2023年 講演者
Speaker Biographies
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Esther Abels, MSc, BioMedical Regulatory Health Science Expert; Past President, Digital Pathology Association
Esther Abels, BioMedical Regulatory Health Science Expert has a background in bridging R&D, proof of concept, socio economics and pivotal clinical validation studies used for registration purposes in different geographies, for both pharma and biotech products. She has a wealth of regulatory and clinical experience specializing in bringing products to clinical utility. She played a crucial role in getting Whole Slide Imaging devices reclassified in USA. Esther drives efforts for reimbursement in Digital Pathology and collaborations with different Pathology Associations. In 2022 she was the president for the Digital Pathology Association (DPA) and she has chaired the DPA Regulatory and Standards Taskforce and facilitates FDA collaborations to drive regulatory and standard clarifications for interoperability and computational pathology in the field of digital pathology. She is also a co-founder of the Alliance for Digital Pathology / Pathology Innovation Collaborative Community where she co-leads the reimbursement workgroup. Esther holds a MSc in Biomedical Health Science from Radboud University Nijmegen.
Edward Abrahams, PhD, President, Personalized Medicine Coalition
Edward Abrahams, Ph.D., is the President of PMC. Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services and products for the benefit of patients and the health system. It has grown from its original 18 founding members in 2004 to more than 200 today. Previously, Dr. Abrahams was the Executive Director of the Pennsylvania Biotechnology Association, where he spearheaded the successful effort that led to the Commonwealth of Pennsylvania’s investment of $200 million to commercialize biotechnology in the state. Earlier, he had been Assistant Vice President for Federal Relations at the University of Pennsylvania and held a senior administrative position at Brown University. Dr. Abrahams worked for seven years for the U.S. Congress, including as a legislative assistant to Senator Lloyd Bentsen, as an economist for the Joint Economic Committee under the chairmanship of Representative Lee Hamilton, and as a AAAS Congressional Fellow for Representative Edward J. Markey. The author of numerous essays, Dr. Abrahams serves on the editorial board of Personalized Medicine and has also taught history and public policy at Brown University and the University of Pennsylvania.
Viktor A. Adalsteinsson, PhD, Director, Gerstner Center for Cancer Diagnostics, Broad Institute of MIT and Harvard
Viktor Adalsteinsson is Director of the Gerstner Center for Cancer Diagnostics at the Broad Institute of MIT and Harvard. He also leads the Blood Biopsy Team in the Broad’s cancer program, a multi-institutional collaboration to profile cancer genomes directly from blood samples. The Blood Biopsy Team includes scientists, engineers, oncologists, and computational biologists spanning numerous investigators and labs at the Broad Institute, MIT, Dana-Farber Cancer Institute, Massachusetts General Hospital, and beyond. The goal of their research is to identify mechanisms of response and resistance to therapy, enable routine monitoring of patients with cancer, and eventually provide a mechanism for early detection of cancer. Adalsteinsson joined the Broad Institute as a research affiliate during his doctoral studies at MIT and was subsequently tapped to lead the Blood Biopsy Team. He retains an affiliation with the Koch Institute for Integrative Cancer Research at MIT. Adalsteinsson holds a PhD in chemical engineering from MIT (laboratory of J. Christopher Love), where he developed novel approaches for functional and genomic profiling of single cells in cancer. In 2017, Adalsteinsson was honored by MIT Technology Review as a visionary member of its 35 Innovators Under 35, and in 2021, he was recognized as one of Clinical Omics’ “Pioneers Under 40.”
Michele Amasio, Senior Manager, R&D, Meridian Bioscience
Michele Amasio, Ph.D. is R&D Manager at Meridian Life Science. Michele obtained a Ph.D in 2009 in Cell, Molecular and Industrial Biology at University of Bologna, studying the role of glycoproteins in the entry process of HSV-1 into the host cell.
Michele and his team are working on developing molecular reagents such as enzymes and mixes for qPCR, LAMP, NGS applications. These reagents have been widely used by the global diagnostic industry for the development of in-vitro diagnostic kits.
Alex Aravanis, MD, PhD, CTO, Senior Vice President, Head of Research and Product Development, Illumina
Alex Aravanis, MD, PhD, is Illumina’s Chief Technology Officer, Head of Research and Product Development. He re-joined Illumina in June 2020 and is responsible for leading Illumina’s research and product development teams in engineering, consumables, applications, user design, software, informatics, and artificial intelligence. These teams are Illumina’s innovation engine and deliver product excellence in next-generation sequencing platforms and applications to accelerate scientific breakthroughs and translation of genomics to the clinic. Alex is an experienced entrepreneur and was involved in founding several start-ups in the life sciences and healthcare. Most recently, he co-founded GRAIL Bio where he served as Chief Scientific Officer and Head of R&D. At GRAIL, Alex led the research, development, operational, and clinical teams developing its multi-cancer early detection test. Alex’s passion for accelerating the commercial application of technology innovation continues in his current role where his responsibilities also include the Illumina Accelerator, the world’s first business accelerator focused solely on creating an innovation ecosystem for the genomics industry. Prior to GRAIL, Alex served as Senior Director of R&D for Illumina, Inc., where he developed multiple technologies, including clinical assays for the analysis of RNA and DNA from fixed tissues, whole exome analysis, massively parallel single-cell transcriptomics, and liquid biopsy using cell-free nucleic acids. Alex earned BS in Electrical Engineering, Computer Science, and Physics Minor from the University of California, Berkeley, as well as an MS and PhD in Electrical Engineering, and an MD from Stanford University. He holds more than 30 (pending and issued) patents and numerous peer-reviewed publications, additionally, he serves on various Scientific Advisor Boards for biotech startups.
Mara G. Aspinall, Managing Director, BlueStone Venture Partners; Professor of Practice, Arizona State University; Advisor, The Rockefeller Foundation
Mara G. Aspinall is a healthcare industry leader and pioneer committed to active civic involvement. She is Managing Director of BlueStone Venture Partners, a venture capital firm investing in diagnostics, medical devices and digital health companies. Aspinall also heads Health Catalysts Group, publishing the popular Sensitive & Specific: The Testing Newsletter and the annual Health Catalysts Diagnostics Year in Review. She is the creator and chief curator of TestingCommons.com - the largest international database of COVID tests on the market and in development. Aspinall is an advisor to The Rockefeller Foundation on COVID diagnostics. She is co-author of The Rockefeller Foundation’s national reports on COVID and heads the implementation of the K-12 National Testing Action Plan. Aspinall is passionate about education on diagnostics, genomics, and personalized medicine. To that end, she co-founded the School of Biomedical Diagnostics at Arizona State University, the first school dedicated to Diagnostics as an independent discipline. Aspinall served as President and CEO of Ventana Medical Systems, now Roche Tissue Diagnostics. Previously, she was President of Genzyme Genetics and Genzyme Pharmaceuticals. Aspinall sat on the U.S. Health and Human Services Secretary’s Advisory Council on Genetics, Health & Society (SACGHS) in the Obama and Bush administrations. Aspinall is also certified in Cybersecurity Oversight from Carnegie Mellon University. Mara was named Arizona Biosciences Leader of the Year by the Arizona Bio Association and one of “100 Most Inspiring People in Life Sciences” by PharmaVOICE and one of Women Inc.’s Most Influential Corporate Board Directors. Ms. Aspinall holds an MBA from Harvard Business School and a BA from Tufts University. She is a member of the Board of Directors of Abcam plc, Castle Biosciences, DA32, OraSure Technologies, and Blue Cross Blue Shield Arizona.
Michael Astion, MD, PhD, Medical Director & Clinical Professor, Lab Medicine, Seattle Children's Hospital
Dr. Astion is a clinical pathologist who is Medical Director, Department of Laboratories at Seattle Children’s Hospital and Professor of Laboratory Medicine and Pathology at the University of Washington. His career is divided between clinical service, teaching, and research and development. He has authored more than 20 software titles, 50 peer-reviewed papers, and 75 editorials. He is working actively, through grants and intellectual property held by the University of Washington and Seattle Children’s, with the insurance industry in the United States to create utilization management rules for clinical laboratory testing. In addition, he is the Creator and one of the Founders of PLUGS, the Patient-Centered Laboratory Utilization Guidance Service, a unique service that helps hospital-based and commercial laboratories actively increase the value of lab testing through aligning with patients and the insurance industry. Dr. Astion is a frequent speaker at professional meetings, where he lectures on issues related to laboratory stewardship and management; laboratory economics and outreach; and medical errors.
Esther Babady, PhD, D(ABMM), FIDSA, FAAM, Chief, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center
Dr. Esther Babady, PhD, is a board-certified clinical microbiologist with expertise in the molecular laboratory diagnosis of infectious diseases. She received her doctoral degree in Biochemistry and Molecular Biology and completed a post-doctoral fellowship in Clinical Microbiology both at the Mayo Clinic in Rochester, MN. She is currently the chief of the Clinical Microbiology Service, an Attending Microbiologist, and Professor in the Department of Pathology and Laboratory Medicine and the Department of Medicine (Infectious Disease Service) at Memorial Sloan Kettering Cancer Center. At a national level, she serves on several professional societies’ committees including those of the American Society for Microbiology, the Pan-American Society for Clinical Virology, and the Association for Molecular Pathology. Her research focus is on the rapid diagnosis of infectious diseases using molecular-based methods and the application of molecular methods for the surveillance and prevention of healthcare acquired infections primarily in immunocompromised cancer patients. Dr. Babady has published extensively on diagnostic molecular microbiology tests. She is a Senior Editor for Microbiology Spectrum and also serves on the editorial boards of the Journal of Clinical Virology and the Journal of Molecular Diagnostics. She is an elected fellow of the Infectious Disease Society of America and the American Academy of Microbiology.
Pat Baird, Head, Global Software Standards, Philips Healthcare
Pat Baird works at Philips as a Software Standards Specialist, with a focus on the use of AI in healthcare. Pat likes to think of his job as “Policy Engineering” - understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, whitepapers, and training to meet those needs. Past roles have included software developer, engineering manager, project manager, lead engineer, and Director of Risk Management before getting involved in regulatory & standards. He co-chairs multiple committees related to artificial intelligence at ISO, CTA, AdvaMed, MITA, and AFDO/RAPS, and is involved with other software committees regarding topics such as agile software development, cloud services for a regulated environment, risk management, cybersecurity, and was a sub-team lead for the IMDRF AI for Medical Devices committee.
Jeffrey Ballyns, PhD, Associate Director, Regulatory Policy, BD
Jeff Ballyns, PhD Is an Associate Director of Regulatory Policy at Becton Dickinson and Company (BD). BD designs, manufactures, and sells a wide range of medical devices, including in vitro diagnostic (IVD) products worldwide. He is responsible for gathering, assessing, and communicating new regulatory policy requirements impacting BD businesses. Prior to working at BD, Dr. Ballyns worked in the Center for Devices and Radiologic Health (CDRH) at the US Food and Drug Administration for 8 years. While at the FDA, he served as a lead reviewer, Branch Chief, and Division Director in the Division of Radiological Health within the Office of In Vitro Diagnostics and Radiological Health. He was responsible for the pre-market review and post-market regulation of radiological imaging devices and artificial intelligence (AI) image analysis software applications. Dr. Ballyns received his bachelor’s and PhD degrees from Cornell University in Mechanical and Aerospace Engineering and Biomedical Engineering respectively.
Lourdes Barrera, PhD, Executive Director, Global Medical Affairs, Merck
Dr. Lourdes Barrera is a Biomedical Researcher and Scientist with in-depth experience leveraging expertise in immunology, medical affairs, precision medicine, diagnostic solutions, and testing technologies. Dr. Barrera holds PhDs in Biological Sciences (Immunology) and in Philosophy of Science (Science Communication) and a master’s degree in Molecular Biology. Dr. Barrera has developed an outstanding career as a medical researcher in respiratory diseases (IPF, HP, COPD) and lung cancer for 20 years. First author of more than 40 scientific peer reviewed publications and multiple congress presentations and scientific talks since 2002. She has had a long-standing relationship with diagnostic and pharmaceutical companies for which she has performed training courses as well as consulting worldwide. Dr. Barrera has a wealth of experience and proven talent leveraging both biomedical expertise and business acumen to drive pharma industry-leading performance. She has held positions as Country Diagnostic Lead, Global Diagnostic Capabilities Director, Global Medical Affairs Lead for Immuno-oncology and most recently, Global Precision Medicine Senior Director at Novartis.
J. Carl Barrett, PhD, Vice President of Translational Science, Oncology, AstraZeneca Pharmaceuticals
Dr. J. Carl Barrett is Vice President & Global Head of Translational Medicine, Oncology R&D at AstraZeneca Pharmaceuticals LP. His responsibility is to develop and execute biomarker strategy and translational sciences efforts to support compound development from research through early and full development in oncology. From 2005-2011, he was Global Head of Oncology Biomarkers and Imaging in Novartis Oncology Translational Medicine. Prior to joining Novartis, Dr. Barrett was the founding Director of the NCI Center for Cancer Research (CCR), which is the NCI intramural center for translation medicine and novel technologies. He also was Chief of the Laboratory of Biosystems and Cancer. Prior to joining NCI, Dr. Barrett was the Scientific Director at the National Institute of Environmental Health Sciences where his efforts focused on integrating new approaches to toxicology by utilization of molecular approaches of toxicogenomics, molecular toxicology, and the Environmental Genome Project. Dr. Barrett’s longstanding research interests focus on the discovery of the critical genetic and epigenetic changes in the cancer cell, in particular the discovery of genes involved in breast cancer (BRCA1) and in the processes of cellular senescence and cancer metastasis. He has made significant contributions to the identification of molecular defects in cancers and the role of the biosystem in the carcinogenesis process. Trained as a chemist at the College of William and Mary, Dr. Barrett received his PhD degree in Biophysical Chemistry from Johns Hopkins University. He has published over 600 research articles and reviews in leading scientific journals and books. He is a member of the Johns Hopkins University Society of Scholars, an elected member of the Ramazini Foundation, an honorary member of the Japanese Cancer Association, and a recipient of multiple NIH awards and Keynote lectures.
Jonathan Beer, Worldwide Precision Diagnostics Strategic Intelligence Lead, Novartis Pharmaceuticals
Jonathan Beer has been with the Novartis since 2011 and has supported multiple investigational new drug Phase III clinical trials which employed diagnostic assays across technology and sample types, including Liquid Biopsies, to select patients for enrollment. Through these trials he has contributed to 7 Pre-Market Approval submissions to the US FDA for Companion Diagnostic Assays and was the Lead for the therascreen PIK3CA RGQ PCR Kit, the CDx assay for alpelisib. In addition to clinical support, Jonathan has led a research lab identifying new and emerging technologies, performs feasibility testing of selected platforms or vendors, and makes recommendations on which assays will provide the highest impact exploratory biomarker data from precious clinical trial samples to Novartis drug development teams. As Dx Strategic Intelligence Lead responsibilities include developing relationships with key Diagnostics Partners, summarizing precision medicine research from major congresses and overseeing market research & testing rates.
Tomasz Beer, MD, CMO, Multi-Cancer Early Detection, Exact Sciences
Dr. Tomasz (Tom) Beer serves as Chief Medical Officer for Multi-Cancer Early Detection at Exact Sciences Corporation since August 2022. Dr. Beer also serves as Adjunct Professor of Medicine at the OHSU Knight Cancer Institute, where he sees men with prostate cancer. Until August 2022, Dr. Beer was the Grover C. Bagby Endowed Chair for Prostate Cancer Research at the OHSU Knight Cancer Institute, where he led the Prostate Cancer Research Program, encompassing basic research, translational research, clinical trials of novel therapeutic strategies in prostate cancer, and studies aimed at enhancing cancer survivorship. He has authored or co-authored more than 280 peer reviewed articles, including investigations of targeted therapies and immunotherapies in prostate cancer, among them vitamin D receptor agonists, androgen receptor antagonists, PSMA targeted radiopharmaceuticals, clustering targeting agents as well as cancer vaccines, CTLA-4 and PD-1 inhibitors, and others. He led the global randomized trial of enzalutamide vs. placebo that demonstrated substantial improvements in overall and progression-free survival as well as quality of life and served as the basis for a global change in the standard of care for advanced prostate cancer. Dr. Beer also served as Deputy Director of the OHSU Knight Cancer institute, and NCI designated Comprehensive Cancer Center and Chief Medical Officer for the Center for Early Detection Advanced Research (CEDAR) within the Knight where he worked closely with a diverse leadership team to speed advances in the early detection of lethal cancers. At CEDAR, Dr. Beer fostered collaborations between clinicians, engineers, and cancer biologists to advance discoveries in early detection of cancer and lead clinical trials of multi-omic blood-based cancer early detection tests.
Suzanne Belinson, PhD, Vice President, Commercial Markets, Tempus, Inc.
Suzanne Belinson, PhD, MPH, is Vice President of Commercial Markets at Tempus Labs Inc. Tempus is a technology company that is making precision medicine a reality by gathering and analyzing clinical and molecular data at scale. Her role focuses on commercial growth for Tempus through the development and execution of partnerships with managed care organizations aiming to improve healthcare value by leveraging data. Before joining Tempus, Dr. Belinson served as Executive Director, Clinical Markets, at the Blue Cross Blue Shield Association. In addition to leading the sales and market development for products and services developed within the Office of Clinical Affairs, Dr. Belinson led the day to day operations of Evidence Street. As part of the leadership team in the Office of Clinical Affairs she also spent time focused on the development of emerging programs and services that enhance value and brand leadership for the independent BCBS Plans. Dr. Belinson received her bachelor’s degree from Cleveland State University, and a PhD in Epidemiology from the University of North Carolina at Chapel Hill. She also holds a Masters in Public Health from the University of Pittsburgh.
Paul Beresford, PhD, Vice President and General Manager, CDx, Diagnostics and Genomics Group, Agilent Technologies
Paul Beresford is the VP/GM of Agilents’ CDx Division. CDx partners with pharmaceutical companies to identify and validate cancer biomarkers, and to develop, register and commercialize companion diagnostic tests based on modalities including IHC and NGS. Paul is responsible for leading CDx strategy and also plays a critical role in delivering Agilent’s mission to improve the human condition by bringing the power of precision oncology to customers, partners, and patients.
Gabriel Bien-Willner, MD, PhD, Medical Director, MolDx, Palmetto GBA
Dr. Bien-Willner is the Medical Director of the MolDX program at Palmetto GBA, a Medicare Administrative Contractor (MAC). MolDX seeks to understand the molecular testing landscape to implement payer controls, coverage, and to set policy for affiliated MACs, which currently cover 28 states. He is a leader in the Precision Medicine space and practices as a Board-certified Anatomic Pathologist and Molecular Genetic Pathologist. Throughout his career, he has been active in research, development, and advancement of molecular diagnostic services, specifically next-generation sequencing. He has worked closely with clinicians to develop clear clinical diagnostic and treatment pathways directing Precision Medicine programs for community cancer centers. Dr. Bien-Willner received his MD and PhD degrees from Baylor College of Medicine, with a PhD in Human Molecular Genetics. He completed his residency, fellowship, and attained a faculty appointment at Washington University in St. Louis prior to leadership roles in laboratory and biotech companies before joining Palmetto GBA.
Bryan Bothwell, Senior Director, Strategy, Business Development, Commercialization, Biotechnologies, Qorvo
Bryan is in charge of global strategy, customer development and commercialization for Qorvo Biotechnologies. Prior, he held senior marketing and business development roles at Intel and TriQuint, with a primary focus on identifying differentiated technology cores and translating into product ventures in areas like 5G. He received undergraduate degrees in Biology/Biochemistry from University of Portland, and master’s in Electrical Engineering and Business Administration from Oregon Health Sciences University and Babson College.
Monica Brivio, Senior Strategy & Business Development Manager, Micronit
Dr. Brivio has gained more than fifteen years of experience in the field of lab-on-a-chip technologies and microfluidics for application in chemistry and life science with focus on cross- disciplinary research in the areas of microfluidics, molecular diagnostics and immunochemistry. Dr. Brivio has experience in managing collaborative projects both at an international and at a national level with various sized consortia. Over the years she has established a considerably large network of contacts both within Academia and Industry and she has built a strong background in applying microfluidics-based technologies to life science.
Robert J. Bujarski, President and COO, QuidelOrtho Corporation
Robert Bujarski, President and Chief Operating Officer of QuidelOrtho Corporation, leads implementation of the company’s strategy and strengthens operational performance. Mr. Bujarski has two decades of enterprise experience spanning the full spectrum of operational, commercial, and legal functions within the diagnostics sector. Mr. Bujarski was the Chief Operating Officer of Quidel Corp. from September 2020 to May 2022, where he architected expansions of the company’s scope and scale and facilitated the seamless integration of Quidel Corp. and Ortho Clinical Diagnostics. Previously, Mr. Bujarski was Quidel’s Senior Vice President for North America Commercial Operations from July 2019 to September 2020, Senior Vice President, General Counsel from March 2007 to September 2020, Senior Vice President, Business Development from August 2009 to July 2019, and General Counsel and Vice President from July 2005 to March 2007. Prior to joining Quidel, Mr. Bujarski was an associate attorney with the law firm of Gibson, Dunn & Crutcher LLP in its transactions practice group from October 2001 to July 2005. Mr. Bujarski received his BA and JD from the University of Arizona.
Brooke Byrd, PharmD, Clinical Oncology Pharmacist, Enterprise Oncology, CVS Health
Brooke Byrd, PharmD, BCOP, is a Clinical Oncology Pharmacist for the Enterprise Oncology division of CVS Health working in her current role since July 2020. With more than ten years’ experience in the field of Oncology she serves as an Oncology subject matter expert for CVSH. In this role, her and her team continually work with providers, payors, clinics, and health systems to improve patient health, provide high quality cancer care, and lower overall treatment costs. Prior to Brooke’s current role at CVSH, she worked in both the oncology ambulatory and independent specialty pharmacy practice setting, most recently serving as the manager of a healthcare system specialty pharmacy. Brooke earned her Doctor of Pharmacy (PharmD) degree from the University of Kentucky, completed a Post Graduate Year One residency at St. Joseph’s Hospital in Lexington, KY, and has earned the Board Certified Oncology Pharmacist® (BCOP) certification. She currently resides in Louisville, KY with her husband and two sons, ages three and one.
Colleen Caleshu, ScM, CGC, Senior Director, Clinical Research, Genome Medical
Colleen is the Senior Director of Clinical Research at Genome Medical, a genomic health and technology company that provides scaled & remote genomics services and technology. She leads Genome Medical’s research efforts, which focus on innovation and scaling in the delivery of genomic medicine.
Alicyn Campbell, Vice President, Head of Digital Health for Oncology R&D, AstraZeneca
Alicyn Campbell is currently Head of Digital Health Oncology R&D at AstraZeneca, where she leads on the development of strategies designed to increase their evidence base and improve care, through intelligent use of emerging technologies. Alicyn has over 12 years of experience in Health Outcomes Research. Prior to joining AstraZeneca she served as the Global Head of Patient Centered Outcomes Research at Genentech/Roche. In that capacity, she was responsible for leadership in the assessment of the patient experience and consulted widely with the FDA and international regulators. She achieved the first ever novel FDA patient reported outcome data approved in label for Hycela and was also responsible for novel patient-reported efficacy data for Hemlibra. She is the Founder, Executive Sponsor and Co-chair of Industry PRO-CTCAE Working Group, recognized as part of the ‘Cancer Moonshot’ initiative by President Biden and is a frequent research collaborator to Friends of Cancer Research and LUNGevity. She has also authored several significant scientific publications and presentations, the latest of which was published in The Lancet Oncology.
Nathan Carrington, PhD, Vice President, Global Regulatory Affairs, Agilent Technologies
Nathan A. Carrington (Nate) is the Vice President of Global Regulatory Affairs at Agilent Technologies. In this role, Nate directs the development of global regulatory strategies designed to enhance successful and expedient registrations across Agilent’s product portfolio, including CDx, SaMD, pathology, and cell analysis product types. His various areas of regulatory interest include Digital Health-related topics such as software qualification, SaMD classification, software clinical evidence requirements, the US FDA Software Precertification Pilot Program, requirements for AI-Based SaMD products, and Real World Evidence. Previously, Nate worked at Roche Diagnostics, where he held various roles of increasing responsibility over a fifteen year span, including Head of Digital Health and Innovation for the Global Regulatory Policy and Intelligence team, Vice President of Quality and Regulatory Affairs for Roche’s Diagnostic Information Solutions (DIS) business, Head of Centralized and Point-of-Care Solutions (CPS) and Solution and Integrated Services (SIS) Regulatory Affairs at Roche’s Rotkreuz Switzerland site, and Director of Regulatory Affairs for Roche Diabetes Care. Nate received his Ph.D. in Analytical Chemistry from the University of Tennessee. His doctoral research examined novel approaches to electrochemical and photometric sensing, and he began work at Roche Diagnostics in 2007 as a Principal Scientist in Roche’s Diabetes Care team.
Lon Castle, MD, CMO, Molecular Genetics & Personalized Medicine, eviCore Healthcare
Dr. Castle is responsible for the clinical performance of the Laboratory and Specialty Drug programs at eviCore healthcare, a wholly-owned subsidiary of Cigna. In addition to his decade-long experience with specialty drugs, Dr. Castle has been working in the genomic and molecular diagnostic field since 2007, both designing initiatives that support the advancement of precision medicine as well as managing programs that ensure these tests are used appropriately.
Philip E. Castle, PhD, Director, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health
Philip E. Castle, PhD, MPH is the Director of the Division of Cancer Prevention (DCP) and Senior, Tenured Investigator in the Division of Cancer Epidemiology and Genetics (DCEG) at the U.S. National Cancer Institute (NCI) (Rockville, MD, USA). From 2014-2020, he was a Professor in the Department of Epidemiology and Population Health at Albert Einstein College of Medicine (Bronx, NY, USA), at which he was granted tenure in 2019. Previously, Dr. Castle was the Chief Scientific Officer of the American Society for Clinical Pathology (ASCP) (2011-2). He was a Senior, Tenured Investigator (2010) and Tenure-Track Investigator (2003-10) in DCEG/NCI. From 1999-2002, Dr. Castle was a Cancer Prevention Fellow in DCP/NCI, during which time he received M.P.H. in Epidemiology in 2000 from the Johns Hopkins University (Baltimore, MD, USA). Dr. Castle received his Ph.D. in Biophysics in 1995 from the Johns Hopkins University. Dr. Castle’s research interests are (1) epidemiology of human papillomaviruses (HPV) and cervical/anogenital cancer; (2) science and translation of cancer prevention strategies; (3) cancer screening; (4) international health; (5) health services research; and (6) evidence-based medicine.
David Cavanaugh, Founding Partner, DeciBio Consulting LLC
David Cavanaugh has 20+ years working at the intersection of business and science within precision medicine. He has first-hand knowledge of pharmaceutical R&D through his 7+ years of work as a bioinformatician within leading biotech companies. Since completing his MBA at the Kellogg School, he has been working as a strategy consultant, first at L.E.K. Consulting and then at DeciBio Consulting, which he co-founded. His specialty is advising diagnostic and pharmaceutical companies to bring new products / innovations to market, drive product / market fit, and crafting strategies that drive sustained competitive advantage.
Jesus Ching, PhD, Vice President, R&D, Mammoth Biosciences
Jesus Ching has over 25 years of experience in molecular diagnostics with key leadership roles in research and development ranging from Director to CTO. Currently, he is the Sr. VP of R&D at Mammoth Biosciences, where he is working on CRISPR technologies for diagnostics. In the past, he successfully managed teams for Cepheid (GeneXpert), Luminex (Aries), and Visby Medical (Handheld PCR Test) that led to FDA-cleared products on the market. Jesus also has over 45 issued patents in the areas of PCR instruments and consumables, sample preparation methods, novel solid phase chemistries, molecular assays, NGS assays, automated fluidic cartridges, and nucleic acid detection chemistries.
Charles Chiu, MD, PhD, Professor, Laboratory Medicine and Medicine/Infectious Diseases; Director, UCSF-Abbott Viral Diagnostics and Discovery Center; Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine
Charles Chiu, MD, PhD is Professor of Laboratory Medicine and Medicine, Division of Infectious Diseases at University of California, San Francisco, Director of the UCSF-Abbott Viral Diagnostics and Discovery Center (VDDC), and Associate Director of the UCSF Clinical Microbiology Laboratory. Chiu currently heads a translational research laboratory focused on next-generation sequencing assay development for infectious disease diagnostics, discovery and investigation of emerging pathogens, including Borrelia burgdorferi (Lyme disease), Ebola virus, enterovirus D68, and Zika virus, and clinical/public health applications of new diagnostic technologies such as nanopore sequencing. He is also actively developing RNA sequencing approaches to detect and identify diagnostic profiles of the body’s response to infection. His work is supported by funding from the National Institutes of Health (NIH), Abbott Laboratories, Department of Defense, NASA/Translational Research Institute, philanthropic grants (Charles and Helen Schwab and Steven and Alexandra Cohen Foundations), and the California Initiative to Advance Precision Medicine. Dr. Chiu has authored more than 80 peer-reviewed publications, holds over 15 patents and patent applications, and serves on the scientific advisory boards for Therabio, Inc., and Mammoth Biosciences, Inc.
Christopher Conn, PhD, Director, Diagnostics Strategy, Amgen
Christopher Conn is a Director and Diagnostics Strategy Lead in the department of Clinical Biomarkers & Diagnostics at Amgen where he is responsible for developing and implementing end-to-end diagnostic development programs spanning early to late phase clinical development. Christopher has over 15 years of cross-functional experience in the diagnostic and pharmaceutical industries from product concept development to commercialization. Christopher has led the companion diagnostic efforts for numerous programs in the biotech and pharmaceutical industries in both oncology and non-oncology therapeutic areas. Christopher has a PhD in cell and molecular biology from the University of Cincinnati College of Medicine and has completed postdoctoral training at St. Jude Children's Hospital and the University of Colorado.
Dana Connors, MSc, PMP, Senior Scientific Program Manager, Cancer Research Partnerships, Foundation for the National Institutes of Health
Dana E. Connors, MSc, PMP is the Senior Scientific Program Manager for Cancer Research Partnerships at the Foundation for the National Institutes of Health. Drawing on experience in the biotechnology industry, non-profit and federal sectors, he works with the Cancer Steering Committee to set strategy and prioritize project pipelines and manages the activities of project teams and working groups to facilitate the advancement and execution of innovative cancer research and biomarker development. In his work with public-private biomedical research partnerships he engages participation from government, industry, academia, patient-advocacy, and private sector organizations to drive international scientific collaboration in multiple disease areas. Ongoing collaborations include analytical validation and clinical utility of liquid biopsy, project opportunities around immuno-oncology biomarkers, development of clinical trial metrics, and Minimal Residual Disease in blood-based cancers.
Ahmet Coskun, PhD, Assistant Professor, Biomedical Engineering, Georgia Institute of Technology
Ahmet F. Coskun (faculty & lab) is currently a Bernie-Marcus Early-Career Professor and Assistant Professor of Biomedical Engineering at Georgia Institute of Technology and Emory School of Medicine. Dr. Coskun directs an interdisciplinary research team at the Single Cell Biotechnology Laboratory. His team’s research aims to study spatial biology in health and disease at the nexus of multiplex bioimaging, microfluidic biodynamics, and big data biocomputation. Using high-dimensional nanoscale imaging datasets, this interdisciplinary program addresses the fundamental challenges in immuno-engineering, cancers, and pediatric diseases. Dr. Coskun was an Instructor at Stanford University School of Medicine. Dr. Coskun received his postdoctoral training from the California Institute of Technology. He holds a Ph.D. degree from the University of California, Los Angeles. He is a recipient of the National Institutes of Health K25 Career Award (2018), the Burroughs Wellcome Fund CASI Award (2016), and the Leukemia & Lymphoma Research Fellowship (2015). His lab is currently funded by a Welcome LEAP grant (2021), Pilot grant from Lung SPORE at Winship (2021), and Georgia Tech & Emory University.
Meggan Czapiga, PhD, Director and IVD Lead, Global Regulatory Affairs Devices, UCB BioSciences
Meggan Czapiga, PhD is Director, Global Regulatory Affairs Devices, IVD Lead at UCB, where she leads the development and implementation efforts for regulatory strategy for IVD/CDx development in Rare Disease and Gene Therapy programs, from early to late development. Prior to UCB, Dr. Czapiga was Senior Director of Companion Diagnostics Programs at Autolus where she led the development and commercialization efforts of companion diagnostics for several Oncology cell therapy programs in the Autolus pipeline. Prior to Autolus, Meggan worked at GSK as Precision Medicine Companion Diagnostic Lead where she focused on developing and implementing Companion Diagnostic strategies including design and development, regulatory, IP and commercial efforts in Oncology, Oncology Cell Therapy and Rare Diseases. Before joining GSK, Meggan worked at Medimmune as a Senior Manager in the Translational Sciences group where she was the head of the pre-clinical/clinical histopathology function. She built and developed a world class team for delivering biomarker discovery data to support intended use as well as building companion diagnostic prototypes for use in early phase clinical trials. Meggan received her PhD in Neuroscience from Georgetown University and conducted her postdoctoral work at the National Institutes of Health - NIAID.
Tara Dalton, PhD, CEO, Altratech Ltd.
Dr Dalton is CEO of Altratech Ltd, is a fellow of the Irish Academy of Engineers, and has published over 100 refereed papers in her role in as a faculty member in the School of Engineering at the University of Limerick. Previously she co-founded Stokes Bio Ltd to develop high-throughput microfluidic PCR instruments for cancer genotyping (acquired by Life Technologies Inc). She has over 50 granted patents and patent applications.
Randy David, PhD, Vice President, Life Science, QURE, a TRC healthcare brand
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.
Kevin Davies, PhD, Executive Editor, The CRISPR Journal; Author, Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing
Kevin has more than three decades’ experience in science publishing as an editor, journalist, author, and publisher. He is the founding editor of Nature Genetics and Bio-IT World magazine and also served as Editor-in-Chief of Cell Press and publisher of Chemical & Engineering News. Kevin is the author of five popular science books including Cracking the Genome, The $1,000 Genome, and an updated version of DNA: The Story of the Genetic Revolution with James D. Watson and Andrew Berry. His most recent book is Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing, published in 2020 by Pegasus Books and supported by a 2017Guggenheim Foundation Fellowship in science writing. He is the founding Executive Editor of The CRISPR Journal and is spearheading the launch of GEN Biotechnology, a new marquee peer review journal, in 2022. Kevin holds a degree in Biochemistry from Oxford University and a PhD in Human Genetics from St Mary’s Hospital Medical School, London. He carried out postdocs at MIT and Harvard Medical School before joining the editorial staff at Nature. He still clings to a British accent.
Nathan Davis, Analyst, RA Capital Management
Nate Davis is an Analyst on the Investment Team at RA Capital Management. Nate conducts due diligence on biotechnology companies at RA Capital and serves as a Board Director for The Covid Apollo Project and Nucleix. Previously, Nate covered atopic dermatitis, psoriasis, dermatology, colorectal cancer, cancer diagnostics, and broader tools and diagnostics as a Senior Associate within RA’s TechAtlas division. Prior to RA Capital, Nate worked as an Investment Analyst at Wolfram Ventures. Nate has a BS in Biological Sciences from University of Vermont.
Jacqueline Davis, Senior Commercial Project Manager, LFADS, Life Science | DxRM, MilliporeSigma
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 for x-ray data collection and structure solving, she transitioned to MilliporeSigma in the Specialty Assays group. Through multiple product launches, including work on nanodiscs, IVD kits, flow cytometry assays, and Duolink, she leveraged her strong background in protein chemistry and immunoassays. Her work in enabling the Duolink Customs offering brought her to the attention of the Assay Development Services group, where she now acts as Senior Commercial Project Manager.
Thomas Defay, Deputy Head, Diagnostic Strategy and Development, Alexion Pharmaceuticals
Tom is Deputy Head of Diagnostics Strategy and Operations for Alexion Pharmaceuticals. Five years ago, Tom joined Alexion with the goal of shortening the diagnostic odyssey for patients with rare disease. Through a collaboration with the Rady Children’s Institute for Genomic Medicine, he contributed to the World Record for achieving the fastest molecular diagnosis using whole genome sequencing in just 19.5 hours. That work was also honored with a RARE Champion of Hope award from Global Genes. Tom has over twenty years of experience leading teams in drug discovery and development. Through his work as a project and portfolio leader, he has delivered numerous novel treatments to the clinic aimed at treating devastating Neurological and Psychiatric disorders. He has also led sections in bioinformatics, data science, genomics, and molecular sciences. Tom received his PhD in BioPhysics from the University of California San Francisco.
Maxime Dhainaut, PhD, Postdoctoral Research Fellow, Genetics & Genomic Sciences, Icahn School of Medicine at Mount Sinai
Maxime received his PhD in immunology in 2015 from the Universite Libre de Bruxelles, under the supervision of Prof. Muriel Moser. During his graduate studies, he investigated the molecular mechanisms involved in regulatory T cells control of T cell priming, with a focus on Tregs/Dendritic cells interaction (Dhainaut, Coquerelle et al., EMBO J, 2015). Maxime then joined the laboratory of Prof. Brian Brown at the Icahn Institute of Medicine at Mount Sinai, where he focused on the molecular mechanisms governing cancer cell escape from T cell immunoediting. Specifically, Maxime developed novel approaches for high-throughput CRISPR/Cas9 functional genomics with high dimensional phenotyping, using Protein Barcodes (Pro-Codes) (Wroblewska, Dhainaut et al., Cell, 2018). The main limitations of phenotyping screens, including Pro-Code/CRISPR genomics, is their incompatibility with spatial read out, which limits their application to phenotypes that can be measured in cell suspensions. Maxime recently developed Perturb-map, a platform for spatial CRISPR genomics, which allows to identify gene perturbations in tissue sections (Dhainaut, Rose et al, Cell, 2022). Using Pro-Code/CRISPR genomics and Perturb-map, Maxime identified genes regulating cancer cells sensitivity to T cell killing, expression of key inhibitory checkpoints, or orchestrating specific immune niche in the tumor microenvironment. Maxime is currently Associate Director in early discovery at Immunai.
Frank Diehl, PhD, Executive Vice President, Multi-Cancer Early Detection, Research & Development, Exact Sciences Corporation
Dr. Frank Diehl is a globally recognized R&D leader with extensive experience in cancer detection. Dr. Diehl is the EVP & Head of Product Solutions at Exact Sciences where 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. Dr. Diehl holds a Ph.D. in molecular pathology from the University of Heidelberg and completed a postdoctoral fellowship at Johns Hopkins University.
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s Hospital Los Angeles; Professor, Pathology and Laboratory Medicine, Keck School of Medicine, University of Southern California
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.
Eric Dishman, CEO, DishStrong Innovation; Former Director, All of Us Research Program, National Institutes of Health
I am a social scientist and actor by training who has spent 30+ years doing, leading, and teaching health innovation and trying to personalize & precision-ize healthcare for myself as a 23-year cancer patient and for all. My first health technology projects and startup attempts were for Paul Allen's think-tank. Much of my career was at Intel Corporation, where I grew from a researcher studying the needs of frail seniors and patients/families struggling with Alzheimer's, cancer, and chronic disease management to an Intel Fellow and Vice President of the Intel Health & Life Sciences Group, responsible for global strategy, R&D, and growth in the sector across 50+ countries. In 2016, the persuasive skills of Dr. Francis Collins, former NIH Director, and President Obama took me to Bethesda to be the founding director of the All of Us Research Program (joinallofus.org) focused on diversifying our research participants and data to inform precision health & medicine. I recently stepped down from my federal position to return to my passions of cancer patient advocacy, writing, backcountry skiing, and joining boards, teaching, and doing occasional consulting projects on precision health and strategic planning.
Nicholas C. Dracopoli, PhD, CSO, Delfi Diagnostics
Nicholas Dracopoli, Ph.D. is Chief Scientific Officer at Delfi Diagnostics. Previously, his work focused on oncology translational science at PGDx, Janssen and Bristol Myers Squibb. Prior to joining the pharmaceutical industry, he spent five years in the biotechnology industry at Sequana Therapeutics. Nic obtained his bachelor’s degree and doctorate from the University of London and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center in New York City, NY and the Massachusetts Institute of Technology (MIT) in Cambridge, MA. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center and as a Section Chief at the National Center for Human Genome Research at the National Institutes of Health, Bethesda, MD. Nic has authored more than 70 scientific publications and has extensive experience in the fields of genomics, molecular biology and cancer research.
Mark Eccleston, PhD, CTO, Products, Volition
Dr Mark Eccleston is an enthusiastic and passionate biotechnology entrepreneur with over 20 years of experience in the sector and is a founding scientist of Volition. He holds a PhD in Polymer Chemistry for biomedical applications and gained an MBA (entrepreneurship) from the University of Dundee in 2008. Dr Eccleston is the Chief Technology Officer at Volition, a company developing next generation blood-based diagnostics for early stage detection of cancer. Mark coordinates commercialisation of Volition’s Research Use kit range based on its proprietary Nucleosomics® technology platform. This epigenetics-based immunoassay approach to rapid, affordable cancer diagnostics is intended to revolutionise cancer screening and diagnosis. Mark is also the founder and Managing Director of OncoLytika Ltd. a technical consultancy company.
Mika Eddy, Founder & CEO, Malama Health
Mika Eddy is the CEO of Malama Health, a maternal health company that delivers tech-enabled care for high risk perinatal conditions. Malama's fully HIPAA compliant solution offers remote monitoring for patients with diabetes and other high risk conditions in pregnancy, making it easier for patients to track and get insights into their health, and for providers to monitor patients to reduce likelihood of adverse events. Prior to Malama, Mika was the Director of Clinical Product Innovation at UnitedHealthcare. Mika received her BA in human biology and MS in management from Stanford University.
Dwight Egan, CEO, Co-Diagnostics, Inc. (Co-Dx)
Mr. Egan co-founded and served as CEO and Chairman of Broadcast International, Inc. from 1984 to 1995. When Data Broadcasting Corporation acquired Broadcast International and created CBS MarketWatch, a leading financial news site, he participated in its initial public offering and remained a senior executive from 1995 to 1999. Mr. Egan is CEO and co-founder of Co-Dx, actively involved in the daily operations and guiding the company’s vision for the future.
Anka Ehrhardt, PhD, Director, Cell-Based Sciences, Merck
Dr. Ehrhardt is a biophysicist with a Ph.D. in human physiology. Throughout her career, she focused on driving biomedical research through efficient application of innovative technologies and strategies. She built and led successful teams in industry, including at Merck, where she headed a laboratory providing leading technologies for cell-based research from early discovery through manufacturing; and at BMS where Dr. Ehrhardt led and grew an international clinical assay team to robustly cover large scale registrational and translational clinical analysis generating clinical decision-driving data and mechanistic insights for immuno-oncology, cardiovascular, immunology, metabolic and rare disease studies. Before returning to Merck, Dr. Ehrhardt fulfilled one of her scientific aspirations at CHDI Foundation, designing and implementing successful clinical biomarker discovery and development strategies for Huntington’s disease. Currently, at Merck, Dr. Ehrhardt is providing strategic and technical leadership for the development and implementation of industry-leading and QC-friendly cell-based assays and models for potency determination that reflect the unique mechanisms of biologics products in clinical studies and beyond.
Anna Elz, Manager, Fred Hutch Innovation Lab, Fred Hutchinson Cancer Research Center
Anna Elz, MSc. joined FHCC to build the Fred Hutch Innovation Lab in March 2020. Most of her molecular genetics career has revolved around utilizing new technology to further research goals while troubleshooting protocols with difficult samples. FHIL lured her away from fisheries genomics to begin testing cutting-edge spatial and single-cell transcription profiling approaches for immuno-oncology research within the Immunotherapy Integrated Research Center. Since FHIL’s inception, Anna has led pilot projects with numerous labs, benchmarked competing platforms, and optimized protocols and procedures to help accelerate research.
Ruth Etzioni, PhD, Professor, Public Health Sciences, Fred Hutch Cancer Center
Dr. Ruth Etzioni is Professor of Biostatistics at the Fred Hutch Cancer Center in the Division of Public Health Sciences where she holds the Rosalie and Harold Rea Brown Endowed Chair. Dr. Etzioni received her PhD in Statistics from Carnegie-Mellon University. She has studied the benefit-harm tradeoffs of cancer early detection for more than 25 years and serves as a member of early detection guidelines panels for the National Comprehensive Cancer Network, the American Urology Association, and the American Cancer Society. Dr Etzioni's group of biostatisticians and cancer modelers was the first to quantify the frequency of overdiagnosis in prostate cancer screening and in 2022 published a definitive study of overdiagnosis associated with breast cancer screening in the US. She is a fellow of the American Statistical Association and recipient of an NCI Outstanding Investigator Award for her research in the area of novel cancer diagnostics.
Krista Ewing, PhD, Senior Global Product Manager, Porex, Filtration Group
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.
David Fabrizio, Vice President, Translational Strategy, Foundation Medicine
David Fabrizio serves as the Vice President of Translational Strategy at Foundation Medicine in Cambridge, MA. Under David’s leadership, Foundation Medicine has pioneered new genomic biomarkers for immunotherapy, including tumor mutational burden (TMB), and launched the first comprehensive genomic profiling test approved by the FDA, FoundationOne CDx. David also led the development of the first blood-based assay to determine immunotherapy response, published in Nature Medicine, which was also selected as one of Nature’s most notable advances of 2018. He holds ten different patents or patent applications for therapeutic and diagnostic methods for cancer, as well as over 30 publications in peer reviewed journals including Nature, Cell, The Lancet and the Journal of American Medical Association (JAMA), and is a member of ASCO and AACR.
Lauren Feldman, Vice President and Head, Value, Access, and Pricing, ADVI
Lauren brings more than 14 years of precision medicine expertise to the ADVI team and her clients. She leads ADVI’s value, access, and pricing work. With a primary focus on molecular diagnostics, she develops innovative commercialization and clinical valuation strategies designed to improve access and accelerate the adoption of precision medicine tools and therapies. Lauren has extensive expertise in oncology products, advising on all aspects of reimbursement, market access, and strategic policy planning. She specializes in launch planning and execution, CPT coding, and Medicare payment policy. She is passionate about providing meaningful, integrated solutions to deliver on the value of genomics-based precision medicine. Prior to ADVI, Lauren worked at the American Medical Association where she was responsible for crafting and implementing innovative coding solutions for disruptive technologies. Prior to the AMA, Lauren worked for a start-up biotechnology company performing discovery research and began her career in academic research at Harvard Medical School and Brigham and Women’s Hospital.
Selena Ferrian, PhD, Principal Scientist, Early Clinical Development, Genentech
After completing her postdoctoral training in Cellular Immunology, Dr. Ferrian joined the Immunotherapy Platform, led by Nobel laureate Professor James Allison at MD Anderson Cancer Center, where she led the implementation of an imaging technology in renal cell carcinoma. She was later appointed at Stanford University as a Sr. Scientist, leading multicenter NIH/NCI clinical trial initiatives for immune monitoring trials in oncology using a multiplexed proteomics technology. Currently Dr. Ferrian drives a new spatial proteomics initiative at Genentech, where her expertise in cellular and tissue proteomics is being used to enhance patient stratification, support pharmacodynamics, and understand molecular mechanisms associated with response/resistance to therapeutic approaches.
Matthew Fickie, MD, Senior Medical Director for Medical Policy, Highmark
Matt Fickie, MD is a Senior Medical Director at Highmark, Inc. Dr. Fickie has been at Highmark since 2018. As Highmark’s internal expert on precision medicine, his focus has been on advancing the use of genetic technologies to improve health outcomes. Dr. Fickie oversees Highmark’s Medical Policy Department which includes Highmark’s innovative Coverage with Evidence Determination program. Prior to joining Highmark, he served as an attending physician at Mount Auburn Hospital in Cambridge, MA. Dr. Fickie is board certified in internal medicine, general pediatrics, and clinical genetics.
Luca Foschini, PhD, President & CEO, Sage Bionetworks
Luca is the Co-founder and Chief Data Scientist at Evidation Health, responsible for data analytics and research and development. At Evidation he has driven research collaborations resulting in numerous publications in the fields of machine learning, behavioral economics, and medical informatics. Previously, Luca held research positions in industry and academic institutions, including Ask.com, Google, ETH Zurich, and UC Santa Barbara. He has co-authored several papers and patents on efficient algorithms for partitioning and detecting anomalies in massive networks. Luca holds MS and PhD degrees in Computer Science from UC Santa Barbara, and ME and BE degrees from the Sant’Anna School of Pisa, Italy.
John L. Fox, MD, Senior Medical Director for the Americas, Illumina, Inc.
John Fox, MD MHA, is currently the Senior Medical Director of the Americas, Market Access, for Illumina, where he is accountable for working with payers and employers to expand access to genomic testing and personalized medicine. He served as the Associate Chief Medical Officer at Priority Health, a provider-sponsored health plan with over 1,200,00 members from June 2000 through May 2019. He was responsible for medical and pharmaceutical technology assessment, use of medical resources, case management, and physician pay-for-performance programs. He was also responsible for development of new programs, including shared decision-making, digital therapeutics, advanced care planning, integrated specialty pharmacy program, surgical optimization initiatives, value-based benefit designs, and contracts, oncology medical home programs, and personalized genomic medicine initiatives. In June 2019 he became the Vice President of Clinical Transformation of Spectrum Health Systems, the parent company for Priority Health, and the Executive Medical Director for the West Michigan ACO, a clinical collaboration between Spectrum Health providers and Answer Health, the largest independent physicians organization in west Michigan.
Megan P. Hall, PhD, Vice President, Medical Affairs, GRAIL LLC
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.
Nicholas Halzack, Director, Health Policy, Roche Diagnostics
Nick is the Director of Health Policy at Roche Diagnostics Corporation. He believes that diagnostics are one of the most crucial elements to improving public health, and that broad access to new diagnostic technologies is based on a solid foundation of reimbursement and access policies. Prior to Roche, Nick worked on federal health policy at the American Society of Anesthesiologists and Nemours Children's Health System. He holds a M.P.H. in Health Policy from The George Washington University and a B.S. in Biological Sciences from Cornell University.
Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center
Dr. Hanash was recruited to MD Anderson Cancer Center in 2011 to lead the Red and Charline McCombs Institute for Cancer Early Detection and Treatment. He was previously program head for Molecular Diagnosis at the Fred Hutchinson Cancer Research Center. Dr. Hanash’s interest and expertise are in the field of cancer diagnostics and the development of blood-based cancer biomarkers for risk assessment and cancer early detection. He is the inaugural president of the International Human Proteome Organization dedicated to the study of the human proteome, and a founder of the US Human Proteome Organization. Dr. Hanash’s approaches to meet the challenge of developing markers that signal the presence of cancer at an early stage to allow detection and effective treatment have included a rigorous painstaking in-depth quantitative profiling of the various types of molecules in the blood to find those that are released early either from the cancer cells or from the host response to the developing cancer. The work emphasizes the need for rigor in experimental design, in data collection and statistical analysis and in developing a mechanistic understanding of the relationship between the identified cancer markers and the developing cancer. This work has sparked innovation in experimental design and statistical analysis of biomarker data aimed at minimizing biases in discovery studies through prospective sample collections that relate most directly to the intended clinical application(s) and at reducing the false discovery rate through integration of data from multiple sources to increase confidence in the significance of the markers.
Christopher M. Hartshorn, PhD, Chief, Digital & Mobile Technologies Section - CTSA Program, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health
I am the Chief of the Digital & Mobile Technologies Section and member of the scientific staff of the Division of Clinical Innovation within the National Institutes of Health's (NIH) National Center for Advancing Translational Sciences (NCATS). In this role, I manage and coordinate programmatic and research activities relevant to the section. My team focuses on bringing more interventions to more people, faster. Furthermore, to enable participants from more diverse backgrounds, those whom have been traditionally medically underserved, and from rural regions of the country to be able to participate in clinical trials. We tackle challenges in the remote delivery of care, building infrastructure for the decentralization of clinical trials, and working to implement solutions for providers and their community to engage and co-design remote patient monitoring. Our vision is to move the needle from bringing patients-to-care, to bringing care-to-patients. We implement this vision by way of the Clinical & Translational Science Award (CTSA) program - the single largest program of its kind within the U.S. DHHS that supports our Nation's clinical research ecosystem and its infrastructure. Prior to joining NCATS, I served as a program director in the Division of Cancer Treatment and Diagnosis at the NIH NCI. During my tenure at NIH, I have founded, guided and managed multiple programs. Prior to joining NIH, I was a member of the research staff at the NIST for projects focused on biomedical and national security applications, as well as subsequent collaborations with the U.S. Department of Defense, U.S. Department of Justice, NIH, Merck and Pfizer. I completed my doctorate at Washington State University and Bachelor of Science degrees from The University of New Mexico.
Duane Hassane, PhD, Vice President, Tempus Labs
Vice President, Tempus Labs, Inc. Dr. Hassane is a translational genomicist overseeing the early-stage oncology portfolio at Tempus. Previously, he was professor at Weill Cornell Medicine focused on precision medicine and biomarker programs across hematologic cancers and solid tumors with expertise in tumor profiling, clonal hematopoiesis, and MRD.
Molly He, PhD, CEO & Co Founder, Element Biosciences
Molly co-founded Element Biosciences and has served as Chief Executive Officer since its inception. She has more than 20 years of experience in technology innovation and management in biotechnology and healthcare industries. Molly was previously a Venture Partner at Foresite Capital, investing in some of the most exciting and innovative companies in healthcare. Before then, she was Senior Director at Illumina, responsible for Illumina’s global protein reagent innovation and improvements, and for leading global scientific and technical teams. She and her team have won twice the Innovation Award, the highest award for innovations with significant revenue impact at Illumina. Prior to Illumina, Molly was the Head of Protein Sciences at Pacific Biosciences, where she was responsible for protein reagent development for their single-molecule real-time sequencing chemistry. She also has years of experience in the pharmaceutical industry. Molly holds more than 50 patents and patents applications in the field of genomics and sequencing. She obtained her PhD from the University of California, Los Angeles in protein biophysics.
Sarah Hersey, MS, MBA, RAC, Vice President, Precision Medicine, Bristol Myers Squibb Co.
Sarah is currently the Vice President of Precision Medicine for Bristol Myers Squibb. She has more than 20 years of industry experience in leading R&D organizations, CLIA and GLP laboratories, device manufacturing, consortiums, assessment and implementation of technology strategies, and development of in vitro diagnostics. In addition, she continuously works to further education and awareness in the Precision Medicine and Companion Diagnostic spaces. Prior to joining BMS, Sarah was the Vice President, Precision Medicine & Companion Diagnostics for Celgene, where she founded their Precision Medicine Organization in 2016. She joined Celgene after having held the position as the Global Head of Future Precision Medicine for Novartis, where the team submitted and gained approval for multiple Health Authority applications; including the first pre-market approval for a distributable NGS CDx. Sarah has also held multiple roles with increasing responsibility within Johnson and Johnson (JNJ) including Global Head of Operations, Assay Program Leader for Companion Diagnostics Center of Excellence, Director of Materials Process Development and Enabling Technologies. At JNJ, Sarah co-led or was the operating company’s representative on key corporate strategic initiatives including, but not limited to: Nanotechnology, Critical to Quality Flow Down and Pathology Business Opportunity Team and had accountability for CLIA laboratories in the US and Europe. In addition, her prior experience also includes start-up and establishment of a GLP laboratory, technical support and quality assurance. Sarah has BS and MS degrees in Chemistry and Biology from Northern Illinois University, Regulatory Affairs Certification (RAC) and an MBA from California State University.
Mark Hiatt, MD, MBA, MS, Vice President, Guardant Health
Mark Hiatt, MD, MBA, MS, currently vice president for a precision oncology company, has served as the chief medical executive for a multi-state health insurance plan and a national medical benefits manager, department leader and board member for a regional health system, and cardiovascular radiologist. He has also been the voice of The Medical Moment on radio stations in two states. Dr. Hiatt completed a fellowship in cardiovascular imaging at Stanford University, residency in radiology and master’s in Health Evaluation Sciences at the University of Virginia, and MD and MBA degrees under full academic scholarships with academic distinction at Wake Forest University. Dr. Hiatt is the former Chair of 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 was honored by the Utah Business Magazine as a Healthcare Hero.
Kenneth C. Hohmeier, PharmD, Associate Professor, Director of Community Affairs, PGY-1 Community-Based Pharmacy Residency Program, The University of Tennessee Health Science Center
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.
Dave S.B. Hoon, PhD, Director, Translational Molecular Medicine and Genome Sequencing, Saint John's Cancer Institute
Dave SB Hoon is Professor, Director of Translational Research at John Wayne Cancer Institute (JWCI), Providence Health System. He is director of Depts of Translational Molecular Medicine and Sequencing Center. Dr. Hoon was a founding member of JWCI in 1991 and has been a pioneer of molecular blood biopsies since the early nineties. He has published over 400 publications mainly on translational molecular cancer research. Has published on the utility of various types of cell-free circulating nucleic acids(cfNA) in different cancer types involving multiple clinical settings and phases of clinical trials. Over the years has developed various types of assays to assess different forms of cfNAs and their utility in early and advanced stages of solid tumor cancers. Advisor of cfNA pharmabiotechs.
Damon Hostin, Lead, Health System Market Access, Illumina, Inc.
Damon serves as Lead for Health Systems in Illumina’s Market Access department. Prior, Damon held multiple leadership positions at Catholic Health Initiatives (CHI), culminating in leading the Precision Medicine Alliance of CHI and Dignity Health (the Precision Medicine Alliance of CommonSpirit Health). Before CHI, he was clinical business leader for Complete Genomics. Earlier, he led the Life Science segment of Strategic Diagnostics’ (SDIX, now Origene) antibody and assay business, including IVD production, research tools and therapeutic candidate generation. Earlier, Hostin managed GenVis Labs, a clinical molecular diagnostic company purchased by Pfizer in 2005. As a part of the founding Team of Actinium Pharmaceuticals, he managed alliances in developing targeted oncology therapeutics. His start in genomics was as Team Leader, Sequencing at Celera Genomics, where he was published on the Human and Drosophila genomes in Science and contributed to pharmaceutical partnerships. His education includes undergraduate studies at Tulane University, Masters studies at Harvard, and certificate programs at Wharton and the NIH.
Andrew James Jackson, Commercial Director, US, Sengenics
Andrew Jackson is the Commercial Director of the US Business Unit at Sengenics.
Andrew graduated from Lancaster University, in Law & Philosophy, with a focus on intellectual property within therapeutic drug discovery. He joined Novartis as a graduate and operated in various commercial roles both in Switzerland & the UK. He has worked in big pharma for 7 years, before entering the biotech world, and supported the commercialization of Sengenics platform back in 2017.
MiRa Jacobs, PhD, Biomedical Engineer, FDA Digital Health Center of Excellence
Dr. MiRa Jacobs is a biomedical engineer working on digital health policy for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Dr. Jacobs’ work is focused on the analysis of, and strategy development for, emerging digital health technologies. She supports a number of the DHCoE’s many ongoing initiatives, including developing new policy and regulatory approaches for the use of Artificial Intelligence (AI) and Machine Learning (ML) in medical devices, as well as efforts to promote international harmonization in these areas to ensure patient safety and advance healthcare. Dr. Jacobs has also worked to advance the Pre-Certification Pilot program as a subject matter expert, applying her experience as a Lead Reviewer and a software and cybersecurity consultant in the Office of Neurological and Physical Medicine Devices in the Office of Product Evaluation and Quality (OPEQ). Prior to joining the FDA, Dr. Jacobs earned her PhD in biomedical engineering from the University of Florida, where her research focused on the characterization of gait modifications in preclinical models of osteoarthritis.
Julie Kaylor, Director, Medical Affairs, Managed Care, Guardant Health
Julie is a certified genetic counselor and has over 10 years of experience in genetics services in a laboratory, hospital, and health plan vendor setting. She has specialized in utilization management to increase access to appropriate genetic testing across health care, achieving a savings of $500,000 from modification or cancellation of inappropriate genetic testing at one pediatric center. She has reviewed prior authorizations, crafted genomics coverage policies, and is currently the Director of Medical Affairs for Managed Care for a cancer diagnostics lab specializing in liquid biopsy. Julie is pursuing her PhD in Healthcare Genetics with a focus on the attributes of the "Value of Genomic Testing". Her passion lies in speaking enthusiastically and effectively to multiple stakeholders while advocating for increased access to quality genetics care and forming partnerships between providers, institutions, health plans, and laboratories.
Gary J. Kelloff, MD, Special Advisor, Cancer Imaging Program, National Cancer Institute, NIH
Gary J. Kelloff, MD has had more than 40 years in cancer research at the National Cancer Institute (NCI), authoring more than 400 publications. Dr. Kelloff is a graduate of the University of Colorado (BS and MD degrees). After post-graduate training in medicine at Emory University, he began his NCI career as an intramural scientist and section head in viral immunology working on retroviruses and oncogenes. After fifteen years in NCI’s intramural program, he developed a basic science, translational research, and clinical development program in cancer prevention, serving as a Branch Chief in the NCI Division of Cancer Prevention. Since 2001, he has been a special advisor for the NCI Division of Cancer Treatment and Diagnosis working on strategies for developing biomarkers for oncology drug development and cancer patient management. He previously led and currently leads several collaborations with FDA and the pharmaceutical industry on drug development strategies and since 2009 has co-chaired on-going efforts under the Foundation for the National Institutes for Health Biomarkers Consortium to create public-private partnerships to define biomarker use in cancer drug development and patient management. Past work has included establishment of a developmental pathway for approval of cancer prevention drugs as part of an AACR initiative and evaluation of tumor burden markers and precancerous histopathology as part of a C Change initiative. Current efforts under the Biomarkers Consortium include consideration of imaging-based biomarkers (FDG-PET/CT, volumetric CT, molecular probes) and new technologies for measuring circulating tumor cells and nucleic acids, minimal residual disease, novel trial designs for evaluating prognostic and predictive biomarkers, molecular signatures and new drugs, including gene expression and proteomic biomarkers, and evaluation of the tumor immune environment. He is also involved in on-going efforts to establish protocol and assay standardization for biomarker evaluation, as well as data-sharing for implementation in personalized medicine in oncology. Related to these efforts, Dr. Kelloff serves on the drug selection and oversight committees for two innovative clinical trials using biomarker-based designs to evaluate new oncology drugs (the I-SPY-2 trial in breast cancer and the Lung-MAP trial in non-small cell lung cancer). New tools for personalized medicine in oncology are evolving from these studies. All the work described has involved collaboration with stakeholders including leaders in industry, academia, FDA and other government agencies, foundations, and advocacy groups and has resulted in many publications addressing specific biomarkers and general drug development strategies.
Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium
Dr. Kessler is professor in the Department of Health Systems and Population Health, University of Washington, which he chaired from 2009 - 2015. He has over 40 years of experience in health services research, including positions at the National Institute of Mental Health, National Cancer Institute, and FDA. At NCI, he and his colleagues substantially changed the way in which cancer surveillance is performed, with the addition of the cancer supplements to the National Health Interview Survey, the SEER-Medicare data system, and the Breast Cancer Screening Consortium and the Breast Cancer Surveillance Consortium. His research record includes focused work in cancer, cancer surveillance research, and regulatory aspects of medical products. He came to UW from U.S. FDA Center for Devices and Radiological Health. His recent collaborative research focuses on patient-centered outcomes and comparative effectiveness research. He also serves as Deputy Chair of the MCED Consortium.
Sean Khozin, MD, MPH, Research Affiliate, Massachusetts Institute of Technology
Sean Khozin, MD, MPH is the Chief Executive Officer of CancerLinQ, a precision oncology enterprise focused on transforming cancer care and research with real-world data and advanced analytics. He is a globally recognized leader in drug development, regulation, and applications of artificial intelligence and machine learning in biomedical research. Dr. Khozin was previously the Global Head of Data Strategy and Data Science Innovation at Johnson & Johnson, leading a worldwide multidisciplinary team charged with the design and implementation of pioneering data science solutions to support the development of innovative new medicines and vaccines. Prior to this, he was a founding member of the US FDA’s Oncology Center of Excellence and Executive Director of Information Exchange and Data Transformation (INFORMED), the FDA’s first data science and technology incubator that he established under special federal authorities. As a uniquely entrepreneurial sandbox housed within the agency responsible for regulating nearly a third of the US economy, INFORMED played a pivotal role in shaping the US FDA’s position on real-world evidence and the use of novel data science solutions in drug discovery and clinical development. Before his tenure in the US federal government, Dr. Khozin was the cofounder of Hello Health, a technology company focused on developing integrated telemedicine, point-of-care data visualization, and advanced analytical systems for optimizing patient care and clinical research. The company’s core technology offerings were first operationalized in a multidisciplinary network of clinics he had founded called SKMD. Dr. Khozin is a board certified oncologist and a Research Affiliate at MIT Laboratory for Financial Engineering. He has over a decade of clinical and basic science research experience at the US National Cancer Institute and currently serves on the boards of Alliance for Artificial Intelligence in Healthcare and the Life Sciences Council of the CEO Roundtable on Cancer.
Stephen F. Kingsmore, MD, President & CEO, Rady Children's Institute for Genomic Medicine
Stephen F. Kingsmore, MD, DSc, President and CEO Rady Children’s Institute for Genomic Medicine San Diego, CA. Stephen Kingsmore, MD, DSc is the founding President and CEO of Rady Children’s Institute for Genomic Medicine (RCIGM) where he leads a multi-disciplinary team of scientists, physicians and researchers who are pioneering the use of rapid and ultra-rapid Whole Genome Sequencing (WGS) to diagnose rare genetic disorders and guide personalize care for critically-ill newborns and children. He is an expert in genomic and systems medicine research. The Institute is a non-profit, research organization embedded within Rady Children’s Hospital- San Diego. RCIGM has developed a clinical Rapid Precision Medicine™ delivery system optimized for speed and accuracy. In medically urgent cases, RCIGM returns preliminary clinical results in less than three days. Dr. Kingsmore came to Rady Children’s from Children’s Mercy Kansas City, where he was the Founding Director of the Center for Pediatric Genomic Medicine. He also held the Dee Lyons/Missouri Endowed Chair in Genomic Medicine at the University of Missouri-Kansas City School of Medicine. In his distinguished career, Dr. Kingsmore has also served as President and CEO of the National Center for Genome Resources; COO of Molecular Staging Inc.; Vice President of Research at CuraGen Corporation; founder of GatorGen; and Assistant Professor at the University of Florida’s School of Medicine. Dr. Kingsmore received MB ChB BAO and DSc degrees from the Queen’s University of Belfast. He trained in clinical immunology in Northern Ireland and did residency in internal medicine and fellowship at Duke University Medical Center. He is a fellow of the Royal College of Pathologists. In 2019, the National Human Genomic Research Institute cited the publication by RCIGM on the use of artificial intelligence to accelerate WGS to diagnose genetic diseases in seriously ill children among the year’s 10 most significant advances in genomic medicine. Recently, Dr. Kingsmore and the team broke their own world speed record for the fastest molecular diagnosis using whole genome sequencing by reducing the time to 13.5 hours.
Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy
Dr. Klepser received his Doctor of Pharmacy from the University of Michigan College of Pharmacy. Subsequently he completed a pharmacy practice residency at Detroit Receiving Hospital and University Health Center and a fellowship in Infectious Diseases at Hartford Hospital in Hartford, Connecticut. Dr. Klepser is currently a Professor of Pharmacy at Ferris State University since 2001. Dr. Klepser’s well-known for his work surrounding use of CLIA-waived point-of-care tests in community pharmacies and community-based antimicrobial stewardship. He has published extensively on these topics and has more than 130 peer-reviewed manuscripts to his credit. Dr. Klepser is a founder and content advisor for the “Community Pharmacy-Based Point-of-Care Testing” certificate program and Vice President of POC Consultants.
Donald G. Klepser, PhD, MBA, Professor and Associate Dean for Academic Affairs, College of Pharmacy, University of Nebraska Medical Center
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.
Alexander C. Klimowicz, PhD, Principal Scientist, Immunology & Respiratory Discovery Research, Boehringer Ingelheim Pharmaceuticals, Inc.
Alexander Klimowicz is a Senior Principal Scientist in the Department of Immunology and Respiratory Discovery Research at Boehringer Ingelheim Pharmaceuticals, Inc. In this capacity he leads the Molecular Histopathology Group, implementing and applying cutting edge in situ techniques, whole slide imaging, and digital image analysis, to build target to disease linkage in human tissue specimens for projects and external collaborations across the Department. Alex holds a PhD in Molecular Biology, and has 14 years of experience in the fields of digital pathology and quantitative immunohistochemsitry. Prior to moving to Boehringer Ingelheim, Alex was an Adjunct Research Assistant Professor in the Department of Oncology at the University of Calgary, where he led a core quantitative immunohistochemsitry lab focused on cancer biomarker research.
Shaunna Kobilis, National Director, Market Access, Adaptive Biotechnologies
Shaunna Kobilis, RN, BSN, OCN, is trained as a hematology oncology nurse in both adult and pediatric oncology. She works as a National Director of Market Access for Adaptive Biotechnologies Corporation, a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease. She is responsible for developing and deploying strategies to expand access to cancer patients through strategic partnerships with payers, both national and regional, including Medicare, Medicaid, Commercial, and other government programs. Ms.Kobilis has held various leadership positions with top national payers to include Kaiser, Cigna and United HealthCare. As a result of her background she is able to bring together the needs of all partners in care working towards the achievement of success in bringing value to the patient, physician and payer. Ms. Kobilis has also experienced the cancer journey as a breast cancer survivor.
Namit Kumar, PhD, Principal Scientist, Computational Biology, Bristol Myers Squibb Co.
Namit Kumar is a Principal Scientist in Informatics & Predictive Sciences at Bristol Myers Squibb (BMS). His research at BMS broadly focusses on using multi-omics approaches to identify clinically applicable biomarkers and indication selection strategies, to advance drugs through early clinical trials. Prior to BMS, Dr. Kumar worked at Merck developing new single-cell sequencing methodologies like REAP-seq with applications including identifying and validating drug targets. He received his PhD from Rutgers University, New jersey with dual major in Computational Biology and Molecular Biosciences conducting research on identifying drivers of intestinal development and disease.
Razelle Kurzrock, MD, Professor, Medicine, Associate Director, Clinical Research, Linda T. and John A. Mellowes Endowed Chair of Precision Oncology, Medical College of Wisconsin; CMO, Worldwide Innovative Network (WIN) for Personalized Cancer Therapy
Razelle Kurzrock, MD is a world-renowned physician-scientist leader in precision medicine as well as in the development of novel therapeutics in the field of oncology. She is recognized for founding, developing and chairing one of the largest Phase 1 clinical trial departments globally while at the University of Texas MD Anderson Cancer Center; the central theme of the department was a personalized medicine strategy. She is also one of the pioneering trialists of the WINTHER precision medicine trial focusing, for the first time, on transcriptomics in addition to genomics. This trial was the signature study of the WIN international consortium (Nature Medicine). During her time at the University of California San Diego Health, Dr. Kurzrock’s charge was leading the Center for Personalized Cancer Therapy as well as the Experimental Therapeutics program, and she also founded a Rare Tumor Clinic focused on precision medicine. The signature study of the center was the IPREDICT study (Nature Medicine, 2019) that gave, for the first time, individualized matched combination therapies to patients with lethal malignancies, hence resulting in improved outcomes. Dr. Kurzrock is also an entrepreneur. She is co-founder of CureMatch, and on the Board of both CureMetrix and CureMatch. Dr. Kurzrock has over 850 publications on Pubmed, an H-index of 126, and has been named to the list of most cited scientists worldwide and to the list of the 25 most important voices in Precision Medicine globally. She has four children and three dogs and lives with her husband Dr Philip Cohen, in San Diego, California.
Chaz Langelier, MD, PhD, Associate Medical Director, Hospital Epidemiology & Infection Prevention; Associate Professor, Medicine, University of California San Francisco, Chan Zuckerberg Biohub
My research seeks to advance the understanding of pneumonia, sepsis, and the acute respiratory distress syndrome (ARDS) by leveraging advanced genomic technologies to study host/pathogen biology, develop novel diagnostics, and track emerging pathogens. Work in my laboratory has led to the development of novel pneumonia and sepsis diagnostic assays that integrate host gene expression profiling and unbiased detection of microbial pathogens. We have deployed these assays for epidemiological surveillance of emerging infections in the United States and abroad, and optimized them to enhance detection of antimicrobial resistant microbes. Throughout the COVID-19 pandemic, my research group has worked to elucidate the host/pathogen biology of SARS-CoV-2 infection, with a goal of understanding determinants of severity and the impact of aging on host inflammatory responses. Together, my work aims to improve the diagnosis, management, and understanding of critical infectious and inflammatory diseases.
Samuel Leavy, PhD, Chief Scientific Officer, ClearNote Health
Samuel joined ClearNote Health at its inception and has co-authored many of the research papers we have published about our epigenomics technology platform and our DNA-based 5-hydroxymethylcytosine (5hmC) biomarker. For more than 20 years, Levy has held leadership positions in genomics and molecular diagnostic development at companies including Celera, Genomic Health, Quanticel Pharmaceuticals (now part of Celgene), and Impact Genomics/Lexent Bio which he co-founded and is now a part of Foundation Medicine. He has also served on the faculty at the J. Craig Venter Institute, Scripps Translational Science Institute and Scripps Research Institute. Levy holds degrees from the University of Bristol and the University of Leeds in the United Kingdom.
Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin
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.
Lauren Leiman, Executive Director, BLOODPAC
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.
Chi-Ming Li, PhD, Senior Principal Scientist, Therapeutic Discovery, Amgen
Dr. Chi-Ming Li trained as a geneticist and molecular biologist at MSSM and Columbia University, respectively, in New York, where he studied genetic lysosomal disorder and cancer biology. Since joining Amgen, Dr. Li has involved in diverse research projects mainly related to disease model characterization, GWAS variant validation, and target identification. Recently, by taking the advantage of the progress in molecular multi-omics, Dr. Li have implemented single-cell multi-omics capacity and capability and been utilizing such a useful platform for target or biomarker discovery as well as MoA or efficacy assessment inside the company. Dr. Chi-Ming Li is currently a Senior Principal Scientist, leading the Research Discovery Genomics group in Therapeutic Discovery organization for Amgen Research.
Catherine Liao, Chief Strategy Officer, CardieX
A passionate technologist and entrepreneur known for her intuition, hustle and know how, Catherine Liao has an uncanny ability to recognize the white space where technology can be used to solve unmet needs. At age 19, Catherine got her start in tech working as a systems engineer for one of the first Internet conferencing services in the 90s. That eventually led her to the World Health Organization, where she successfully scaled WHO’s web infrastructure during the peak of the SARS epidemic, when demand for content exploded 20x overnight, topping over 14 million hits a day. As the Chief Strategy of CardieX, Catherine now leads the go-to-market strategy for an innovative global medical devices company specializing in heart health. Prior to CardieX, Catherine served as the co-founder and CEO of Blumio, a venture-backed startup that developed a wearable sensor for blood pressure monitoring. The company was acquired by CardieX in 2022. Before embarking on her entrepreneurial journey, Catherine worked with some of the world’s largest enterprises, leveraging technology to drive business outcomes for over a decade. At Cisco, she helped commercialize technologies that enhanced the efficiency of business-critical applications, including the timely transmission of medical images, a breakthrough that allowed physicians to make medical decisions without delays. Leading a solutions marketing team at Riverbed, she spearheaded the go-to-market strategy of the company’s application performance platform. An active leader in the startup community with an MBA from Imperial College London and MSc in Health Economics from London School of Economics, Catherine provides guidance and mentorship to other entrepreneurs as an Executive Mentor for Santa Cruz Accelerates and a Program Lead for the Startup Leadership Program. In her downtime, you’ll likely find Catherine at her favorite wine bar where she serves as an investor-and chief glass washer.
Minetta C. Liu, MD, CMO, Natera, Inc.
Minetta C. Liu, MD, is a Professor of Oncology and Research Chair for the Department of Oncology with a secondary appointment in the Department of Laboratory Medicine and Pathology at Mayo Clinic Rochester. Dr. Liu also serves as Co-Leader of the Genomics in Action Strategic Priority for the Center of Individualized Medicine. She holds positions in several external professional organizations, including Co-Chair of the Clinical Working Group for the Evelyn H. Lauder Founder’s Fund Collaboration; Co-Chair of the Correlative Science Working Group for the Translational Breast Cancer Research Consortium; and Chair of the Circulating Biomarker Working Group for the Alliance for Clinical Trials in Oncology. As a physician and translational researcher, Dr. Liu specializes in breast medical oncology and promotes the latest advances in clinical and laboratory-based research across the spectrum of malignancies. She is dedicated to improving patient outcomes through the use of molecular diagnostic tools to promote precision cancer care. Her laboratory efforts focus on expanding the availability and clinical applications of circulating blood-based biomarker assays for drug selection and disease monitoring in advanced malignancies, for the detection of molecular residual disease in early stage cancers, and for multicancer early detection in healthy and/or at-risk individuals.
Yuhwa Lo, PhD, Professor, Electrical & Computer Engineering, University of California, San Diego
Yuhwa Lo received his PhD in Electrical and Computer Engineering from UC Berkeley. He is the William SC Chang Distinguished Professor of UCSD, and published over 500 peer reviewed articles in the fields of single cell technologies, biophotonics, lab-on-chip, microfluidics, and nanophotonics. He is a co-founder of NanoCellect Biomedical. He is a fellow of the IEEE and the Optical Society of America.
Elizabeth M. Marlowe, PhD, D(ABMM) Senior Scientific Director, Head R&D Infectious Diseases & Immunology, Quest Diagnostics Nichols Institute
Dr. Beth Marlowe is the Senior Scientific Director and head of R&D for Quest Diagnostics Infectious Diseases and immunology. Dr Marlowe joined Quest in June of 2019. Since January 2020, her team has played a key role in the COVID-19 response. Previously she has worked as the as the Global Director of Medical Affairs for Microbiology at Roche Molecular Systems, provided laboratory leadership for over a decade within the Kaiser Permanente Regional Laboratories and assay development for Gen-Probe (now Hologic).She is a diplomat of the American Board of Medical Microbiology, past-president for the So Cal branch of the American Society for Microbiology (ASM), past editor for the Clinical Microbiology Newsletter, served as an elected member to the Council on Microbial Sciences for ASM and as a member of CLIAC, the federal advisory committee for CLIA to the United Stated Health and Human Services Secretary. She is currently an elected member of the Board of Directors for ASM.Her research areas of interest are focused on the translation of new infectious disease diagnostics for use in evidence-based research for clinical and public health microbiology practice.
Jackie Martinez, Head of Product, Primary Health
Jackie Martinez is a motivating force behind Primary.Health’s mission to increase access to quality healthcare with a platform that adapts to the needs of communities and providers. She’s also passionate about advancing knowledge through research and believes tech can be used to free up researchers to do what they do best, find answers.
Jean-Francois Martini, PhD, Translational Oncology Lead, Global Product Development - Oncology, Pfizer Inc.
Jean-Francois Martini has 20 years of biotech and pharma industry experience in pharmacology and clinical translational sciences and is author/coauthor of over 50 scientific publications. He is currently Executive Director, Translational Oncology Lead, Global Product Development-Oncology and has been at Pfizer, in La Jolla, California, since December 2011. He was previously Sr. Director, Translational Medicine, at Exelixis, So San Francisco, California, where he contributed to the approval of cobimetinib (preclinical in vivo pharmacology, partnered with Genentech) and cabozantinib (first approval in MTC) and to projects such as the alliance with Sanofi for the PI3K programs and out-licensing of esaxerenone (mineralocorticoid receptor blocker, approved in Japan for the treatment of hypertension) to Daiichi Sankyo. He completed his postdoctoral training at University of California, San Francisco, where he studied the antiangiogenic properties of fragments of Prolactin and Growth Hormone, after obtaining a PhD in Biochemistry and Molecular Biology from University of Paris XI, France. At Pfizer, he currently leads and/or supports the translational strategy for the next generation of CDK inhibitors; the Renal Cell Cancer franchise (sunitinib and axitinib); and lorlatinib (ALK/ROS1 inhibitors) in Lung Cancer. He also leads the cross functional efforts in the area of liquid biopsy/cfDNA (represents Pfizer as part of Blood Profiling Atlas-Cancer; Friends of Cancer Research), and is the Pfizer board of director representative for the WIN consortium.
Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.
Marielena Mata, PhD is Director and Diagnostic Lead at Pfizer, where she Leads the development and commercialization efforts of companion diagnostics for Oncology assets from early to late development. Prior to Pfizer, Dr. Mata was Head of Personalized Medicine and Companion Diagnostics at GSK where she was responsible for implementation of the Precision Medicine strategy across the GSK portfolio encompassing technical, development, regulatory, commercial, IP and business development efforts. Previously, at Janssen R&D, Inc. Dr. Mata was responsible for the design and implementation of biomarker strategies for Oncology assets, where she led the development of Circulating Tumor Cell based assays as companion diagnostics as well as the development of next generation circulating tumor cell isolation technologies based on microfluidics. Earlier, she established and managed the Biomarkers biobank. In addition to her work in Oncology drug development, Maty, as she is known, has a strong interest in women’s career development and mentorship and is the recipient of the AWIS-PHL Elizabeth Bingham Mentoring Award. Dr. Mata obtained a BA in Biology at the University of North Carolina at Greensboro and her PhD and postdoctoral training in Immunology at the University of Pennsylvania.
Molly McGinniss, Senior Director, Population Genomics and Precision Medicine, Genome Medical
Molly McGinniss, MS, CGC, is Senior Director of Client and Partner Relations for Population Genomics at Genome Medical, a digital health company and specialty medical group focused on genetics and genomics. Through the Genome Medical Precision Insights team, she provides strategic consulting and support services to health care partners developing precision medicine and population genomics programs. She is a board-certified genetic counselor with extensive clinical and commercial experience. Molly began her career as a clinical genetic counselor providing prenatal, pediatric, and adult genetic counseling services. Prior to joining Genome Medical, she led global market development at Illumina for the genetic disease testing clinical segment. Molly received her B.S. in Biology from Loyola Marymount University in Los Angeles, and her M.S. in Genetic Counseling from Boston University. She currently serves as the President of the Accreditation Council for Genetic Counseling (ACGC), having served on the Board of Directors since 2017.
Joe McKenna, Vice President, Commercial Partnerships & Growth Strategy, GRAIL
Responsible for building key industry partnerships to generate adoption and growth of GRAIL's multi-cancer early detection test, Galleri. I lead our in-market teams cultivating relationships with Employers, Payers and Life Insurers.
Akil Merchant, MD, PhD, Associate Professor, Medicine & Director, Imaging Mass Cytometry Core, Cedars-Sinai Medical Center
Akil Merchant is a physician-scientist with a focus on understanding the role of the tumor microenvironment in cancer development, progression, and response to immunotherapy. He is the founding director of the imaging mass cytometry core facility at Cedars Sinai Cancer and is co-director of the Lymphoma clinical program.
Tom Miller, Founder & Managing Partner, GreyBird Ventures, LLC
Tom Miller is a global healthcare industry leader and an experienced and visionary CEO. He graduated from the University of Massachusetts at Lowell and then received a Masters degree in Medical Physics from the Harvard University/MIT Health Sciences and Technology Program. Tom initially pursued an academic career, working at Los Alamos National Laboratory, the Swiss Institute for Nuclear Research (now the Paul Scherer Institute), Brookhaven National Laboratory, and the Massachusetts General Hospital. Tom then joined Siemens Medical Systems where, after 9 years, he became the first non-German CEO of a German factory and business unit. He left Siemens after 15 years to become CEO of the global medical operations of Carl Zeiss. After completing a successful turnaround, he joined Analogic Corporation as CEO. After three years and a doubling of the stock price, Tom left to help establish and become CEO of LightLab Imaging, a leader in the field of cardiovascular optical coherence tomography. Subsequently, after a profitable sale of LightLab to a Japanese company, Tom re-joined Siemens, where he became a member of the operating board and CEO of the Customer Solutions Division of Siemens Healthcare, responsible for 26,000 employees in over 130 countries. Tom is a frequent speaker on healthcare technology and business at such venues as the National Press Club, the National Library of Medicine, the National Institute of Health, and the American Hospital Association. He was selected by the diagnostic imaging industry to provide Congressional testimony to the House Health Sub-Committee in June of 2009 and to speak on breast cancer technology at the European Parliament in 2012. Sponsored by the American Hospital Association, Tom gave the keynote speech on Sustainable Healthcare and Precision Medicine at the Health Executive Forum in Arizona in 2013; he also gave a keynote speech at the 2013 Arab Health meeting in Dubai on the same topic. In addition, Tom gave the 2013 commencement address at the India Institute of Technology in Roorkee, and keynote addresses to the Chinese Private Hospital Association in 2014 in Wuhan, the Innovation for Health Conference in 2015 in Amsterdam, the 2015 TiE Leapfrog Conference in Bangalore, and the 2016 World Executive Healthcare Forum in Montreal. Tom Serves on the Board of Atlas 5D and Chairs the Board of Ceres Nanosciences and Hummingbird Diagnostics.
Cheryl Miller, Vice President, Retail Sales and Marketing, QuidelOrtho
Cheryl Miller holds a Master’s Degree in Business from the University of Wisconsin Milwaukee, a Bachelor’s Degree in Finance from Miami University and has achieved her CFP (Certified Financial Planner) designation from the College of Financial Planning. Miller’s career has focused on leading and executing corporate strategy in both the medical and dental markets. She is currently the Vice President of Retail Sales and Marketing at QuidelOrtho Corporation. In this role, she is responsible for the company’s consumer commercial strategy focusing on the development of a self-testing category portfolio for retail partners. For the past nine years, Miller has been instrumental in supporting and driving pharmacy test and treat initiatives. Under Miller’s leadership, QuidelOrtho invested in legislative efforts in multiple states driving change in pharmacy law with a focus on the expanded role of the pharmacist. Her prior role at Quidel was VP of New Market Development focused on identifying, developing, and commercializing untapped market opportunities within new customer segments. She leads the organization’s word of mouth marketing initiatives, leveraging the circle of care from consumer awareness and education to pharmacy and physician testing/reporting. Miller was also named on the Virena patent for the first wireless cloud-based system that aggregates de-identified patient results at near-real time allowing for improved public health surveillance, remote instrument management and consumer disease mapping and education. Prior to joining Quidel, Miller served as Vice President of Sales & Marketing at the Brewer Company, General Manager at Hu-Friedy Mfg., Inc., Director of US Marketing at Leica Microsystems and held multiple positions at Abbott Diagnostics including; Capital Equipment Sales and Senior Global Product Management positions. Miller has held numerous volunteer positions at St. Athanasius including Director of Finance, School Board President, Parish Council President. She has been a past elected board member of OSAP (Organization for Safety and Asepsis and Prevention) and is currently treasurer of her local community Golf Course, Canal Shores located in Evanston, IL.
Kenna R. Mills Shaw, PhD, Executive Director, Institute for Personalized Cancer Therapy, MD Anderson Cancer Center
Dr. Shaw is executive director of the Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy (Khalifa Institute). She joined The University of Texas MD Anderson Cancer Center in 2013, bringing an extensive background in science leadership and education. Dr. Shaw is responsible for daily operations at the Khalifa Institute and its work to improve molecular characterization of tumors and apply that knowledge to clinical trials and advanced patient care. She also is operations director for MD Anderson’s Cancer Genomics Laboratory and administrative director of the Precision Oncology Decision Support System. Prior to joining MD Anderson, Dr. Shaw spent four years with The Cancer Genome Atlas (TCGA), a flagship project of the National Cancer Institute focused on accelerating understanding of the molecular basis of cancer. She was scientific projects manager for a year, during which she served as the lead technical and public communications officer. In 2010 she was promoted to director and provided oversight and leadership to the TCGA’s complex research program with more than 300 funded components. Dr. Shaw earned undergraduate degrees in Spanish and Biology at the College of William and Mary, and completed her doctoral degree in cell and developmental biology at Harvard University. Dr. Shaw is executive director of the Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy (Khalifa Institute). She joined The University of Texas MD Anderson Cancer Center in 2013, bringing an extensive background in science leadership and education. Dr. Shaw is responsible for daily operations at the Khalifa Institute and its work to improve molecular characterization of tumors and apply that knowledge to clinical trials and advanced patient care. She also is operations director for MD Anderson’s Cancer Genomics Laboratory and administrative director of the Precision Oncology Decision Support System. Prior to joining MD Anderson, Dr. Shaw spent four years with The Cancer Genome Atlas (TCGA), a flagship project of the National Cancer Institute focused on accelerating understanding of the molecular basis of cancer. She was scientific projects manager for a year, during which she served as the lead technical and public communications officer. In 2010 she was promoted to director and provided oversight and leadership to the TCGA’s complex research program with more than 300 funded components. Dr. Shaw earned undergraduate degrees in Spanish and Biology at the College of William and Mary, and completed her doctoral degree in cell and developmental biology at Harvard University.
Dan Milner, MD, MSc, MBA, Consultant Pathologist, ASCP
Dr. Milner completed his MD at the University of Alabama School of Medicine in 2000 and his residency/fellowship in Anatomic Pathology/Clinical Pathology/Microbiology at the Brigham and Women’s Hospital in 2005. His masters of science in epidemiology is from the Harvard T. H. Chan School of Public Health were he remains an adjunct professor. He completed his masters in business administration from the UAB Collat School of Business. Dr. Milner began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In parallel with this, he has been heavily involved in pathology capacity building in many countries and, most notably, led the team that built an anatomic pathology laboratory in Rwanda, Haiti, Liberia, and DRC for advance cancer diagnostics. Before joining ASCP in 2016, Dr. Milner spent 11 years at the Brigham and Women’s Hospital/Harvard Medical School where he taught pathology, microbiology, and infectious disease; was the primary lead for infectious disease consultations in AP/CP; and was the recipient of numerous research grants in the areas of malaria and HIV. Dr. Milner is the author of over 150 publications and has presented national and internationally on his work in more than 25 countries. At ASCP, Dr. Milner is responsible for medical oversight of all organizational activities. He provides vision, direction, and execution of ASCP’s Center for Global Health programs including communicable and non-communicable diseases. Dr. Milner and the CGH manage over 80 active collaborations with governments, NGOs, industry, academic centers, and international organizations with activity in more than 30 countries. Dr. Milner’s leadership roles/experience with global efforts is extensive and he serves as a direct collaborative consultant in the area of diagnostic pathology for global health to Partners in Health, Mount Sinai, Memorial Sloan Kettering, Clinton Health Access Initiative, American Cancer Society, BIO Ventures for Global Health, Bristol-Myers Squibb, World Health Organization, World Economic Forum, International Collaboration for Cancer Reporting, International Cancer Control Partnership, City Cancer Challenge, and the Union for International Cancer Control.
Michael J. Mina, MD, PhD, CSO, eMed
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.
William G. Morice II, MD, PhD, President & CEO, Mayo Clinic Laboratories; Professor & Past Chair, Mayo Clinic Department of Laboratory Medicine and Pathology; Chair, American Clinical Laboratory Association Board of Directors
After completing my MD/PhD (Immunology) training at Mayo Medical School in 1994 I completed an intern year and AP/CP residency, and surgical pathology and hematopathology fellowships at the Mayo Clinic College of Medicine and joined the staff as a hematopathologist in 2000. I served as the division chair of hematopathology at Mayo Clinic from 2009 to 20015, as the Chair of the Mayo Clinic Department of Laboratory Medicine and Pathology, and President of Mayo Clinic Laboratories from February 2015 until November 2022, and now serves as the President & CEO of Mayo Collaborative Services/Mayo Clinic Laboratories. I have been blessed to have a rewarding career as an academic pathologist developing new clinical laboratory tests for the diagnosis of hematologic malignancies and authoring over 200 papers, abstracts, and book chapters. I have carried my passion for innovation into my leadership roles working to conceptualize and lead implementation of ideas that expand delivery of diagnostic services globally and continue to establish, manage, and maintain Mayo’s reputation as prestigious, world-renowned global reference laboratory assisting healthcare providers worldwide advance patient care and broaden access to specialized testing. In addition to my leadership roles at Mayo Clinic, I have served as the Chair of the Board of Directors of the American Clinical Laboratory Association and the Co-Chair of the Industry Advisory Group to the Global Fund Access to Covid Tools Accelerator-Diagnostics.
Daniel Nichita, MD, Senior Product Marketing Manager, Beckman Coulter
Daniel is a senior product manager with Beckman Coulter working on AI-driven clinical decision support (CDS) solutions that aid the diagnosis of serious conditions like sepsis in acute care settings. He is also the founder of ESCAVO, a company supplying mobile applications that support evidence-based clinical practice in sepsis, emergency medicine, and other areas. Daniel is passionate about technology innovation in medicine, has over 15 years of experience in digital health, and holds degrees in medicine from New York Medical College and biomedical engineering from the University of Southern California.
James Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and Immunology, Medical Director, Clinical Chemistry and POCT, Vanderbilt University School of Medicine
James H. Nichols, PhD, DABCC, FACB is a Professor of Pathology, Microbiology, and Immunology, Medical Director of Clinical Chemistry and Point-of-Care Testing at the Vanderbilt University Medical Center. Dr. Nichols received his BA in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete a Master’s and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign. Jim was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions. Jim later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA and was a Professor of Pathology at Tufts University School of Medicine. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology.
Scott Patterson, PhD, Vice President, Biomarker Sciences, Gilead Sciences, Inc.
Dr. Patterson joined Gilead early in 2015 to lead biomarker and associated translational and molecular epidemiology approaches across all therapeutic areas, Oncology, Inflammation (including fibrosis) and host HBV/HIV Cure efforts (aside from direct acting antivirals); including biomarkers which transition to in vitro diagnostics. He was instrumental in establishing the Renown Institute for Health Innovation Strategic Collaboration and other translational partnerships and serves on multiple Joint Steering Committee’s for Gilead partnerships/collaborations as well as the Executive Committee of the FNIH PACT. He was at Amgen, Inc. in research from 1993-2000 and Executive Director, Medical Sciences, establishing and leading their biomarker and in vitro diagnostics programs across all therapeutic areas from 2003-2015. From 2000-2003 he was VP, Proteomics at Celera Genomics Group and CSO at Farmal Biomedicines, LLC. Dr. Patterson has a B.Sc and Ph.D. from The University of Queensland, Australia where he also worked, and was a Staff Investigator at Cold Spring Harbor Laboratory, New York
Cindy Perettie, Head, Roche Molecular Labs
Cindy Perettie is the Head of Roche Diagnostic Molecular Lab Customer Area with a focus on PCR Systems and Sequencing Systems. Ms. Perettie was the CEO of Foundation Medicine and is now the Chairman of the Board. Ms. Perettie is also a board member for Freenome, focusing on Early Cancer Detection with Liquid Biopsy. Prior to joining Foundation Medicine, Ms. Perettie served as Senior Vice President of Global Oncology Product Strategy for Roche Pharma. Ms. Perettie began her tenure at Genentech as a program team leader for Avastin, and she led several successful therapy launches in the U.S. and abroad for Roche and Genentech. Since joining in 2004, she held roles of increasing responsibility at Genentech/Roche, including Vice President of Global Regulatory Strategy and Operations and Regional Head of Europe, Middle East and Africa operations for Global Development. In 2012, Ms. Perettie took a hiatus from Genentech/Roche to join Sarah Cannon Research Institute (SCRI) as President, where she gained invaluable insights into the day-to-day care of people living with cancer.
Omar Perez, PhD, Head, Medical Diagnostics, AstraZeneca
Perez is the Head of Medical Diagnostics, US Medical Affairs Oncology at Astrazeneca. Dr. Perez has over 17 years designing, deploying and leading high-visibility oncology initiatives supporting global companion diagnostic developments, strategic partnerships and commercialization opportunities. Before joining Astrazeneca, he oversaw the global CDx developments for the GSK oncology portfolio, leading to diagnostic products for niraparib and dostarlimab. During his time at Pfizer, he led global CDx activities supporting the drug approvals of crizotinib, lorlatinib, dacomitinib talazoparib and inotuzomab. Notably, he led the first FDA approved NGS product for multiple targeted agents and helped establish the Center for Precision Medicine in LATAM to support Pfizer oncology products.Dr. Perez’s background includes roles in biotech and diagnostic companies, including co-founding Nodality, a diagnostic company focused on hematological malignancies. He is an inventor of the multiparametric phospho-proteomic flow technologies and an author of 37 publications and 35 patents. Dr. Perez received his doctorate in Molecular Pharmacology from Stanford University. He holds a B.A in both Molecular Biology and Philosophy and Chemistry degrees from the University of California, Berkeley. He received an executive education certificate in management and leadership at the MIT Sloan School of Management and has a Regulatory Affairs Certification.
Dave Persing, MD, PhD, Executive Vice President, CSO, Cepheid; CSO, Danaher Diagnostics Platform
David (Dave) Persing, MD, PhD, is Executive Vice President and Chief Scientific Officer at Cepheid and in 2017 was appointed Chief Scientific Officer (CSO) for the Danaher Diagnostics Platform. He has spent most of his 30-year career in biomarker discovery, translational medicine and innovation in the diagnostics space. As CSO, Danaher Diagnostics Platform, he has the responsibility for providing scientific, medical and strategic input to the Diagnostics' Operating Companies and Platform leadership. He also has the responsibility for development of new clinical processes, technologies or products that advance patient care, innovation and competitive positioning of the Danaher Diagnostics group of operating companies. Dave joined Cepheid in 2005 and has since focused on the enablement of molecular diagnostic technology to meet global needs in infectious diseases and oncology. He conducted his scientific and medical training with Don Ganem and Nobel laureate Harold Varmus at the University of California, San Francisco. After residency training in Clinical Pathology at Yale University, he held leadership roles in academia and industry starting in the early 1990s with the design, implementation, and scaleup of the first PCR reference laboratory at the Mayo Clinic. His interest in the democratization of molecular diagnostic methods has been longstanding, starting in 1993 with his publication of the first of five widely adopted textbooks to include PCR protocols and guidelines for laboratory operations. He has published over 300 peer-reviewed articles and reviews, including multiple articles in the New England Journal of Medicine, Science, and PNAS. In 2020, he was named to the Fierce Pharma list of the 22 most influential scientists in the fight against COVID-19. To maintain a connection with the latest trends in translational medicine, Dave also serves as Consulting Professor of Pathology at Stanford University School of Medicine. He obtained his MD and PhD degrees from UCSF in 1988.
Steven R. Peskin, MD, MBA, MACP, Senior Advisor, ADVI; Associate Clinical Professor, Medicine, Rutgers RWJ Medical School; Course Director, Internal Medicine Grand Rounds, Penn Medicine Princeton Healthcare
Steven R. Peskin, MD, MBA, MACP is currently serving in an advisory role to several companies in life sciences, medical device industry, and physician services organizations. Up until August 2022 he was the Executive Medical Director, Population Health at Horizon Blue Cross Blue Shield of New Jersey. His expertise encompasses physician leadership, population health management, clinical and operational performance improvement in health care, medical education and scientific communications. He has been one of the driving forces for the creation of and successful maturation of value based models in New Jersey. Dr. Peskin is an Associate Clinical Professor in the Department of Medicine at Rutgers Robert Wood Johnson Medical School. He is a clinical preceptor at The Eric B. Chandler Clinic for interns and residents in Internal Medicine. Dr. Peskin assists with the Population Health and business of medicine training for the Rutgers RWJ Internal Medicine physicians in training. Dr. Peskin was advanced to Master of the American College of Physicians in 2020. Dr. Peskin received his bachelor’s degree from The University of North Carolina Chapel Hill and medical degree from Emory University School of Medicine. He completed residency at Saint Elizabeth’s Medical Center in Boston and holds an MBA from the Sloan School of Management at Massachusetts Institute of Technology.
Paul Pinsky, PhD, Chief, Early Detection Research, NIH NCI
Paul Pinsky is currently chief of the Early Detection Branch, Division of Cancer Prevention, National Cancer Institute, NIH. The branch has sponsored several large-scale trials of cancer screening, including the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and the National Lung Screening Trial (NLST). The branch has a grant portfolio related to cancer screening and early detection and advises on clinical trial design and evaluation of evidence in the cancer screening field. Dr. Pinsky received an M.P.H. in epidemiology from Columbia University and a Ph.D. in applied mathematics from the University of Maryland, College Park. He has previously worked at the Centers for Disease Control and the Food and Drug Administration. He has published over 50 first-authored papers in cancer prevention and related fields. His interests include cancer screening, chemoprevention, epidemiology, clinical trials, and modeling.
Rachana N. Pradhan, PhD, Postdoctoral Fellow, Oncology Bioinformatics, Genentech
Rachana Pradhan is a postdoctoral fellow in Oncology Bioinformatics at Genentech where she investigates the role of fibroblasts and other stromal cell types in inflammatory & fibrotic diseases along with cancer indications. She specializes in implementing integrative data analyses to infer biological meaning from single-cell multimodal assays. Her recent work includes the construction of mouse and human fibroblast atlases, spanning multiple tissues and disease indications available at https://www.fibroxplorer.com/. Prior to Genentech, Rachana obtained her PhD at the Swiss Federal Institute of Technology, Lausanne (EPFL) in Bioengineering with a focus on functional genomics.
Jennifer Quigley, Senior Director, Global Precision Diagnostics Hematology, Novartis Pharmaceuticals
Jennifer is a passionate diagnostic veteran, with more than 20 years of experience in specialty testing. Currently a Senior Director of Global Precision Diagnostics at Novartis, she also held leadership positions in sales, strategy, and program development at Labcorp, PathAI and Miraca Life Sciences and has consulted laboratories and companies in the US and Europe. She has a breadth of knowledge and understanding of the diagnostic landscape and practical implications of test availability to therapeutic decisions. Jennifer has advised on, designed, launched, and promoted commercial diagnostic tests and diagnostic programs, working along the continuum with drug development scientists, pathologists, laboratorians, and treating physicians. She is singularly focused on improving patients access to appropriate treatment through access to testing. Jennifer studied biology and geology at the University of Pittsburgh and completed certificate programs in strategy, leadership, and negotiation at Carnegie Mellon University Tepper School of Business. She resides in Pittsburgh, Pennsylvania with her family.
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC
Bruce Quinn, MD, PhD, is a professional strategy consultant helping innovative companies achieve their goals under U.S. federal health policies. His consulting practice, with offices in Los Angeles and San Francisco, works with leading genomic, medical technology, and biopharma companies. Originally trained as a neuropathologist, earlier in his career he held tenure-track faculty positions at NYU Medical School and the Northwestern University School of Medicine. As a physician executive, he has held positions with Accenture’s healthcare strategies practice, the Medicare program, and with health policy groups in two law and lobbying firms. Recent publications have included articles on defining clinical utility for diagnostic tests and a review of the emerging digital genomics industry. In addition, his blog, www.DiscoveriesInHealthPolicy.com, covers innovative health care policy developments and receives over 100,000 hits per year. The website for Dr. Quinn’s firm is www.brucequinn.com.
Rajiv Raja, PhD, Senior Director, Experimental Medicines Unit, GSK
Rajiv Raja, Ph.D. is currently a Senior Director leading innovation at Experimental Medicines Unit at Glaxo SmithKline. Before joining GSK, Dr. Raja was Senior Director of Translational Medicine Oncology at AstraZeneca where he functioned as the biomarker lead for late-stage lung and bladder cancer programs as well as the Head of Translational Genomics Laboratory. In this role, Rajiv is known for his contributions to the development of ctDNA-based tumor mutational burden (TMB), molecular response (MR) and minimal residual disease (MRD) as biomarkers in solid tumors. Before joining AstraZeneca, Rajiv worked as Biomarker Lead and Head of Clinical Assays and Technologies at Genentech/Roche where he developed biomarker strategies for antibody-drug conjugate (ADC) programs and led a team of scientists and research associates in developing molecular biomarker assays and next-generation technologies for use in clinical trials in collaboration with partners such as Roche Molecular Diagnostics (RMS) and Foundation Medicine. Dr. Raja received his Ph.D. in Molecular Genetics from Oklahoma State University and post-doctoral training at University of Illinois at Urbana-Champaign. He has held positions at the University of California at San Francisco, Lawrence Livermore National Laboratory, Arcturus Biosciences and Molecular Devices and has over 60 peer-reviewed publications and clinical presentations at conferences to his credit.
Sara Riordan, Past President, National Society of Genetic Counselors
Sara Riordan, M.S., CGC served as the 2021 President of the National Society of Genetic Counselors, where she focused on growing a diverse workforce and advocating for equitable access to genetic counselor services. Most recently, Riordan was the Vice President of Clinical and Research Programs at Unified Patient Network, a precision health ecosystem that facilitated clinical and research collaboration between health systems, patients and biopharma. Her focus at UPN was on implementing robust clinical genetic testing and return of results experiences, while fostering continued patient and provider engagement with education and research. Riordan has held previous roles at leading biotechnology and precision oncology diagnostics firms such as Thermo Fisher Scientific, Life Technologies, and Oncocyte. As a consultant and entrepreneur, Riordan has also worked with many early-stage companies in developing and commercializing genomic tests and applications. Riordan received her Masters in Genetic Counseling from the University of Arizona and completed a Masters in Human Genetics at the University of California, Los Angeles.
Hakan Sakul, PhD, Vice President and Head, Diagnostics, Pfizer Inc.
Hakan Sakul oversees Pfizer’s diagnostics programs across the pharmaceutical portfolio. He has held positions of increasing responsibility at Pfizer since 1999 and led development and implementation of Pfizer’s companion diagnostics (CDx) strategy. Under his leadership, over two dozen CDx approvals have been granted globally for 6 Pfizer drugs, starting with Pfizer’s flagship Xalkori CDx program in 2011. Hakan’s pharma career started at Parke-Davis Pharmaceuticals. Prior to that, he worked in statistical genetics, human genetics, and pharmacogenomics fields. Hakan serves on the Boards of the Personalized Medicine Coalition and Progentec Diagnostics, scientific advisory board of Luminex Corp, and the Precision Medicine Advisory Council for CA Gov. Newsom’s Precision Medicine initiative. Hakan holds a PhD degree in Quantitative Genetics from the University of Minnesota.
Nikolay Samusik, PhD, CEO, Parhelia Biosciences
Nikolay is the CEO and Founder of Parhelia Biosciences and a Co-founder of Akoya Biosciences. Nikolay did his PhD from Max Plank University and a post-doc with Garry Nolan at Stanford. He has a number of publications in single-cell and computational biology. In 2021 he decided to dedicate himself to his new venture, Parhelia Biosciences, with a goal to bring accessible tissue staining automation to every lab.
Howard I. Scher, MD, Head of Biomarker Development Program, Member and Attending Physician, Department of Medicine, Memorial Sloan Kettering Cancer Center
Howard I. Scher, MD, FASCO is Head of the Biomarker Development Program and Member and Attending Physician at Memorial Sloan Kettering Cancer Center (MSK); Professor of Medicine at Weill Cornell Medical College; and D. Wayne Calloway Chair in Urologic Oncology. His research focuses on the codevelopment of targeted therapies and biomarkers to guide treatment selection, improve drug evaluation, and accelerate regulatory approvals. Dr. Scher led PCWG2 and PCWG3, international efforts to standardize the design and analysis of prostate cancer trials. Translating insights into molecular and genetic prostate cancer features to the clinic, he led the development of FDA-approved Zytiga and Xtandi. Dr. Scher serves as PI of the NIH SPORE in Prostate Cancer at MSK and the Department of Defense-sponsored Prostate Cancer Clinical Trials Consortium (PCCTC), and received an AACR Team Science Award for his multidisciplinary work developing AR inhibitors. Dr. Scher was elected to the Association of American Physicians.
Brock Schroeder, PhD, Vice President, Market Access, Illumina
Brock Schroeder is Vice President of Market Access Illumina, where he leads efforts to generate evidence of clinical and economic utility of current and emerging clinical applications of NGS to support HTA, payer coverage, and patient access to clinical genomic tools. Prior to joining Illumina in 2017, Brock led Medical Affairs at Biotheranostics. Brock’s industry experience includes multiple therapeutic areas, including oncology, rare diseases, and reproductive health. Brock has authored >25 peer-reviewed manuscripts and >50 scientific congress abstracts. He received his BA in Biology from Washington University and his PhD in Neuroscience from University of Wisconsin-Madison.
Julie Shaw, PhD, Clinical Biochemist & Director for POCT, EORLA, Ottawa Hospital
I am head of the Division of Biochemistry and Director of the POCT program at The Ottawa Hospital. I’m also the Regional Lead for both Biochemistry and POCT for the Eastern Ontario Regional Laboratories Association. I chair the Canadian Society for Clinical Chemists’ POCT interest group and sit in the POCT working group of the International Federation of Clinical Chemistry.
Douglas Shepherd, PhD, Assistant Professor, Biological Physics, Arizona State University
Douglas Shepherd is an assistant professor in the Center for Biological Physics and the Department of Physics at Arizona State University. He is currently a Scialog Advanced Bioimaging fellow and lead a group of researchers that form the Quantitative Imaging and Inference Laboratory (qi2lab). Prior to joining Arizona State University, he was an assistant professor in the Departments of Physics and Pharmacology at the University of Colorado Denver Anschutz Medical Campus from 2013-2019. He received his Ph.D. in Physics from Colorado State University and was a postdoctoral fellow at the Center for Integrated Nanotechnologies and Center for Nonlinear Studies at Los Alamos National Laboratory from 2011-2013. The focus of qi2lab research is developing quantitative imaging and statistical inference tools to build predictive models of genetic regulation in multi-cellular systems.
Jacqueline Shreibati, MD, Senior Clinical Lead, Devices & Services (Consumer Health), Google
Dr. Jacqueline Shreibati, MD, is a digital health executive, health services researcher, and safety net cardiologist. Featured in Business Insider’s 2022 list of 30 leaders under 40 transforming healthcare, Dr. Shreibati is known for building value in ambiguous and lean environments, developing novel approaches to grow digital health solutions, and influencing technical teams towards efficient growth and equitable impact. As senior clinical lead at Google, she oversees a team of physicians guiding consumer health projects, including wearables and the Android developer ecosystem, and covering focus areas including interoperability, heart health, women’s health and sleep health. She was previously Chief Medical Officer at AliveCor, a start-up pioneering FDA-cleared artificial intelligence techniques for mobile EKGs. Dr. Shreibati is adjunct faculty at Stanford University School of Medicine, and practices general cardiology at a federally qualified health center in Redwood City. She received her BA from Columbia, and MD and MS in health services research from Stanford.
Angela Silvestro, Director, Companion Diagnostics, GSK
Angela Silvestro is a director of Precision Medicine and Companion Diagnostics at GSK, where she develops and guides companion diagnostic strategy within the oncology portfolio. Previously, Angela was part of the Precision Medicine group at Novartis, where she focused primarily on the application of clinical trial assays and companion diagnostics in various solid tumors. While at Novartis, Angela evaluated multiple feasibility studies to assess emerging and novel platforms and technologies that may be future diagnostics. Across roles, Angela has focused on expanding the use of liquid biopsies for treatment decision-making and monitoring and in furthering the development of harmonized standards and practices for their implementation and development. Prior to working in oncology precision medicine, Angela supported plasma-based infectious disease diagnostics development at Beckman Coulter. Angela earned an undergraduate degree from Tufts University and an MS degree in Biology from Northeastern University.
Ajit Singh, PhD, Partner, Artiman Ventures
Ajit is Managing Director at Silicon Valley based Artiman Ventures He is also an Adjunct Professor in the School of Medicine at Stanford and serves on the Board of Trustees of American Association for Cancer Research (AACR) Foundation. Additionally, he is on the Board of Directors of Cadila Pharmaceuticals, Leo Cancer Care, and Sofie Biosciences. In the past, he has served as the global CEO of Siemens Oncology. Subsequently, he was the CEO of BioImagene, a cancer diagnostics startup, acquired by Roche. He also served as Senior Advisor to the Tata Trusts Cancer program. Ajit has a Ph.D. in Computer Science from Columbia, a Master’s in Computer Engineering from Syracuse and a bachelor’s in Electrical Engineering from Banaras Hindu University. He has published 2 books and 5 patents. His Top-10 Book Review is carried by various blogs and journals in December every year.
Sherie Smalley, MD, Vice President & Medical Director, ADVI
Dr. Smalley is VP and Medical Director at ADVI. A physician executive with more than 20 years of healthcare experience, she is board certified in anatomic and clinical pathology. Her passion is improving health outcomes by promoting patient-centered, high-quality healthcare. Prior to joining ADVI, she served as Chief Medical Officer at ‘Ohana Health Plan and Medical Director at AlohaCare in Hawaii. Before moving to Hawaii, she was the Senior Medical Director of Medical Policy at UPMC Health Plan in Pittsburgh where she chaired the technology assessment committee, oversaw evidence-based coverage policies, and the evaluation of emerging technologies. Prior to her time with UPMC, she was Chief of the Medical Policy and Benefits Branch of the California Department of Healthcare Services; a clinical leadership role in California's MediCal (Medicaid) program.
Michael Snyder, PhD, Stanford W. Ascherman Professor & Chair, Department of Genetics, Director, Center for Genomics & Personalized Medicine, Stanford University
Michael Snyder is the Stanford Ascherman Professor and Chair of Genetics and the Director of the Center of Genomics and Personalized Medicine. Dr. Snyder received his Ph.D. training at the California Institute of Technology and carried out postdoctoral training at Stanford University. He is a leader in the field of functional genomics and multiomics, and one of the major participants of the ENCODE project. His laboratory study was the first to perform a large-scale functional genomics project in any organism, and has developed many technologies in genomics and proteomics. These including the development of proteome chips, high resolution tiling arrays for the entire human genome, methods for global mapping of transcription factor (TF) binding sites (ChIP-chip now replaced by ChIP-seq), paired end sequencing for mapping of structural variation in eukaryotes, de novo genome sequencing of genomes using high throughput technologies and RNA-Seq. These technologies have been used for characterizing genomes, proteomes and regulatory networks. Seminal findings from the Snyder laboratory include the discovery that much more of the human genome is transcribed and contains regulatory information than was previously appreciated (e.g. lncRNAs and TF binding sites), and a high diversity of transcription factor binding occurs both between and within species. He launched the field of personalized medicine by combining different state-of-the-art “omics” technologies to perform the first longitudinal detailed integrative personal omics profile (iPOP) of a person, and his laboratory pioneered the use of wearables technologies (smart watches and continuous glucose monitoring) for precision health. He is a cofounder of many biotechnology companies, including Personalis, SensOmics, Qbio, January, Protos, Oralome, Mirvie and Filtricine.
Sudhir Srivastava, PhD, Chief, Cancer Biomarkers Research Group, NIH NCI
Dr. Srivastava is Senior Scientific Officer and Chief of the Cancer Biomarkers Research Group in the Division of Cancer Prevention, National Cancer Institute. He joined the National Cancer Institute in 1988. Since 1990, he has served as program director in the Division of Cancer Prevention and focused his responsibility in developing molecular approaches to cancer early detection, screening and prevention. He has conceptualized and implemented several programs to study the biology and early detection of precancer lesions, with a primary emphasis on translational research on cancer screening, early detection, risk assessment and enabling technologies including artificial intelligence (.https://prevention.cancer.gov/research-groups/cancer-biomarkers/about-cancer-biomarkers) Dr. Srivastava is an internationally recognized leader in cancer biomarker research. He is best known for his seminal contributions to improving systems approach to biomarker discovery, development and validation. In 2000, Dr. Srivastava developed and implemented a novel approach to collaborative clinical research on cancer biomarkers through the establishment of the Early Detection Research Network (EDRN; www.cancer.gov/edrn ), a flagship program at the National Cancer Institute, National Institutes of Health. Under his leadership the network has begun translating biomarkers into clinical tests (> 8 FDA approved and > 13 CLIA certified) for early detection and diagnosis, risk assessment, and prognosis. He has spearheaded the role of chemical sciences in oncology by establishing the NCI’s Alliance of Glycobiologists (www.glycomics.cancer.gov) v to study the structure-function relationship of glycans, AI for improving prediction, noninvasive technologies, such as liquid biopsy to multi-analyte, multi-cancer screening, and biomarkers in cancer detection and diagnosis of rare cancers, such as pancreas, liver and ovary. He has played a key role in conceptualizing and implementing informatics infrastructure for the EDRN in collaboration with NASA (Jet Propulsion Laboratory), a model collaboration being followed elsewhere in NIH. Dr. Srivastava is best known for his work on developing medical guidelines on the diagnosis of Hereditary Non-polyposis Colorectal Cancer (HNPCC). He played a pivotal role in the development of the Bethesda Guidelines for diagnosing HNPCC, which is in clinical practice world-wide. He has received several honors and awards and is a member of a number of scientific committees world-wide. In 1995, he was elected to the American Joint Committee on Cancer (AJCC) which is responsible for developing staging criteria for cancers for worldwide use and currently serves on the AJCC Executive Committee. He has been a visiting Professor at several medical and academic institutions and has delivered several inaugural and keynote addresses. In 2017, he was appointed as an inaugural head of the Human Proteome Organization’s External Development Initiatives (HEDI; www.hupo.org ). He has delivered lectures as a Keynote Speaker in more than 150 professional meeting and was invited in 2013 by the US Congress to speak on the early detection research programs at NCI. Currently, he is serving on the Planning Committee of the National Academies of Science to host a workshop on screening and early detection in 2020. He is founding Editor-in Chief of the journal Cancer Biomarkers) https://www.iospress.nl/journal/cancer-biomarkers) published by the IOS press and serves as Associate Editors and reviewers for several internally know journals. He has published more than 200 research papers, review articles and commentaries in peer reviewed journals. He has edited several monographs and five book: Early Detection of Cancer: Molecular Markers, published by the Futura Publishing Company in 1995 and Molecular Pathology of Cancer, published by IOS Press, Amsterdam in 1999; Informatics in Proteomics (2005) published by Francis and Taylor, New York; Translational Pathology of Early Cancer (2012), published by the IOS Press and Biomarkers in Cancer Screening and Early Detection, published by Wiley, New York, 2017. Dr. Srivastava has received numerous NCI and NIH awards for his leadership in biomarker research and received a Team Science Award for Informatics by the Jet Propulsion Laboratory, NASA for his visionary and innovative use of NASA Data System Technologies in biomedical science. In 2016, he received a Cancer Prevention Distinguished Alumni Award for his accomplishments and mentoring of fellows. Recently, he was awarded Distinguished Public Service Award (2016) by the American Pancreatology Association and a Distinguished Clinical and Translational Proteomics Award (2017) by HUPO International the Distinguished Alumni Award (2016), Cancer Prevention Fellowship Program, NCI . He was featured in Wired magazine in August 2003 for his leadership in cancer diagnostics. He has been planning and managing comprehensive extramural scientific programs for more than 26 years. In 2016, he was invited to brief the US Congress on progress made on biomarkers for cancer early detection. He has successfully managed several mission-critical goals of the National Cancer Institute at various fronts including conceptual, infrastructure, dependency linkage, and coordination among various federal, academic and private sector constituents. He has successfully developed partnerships with National Institute of Standards and Technology, DOD’s Center for Prostate Disease Research, DOE’s Pacific Northwest National Laboratory and Jet Propulsion Laboratory on shared interests. In addition, he has developed collaborations with international and non-profit foundations, such as Japan’s Agency for Medical Development and research, CR-UK, Chinese National Cancer Institute, PanCAN, Lustgarten and Kenner’s Family Research Foundation.
Andrea L. Stevens, PhD, Director, Precision Medicine Access Strategy, Janssen Pharmaceuticals, Inc.
Andrea is passionate about Precision Medicine and the role that quality testing plays in providing patients access to life changing medicines. She joined Janssen in March 2020, following 7 years in market access consulting, culminating in her appointment as Director of Value and Access at WG Group. Andrea was previously a member of the Scientific Affairs team at Quest Diagnostics Clinical Trials focused on genetic testing. Andrea holds a PhD in Transplantation Immunobiology from University College London and studied at the Anthony Nolan Research Institute.
Timothy Sweeney, PhD, Co-Founder & CEO, Inflammatix, Inc.
Tim Sweeney, MD, PhD, is co-founder and CEO of Inflammatix. Tim has extensive experience in medical practice (general & trauma surgery), bench research, and bioinformatics/machine learning. While training at Stanford he helped invent the core technology on which Inflammatix is based, is named on over a dozen patents related to medical diagnostics, and has published >100 manuscripts & abstracts. He is PI (through Inflammatix) on multiple development contracts from DARPA, BARDA, and NIH, and brought Inflammatix to recognition as the ‘Most Disruptive Technology’ at AACC in 2019, and the “Fierce 15” list in 2020.
Ryan J. Taft, PhD, Vice President, Scientific Research, Illumina
Dr. Taft is Vice President, Scientific Research where leads a team of scientists focused on the deployment of genomic technologies for patients worldwide, especially the use of whole genome sequencing as a platform for genetic testing. His activities include oversight of the Illumina Clinical Services Laboratory’s clinical whole genome sequencing test, pediatric and adult diagnostic trials, bioinformatic innovation and novel application development. Dr Taft also oversees a philanthropic program, iHope, which provides patients across the globe pro bono access to clinical whole genome sequencing, which, through a partnership with Genetic Alliance and a $120M in-kind donation from Illumina Inc, will scale to support tens of thousands of patients over the next five years. Dr. Taft has helped describe more than a dozen novel genetic disorders, and was one of the first to use short-read whole genome sequencing to resolve an undiagnosed disease. He is an active advisor to genomic technology companies, nonprofits and academic institutions. He holds various other industry positions including serving as non-voting member of the Genetic Alliance board, the Illumina representative at the US National Academy of Medicine’s Roundtable on Genomics and Precision Health, and on the steering committee of the Medical Genome Initiative. Dr. Taft has received several awards, including a Biocom Life Science Catalyst Award for innovation in the life sciences and the University of Queensland's 2021 International Alumnus of the Year.
Shabnam Tangri, PhD, CSO, Navigate BioPharma Services, Inc.
Shabnam Tangri is an accomplished R & D leader with over 20 years of experience in drug development and diagnostics. Shabnam holds a Ph.D in immunology and has an extensive patent and publication record. Currently, Shabnam serves as the CSO at Navigate BioPharma Services. Her teams have contributed to several drug and diagnostic approvals over the years such as CAR-T and the first NGS based companion diagnostic for lung cancer.
Janis Taube, MD, Professor, Dermatology and Pathology, Johns Hopkins University School of Medicine
Dr. Taube’s research interests center on the immune evasion by solid tumors, specifically studying the PD-L1/PD-1 axis, and the identification of potential biomarkers that can help select patients with malignancies for novel immunotherapeutic treatment regimens. This requires a focus on immunohistochemical and molecular methods for identifying cell surface antigens and signaling pathways in paraffin-embedded tissue. Most recently, Dr. Taube has been collaborating with Dr. Szalay, a Big Data expert from Astronomy, to develop the new multispectral tissue imaging 'AstroPath' platform and query the resultant datasets to further biomarker development.
Timothy Taxter, MD, Senior Medical Director, Algorithmic Diagnostics, Tempus Labs
Dr Timothy Taxter is a Senior Medical Director of Algorithmic Diagnostics at Tempus where he leads the development and commercialization of diagnostic, prognostic and predictive biomarkers in oncology. Additionally, Dr Taxter supports validation efforts of companion diagnostic tests through pharma and biotech partnerships. Dr Taxter attended Fellowship in Development Therapeutics and Residency in Clinical Pathology at Northwestern Memorial Hospital with a focus on non-invasive prostate cancer diagnostics.
Bruce J. Tromberg, PhD, Director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health; Lead, NIH’s Rapid Acceleration of Diagnostic Technologies (RADx Tech) Program
Dr. Tromberg is the Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH) where he oversees a portfolio of research programs focused on developing, translating, and commercializing engineering, physical science, and computational technologies in Biology and Medicine. In addition, he leads NIBIB’s Rapid Acceleration of Diagnostics (RADx Tech) innovation initiative to increase SARS-COV-2 testing capacity and performance. Prior to joining NIH in January 2019, he was a professor of Biomedical Engineering and Surgery and director of the Beckman Laser Institute and Medical Clinic (BLIMC) at the University of California, Irvine (UCI). Dr. Tromberg specializes in the development of optics and photonics technologies for biomedical imaging and therapy. He has co-authored more than 450 publications and holds 24 patents in new technology development as well as bench-to-bedside clinical translation and commercialization of devices.
Ephraim L. Tsalik, MD, MHS, PhD, FIDSA, Vice President & CSO, Infectious Disease, Danaher Corp.
Ephraim Tsalik is the VP and Chief Scientific Officer for Infectious Disease at Danaher Diagnostics, the parent company of Cepheid, Beckman Coulter, and Radiometer among others. He obtained his MD and PhD from Columbia University. He then completed clinical training in Internal Medicine and Infectious Diseases at Duke University while earning a Master of Health Science in Clinical Research. At Duke University, Dr. Tsalik led a research program developing host response biomarkers for infectious disease. This led to the founding of Predigen, which was subsequently acquired by Biomeme. Joining Danaher in early 2022, Dr. Tsalik is helping to realize the future of infectious disease diagnostics. He also remains clinically active at the Durham VA Health Care System and maintains an adjunct appointment with Duke University.
Alison Urvalek, Senior Director, Clinical Diagnostics, Loxo@Lilly
Alison Urvalek is currently a Senior Director in Clinical Biomarkers and Diagnostic Development at Loxo@Lilly where she leads external research collaborations aimed at identifying approaches to increase comprehensive molecular testing for patients with cancer. This passion for appropriate molecular testing also carries into her work focused on the diagnostics used within clinical trials. Prior to this role she worked as a Diagnostic Medical Science Liaison focused on education around identifying appropriate patients who may benefit from precision medicines. Before joining Loxo@Lilly Alison worked in a medical communications and advertising agency supporting drug development and launch endeavors. She holds a PhD in Biomedical Science from Albany Medical College and completed a postdoctoral fellowship at Weill Cornell Medical College.
Ioannis Vlachos, PhD, Director, Spatial Technologies, Beth Israel Deaconess Medical Center; Assistant Professor, Pathology, Harvard Medical School; Associate Member, Broad Institute of MIT & Harvard
Dr. Vlachos is an Assistant Professor of Pathology, Beth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School (HMS), and the Co-Director of the Bioinformatics Program, Cancer Research Institute, BIDMC. He is also the Director of the Spatial Technologies Unit, BIDMC/HMS Initiative for RNA Medicine, and an Associate Member of the Broad Institute of MIT & Harvard. His group focuses on creating novel in silico and experimental methods for reverse translation. He has also worked extensively in whole genome and RNA Medicine/non-coding RNA applications.
Tim Wesselman, Founder, CEO, Rosalind, Inc.
Tim Wesselman is the founder and CEO of Rosalind, a life sciences company revolutionizing the way we visualize, store and interpret multi-omic data in drug discovery, infectious disease research and translational medicine. A graduate of multiple programs in Finance, Accounting, Investor Relations and Strategic Marketing from Columbia University, Rice University and University of Michigan, as well as obtaining a B.S. Mechanical Engineering degree from Texas A&M University.
Jay Wohlgemuth, MD, CMO and Senior Vice President, R&D, Medical and Population Health, Quest Diagnostics
Jay G. Wohlgemuth, M.D., is Chief Medical Officer and Senior Vice President, Research & Development and Medical for Quest Diagnostics. Based at Quest Diagnostics Nichols Institute, in San Juan Capistrano, California, Dr. Wohlgemuth is responsible for Research & Development (R&D), Medical Affairs and Medical/Lab Quality. In addition, he is responsible for improving outcomes for employees who use Quest's health benefits. Dr. Wohlgemuth has many years of experience in medical diagnostics and research and development. He rejoined Quest in 2016 from HealthTap, a health information start-up, where he served as Senior Vice President and Chief Healthcare Officer. Prior to that, he was Senior Vice President, R&D, Medical and Chief Scientific Officer with Quest. Dr. Wohlgemuth originally joined Quest in 2009 from Genentech, where he was Director, Clinical Diagnostics, ITGR (Immunology, Tissue Growth and Repair) and Global Development Team Leader for Ocrulizumab. He also served as Vice President, Research and Development for VIA Pharmaceuticals and as Chief Medical Officer for the molecular diagnostics company XDx, a company he co-founded. In addition, Dr. Wohlgemuth served as Vice President, Research & Development for XDx. For his work at XDx he was awarded Technology Pioneer 2005 at the World Economic Forum in Davos. Received the C Everett Koop award for the best population health program in the US in 2020. He serves on the Board of Directors for the Diagnostic Labs of Oklahoma, The Anne and Henry Zarrow Charitable Foundation, and Personalized Medicine Coalition. Dr. Wohlgemuth earned his bachelor’s degree in biology from Harvard College and his medical degree from Stanford University School of Medicine, where he also served a fellowship in cardiovascular medicine.
Kyoung Jae Won, PhD, Associate Professor, Computational Biomedicine, Cedars Sinai Medical Center
Dr. Kyoung-Jae Won received the BS and MS degrees in Electronics from Chung-Ang University, Korea, in 1996, and 1998, respectively. He received his PhD in Electronics and Computer Science from the University of Southampton, UK, in 2006. He worked at the University of Copenhagen in 2006 and the University of California San Diego (UCSD) from 2007 to 2010 as a postdoctoral researcher. During this time, he applied hidden Markov Models to various biological questions including epigenomics gene regulation. He joined at the School of Medicine, University of Pennsylvania as a Research Assistant Professor in 2011 and BRIC, University of Copenhagen as an Associate Professor in 2018. He joined Cedars-Sinai in 2022. He is interested in developing computational algorithms for single-cell and spatial genomics data.
Stephane Wong, PhD, Senior Director, Immuno-Oncology and Specialty Diagnostics, GSK
Stephane Wong is currently the senior director at GlaxoSmithKline (GSK) in the Experimental Medicine Unit leading a team focused on immuno-oncology, Specialty, and near patient diagnostic development to support clinical trials and regulatory diagnostics submission. Prior to GSK, he was the Global Head of the Immuno-Oncology Diagnostics Center of Excellence and led multiple programs in the Precision Medicine/Companion Diagnostic division(s) of Novartis Global Drug Development. Prior to Novartis, he was the Chief Scientific Officer and Chief Operating Officer of MolecularMD (now part of ICON), an oncology focused diagnostic company that he co-founded. Stephane obtained his PhD in Molecular Biology under the mentorship of Owen Witte and MBA from UCLA.
Christopher W. Woods, MD, MPH, Professor, Medicine, Global Health & Pathology, Duke University
Dr. Woods is the Executive Director of the Hubert-Yeargan Center for Global Health; Associate Director of the Center for Applied Genomics and Precision Medicine; professor in the Departments of Medicine and Pathology at Duke University; an adjunct professor in Epidemiology at the University of North Carolina at Chapel Hill School of Public Health; and an adjunct professor in the Emerging Infections Program at the Duke-National University of Singapore Graduate Medical School. Clinically, he serves as Chief of Infectious Diseases Durham VA Health System. Dr. Woods has published over 210 peer-reviewed articles and has a particular interest in the diagnostic capacity in the developing world and the epidemiology of emerging and re-emerging infectious diseases. As an infectious diseases clinician and medical microbiologist, his approach to host genomic response has been called a paradigm shift in the field of infectious disease diagnostics.
Paul Yager, PhD, Professor, Department of Bioengineering, University of Washington
Paul Yager, PhD, is a professor in the Department of Bioengineering at the University of Washington. After 7 years at the Naval Research Laboratory, he joined the University of Washington in 1987, and served as department chair from 2007 to 2013. Initially working on self-organizing lipid microstructure and optically-based biomedical sensors, since 1992 his lab has explored the fundamentals of microfluidics, and applications thereof in analysis of biological fluids for point-of-care medical diagnostics in the developed and developing worlds. Since 2005, Yager has worked toward rapid low-cost sensitive pathogen identification with support from the Bill & Melinda Gates Foundation, NIH, NSF, DARPA and DTRA. Today, his lab focuses on developing two-dimensional porous (paper) networks for ultra-low-cost point-of-care pathogen identification, including home NAAT tests for HIV virus, SARS-CoV-2, and other respiratory pathogens. Yager is a Fellow of AIMBE, the Washington State Academy of Sciences, and NAI. Specifics are at http://faculty.washington.edu/yagerp/. He is also a co-founder and CSO of UbiDX, a startup in home diagnostics and healthcare.
Brenda Yanak, Founder, Clinical Transformation Partners LLC
Ms. Yanak is a Pharmaceutical & Central Lab executive known for successfully translating scientific strategy into clinical operations, via technology and innovation. She developed an Innovation Operating Model to pilot digital health and other ideas to transform drug development, and envisioned and led a multi-year strategic program to operationalize Precision Medicine at a Top 5 pharma, including transformation of the end-to-end specimen management policy, process, and technology infrastructure: standardizing protocols, digitizing informed consent, developing virtual specimen tracking, and using artificial intelligence to automate clinical study reports to expedite creation of big datasets for mining new biomarkers. Brenda has led transformative initiatives at several major companies, and acts as an Advisor to the Summit for Clinical Operations Executives (SCOPE).
Eugene Yeo, PhD, MBA, Professor, Cellular and Molecular Medicine, University of California, San Diego; Founding Member, Institute for Genomic Medicine
Gene Yeo, PhD, MBA is a Professor of Cellular and Molecular Medicine at the University of California San Diego (UCSD), a founding member of the Institute for Genomic Medicine and member of the UCSD Stem Cell Program and Moores Cancer Center. Dr. Yeo has a BSc in Chemical Engineering and a BA in Economics from the University of Illinois, Urbana-Champaign, a Ph.D. in Computational Neuroscience from Massachusetts Institute of Technology and an MBA from the UCSD Rady School of Management. Dr. Yeo serves as Co-Director of the Bioinformatics and Systems Biology Graduate Program and Associate Director of a Genetics T32 training program at UCSD. Dr. Yeo is a computational and experimental scientist who has contributed to RNA biology and therapeutics. His primary research interest is in understanding the importance of RNA processing and the roles that RNA binding proteins (RBPs) play in development and disease. Since inception, Dr. Yeo’s lab has focused on uncovering molecular principles by which RBPs affect gene expression, how RBP-mediated post-transcriptional gene networks contribute to cellular homeostasis in stem cells and the brain, and how mutations in RBPs lead to human developmental and neurodegenerative disease. His lab pioneered computational algorithms and experimental methods in human disease-relevant systems to conduct systematic and large-scale studies. These multidisciplinary methods combine machine learning, biochemistry, molecular biology, genomics, chemistry and materials research. His lab develops methods that are systematic, robust and adoptable, such as enhanced CLIP for the purposes of large-scale mapping of protein-RNA interactions (Van Nostrand et al, Nature Methods, 2016). Gene’s lab is a major contributor of resources to study RBPs that enable hundreds of labs across many areas of bioscience, such as the world’s largest resource of RBP-specific antibodies that facilitated generation and interpretation of the most comprehensive maps of RBP-binding sites to date for hundreds of RBPs (Van Nostrand et al, Nature, 2020). They have also systematically uncovered RBPs that condense into RNA granules during stress and demonstrated strategies to leverage these for therapeutic use in neurodegeneration (Markmiller et al, Cell, 2018; Fang et al, Neuron, 2019; Wheeler et al, Nature Methods, 2020). His lab also demonstrated in vivo RNA targeting with CRISPR/Cas proteins (Nelles et al, Cell, 2016) with proof of concept in repeat expansion disorders (Batra et al, Cell, 2017; Batra et al, Nature Biomedical Engineering, 2020). Recently his lab has developed the STAMP technology (Brannan et al, Nature Methods, 2021) which is the first transcriptome-wide method for identify RNA binding protein sites and translation measurements at single-cell resolution. Work from the Yeo lab has been highlighted in Nature Methods and Nature Reviews Genetics as “Method to Watch” and featured as a top story in Discover magazine. These efforts have led to clinical programs to develop medicines for RNA-related diseases.Dr. Yeo has authored more than 200 peer-reviewed publications including invited book chapters and review articles in the areas of neurodegeneration, RNA processing, computational biology and stem cell models; and served as Editor on two books on the biology of RNA binding proteins. Gene is on the Editorial Boards of the journals Cell Reports, Cell Research and eLife, and on the Advisory Board of Review commons. Gene joined UCSD as an Assistant Professor in 2008, was promoted with tenure to Associate Professor in 2014 and to Professor in 2016. Gene was the first Crick-Jacobs Fellow at the Salk Institute (2005-2008). Other awards include the Alfred P Sloan Fellowship in recognition of his work in computational molecular biology (2011), Alpha Chi Sigma-Zeta Chapter Krug Lecturer (2016), Singapore National Research Foundation Visiting Investigatorship Award (2017), the inaugural Early Career Award from the International RNA Society (2017), the Blavatnik National Award Finalist (2018 & 2019), San Diego Xconomy Awardee for ‘Big Idea’ (2019) and Highly Cited Researcher in Cross-Field category (2019, 2020, 2021), recognizing the world’s most influential researchers of the past decade. Gene is also a Paul Allen Distinguished Investigator (2020) and received the 2021 Elisa Izaurralde Award for Innovation in Research, Teaching and Service from the RNA Society. Gene is a co-founder of biotech companies which includes Locanabio, Eclipse Bioinnovations, Enzerna, Proteona, Trotana and Circ Bio. Gene serves or had served on the scientific advisory boards of the Allen Institute of Immunology, Locanabio, Eclipse Bioinnovations, Proteona, CircBio, Aquinnah, Cell Applications, Tecan, LGC, Sardona Therapeutics, Ladder Therapeutics, Insitro, Trotana, Nooma and Ribometrix. Gene is a senior advisor to Accelerator Life Sciences Partners. Gene’s lab has current or previous support from the National Institute of Health, National Science Foundation, California Institute for Regenerative Medicine, TargetALS, ALS Foundation, Department of Defense, Myotonic Dystrophy Association, Myotonic Dystrophy Foundation, Chan-Zuckerberg Initiative, Takeda, Genentech and Roche.
Peng Yin, PhD, Professor, Systems Biology, Harvard Medical School, Wyss Institute, Harvard University
Peng is a Professor in the Department of Systems Biology at Harvard Medical School. Peng’s lab uses synthetic DNA/RNA to construct, manipulate, and visualize nanoscale structures. They have developed a general framework to program DNA/RNA strands to self-assemble into structures with user-specified geometry or dynamics. By interfacing these nanostructures with other functional entities (e.g. fluorophores, proteins, inorganics, living cells), they have introduced digital programmability into diverse application areas, e.g. fabrication of inorganic nanoparticles with user-prescribed shapes, robust DNA/RNA probes with near optimal binding specificity for detecting single-base genetic changes, RNA-based synthetic regulators with unprecedented dynamic range and orthogonality for complex programming of protein translation in living cells and on paper-based systems, and highly multiplexed (10+), precisely quantitative (90%+ precision), ultra-high resolution (< 5 nm) super-resolution imaging using DNA-PAINT.
Hoi-Ying Elsie Yu, PhD, System and Core Laboratory Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Health System
Dr. Elsie Yu is a Medical Laboratory Director at Geisinger Health System with a system leadership role in Clinical Chemistry, Immunology, Toxicology and Point-of-Care Testing. She is also a Clinical Associate Professor at Geisinger Commonwealth School of Medicine. In 2016, she was named “40 Under Forty Top Five” by American Society of Clinical Pathology. Outside of Geisinger, she has participated at various special project committees (e.g. CLSI, NKF and AACC committees) to promote proper laboratory utilization. Since she joined Geisinger in 2010, Geisinger has grown from a two- to nine-hospital system with over 80 clinics. During this rapid growth, she has integrated different hospitals and clinics to the Geisinger Health System through consolidation and standardization to enhance testing services. Her main interest is to improve laboratory test utilization and operational efficiency. Much of her work requires extensive collaboration with clinical providers to achieve system standardization and clinical effectiveness. Two such examples include her effort to - curb the opioid epidemic with enhanced urine drug testing program and decision support - improve ED throughput and transform cardiac care by implementing high sensitive troponin She earned her PhD in Cellular and Molecular Biology at University of Wisconsin - Madison, completed her clinical fellowship at Boston’s Children Hospital. She is board-certified by the American Board of Clinical Chemistry.
Noah Zimmerman, PhD, Vice President, Translational Science, Tempus
Noah Zimmerman is Vice President of Translational Science at Tempus, where he oversees Research & Development for the Cardiology business. Prior to joining Tempus, Dr. Zimmerman was an Assistant Professor at the Icahn School of Medicine at Mount Sinai, and director of the Health Data and Design Innovation Center. His research is aimed at improving decision-making in healthcare by developing and deploying methods to analyze large volumes of heterogeneous data. He is the author of numerous peer reviewed scientific articles, a textbook on measures for digital medicine, and a children’s blockchain board book. He received his Ph.D. from Stanford University in Biomedical Informatics and a B.S. in Computer Science and Philosophy from the University of Maryland, College Park.
Asaf Zviran, PhD, Co-Founder, CEO & CSO, C2i Genomics
Asaf Zviran is the co-founder, CEO and CSO of C2i Genomics, a company that advances personalized cancer drug development and treatment by providing vital real-time cancer detection and monitoring at a global scale. Dr. Zviran lead the company development from Academy research concept to VC-backed growth-stage company. Dr. Zviran brings over 15 years of R&D management in life science and defense, including numerous high impact scientific publications and patents. As a former cancer survivor, Asaf is committed to improving cancer patients’ quality of life and outcomes.
Maryellen de Mars, PhD, Program Director, Clinical Diagnostics, Medical Device Innovation Consortium
Maryellen de Mars recently joined MDIC in the role of SRS Technical Project Manager. Before joining MDIC, Dr. de Mars worked at Integrated Nano-Technologies, Inc. (INT) where she led efforts towards regulatory approval and market launch of a novel molecular platform for detection of COVID-19. Prior to INT, Dr. de Mars led the business unit at ATCC focused on standards and related services supporting life science research and development. While at ATCC, she served as an industry representative in early MDIC SRS efforts to help mold and define the current project. Prior to ATCC, Dr. de Mars served as COO and VP of Clinical Operations at USDS, Inc., an independent third party evaluating the performance of molecular diagnostic tests to support regulatory, reimbursement and adoption efforts. She also served as Director, Clinical Biomarkers at Critical Path Institute (C-Path), leading collaborative efforts to evaluate and improve the utility of clinical biomarkers and optimize the pathway for development of companion diagnostics. She served as Executive Director of Genomics Services at Gene Logic, Inc. as well as Director of Gene Logic’s biorepository. Dr. de Mars led business development and marketing efforts for several product lines at Life Technologies, Inc., now ThermoFisher. Dr. de Mars holds a BA from Smith College and a PhD in virology from the University of Texas.
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