講演者

Dr. April Abbott is the Director of Microbiology and Molecular Diagnostics at Deaconess Health System in Evansville, Indiana. Dr. Abbott earned her doctoral degree from the University of Texas at Houston, and completed a post-doctoral fellowship in Medical and Public Health Microbiology at the University of Washington. She is a board certified diplomate of the American Board of Medical Microbiology. Dr. Abbott’s clinical interests include: the advancement of antimicrobial susceptibility testing, development of molecular techniques to improve detection of pathogens, and diagnostic stewardship. She is a long-time member of the American Society for Microbiology, the editorial board of the Journal of Clinical Microbiology, and serves on working groups for Clinical Laboratory Standards Institute.

• Advanced Diagnostics for Infectious Disease

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.

• Advancing Novel Frameworks for Companion Diagnostics

Dr. Alexey Aleshin has led the oncology clinical development efforts at Natera, Inc., since 2018. Prior to this, he worked on the various novel ctDNA technologies while at Stanford University. He remains a clinical adjunct faculty in the division of Hematology at Stanford, where his work focuses on novel diagnostics assays for treatment decision support in hematologic malignancies. He received a BA in Statistics from UC Berkeley and his MD/MBA degrees at UCLA. He completed his clinical training in internal medicine and hematology/oncology at Stanford University.

• Early Cancer Surveillance

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

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Dr. Neil Anderson is Assistant Director of Clinical Microbiology and Medical Director of the Molecular Infectious Disease Laboratory at Washington University School of Medicine in St. Louis, MO. He is also Associate Professor of Pathology and Immunology and the Program Director for the Anatomic and Clinical Pathology residency at the Wash U School of Medicine. Dr. Anderson completed his MD and residency in Clinical and Anatomical Pathology at the Medical College of Wisconsin. He then moved to Minnesota and completed a fellowship in Clinical Microbiology at Mayo Clinic and obtained his ABMM certification. Dr. Anderson’s work has been focused on both virology and novel molecular diagnostics. A particular interest of his has been how multiplexed molecular assays can be best utilized for patient care.

• Advanced Diagnostics for Infectious Disease

Dr. Anderson is a Biologist with the Division of Microbiology Devices at FDA reviewing 510(k)s and pre-submissions for diagnostic medical devices. Prior to working at FDA, she earned her PhD in Biochemistry from Tulane University and completed post-doctoral fellowships at Children’s Memorial Research Center in Chicago, IL, and Loyola University Medical Center in Maywood, IL. Dr. Anderson also served as an FDA Commissioner’s Fellow in the Office of Regulatory Affairs where she investigated various molecular typing methods used to characterize bacterial pathogens.

• Advanced Diagnostics for Infectious Disease

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

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

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 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 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 Food and Drug Administration. Previously he founded, grew, and sold the science search company Pubget.

• Advanced Diagnostics for Infectious Disease

Jason Ausili, PharmD, is the Head of Pharmacy Transformation at EnlivenHealth, where he’s focused on delivering innovative clinical-based technology solutions that help mobilize pharmacists as care providers and practice at the top of their license. Jason received his Doctor of Pharmacy degree from Butler University and his Master of Science in Legal Studies from Cornell Law School. He’s held a variety of roles across the spectrum of community pharmacy and throughout his career has stayed centered on the aim to expand the scope of pharmacy practice and ensure pharmacists receive equitable payment for clinical services and improving patient outcomes.

• Decentralized POC Testing

Dr. Marisa Azad completed a combined MD/PhD at McMaster University in Biochemistry in 2016. She completed a residency in Internal Medicine at McMaster University and a fellowship in Infectious Diseases at the University of Ottawa prior to completing an advanced fellowship in Orthopedic Infectious Diseases in 2022 at the Mayo Clinic. She is currently an Assistant Professor of Medicine in the Division of Infectious Diseases at The Ottawa Hospital, an Associate Clinical Scientist at the Ottawa Hospital Research Institute, and a Mayo Clinic Research Collaborator. Her research focuses on exploiting the molecular and microbial mechanisms of periprosthetic joint infections to develop novel rapid diagnostics and therapeutics.

• Advanced Diagnostics for Infectious Disease

Dr. Esther Babady, PhD, is a board-certified clinical microbiologist with expertise in the molecular laboratory diagnosis of infectious diseases. She received her doctoral degree in Biochemistry and Molecular Biology and completed a post-doctoral fellowship in Clinical Microbiology both at the Mayo Clinic in Rochester, MN. She is currently the chief of the Clinical Microbiology Service, an Attending Microbiologist, and Professor in the Department of Pathology and Laboratory Medicine and the Department of Medicine (Infectious Disease Service) at Memorial Sloan Kettering Cancer Center. At a national level, she serves on several professional societies’ committees including those of the American Society for Microbiology, the Pan-American Society for Clinical Virology, and the Association for Molecular Pathology. Her research focus is on the rapid diagnosis of infectious diseases using molecular-based methods and the application of molecular methods for the surveillance and prevention of healthcare acquired infections primarily in immunocompromised cancer patients. Dr. Babady has published extensively on diagnostic molecular microbiology tests. She is a Senior Editor for Microbiology Spectrum and also serves on the editorial boards of the Journal of Clinical Virology and the Journal of Molecular Diagnostics. She is an elected fellow of the Infectious Disease Society of America and the American Academy of Microbiology.

• Advanced Diagnostics for Infectious Disease
• Enabling Point-of-Care Diagnostics

Beginning as a hobby, studying and observing business became a passion of mine. From a young age, all I wanted to do was invest, grow, build, support, and be a part of companies that change perspectives. Companies that move society forward. As with many entrepreneurs, I have learned from the experiences of growth and decline but have fully enjoyed every minute. Several years ago, I found my true passion in Healthcare Innovation. Healthcare Innovation companies are an intriguing crossroads of helping others, growing businesses with new and unknown products, and having the ability to shift and refresh the healthcare system.

• Early Cancer Surveillance

Stacy G. Beal, MD is the Laboratory Director of LetsGetChecked in Monrovia, CA, and the Director of the Microbiology Laboratory at the University of Florida in Gainesville, FL. She completed medical school at the University of Florida, a Clinical Pathology residency at Baylor University Medical Center in Dallas, Texas, and a fellowship in Medical Microbiology at the University of Texas-Southwestern, also in Dallas. She is board certified in Clinical Pathology, Medical Microbiology, and Clinical Informatics by the American Board of Pathology. Her interests include rapid diagnostic tests, laboratory stewardship, and regulatory aspects of laboratory testing. She is an expert in laboratory quality and systems engineering. For several years, she served on the College of American Pathologists Quality Practices Committee. Additionally, she is a renowned teacher in the field of clinical pathology. While not working, Dr. Beal is likely to be found dancing to Disney songs with her two daughters, on a tandem bike ride with her husband, or listening to a podcast about cooking while going for a long walk.

• Enabling Point-of-Care Diagnostics

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.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Dr. Billings has devoted his life to studying and teaching medicine and genetics, while accelerating the use of a broad range of novel genomic technologies in clinical settings. Over his decades in healthcare, he has established key business partnerships, driving adoption of innovative discoveries and commercial success. His leadership is backed by notable achievements-physician, researcher, founder, senior executive, or director of multiple public and private companies, and scientific advisor for government entities. Dr. Billings has held academic appointments at Harvard University, U.C. San Francisco, Stanford University, and U.C. Berkeley; and served as a board-certified internist and medical geneticist at leading medical centers. His published doctoral studies at Harvard were supervised by Dr. Baruj Benacerraf who subsequently received the Nobel Prize in Medicine. In addition, he has served on the Scientific Advisory Board of the Food and Drug Administration (FDA), the Genomic Medicine Advisory Committee at the Department of Veterans Affairs, and as an appointee to the Secretary’s Advisory Committee on Genetics, Health, and Society at the Department of Health and Human Services. Previously, he has been Chief Medical Officer or Senior Physician at Laboratory Corporation of America Holdings, Life Technologies Corp., Thermo Fisher Scientific, Inc., and Natera, Inc. He holds an MD and a PhD in Immunology from Harvard, and an Artium Baccalaureus, summa cum laude from U.C. San Diego.

• Early Cancer Surveillance

Bischof works in the area of thermal bioengineering with a focus on biopreservation, thermal therapy, and nanomedicine. His awards include the ASME Van Mow Medal and Fellowships in societies including Cryobiology, JSPS, ASME and AIMBE. He has served as the President of the Society for Cryobiology and Chair of the Bioengineering Division of the ASME. Bischof obtained a BS in Bioengineering from U.C. Berkeley (UCB) in 1987, an MS from UCB and U.C. San Francisco in 1989, and a PhD in Mechanical Engineering from UCB in 1992. After a post-doctoral Fellowship at Harvard in the Center for Engineering in Medicine, he joined the faculty of the University of Minnesota in 1993. Bischof is now a Distinguished McKnight University Professor and Kuhrmeyer Chair in the Departments of Mechanical and Biomedical Engineering, the Medtronic-Bakken Endowed Chair, Director of the Institute for Engineering in Medicine at the University of Minnesota, and Director of the new NSF Engineering Research Center ATP-Bio.

• Decentralized POC Testing

Dr. Maikel Boot was trained as a molecular microbiologist with a key focus on infectious disease. After obtaining his PhD at the University of Amsterdam, Maikel was awarded an EMBO Fellowship for his Postdoc at Yale University in cell biology, microbiology, and optical physics. During the pandemic, Maikel collaborated with Dr. Anne Wyllie's Yale team to help investigate how to set up cheap and accessible saliva-based SARS-CoV-2 screening (now called SalivaDirect). After his Postdoc, Maikel started working with PreScouter, a research consulting firm, where he is now a technical director for the health care and life science team. Maikel is also at the helm of PreScouter Dx, a spin-off company that helped PreScouter clients gain access to saliva-based SARS-CoV-2 testing and drugs-of-abuse testing. As a Technical Director, Maikel has led over 80 projects ranging from strategic R&D consulting, POC diagnostics, decentralized clinical trials, AI for clinical trial recruitment, and diagnostic wearables, to gene therapy, minimally invasive surgical technologies, and more. Beyond his role at PreScouter, Maikel is also involved with Medstone, working on the development of an NLP-based AI algorithm called SURUS that can be used to scan and extract complex scientific data from scientific publications and clinical trials to conduct live meta-analyses. Maikel is a dynamic team member who separates himself from the pack through his ability to drill down to the core of the client’s goals and deliver tangible solutions supported by data and insights.

• Decentralized POC Testing

Adam R. Borden joined ACLA in July 2022 as Senior Vice President of Policy and Strategy. He has had a diverse career in healthcare and has developed deep knowledge and understanding of federal health policy, provider reimbursement, and the changing landscape of healthcare delivery in the United States. Adam was previously Vice President of Market Access and Reimbursement at Cleerly, Inc. and Senior Director of Policy and Reimbursement Strategy at Siemens Healthineers, where he led strategic efforts for all business areas including imaging, laboratory diagnostics, and digital products. During this time, Adam served as Chair of the Reimbursement Committee at the Medical Imaging & Technology Alliance (MITA) and Chair of the Diagnostics Payment Work Group at AdvaMedDx. Adam also spent time as Vice President/Director at the premier D.C.-based policy consulting firm Avalere Health, and worked in health policy, reimbursement, and administrative roles at the American Gastroenterological Association and several leading academic medical centers. He is a member of the Advisory Board at the Cancer Support Community's Cancer Policy Institute. Adam holds a Bachelor of Arts degree from Rutgers University and a Master of Health Administration degree from A.T. Still University of Health Sciences.

• SC1: PAMA Reform: Reimbursement Challenges and Pathways Forward

Tara Burke joined AdvaMed in 2022 and currently serves as Vice President of Payment and Healthcare Delivery Policy. Previously, he 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.

• SC1: PAMA Reform: Reimbursement Challenges and Pathways Forward

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

• Advanced Diagnostics for Infectious Disease

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• SC1: PAMA Reform: Reimbursement Challenges and Pathways Forward

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• Enabling Point-of-Care Diagnostics

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• Early Cancer Surveillance

Caroline Corner, PhD is an ICR Westwicke Partner leading the San Francisco practice in Medical Technology. As part of her strategic leadership, she works with both public and private companies in the medical device, diagnostics, and life science tools areas and has participated in numerous IPOs and capital raises for small- to mid-cap companies. Caroline’s expertise and extensive C-level industry relationships stem from more than 12 years working in sell-side equity research, during which she held senior research positions at Cantor Fitzgerald, Pacific Growth Equities and Wells Fargo Securities, as well from as a role heading investor relations within a publicly-traded life science company. Prior to entering equity research, she held engineering and product development positions at Baxter Transfusion Therapies and Eli Lilly and Company. Caroline received her Ph.D. in Biological Engineering from Cornell University and a BS in Biological Systems Engineering from Virginia Tech.

• Early Cancer Surveillance

Dr. Karissa Culbreath is Medical Director and Division Chief of Infectious Diseases at Tricore. Dr. Culbreath received a PhD in Microbiology and Immunology from Vanderbilt University in Nashville, TN, and completed a fellowship in Medical and Public Health Microbiology at the University of North Carolina at Chapel Hill through the American Society of Microbiology. She is board certified by the American Board of Medical Microbiologists. She currently serves as the Chair of the American Board of Medical Microbiology. Dr. Culbreath is active in the clinical microbiology community serving on various committees and editorial boards. Her research interests: implementation laboratory automation in the clinical laboratory and advancing health equity through laboratory diagnostics in resource limited communities.

• Advanced Diagnostics for Infectious Disease

Randy E. David responsible for partnership development, strategy mapping, and study compliance within QURE’s Life Sciences division. Dr. Randy collaborates with biomedical scholars and executives interested in rapidly scaling access to innovative technologies in the U.S. market by designing bespoke studies, from inception through peer-reviewed publication, and ultimately, facilitating product reimbursement by health insurance payers.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

After receiving degrees in Biology and Chemistry, Jackie began her career in structure-based drug design at Pfizer.  After a decade expressing, purifying, and crystallizing proteins, she moved to MilliporeSigma.  Through work on multiple product launches including IVD kits, and Duolink, she leveraged her strong background in protein chemistry and immunoassays.  This work brought her to the attention of the Assay Development Services group, where she is now Senior Commercial Project Manager.  

• Enabling Point-of-Care Diagnostics

Dr. Utkan Demirci is a tenured professor at Stanford University School of Medicine and currently serves as the interim director and division chief at the Canary Center for Cancer Early Detection in the Department of Radiology. Prior to joining Stanford in 2014, he held the position of Associate Professor at the Brigham and Women’s Hospital, Harvard Medical School, at the Harvard-MIT Health Sciences and Technology division. His research group is focused on the early detection of cancer and has made significant contributions to the development of microfluidic platforms and point-of-care technologies for sorting rare cells and exosomes. He was elected as a fellow of the American Institute of Medical and Biological Engineering in 2017. With a PhD in Electrical Engineering from Stanford University in 2005, as well as an MS in Electrical Engineering and an MS in Management Science and Engineering in the same year, Dr. Demirci has an impressive academic background. He has published over 250 peer-reviewed articles, 300 abstracts and proceedings, 24 book chapters and editorials, and 7 edited books. Additionally, he holds over 25 patents, both granted and pending, and serves on the editorial board of various peer-reviewed journals. Dr. Demirci's pioneering work in infertility has resulted in the creation of cutting-edge devices and platforms. These innovations have undergone translation and approval by the FDA and CE, making them readily accessible to patients globally.

• SC2: Translating CTCs, ctDNA, and Exosomes for Clinical Use

A biologist with international experience on cancer metastasis. I received my PhD degree from the Department of Biology, University of Patras in Greece, where I elucidated how the crosstalk of different signaling pathways regulate prostate cancer progression. Then, I worked for the pharmaceutical enterprise Immupharma PLC in Paris, France, where I studied the potential anti-cancer and anti-angiogenic activity of novel multivalent pseudopeptides that were in Phase I clinical trials. My first post-doctoral training took place at the Cell Signaling Group in the CRUK Manchester Institute, UK. I demonstrated how the spatiotemporal regulation of well-known cell-cell adhesion proteins affect the nuclear activity of YAP/TAZ and the invasion of colorectal cancer cells. Then, I gained a Marie Sklodowska-Curie Postdoctoral Fellowship and joined the AcetoLab at the ETH Zurich, Switzerland, to study the biology of the Circulating Tumour Cells (CTCs). I found an unexpected pattern of CTC generation dynamics and I demonstrated that most spontaneous CTC intravasation events in breast cancer occur during sleep. In June 2023, I will start a new role as a Junior Group Leader at the Beatson Institute for Cancer Research in Glasgow, UK.

• Liquid Biopsy for Disease Management

Dr. Frank Diehl is a globally recognized R&D leader with extensive experience in cancer detection, having pioneered the use of circulating tumor DNA to detect and track cancer. At Exact Sciences he is leading the development of a multi-cancer early detection test, utilizing multiple classes of biomarkers. Previously, he co-founded one of the first liquid biopsy companies, Inostics and completed a postdoctoral fellowship at Johns Hopkins University, working in the laboratory Dr. Bert Vogelstein, where he developed a DNA blood test for colorectal cancer screening. Dr. Diehl holds a Ph.D. in molecular pathology from the University of Heidelberg.

• Early Cancer Surveillance

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 peered-reviewed publications and is a frequent speaker on the topics of molecular diagnostics.

• Advanced Diagnostics for Infectious Disease

Nicholas Dracopoli, Ph.D. is Chief Scientific Officer at Delfi Diagnostics. Previously, his work focused on oncology translational science at PGDx, Janssen and Bristol Myers Squibb. Prior to joining the pharmaceutical industry, he spent five years in the biotechnology industry at Sequana Therapeutics. Nic obtained his bachelor’s degree and doctorate from the University of London and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center in New York City, NY and the Massachusetts Institute of Technology (MIT) in Cambridge, MA. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center and as a Section Chief at the National Center for Human Genome Research at the National Institutes of Health, Bethesda, MD. Nic has authored more than 70 scientific publications and has extensive experience in the fields of genomics, molecular biology and cancer research.

• Early Cancer Surveillance

Rob leads reimbursement and HEOR activities for Thermo Fisher Scientific’s clinical sequencing division. Experienced in all facets of NGS testing’s coverage, coding, and billing - Rob works with lab and pharma clients to explain the complex and often contradictory U.S. environment and devise pathways to achieve their desired goals. He’s also worked with Oncomine Dx Target Test: The first FDA-approved next-generation sequencing (NGS) in vitro diagnostic test for non-small cell lung cancer. This companion diagnostic is now covered nationally by Medicare and dozens of commercial payers. Rob joined Thermo Fisher in 2012 through an acquisition of Navigenics, where he led the development and growth of payers and employers. Rob was also a Territory Vice President at RelayHealth, with duties that included payer-facing sales of secure messaging and e-prescribing. He also held senior sales and sales management positions with UnitedHealthcare.

• Advancing Novel Frameworks for Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Decentralized POC Testing
• Enabling Point-of-Care Diagnostics

Dr. Rebekah Dumm is an Assistant Professor in Pathology and Immunology at Washington University School of Medicine, where she also serves as an Assistant Director of the Clinical Microbiology Laboratory at Barnes Jewish Hospital in St. Louis. Dr. Dumm completed her PhD at Duke University and Clinical Microbiology fellowship at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia. Her research interests focus on test utilization in clinical microbiology, antimicrobial resistance, and advanced molecular diagnostics.

• Advanced Diagnostics for Infectious Disease

Dr. Gozde Durmus is an Assistant Professor of Radiology at Stanford University. She conducted her postdoctoral research at Stanford; working with Prof. Ronald W. Davis at the Stanford Genome Technology Center. She received her Ph.D. degree in Biomedical Engineering from Brown University in May 2013, with a minor in Innovation Management and Entrepreneurship. She is also an alumna of the Ignite Program at the Stanford University Graduate School of Business. She was a Fulbright Scholar at Boston University and received her M.Eng. degree in Biomedical Engineering as a College of Engineering Fellow in 2009. She received her B.S. degree in Molecular Biology and Genetics from Middle East Technical University (METU) in 2007. She has been recognized among the "Top Innovators Under 35" (TR35) by the MIT Technology Review. She received the Career Award at Scientific Interface from Burroughs Wellcome Fund (BWF-CASI) in 2018. She has been named a "Rising Star in Biomedicine" by the Broad Institute of MIT and Harvard. Recently, Dr. Durmus has received major research awards, such as the Moore Inventor Fellow, Baxter Faculty Scholar Award, and Koret Foundation Catalyst Award. Dr. Durmus is also a co-founder of LevitasBio, a start-up company in Silicon Valley commercializing magnetic levitation-based devices for label-free sample processing.

• SC2: Translating CTCs, ctDNA, and Exosomes for Clinical Use

Krista began her career in diagnostics working in genetic testing laboratories for clinical and research applications. Since joining Porex in 2017, she has held various roles using her laboratory background to help customers discover customized solutions for a variety biomedical applications, including diagnostics. Krista holds a bachelor’s degree in Biological Engineering from Mississippi State University as well as a MSE and PhD from the University of Texas at Austin. 

• Enabling Point-of-Care Diagnostics

Stephen Ezell is Vice President, Global Innovation Policy at the Information Technology and Innovation Foundation (ITIF) and Director of ITIF’s Center for Life Sciences Innovation. He also leads the Global Trade and Innovation Policy Alliance. His areas of expertise include science and technology policy, international competitiveness, trade, and manufacturing. Ezell is the coauthor of Innovating in a Service-Driven Economy: Insights, Application, and Practice (Palgrave Macmillan, 2015) and Innovation Economics: The Race for Global Advantage (Yale, 2012).

• Early Cancer Surveillance

Lauren brings more than 14 years of precision medicine expertise to the ADVI team and her clients. She leads ADVI’s value, access, and pricing work. With a primary focus on molecular diagnostics, she develops innovative commercialization and clinical valuation strategies designed to improve access and accelerate the adoption of precision medicine tools and therapies. Lauren has extensive expertise in oncology products, advising on all aspects of reimbursement, market access, and strategic policy planning. She specializes in launch planning and execution, CPT coding, and Medicare payment policy. She is passionate about providing meaningful, integrated solutions to deliver on the value of genomics-based precision medicine. Prior to ADVI, Lauren worked at the American Medical Association where she was responsible for crafting and implementing innovative coding solutions for disruptive technologies. Prior to the AMA, Lauren worked for a start-up biotechnology company performing discovery research and began her career in academic research at Harvard Medical School and Brigham and Women’s Hospital.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Lee A. Fleisher, MD, was named the Chief Medical Officer and Director of the Center for Clinical Standards and Quality for the Centers for Medicare and Medicaid Services in July 2020. In this capacity, he is responsible for executing all national clinical, quality, and safety standards for healthcare facilities and providers, as well as establishing coverage determinations for items and services that improve health outcomes for Medicare beneficiaries. He is currently Emeritus Professor of Anesthesiology and Critical Care at the University of Pennsylvania Perelman School of Medicine. From 2004 through July 2020, he was the Robert D. Dripps Professor and Chair of Anesthesiology and Critical Care and Professor of Medicine at the University of Pennsylvania. He received the Linback Award for Distinguished Teaching from the University of Pennsylvania in 2016. His research focuses on perioperative cardiovascular risk assessment and reduction, measurement of quality of care, decision making, implementation of cultural change and health policy. In 2007, he was elected to membership of the National Academy of Medicine (formerly Institute of Medicine) of the National Academy of Sciences and served on Committees of the NAM.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Mark Fleury, PhD is a policy principal for the American Cancer Society Cancer Action Network (ACS CAN), where he has worked since 2013. He specializes in research, drug development, and regulatory policies along with other science and technology related projects. He has worked on reform of diagnostic testing oversight, helped lead a coalition in 2016 that authored a landscape report on drug development challenges in pediatric cancer, and led another coalition in 2017 that created a report and recommendations focused on overcoming cancer clinical trial enrollment barriers. Throughout his work, Mark has striven to incorporate patient perspectives into inherently science-based issues, advocating for the inclusion of patients as partners throughout the bench to bedside translation of science. He holds a PhD in bioengineering from the Ecole Polytechnique Federale de Lausanne in Switzerland, conducted post-doctoral research at MIT, and previous policy experience includes time as a staffer to a U.S. Senator.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Pauline Funchain, MD, specializes in medical oncology of melanoma, high risk skin cancers, and cancer genetics. She serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, as well as Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Dr. Funchain co-chaired the inaugural ASCO Guidelines Panel on Systemic Therapy in Melanoma, and serves on the ASCO Guidelines Panel on Immune Related Adverse Events (irAEs). She developed and leads the first irAE tumor board established in the US as well as the Management of Checkpoint Inhibitor Toxicity, the first medical conference focused on the advancement of irAE management. Her translational science research interests include the genetics and genomics, both germline and somatic, of cancer. Her primary research interests are in the genetics and genomics of melanoma, the practical translation of genomic data into clinical precision oncology, and predictors of clinical outcomes and adverse events related to immunotherapy. She is the lead investigator in the philanthropically-backed Gross Family Melanoma Registry, an actively accruing study of familial melanoma.

• Liquid Biopsy for Disease Management

Francesco Gatto is the Co-Founder and Chief Scientific Officer of Elypta, a molecular diagnostics company in Stockholm, Sweden. He obtained a B.Sc. and M.Sc. in Chemical Engineering from the University of Padova, Italy in 2011 and a Ph.D. in Systems Biology and Bioinformatics in Jens Nielsen lab at Chalmers University of Technology, Sweden in 2015. In 2016, he was Visiting Scholar at the University of California, San Diego in Bernhard Palsson lab. He co-founded Elypta in 2017 and he is currently Affiliated Researcher at Karolinska Institute in Jonas Bergh lab as well as at Chalmers. His research projects resulted in four patent families that paved the way to the foundation of Elypta, whose core technology revolves around an innovative liquid biopsy for cancer, possibly the first one based on metabolism. He led the early entrepreneurial activities to secure venture capital and public funding - now exceeding 10 M€. He is the project leader for 2.3 M€ EU Horizon2020 grant to conduct the largest ever clinical study in kidney cancer diagnostics. He has authored 25+ papers on cancer research. He lectured in international advanced courses in systems biology, co-organized 2 national conferences, contributed to the National Encyclopedia of Italy, and was an invited speaker in several conferences and symposia - including the EU Joint Research Centre. He is a member in the American Association of Cancer Research, the European Association of Urology, and the American Society of Clinical Oncology and the Aspen Institute (Italian Talents Abroad). Francesco was enlisted in the MIT Technology Review 35 Under 35 in Europe in 2018, in the GEN A-List Top 10 Under 40 in 2019. He was the 2019 recipient for the Karin Markides Prize and for the 2019 National SKAPA Innovation Prize in Memory of A. Nobel.

• Early Cancer Surveillance

Dr. Bernard Gouget, PhD, MSc, LL.D., is President of the Healthcare Division Executive Committee, Comite Francais d’accreditation (Cofrac), and President of the National Committee for the selection of Reference Laboratories, Ministry of Health. He was an assistant Professor in physiology at the University of Medicine Paris-Cite and a Counsellor for Public Health at the Federation Hospitaliere de France (FHF) until 2019. He is co-chair of the SFBC (France) International committee and EFLM-Labac representative. As Chair of the TF on IFCC History, he is writing the IFCC 70th anniversary book. He is chairing the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM)..

• Enabling Point-of-Care Diagnostics

Erin H. Graf, Ph.D., D(ABMM) is an Associate Professor and Co-Director of Microbiology at the Mayo Clinic Arizona. She was formerly the Director of the Infectious Disease Diagnostics Laboratory at the Children’s Hospital of Philadelphia and an Assistant Professor of Clinical Pathology at the Perelman School of Medicine at the University of Pennsylvania. Dr. Graf completed her Ph.D. in Cell and Molecular Biology at The University of Pennsylvania studying HIV latency. She then went on to complete an ASM accredited postdoctoral training program in medical and public health microbiology at ARUP Laboratories and the University of Utah. Dr. Graf is board certified in medical microbiology. Her research interests include the applications of next generation sequencing and metagenomics for diagnostic and epidemiologic investigations, as well as emerging rapid diagnostic technologies paired with diagnostic stewardship.

• Advanced Diagnostics for Infectious Disease

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

• Advanced Diagnostics for Infectious Disease

Megan P. Hall, PhD established and leads Medical Affairs at GRAIL, LLC, where her team is responsible for educating health care providers on, and generating and disseminating evidence supporting, Galleri, a multi-cancer early detection test, as well as on the cancer care landscape. Previously, Megan was Director of Medical Communications at Jazz Pharmaceuticals, where she led healthcare provider-focused publication and education strategies for the company’s hematology/oncology and chronic pain portfolios. Before Jazz, Megan established a Medical Communication team at Natera to support the launch of the Panorama non-invasive prenatal test, and was an editor at the flagship open access journal, PLOS Biology. She also held research roles funded by the American Heart Association, California Institute of Regenerative Medicine, National Institutes of Health, and the Howard Hughes Research Foundation. Megan earned a BS in Biological Sciences (Biochemistry focus) from the University of California at Santa Barbara, and a PhD in Microbiology, Immunology, and Molecular Genetics from the University of California at Los Angeles.

• Early Cancer Surveillance

Nick is the Director of Health Policy at Roche Diagnostics Corporation. He believes that diagnostics are one of the most crucial elements to improving public health, and that broad access to new diagnostic technologies is based on a solid foundation of reimbursement and access policies. Prior to Roche, Nick worked on federal health policy at the American Society of Anesthesiologists and Nemours Children's Health System. He holds a M.P.H. in Health Policy from The George Washington University and a B.S. in Biological Sciences from Cornell University.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• SC1: PAMA Reform: Reimbursement Challenges and Pathways Forward

Giles recently led a start-up developing a POC urinary tract infection platform and has served as a board member of over 50 organizations, mainly medical technology companies in the UK, USA, Japan and Australia. He has wide experience of developing products in fast growth companies, capital raising, M&A and international business, gained in part as an operating partner and advisor to two mid cap US Healthcare investment banks. He has held ministerial appointments in UK research & economic development roles. He currently serves on the Scottish Government Industry Leadership Group for Life Sciences and as a Vice Chairman of ABHI. Giles has received many awards for work in business and medical technology development. He was elected FRSA in 1998.

• Enabling Point-of-Care Diagnostics

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

• Early Cancer Surveillance

Dr. Hanson is an Associate Professor of Medicine and Pathology at the University of Utah, where she serves as Section Chief for Clinical Microbiology and Director of the Transplant Infectious Diseases Service Kim is an expert in ID diagnostics and the infectious complications of transplantation and cancer care.

• Advanced Diagnostics for Infectious Disease

Umer Hassan is an Assistant Professor in the Department of Electrical and Computer Engineering and Core Faculty Global Health Institute at Rutgers University. Before joining Rutgers, he worked as a Research Scientist in the Department of Bioengineering at University of Illinois Urbana-Champaign (UIUC) with a Research Affiliate appointment at Carle Foundation Hospital, Urbana. Dr. Hassan’s research efforts have been focused on developing bioengineering solutions for global-health applications including point-of-care (PoC) biosensors development for disease diagnosis. Dr. Hassan has received Brandt Early Career Investigator Award in Precision Medicine (2017), BMES Career Development Award (2017), Baxter Young Investigator Award (2016, 17), Emerging Engineer Award (2015), Cozad New Venture Competition Award (2014), NSF I-Corps Fellowship (2014) and Our Common Future Fellowship (2010). In 2014, Umer cofounded a startup, Prenosis, Inc. that is working on commercializing his developed biosensors.

• Decentralized POC Testing

Lucy has been consulting to IVD test manufacturers since 2015 supporting more than 20 companies and building a deep understanding of all segments of the molecular diagnostics market. She also works for various organisations in the global public health sector where the emphasis is on building access to diagnostics in low and middle income countries. She has 30 years of experience commercializing products in the Life Science Research and Diagnostics industries, with a focus on molecular diagnostics. She has managed sales and marketing teams in 3 countries - South Africa, Canada and the US and has led marketing teams with global responsibility for more than 10 years. She has successfully commercialized IVD tests in diverse market environments - emerging economies and developed markets, markets with both public and private healthcare systems, and innovative new markets as well as competitive, mature markets. She worked for Roche Diagnostics for many years in various roles, and subsequently led diagnostics programs for GenProbe Inc. (now Hologic) and Singulex. She holds a Bachelor of Science Honours degree in Medical Biochemistry from the University of Cape Town Medical School, and an MBA from IMD in Switzerland

• Enabling Point-of-Care Diagnostics

Dr. He is an assistant professor from the Department of Pharmaceutics, College of Pharmacy at the University of Florida. She obtained her PhD degree from the University of Alberta and postdoc training from the University of California, Berkeley. Dr. He is the senior member of national academy of inventors, Editorial Board member of Pharmaceutics, and the Gordon and Betty Moore Foundation Review Committee and Board Advisor, as well as the Advisory Board Member of journal Lab on Chip (LOC). Her journal review efforts have been recognized as the Outstanding Reviewer in 2018, 2020, and 2021 from the LOC Royal Society of Chemistry. Dr. He Received NIH Maximizing Investigator’s Research Award for Early-Stage Investigators in 2019, and she also received the LOC Emerging Investigator Award in 2019. Dr. He’s innovation leads to more than 20 pending and issued patents for advancing the innovative exosome research. Her recent publication appeared in the journal of Nature Biomedical Engineering and highlighted as the Editorial Story, as well as in the Journal of Extracellular Vesicles.

• Liquid Biopsy for Disease Management

Xiaoming (Shawn) He is a Professor of Bioengineering at the University of Maryland, College Park, MD, USA. His current research is focused on developing micro and nanoscale biomaterials and devices to engineer totipotent, pluripotent, and multipotent stem cells for the treatment and early detection of various diseases including but not limited to cancer, infertility, cardiovascular diseases, diabetes, and neurological disorders. He has published >140 peer-reviewed journal articles in high-ranking journals including Nature Nanotechnology, Nature Biomedical Engineering, and Nature Communications, in addition to one book and four book chapters. He served as the Chair of the American Society of Mechanical Engineers (ASME) Biotransport Committee, and has been an associate editor or editorial board member of five different journals. He is a fellow of the ASME and the American Institute of Medical and Biological Engineering (AIMBE).

• Liquid Biopsy for Disease Management

Mark Hiatt, MD, MBA, MS, has served as a cardiovascular radiologist; chief medical executive for a health insurance plan and a medical benefits management company; vice president of medical affairs for a precision oncology company; leader of a clinical department; and board member for a regional health system, national accreditation body, and blockchain company. He was also the voice of The Medical Moment on radio stations in two states. Dr. Hiatt completed a fellowship in cardiovascular imaging at Stanford, residency in radiology and master’s in Health Evaluation Sciences at the University of Virginia, and MD and MBA degrees under full academic scholarships and with academic distinction at Wake Forest University. He also earned two bachelor’s (in economics and Italian), with two minors (in chemistry and zoology), under a full academic scholarship. Dr. Hiatt chaired the Greater Salt Lake Chapter of the American Red Cross and was appointed by the Governor of Utah to serve on that state’s Medical Education Council and Digital Health Service Commission (for which he is the past Chair). He has presented or moderated at over 175 conferences and published more than 75 articles and chapters, as well as a book. The Utah Business Magazine honored him as a Healthcare Hero.

• Early Cancer Surveillance
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Kenneth C. Hohmeier, PharmD is an Associate Professor & Director of Community Affairs in the Department of Clinical Pharmacy and Translational Science at the University of Tennessee Health Science Center. Dr. Hohmeier has an extensive background in pharmacy practice and practice-based and implementation science research, including post-graduate residency training in community pharmacy, credentials in lean six sigma, implementation science, the Innovator’s DNA, and change leadership. He has successfully established and provided clinical pharmacist services within several community pharmacy settings in a wide variety of rural, suburban, and urban locations. His background also includes extensive leadership experience both in practice and within professional organizations, with past and current positions held at local, regional, and national levels including the American Pharmacists Association, Ohio Pharmacists Association, and Tennessee Public Health Association. His specific areas of research focus are in clinical service implementation in community pharmacy settings, medication therapy management (MTM), and innovative clinical pharmacy practice models. He has served as Primary Investigator (PI) or Co-PI on over 15 grant-funded projects advancing the role of the community pharmacist to increase patient care activities, such as vaccinations, MTM, and other clinical services.

• Decentralized POC Testing

Tony Jun Huang is the William Bevan Distinguished Professor of Mechanical Engineering and Materials Science at Duke University. Previously he was a professor and the Huck Distinguished Chair in Bioengineering Science and Mechanics at The Pennsylvania State University. He received his Ph.D. degree in Mechanical and Aerospace Engineering from the University of California, Los Angeles (UCLA) in 2005. His research interests are in the fields of acoustofluidics, optofluidics, and micro/nano systems for biomedical diagnostics and therapeutics. He has authored/co-authored over 250 peer-reviewed journal publications in these fields. His journal articles have been cited more than 25,000 times, as documented at Google Scholar (h-index: 85). He also has 26 issued or pending patents. He was elected a fellow of the following seven professional societies: the National Academy of Inventors (NAI), the American Association for the Advancement of Science (AAAS), the American Institute for Medical and Biological Engineering (AIMBE), the American Society of Mechanical Engineers (ASME), the Institute of Electrical and Electronics Engineers (IEEE), the Institute of Physics (IoP), and the Royal Society of Chemistry (RSC). Huang’s research has gained international recognition through numerous prestigious awards and honors including a 2010 National Institutes of Health (NIH) Director’s New Innovator Award, a 2012 Outstanding Young Manufacturing Engineer Award from the Society for Manufacturing Engineering, a 2013 American Asthma Foundation (AAF) Scholar Award, JALA Top Ten Breakthroughs of the Year Award in 2011, 2013, and 2016, the 2014 IEEE Sensors Council Technical Achievement Award, the 2017 Analytical Chemistry Young Innovator Award from the American Chemical Society (ACS), the 2019 Van Mow Medal from ASME, and the 2019 Technical Achievement Award from the IEEE Engineering in Medicine and Biology Society (EMBS).

• Liquid Biopsy for Disease Management

Dr. Melissa Hunter-Ensor is Co-Chair of Greenberg Traurig's Global Patent Prosecution Group. Melissa focuses her practice on the intellectual property and commercial needs of clients spanning a variety of technologies, including medical device, regenerative medicine, proteomics/genomics, synthetic biology, biologics, pharmaceutical, chemical, agricultural, and diagnostics. Melissa has experience representing clients throughout the business cycle, from start-ups and universities, to global pharmaceutical companies, assisting them with patent portfolio management and strategic alliances, as well as litigation and pre-litigation strategy. She also assists venture capital firms and other investors in assessing the IP risks of target investments, and conducts IP patent and licensing due diligence in connection with life science and other technology transactions. Before becoming a lawyer, Melissa earned a Ph.D. in neuroscience from the University of Pennsylvania and her thesis research resulted in a first author paper in Cell. She followed this accomplishment with a four-year post-doctoral fellowship at the Massachusetts Institute of Technology laboratory of Nobel laureate H. Robert Horvitz where she was a Jane Coffin Childs fellow.

• Advancing Novel Frameworks for Companion Diagnostics

Eugean Jiwanmall’s past professional experiences include basic science and clinical research. In his current role as a Senior Research Analyst for Medical Policy & Technology Evaluation at Independence Blue Cross’ Medical & Claim Payment Policy Department within Facilitated Health Networks and Medical Affairs, he has served as the subject-matter-expert, writer, reviewer, communicator, presenter, consultant, adviser/facilitator, and decision-maker for hundreds of medical policy topics and technology assessments within dozens of clinical disciplines and multiple business areas. Eugean has led & participated in numerous roles & capacities in a number of conferences, summits, and other national & international events etc. upon invitations. He has been invited by renowned organizations, evaluator bodies, & thinktanks etc. to be key informant, KOL, & renowned expert & faculty on a variety of complex and challenging topics, and recognized in print & media communications & publications for these works. Eugean has and continues to serve on multiple leading advisory boards and panels per invitations. Due to his expertise & experience, Eugean has been invited to advise & provide knowledges and inputs to grants & research studies (including those for National Institutes of Health (NIH)); and he has made contributions towards these efforts over the years. Eugean has taken and completed graduate coursework in bioethics at the University of Pennsylvania School of Medicine. He holds a bachelor’s degree in biological sciences with honors from Drexel University (minor was in business administration), a master’s degree of public health in evaluative clinical sciences from Dartmouth Medical School, and an MBA in healthcare management and economics with honors from Drexel University.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Joen is President and owner of MDC Associates, Inc. a full-service, regulatory affairs, quality assurance and clinical research (RA/QA/CRO) service provider to in vitro diagnostic (IVD) companies. Joen has 20 years of regulatory, clinical affairs, marketing, sales, business development and management experience in the IVD industry. Prior to MDC he was Head of Global Marketing for Accelerate Diagnostics, Inc. where he was responsible for strategic marketing, product management and clinical affairs. During his time in industry, Joen helped to define, develop and commercially launch more than 16 FDA cleared, CE-marked IVD products in the United States and Europe. Prior to joining the IVD industry Joen was a Healthcare Investment Banker with Lehman Brothers in London. Joen has degrees in Molecular Biology & Biochemistry and Economics from Wesleyan University.

• Enabling Point-of-Care Diagnostics

Greg Jones is currently an employee of Inivata, Inc where he is responsible for coordinating external strategic collaborations and is the technical subject matter expert for the company. Greg has 35 years of experience as the project lead in the development of IVDs including multiple BLA, PMA, 510K and LDT assays. In his career he has been responsible for assuring that the assays developed meet all regulatory requirements for the satisfactory validation and transfer to manufacturing or to the testing laboratory. He has worked at MDxHealth, BioMerieux and Organon Teknika in various product development and management roles.

• Liquid Biopsy for Disease Management

Seamus Kearney graduated from the Queen's University of Belfast with an MSc in Engineering and immediately began his career in the medical devices industry, where he has spent the last 22 years in a variety of roles from development lead, project management, QA/RA and clinical operations. Seamus has worked with many of the global leaders in the in vitro diagnostics industry, including J&J, Roche Diagnostics and QIAGEN and founded ARC Regulatory in 2010 with the aim of supporting companies in the IVD sector through myriad global regulations for device development and clinical validation. Over the past 7 years, ARC has focused on the precision medicine sector, supporting pharma and their Dx partners in global compliance from vendor selection, due diligence, Dx regulations, GCP, study management and monitoring.

• Advancing Novel Frameworks for Companion Diagnostics

Michael R. King is the J. Lawrence Wilson Professor and Department Chair of Biomedical Engineering at Vanderbilt University. He has written textbooks on statistical methods and microchannel flows, and has received several research awards from the National Science Foundation, American Society of Mechanical Engineers, American Society of Clinical Chemistry, and New York State. King is a Fellow of the American Institute for Medical the Biological Engineering, the Biomedical Engineering Society, the International Academy of Medical and Biological Engineering, and the American Association for the Advancement of Science, and served as founding Vice President of the International Society of Bionic Engineering. He is the Editor-in-Chief of Cellular and Molecular Bioengineering, an official journal of the Biomedical Engineering Society, and served as the Chair of the Biomedical Engineering Council of Chairs. He is currently the Chair-Elect of the College of Fellows of the American Institute for Medical and Biological Engineering.

• Liquid Biopsy for Disease Management

Dr. Klepser received his Doctor of Pharmacy from the University of Michigan College of Pharmacy. Subsequently he completed a pharmacy practice residency at Detroit Receiving Hospital and University Health Center and a fellowship in Infectious Diseases at Hartford Hospital in Hartford, Connecticut. Dr. Klepser is currently a Professor of Pharmacy at Ferris State University since 2001. Dr. Klepser’s well-known for his work surrounding use of CLIA-waived point-of-care tests in community pharmacies and community-based antimicrobial stewardship. He has published extensively on these topics and has more than 130 peer-reviewed manuscripts to his credit. Dr. Klepser is a founder and content advisor for the “Community Pharmacy-Based Point-of-Care Testing” certificate program and Vice President of POC Consultants.

• Decentralized POC Testing

Donald Klepser is Professor of Pharmacy Practice and Science and Associate Dean for Academic Affairs at the University of Nebraska Medical Center, College of Pharmacy. He has a Ph.D. in Pharmaceutical Socioeconomics from the University of Iowa, an MBA from the University of Minnesota’s Carlson School of Management, and a Bachelor’s degree in Communications from the University of Michigan. He has studied the use of POC testing in community pharmacies for the past 13 years and is currently the primary investigator on grants to develop community pharmacy practice models for managing diseases such as Covid-19, RSV, HIV, HCV, influenza, and group A Streptococcus. He is also the primary investigator on grants to validate and implement point-of-care tests in pharmacy settings. As President of POC Consultants, Inc., Dr. Klepser has served as a consultant to both retail pharmacy chains and diagnostic testing companies.

• Decentralized POC Testing

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

• Decentralized POC Testing

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

• Decentralized POC Testing

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

• Advanced Diagnostics for Infectious Disease
• Enabling Point-of-Care Diagnostics

Eunice Lee is currently at Guardant Health. She provides strategic guidance to support the product portfolio and engages on regulatory policy issues. Before joining Guardant Health, Eunice was Executive Director at Merck, where she oversaw the Regulatory Affairs Companion Diagnostics team. Prior to that, she was at the FDA in CDRH as Chief of the Molecular Pathology and Cytology Branch and a Senior Scientific Reviewer in the Office of In Vitro Diagnostics and Radiological Health; and in the Office of the Commissioner as a Senior Advisor in the Office of Combination Products. She was also a Scientist at the National Cancer Institute at NIH. Eunice earned an A.B. from Bryn Mawr College and a Ph.D. from MIT and completed a post-doctoral fellowship at Stanford University.

• Advancing Novel Frameworks for Companion Diagnostics

Lauren C. Leiman is currently the Executive Director of the Blood Profiling Atlas in Cancer (BloodPAC), a consortium focused on creating an open database for liquid biopsies to accelerate the development of safe and effective blood profiling diagnostic technologies for patient benefit. Prior to running BloodPAC, she was the Senior Director of External Partnerships at White House Cancer Moonshot Task Force during the Obama Administration. Previously, Lauren was a Senior Advisor for the Melanoma Research Alliance and Director of Philanthropy at Elysium Management LLC in New York City. From 2008-2010, Lauren worked for the Millennium Promise Alliance, where she led the major gifts fundraising effort and spent significant time in sub-Saharan Africa. Lauren was also the head of marketing and investor relations at Steel Partners, LP, an activist hedge fund investing globally. Lauren received her undergraduate degree in communications from the University of Pennsylvania's Annenberg School. She also holds an MBA in international business from the University of North Carolina's Kenan-Flagler Business School and a master's degree in public relations and corporate communications from NYU.

• Early Cancer Surveillance
• Liquid Biopsy for Disease Management

Dun Liang is an accomplished expert in diagnostics regulatory affairs and development, with extensive experience in both industry and government. He currently leads the CDx/Dx regulatory function team at Eli Lilly, overseeing its oncology development programs globally. Dun provides critical strategic and tactical guidance, interpretation, and assessment on CDx/Dx regulatory policies and strategies to support trial planning and decision making in major geographic areas. Prior to joining Loxo@Lilly, Dun worked as a lead reviewer at the FDA, where he organized and led regulatory reviews of molecular genetics and pathology devices for oncology. He also served as the subject matter expert on CDx/Dx for oncological drug reviews. Before his tenure at the FDA, he was a test developer and entrepreneur who developed, validated, and commercialized NGS LDTs. Dun earned his PhD from Florida State University and completed his postdoctoral training at the NIH. He is certified as a High-complexity Clinical Laboratory Director by the American Board of Bioanalysis (ABB).

• Advancing Novel Frameworks for Companion Diagnostics

Dr. Rachael Liesman is an Associate Professor of Pathology at the Medical College of Wisconsin, where she is the director of clinical microbiology. She received her PhD in Microbiology and Immunology from the University of North Carolina at Chapel Hill and completed a fellowship in clinical microbiology at the Mayo Clinic. Prior to moving to Wisconsin, she was the Director of Microbiology and Molecular Microbiology at the University of Kansas Health System. She is an active member of ASM, is a Diplomate of the American Board of Medical Microbiology, and recently completed a term as the President of the Southwestern Association for Clinical Microbiology.

• Advanced Diagnostics for Infectious Disease

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

• Early Cancer Surveillance

Christina has spent the last 25+ years creating more than 300 events hosted by CHI. She is the creator and driving force behind the PEGS Summit, now in its 18th year, and the Molecular Medicine Tri-conference, now in its 29th year, and has identified and developed emerging topics including bispecific antibodies, genomics, molecular diagnostics, phage display, point-of-care diagnostics, bioinformatics and many more. Christina emphasizes the importance of bringing together the academic and industrial sectors to create environments where innovation is fostered and commercial applications are advanced.

• Early Cancer Surveillance
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Decentralized POC Testing

Dr. Lockwood is Director of the Genetics and Solid Tumors Laboratory and an associate professor of Laboratory Medicine at the University of Washington Medical Center. She is board-certified in clinical molecular genetics and clinical chemistry and received her Ph.D. in Cellular and Molecular Biology at the University of Wisconsin. Dr. Lockwood completed clinical postdoctoral fellowship training at the Washington University School of Medicine in St. Louis where she was also a faculty member. Dr. Lockwood’s clinical expertise is the application of molecular methods to advance precision medicine for prenatal screening, genetic disorders, and molecular oncology. Her research focuses on the development and implementation of innovative genomic methods to guide patient care. She has most recently fostered clinical deployment of cell-free DNA diagnostics in pregnancy and oncology.

• Liquid Biopsy for Disease Management

No bio available.

• Advancing Novel Frameworks for Companion Diagnostics

Nathalya Mamane is the CEO and founder of RT MicroDx. Nathalya has over two decades of experience in sales, marketing, and successful entrepreneurship and ran her own planning business, NM Events, for 13 years before earning her MBA from Babson College. During that time, she built a strong network of vendors and clients. Motivated by her experiences as a mother of four, Nathalya began RT MicroDx in 2021 with the vision of making at-home diagnostics more affordable, especially for families in need of reliable healthcare. By combining her expertise in strategic business planning and her passion for health equity, Nathlaya is prepared to disrupt the healthcare landscape by making testing more accessible at home.

• Decentralized POC Testing

Dr. Martin is working to apply physical science and engineering approaches to study the mechanical properties of circulating tumor cells (CTCs), and discovered novel microtentacles on the surface of CTCs that promote metastasis. Dr. Martin received his Ph.D. from the University of California, San Diego, after training as a Howard Hughes undergraduate research fellow at the University of Virginia. Dr. Martin completed a Damon Runyon postdoctoral fellowship at Harvard Medical School that combined functional genomic studies with mouse models of breast tumor metastasis, under the mentorship of Dr. Phil Leder. Dr. Martin is currently the Drs. Angela and Harry Brodie Professor of Translational Cancer Research and co-leader of the Hormone-Related Cancers program at the Marlene and Stewart Greenebaum NCI Comprehensive Cancer Center (UMGCCC) at the University of Maryland School of Medicine.

• Liquid Biopsy for Disease Management

No bio available.

• Advancing Novel Frameworks for Companion Diagnostics
• Advanced Diagnostics for Infectious Disease
• Decentralized POC Testing

Jackie Martinez leads the Product team at Primary.Health. Since joining as a founding team member, she led Primary.Health’s product launches of community-based testing, mass vaccination, and student health. Prior to her current position, Jackie’s experience spans roles in research projects in East Africa, strategy and analytics at Google, and data strategy at the fintech company Movii.

• Enabling Point-of-Care Diagnostics

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

• Early Cancer Surveillance

Michael Mina, MD, PhD is a physician-scientist and Assistant Professor in the department of Epidemiology and Immunology and Infectious Diseases at the Harvard School of Public Health. He is also a pathologist at Brigham and Women’s Hospital and Harvard Medical School where he helps to oversee molecular virology. He is a recent recipient of the National Institutes of Health NIH Director’s Early Independence Award, and his public health efforts have been highlighted by The Economist Magazine where he was named one of eight Global Progress Makers. He has received numerous national and international recognitions for his research on childhood infectious diseases and vaccines. Michael has been on the front lines of the COVID-19 pandemic since it began, helping to advise state, national, and international institutions and governments and has been instrumental in setting up high throughput COVID-19 testing programs at the Broad Institute of MIT and Harvard, where he is also an Associate Member. His research focuses on monitoring and tracking outbreaks of novel and seasonal viruses through the global population. His laboratory at the Harvard School of Public Health develops new technologies and statistical algorithms that measure the immune system response in fine detail and leverages immunological data to detect and forecast pathogen movement. His clinical work at the Brigham and Women’s Hospital is as a medical director overseeing molecular virology diagnostics. Most recently, Michael is working with colleagues at the Ragon Institute, the MIT Sloan School and Princeton University to develop a Global Immunological Observatory (GIO) - a not-for-profit network of high throughput laboratories to monitor emerging and existing pathogens in the US and globally. The objective is to create a virus monitoring system that matches the weather forecasting systems in use globally today.

• Advanced Diagnostics for Infectious Disease

Dr. Lori Minasian, a medical oncologist, is the Deputy Director for the Division of Cancer Prevention at the NCI. She is a leader in the NCI clinical trials enterprise, first leading the NCI’s Community Clinical Oncology Program (a community-based clinical trials program) for over 15 years, and then supporting a variety of the processes in the restructuring of the NCI’s clinical trials programs. She oversees one of the four boards that make up the Central Investigational Review Board (CIRB) for the NCI’s clinical trials programs. She has facilitated the development of numerous cancer prevention and symptom management clinical trials and has fostered the incorporation of patient reported outcomes in cancer clinical trials. Currently, Dr. Minasian leads the NCI’s Multi-Cancer Detection Trial Team which is developing a framework for the evaluation of MCD assays for the purpose of cancer screening. She leads the development of a new clinical trials network which will systematically evaluate a variety of different technologies for the purpose of cancer screening. In addition to her scientific administrative position, she has participated in the NCI’s Women’s Malignancy Clinic seeing patients, supervising fellows and participating in the development and implementation of clinical trials using novel agents. Dr. Minasian earned a Medical Degree from the George Washington University School of Medicine in Washington, D.C. She completed her internal medicine residency at Case Western Reserve University and a fellowship in medical oncology at the Memorial Sloan-Kettering Cancer Center.

• Advancing Novel Frameworks for Companion Diagnostics
• Early Cancer Surveillance

Dr. Mulvaney is a health science administrator working on project applied towards the design and development of biosensors and the next generation of diagnostic devices.

• Decentralized POC Testing

Dr. Samia Naccache is the Technical Director of Microbiology and Molecular Microbiology for Labcorp's West Division, and the co-discipline director for Routine Microbiology, at Labcorp. Her interests include antimicrobial susceptibility testing, outpatient antimicrobial stewardship, and rapid molecular diagnostics. After earning her PhD from the University at California, San Diego, she completed postdoctoral fellowships in virology at The Scripps Research Institute, laboratory medicine at the University of California San Francisco, and in medical and public health microbiology at Children’s Hospital Los Angeles. She is a diplomate of the American Board of Medical Microbiology (ABMM) and is also a board-certified medical technologist and public health microbiologist.

• Advanced Diagnostics for Infectious Disease

A highly-experienced medical device regulatory specialist and EU MDR / IVDR expert, Heidi’s experience includes conducting technical documentation assessments (TDA) of Class II and Class III medical devices and managing conformity assessments, from initial application through to certification and ongoing surveillance activities, including EU MDR, EU IVDR, EN ISO 13485, EN ISO 14971, and MDSAP audits. Heidi's current role is as a Senior Medical Device Regulatory Consultant, undertaking a wide range of projects advising clients on regulatory strategies in relation to EU MDR, EN ISO 13485, EN ISO 14971, and other relevant international standards, as well as conducting technical and QMS audits to identify gaps in a client's regulatory approach and documentation. Heidi is also currently delivering a series of courses on medical device risk, clinical data and regulatory strategy, as well as being an External Partner for an EU Notified Body.

• Advancing Novel Frameworks for Companion Diagnostics

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

• Liquid Biopsy for Disease Management

Hai Nguyen-Tran, MD, is a Pediatric Infectious Diseases Fellow at the University of Colorado School of Medicine and will complete her fellowship in July 2023. She obtained her undergraduate degree in Biochemistry and minor in Chemistry at the University of Minnesota-Twin Cities and completed her pediatric residency at the University of Colorado School of Medicine. She is also a Global Health fellow through the Center for Global Health and pursuing her Masters of Science in Clinical Sciences degree. Her research interests include global health and emerging infectious diseases such as EV-D68. Her current projects include assessing the utility of immunologic surveillance for pandemic preparedness and evaluating the duration of shedding of Enterovirus D68 in the upper respiratory tract.

• Advanced Diagnostics for Infectious Disease

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

• Enabling Point-of-Care Diagnostics

John Nolan is a Professor at The Scintillon Institute, where his research group develops and applies new technologies for cytometry. Current projects in his lab include spectral flow cytometry, single particle analysis of natural and synthetic nanoparticles, and surface enhanced Raman scattering (SERS) in cytometry. He is on the Editorial Boards of Cytometry and Current Protocols in Cytometry, a Fellow of the American Institute of Medical and Biological Engineering (AIMBE), and Past President of the International Society for Advancement of Cytometry (ISAC).

• Liquid Biopsy for Disease Management

Lesley Northrop is the Chief Diagnostic Officer at Everly Health. She is a PhD-trained neuroendocrine biologist and a clinically-boarded molecular geneticist. She has spent the past 20 years working in clinical diagnostics, developing high-throughput, high-complexity diagnostic tests that meet clinical unmet need. Lesley's early training started in species survival of the giant panda and moved into developing genomic tests for humans affected with infertility, including early-detection of specific cancers through liquid biopsy detection. She has built and secured CLIA/CAP/NYS-licensure for several clinical dx labs as a licensed laboratory director and acts as a clinical translational scientist from ideation to commercial launch of diagnostic tests.

• Decentralized POC Testing

Miguel R. Ossandon has a dual background in clinical laboratory and computer science. He began working in cancer research at the Lombardi Cancer Center at Georgetown University, and he is currently working for the National Cancer Institute since 2007 as a Program Director in the Diagnostic Biomarkers and Technology Branch in the Cancer Diagnosis Program. As a program director, he managed a diversified grant portfolio focused on microfluidic and liquid biopsy technologists, and computational modeling/machine learning approaches for cancer diagnosis.

• Liquid Biopsy for Disease Management

Vihanga Pahalawatta has over 10 years of industry experience related to In Vitro Diagnostic (IVD) products and companion diagnostics in Research and Development and Regulatory Affairs. Vihanga currently provides support for companion diagnostics programs at various stages of development covering global regulatory requirements for clinical studies and registration at AbbVie. Her regulatory experience also includes on-market product support, managing advertising and promotional material, and global registrations for IVDs. Prior to joining AbbVie Vihanga led the global regulatory team at Abbott Molecular Inc. Vihanga has a Bachelor’s degree from the University of Peradeniya in Sri Lanka and a Master’s and PhD from Washington State University.

• Advancing Novel Frameworks for Companion Diagnostics

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.

• Advancing Novel Frameworks for Companion Diagnostics

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

• Advanced Diagnostics for Infectious Disease

Dr. Alpa V. Patel earned her Bachelor of Science from the University of Florida, her Master of Public Health in Epidemiology from the Rollins School of Public Health at Emory University, and her Doctoral degree in Preventive Medicine with a concentration in Epidemiology from the Keck School of Medicine at the University of Southern California. She is the Senior Vice President of Population Science at the American Cancer Society where she oversees a team of approximately 50 research and study operations staff. These multi-disciplinary scientists use their research expertise in epidemiology and behavioral science to increase the understanding about the causes of cancer and how to improve treatment outcomes after a cancer diagnosis. She also serves as the principal investigator of the Cancer Prevention Studies (CPS) II and 3, providing strategic and operational oversight for the studies, including their biospecimen and data management. CPS-II and 3 are long-term, large-scale, epidemiologic cohort studies established by the American Cancer Society in 1982 and 2006-2013, respectively. Combined, these two cohorts include over 1.5 million participants with a variety of over 400,000 biologic samples (such as blood, buccal cells, saliva, stool, and tumor tissue), and are focused on better understanding cancer risk as well as improving outcomes and quality of life after a cancer diagnosis. Dr. Patel is a recognized leader in the development of population cohort studies and as a cancer epidemiologist, particularly related to physical activity, sedentary behavior, and obesity in relation to cancer risk and survival. She serves on the National Cancer Institute’s Board of Scientific Counselors along with several other national and international scientific advisory committees, is a Fellow of the American College of Sports Medicine, on the editorial board of several cancer-related journals. She has published approximately 250 scientific articles and book chapters, and her research has contributed significantly to national and international cancer prevention guidelines, such as the US Physical Activity Guidelines for Health and the American Cancer Society’s Nutrition and Physical Activity Guidelines for both cancer prevention and cancer survivorship.

• Early Cancer Surveillance

No bio available.

• Early Cancer Surveillance

Dr. Matthew Prime BSc, MBBS, PHD, MRCS(Eng) Head of Evidence Generation, Roche Information Solutions Matt Prime trained as a doctor at University College London in the UK. He spent 12 years in clinical practice in the UK working as a Trauma & Orthopaedic Surgeon, the last 5 years at St Mary’s Hospital part of Imperial College Healthcare NHS Trust. He achieved his PhD from Imperial College London in healthcare policy focused on the enablers & barriers for digital health innovation in the UK. In 2013 he co-founded a digital health company to digitize care coordination for patients with traumatic injuries, the platform his company developed is now widely deployed within hospitals in the UK & Ireland. Matt joined Roche in 2018 and today he is the Head of Evidence Generation for Roche Information Solutions.

• Decentralized POC Testing

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.

• Advancing Novel Frameworks for Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Decentralized POC Testing
• Enabling Point-of-Care Diagnostics

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

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Gail E. Radcliffe, PhD has more than 20 years of experience assisting medical device and diagnostics companies with technical assessment and clinical/regulatory issues. Gail founded Radcliffe Consulting in 1998 after having worked at GENE-TRAK, where she developed IVD assays for several infectious disease organisms including HIV, CMV, TB and Chlamydia and was responsible for instituting the clinical affairs group. She later joined Cytyc Corporation, where she identified novel applications for the ThinPrep Processor and helped forge partnerships with other health care companies to expand product offerings. As a consultant, Gail has provided assistance to start-up and established medical device companies with regulatory strategy (IVD vs. CLIA lab) and submissions, quality systems development, and clinical trial support. Consulting engagements have encompassed a wide range of products including cutting edge digital pathology instruments, stem cell laser dissection devices, companion diagnostics, and multiplex molecular, NGS, POC and CLIA Waived in vitro diagnostic devices. She has been working around the clock for the past 2 years with manufacturers and laboratories developing SARS-COV-2 diagnostic products as a regulatory consultant with the RADx program. This program is an NIH funded initiative for the Rapid Acceleration of Diagnostic Products to get everyone back to school and work. Gail obtained a PhD in Molecular Biology from Brown University and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School. She is a member of the Regulatory Affairs Professional Society (RAPS), American Society of Microbiology (ASM) and Sigma Xi. She is on the Board of Trustees of the Massachusetts Biomedical Initiatives and acts as an advisor to venture capital companies.

• Advanced Diagnostics for Infectious Disease
• Decentralized POC Testing

Kristin Robinson is a Senior Regulatory and Clinical Consultant with ProPharma. A chemical and biomedical engineer by training, Kristin has worked in the Medtech industry for 20 years. Kristin leverages pragmatic experience leading regulatory and clinical development of IVD initiatives as a subject matter expert. This breadth of expertise provides thought leadership management of complex cross-functional projects and strategic advisement for innovative start-ups and large multinationals.  

• Enabling Point-of-Care Diagnostics

Mary received her PhD in biological and biomedical sciences from Harvard University. She completed her postdoctoral training at the University of Southern California. Mary joined Abbott in 2014 and has since added several new pathogens (HCV, HDV, SARS-CoV-2) to the Abbott Pandemic Defense Coalition’s Surveillance Program, supported Abbott's COVID-19 diagnostic assay development, published 36 research papers, and was named one of Business Insider’s 30 under 40 Young Leaders in Biotech in 2017.

• Enabling Point-of-Care Diagnostics

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

• Enabling Point-of-Care Diagnostics

Chantelle Schenning is a strategic healthcare leader dedicated to transforming the industry and improving the population’s health. She has over 16 years of healthcare experience spanning across clinical work, operations management, strategic leadership, and legislative affairs. Prior to Invitae, Chantelle worked at Kaiser Permanente, Johns Hopkins Hospital, and low-income community practices in Baltimore. Her clinical experience ranges from medical assistant and laboratory technician, to surgical neurophysiologist in Johns Hopkins’ Neurosurgery department. Chantelle’s health system leadership included departments such as Johns Hopkins’ Radiation Oncology, Kaiser Permanente’s Primary and Complex care teams, and regional executive leadership across Kaiser Permanente’s Northwest footprint. In her current role, she leads a team focused on advancing adoption of genetics into standard care, which includes Federal and State legislative affairs as well as strategic design and implementation. Chantelle is the 2018 winner of Press Ganey’s National Success Story Award. She holds a PhD in Health Services focused on Public Health Leadership, Masters in Healthcare Administration, and Bachelors in Biology (Pre-med track). Outside of work, she is appointed to the El Dorado County Commission on Aging, volunteers for Live Violence Free, teaches at a local community college, and is a member of the American College of Healthcare Executives.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

No bio available.

• Advancing Novel Frameworks for Companion Diagnostics

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

• Enabling Point-of-Care Diagnostics

Graduate of University of Kentucky COP. Operating 9 Stores throughout Kentucky, Indiana, & Illinois

• Decentralized POC Testing

I am a 2012 graduate of Sullivan University College of Pharmacy. I worked at Walgreens as a technician and pharmacist for 6 years. I have been with Sheldon’s Express Pharmacy since 2014.

• Decentralized POC Testing

Anthony “Nino” Sireci, MD is the Senior Vice President, Diagnostics Development at Loxo Oncology at Lilly. Dr. Sireci is a board certified Clinical Pathologist and a practicing molecular pathologist. Prior to joining Loxo, he was an Assistant Professor of Pathology and Cell Biology at Columbia University and a medical director in the Laboratory of Personalized Genomic Medicine at Columbia Medical Center. He is an active member of the Association for Molecular Pathology (AMP) where he serves on the organizations’ Strategy Committee and was the former vice chair for new codes and pricing on the Economic Affairs Committee. He is also a member of the Pathology Coding Caucus in the College of American Pathologists (CAP) and the Molecular Pathology Advisory Group in the American Medical Association (AMA). Dr. Sireci received a B.A in chemistry from New York University, an MD from the Johns Hopkins University School of Medicine and a Masters in Biostatistics from the Mailman School of Public Health at Columbia University. He completed his residency training in Clinical Pathology in the New York Presbyterian Hospital-Columbia, where he also served as chief resident.

• Advancing Novel Frameworks for Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Decentralized POC Testing
• Enabling Point-of-Care Diagnostics

John J. Sninsky, PhD, is the CSO-CIO of Molecular Stethoscope. He has been an independent consultant in Translation Science and Medicine with a specialty in Translational Diagnostics. John has a comprehensive and deep understanding of the development and application of pioneering molecular procedures and biomedical informatics to the translation of research-grade biomarker assays into clinical-grade clinically-adopted diagnostic tests as well as diagnostic tests paired with pharmacotherapies. John is the author of more than 110 scientific papers including advanced methods in molecular biology, next-generation sequencing, lipid sub-fractionation, application of the polymerase chain reaction (PCR) to virology and cancer, as well as genome-wide genetic association studies for multiple common, complex diseases and clinical-grade and reimbursed NGS. He advises commercial translation efforts at Stanford University (SPARK) and University of California, San Francisco (CATALYST), and lectures in Therapeutic and Diagnostic Regulatory Science at University of California, Berkeley (UCB), as well as in Bioengineering for the joint UCSF-UCB program for Masters in Translational Medicine.

• Early Cancer Surveillance

Prof. Soper (since 2016) is a Foundation Distinguished Professor in Chemistry and Mechanical Engineering at the University of Kansas. At KUMC, Prof. Soper holds an adjunct appointment in the Cancer Biology Department and is a member of the KU Cancer Center. He also holds an appointment at Ulsan National Institute of Science and Technology in Ulsan, South Korea, where he is a World Class University Professor. As a result of his efforts, Prof. Soper has secured extramural funding totaling >$105M, has published over 245 peer-reviewed manuscripts (h index = 67; 16,188 citations); 31 book chapters and 71 peer-reviewed conference proceeding papers, and is the author of 12 patents. He is also the founder of a startup company, BioFluidica, which is marketing devices for the isolation and enumeration of circulating tumor cells. Soper recently founded a second company, Sunflower Genomics, which is seeking to market a new DNA/RNA single-molecule sequencing platform. His list of awards includes Chemical Instrumentation by the American Chemical Society, the Benedetti-Pichler Award for Microchemistry, Fellow of the AAAS, Fellow of Applied Spectroscopy, Fellow of the Royal Society of Chemistry, R&D 100 Award, Distinguished Masters Award at LSU and Outstanding Scientist/Engineer in the state of Louisiana in 2001. Finally, Prof. Soper has granted 48 PhDs and 7 MS degrees to students under his mentorship. He currently heads a group of 15 researchers. His major discoveries include: (1) Technology for the detection of circulating tumor cells that can manage a variety of cancer diseases using a simple blood test (test has been demonstrated in multiple myeloma, pediatric acute lymphoblastic leukemia, acute myeloid leukemia, pancreatic, breast, colorectal, prostate, and ovarian cancers); (2) new hardware and assay for the point-of-care diagnosis of acute ischemic stroke; (3) single-molecule DNA and RNA sequencing nanotechnology; and (4) currently working on a home-test for COVID-19 infections (handheld instrument and the associated assay).

• Liquid Biopsy for Disease Management

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

• Early Cancer Surveillance
• Liquid Biopsy for Disease Management

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

• Early Cancer Surveillance

Dr. Esta Sterneck’s work addresses the complexities of signaling pathways that govern breast cancer progression and metastasis through multifaceted approaches in mouse models and ex vivo paradigms. Dr. Sterneck received her PhD from the University of Heidelberg following training at the European Molecular Biology Laboratory (EMBL) and the Center for Molecular Biology Heidelberg (ZMBH) in Germany. Her thesis work investigated oncogene cooperation in leukemia cells and revealed their coordinate induction of an essential autocrine growth factor. During her postdoctoral training at the Advanced BioScience Laboratories-Basic Research Program in Frederick, MD, Dr. Sterneck used genetically engineered mice to elucidate transcriptional mechanisms that govern mammary gland and ovarian biology. As a Principal Investigator at the National Cancer Institute, Dr. Sterneck built her research program on dissecting oncogenic and tumor suppressor-like activities of the C/EBP transcription factors, with current focus on discovery of targetable vulnerabilities of circulating tumor cells and metastasis of TNBC and inflammatory breast cancer. Dr. Sterneck is member of the steering committee of the trans-NIH Liquid Biopsies Scientific Interest Group.

• Liquid Biopsy for Disease Management

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

• Advancing Novel Frameworks for Companion Diagnostics

No bio available.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Sarah Thibault-Sennett joined ACLA in April 2023 as Senior Director of Reimbursement Policy. Sarah was previously the Director of Public Policy & Advocacy at the Association for Molecular Pathology (AMP). Her areas of expertise focus on coding, coverage, and reimbursement issues affecting molecular diagnostic tests. Additionally, she has a strong background in patient engagement and regulatory issues affecting molecular pathology. She has a PhD in Molecular and Cell Biology from the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD, and a background in molecular genetics and developmental biology. She moved into public policy with the goal of increasing patient access to appropriate diagnostic testing.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Dr. Tseng joined the faculty of David Geffen School of Medicine at UCLA in 2003. He is currently a Professor of Molecular & Medical Pharmacology, who also holds joint memberships in the California NanoSystems Institute, Crump Institute for Molecular Imaging, and Jonsson Comprehensive Cancer Center on the UCLA campus. His research interest falls in developing nanotechnology-enabled diagnostic and therapeutic solutions for cancer and genetic diseases.

• Liquid Biopsy for Disease Management

Apostolia Tsimberidou, MD, PhD is a Tenured Professor of Medicine in the Department of Investigational Cancer Therapeutics at The University of Texas, MD Anderson Cancer Center. Dr Tsimberidou pioneered the personalized medicine program in advanced cancers. In 2007, she started the IMPACT (Initiative for Personalized Medicine and Advanced Cancer Therapy) program and demonstrated that identifying tumor molecular aberrations and selecting therapy based on tumor abnormalities of individual patients with advanced cancer is associated with higher rates of response, progression-free survival and overall survival compared with those of standard approaches. Her work has garnered extensive media coverage at the ASCO’s prestigious official Press Program in 2011 and 2018 and in The Economist, the Wall Street Journal, the Bloomberg report and the Boston Globe. Dr. Tsimberidou has a track record of developing highly innovative clinical trials that have both changed the standard of practice of oncology and the improved the outcomes of patients with solid tumors and hematologic malignancies for >20 years. She has a substantial publication record (>275 articles; first or senior author: >115 original and 25 invited) in high-impact peer-reviewed journals including Nature Medicine, Journal of Clinical Oncology, Blood, Annals of Oncology, and Clinical Cancer Research. She has written reviews and book chapters and co-edited a major textbook entitled “Translational Oncology: Targeted Therapy in Cancer”. She has received various prestigious awards including a Career Development Award from ASCO and multiple independent grants. She served on several ASCO committees, and she was the Chair of ASCO’s Clinical Research Committee from 2016-2017. She is a Co-Chair of ASCO’s TAPUR tumor board, and a Member of the Board of Directors of Personalized Medicine Coalition. Dr. Tsimberidou is committed to high-quality clinical research to accelerate the implementation of precision oncology through innovative therapeutic approaches, education, and patient care to improve clinical outcomes.

• Advancing Novel Frameworks for Companion Diagnostics
• Early Cancer Surveillance
• Liquid Biopsy for Disease Management
• Advanced Diagnostics for Infectious Disease
• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics
• Decentralized POC Testing
• Enabling Point-of-Care Diagnostics

Greg Tsongalis is the Director of the Center for Clinical Genomics and Advanced Technology (CGAT) at the Dartmouth-Hitchcock Medical Center and Norris Cotton Cancer Center (NCCC) in Lebanon, NH and a Professor and Vice Chair for Research in the Department of Pathology and Laboratory Medicine at the Audrey and Theodor Geisel School of Medicine at Dartmouth in Hanover, NH. His area of expertise is in the development and implementation of clinical molecular diagnostic technologies. He has authored/edited thirteen textbooks in the field of molecular pathology, published more than 250 peer reviewed manuscripts, and has been an invited speaker at both national and international meetings. He has served on numerous committees of the AACC, ASIP, FASEB, and AMP where he is a past President. He serves on the editorial boards of multiple journals and also serves on numerous corporate scientific advisory boards.

• Enabling Point-of-Care Diagnostics

Dr. Vansant is SVP of Commercialization at BioFluidica. He has over 20 years of experience in nucleic acid, proteomic and biochemical analysis. His scientific and business development roles have been in GLP-certified and CLIA / CAP-accredited CRO laboratories.  His work has included technology transfer and the development of innovative technologies for biomarker and drug development support, with an emphasis on oncology. 

• Liquid Biopsy for Disease Management

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.

• Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Dr. Andrew Weitz joined the NIBIB as a Program Director in 2017. He supports a variety of trans-NIH and trans-agency initiatives, with a focus on health informatics, digital health, and open science. Dr. Weitz leads digital health strategy for the Rapid Acceleration of Diagnostics (RADx) Tech program, which received more than $1.5B from Congress to speed the development and commercialization of point-of-care and home-based diagnostic tests. In this role, Dr. Weitz established the RADx MARS program and MakeMyTestCount.org, which facilitate standardized test result reporting from over-the-counter diagnostics. He has also held leadership roles in other NIH initiatives including Home Test to Treat, REsearching COVID to Enhance Recovery (RECOVER), and Say Yes! COVID Test. In addition, Dr. Weitz is part of the leadership team for Stimulating Peripheral Activity to Relieve Conditions (SPARC), a program focused on electrical stimulation of peripheral nerves for treating various diseases and conditions. Prior to joining NIH, Dr. Weitz was a Research Assistant Professor at the University of Southern California Institute for Biomedical Therapeutics, where he investigated novel neuromodulation approaches for treating blindness.

• Enabling Point-of-Care Diagnostics

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

• Enabling Point-of-Care Diagnostics

As compared to the gold standard nasopharyngeal swab, Wyllie’s work has identified saliva as a reliable sample type for the sensitive detection of Streptococcus pneumoniae (pneumococcus) in healthy adults and more recently, during the COVID-19 pandemic response, for SARS-CoV-2. Improved detection of the pneumococcus has unveiled hidden reservoirs in older adults which holds importance when new vaccination strategies for preventing pneumococcal disease are being considered. For COVID-19, sampling saliva can alleviate many of the bottlenecks encountered in the mass testing strategies required to control continuing outbreaks. In an effort to address many of these issues, Wyllie validated and optimized saliva for SARS-CoV-2 detection and developed SalivaDirect: a simple, scalable and importantly, cost-effective method to help alleviate SARS-CoV-2 testing demands. Wyllie is now propelling the use of saliva as a superior sample for high-quality, low-cost surveillance of respiratory pathogens, having validated the simplified PCR approach for influenza, RSV, mpox virus, among others. Wyllie’s SalivaDirect Initiative at the Yale School of Public Health remains devoted to providing public health guidance, advancing saliva diagnostics, and enabling the safe re-opening of communities worldwide.

• Advanced Diagnostics for Infectious Disease
• Enabling Point-of-Care Diagnostics

Min Yu, M.D., Ph.D, received her medical degree from China and Ph.D. in genetics from Stony Brook University and Cold Spring Harbor Laboratory (CSHL). She pursued postdoctoral training at Massachusetts General Hospital, Harvard Medical School, where she characterized circulating tumor cells isolated from the peripheral blood of cancer patients. Dr. Yu joined the Department of Stem Cell Biology and Regenerative Medicine and the USC Norris Comprehensive Cancer Center as an assistant professor in 2014, and her lab focuses on the mechanisms of cancer metastasis. In addition to the NIH Director’s New Innovator Award, she received the NCI career transition (K22) award, the STOP CANCER Research Career Development Award, the Pew-Stewart Scholar for Cancer Research award, the Donald E. & Delia B. Baxter faculty fellowship, and the Era of Hope Scholar award from DoD.

• Liquid Biopsy for Disease Management