Vice President, co-Director of Business Development and Director of Business Innovations at ARUP. He joined ARUP in 1984 as a medical technologist and while at ARUP advanced to positions with progressive responsibility over his 30-year tenure.

• Advanced Diagnostics for Infectious Disease

Vershalee Shukla, MD is the Co-Founder and Medical Director of Vincere Cancer Center and Vincere’s First Responder Cancer Screening Program. Dr. Shukla is a board-certified radiation oncologist with training at Baylor College of Medicine and the Heidelberg Heavy Ion Therapy Center in Germany. She practices at various hospitals throughout Arizona, including Honor Health and the world-renowned Barrow Neurological Institute. She started the First Responder Cancer Screening Program at Vincere that screens over 1000 first responders each year. She is a member of the ad-hoc Senate committee in Arizona advocating for firefighter health and wellness, and has helped change policies regarding cancer coverage in the state of Arizona. She is also a member of Astro-American Society of Therapeutic Radiation Oncology, the American Lung Cancer Society, and the Radiological Society of North America.

• Early Cancer Surveillance

No bio available.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Lauren Silvis serves as Senior Vice President of External Affairs at Tempus, overseeing regulatory, public policy, and government affairs. Silvis has held number of senior career public health roles, serving as a Senior Advisor at the Department of Health and Human Services, Chief of Staff of the U.S. Food and Drug Administration, and Deputy Center Director for Policy in FDA’s Center for Devices and Radiological Health. During her time in government, she advanced policies to promote innovation in precision medicine, real world evidence, clinical trials, and digital health. Silvis serves as a board member for the Personalized Medicine Coalition and the American Heart Association, Greater Washington Region. She was a partner at the international law firm Sidley Austin LLP, focusing on regulation of pharmaceuticals and medical devices. Silvis graduated from Duke University and earned her law degree from Georgetown University Law Center.

• Clinical Biomarkers and Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Enabling Point-of-Care Diagnostics

Dr. Laura Simmer joined Optum Evidence Engine in 2022 and leads market access engagements with diagnostic company clients. Laura has led projects in multiple areas, including early cancer detection, women’s health, and rare genetic disease. ?She has experience in the evaluation of novel health care technology from an investment perspective, including a year as vice president at Redmile Group, a health care-focused hedge fund, and four years at TD Cowen, an investment bank, where she conducted scientific diligence on biotechnology companies. ?Laura earned an MD from the University of Chicago Pritzker School of Medicine and a BA from Williams College, where she graduated cum laude. Prior to medical school, she oversaw clinical oncology research at the Dana-Farber/Brigham and Women’s Cancer Center.?

• Early Cancer Surveillance

Usha has more than 15 years of oncology drug and diagnostic (Dx) development experience at three multinational pharmaceutical companies: Roche, Merck and Janssen. Currently she is a Global Diagnostic development lead for prostate cancer at J&J.

• Clinical Biomarkers and Companion Diagnostics

Ove V. Solesvik is the CEO and co-founder of GreinDX AS. He has over 35 years of experience in the MedTech and Life Science industry, leading research and business development activities in small and large organizations. Solesvik founded GreinDX in 2019 together with a team of innovative and serial entrepreneurs from Norway, Israel and Canada, with the ambition to develop a complete novel liquid biopsy platform. Solesvik is also a co-founder of Naalos Holding AS, a company developing advanced micro-sized radiofrequency metamaterial-based sensing technology, and he has during the last 7 years served as an advisor for Aleap AS, the largest health incubator in Scandinavia. Solesvik has spent 3 years as a visiting scientist at NCI (Frederick, MD) and 5 years as a technology attaché in Boston MA. Ove Solesvik holds a MSc in Biophysics from the Norwegian Institute of Science and Technology.

• Liquid Biopsy for Disease Management

No bio available.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Nicole St Jean is the Global Head of External Innovation & Partnering for Precision Medicine at GSK Research & Development. She leads a team based in US & UK responsible for establishing external business strategy and partnerships in Precision Medicine, covering various disease areas such as cancer, infectious disease, and respiratory/immunology. Nicole joined GSK in 2021 after over a decade at AstraZeneca, where she, together with a team successfully launched over a dozen diagnostics linked to four (4) FDA-approved medicines. She is passionate about innovation in healthcare and recently successfully completed the executive program in Artificial Intelligence in Pharma and Biotech at MIT. In 2024, Nicole was appointed Chairperson of the board of directors for the Precision Cancer Consortium (PCC), which aims to improve global patient access to comprehensive genomic testing in routine care and clinical trials. Nicole is also an active member of Women in Healthcare - DC chapter. She holds a B.S. and B.A. in Biology and Business Management from the University of Rhode Island, an MBA from Boston College, and has completed executive programs in corporate governance and boards and women’s executive leadership at the Wharton School, University of Pennsylvania USA.

• Clinical Biomarkers and Companion Diagnostics

Dr. Meghan Starolis is a board-certified clinical laboratory director who specializes in molecular methods of disease detection. She currently serves as Senior Science Director, Infectious Disease at Quest Diagnostics in Chantilly, Virginia. In addition to serving as section director for the molecular infectious disease department, she is a key leader supporting R&D initiatives, developing strategy alongside business partners, and developing and maintaining best practices at all laboratories within Quest that perform molecular testing. In addition to this role, Dr. Starolis is a Council Member of the PASCV and serves on the Education Committe and as Chairperson of the Clinical Practice and Public Policy Committee. She also serves on the Infectious Disease Subcommittee for AMP as the representative to the Clinical Practice Committee. She serves as Vice Chair of the Coding and Reimbursement Committee for ASM. She enjoys teaching and mentoring students and has an adjunct faculty position at George Mason University, her alma matter, where she teaches Medical Microbiology. Dr. Starolis earned both her Masters and Ph.D. at George Mason University (Fairfax, Virginia) in Microbiology and Infectious Disease where her research centered on molecular mechanisms of virulence in biothreat and emerging pathogens.

• Advanced Diagnostics for Infectious Disease

Rachel is a highly experienced government relations and legislative affairs strategist and advocate who is informed by a solid foundation of health policy knowledge and years working as a leading health policy aide on Capitol Hill and in the Executive Branch, and as an advisor to a variety of clients. Prior to joining M+, Rachel was the director of government affairs for a leading virtual care company. She led efforts to build the profile of the organization in a fast-moving, innovative policy and regulatory environment encompassing issues related to primary care and behavioral and mental health services provided via virtual care, as well as medical professional licensing, privacy, and security. She also previously served as the director of policy and government relations for a health IT contractor, where she developed the company’s first strategic plan for government relations. Rachel was previously lead legislative liaison at the US Department of Health and Human Services’ Office of the National Coordinator for Health IT (ONC) where she was instrumental in providing research, analysis and feedback to members of Congress and staff on the 21st Century Cures legislation, among other relevant policies. Rachel also created short- and long-term strategic outreach plans that increased ONC’s visibility and profile. Earlier in her career, Rachel served in several senior health legislative roles in the personal offices of Members of Congress, including most notably Congresswoman Diana DeGette. She was the primary staff for a variety of health policy issues, including diabetes, medical research, drug and medical device development, data sharing and privacy, mental health and health IT policy, and was a lead staff person creating and driving the 21st Century Cures Act. In these roles, Rachel engaged with many external stakeholders to advance legislative and regulatory challenges and coordinate action on items such as legislation, hearings, briefings and letters to congressional leadership and the administration.

• Clinical Biomarkers and Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Enabling Point-of-Care Diagnostics

Ester Stein is Senior 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.

• Enabling Point-of-Care Diagnostics

Dr. Panieh Terraf, PhD, FACMG, is a board-certified medical geneticist at MSKCC specializing in cancer genomics. Her research focuses on enhancing the diagnostic yield of genomic testing and reducing the existing disparities in precision oncology. She is also actively involved in shaping clinical guidelines and serves on multiple national committees.

• Liquid Biopsy for Disease Management

Dr. Rolf Thermann is a Lead Auditor, IVD Product Expert, and TUVs leading Expert for Companion Diagnostics (CDx). Prior to joining TUV Rheinland, Dr. Thermann spent over 10 years in the Pharmaceutical and IVD industries in various leading roles in product development, including CDx products.

• Clinical Biomarkers and Companion Diagnostics

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.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Ben is the Executive Director of the Global CEO Initiative on Alzheimer’s Disease and a Managing Director at High Lantern Group. Previously, he led field reimbursement for Janssen and was the Chief of Staff Johnson & Johnson’s Vice Chairman prior to his appointment as CEO. Ben also worked within J&J’s Government Affairs & Policy, Global Public Health and Global Commercial Strategy teams. Before J&J, Ben was a Director at Global Health Strategies. He holds a PhD in Molecular Biology and a Master in Public Policy from Princeton University.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Susan Van Meter was named ACLA President in March 2022. She previously served as Executive Director of AdvaMedDx where she directed the policy, advocacy, communications, regulatory, payment, and legislative strategy, and operations of the association, which represents manufacturers of in vitro diagnostic (IVD) clinical tests in the U.S. and abroad. In this role, she also developed the association’s robust response to the COVID-19 pandemic and ongoing advocacy efforts. Prior to her role at AdvaMedDx, Van Meter served as the Senior Vice President of Federal Relations at the Healthcare Association of New York State (HANYS), where she was responsible for developing their priorities and strategies to further the interests of their hospital and health system members. She also previously worked in the Centers for Medicare & Medicaid Services’ (CMS) Office of Legislation. Van Meter holds undergraduate and graduate degrees from Villanova University and Boston University, respectively.

• Clinical Biomarkers and Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Enabling Point-of-Care Diagnostics

Larry has over 45 years of experience in the diagnostics industry. He is the Principal and Founder of IVD Logix and also co-founded Market Diagnostics International, where he developed the IVD Insights and IVD Labfile syndicated databases on in vitro diagnostic testing. Prior to that, he was a senior consultant and co-founder at CaseBauer & Associates, an international business development and research firm exclusively focused on in vitro diagnostics. He has held senior legislative/regulatory affairs and market research positions with Becton Dickinson and Company, AdvaMed, and IQVIA. He is the most recent Past President of the Diagnostics Marketing Association and currently serves on the editorial advisory board of Inside Precision Medicine and the programming advisory board of the Cambridge Healthtech Institute.

• Enabling Point-of-Care Diagnostics