Speaker Biographies

Neeraj Adya has over 20 years of experience in the In Vitro Diagnostics (IVD) industry. He is currently the Head of Diagnostics at Genmab, where he leads the diagnostic team in evaluating and manage diagnostic strategies across assets. Prior to Genmab, Neeraj spent approximately four years as the Diagnostic Lead at Bristol-Myers Squibb and prior to that, 16 years developing diagnostic products at Abbott Labs, including Abbott Molecular where he led multiple companion diagnostic programs with various Pharma partners. Neeraj received his PhD in Molecular Biology from Case Western Reserve University followed by Post-Doctoral research at the National Institutes of Health.

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

Ramy Arnaout MD, DPhil, is Associate Director of the Clinical Microbiology Laboratories in the Department of Pathology at Beth Israel Deaconess Medical Center (BIDMC) and Beth Israel Lahey Health in Boston, MA, where he is also Director of Clinical Informatics resident training. In addition, Dr. Arnaout is an Associate Professor of Pathology at Harvard Medical School, where his research focuses on the appropriate use of laboratory testing, rapid testing, and computational immunology; is faculty in the Department of Systems Biology at Harvard Medical School and the Division of Clinical Informatics in the Department of Medicine at BIDMC, and is President-Elect of the American Society of Microbiology, Northeast Branch. He is a former chair of the Clinical Laboratory Improvement Advisory Committee, which advises the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, and the Food and Drug Administration. Previously he founded, grew, and sold the science search company Pubget.

Ken Bahk, PhD is an entrepreneur, investor, and healthcare strategist focused on translating science and technology into scalable, real-world healthcare solutions. He has founded, built, or invested in health technology startups, with successful exits valued at multiple billions. He is the founder and Managing Partner of Health Equity Innovation Partners, a firm dedicated to identifying leading technologies and integrating them into rural and underserved health systems to measurably improve access, quality, and outcomes. Over the past five years, this team has further refined an approach centered on rigorous technology diligence, cross-sector alignment, and disciplined follow-through from pilot to scaled adoption. Earlier in his career, Ken designed and led global, disease-focused innovation ecosystems for multiple family offices, integrating science, capital, philanthropy, and company creation to accelerate patient impact. He has served as an advisor to institutions including the White House, the National Science Foundation, J.P. Morgan, and the Duke-Margolis Center for Health Policy. Ken holds a PhD and an MBA from Northwestern University.

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.

Suzanne Belinson, PhD, MPH, is Vice President of Commercial Markets at Tempus Labs Inc. Tempus is a technology company that is making precision medicine a reality by gathering and analyzing clinical and molecular data at scale. Her role focuses on commercial growth for Tempus through the development and execution of partnerships with managed care organizations aiming to improve healthcare value by leveraging data. Before joining Tempus, Dr. Belinson served as Executive Director, Clinical Markets, at the Blue Cross Blue Shield Association. In addition to leading the sales and market development for products and services developed within the Office of Clinical Affairs, Dr. Belinson led the day to day operations of Evidence Street. As part of the leadership team in the Office of Clinical Affairs she also spent time focused on the development of emerging programs and services that enhance value and brand leadership for the independent BCBS Plans. Dr. Belinson received her bachelor’s degree from Cleveland State University, and a PhD in Epidemiology from the University of North Carolina at Chapel Hill. She also holds a Masters in Public Health from the University of Pittsburgh.

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.

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

Clarisa Blattner is the Senior Director of Revenue and Payor Optimization at XiFin, Inc. She serves as a subject matter expert in revenue cycle management (RCM) and payor and market strategies, focusing on achieving operational efficiencies and maximizing revenue. With over 25 years of experience in the healthcare sector, Clarisa has an extensive background in revenue cycle management, particularly within the healthcare industry. Previously, she oversaw the billing and reimbursement operations for the outsourced billing department. She cultivated and directed a large team of revenue cycle personnel to service diagnostic providers in multiple specialties. She has served in leadership roles at prominent organizations such as US Labs, Clarient, and MDxHealth. In her current role, Clarisa works closely with new and existing customers to implement and operate innovative capabilities tailored to their unique needs. Leveraging her deep knowledge of market access and payor policy, she functions as a trusted advisor, offering recommendations that maximize the utility of XiFin’s products and services to achieve revenue targets. Beyond her day-to-day responsibilities, Clarisa is committed to sharing her industry expertise through public speaking engagements and networking events. She holds a Bachelor of Science degree in Biological Sciences from the University of Southern California, as well as a certificate in Business Administration. Additionally, she is credentialed as a Certified Coding Specialist (CCS) through AHIMA and as a Certified Professional Coder (CPC) through AAPC. Clarisa’s leadership and subject matter expertise make her a pivotal asset to XiFin and its clients, helping them navigate the complexities of the modern healthcare revenue landscape.

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.

Dr. Holly J. Butler, BSc, PhD, MBA, is Chief Technical Officer and co-founder director of Dxcover, the diagnostics company pioneering multiomic spectral analysis for early cancer detection. A leader in clinical spectroscopy and biophotonics, she has extensive research experience and has been recognised with entrepreneurial awards early in her career. Holly brings both deep scientific expertise and strategic leadership to the development and scaling of Dxcover’s next-generation diagnostic platform. She has played a central role in the scientific development, clinical validation, and regulatory approval of Dxcover’s technology, including the company’s first commercial test for brain cancer. Alongside her technical leadership, she supports Dxcover’s international growth through strategic oversight of product development and market expansion.

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.

Jerry Conway, Senior Vice President of Market Access, joined Belay Diagnostics in April 2024 with over 34 years of sales and executive management experience in the routine clinical and esoteric laboratory marketplaces. His experience includes physician sales and marketing, payer contracting and reimbursement in a wide range of business environments, including Fortune 500 and start-up companies. Jerry was previously with GeneDx, Scipher Medicine, CDx Diagnostics, Inc., Foundation Medicine Inc. (FMI), Metamark Genetics, and Genzyme Genetics in senior Market Access leadership roles. At FMI, Jerry was responsible for reimbursement of all diagnostic products, including successful achievement of the FDA-approved FoundationOneCDx universal companion diagnostic platform and National Coverage Determination (NCD) by CMS under the Parallel Review Program. Under his leadership at Genzyme Genetics, Jerry helped to favorably position the company for a $975 million acquisition by Laboratory Corporation of America® Holdings on December 1, 2010. Prior to his career in market access and reimbursement, Jerry was employed by Damon Clinical Laboratories, Metpath/Corning and Long Term Care Services, Inc. in various diagnostic field sales and management roles in the physician and long term care markets.

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.

Hariharan Easwaran, MSc, PhD, is an Associate Professor of Oncology at the Sidney Kimmel Cancer Center at Johns Hopkins University. He is a cancer epigenetics researcher whose lab focuses on how epigenetic changes—especially DNA methylation—evolve during aging, environmental exposures, and early tumor initiation, how these alterations predispose cells to cancer, and how these changes can be used to develop novel biomarker strategies. His group integrates various models with genomic and epigenomic profiling and computational analysis to dissect early carcinogenic mechanisms and to develop epigenetic biomarkers, including cell-free DNA–based approaches for cancer detection.

John Fox, MD MHA, is currently the Senior Medical Director of the Americas, Market Access, for Illumina, where he is accountable for working with payers and employers to expand access to genomic testing and personalized medicine. He served as the Associate Chief Medical Officer at Priority Health, a provider-sponsored health plan with over 1,200,00 members from June 2000 through May 2019. He was responsible for medical and pharmaceutical technology assessment, use of medical resources, case management, and physician pay-for-performance programs. He was also responsible for development of new programs, including shared decision-making, digital therapeutics, advanced care planning, integrated specialty pharmacy program, surgical optimization initiatives, value-based benefit designs, and contracts, oncology medical home programs, and personalized genomic medicine initiatives. In June 2019 he became the Vice President of Clinical Transformation of Spectrum Health Systems, the parent company for Priority Health, and the Executive Medical Director for the West Michigan ACO, a clinical collaboration between Spectrum Health providers and Answer Health, the largest independent physicians organization in west Michigan.

David Gaston is a clinical microbiologist and infectious disease physician. He obtained his MD and PhD in the University of Alabama at Birmingham Medical Scientist Training Program (MSTP), thereafter completing internal medicine residency at the University of Utah, infectious disease fellowship at Yale-New Haven Hospital, and clinical microbiology fellowship at Johns Hopkins Hospital. He directs the Molecular Infectious Disease Laboratory (MIDL), a section of the clinical microbiology laboratory at VUMC. His clinical and research interests are development and implementation of molecular methods (specifically next-generation sequencing technologies) for rapid, robust, and reliable pathogen identification and characterization in infectious disease 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.

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.

Paul is a highly regarded physician and healthcare executive with deep experience in both the academic and patient care spaces. He offers clients critical insights across a wide range of clinical areas and healthcare technologies, and provides guidance on Medicare policy and regulatory requirements. Paul also has significant experience in health outcomes research and scientific computing. Before joining McDermottPlus, Paul had a varied career spanning academia, private practice, and Medicare policy. After leaving academia, he established and ran his own medical practice serving patients in addition to advising large institutions on utilization management and quality improvement before becoming a chief medical officer at Palmetto GBA and MolDX director of clinical science leading coverage and payment determinations for new molecular medicine technologies. In this role, he was instrumental in forging consensus among Medicare contractors on emerging and sometimes controversial areas of medicine in a highly visible program, and served as a primary point of contact between MolDX and the Centers for Medicare & Medicaid Services. Paul now works for McDermott+ Consulting assisting manufacturers and health care providers in bringing innovative patient care products to market.

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.

Joyce Gresko is an attorney in Alston & Bird’s Washington, D.C. office, where she is a member of the Health Care Group and Legislative & Public Policy Team. She focuses her practice on health care regulatory, legislative, and compliance matters. Her clients include clinical laboratories, medical device manufacturers, health care professional associations, and other related health care entities. She assists her clients with understanding and resolving issues relating to Medicare and Medicaid coverage, coding, and payment, federal and state fraud and abuse laws, effective compliance programs, and health care quality. Joyce also leads Alston & Bird’s Government Ethics & Compliance practice, advising corporate and political committee clients on federal and state election law and lobbying requirements. She thinks about her clients’ needs holistically and strategically and brings a practical approach to problem-solving. Joyce earned a B.A. from the University of Michigan and a J.D. from Georgetown University.

Gary Gustavsen joined Health Advances in 2005 and co-leads its Precision Medicine Practice. A noted writer and workshop leader in the field of companion diagnostics and personalized medicine, his work focuses on commercialization strategy, value justification, and due diligence for both diagnostic and therapeutic companies. Prior to joining Health Advances, Gary held research positions at Brookhaven National Lab, Becton Dickinson, OSI Pharmaceuticals, and Millennium Pharmaceuticals. Gary has a background in Biomedical Engineering with a bachelor’s degree from Duke University and a master’s degree from Stony Brook University.

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.

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

Dr. Mark Hiatt is a Stanford-trained physician-executive who helps precision medicine and diagnostic companies validate their technologies and navigate regulatory and reimbursement pathways. He previously led medical affairs at Guardant Health, where he supported the clinical integration of liquid biopsy technologies in oncology. With leadership experience across payer organizations, benefit managers, and accreditation bodies, Dr. Hiatt brings a 360-degree perspective on diagnostic value demonstration, access strategy, and clinical utility in precision oncology.

Lee H. Hilborne, MD, MPH is a professor of pathology and laboratory medicine at UCLA, senior health services researcher at RAND, and senior medical director in Medical Affairs at Quest Diagnostics. He has been a leader in medical quality and laboratory medicine for four decades, including serving as ASCP president in 2007. He is a member of ASCP’s Commissions on Membership and Public Policy and as ASCP’s advisor to the CPT Editorial Panel; he served as a member of the Panel for eight years. He was also the founding chair of the PLA Technical Advisory Group (PLA-TAG). Dr. Hilborne has given hundreds of invited presentations nationally and internationally and has well over 100 publications in peer-reviewed journals. Locally, Dr. Hilborne is a Health and Safety Commissioner for the City of Beverly Hills, having been a member of the Commission for four years.

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.

Gillian Hooker serves as the Chief Scientific Officer of Concert, a Nashville-based Health IT firm building an infrastructure to enable precision medicine. She also serves as an adjunct faculty member in the Vanderbilt University School of Medicine and the chair of the Tennessee Rare Disease Advisory Council.

Dr. Zhen Huang specializes in developing and translating advanced biosensors and in vitro diagnostic platforms to enhance pathogen biomarker detection and clinical diagnostics for infectious diseases. His research bridges fundamental science and clinical practice, driving innovations in diagnostic accuracy for complex biological samples, and enabling personalized disease diagnosis and treatment. Dr. Huang has served as the principal investigator or lead investigator on four research grants, including one NIH R01 grant. He has published over 40 peer-reviewed articles in top journals, including Nature Reviews Bioengineering, The Lancet Microbe, Nature Nanotechnology, Nature Biomedical Engineering, Nature Communications, Science Advances, Journal of Clinical Investigation, Advanced Science, and ACS Nano et al. He also served as an associate editor for a published monograph and received a provincial scientific and technological award as a primary contributor. Additionally, he holds one international, one U.S., and two Chinese patents, with two successfully commercialized.

Cheryl James is the Manager for the Laboratory Coding and Strategy group at Mayo Clinic/Mayo Clinic Laboratories. She has 30 years' experience in Cytogenetics prior to taking on the role for laboratory coding. In this role she and her team ensure that laboratory tests are coded appropriately. She is involved in discussions on appropriate coding for new tests and partners in discussions on reimbursement and coverage for laboratory testing. On behalf of Mayo she submits code applications to AMA CPT Editorial Panel and for codes approved, presents reimbursement recommendations at the CMS CLFS Annual Meeting. She is involved with the American Clinical Laboratory Association CPT Committee and actively involved in their CPT Workgroups.

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.

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.

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.

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.

Caitlin Kubler is the senior director of policy and advocacy of Prevent Cancer Foundation. Caitlin strengthens the Foundation’s efforts to prioritize funding for cancer research, reduce health care disparities and support legislation that improves access to health care, prevention and screenings. She builds relationships and unites cancer-focused organizations around the importance of prevention and early detection in accomplishing the joint mission of reducing cancer deaths. Caitlin brings to her work at the Foundation over 15 years’ experience in the health field. Caitlin holds a bachelor’s degree in health science management from George Mason University and a Master of Science degree in health and medical policy from George Mason University.

I aspire to make healthcare better! 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/solution 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.

Dr. Kaouthar Lbiati is a biopharma chief executive, board director, strategic advisor and mentor to the U.S. International Trade Administration’s “Select Global Women in Tech” program. Recognized in Marquis Who’s Who (2024) for her leadership in biotechnology, pharmaceuticals, and global health, she has played pivotal roles across early-stage and more established public and private life science companies. She has successfully led cross-functional and multinational teams, secured regulatory approvals, commercialization, and reimbursement for multiple innovative therapies across diverse markets, and attracted multimillion-dollar investments. Throughout her career, she has forged global partnerships and delivered high-impact initiatives that improved patient outcomes and expanded access to cutting-edge technologies. Her influence extends from operational leadership to the boardroom, where she has overseen strategic direction, guided organizations through crises and major restructurings, and consistently positioned companies for scalability and long-term success. Dr. Lbiati is also the author of several op-eds on ecosystem development, industrial and technological policy, and global health, published across international outlets. She earned a Doctor of Medicine (MD) from Mohammed V University in Rabat, a Specialized Executive Master’s from ESSEC Business School in Paris, and a Master of Science in International Policy and Health Economics from the London School of Economics (LSE). She also completed executive programs at Harvard Business School and Columbia Business School.

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.

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.

Dr. Lias studied at the Johns Hopkins University School of Medicine, where she received her Ph.D. in Biochemistry, Cellular, and Molecular Biology. Currently, Dr. Lias is the Acting Director of FDA’s Office of in vitro Diagnostic Devices. During her FDA career of nearly two decades, she has led efforts to promote the development of new therapeutic and diagnostic devices, including devices for diabetes and drug dosing and monitoring. In 2017, Dr. Lias received the Samuel J. Heyman Service to America Medal in Management Excellence. This honor was awarded for work promoting the efficient development and approval of the first automated insulin dosing system.

Michael N. Liebman, PhD (theoretical chemistry and protein crystallography) is Managing Director of IPQ Analytics, LLC and CSO of United Cancer Centers after serving as Executive Director of the Chan Soon-Shiong Institute for Molecular Medicine. He is Adjunct Professor of Pharmacology and Physiology, Drexel College of Medicine and Adjunct Professor of Drug Discovery, Wenzhou Medical University and Fudan University. He serves on the Advisory Board for the Center of Biomedical and Health Research, University of Massachusetts (Lowell). Previously, he was Director, Computational Biology and Biomedical Informatics, University of Pennsylvania Cancer Center. He served as Global Head of Computational Genomics, Roche. He serves on the Board of the Nathaniel Adamczyk Foundation in Pediatric ARDS. Michael chairs Translational Medicine for the PhRMA Foundation and serves on the IUPAC Division on Human Health. His research focuses on computational models of disease that stress complexities of real-world patients and real-world clinical practice utilizing systems-based approaches for representation and analysis for pharma and healthcare. Current application areas include: multiple sclerosis, heart failure, and a focus on women’s health: triple negative breast cancer, hypertension and hypertensive disorders of pregnancy, infant-maternal morbidity and mortality, perimenopause-menopause transition with an emphasis on underserved populations and health disparities.

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.

Minetta C. Liu, MD, is a Professor of Oncology and Research Chair for the Department of Oncology with a secondary appointment in the Department of Laboratory Medicine and Pathology at Mayo Clinic Rochester. Dr. Liu also serves as Co-Leader of the Genomics in Action Strategic Priority for the Center of Individualized Medicine. She holds positions in several external professional organizations, including Co-Chair of the Clinical Working Group for the Evelyn H. Lauder Founder’s Fund Collaboration; Co-Chair of the Correlative Science Working Group for the Translational Breast Cancer Research Consortium; and Chair of the Circulating Biomarker Working Group for the Alliance for Clinical Trials in Oncology. As a physician and translational researcher, Dr. Liu specializes in breast medical oncology and promotes the latest advances in clinical and laboratory-based research across the spectrum of malignancies. She is dedicated to improving patient outcomes through the use of molecular diagnostic tools to promote precision cancer care. Her laboratory efforts focus on expanding the availability and clinical applications of circulating blood-based biomarker assays for drug selection and disease monitoring in advanced malignancies, for the detection of molecular residual disease in early stage cancers, and for multicancer early detection in healthy and/or at-risk individuals.

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.

Minjie Luo, PhD, is an Associate Professor of Pathology and Laboratory Medicine at the Perelman School of Medicine at the University of Pennsylvania and a Director in the Genomic Diagnostics Laboratory at the Children’s Hospital of Philadelphia. She also serves as the Program Director for the Laboratory Genetics and Genomics Fellowship. Dr. Luo is board-certified by the American Board of Medical Genetics and Genomics in both Clinical Cytogenetics and Clinical Molecular Genetics. Her clinical responsibilities involve the diagnosis of both cancer and constitutional disorders using multiplatform genomic testing, as well as developing new assays, supporting quality improvement, and participating in clinical service. Her academic interests include the detection and interpretation of germline variants associated with cancer predisposition in pediatric populations to support early tumor detection and surveillance.

Dr. Shahla Masood is a Persian born physician, who currently holds the positions of Professor and Chair of the Department of Pathology at University of Florida College of Medicine – Jacksonville and Chief of Pathology and Laboratory Medicine at UF Health Jacksonville. She is also the Director of the Cytopathology and Breast Pathology Fellowship Training Programs. As an internationally recognized expert in breast cancer diagnosis and prognosis, Dr. Masood has fostered the concept of an integrated multidisciplinary approach in breast cancer care, research, and education. She is the founder and first Editor-in-Chief of The Breast Journal, the founder and past president of the “International Society of Breast Pathology,” the Director of the “Annual Multidisciplinary Symposium on Breast Disease”, and “The Breast Health Public Forum: What everyone should know about breast health”. Dr. Masood is heavily involved in the study of minimally invasive procedures such as fine needle aspiration biopsy in providing diagnostic and prognostic information in high risk and breast cancer patients. She defined the cytomorphology of high-risk proliferative breast disease in the early 1990’s and has pioneered the concept of cytomorphology as a breast cancer predictor and introduced the concept of “Masood Cytology Index”. Dr. Masood is the author of several textbooks, book chapters, and numerous publications. She is a frequent speaker at national and international symposiums and consensus meetings. She is also a member of the board of trustees of several prestigious scientific societies and organizations at local, regional, national and international levels, including serving as a member of the American Cancer Society National Breast Cancer Roundtable (ACS NBCRT). Dr. Masood has received numerous awards and recognition for her scientific work, her contribution to advancing global breast health education and her efforts to improve the quality of breast health care. She is the recipient of the University of Florida COM-Jacksonville “Women in Medicine & Science, 2024 Distinguish Faculty Award”, “The 2010 Breast Health Global Initiative Award,” “Courage to Teach Award” from National Accreditation Council for Graduate Medical Education, and Florida Times Union “Eve Award,” to name a few. She has been named as one of the Top Doctors in America, Top Doctors in Cancer and one of the 20 Top Most Influential Professors in Oncology at an international level. In 2015 and 2024, Dr. Masood was honored in Rome, Italy by Italian President and Susan G. Komen Italia, a partnership between Susan. G. Komen and the Catholic University in Rome for her widespread contributions to breast cancer advocacy, and initiation of the Italian “Race for the Cure” in 2000. Dr. Masood is a patient advocate, a partner in community affairs and an accomplished artist and gourmet chef. She is the mother of two accomplished physicians, Dr. Ali Kasraeian, a urologist, and Dr. Sina Kasraeian, an orthopedic surgeon.

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

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.

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.

John J. Meduri is a 40+ year IVD industry veteran. Initially trained as a clinical immunologist and microbiologist, Mr. Meduri has led global strategy, commercialization and M&A activities at BD, MRL, and Accelerate Diagnostics, launching numerous transformative diagnostic platforms to the global market. He is a University of Pennsylvania Wharton Fellow and a Johns Hopkins Distinguished Alumnus Award recipient.

Michael Mina, MD, PhD is an epidemiologist, immunologist and clinical pathologist. He is also an executive and consultant to governments, biotech, and life sciences companies. He was formerly a professor in the Departments of Epidemiology and Immunology & Infectious Diseases, at the Harvard T.H. Chan School of Public Health; in clinical pathology at Harvard Medical School and an associate faculty at the Broad Institute of MIT and Harvard. He was the associate medical director for molecular virology diagnostics at Brigham and Women's Hospital and started and helped lead the Broad Institute’s high throughput COVID-19 testing facility. His research focused on developing extremely multiplexed assays for immune profiling and mathematical models towards understanding effects of viral infections on immunity; the development and maintenance of immunity through life; and development of a global immunological observatory for pathogen spread. Dr. Mina became Chief Science Officer of eMed, a digital first healthcare company that improves effectiveness of home-based testing by linking home tests to telemedicine. In 2020, eMed collaborated with Abbott to bring the first low-cost COVID-19 rapid test - the BinaxNOW Home Test - into US Households enabling real-time result certification and public health reporting from anywhere helping millions of people travel internationally and return to work and school. Dr. Mina is also the Executive Director of the Immune Observatory, a 501(c)3 not-for-profit for pathogen monitoring and surveillance through next generation immunological tools. Dr. Mina advises US Federal and state governments, including both White Houses through COVID-19, US Congress, CDC, and FDA. He was the recipient of the NIH Director's Early Independence Award and was named by the Economist as a Global Progress Maker. He currently helps lead numerous large NIH funded programs including leading the implementation of the NIH Home Test to Treat Program and co-PI of the COVID-19 Paxlovid Rebound Cohort Study

Jackie Moriarty is Vice President of Market Access at Geneoscopy, where she leads payer strategy and government affairs for the FDA-approved ColoSense colorectal cancer screening test. She focuses on building integrated access strategies that translate regulatory and policy milestones into real-world patient access.

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.

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.

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.

Prof. Klaus Pantel is chairman of the Institute of Tumour Biology at the University Medical Center Hamburg-Eppendorf. He graduated in 1986, and after his postdoctoral period in the USA he performed research at the Institute of Immunology, University of Munich for 10 years. The pioneer work of Prof. Pantel in the field of cancer micrometastasis, circulating tumor cells and circulating nucleic acids is reflected by more than 550 publications in excellent high ranking biomedical and scientific journals and has been awarded the AACR Outstanding Investigator Award 2010, German Cancer Award 2010, and two ERC Advanced Investigator Grants 2011 and 2019. Moreover, Prof. Pantel is the founder and chairman of the European Liquid Biopsy Society (ELBS).

Dr. Anil Parwani is a Professor of Pathology at The Ohio State University. He serves as the Vice Chair and Director of Anatomical Pathology. Dr. Parwani is also the Director of Pathology Informatics and Director of the Digital Pathology Shared Resource at The James Cancer Hospital. His research is focused on diagnostic and prognostic markers in bladder and prostate cancer, and molecular classification of renal cell carcinoma. Dr. Parwani has expertise in the area of surgical pathology, viral vaccines and immunology, and pathology informatics including designing quality assurance tools, bio banking informatics, clinical and research data integration, applications of whole slide imaging, digital imaging, telepathology, image analysis and lab automation. Dr. Parwani has authored over 300 peer-reviewed articles in major scientific journals and several books and book chapters. Dr. Parwani is the Editor-in-chief of Diagnostic Pathology and one of the Editors of the Journal of Pathology Informatics.

A native of New York, Dr. Peter A. Prieto dedicated his career to oncology after the personal loss of his father to sarcoma. Dr. Prieto is a quadruple board-certified surgical oncologist and tumor immunotherapist with extensive expertise in melanoma, soft tissue sarcoma, and breast cancer. He completed his general surgery residency at the Yale University School of Medicine, including a three-year surgical oncology and immunotherapy research fellowship at the National Cancer Institute (NIH) under the mentorship of Dr. Steven A. Rosenberg, where he served as a co-investigator on pioneering adoptive cell therapy clinical trials. Dr. Prieto further refined his clinical expertise at the University of Texas MD Anderson Cancer Center, completing a fellowship in Complex General Surgical Oncology and a post-doctoral research fellowship under Drs. Jennifer A. Wargo and Funda Meric-Bernstam. During his tenure at MD Anderson, he was instrumental in the development and analysis of a landmark phase II trial investigating neoadjuvant targeted therapy in high-risk resectable stage III BRAF-mutant melanoma. Transitioning from academic medicine to executive leadership, Dr. Prieto now serves as the Senior Vice President of Medical Affairs at Tempus AI. In this role, he leads strategic initiatives at the intersection of artificial intelligence, digital pathology, and molecular diagnostics. He is a primary advocate for the integration of multimodal data—including the Immune Profile Score (IPS) and AI-driven digital pathology models—into the clinical workflow to advance precision oncology. In addition to his leadership at Tempus, Dr. Prieto holds board certifications in Anti-Aging & Regenerative Medicine and Medical Quality, and is a Fellow of the American College of Surgeons (FACS). A prolific author of high-impact publications and a frequent international speaker, Dr. Prieto remains committed to his mission of treating every patient like family while scaling the impact of AI-driven healthcare solutions to global populations.

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.

Kristin Rastatter is the Director of Advocacy at the Urgent Care Association, where she leads the organization’s federal and regional Advocacy strategy on behalf of Urgent Care centers nationwide. Her work is grounded in direct engagement with federal agencies, including the Centers for Medicare and Medicaid Services, and close collaboration with state and regional chapters to advance shared policy priorities. Kristin focuses on ensuring that policymakers understand how Urgent Care operates in practice, not in theory. She works with leaders across the country to identify regulatory barriers, payment challenges, and workforce issues, and then translates those realities into clear, credible advocacy at both the national and local levels. A growing part of her work involves policy considerations tied to enhanced Urgent Care centers, including expanded clinical capabilities, diagnostics, and evolving sites of service. She is known for connecting high‑level policy decisions to real operational impact, helping Urgent Care leaders navigate change while shaping the policies that will define the next phase of the industry.

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.

Peggy Robinson is CEO at Caza Health LLC, an Axon Connected company focused on providing better diagnostics for women’s health. Prior to joining Axon Connected, Peggy was the US Vice President for ANGLE, plc, a world-leading liquid biopsy company with pioneering products in cancer diagnostics and fetal health. At ANGLE, Peggy led the commercialization of products in North America as well as built global KOL relationships and drove strategic alliances. As an accomplished Senior Marketing Executive with over 20 years of experience in diagnostic global marketing, Peggy has served in various marketing, marketing communications, market development, strategic alliances, consulting, sales, and technical service roles in diagnostics, molecular, life sciences, and CROs with such companies as Chiron, Bayer Diagnostics, Covance, EMD Millipore, BioMark Consulting, LLC, Immunicon, and Janssen Dx, a Johnson and Johnson company. She has launched various product lines domestically and internationally and has managed the associated international partnerships in the development of new products. Additionally, she has worked in developing collaborations with major pharmaceutical/biotech companies to market research use only products, early in their lifecycle. Peggy earned a BS in Biology/Medical Technology at Millersville University and is a registered Medical Technologist. Peggy was the President of the Diagnostics Marketing Association and awarded the Jerry R. Goldsmith Award for marketing excellence, by leaders in the industry.

Dr. Robinson, a native of Kansas, received his undergraduate B.A. degree in anthropology at the University of Kansas and his medical degree from the Washington University School of Medicine in St. Louis, Missouri. He completed his internship and residency in general and cardiothoracic surgery directed by Dr. David Sabiston at the Duke University Medical Center. Additionally, he completed a fellowship in cardiac research and clinical cardiac surgery at the St. Thomas’ Hospital in London. He also served as a Flight Surgeon at the rank of Major, USAF in Thailand during the Vietnam War. A Diplomat of the American Board of Surgery, the American Board of Thoracic Surgery as well as certified in Surgical Critical Care, Dr. Robinson began his practice at the University of Nebraska Medical Center where he was an Associate Professor of Surgery and Pharmacology and the Clinical Director of the Clinical Perfusion Science Education Program. Dr. Robinson then came to the University of South Florida College of Medicine in Tampa in 1994 where he is a Professor of Surgery (Thoracic) and Interdisciplinary Oncology. He practices thoracic surgical oncology at the Moffitt Cancer Center as a Senior Member with Tenure of the Moffitt Medical Group. He is Director, Lung Cancer Early Detection (LEAD) Center at Moffitt which includes the Lung Cancer Screening Program, Lung Nodule Clinic and Lung Surveillance Clinic. Dr. Robinson is the author or co-author of over 180 medical publications. He is Principal Investigator on 3 research protocols involving lung cancer in never-smoking women, the use of biomarkers for early lung cancer diagnosis, and a clinical study evaluating the influence of nutrition and the gut microbiome on the effectiveness of immunotherapy. Clinically, he is a member of the multidisciplinary thoracic oncology group involved in the evaluation and treatment of lung cancer, thymoma, and other thoracic cancers which includes aggressive, combined modality therapy including numerous clinical trials.

Zach Rothstein is Executive Director for AdvaMedDx. In this role, Zach directs 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. Prior to this position, Zach was AdvaMed’s Senior Vice President for Technology and Regulatory Affairs where he worked closely on regulatory and legal matters impacting medical devices, with a particular emphasis on digital health, medical device software, cybersecurity, labeling, and post-market surveillance. Zach is also a member of the World Health Organization’s Digital Health Technical Advisory Group’s Roster of Experts. Prior to joining AdvaMed, Zach was Deputy Senior Counsel for Public Policy at Samsung Electronics where he was responsible for the company’s medical device and healthcare regulatory and policy issues. In this position, Zach counseled Samsung’s global business units through all stages of product development on U.S. regulations affecting medical devices. Zach also planned and executed the company’s FDA and healthcare regulatory and legislative policy objectives. While at Samsung, Zach served on the Board of Directors for the Personal Connected Health Alliance (formerly Continua) and the Consumer Electronics Association’s Health and Fitness Technology Division. Prior to joining Samsung, Zach was an attorney in the FDA and Healthcare practice at the law firm of Morgan, Lewis & Bockius LLP. In this role, Zach served as outside counsel to various healthcare companies on FDA and HHS regulatory, compliance, and enforcement matters. Zach earned his JD from The Catholic University of America, where he was a notes and comments editor of the Law Review, President of the Moot Court Board, and won first place and best brief awards at the 2009 National Telecommunications Moot Court Competition. Zach received his BA in political science and criminal justice from Indiana University, Bloomington.

Shaunak Roy, PhD, is the Senior VP of Research and Development at Visby Medical, where he spearheads the innovation of instrument-free, rapid PCR diagnostic platforms. With over 20 years of leadership in molecular diagnostics, Dr. Roy has directed the technical development and FDA clearance of eight diagnostic products, including a landmark 2025 De Novo OTC clearance for sexual health. His expertise centers on bridging scientific innovation with operational excellence, specifically in the areas of assay integration, surface chemistry, and the engineering of scalable, regulated systems. In previous roles, he held key engineering and management positions at InSilixa, GeneWeave Biosciences (acquired by Roche), and Complete Genomics. An inventor of more than 30 patents, Dr. Roy holds a PhD in Chemical Engineering from Stanford University and is a specialist in translating breakthrough technology into high-impact, point-of-care clinical solutions.

As former VP and Head of Diagnostics, Dr. Hakan Sakul founded and led Pfizer’s Diagnostics group, with dozens of drug/diagnostics combination approvals in global markets under his leadership. During his 24-year tenure at Pfizer, Hakan also held leadership positions in Clinical Pharmacogenomics, Molecular Profiling, and Translational Oncology. One of his most significant professional accomplishments was to lead Pfizer’s flagship CDx program for Xalkori®, resulting in simultaneous FDA approvals of the drug/diagnostic combination in 2011. Prior to Pfizer, Hakan worked in the biotech industry in human genetics and statistical genetics. Hakan’s contributions to precision medicine and diagnostics have been widely recognized through both internal and external awards and frequent speaking engagements. He is a former member of the Board of The Personalized Medicine Coalition, served as a Scientific Advisory to Luminex Corp, and currently is a Board member of Progentec Diagnostics, as well as BASH Biotech. Hakan is a member of California Gov Newsom’s Precision Medicine Advisory Council. He received his BS and MSc degrees from Ankara University in Turkey, PhD in Quantitative Genetics from the University of Minnesota as a Rotary Foundation Scholar and conducted postdoctoral studies at the University of California-Davis. He has authored over 30 refereed scientific articles as well as many other publications. Hakan is keenly interested in molecular diagnostics, liquid biopsy and related medical technologies to advance Precision Medicine for the improvement of individualized healthcare.

Giles looks after the Diagnostics Team at TTP, a Cambridge (UK) based innovation and product development company. Giles is a strong advocate for the value and importance of distributing diagnostics and has been developing tools in this field for most of his career. At TTP, he has worked with start-up and major multinationals in developing new innovative products and technology for life science, chemistry, and diagnostic applications. Giles also acts as an Entrepreneur in Residence for Oxford University, where he advises nascent entities on commercialization opportunities. By background Giles is a Physical Chemist and has degree and PhD from Oxford University and has recently seen the second edition of an undergraduate textbook he co-wrote- Electrode Potentials published by Oxford University Press.

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.

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.

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

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.

Dr. Srivastava is Senior Scientific Officer and Chief of the Cancer Biomarkers Research Group in the Division of Cancer Prevention, National Cancer Institute. He joined the National Cancer Institute in 1988. Since 1990, he has served as program director in the Division of Cancer Prevention and focused his responsibility in developing molecular approaches to cancer early detection, screening, and prevention. He has conceptualized and implemented several programs to study the biology and early detection of precancer lesions, with a primary emphasis on translational research on cancer screening, early detection, risk assessment, and enabling technologies, including artificial intelligence (https://prevention.cancer.gov/research-groups/cancer-biomarkers/about-cancer-biomarkers). Dr. Srivastava is an internationally recognized leader in cancer biomarker research. He is best known for his seminal contributions to improving systems approach to biomarker discovery, development, and validation. In 2000, Dr. Srivastava developed and implemented a novel approach to collaborative clinical research on cancer biomarkers through the establishment of the Early Detection Research Network (EDRN; www.cancer.gov/edrn), a flagship program at the National Cancer Institute, National Institutes of Health. Under his leadership, the network has begun translating biomarkers into clinical tests (> 8 FDA-approved and > 13 CLIA-certified) for early detection and diagnosis, risk assessment, and prognosis. He has spearheaded the role of chemical sciences in oncology by establishing the NCI’s Alliance of Glycobiologists (www.glycomics.cancer.gov) to study the structure-function relationship of glycans, AI for improving prediction, noninvasive technologies, such as liquid biopsy to multi-analyte, multi-cancer screening, and biomarkers in cancer detection and diagnosis of rare cancers, such as pancreas, liver and ovary. He has played a key role in conceptualizing and implementing informatics infrastructure for the EDRN in collaboration with NASA (Jet Propulsion Laboratory), a model collaboration being followed elsewhere in NIH. Dr. Srivastava is best known for his work on developing medical guidelines on the diagnosis of Hereditary Non-Polyposis Colorectal Cancer (HNPCC). He played a pivotal role in the development of the Bethesda Guidelines for diagnosing HNPCC, which is in clinical practice worldwide. He has received several honors and awards and is a member of a number of scientific committees worldwide. In 1995, he was elected to the American Joint Committee on Cancer (AJCC) which is responsible for developing staging criteria for cancers for worldwide use, and currently serves on the AJCC Executive Committee. He has been a visiting Professor at several medical and academic institutions and has delivered several inaugural and keynote addresses. In 2017, he was appointed as the inaugural head of the Human Proteome Organization’s External Development Initiatives (HEDI; www.hupo.org ). He has delivered lectures as a Keynote Speaker in more than 150 professional meetings and was invited in 2013 by the US Congress to speak on the early detection research programs at NCI. Currently, he is serving on the Planning Committee of the National Academies of Science to host a workshop on screening and early detection in 2020. He is founding Editor-in-Chief of the journal Cancer Biomarkers (https://www.iospress.nl/journal/cancer-biomarkers) published by the IOS press and serves as Associate Editors and reviewers for several internally known journals. He has published more than 200 research papers, review articles, and commentaries in peer-reviewed journals. He has edited several monographs and five book: Early Detection of Cancer: Molecular Markers, published by the Futura Publishing Company in 1995 and Molecular Pathology of Cancer, published by IOS Press, Amsterdam in 1999; Informatics in Proteomics (2005) published by Francis and Taylor, New York; Translational Pathology of Early Cancer (2012), published by the IOS Press and Biomarkers in Cancer Screening and Early Detection, published by Wiley, New York, 2017. Dr. Srivastava has received numerous NCI and NIH awards for his leadership in biomarker research and received a Team Science Award for Informatics by the Jet Propulsion Laboratory, NASA for his visionary and innovative use of NASA Data System Technologies in biomedical science. In 2016, he received a Cancer Prevention Distinguished Alumni Award for his accomplishments and mentoring of fellows. Recently, he was awarded Distinguished Public Service Award (2016) by the American Pancreatology Association and a Distinguished Clinical and Translational Proteomics Award (2017) by HUPO International the Distinguished Alumni Award (2016), Cancer Prevention Fellowship Program, NCI. He was featured in Wired magazine in August 2003 for his leadership in cancer diagnostics. He has been planning and managing comprehensive extramural scientific programs for more than 26 years. In 2016, he was invited to brief the US Congress on progress made on biomarkers for cancer early detection. He has successfully managed several mission-critical goals of the National Cancer Institute at various fronts, including conceptual, infrastructure, dependency linkage, and coordination among various federal, academic, and private sector constituents. He has successfully developed partnerships with National Institute of Standards and Technology, DODs Center for Prostate Disease Research, DOEs Pacific Northwest National Laboratory, and Jet Propulsion Laboratory on shared interests. In addition, he has developed collaborations with international and non-profit foundations, such as Japan’s Agency for Medical Development and research, CR-UK, Chinese National Cancer Institute, PanCAN, Lustgarten and Kenner’s Family Research Foundation.

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.

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.

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.

Patrick Strasser is the Co-Founder and CEO of Wholomics, where he leads the development of next-generation blood-based cancer detection built on serum functional multi-omics measured by proprietary NMR and interpreted with machine learning. Trained as a biochemist at the Technical University of Munich and having conducted cancer biology research at the Whitehead Institute at MIT (in Prof. Robert A. Weinberg’s lab) as well as at Dana-Farber, Patrick bridges deep mechanistic biology with clinical translation. He has led Wholomics’ multi-center MCED program across European clinical sites and presented results on multi-cancer early detection and pancreatic cancer detection at ASCO/JCO, with a focus on rigorous validation, clinically practical follow-up pathways, and scalable deployment through partnerships with leading cancer centers and diagnostic operators.

Lauren has situated her career squarely where technology and innovation meets the law – in regulatory. Lauren got her first experience working on regulatory topics related to agriculture at Dow AgroSciences and the Indiana Farm Bureau and after completing law school quicky transitioned to the biotech sector in regulatory affairs at Roche Diagnostics supporting their in vitro diagnostics product submissions to the FDA. Lauren is now Director of Regulatory Policy & Strategy focusing on topics related to digital health, diagnostics, and decentralized clinical trials at Eli Lilly and Company.

Iakovos Toumazis, an Operations Researcher and mathematical modeler, is an Assistant Professor in the Department of Health Services Research at MD Anderson Cancer Center. He directs a computational lab focusing on developing decision-analytical models to inform decisions covering the entire cancer care spectrum from primary prevention to survivorship. He received his BS in Mathematics with a major in Probability & Statistics from the University of Patras, Greece, and a MS and PhD in Industrial Engineering from the State University of New York at Buffalo. Before joining MD Anderson, Dr. Toumazis completed a postdoctoral fellowship at Stanford University. Dr. Toumazis is an active member of the NCI-sponsored consortium Cancer Intervention and Surveillance Modeling Network (CISNET) Lung Working Group and of the National Lung Cancer Roundtable (NLCRT) Shared Decision-Making Task Group. He was a key member of the modeling team that informed the US Preventive Services Task Force recommendation on lung cancer screening in 2021. In 2023, he served as an expert advisor to the American Cancer Society (ACS) Guideline Development Group for the update of the ACS lung cancer screening guideline. His research interests include sequential decision-making under uncertainty, applications of operations research in healthcare, simulation modeling, risk prediction modeling, robust optimization, and cost-effectiveness analyses of healthcare interventions across the cancer care continuum. To date, Dr. Toumazis has authored more than 50 publications and is the developer of the CHRONOS-series of natural history models that simulate the natural disease progression of various cancers, including lung and ovarian cancers. Supported by the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32) from the National Institutes of Health (NIH), he developed the ENGAGE framework, a decision-analytic model that optimizes screening decisions for lung cancer screening at the individual level. He received a prestigious MERIT Award (R37) from the NIH in 2021 to continue his work on personalized lung cancer screening decision-making. His research program is currently supported by the National Cancer Institute and the Cancer Prevention and Research Institute of Texas (CPRIT), among others.

Dr. Tran is a board-certified high complexity laboratory director (HCLD) through the American Board of Bioanalysis. His personal mission is to develop, evaluate, and implement cutting-edge biosensor technologies to advance laboratory medicine and expand access to care. Dr. Tran’s clinical work focuses on creating synergistic diagnostic pathways that integrate highly automated centralized testing with mobile, near-patient, and point-of-care solutions. As an HCLD-boarded laboratory scientist, he has broad expertise across all technical domains of clinical pathology. His primary areas of specialization include clinical chemistry, molecular infectious disease testing, and point-of-care diagnostics.

Alex Trick, PhD, is an inventor and entrepreneur developing novel molecular diagnostics tools to guide treatment and reduce barriers to care. As co-founder and CEO of Prompt Diagnostics he leads the creation of a point-of-care PCR platform for diagnosis and characterization of infectious diseases. In his efforts to bring lab-quality molecular diagnostics to the point-of-care, Alex has overseen projects sponsored by the NIH, NSF, CDC, RADx, and CARB-X and co-authored 20 peer-reviewed publications and 4 patents.

Dr. Eric Walk is Chief Medical Officer at PathAI in Boston, MA. He is head of the Medical group, overseeing the Medical Affairs, Pathology, Clinical Science, Regulatory and Quality functions. Eric has over 20 years of experience in precision medicine, including oncology drug development, companion diagnostics development and AI pathology. Prior to joining PathAI, he was Chief Medical and Scientific Officer at Roche Tissue Diagnostics/Ventana Medical Systems, where he led Medical & Scientific Affairs, overseeing the validation and FDA clearance/approval of multiple IVD assays, companion diagnostics and digital pathology algorithms. Eric began his industry career at Novartis Oncology, where he held positions in Early Clinical Development and Translational Medicine, working to implement biomarker and precision medicine strategies for early and late stage targeted oncology therapeutics. Eric is a Phi Beta Kappa graduate of Johns Hopkins University and holds an MD degree from the University of Virginia School of Medicine. He is board certified in Anatomic and Clinical Pathology and is a Fellow of the College of American Pathologists (CAP). He is currently a member of the CAP Digital & Computational Pathology Committee, SITC Pathology Committee, and Digital Pathology Association (DPA) Board.

Dr. Gabriel Wardi completed his undergraduate and graduate education in Atlanta. He moved to San Diego for his residency in Emergency Medicine where he served as chief resident during his final year of residency. He is the first graduate of the joint Critical Care Medicine fellowship offered by the Division of Pulmonary and Critical Care and Department of Emergency Medicine. He joined the faculty in July 2017 and attends in both the emergency department and the ICUs at UCSD as an associate professor and founding Chief of the Division of Critical Care within the Department of Emergency Medicine. Dr. Wardi’s research interests include sepsis, the ED-ICU interface, resuscitation, cardiac arrest management, and use of machine-learning to improve patient-centered outcomes. He is currently funded by the NIH to study how big data and machine-learning can improve outcomes of sepsis patients. He oversaw the clinical implementation of a novel deep-learning model to predict sepsis at UC San Diego Health, which resulted in a 17% relative decrease in sepsis-related mortality. He has received various awards for teaching and mentoring and has been selected as a "Top Doctor" in San Diego multiple times.

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

Yanghee Woo, MD, is Professor of Surgery and a surgical oncologist at City of Hope, who is internationally recognized for her work in gastric cancer research and treatment. Her work focuses on improving outcomes through earlier detection, innovative surgical care, and translational science. Dr. Woo leads a clinical trial (NCT06408220) evaluating gastric cancer screening strategies in high-risk populations in the United States, with the goal of identifying the disease at earlier and more treatable stages. Dr. Woo is one of the founding members of the Gastric Cancer Disparities Initiative, a U.S. national effort dedicated to eliminating disparities in gastric cancer through research, awareness, and improved access to screening and care. She also served as Site Principal Investigator for the Stand Up To Cancer gastric cancer interception research program, focused on advancing strategies to detect and intercept gastric cancer before it becomes advanced disease. Her research program integrates clinical trials, molecular biology, and emerging technologies to better understand gastric cancer biology and develop strategies for prevention and early diagnosis. In addition to her work in early detection, she has led pioneering studies in enhanced recovery pathways for gastric cancer surgery, immune biomarker discovery, and is advancing novel therapies for advanced disease, including oncolytic virus–based immunotherapy. Looking ahead, Dr. Woo is developing future studies evaluating DEXG2 (Cizzlebio), a noninvasive blood-based epigenetic test designed for the early detection of gastric cancer, with the aim of expanding accessible screening approaches and improving early diagnosis in at-risk populations. Through her clinical and research efforts, Dr. Woo is dedicated to transforming gastric cancer from a disease often diagnosed at late stages into one that can be detected earlier, treated more effectively, and ultimately prevented.

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.