PLENARY KEYNOTE SPEAKERS
Jennifer Dickey, RAC, Ph.D., Office of In Vitro Diagnostics, DIHD, US Food and Drug Administration
Dr. Dickey obtained her Ph.D. in biochemistry at Vanderbilt University, and then performed post-doctoral research at the National Cancer Institute in the Laboratory of Molecular Pharmacology. She then joined FDA as an Interagency Oncology Task Force fellow in the CDER Office of Biotechnology Products. She is currently a regulatory reviewer in CDRH/OIR in the Immunological and Hematological Genetic Disorders branch. She specializes in review of leukemia/lymphoma diagnostics and radiation biodosimetry.
Andrea Ferreira-Gonzalez, Ph.D., Professor, Pathology; Director, Molecular Diagnostics Lab, Virginia Commonwealth University
Andrea Ferreira-Gonzalez, Ph.D. is currently Professor and Chair of the Division of Molecular Diagnostics in the Department of Pathology at Virginia Commonwealth University. She is also the Director of the Molecular Diagnostics Laboratory at Virginia Commonwealth University Health System. She is an expert in molecular diagnostics in the area of genetics, oncology, coagulation and infectious diseases. She has been recognized both nationally and internationally for her work in the field of molecular diagnostics. Her publication record demonstrates over 80 publications in peer-reviewed literature and she has been sought after to contribute eight chapters to books in clinical molecular analysis. Dr Ferreira-Gonzalez is a consultant on the Clinical Genetics Panel of the Medical Devices Advisory Committee, Center for Devices and Radiological Health for the Food Drug Administration. She served as a member of the Secretary of HHS Advisory Committee on Genetics, Health and Society (SACGHS) and the Chair of the SACGHS Task Force on Genetic Testing Oversight. In addition, she served on the Secretary of HHS Personalized Healthcare Workgroup. She also served as member of Clinical Laboratory Improvement Advisory Committee (CLIAC) to HHS. She has been involved in the development of clinical guidelines with the Clinical and Laboratory Standards Institute. Dr Ferreira-Gonzalez also served as President and Chair of the Professional Relations Committee for the Association for Molecular Pathology. She is currently the chair of the LDT Working group for AMP Professional Relations Committee.
Madhuri Hegde, Ph.D., FACMG, Professor, Human Genetics; Executive Director, Emory Genetics Laboratory, Emory University School of Medicine
Ms. Madhuri Hegde, Ph.D., FACMG, is an Associate Professor at the Emory University School of Medicine Department of Human Genetics and the Scientific Director of the Emory Genetics Laboratory. Ms. Hegde has been a Member of Clinical Advisory Board at Genome Quest, Inc. since October 20, 2011. The primary focus of Dr. Hegde's clinical work is the development of high-throughput sequencing strategies for rare disorders using sequence capture technologies, robotics, next-generation sequencing, oligonucleotide array platforms, robotics and using predictive analysis tools and biological testing. Her research focuses on functional analysis of sequence variants in disease associated genes, specifically mental retardation and muscular dystrophies, and translating what is learned in the basic research laboratory to clinical practice.
Joany Jackman, Ph.D., Investigator, Center for Point of Care Tests for STD, Johns Hopkins University School of Medicine
In 1980, Dr. Jackman received a B.A. in American Studies, Brandeis University; B.S. in Biological Sciences, University of Connecticut in 1981; and a Ph.D., Program in Cell and Molecular Biology, University of Vermont in 1990. In 2000, she joined the staff at The Johns Hopkins University Applied Physics Laboratory. Dr. Jackman began working in the area of infectious disease at US Army Medical Research Institute of Infectious Disease in 1997. The focus of this work was to develop novel methods of rapid pathogen identification and diagnosis of infection using mass spectrometry and microarray methodologies. Dr. Jackman joined the Johns Hopkins University Applied Physics Laboratory in 2000 where she has continued her work in rapid pathogen identification and advises in biocontainment facility design and operations. In 2003 she received the Christopher Columbus Homeland Security Award in the area of Emergency Response. Dr. Jackman is developing methods to analyze breath for novel markers of infection. Dr. Jackman is a Sigma Xi Distinguished Lecturer where she provides presentations on Agroterrorism, Biothreat Detection, Breath as a Diagnostic, and the History of Bioterrorism. During the past eight years, Dr. Jackman has participated in technology reviews for Department of Defense such as Joint Program Executive Office and other military agencies and conducted technology reviews and testing for DARPA. In addition, Dr. Jackman has been an active member of the Maryland Fire Rescue Service in the Washington area and is certified to the level of EMT-B and Firefighter II.
Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP
As a clinical molecular geneticist, Dr. Lyon combines clinical laboratory responsibilities with research and development. Her research focus is on developing and evaluating technologies for detecting human mutations. These include methods for mutation scanning and gene or exonic level deletion and duplications. To determine whether several variants are on the same or different chromosome, she is developing molecular haplotyping methods. In addition, her laboratory studies the significance of variants identified in the clinical laboratory. They have adapted a statistical research model used in genetic linkage to determine the strength of genetic evidence that detected variants are deleterious or benign. She is involved with evaluating and establishing locus specific databases that combine genetic variants with clinical symptoms.
Harry Glorikian, Healthcare Consultant
MAIN PROGRAM SPEAKER BIOGRAPHIES
Edward Abrahams, Ph.D., President, Personalized Medicine Coalition
Edward Abrahams, Ph.D., is president of the Personalized Medicine Coalition (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 230 today. The author of numerous essays, Dr. Abrahams has also taught history and public policy at Brown University and the University of Pennsylvania.
Randy Allen, Ph.D., Director, Global Markets Team, Clinton Health Access Initiative (CHAI)
Randy Allen, Ph.D. serves as Director of Global Markets for the Clinton Health Access Initiative (CHAI). CHAI facilitates access of patients in those nations hit hardest by HIV, tuberculosis, and malaria to life saving diagnostics and pharmaceuticals. Dr. Allen recently served as Director of Business Development for the David H Murdock Research Institute (DHMRI) where he contributed to the design and up fit of over 80,000 sq. ft. of laboratory space and the purchase of over $30 million in scientific equipment. He was previously CEO of Hybrizyme Corp., a biotechnology company specializing in the development of receptor-based assays. Dr. Allen started his career in industry as Director of Immunology and founding member of EnSys, Inc., a publicly traded company that pioneered the use of immunoassay methods for environmental analysis. He holds numerous patents in immunoassay and receptor-based assay design. He earned an MS in pathology from Michigan State University and his Ph.D. in Biochemistry and Molecular Biology from the Oak Ridge National Laboratory School of Biomedical Sciences. Dr. Allen completed post-doctoral training at the National Institutes of Environmental Health Sciences as an NIH Senior Staff Fellow.
Sami S. Amr, Ph.D., Instructor, Pathology, Harvard Medical School; Director, PCPGM Research Core; Assistant Director, Lab for Molecular Medicine, Partners Center for Personalized Genetic Medicine
Dr. Amr currently serves as Director of the Translational Genomics Core and Assistant Director of the Lab for Molecular Medicine at Partners HealthCare Center for Personalized Genetic Medicine (PCPGM), and holds a faculty position in the Department of Pathology at Brigham and Women’s Hospital and Harvard Medical School (HMS). Sami received his training in clinical molecular genetics at HMS, during which he was directly involved in the development, validation, and implementation of NGS targeted gene panels for clinical diagnostics. In his current role at PCPGM, Sami plays a leadership role in leveraging technological advances to improve genetic testing and reporting for inherited diseases with a focus on hearing loss.
Philipp Angenendt, Ph.D., Director, Global Operations, Sysmex Inostics GmbH
Philipp Angenendt is responsible for global service operations at Sysmex Inostics. Before, he was part of the management team of Inostics GmbH with a special focus on sales and operations. Philipp has over 8 years of experience in cancer diagnostics and was involved in cancer genome sequencing projects at the Ludwig Center for Cancer Genetics and Therapeutics at The Johns Hopkins University in Baltimore, Maryland. Philipp Angenendt obtained his Ph.D. from the Freie Universitaet Berlin and the Max-Planck-Institute for Molecular Genetics in Berlin, where he was honored with the Dieter-Rampacher Prize as the youngest Ph.D. candidate of the Max-Planck Society. After graduation, he worked at the German Cancer Research Center (DKFZ) in Heidelberg and authored more than 15 peer-reviewed papers in genomics and proteomics.
Melinda Baker, Ph.D., Solution Scientist, Life Science, IP & Science, Thomson Reuters
Melinda Baker, PhD is a Solution Scientist at Thomson Reuters where she provides systems biology and pre-clinical science technical expertise for Discovery and Translational Science applications, including web applications, application programming interfaces and contract research projects. Dr Baker earned her PhD at Princeton University and her B.S. from Michigan State University College Natural Science. Following her studies, Dr. Baker completed a post-doctoral fellowship at the Rutgers Biomedical and Health Sciences, formerly the New Jersey Medical School.
Richard “Mike” Barlow, Vice President, Palmetto, GBA
Thirty five plus years of health service industry management experience with progressive leadership responsibilities within the healthcare provider and Medicare contractor companies. As the Palmetto GBA MolDX® program executive works closely with clinical leadership and staffing to apply clinical knowledge effectively into an operational setting and to integrate these operational, technical, and clinical elements and to establish effective controls, coverage and policy elements.
J. Carl Barrett, Ph.D., Vice President, Translational Sciences, Onc iMed, AstraZeneca
Dr. J. Carl Barrett is Vice President of Translational Science in the Oncology Innovative Medicines Unit at AstraZeneca Pharmaceuticals. 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. 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 Ph.D. 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.
Lora J.H. Bean, Ph.D., F.A.C.M.G., Assistant Professor, Senior Director, Molecular Diagnostic Laboratory, Emory Genetics Laboratory, Human Genetics, Emory University
Lora J. H. Bean is an Assistant Professor in the Department of Human Genetics and a Director of the Emory Genetics Laboratory Molecular Diagnostic Laboratory. She earned her B.S. degree from the Pennsylvania State University in Biology with an emphasis in Developmental Biology and Genetics and her PhD in the Department of Human Genetics at Case Western Reserve University. As a postdoctoral fellow at Emory University, she ascertained a large sample of Down syndrome with complete AVSD. This research has continued to determine in the role that genetic variation within genes play in the etiology of heart defects in Down syndrome. While at Emory University she also completed clinical laboratory training and achieved certification from the American Board of Medical Genetics in Molecular Diagnostics. Dr. Bean served as Laboratory Director in the Molecular Diagnostic Laboratory at Emory Genetics Laboratory (EGL) and EGL Molecular Laboratory Operations Representative beginning in 2005 and continuing as a Senior Director in the Molecular Diagnostic Laboratory in 2013. The EGL Molecular Diagnostic Laboratory performs traditional clinical molecular testing, such as genotyping, fragment analysis and Southern blotting, but also newer techniques such as sequencing for rare diseases, next generation sequencing, gene targeted microarrays, and most recently whole exome sequencing. Dr. has an interest in the application of molecular techniques in newborn screening and was responsible for implementation and oversight for the first five years of second tier molecular testing for cystic fibrosis newborn screening in the state of Georgia. In addition, Dr. Bean serves as a member of the American College of Medical Genetics Laboratory QA / QC Committee.
Chetan Bettegowda, Ph.D., Assistant Professor, Neurosurgery and Oncology, Johns Hopkins University School of Medicine
Dr. Bettegowda is an Assistant Professor of Neurosurgery and Oncology at Johns Hopkins. He received his MD and PhD degrees from the Johns Hopkins University School of Medicine. He completed his general surgery internship and neurosurgical residency at the Johns Hopkins Hospital. He completed his PhD training and post-doctoral fellowship in the laboratory of Bert Vogelstein and Kenneth Kinzler. Dr. Bettegowda's research interests are currently focused on developing non-invasive biomarkers for individuals with a wide array of tumors.
Rainer Blaesius, Ph.D., Technology Manager, Genomic Sciences Group, BD Technologies
Dr. Blaesius received his PhD in Biochemistry from the Free University in Berlin. After continuing his graduate work on G Protein Coupled Receptor Signaling in his postdoctoral studies at UNC Chapel Hill he developed GPCR based assays for drug discovery as a Senior Scientist at KarobioUSA. Subsequently he joined BD Technologies as a Senior Scientist and led the development of antibodies for cancer screening and staging assays. A team of scientists under his guidance then developed a novel screening platform for Stem Cells which was used for collaborations with various Pharmaceutical companies as well as BD-internal product development in support of Stem Cell Therapies. In his present position as Technology Manager Dr. Blaesius leads a project directed at using Flow Cytometry for Solid Tumor Tissues and Fluorescence ActivatedCell Sorting (BD FACS™) to enable Single Cell Molecular analysis of Solid Cancers.
Mark S. Boguski, M.D., Ph.D., Associate Professor, Pathology, Center for Biomedical Informatics, Harvard Medical School
Mark Boguski, M.D., Ph.D. is Co-Founder and Chief Medical Officer of Genome Health Solutions. He also serves on the faculty of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston where he founded the Genomic Medicine Initiative in 2009. Dr. Boguski is a pioneer in the fields of bioinformatics and genomics and has previously held faculty positions at the Johns Hopkins University School of Medicine, the U.S. National Institutes of Health, the U.S. National Library of Medicine and as an executive in the biotechnology and pharmaceutical industries. He is a former vice president of Novartis and a Visionary and Influencer according to the Personalized Medicine Coalition. Boguski is a member of the Institute of Medicine of the U.S. National Academies, the American College of Medical Informatics, the Society for Participatory Medicine and is also a Fellow of the College of American Pathologists. He is a graduate of the Medical Scientist Training Program at Washington University in St. Louis.
Robert A. Bonomo, M.D., Chief, Medical Service, Louis Stokes Cleveland VA Hospital; Vice Chair, Veterans Affair, Medicine, University Hospital Case Medical Center
Dr. Robert A. Bonomo is Chief of the Medical Service at the Louis Stokes Cleveland VA Hospital. He also serves as Vice Chair for Veterans Affairs in the Department of Medicine at University Hospital Case Medical Center. Dr. Bonomo is also Professor of Medicine, Pharmacology, Molecular Biology and Microbiology at Case Western Reserve University. The research interests of Dr. Bonomo include the molecular basis of antibiotic resistance in Gram negative bacteria, the testing of novel antibacterial compounds, and the use of rapid molecular methods in the diagnosis of infectious diseases. Recent investigations in the Bonomo lab have centered upon the genetic and amino acid sequence requirements of carbapenemase enzymes.
Jeff Boyd, Ph.D., Senior Vice President, Molecular Medicine; The Robert C. Young, M.D., Chair in Cancer Research; Executive Director, Cancer Genome Institute; Chief, Division of Molecular Pathology; Professor, Cancer Biology Program, Fox Chase Cancer Center
Boyd is an international expert in translational research and has particular expertise in the genetics of breast, ovarian and endometrial cancer. He has helped define the role of tumor suppressors and oncogenes in these malignancies, most notably the p53, BRCA1 and BRCA2 tumor suppressor genes and their role in the development of breast and ovarian cancer. Boyd's previous position was director of the Curtis and Elizabeth Anderson Cancer Institute and vice president of oncology and research at the Memorial University Medical Center in Savannah, Georgia. He also served as the professor of medicine, surgery, obstetric and gynecology at the Mercer University School of Medicine. At Mercer University, he served as the assistant dean of research. He also holds the title of Distinguished Cancer Scholar from the State of Georgia. Prior to his roles in Savannah, Boyd served a variety of leadership roles at the Memorial Sloan Kettering Cancer Center in New York. At MSKCC, he was director of the gynecology and breast research laboratory in the department of surgery as well as the director of diagnostic molecular genetics laboratory within the department of medicine. Before serving at MSKCC, he had faculty positions at the University of Pennsylvania, the University of North Carolina and the National Institutes of Health (NIH).
Roslyn Brandon, Ph.D., CEO and Co-Founder, Immunoexpress
Dr. Brandon is C.E.O. and co-founder of Immunexpress, a company with novel genomic and proteomic biomarkers focused on the diagnosis of sepsis. Experienced business executive and founding CEO of life sciences start-ups, directly responsible for driving Immunexpress’s business and technology development to date. Dr. Brandon Has raised over $30 million in high risk dilutive equity capital and non-dilutive grant funding over the last 10 years.
Catherine Brownstein, M.D., Instructor, Pediatrics, Harvard Medical School and Boston Children’s Hospital
Catherine Brownstein, M.P.H, PhD, is an instructor of Pediatrics at Harvard Medical School and a project manager at Boston Children’s Hospital’s Research Connection, where she has worked to develop their research sequencing and pharmacogenomics programs. She has over 10 years of experience in genetics and toxicology, specializing in bone and endocrine disorders. Her research has elucidated phosphate regulation and the genetic causes of nemaline myopathy and Cantu syndrome. Dr. Brownstein received her Bachelor of Arts degree from Amherst College, and her joint MPH-MEM degree and PhD from Yale. Before joining BCH in 2011 she worked as a toxicologist for the Massachusetts Department of Public Health, and at the Health 2.0 startup PatientsLikeMe.
Lon Castle, M.D., Medical Science Liaison, Medical Affairs, CardioDx
Dr. Castle joined CardioDx in 2013 as a Medical Science Liaison responsible for managed care. He is tasked with securing payer coverage for the company’s proprietary gene expression test. Previously, Dr. Castle worked for Express Scripts/Medco for 12 years as Senior Director of Clinical Innovation where he designed and implemented the company’s personalized medicine testing programs. Dr. Castle’s background is in Family & Community Medicine with fellowship training in Sports Medicine.
Patricia Chan, Chief Technology Officer, Maverix Biomics
Patricia Chan has over fifteen years of software development experience in the biotech industry. She was a senior software architect at Affymetrix, responsible for designing microarray data deliverables and developing bioinformatics software. Prior to Affymetrix, she was a software engineer at Alza and IBM. She has been a research scientist at the University of California, Santa Cruz, with expertise in non-coding RNA gene discovery, metagenomic analysis, and microbial genome browser development. Dr. Chan holds dual bachelor’s degrees, an MBA from Santa Clara University, and a PhD in bioinformatics from the University of California, Santa Cruz.
Rong Chen, Ph.D., Assistant Professor, Genetics and Genomic Sciences; Director, Clinical Genome Informatics, Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai
Dr. Chen is Director of Clinical Genome Informatics at Icahn Institute of Genetics and Multiscale Biology. He leads Personalized Cancer Therapy to sequence both DNA and RNA of cancer patients, identify and integrate somatic mutations, copy number aberrations, dis-regulated genes, and gene fusions to identify driver genes and pathways and suggest therapeutics. Prior to Mount Sinai, he led the collaborative efforts at Stanford University to drive personalized medicine and clinical diagnosis on Mendelian and complex diseases using genome and exome sequencing. Dr. Chen also helped launch a startup company Personalis, which won the VA's contract for the Million Veteran Genome project. Dr. Chen has a broad interest in translational bioinformatics and genome interpretation, and has published over 60 papers in Lancet, Cell, Nature Biotechnology, Nature Methods, PNAS, AJHG, PLoS Genetics, PLoS Computational Biology, Genome Research, Genome Biology, Genome Medicine, AJT, and Proteins. He holds numerous patents for software and databases on personalized medicine, diagnosis, and structure modeling.
Charles Chiu, M.D., Ph.D., Assistant Professor, Lab Medicine and Medicine, Infectious Diseases, University of California San Francisco
Dr. Charles Chiu, M.D., Ph.D., is an Assistant Professor in Laboratory Medicine and Medicine, Infectious Diseases at the University of California, San Francisco. He is also the Director of UCSF-Abbott Viral Diagnostics and Discovery Center (VDDC) at China Basin and Associate Director of the UCSF Clinical Microbiology Laboratory. Charles is an expert in the emerging field of clinical metagenomics, and his research is focused on the development and validation of microarray and next-generation sequencing (NGS) technologies for viral discovery and pathogen diagnostics, with over 20 patents and peer-reviewed publications on these topics. In addition, he is the principal investigator of a 5-year R01 grant from the NIH on multiplexed blood bank pathogen screening, California Discovery, UC-MEXUS, and National Research Fund for Tickborne Diseases (NRFTD) grants on the microbial epidemiology of encephalitis, diarrhea, and Lyme disease, a QB3 Rogers Family Foundation Award in translational diagnostics, and a UCSF-Abbott Viral Discovery Award. Charles is also an active practicing infectious diseases physician at UCSF. Charles has active collaborations with research groups and public health agencies worldwide, including Abbott Diagnostics, Inc., Blood Systems Research Institute, the California Department of Public Health, the United States CDC, the American Red Cross, and the Texas Biomedical Research Institute.
John Clarkson, Ph.D., Chief Executive, Atlas Genetics
John Clarkson was founding Chief Executive of Atlas Genetics. He has worked previously in diagnostics and life science companies with Osmetech plc and Molecular Sensing plc in both commercial and technical roles. His background is in molecular biology and microbiology.
Laura Conlin, Ph.D., FACMG, Scientific Director, Division of Genomic Diagnostics, Children’s Hospital of Philadelphia; Assistant Professor, Pathology and Laboratory Medicine, Perelman School of Medicine at the University of Pennsylvania
I am a Director in the Division of Genomic Diagnostics at the Children’s Hospital of Philadelphia and an Assistant Professor in Pathology at the Perelman School of Medicine at the University of Pennsylvania. Our clinical laboratory carries out cytogenetic, single-gene, and genome-wide diagnostic testing in the pediatric population. I am currently a co-investigator in a Clinical Sequencing Exploratory Research (CSER) study investigating the clinical utility and implication of whole-exome sequencing in four pediatric populations. Additionally, my research interests include identification of mosaicism, modeling mechanisms of genetic alterations with focus on ring chromosomes, and disease gene discovery using SNP arrays, bioinformatics, whole-exome and whole-genome sequencing.
Robert Cook-Deegan, M.D., Research Professor, Institute for Genome Sciences & Policy, Sanford School of Public Policy, Duke University
Robert Cook-Deegan became Director for Genome Ethics, Law & Policy in July 2002. He was previously director of the Robert Wood Johnson Foundation Health Policy Fellowship program (2000-2002) at the Institute of Medicine (IOM), National Academy of Sciences, a Robert Wood Johnson Health Policy Investigator at Georgetown University (1999-2002), and a seminar leader at Stanford-in-Washington (1996-2003). He worked at The National Academies in various capacities from 1991 until coming to Duke. He is the author of The Gene Wars: Science, Politics, and the Human Genome (New York: Norton, 1994; paperback 1996; tr. Korean 1995, Japanese 1996) and an author on over 200 articles. Dr. Cook-Deegan was a member of the Board of Directors, Physicians for Human Rights, 1988-1996, with whom he participated in human rights missions to Turkey, Iraq and Panama. In 1996, Dr. Cook-Deegan was a Cecil and Ida Green Fellow at the University of Texas, Dallas, following his work for the report Allocating Federal Funds for Science and Technology (the "Press Report"). From 1991-4, he directed IOM' s Division of Biobehavioral Sciences and Mental Disorders. He worked for the National Center for Human Genome Research 1989-90, after serving Acting Executive Director of the Biomedical Ethics Advisory Committee of the U.S. Congress 1988-9. Dr. Cook-Deegan was an AAAS Congressional Science & Engineering Fellow 1982-3 and spent six years at the congressional Office of Technology Assessment. This followed two years of postdoctoral research on the molecular biology of oncogenes with Lasker Award scientist Raymond L. Erikson, after completing his internship in pathology at the University of Colorado. He received his MD degree from the University of Colorado in 1979 and his bachelor' s degree in chemistry, magna cum laude, in 1975 from Harvard College. He grew up in Denver.
Seth D. Crosby, M.D., Director, Alliances and Partnerships, Genetics, Washington University School of Medicine
Seth Crosby is the Director of Partnerships and Alliances in the Department of Genetics at Washington University. Crosby works with groups within and outside the University to leverage technology to achieve research and clinical goals. He has been at Washington University for nearly 12 years. During that time he directed the Department of Genetics Microarray Core, which is now part of GTAC and then GTAC, itself, during its first two years. Prior to that, he was the Director of Translational Research at the Genome Center (now the Genome Institute). Prior to his tenure at Washington University, Dr. Crosby worked in the field of genomics and drug discovery at Abbott Laboratories, Pfizer and Pharmacia.
Robert D. Daber, Ph.D., Director, Research and Development and Sequencing Operations, Bio-Reference Laboratories
Dr. Robert Daber is a board certified clinical cytogeneticist with expertise in bio-informatics and clinical next-generation sequencing. He holds a PhD in Biochemistry and Molecular Biophysics from the University of Pennsylvania School of Medicine and received his clinical genomic training while a Fellow at the Children's Hospital of Philadelphia. After fellowship he was responsible for building and directing the clinical genomics laboratory at the University of Pennsylvania. This included the design of new laboratory space, the development and implementation of several gene panels as well as building a customized LIMS system for sample tracking, variant review and report generation.
Shahriar Dadkhah, M.D., MBA, FACC, FSCAI, Associate Professor, Medicine, University of Illinois; Director, Cardiology Research, Saint Francis Hospital
Dr. Shahriar Dadkhah is a board certified interventional cardiologist. Dr. Dadkhah’s passion for medicine stems from his love of clinical research. Dr. Dadkhah has been conducting research since 1979. He has authored over fifty publications in journals such as the American Journal of Cardiology, Angiology, Circulation, and Critical Pathways in Cardiology. He has also authored a Chapter on the epidemiology and demography of coronary artery disease in the Short Stay Management of Chest Pain textbook and chapter on Heart Failure and Kidney disease in the Short Stay Management of Acute Heart Failure textbook.
Mark Del Vecchio, Senior Director, Regulatory Affairs, Molecular Diagnostics, Women's Health and Cancer Corporate, BD Diagnostics
Mark Del Vecchio has recently joined BD Diagnostics as Senior Director of Regulatory Affairs, Molecular Diagnostics/Women’s Health and Cancer, with over 20 years of clinical and regulatory experience in the biotechnology and molecular in-vitro diagnostic (IVD) industries. Prior to coming to BD, Mr. Del Vecchio served as Vice President of Regulatory Affairs for Nanosphere and LipoScience, Vice President of Regulatory and Clinical Affairs for Digene Corporation (now Qiagen), Director of Regulatory Affairs in the Food, Drug, Medical Device, and Agriculture practice at Hogan and Hartson, LLP, (now Hogan Lovells) and Manager of Clinical Affairs for Roche Molecular Systems. In these positions, Mr. Del Vecchio has acquired extensive experience interacting with the US Food and Drug Administration (FDA) Office of In-Vitro Diagnostics and Radiological Health (OIR) and several international regulatory authorities, having worked predominantly with IVD’s on the leading-edge of diagnostic technology. Mr. Del Vecchio currently co-chairs the AdvaMedDX Diagnostics Task Force and has also served as Special Representative to the AdvaMed Board of Directors and as a member of the AdvaMed Diagnostic Sector Technology and Regulation Sub-Committee. Mr. Del Vecchio has presented at several workshops and conferences sponsored by the FDA, AdvaMed, Association of Medical Diagnostics Manufacturers (AMDM), and Regulatory Affairs Professional Society (RAPS), addressing topics related to IVD technology, policy, and regulation. Mr. Del Vecchio holds a Bachelor of Science degree in Biochemistry from the University of Scranton.
Maximilian Diehn, M.D., Ph.D., Assistant Professor, Radiation Oncology, Stanford Cancer Institute, Institute for Stem Cell Biology & Regenerative Medicine, Stanford University
Maximilian Diehn MD, PhD is an Assistant Professor of Radiation Oncology at Stanford University and has co-appointments in the Stanford Cancer Institute and Institute for Stem Cell Biology and Regenerative Medicine. He is a board certified Radiation Oncologist and specializes in treatment of lung cancer. Dr. Diehn’s research programs span basic, translational, and clinical studies. He has made significant contributions in number of areas, including in cancer stem cell biology and cancer genomics, and his work has been recognized with numerous honors, including the NIH Director’s New Innovator Award. Dr. Diehn’s group recently developed a next generation sequencing-based method for detection of circulating tumor DNA called CAPP-Seq. Further development and clinical application of this approach are major ongoing research efforts.
David P. Dimmock, M.D., Associate Professor, Pediatrics, Medical College of Wisconsin
David P. Dimmock, MD is an Associate Professor at the Medical College of Wisconsin. Dr. Dimmock completed medical school at St. George’s Hospital Medical School. He completed his Pediatric training at St. Joseph Hospital in Phoenix and his Clinical & Biochemical Genetics training at Baylor College of Medicine in Houston. Dr. Dimmock is a clinical geneticist with an interest in the diagnosis of mitochondrial disorders. He is a nationally renowned expert on the clinical application of whole genome sequencing. His translational research interests are focused on developing better diagnostic testing for mitochondrial disorders. Dr. Dimmock’s basic science laboratory studies the interplay between mitochondrial dysfunction and predisposition to liver disease. The FDA Office of Orphan diseases has asked Dr. Dimmock to participate in ad-hoc reviews. He is a member of the Society of Inherited Metabolic Diseases.
Kenneth Emancipator, M.D., Merck Research Laboratories
Kenneth Emancipator, MD, DABP is nationally renowned pathologist who currently leads all companion diagnostics programs at Merck Research Laboratories and serves on the Board of Directors of the American Society for Clinical Pathology (ASCP). He is also a regular reviewer for the American Journal of Clinical Pathology. He has in-depth experience with in vitro diagnostics from every perspective, having served as medical director both for academic clinical laboratories and for diagnostics manufacturers, and having been a reviewer for the US Food and Drug Administration. Dr. Emancipator received his A.B. degree from Harvard University and his M.D. from St. Louis University. He completed his medical internship at Westchester County Medical Center and his pathology residency at the State University of New York at Stony Brook. He has held appointments at the US National Institutes of Health, Cornell University, Beth Israel Medical Center, Bayer Healthcare, Siemens Healthcare, and Abbott Molecular prior to joining Merck in 2011. He also has held various leadership positions with ASCP since 1994. He has published 61 articles and given 86 extramural presentations. Dr. Emancipator’s primary interest has always been the role of diagnostic tests in driving clinical decisions. His current focus is personalized medicine and precision diagnostics. When not in his office at Merck, he is most likely to be found along the beaches and coastal waterways of Eastern Long Island.
David Erickson, Ph.D., Associate Professor, Sibley School of Mechanical & Aerospace Engineering, Cornell University
Prof. David Erickson is an Associate Professor in the Sibley School of Mechanical and Aerospace Engineering at Cornell University. Prior to joining the faculty in 2005, he was a postdoctoral scholar at the California Institute of Technology and he received his Ph.D. degree from the University of Toronto in 2004. He is currently an associate editor of the Journal Smart Materials and Structures and the Journal of Microfluidics and Nanofluidics. Research in the Erickson lab is primarily funded through grants from the NSF, NIH, ARPA-E, ONR, DOE and DARPA. Prof. Erickson is the Co-Founder of Optofluidics, Inc. which is commercializing high-throughput nanoparticle analysis systems and was named Philadelphia life-sciences start-up of the year in 2012. In recent years, Dr. Erickson has received the DARPA-MTO Young Faculty Award, the NSF CAREER Award, and the Department of Energy Early Career Award. In 2011 he was awarded the Presidential Early Career Award for Scientist and Engineers (PECASE) by President Obama. For his efforts in co-founding the field of optofluidics, Erickson was named a fellow of the Optical Society of America in 2012.
Mark T. Esser, Ph.D., Director, Translational Medicine, Infectious Diseases and Vaccines, MedImmune
Brigitte Faas, Ph.D., Clinical Laboratory Geneticist, Human Genetics, Radboud University Nijmegen Medical Center
Dr. Brigitte Faas is Clinical Laboratory Geneticist at the department of Human Genetics at the Radboud University Medical Center in Nijmegen, The Netherlands. As such, she is responsible for the prenatal diagnostic laboratory service and for developing and implementing new laboratory techniques. She has been involved in noninvasive prenatal testing since the 1990's, when, during her PhD thesis, she was studying the possibilities to perform noninvasive prenatal diagnosis for the Rhesus antigens. At the laboratory in Nijmegen, all established prenatal techniques are in use, such as karyotyping, QF-PCR, SNP array analysis and whole genome noninvasive prenatal testing. dr Faas was involved in the European external quality control service for many years. She is now involved in the educational activities of the International Society for Prenatal Diagnosis, is member of the scientific committee of that society and is associate editor for Prenatal Diagnosis of the Genetics and Genomics section.
Helen Fernandes, Ph.D., Pathology & Laboratory Medicine, Weill Cornell Medical College
Helen Fernandes, PhD, is an Associate Professor of Pathology in the Department of Pathology and Laboratory Medicine at Weill Cornell Medical College and serves as the Chief of the Solid Tumor section in Molecular Diagnostics at New York Presbyterian Hospital. She has over 17 years of experience in Molecular Pathology and established the largest non-commercial molecular diagnostics laboratory in the state of New Jersey at the University of Medicine & Dentistry of New Jersey.Dr Fernandes is involved in the training and education of molecular diagnosticians and has presented at several meetings and webinars nationally and internationally. She is an active committee member of the Association for Molecular Pathology (AMP), a board member of the American Board for Clinical Chemistry (ABCC) and a member of the consensus committee for molecular methods for Clinical Laboratory Standards Institute (CLSI). She serves on the editorial board of journals, has contributed chapters in books and has more than 37 research articles in peer reviewed journals. Her research interests are in the pathogenesis and association of genomic variants in solid tumors and infectious diseases.
Jonathan Frampton, Ph.D., Global Product Manager, Horizon Diagnostics
Jonathan is the Global Diagnostic Product Manager at Horizon Discovery. In his role, he works closely with a broad range of European, North American and EMEA oncology-focused Quality Assurance Schemes with the goal of driving the standardization and normalization of NGS assays across the globe. Jonathan holds a PhD from University of Sussex in Genomic DNA Damage and Stability and has extensive product development experience through previous roles including Cambridge-based antibody company Abcam.
Carlos Gil Ferreira, M.D., Executive Director, INOVA-CANCER; Director, Clinical Research, Brazilian National Cancer Institute
Dr. Ferreira graduated in Medicine from the Federal University of Juiz de Fora (1992), and did his residency in internal medicine at UERJ in 1994 and in Clinical Oncology at (INCA) in 1997. He received his PhD in Experimental Oncology at the Free University of Amsterdam in 2001. His previous roles have been as Senior Researcher and Coordinator of Clinical Research and Technological Embedding at the National Cancer Institute (INCA), Founder and Coordinator of the National Tumor and DNA Bank (BNT), and Coordinator of the National Network for Clinical Cancer Research (RNPCC), and Coordinator of the National Network for Drug Development (REDEFAC). Supervised and co-supervised 20 master dissertations and 8 doctoral theses. He currently supervises 4 post doctorate candidates. His experience is in the area of Medicine, with an emphasis on Oncology, acting on the following topics: lung cancer, drug development, applied molecular biology, biomarkers, network projects and tumor bank. He has a major role in projects for health innovation with a focus on strategic partnerships for the development of drugs, kits and equipment in oncology. He is now the Executive Director of INOVA-CANCER, a program of the Ministry of Health to foster technology development and access to cancer care in Brazil.
Thomas M. File, Jr. M.D., MSc, MACP, FIDSA, FCCP, Chair, Infectious Disease Division, Summa Health System; Professor, Internal Medicine; Master Teacher; Chair, Infectious Disease Section, Northeast Ohio Medical University (NEOMED)
Dr. File is a Master of the American College of Physicians, a fellow and a past member of the Board of Directors of the Infectious Diseases Society of America (IDSA), and a fellow of the American College of Chest Physicians. He is President of the Board of Directors of the National Foundation for Infectious Diseases and is a member of many other professional societies, including the American Society for Microbiology, the American Thoracic Society (ATS) and the European Society of Clinical Microbiology and Infectious Diseases. He is a previous Chairperson of the Standards and Practice Guidelines Committee of the IDSA and has also served as a member of the IDSA and ATS committees for guidelines on community-acquired pneumonia; and is a member of the IDSA guidelines panels for hospital-acquired pneumonia, influenza and sinusitis. He is a past-president of the Infectious Disease Society of Ohio, and of the Northeastern Ohio Task Force on AIDS. Primary research interests that Dr File has pursued include community-acquired respiratory tract infections, immunizations in adults, bacterial resistance in respiratory infections, infections in patients with diabetes, soft tissue infections, and evaluation of new antimicrobial agents. He has had extensive experience in the development and implementation of randomized clinical trials for evaluation of new antimicrobials. A frequent lecturer both nationally and internationally, Dr. File has published more than 250 articles, abstracts and textbook chapters, focusing on the diagnosis, etiology and treatment of infectious diseases, and in particular, respiratory tract infections.
Eric Fung, M.D., Ph.D., Vice President, Research and Development, Clinical Applications, Affymetrix
Eric Fung, MD, PhD is Vice President R&D, Clinical Applications at Affymetrix, Inc. Dr. Fung earned his MD, PhD at the Johns Hopkins University School of Medicine and his BS from the California Institute of Technology. Previously, Dr. Fung was CSO at Vermillion, Inc. where he developed and obtained FDA clearance for OVA1, the first IVD multivariate index assay for ovarian tumor triage. Dr. Fung has also held research leadership positions at Ciphergen and Roche.
Wayne W. Grody, M.D., Ph.D., Professor, Medical Genetics and Molecular Pathology, Pathology & Lab Medicine, Pediatrics, and Human Genetics; Director, Molecular Diagnostic Laboratories and Clinical Genomics Center, UCLA School of Medicine
Wayne W. Grody, M.D., Ph.D. is a Professor in the Departments of Pathology & Laboratory Medicine, Pediatrics, and Human Genetics at the UCLA School of Medicine. He is the director of the Diagnostic Molecular Pathology Laboratory within the UCLA Medical Center, one of the first such facilities in the country to offer DNA-based tests for diagnosis of a wide variety of genetic, infectious, and neoplastic diseases, as well as bone marrow engraftment, patient specimen identification and paternity testing by DNA fingerprinting. He is also an attending physician in the Department of Pediatrics, specializing in the care of patients with or at risk for genetic disorders. He has been one of the primary developers of quality assurance and ethical guidelines for DNA-based genetic testing for a number of governmental and professional agencies including the FDA, AMA, CAP, ACMG, ASHG, NCCLS, CDC, NIH-DOE Human Genome Project (ELSI program), and PSRGN. He served as a member of the NIH-DOE Task Force on Genetic Testing, and was the working group chair for development of national guidelines for cystic fibrosis and factor V-Leiden mutation screening. Most recently, he was appointed chair of an Advisory Committee on Genomic Medicine for the entire VA healthcare system, and is President-Elect of the American College of Medical Genetics. He did his undergraduate work at Johns Hopkins University, received his M.D. and Ph.D. at Baylor College of Medicine, and completed residency and fellowship training at UCLA. He is double board-certified by the American Board of Pathology (Anatomic and Clinical Pathology, Molecular Genetic Pathology) and the American Board of Medical Genetics (Clinical Genetics, Molecular Genetics, and Biochemical Genetics).
Jeremy Goecks, Ph.D., Assistant Professor, Computational Biology, Integrative Systems Biology and The Computational Biology Institute, George Washington University
Jeremy is an Assistant Professor of Computational Biology at George Washington University. His research agenda centers on (a) using high-throughput biomedical data for disease prediction and treatment, with a focus on cancer and (b) creating interactive computing systems that enable anyone, regardless of their background, to effectively use high-throughput analyses for biomedical applications. He is a lead member of the Galaxy project; Galaxy is a popular Web-based platform for performing accessible, reproducible, and transparent genomics research. Jeremy received his Ph.D. from Georgia Tech and his B.S. (with Honors) from the University of Wisconsin.
Daniel Grosu, M.D., MBA, Vice President, Clinical Development & Medical Affairs, Illumina Inc
Dr. Daniel Grosu joined Illumina in 2011 and is currently the Vice President of Clinical Development and Medical Affairs at the Company. He led the team that carried out the clinical trials supporting the recent FDA clearance of the MiSeqDx, the first NGS platform to receive marketing authorization from the FDA and CE Marking in Europe. Dr. Grosu has had a longstanding interest in innovative diagnostic technologies, spanning previous assignments with Siemens Medical Solutions, Bayer HealthCare Pharmaceuticals, and Johnson & Johnson. He holds an MD (with Distinction in Research) from Saint Louis University School of Medicine, and an MBA from the University of Oxford.
John W. Hanna, MBA, Senior Director, Policy & Reimbursement, Veracyte Inc.
John leads the managed care team at Veracyte Inc., focusing on coverage, contracting, and reimbursement for the company’s flagship molecular diagnostic product Afirma. He also heads up the company’s government affairs and policy initiatives. John began his career in health policy and managed care at America’s Health Insurance Plans (AHIP) in Washington D.C. Prior to joining Veracyte, John spent five years at Humana Inc., one of the nation’s largest commercial health insurers.
Michael Heller, Ph.D., Professor, Nanoengineering and Bioengineering, University of California San Diego
Michael J. Heller: Ph.D., Biochemistry, Colorado State University 1973; NIH Postdoctoral Fellow, Northwestern University; Supervisor DNA Technology Amoco, 1976-1984; Director Molecular Biology, Molecular Biosystems,1984-1987; Co-founder/President, Integrated DNA Technologies,1987-1989; Co-founder/CTO, Nanogen, 1993-2001; Professor, Departments of Nanoengineering and Bioengineering at the University California San Diego (2001–Present). Work includes development of sample to answer diagnostic systems for cancer and other diseases; with over 50 US patents in the diagnostic and nanotechnology areas.
James Hicks, Ph.D., Research Professor, Cancer Genomics, Cold Spring Harbor Laboratory
Dr. James Hicks is Research Professor of Cancer Genomics at Cold Spring Harbor Laboratory. He received his Ph.D. in 1975 from the University of Oregon, followed by a postdoctoral fellowship at Cornell University. In 1978 he co-founded the yeast molecular genetics group at CSHL, working on moveable genetic elements in mating type switching and other developmental processes. In 1990 he entered the biotechnology industry, becoming one of the founding scientists of ICOS Corporation in Seattle. After ten years as an entrepreneur, starting several companies in the Internet and health sciences area, he returned to Cold Spring Harbor Laboratory in 2004, joining Dr. Mike Wigler to work on the genomics and epigenomics of breast cancer. In his current work he and his colleagues are applying next-generation DNA sequencing strategies to perform genomic analysis on single cancer cells, a strategy designed to understand how cancers evolve and become resistant to treatment. This technology is now being applied in clinical settings and focused on matching patients with the most effective treatments, and making real the concept of personalized medicine. Dr. Hicks has co-authored over 100 articles on yeast genetics and cancer genomics and serves on the advisory boards of several biotechnology companies.
Mark Hills, Ph.D., Research Scientist, Peter M. Lansdorp Laboratory, BC Cancer Research Centre
Mark Hills received his Ph.D working on telomere genetics at the University of Leicester, UK. Moving to the laboratory of Peter Lansdorp at the BC Cancer Agency, he has worked on multiple projects relating to telomeres in the hematopoietic system; normal hematopoietic turnover, late-graft failure, and hematopoietic disease and malignancy. His research focus shifted into genomics, using exome sequencing to identify causal mutations in myelodysplastic syndromes, before completely switching to bioinformatics. His current research interests focus on writing software to create genome assemblies from Strand-seq data, and to map structural variation in both normal and cancer cells.
Frank Holtrup, Ph.D., Head, R&D Lab Services, Sysmex Inostics
As Head of R&D Service Laboratories at Sysmex Inostics, Frank Holtrup is responsible for the development of assays and new biomarker detection concepts based on BEAMing digital PCR and Next Generation Sequencing. Having worked for several biotech companies, he gained a strong background in cancer biology and functional genomics. He earned his graduate degree from the University of Heidelberg, and the German Cancer Research Center (DKFZ) also in Heidelberg.
Patric Hooper, Founding Partner, Hooper, Lundy & Bookman, PC
Mr. Hooper received his A.B. degree in economics from the UCLA in 1970 and his J.D. from the University of San Diego School of Law in 1973. As one of the founding partners of Hooper, Lundy & Bookman, P.C., Mr. Hooper continuously advises health care providers of Medicare, Medicaid and CHAMPUS fraud and abuse issues and on state anti-rebate and referral issues. He is a former general counsel to the NAPTCC, and is a member of the AHLA, the HFMA, the CSHA, and the CCLA. He was also the first chair of the Fraud and Abuse Interest Group of the ABA Health Law Section. In May 2013, Mr. Hooper received the prestigious UCLA Longevity Center ICON Award for "Visionary Leadership in Healthcare Law." He is an annual recipient of "Best Healthcare Lawyer" awards issued by state and national publications such as Chambers USA and the Best Lawyers In America.
Dr. Pawan K. Jain, M.D., Ph.D. , Senior Regulatory Scientist, Division of Emerging and Transfusion Transmitted Disease, Office of Blood Research and Review, Center for Biologics Evaluation Research, FDA
Dr. Jain has several years of experience in biomedical research at the National Institutes of Health, USA, and has been working at the Center for Biologics Evaluation and Research, Food and Drug Administration for more than 10 years, and contributes towards review of HIV diagnostic devices and Blood Safety and Availability.
David James, Senior Vice President, IVD Division, Invetech
David James is the Senior Vice President of Diagnostics at Invetech, a full spectrum product realization partner that assists companies in creating ground breaking products through excellence in design, engineering and manufacturing. David has more than 25 years of experience providing consulting and development services in specialist areas including Invitro and Point of Care Diagnostics, Life sciences and Cell Therapy automated production systems. David is recognized for his insights and expertise in managing complex projects that are at the forefront of technology, and collaborating with clients and multi-disciplinary teams to develop market-winning solutions. He is a vocal advocate for technical risk management within new product development and specifically the impact of early stage decision-making on the commercial success of a product.David holds a bachelor’s degree in Engineering from the University of Melbourne, is a regular conference speaker, holds several patents and is the author of numerous articles and white papers.
François Jean, Ph.D., Scientific Director, UBC Facility for Infectious Disease and Epidemic, Research (FINDER), Associate Professor, Department of Microbiology and Immunology, Laboratory for Antimicrobial Therapy, University of British Columbia
Dr. François JEAN is the scientific director of the University of British Columbia Facility for Infectious Disease and Epidemic Research (www.finder.ubc.ca) and a tenured associate professor in the field of virology.He has been leading major research initiatives funded by CIHR to discover novel broad-spectrum antiviral agents and biomarkers directed at human viruses of great concern around the world. Dr. Jean holds 11 collective invention disclosures, has published 146 peer-review papers and abstracts, has given 64 invited presentations, and has mentored 81 trainees in virology (www.microbiology.ubc.ca/jean).
Andreas Jeromin, Ph.D., Scientific and Medical Officer, Quanterix Corporation
Andreas Jeromin, PhD, has established research programs in translational neuroscience in both industry and biotech for the last 15 years and co-authored more than 100 publications. He has also been elected a member of the Dana Alliance for Brain Initiatives. Andreas Jeromin has led biomarker qualification programs in diagnostics and therapeutics in acute neurological injury and neurodegeneration. This included several drug development program from POC to a NINDS-supported phase III trial (Protect III). He also supports as member of the SABs or steering committee, several biomarker qualification efforts such as ADNI, the Coalition against Major Diseases (CAMD) directed by the Critical Path Institute (C-PATH), the Alzheimer's Association CSF QC and biomarker assay standardization initiatives in other CNS disorders, including MS (Accelerated Cure, ALS and PD. He is the founder and CSO of Atlantic Biomarkers, LLC, and joined Quanterix, Inc. as scientific and medical advisor in 2014.
Shana Kelley, Ph.D., Chief Technology Officer, Xagenic Inc.
Shana Kelley is a founder of Xagenic Inc. and the company’s Chief Technology Officer. She also holds a faculty appointment at the University of Toronto, and has research interests ranging from the development of new diagnostic technologies to drug delivery. Dr. Kelley was a co-founder of GeneOhm Sciences, a San Diego-based diagnostics company that was acquired by Becton Dickinson in 2005. She has been recognized with a variety of distinctions, including being named one of "Canada’s Top 40 under 40" and a NSERC E.W.R. Steacie Fellow. She has also been recognized with the Steacie Prize and was also named a "Top 100 Innovator" by MIT's Technology Review. Dr. Kelley obtained a Ph.D. in Chemistry from the California Institute of Technology
Muin J. Khoury, M.D., Ph.D., NCI Epidemiology and Genomics Research Program, CDC Office of Public Health Genomics
Dr. Khoury is the founding director of the CDC's Office of Public Health Genomics. The Office was formed in 1997 to assess the impact of advances in human genetics and the Human Genome Project on public health and disease prevention. CDC's Office of Public Health Genomics serves as the national focus for integrating genomics into public health research and programs for disease prevention and health promotion. Dr. Khoury has developed a number of successful ongoing national and international initiatives to translate advances in genomics and related technologies to recommendations and actions that improve health and prevent disease throughout the life stages. Since 2007, he has also served the National Cancer Institute as senior advisor in public health genomics in the Division of Cancer Control and Population Sciences External Web Site Icon. Since 2011, he leads the Epidemiology and Genomics Research Program External Web Site Icon in the same Division. Dr. Khoury received his B.S. degree in Biology/Chemistry from the American University of Beirut, Lebanon and his medical degree and Pediatrics training from the same institution. He received a Ph.D. in Human Genetics/Genetic Epidemiology and training in Medical Genetics from Johns Hopkins University. Dr. Khoury is board certified in Medical Genetics.
Scott Kopetz, MD, PhD, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Dr. Scott Kopetz graduated Summa Cum Laude from Vanderbilt University with a bachelor’s degree in Biomedical Engineering/Electrical and received his medical degree from Johns Hopkins School of Medicine. He obtained his residency training in Internal Medicine at Duke University Medical Center, followed by a medical oncology fellowship at M. D. Anderson Cancer Center. Dr. Kopetz joined M. D. Anderson Cancer Center in 2006 as an Assistant Professor of Medicine in the Department of Gastrointestinal Medical Oncology. He subsequently completed a Ph.D. at M.D. Anderson in cancer biology with thesis focus on mechanisms of chemotherapy resistance in colorectal cancer. Dr. Kopetz is board-certified in Internal Medicine and in Medical Oncology. He has authored over 100 peer-reviewed articles in respected scientific journals such as Journal of Clinical Oncology, Lancet, Cancer Research, Cancer, Clinical Cancer Research, and JAMA, and is a member of the editorial board for Clinical Cancer Research, Journal of Clinical Oncology, Carcinogenesis, and JNCI. In addition, he was a recipient of peer-reviewed grants from American Society of Clinical Oncology and the National Institute of Health, among others. He is the principal investigator several phase I and II clinical trials, including of Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC) study, a novel biomarker enrichment program for colorectal cancer. His research interests include the biology of the refractory colorectal cancer and the development of novel therapeutics for molecularly distinct subsets of colorectal cancer patients.
Bruce Korf, M.D., Ph.D., Wayne H. and Sara Crews Finley Chair, Medical Genetics; Professor and Chair, Genetics; Director, Heflin Center for Genomic Sciences, University of Alabama at Birmingham
Dr. Korf completed his undergraduate studies and MD at Cornell University and received his PhD in genetics and cell biology from Rockefeller University. He then did training in pediatrics, child neurology, and genetics at Children’s Hospital, Boston, and is board certified in all three areas, as well as clinical cytogenetics and clinical molecular genetics. He served as clinical director and associate chief of the Children’s Hospital, Boston Division of Genetics until 1999, when he assumed the role of medical director of the Harvard-Partners Center for Genetics and Genomics. In 2003 he moved to University of Alabama at Birmingham, where he is the Wayne H. and Sara Crews Finley Professor of Medical Genetics, chair of the Department of Genetics, and director of the Heflin Center for Genomic Sciences. Dr. Korf is past president of the Association of Professors of Human and Medical Genetics and of the American College of Medical Genetics and Genomics and currently is president of the ACMG Foundation for Genetic and Genomic Medicine. He has served on the Liaison Committee on Medical Education and the Board of Scientific Counselors of the National Cancer Institute and of the National Human Genome Research Institute at the NIH. Dr. Korf is author of Human Genetics and Genomics, co-author of Medical Genetics at a Glance, and co-editor of Current Protocols in Human Genetics and Emery and Rimoin’s Principles and Practice of Medical Genetics. His research focus is the genetics and treatment of neurofibromatosis type 1 and he also has a major interest in genetics and genomics education and the integration of genetics into medical practice.
Matthew Kreifels, Manager,Research & Development, Molecular Technology, Streck, Inc.
Matthew Kreifels is the Molecular Technology Manager for Streck. He has been employed with Streck, Inc. for 14 years and has held various roles in instrument and manufacturing equipment development. For the last four years, he has worked with internal and external teams to develop and commercialize a rapid molecular thermal cycling platform. The first instrument, a rapid conventional thermal cycler, and a patented plastic PCR tube consumable were released in 2012. Currently his team is developing a rapid 20-minute real-time thermal cycling platform. The application fields for the molecular platform include forensics, gram-negative resistance gene detection, tissue typing and related research. Matthew received a dual master’s degree in business and bio-science management in 2012 from Creighton University, Omaha, NE.
Parveen Kumar, Research Scientist, Thierry Voet Laboratory, Human Genetics, University of Leuven
Parveen Kumar is a Ph.D. student in the laboratory of Prof. Thierry Voet at University of Leuven, Belgium. His major area of interest is single-cell genomics to study genome instability and genetic heterogeneity in tumors at high resolution. Recently, they have published a novel method to study DNA mutation rate per cell-cycle using paired-end single-cell sequencing. They have also provided a proof-of-principle for sequencing of disseminated tumor single cells and correlation with primary copy number profiles.
Eric Lai, Ph.D., Senior Vice President & Head, Pharmacogenomics, Takeda Pharmaceuticals
Dr. Eric Lai is Senior Vice President and Head of Pharmacogenomics at Takeda Pharmaceutical. Before he joined Takeda, he was the SVP and Head of Research and Development at Gen-Probe (now part of Hologic Inc) from 2009 – 2012 and before that he was the VP of Pharmacogenetics at GlaxoSmithKline for over 13 years. Dr. Lai received his Ph.D., from Columbia University and did his post-doctoral training at Dr. Lee Hood’s laboratory at CalTech in the early days of the Human Genome Project. He was the co-scientific leader of The SNP Consortium and the Severe Adverse Reaction Consortium. For almost 20 years, Dr. Lai has focused his efforts in the clinical application of Pharmacogenomics in drug development and drug safety. Dr. Lai discovered the association of HLA5701 to Abacavir hypersensitivity reaction and oversaw the clinical development and application of this test.
Melissa J. Landrum, Ph.D., Staff Scientist, NIH/NLM/NCBI
Melissa J. Landrum received her PhD in human genetics from Johns Hopkins University, where she studied a viral vector for gene therapy in Garry Cutting's lab. She came to NCBI in 2000, where she worked on gene annotation for human and other mammalian genomes as part of the RefSeq project. In 2013, she joined the medical genetics group at NCBI; she is now the scientific lead for ClinVar and other related resources.
Nathan A. Ledeboer, Ph.D., D(ABMM), Assistant Professor & Medical Director, Clinical Microbiology, Medical College of Wisconsin
Dr. Ledeboer received his B.A. Degree from Dordt College in 2000 and 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 became an Assistant Professor of Pathology at the Medical College of Wisconsin and Medical Director of Clinical Microbiology and Molecular Diagnostics at Froedtert Hospital and Dynacare Laboratories in Milwaukee, WI where he has remained for more than 5 years. In addition to his service activities as director of clinical microbiology and molecular diagnostics at a large academic medical center, Dr. Ledeboer continues to develop his research career. His research endeavors, particularly in the area developing diagnostic tools for infectious diseases, have led to numerous publications in peer-reviewed journals. He has been Chairman of Public and Professional Affairs for the South Central Association for Clinical Microbiology and served on the American Society for Microbiology’s Clinical Microbiology Task Force. Dr. Ledeboer is currently a member of the American Board of Medical Microbiology Exam committee, a member of the Committee on Postgraduate Educational Programs through the American Society for Microbiology, and is the microbiology scientific program chair for The Association for Mass Spectrometry: Applications to the Clinical Laboratory. He is currently a member of the editorial board of the Journal of Clinical Microbiology and serves as an ad hoc reviewer for numerous other journals in infectious diseases and clinical microbiology. He has delivered nearly 100 invited lectures in various medical-scientific educational forums worldwide and has served as an investigator on more than 75 funded research projects. In 2011, he received the distinguished Siemens Young Investigator Award from the American Society for Microbiology.
Nicholas J. Lench, Ph.D., FRCPath, Director, NE Thames Regional Genetics Service, Great Ormond Street Hospital for Children NHS Foundation Trust
Nick is Director of the NE Thames Regional Genetics Service at Great Ormond Street Hospital for Children, London, which provides a clinical service and DNA diagnostic testing to a population of approximately 4.5M people. Nick holds an honorary appointment with the UCL Institute of Child Health, Genetics and Genomics Medicine Programme. Nick has extensive experience as an active research scientist gained at the University of Leeds, University of London and University of North Carolina, Chapel Hill and was awarded a personal chair in Medical Genetics at Cardiff University in 2005. He has authored over 100 peer-reviewed publications. Nick studied for his PhD at St Mary's Hospital Medical School, London contributing to the mapping and cloning of the gene for cystic fibrosis.
Zhenyu Li, Ph.D., Assistant Professor, Department of Engineering and Computer Engineering, The George Washington University
Dr. Zhenyu Li is an assistant professor in the Electrical and Computer Engineering department at the George Washington University where he leads the Nanophotonics and Microfluidics Laboratory. Dr. Li received his Ph.D. degree in Electrical Engineering from the California Institute of Technology (Caltech) in 2008. From 2008-2009, he was a postdoctoral scholar in the Nanofabrication group at Caltech. His research interests include nanophotonics, microfluidics, and their applications in POC diagnostics.
Rajyalakshmi “Raja” Luthra, Ph.D., Director, Molecular Diagnostic Laboratory (MDL) and Molecular Genetic Pathology Fellowship Program; Medical Advisor, Molecular Genetic Technology Program, School of Health Professions; Professor, Hematopathology, The University of Texas MD Anderson Cancer Center
Dr. Raja Luthra is a professor in the Division of Pathology and Laboratory Medicine and serves as the Director of the Molecular Diagnostics Laboratory at The University of Texas M.D. Anderson Cancer Center. She has established a state-of-the-art Molecular Diagnostic Laboratory that serves cancer patients. Dr. Luthra is instrumental in developing and implementing diagnostic molecular assays using various technologies including HiSeq, MiSeq, Ion Torrent and Ion Proton next generation sequencing platforms for clinical management of patients with cancer. Dr. Luthra has published over 170 peer-reviewed articles in molecular diagnostics and molecular oncology. She plays a prominent role in education as the Director of the Molecular Genetic Pathology Fellowship Program and as the Medical Advisor for Molecular Genetic Technology programs at M.D. Anderson Cancer Center and The University of Texas Health Science Center at Lubbock, Texas.
Michael Masterman-Smith, Ph.D., Entrepreneurial Scientist, UCLA California NanoSystems Institute
Dr. Masterman-Smith is a Molecular & Medical Pharmacology Ph.D. from the Geffen UCLA School of Medicine with postdoctoral training in the development of microfluidics-based single-cell analysis technologies in the Department of Bioenegineering in the UCLA Samueli School of Engineering. He was co-discoverer of human cancer stem cells in soft tissue cancers and pioneered methodologies to create cancer stem cell lines from patient biopsy tissues. These seminal studies underlie a new and rapidly expanding field of cancer biology. As an interdisciplinary technology developer and cancer biologist in the California NanoSystems Institute, he invented an award-winning high-sensitivity single-cell diagnostic and drug development technology to complete an NCI Alliance for Nanotechnology in Cancer clinical feasibility trial ahead of schedule and under budget. Publications have been cited >1500 times and led to key leadership roles in the founding of several biotechnology companies.
Thomas May, Ph.D., Associate Professor, Bioethics and Medical Humanities; Director, Graduate Program in Bioethics, Center for Bioethics and Medical Humanities, Medical College of Wisconsin
Thomas May is an Associate Professor of Bioethics, Center for Bioethics and Medical Humanities and Institute for Health and Society, at the Medical College of Wisconsin. His research focuses on moral, social and political issues in public health and health care policy, including issues of justice, genetics and genomics, bioterrorism defense and response, and childhood vaccination. Dr. May has published a number of articles and authored two books in these areas, and he has served as a consultant to the Florida Department of Health, as a member of the American Philosophical Association’s Committee on Philosophy and Medicine, and as Chair of the American Public Health Association ‘Ethics Forum’.
Raja Mazumder, Ph.D., Associate Professor, Biochemistry and Molecular Biology, George Washington University
Applied bioinformatics strongly rooted in evolutionary biology form the basis of Dr. Mazumder’s research program at the George Washington University in Washington, DC. Many bioinformatics predictions have been validated in his laboratory, with a few that are in the wet-lab testing phase. His current research goals include conducting a comprehensive comparative analysis at the genomic level (next-generation sequence data) to connect sequence variation to phenotype, develop methods to efficiently store and process big data and create bioinformatics data-warehouse and workflows for "omics" data integration using private, public and personal cloud computing technologies. His method applies knowledge derived using bioinformatic approaches in conjunction with experimental data to identify potential experimental targets for development of diagnostics/therapeutics.
Daniel McClernon, President, CSO, Virology, bioMONTR Labs
Daniel McClernon is co-founder and President of bioMONTR labs, an infectious disease laboratory specializing in assay development and clinical testing. A former Principal Scientist with 30 years experience in pharmaceutical drug discovery, Daniel began his career at Burroughs Wellcome pharmaceutical company where he studied/developed tests for screening DNA Topoisomerase and Herpes Simplex Virus Inhibitors. In 1995 he moved over into HIV clinical research, contributing to the FDA approvals of four GlaxoWelcome HIV drugs. His current work involves applying molecular technologies for clinical applications pursuant to global healthcare initiatives such as sample transport, drug resistance and viral load. He is based in Research Triangle Park, North Carolina.
Heather McLaughlin, Ph.D., MB(ASCP)CM, Instructor of Pathology, Massachusetts General Hospital and Harvard Medical School and Assistant Laboratory Director, Laboratory for Molecular Medicine, Partners HealthCare Personalized Medicine
Dr. McLaughlin received a B.S. in Diagnostic Molecular Science from Michigan State University, a Ph.D. in Human Genetics from the University of Michigan and has just completed a Clinical Molecular Genetics Fellowship at the Harvard Medical School Genetics Training Program. She has recently accepted a position at Partners HealthCare Personalized Medicine’s Laboratory for Molecular Medicine, where she will serve as an Assistant Laboratory Director. Dr. McLaughlin’s clinical interests focus on molecular diagnostic testing for inherited cardiomyopathies and pulmonary disorders and the implementation of exome and genome sequencing into the clinical laboratory. She is also interested in exploring incidental findings in individuals undergoing genomic sequencing and developing reporting formats that will aid in the integration of genomic sequencing into clinical medicine.
Christine Micheel, Ph.D., Research Assistant Professor, Medicine, Vanderbilt-Ingram Cancer Center; Managing Editor, MyCancerGenome.org
Christine Micheel joined the Vanderbilt-Ingram Cancer Center in December 2011 as managing editor for MyCancerGenome.org. Prior to moving to Nashville, Dr. Micheel spent four years at the Institute of Medicine (IOM) in Washington, DC, beginning in January 2008 as a Mirzayan Science and Technology Policy Graduate Fellow in the National Cancer Policy Forum (NCPF) and Board on Health Care Services. She was the study director for the studies Evolution of Translational Omics and Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Prior to her work at the IOM, Dr. Micheel held a postdoctoral position at the IBM Almaden Research Center in San Jose, Calif., where she studied interactions between biomolecules, such as DNA and antibodies, and nanomaterials. She completed her Ph.D. in chemistry from the University of California, Berkeley, with the support of a Howard Hughes Medical Institute Predoctoral Fellowship. Her research was focused on nanobioscience.
Jennifer Morrissette, Ph.D., Scientific Director, Clinical Cytogenetics Laboratory; Clinical Director, Center for Personalized Diagnostics (CPD), University of Pennsylvania Perelman School of Medicine
Jennifer Morrissette, PhD is the Scientific Director of the Clinical Cytogenetics Laboratory and the Clinical Director of the Center for Personalized Diagnostics (CPD) at the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA. She is certified in Clinical Molecular Diagnostics and Clinical Cytogenetics through the American Board of Medical Genetics and has been a clinical laboratory director for 9 years. Dr. Morrissette joined the University of Pennsylvania, Department of Pathology as the Scientific Director of Clinical Cancer Cytogenetics in 2010. Previous to the University of Pennsylvania, she was an Assistant Professor at Drexel University and Director of Clinical Cytogenetics and Molecular Genetic Diagnosis at St Christopher’s Hospital for Children. Dr. Morrissette was a founding member of the Center for Personalized Diagnostics, a joint initiative between the Department of Pathology and the Abramson Cancer Center.
Muhammed Murtaza, Ph.D., Research Assistant Professor, TGen
Muhammed Murtaza leads the circulating nucleic acids program as Research Assistant Professor at TGen, the Translational Genomics Research Institute in Phoenix, AZ. Murtaza received medical training from the Aga Khan University in Pakistan. He then pursued doctoral studies with Nitzan Rosenfeld at the University of Cambridge in England, working on methods and applications of sequencing circulating tumor DNA in solid cancer patients.
Jerod Nagel, Pharm.D., BCPS (AQID), Clinical Specialist, Infectious Diseases, Clinical Assistant Instructor, Director Infectious Diseases Residency, University of Michigan Hospital and Health Systems, University of Michigan, College of Pharmacy
Dr. Nagel is currently an Infectious Diseases specialist at the University of Michigan Hospital and Health Systems, and Infectious Diseases Residency Program Director. Dr. Nagel holds a faculty appointment as Clinical Assistant Professor, and lectures in five courses for the School of Public Health, Nursing School and College of Pharmacy. He graduated from Purdue University and completed his Infectious Diseases residency at Meriter Hospital in Madison, Wisconsin. His clinical responsibilities at the hospital include ensuring appropriate antibiotic utilization, proving care for infectious diseases consult patients, and implementation of quality improvement processes related to infectious diseases. He has over 30 peer review publications and abstracts, including evaluating patient outcomes following implementation of molecular diagnostic testing.
Peter Nagy, Ph.D., Director, Clinical Next-Generation Sequencing Lab; Assistant Professor, Pathology and Cell Biology, Columbia University
Dr. Peter Nagy is director of the clinical next-generation sequencing laboratory at Columbia University. He received his medical training at the University of Pecs in Hungary and his Ph.D. in biochemistry at Purdue University. He trained in anatomic and molecular genetic pathology at Stanford University and worked as associate director of molecular pathology laboratories at the University of Iowa and since 2010 at Columbia University. At these institutions he introduced CGH and Next-gen sequencing technologies into clinical practice. Dr. Nagy also maintains an active research program investigating the role of transcriptional regulators in the pathogenesis of neurodegenerative disorders.
Peter Nemes, Ph.D., Assistant Professor, Chemistry, The George Washington University
Peter Nemes, Ph.D., is an Assistant Professor of Chemistry (2013–Present) at the George Washington University, Washington DC, whence he obtained his Ph.D. in Chemistry in 2009. He completed his postdoctoral research in Bioanalytical Chemistry for Neurobiology at the University of Illinois—Urbana-Champaign, IL. In 2011, he assumed a Laboratory Leader position with the U.S. Food and Drug Administration (Silver Spring, MD), where he established a mass spectrometry facility and regulatory research program with the U.S. Public Health Emergency Medical Countermeasures Enterprise to develop a scientific framework permitting to combat present and future threats (chemicals and biologics) to the public. Prof. Nemes’s current research at the George Washington University is focused on the development of next-generation mass spectrometry platforms to assess the metabolome and proteome of volume-limited samples including single cells. Prof. Nemes has authored and co-authored 3 book chapters and 23 peer-reviewed publications, and has presented or co-presented the results at 30+ national or international conferences. He has received the 2008 International Research Fellowship Award by the Dimitris N. Chorafas Foundation (Switzerland), the 2009 The American Institute of Chemists prize in Chemistry by The American Institute of Chemists (Washington, DC), the 2010 Science and Technology Innovation Award by Baxter Healthcare Corporation (Chicago, IL), and the 2011 Special Recognition Award by the U.S. Food and Drug Administration. Prof. Nemes is the co-inventor of laser ablation electrospray ionization (LAESI) mass spectrometry and holds four shared patents for the technology.
Susan M. Novak-Weekley, Ph.D., D(ABMM), Director, Microbiology, Kaiser Permanente, SCPMG Regional Reference Laboratories
Dr. Susan Novak-Weekley is the Director of Microbiology at the Kaiser Permanente Regional Reference Laboratories in Southern California. Dr. Novak received her Ph.D. at the University of Arizona in Microbiology and did a post-doctoral fellowship in clinical microbiology at the University of California Los Angeles Medical Center and Wadsworth Veterans Administration Medical Center. Dr. Novak has been the Director of Microbiology at Kaiser Permanente for 9 years servicing 3.6 million members, 14 hospitals and over 100 clinics and medical offices providing microbiology, serology and molecular infectious disease testing.
Anders Nygren, Ph.D., Director R&D, Agena Bioscience, Inc.
Dr. Nygren serves as the Director, Research and Development at Agena Biosciences. He joined Agena Bioscience, formerly Sequenom in 2008, serving in various roles within the R&D department. Since joining Agena Biosciences Dr Nygren has focused of on different aspects of nucleic acid analysis with emphasis on ultrasensitive detection of somatic mutations isolated from tumor and circulating cell free DNA. Dr. Nygren received his Master of Science in Molecular Biotechnology at Uppsala University and his PhD in clinical chemistry at the Free University of Amsterdam.
Pankaj Oberoi, Ph.D., Vice President, Commcercial Assays, Meso Scale Discovery
Dr. Oberoi is Vice President for Commercial Assays at Meso Scale Discovery and is responsible for commercialization of Biomarker Assays. Dr. Oberoi has been at MSD for over 15 years. Previously, he was Director of Research and Development leading the assay development process development of MSD’s validated product line (V-PLEX) for a wide range of applications including: cytokines, safety biomarkers, metabolic, neurological disorders, angiogenesis, growth factors, and immunogenicity. Prior to MSD Pankaj received his Ph.D. from the Harvard-MIT Division of Health Sciences and Technology.
Aydogan Ozcan, Ph.D., Chancellor's Professor, University of California, Los Angeles, Electrical Engineering Department, Bioengineering Department; Associate Director, California NanoSystems Institute (CNSI)
Dr. Aydogan Ozcan is the Chancellor’s Professor at UCLA leading the Bio- and Nano-Photonics Laboratory at the Electrical Engineering and Bioengineering Departments. Dr. Ozcan holds 22 issued patents (all of which are licensed) and >15 pending patent applications and is also the author of one book and the co-author of more than 350 peer reviewed research articles in major scientific journals and conferences. Dr. Ozcan is a Fellow of SPIE and OSA, and has received major awards including the Presidential Early Career Award for Scientists and Engineers (PECASE), SPIE Biophotonics Technology Innovator Award, SPIE Early Career Achievement Award, ARO Young Investigator Award, NSF CAREER Award, NIH Director’s New Innovator Award, ONR Young Investigator Award, IEEE Photonics Society Young Investigator Award and MIT’s TR35 Award for his seminal contributions to near-field and on-chip imaging, and telemedicine based diagnostics.
David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine
David Parker, PhD, is the Vice President of Market Access Strategy at Precision for Medicine. David has over 25 years of experience in the healthcare industry, including 16 years of strategy consulting experience centered on the intersection of reimbursement, health economics, clinical science, and marketing strategy. His consulting encompasses all aspects of reimbursement, market access, and evidence development strategy with a particular focus on personalized medicine, molecular and advanced diagnostics, and medical devices.
Throughout his career, David’s work has resulted in numerous successful product launches, guided major investment and acquisition decisions, and driven favorable coverage and payment determinations by public and private payers alike. His consulting career was preceded by 11 years of increasingly responsible product and marketing management, strategic planning, and business development roles at biotechnology companies ranging from development-stage to units of Fortune 500 businesses. David is a frequent speaker and the author of peer-reviewed publications as well as book chapters in the biomedical sciences and health economics.
David received his A.B. degree in Biochemistry from Princeton University and his PhD in Cell and Developmental Biology from the Massachusetts Institute of Technology, where he was a National Science Foundation Fellow.
Donald “Will” Parsons, M.D., Ph.D., Assistant Professor, Pediatrics, Molecular & Human Genetics, Baylor College of Medicine, Texas Children’s Cancer Center
Will Parsons is a board-certified pediatric oncologist and the Co-Director of the Neuro-Oncology Program and the Cancer Genetics & Genomics Program at Texas Children’s Cancer Center (TCCC), Baylor College of Medicine (BCM). He is the Director of the Center for Personal Cancer Genomics and Therapeutics at TCCC, with joint appointments in the BCM Department of Molecular and Human Genetics and at the BCM Human Genome Sequencing Center. His research focuses on and the use of sequencing-based methods to identify novel genetic alterations which may serve as targets for molecular diagnostics and therapeutics and the clinical application of genomic technologies in pediatric cancer care.
Anami Patel, Ph.D., Technical Director, Molecular Diagnostics Laboratory, Le Bonheur Children’s Hospital
Anami Patel, Ph.D MB (ASCP)CM DLMCM serves as Technical Director of the Molecular Diagnostics Laboratory at Le Bonheur Children’s Hospital. He is also Assistant Professor at the Department of Pediatrics at the University of Tennessee-Memphis. Dr. Patel received his MS, BS and Ph.D degrees from the Sardar Patel University in Nagar, India. His primary area of interest is molecular diagnostics and infectious diseases.Recent Published Research Includes:
Multi-Center Evaluation of the Adenovirus R-gene US Assay for the Detection of Adenovirus in Respiratory Samples.
Etiology of Pneumonia in the Community (EPIC) Study Team. Incidence and Etiology of Community-acquired Pneumonia Requiring Hospitalization among U.S. Children. (submitted)
Robin Patel, M.D.(CM), FRCP(C), D(ABMM), FIDSA, FACP, F(AAM), Chair, Clinical Microbiology; Consultant, Clinical Microbiology and Infectious Diseases; Professor, Microbiology and Medicine, College of Medicine, Mayo Clinic
Dr. Robin Patel graduated from Princeton University with a BA in Chemistry in 1985 and from McGill University in Montreal, Canada with an M.D.(C.M.) in 1989. She then moved to Rochester, Minnesota, where she completed residencies in Internal Medicine and Microbiology and a fellowship in Infectious Diseases at the College of Medicine, Mayo Clinic. In 1996, upon completion of post-graduate training, she joined the staff of Mayo Clinic. She is currently Professor of Medicine, and Professor of Microbiology, Director of the Clinical Bacteriology Laboratory and the Infectious Diseases Research Laboratory, and Chair of the Division of Clinical Microbiology, Mayo Clinic.
Bruce K. Patterson, M.D., CEO, Incell Dx, Inc
Dr. Patterson, CEO and Founder of IncellDx Inc has authored over 100 manuscripts and book chapters and was the Medical Director of Diagnostic Virology at Stanford University Hospitals and Clinics. IncellDx, the company founded by Dr. Patterson in 2009 has won the Silicon Valley/San Jose Business JournalEmerging Biotech Company of the Year in 2011 and the Frost & Sullivan North American Molecular Diagnostics Product Leadership Award in 2012 for their HPV OncoTect product among others.
Donna Polizio, Associate Director, Government Accounts, Genomic Health
Donna Polizio has had a long career in the diagnostics industry starting at Coulter Corporation back in the early 1990s. She is currently at Genomic Health as the Associate Director for Government Markets –She is the lead for the Medicare Administrative Contractors (MACs), Medicaid, all of the Military Segment including DoD, VA and Tricare. Previously, Donna was the Director of Reimbursement at RedPath Integrated Pathology. In her role there she led efforts to gain Medicare coverage for their PathfinderTG test which provides physicians with clarity for pancreatic cysts. Prior to RedPath Donna’s entry into the Laboratory Developed Tests market was as Director of Reimbursement at Aureon Biosciences where she led their reimbursement efforts in support of their prostate cancer assay designed to provide risk of prostate cancer recurrence. Before Aureon, Donna served in several roles in her 9 years at Cytyc/Hologic to include sales of devices in the breast and cervical cancer market and also began her managed care career by securing medical policy for their devices and laboratory tests.
Jason Poole, Ph.D., Director, Research & Development, Trovagene
Jason has more than a decade of experience developing and commercializing products for the clinical diagnostic and research markets. He has successfully launched more than a dozen products offering testing utility in the areas of fertility, infectious disease and oncology. He holds publications, patents and pending patents in several areas of molecular biology and genetics including stem cell biology, mitochondrial genetics and oncology. He currently leads the development of cell-free molecular diagnostic assays for Trovagene at their San Diego facility.
Aniruddha Puntambekar, Ph.D., Executive Vice President, Siloam Biosciences, Inc.
Dr. Puntambekar is the lead inventor for the revolutionary Optimiser™ microfluidic ELISA technology and has over 14 years of experience in microfluidic system development. He has managed the development of the paradigm shifting approach in developing the novel Optimiser™ technology and extending its application beyond a lifescience consumable to an IVD/POCT system component (the TROVA™ POCT platform).
John Quackenbush, Ph.D., Co-Founder and CEO, GenoSpace; Professor, Dana-Farber Cancer Institute and Harvard School of Public Health, Biostatistics and Computational Biology
John Quackenbush received his PhD in 1990 in theoretical physics from UCLA working on string theory models. Following two years as a postdoctoral fellow in physics, Dr. Quackenbush applied for and received a Special Emphasis Research Career Award from the National Center for Human Genome Research to work on the Human Genome Project. He spent two years at the Salk Institute and two years at Stanford University working at the interface of genomics and computational biology. In 1997 he joined the faculty of The Institute for Genomic Research (TIGR) where his focus began to shift to understanding what was encoded within the human genome. Since joining the faculties of the Dana-Farber Cancer Institute and the Harvard School of Public Health in 2005, his work has focused on decoding and modeling the networks of interacting genes that drive disease. In 2011 he and partner Mick Correll launched GenoSpace to facilitate genomic data analysis and interpretation, focused on accelerating research and delivering relevant and actionable solutions for precision medicine. John and GenoSpace were recognized by the White House as “Open Science Champions of Change” for developing tools to make genomic data accessible to scientists, physicians, and the general public.
Erica Ramos, MS, CGC, Clinical Genomics Specialist, Certified Genetic Counselor, New and Emerging Opportunities, Illumina, Inc.
Erica Ramos received her Master’s degree in genetic counseling from the University of California, Irvine in 2001. After graduation, she worked as a prenatal and preconceptional genetic counselor for Genzyme Genetics in multiple Southern California clinics. In 2005, she moved to Las Vegas to help start Amigenics, a unique adult genetics specialty clinic. While at Amigenics, she helped to create an innovative breast cancer risk assessment program and was the first genetic counselor to focus on adult and cancer genetics in Las Vegas. In July 2012, Ms. Ramos joined Illumina as a Clinical Genomics Specialist, where she provides support and guidance to the Illumina Clinical Services Laboratory and its clients to advance the use of whole-genome sequencing in clinical care. Ms. Ramos is also active in the National Society of Genetic Counselors and was recently elected to the 2014 NSGC Board of Directors as a Director at Large. Additionally, she has served on the Education Committee, Cancer SIG Quality Initiative Task Force and Genetic Counseling Advanced Degree Task Force (GCADTF).
David A. Rasko, Ph.D., Associate Professor, Microbiology & Immunology, University of Maryland School of Medicine Institute for Genome Sciences
Dr. Rasko is an Associate Professor in the Department of Microbiology and Immunology and a member of the Institute for Genome Sciences. During his career he has developed expertise in comparative microbial genomics, bioinformatics and functional genomics. Dr. Rasko has led comparative genome sequencing and analysis projects for important human diarrheal pathogens, focusing on Escherichia coli and Shigella species. He has developed comparative bioinformatics tools designed to characterize the genetic diversity in closely related bacterial isolates. His comparative work has laid the framework for the continued functional study of the evolution of these pathogens, which has recently been expanded to include Shigella spp., as well as functional studies of these unique and conserved gene features. Current studies in the lab extend these early large-scale comparative studies with the second and third generation sequencing methodology to examine pathogen evolution with a focus on enterics. Newer technologies are being utilized to understand the complex regulatory networks of these bacterial pathogens in the context of the host and other environmental signals. Overall this systems approach to pathogens will provide a more comprehensive view of the pathogen and allow the construction of better models to identify these pathogens as well as predict virulence and host interactions.
Greg Richard, Senior Vice President & General Manager, Interpace Diagnostics, PDI, Inc.
Greg Richard, Sr. Vice President of PDI, Inc. and GM of InterpaceDiagnostics, has been in the healthcare business for over 25 years in various industries including managed care, biotech pharmaceuticals, CRO services, and diagnostics. He started his career in sales at Aetna and moved to Genentech as the Director of Managed Care. He transitioned in to the diagnostics industry as the Vice President of Managed Care for Quest Diagnostics and served in this role for 8 years. Greg also led the international clinical trials sales team while at Quest. Following his tenure at Quest, Greg worked for several privately held companies including CRO’s, molecular diagnostics, and anatomic pathology services. He also served as the Sr. Vice President of Sales for the Northeast Division of LabCorp. Greg is a certified Six Sigma Green Belt and frequent speaker at healthcare industry conferences.
Katherine Richardson, Vice President, Research & Development, Transgenomic, Inc.
Dr. Richardson holds an SB degree in Life Sciences from the Massachusetts Institute of Technology and a PhD in Molecular Cellular and Developmental Biology from Iowa State University. Prior to joining Transgenomic, she worked for eight years as a scientist with OSI Pharmaceuticals, where she specialized in molecular biology research and development in the area of oncology. Previously Dr. Richardson was with Eli Lilly and Company for nine years as a senior toxicologist specializing in genetic toxicology and molecular carcinogenesis. At Eli Lilly, Dr. Richardson was part of the group that identified the link between the BRCA-1 gene and hereditary breast cancer.
Vincent Ricchiuti, Ph.D., Associate Professor, Director, Clinical Chemistry andToxicology, Department of Pathology and Laboratory Medicine, UC Health University Hospital
Dr. Ricchiuti is currently Director of Clinical Chemistry and Toxicology at University of Cincinnati Medical Center (UCMC), and Associate professor at University of Cincinnati, in the Department of Pathology and Laboratory Medicine, College of Medicine, Cincinnati Ohio. Since he joined UCMC in 2012, He aids in growing the clinical laboratory tests menu and his responsibilities include supervising validation and implementation of new assays and technologies in the Clinical Laboratory. He helps to oversee daily operations of the laboratories as well as the quality assurance program for clinical chemistry, toxicology, point of care testing, immunology sections of Clinical Laboratory. As a faculty he trains the next generation of Pathologists, Medical and Grade Students in Clinical Science applied to Laboratory Medicine. Prior to UCMC, Dr. Ricchiuti was the Senior Director of Clinical Biomarkers at Medpace Reference Laboratories (MRL), Cincinnati OH (2011-2012). At MRL, Dr. Ricchiuti was the clinical chemistry and scientific liaison with sponsors for assay development at a global level (USA, China, Europe and India). For 12 years, Dr. Ricchiuti was head of Clinical Research and Endocrinology Division Clinical Laboratories at Brigham and Women's Hospital (BWH) and Harvard Medical School (HMS), Boston MA: during 2008-2011, Director of Harvard Catalyst Central Laboratories, formal National Institute of Health-Clinical Research and Translational Medicine Center, namely “Harvard Catalyst” at HMS; during 1999-2008, Director of the General Clinical Research Center (GCRC) Core Laboratories at the BWH. Dr. Ricchiuti was Associate Biochemist at Endocrinology, Diabetes and Hypertension and is faculty in Medicine at HMS. His research focuses on investigating cardiovascular risk factors.
Gabe Rudy, Vice President, Product Development, Golden Helix
Gabe is a 10-year veteran at Golden Helix and spends his days collaborating with a diverse set of scientists and building solutions to enable their research. An alumnus of Montana State, he earned his Master’s in Computer Science from the University of Utah before setting his sights on the fast-changing field of genomics and bioinformatics. Gabe has been involved in developing various algorithms from copy number segmentation to runs of homozygosity and rare variant association testing. Gabe blogs about the genomics field from the perspective of someone building solutions and curating genomic annotations and public databases. His series "A Hitchhiker’s Guide to Next Generation Sequencing" has become quite popular as a starter guide for those entering the field.
Carol Saunders, Ph.D., FACMG, Director, Molecular Genetics Laboratory, Department of Pathology & Laboratory Medicine; Associate Professor, Department of Pathology, UMKC School of Medicine, Children’s Mercy Hospital
Mark Sausen, Ph.D., Director, R&D, Personal Genome Diagnostics
Dr. Mark Sausen, Ph.D. is the Director of Research and Development at Personal Genome Diagnostics. Mark has led and published several studies related to next-generation sequencing in cancer. These analyses have included the identification of prognostic mutations in neuroblastoma, as well as, genome-wide analyses of circulating tumor DNA in cancer. Mark is currently developing approaches for the noninvasive detection and genotyping of structural alterations in cancer patients.
Heinz Schimmel, Ph.D., Scientific Officer, Standards for Innovation and Sustainable Development (SID), European Commission - Joint Research Centre (JRC)
Heinz Schimmel is scientific officer at the European Commission - Joint Research Centre – Institute for Reference Materials and Measurements (IRMM). He is coordinating Life Science related standardization and reference material development activities at IRMM, consultant to the Scientific Division of IFCC, co-chair of WG1 of JCTLM, member of ISO TC212 and CLSI working groups related to standards for laboratory medicine and was involved in EU supported projects on quality assurance in (clinical) molecular diagnostics.
Hemanth Shenoi, Ph.D., Director, Business Development, Lucigen Corporation
Hemanth Shenoi, Ph.D. has served as Lucigen’s Director of Business Development since June 2013. Prior to joining Lucigen, Dr. Shenoi spent 4 years at Exact Sciences and 11 years at Promega in various product management, marketing and training roles. He holds a Ph.D. in Immunology from Washington University in St. Louis and a BS in Biology-Honors from the University of Illinois.
Vahan Simonyan, Ph.D., HIVE Project Lead, CBER, FDA
As a Principal Investigator in High Performance Computing (HPC) at the Center for Biologics Evaluation and Research, Food and Drug Administration (FDA), Vahan develops computing environments that facilitate collaborative research using biomedical data with strict security protocols. His research interests are centered on the provision of bioinformatics support for high-throughput sequencing technologies, including the design, development, installation and support of computational clouds for genomic and other biological data. One of the key items being developed in collaboration with Dr. Raja Mazumder at George Washington University is a High-performance Integrated Virtual Environment (HIVE) which allows users to compute and share big-data. Vahan has over 20 years of hands-on experience in a variety of bio-chemical and technological disciplines. He has prepared and participated in many national and international cooperative grants and published over 40 publications in scientific journals and conference proceedings. Having spent 12 years at NIH/NCBI, he has turned his focus toward genomic advancement and gained much experience with high-throughput nucleotide and protein sequence analyses. Combined with a thorough IT training in R&D, architecture, design, implementation, testing and production, he is well-placed to make major contributions to the growing field of bioinformatics through HIVE.
Denis Smirnov, Associate Scientific Director, US Biomarker Oncology, Janssen R &D US
Denis has worked in various industrial and academic settings, including Immunicon Corp, Howard Hughes Medical Institute and On-Q-ity. Denis currently is an Associate Scientific Director at Janssen Pharmaceuticals.
Judi Smith, Vice President, In Vitro Diagnostics and Quality, Precision for Medicine
Judi Smith is the Vice President, In Vitro Diagnostics Regulatory and Quality at Precision for Medicine. She has worked in the medical products regulatory submissions and approvals, quality, and clinical trial areas for over 30 years. She also has expertise with in vitro diagnostic products, biological in vitro diagnostic assays, and the establishment of quality systems for diagnostic products. She has developed and implemented clinical trials for these products, which were used to generate data for their regulatory submissions.
In addition, Judi is a member of the FDA/Industry Roundtable and was awarded the FDA Group Recognition Award. She has served as President of the Association of Medical Diagnostics Manufacturers since 2006.
Judi received her Bachelor of Science from Temple University and her Master of Science from the Medical College of Pennsylvania.
Matthew Snyder, Graduate Student, Genomic Sciences, University of Washington
Matthew Snyder is a graduate student with Dr. Jay Shendure in the Department of Genome Sciences at the University of Washington. His research interests involve the development of noninvasive diagnostic and screening tests for maternal and fetal medicine, with a particular focus on developing low-cost assays for use in the developing world.
Richard St.Clair, Vice President, Commercialization, Evogen Inc.
Utilizing wide reaching contacts, Rich is experienced and successful in managing all phases of the product life cycle including taking products from ideation and development to market launch, and rationalization of product portfolios to revitalize mature products or divest those that have reached the end of their life cycle.
Gregory Storch, M.D., Ruth L. Siteman Professor, Pediatrics, Director, Divisions of Pediatric Infectious Diseases and Lab Medicine, Washington University School of Medicine; Medical Director, Clinical Labs, St. Louis Children’s Hospital
Dr. Storch is the Ruth L. Siteman Professor of Pediatrics and Professor of Medicine and of Molecular Microbiology at Washington University School of Medicine, the Director of the Divisions of Pediatric Infectious Diseases and Pediatric Laboratory Medicine, and the Medical Director of Clinical Laboratories at St. Louis Children’s Hospital. He received his AB degree from Harvard College and his MD from NYU School of Medicine. He was an intern and resident in internal medicine at the Jewish Hospital of St. Louis. He then spent two years working for the Centers for Disease Control as an Epidemic Intelligence Service Officer, stationed in the Louisiana Department of Health in New Orleans. He then did an infectious disease fellowship at Washington University. After completing his fellowship in 1981, he joined the faculty in the Department of Pediatrics of the Washington University School of Medicine, where he has been ever since. Dr. Storch’s research interests are in molecular diagnosis of infectious diseases and pathogen discovery. He also serves as Medical Director of Project ARK, an umbrella organization that provides medical and support services for children, youth, women, and families affected by HIV.
Michael Super, Ph.D., Senior Staff Scientist, Advanced Technology Team, Wyss Institute at Harvard
Super’s research leverages protein engineering to design therapeutic and diagnostic devices to treat cancer, infectious & immunological diseases. Prior to joining the Wyss, Super spent 17 years in the Biotechnology industry, employed in companies ranging from start-ups to large Pharma. In industry, Super was the Director of the Protein Biochemistry, Immunobiology and Hybridoma Antibody groups, focusing on the design, development and production of therapeutic antibodies for cancer and autoimmune disease therapy. Super received his M.Sc. in Biomolecular Organization at Birkbeck College and his Ph.D. in Medical Immunology at the Institute of Child Health, University of London, followed by postdoctoral work at Harvard in Hematology/Oncology and Infectious disease.
William Fraser Symmans M.D., Professor of Pathology, The University of Texas MD Anderson Cancer Center
Dr. Symmans is Director of Research Operations for the Pathology Department at MD Anderson Cancer Center where he practices Breast Surgical Pathology and Cytopathology and co-directs the Breast Cancer Pharmacogenomics Program. He also directs the Translational Research Program for The Alliance Cooperative Group of the National Clinical Trials Network for North America. Dr. Symmans received his medical degree from the University of Auckland, New Zealand in 1987. He completed his residency training in Anatomical Pathology at Columbia University College of Physicians and Surgeons, New York City and fellowship training in Cytopathology at MD Anderson Cancer Center, Houston. Dr. Symmans joined the faculty of New York University Medical Center in 1993 and moved to MD Anderson Cancer Center in 2000. Dr. Symmans' research is focused on breast cancer, with specific emphasis on neoadjuvant (pre-operative) treatment trials for evaluation of chemosensitivity and development of diagnostic tests to select the most effective treatments for individuals with breast cancer. Dr Symmans has adapted genomic technologies to clinical needle biopsies of breast cancer in order to use gene expression profiling to identify important genes for response to chemotherapy and, independently, to endocrine therapy; to validate gene expression tests with clinical potential; and to establish their performance in the context of clinical testing.
AmirAli Talasaz, Ph.D., President & CTO, Guardant Health, Inc.
Dr. Talasaz is a serial entrepreneur in the sample preparation and clinical research fields. Prior to co-founding Guardant, he was Senior Director of Diagnostics Research at Illumina. Before Illumina, he founded Auriphex Biosciences, which focused on purification and genetic analysis of circulating tumor cells for cancer management. The technology was acquired by Illumina in 2009. Dr. Talasaz received his PhD in electrical engineering and MSc in management science from Stanford.
Živana Težak, Ph.D., Associate Director, Science and Technology, Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH), FDA
Živana Težak, Ph.D., is an Associate Director for Science and Technology, Personalized Medicine Staff, in the Office of In Vitro Diagnostic Device (IVD) Evaluation and Safety (OIR), at the Center for Devices and Radiological Health, Food and Drug Administration (FDA). Prior to joining the FDA in 2004, as a scientific reviewer in microbiology, genomics and molecular biology, Dr. Težak worked in the biotechnology industry, holding research and development scientist positions in a bioinformatics and array developer company. Dr. Težak received a Ph.D. in Biochemistry/Molecular Biology from Florida State University in 1997. From 1998 to 2001 she was a research fellow at the University of Pittsburgh Medical Center and Children’s National Medical Center, Research Center for Genetic Medicine, working on neuromuscular disorders, human genetics, gene therapy and high-throughput screening technologies. Her work resulted in a number of publications in peer-reviewed journals, book chapters and proceedings. In her current position, Dr. Težak has been leading efforts to develop flexible regulatory policies for novel technology-based IVDs, such as next-generation sequencing, in order to enable their smoother translation into the clinic.
Alain R. Thierry, Ph.D., Senior Investigator, Research Institute in Oncology of Montpellier, INSERM
A.R. Thierry specific expertise is particularly applicable to research focusing on the study of the diagnostic capacity of circulating DNA (cfDNA) towards supporting personalised medicine. Based upon crucial observations on cfDNA structure and size his team made possible high specificity and sensitivity of cfDNA analysis. A.R. Thierry has coordinated the first prospective blinded multicentric study showing the validation of the plasma analysis for the detection of KRAS and BRAF mutations from colorectal patient plasma samples.
Peter J. Tonellato, Ph.D., Director, Laboratory for Personalized Medicine, Center for Biomedical Informatics, Pathology, Beth Israel Deaconess Medical Center and Harvard Medical School
Peter Tonellato joined the Center for Biomedical Informatics (CBMI) after completing a stint as CEO of POINTONE Systems, the personalized medicine software company he founded in 2001. Previously, Dr. Tonellato was Founding Director (1997-2004) of the Bioinformatics Research Center at the Medical College of Wisconsin. At CBMI, Dr. Tonellato created the Laboratory for Personalized Medicine to focus on research, development, and commercial translation of clinical, physiological, and genetic knowledge to benefit health care. Dr. Tonellato has worked in the area of biomathematics, computational biology, and biomedical informatics since completing his degree in applied mathematics at the University of Arizona in 1985.
Ephraim L. Tsalik, M.D., MHS, Ph.D., Assistant Professor, Medicine, Division of Infectious Diseases, Institute for Genome Sciences & Policy, Duke University Medical Center
Ephraim Tsalik is an Assistant Professor in the Department of Medicine, Division of Infectious Diseases. He also holds an appointment in the Emergency Department Service at the Durham VA Medical Center. He earned his MD and PhD from Columbia University followed by residency and fellowship training at Duke University. He also obtained a Masters in Health Services with a focus on Clinical Research during his fellowship training at Duke. Dr. Tsalik is a leading member of the Acute Infectious Diseases Clinical Research Unit, headed by Drs. Geoff Ginsburg and Chris Woods. The focus of Dr. Tsalik's work is to explore the nature of host-pathogen interactions through genomic medicine technologies. This information provides insight into infectious disease pathophysiology. It can also be used to develop novel diagnostic tools for the clinical management of acute infectious diseases, which is the major focus of Dr. Tsalik's work.
Sean R. Tunis, M.D., MSc, Founder & Director, Center for Medical Technology Policy
Sean Tunis, MD, MSc. is the President and Chief Executive Officer of the Center for Medical Technology Policy in Baltimore, Maryland. CMTP’s main objective is to improve the quality, relevance and efficiency of clinical research by providing a neutral forum for collaboration among experts, stakeholders and decision makers. Dr. Tunis was a member of the Institute of Medicine Committee on Initial National Priorities for Comparative Effectiveness Research. He advises a wide range of domestic and international public and private health care organizations on issues of comparative effectiveness, evidence based medicine, clinical research, reimbursement and health technology policy. Through September of 2005, Dr. Tunis was the Chief Medical Officer at the Centers for Medicare and Medicaid Services (CMS), where he had lead responsibility for clinical policy for the Medicare and Medicaid programs. Previously he served as the Director of the Health Program at the Congressional Office of Technology Assessment and as a health policy advisor to the U.S. Senate, where he worked on pharmaceutical and device policy issues. Dr. Tunis trained at the University of California in Los Angeles and the University of Maryland in Internal Medicine and Emergency Medicine, and holds adjunct faculty positions at the Center for Health Policy at Stanford University, the Department of Internal Medicine at the Johns Hopkins School of Medicine, and the Department of Surgery at the University of California at San Francisco.
Eric van Gieson, Ph.D., R&D Director, Diagnostics and Biosurveillance, MRIGlobal
Dr. Van Gieson is the Director of Diagnostics and Biosurveillance Innovation at MRIGlobal and has served in several organizations with the goal of improving the linkage between diagnostics and disease surveillance. His work has primarily been focused on point of care diagnostics for military and commercial applications, however, he has initiated a number of government programs aimed at revolutionizing the technologies that drive laboratory-based diagnostics. Dr. Van Gieson has a Ph.D. in Biomedical Engineering and a B.S. in Chemical Engineering from the University of Virginia. He has worked in industry as well as government settings and has publications on topics ranging from genomic analysis to unmanned systems autonomy. He led several technology survey efforts for the Department of Defense in diagnostics and has supported several major diagnostics science and technology development programs in the DoD. Most recently, Dr. Van Gieson served as a reviewer on the Nokia Sensing XChallenge on behalf of the XPrize Foundation, where he continues to advise and help to shape future diagnostics challenge efforts with XPrize.
Vickie L. Venne, MS, LGC, Senior Genetic Counselor, Genomic Medicine Service, Department of Veterans Affairs, VA Salt Lake City Health Care System
Vickie Venne is Senior Genetic Counselor with DVA, responsible for implementing Genomic Medicine Services, a national clinical service which provides genetic services to Veterans using the VA’s telehealth infrastructure. Ms. Venne received her degree from Sarah Lawrence College in 1978 and since then has practiced in both clinical and laboratory settings in prenatal, pediatric, and adult genetics. She has been involved in public health and policy both nationally and locally.
Jan Vijg, Ph.D., Professor and Chairman, Genetics, Albert Einstein College of Medicine
Combining a passion for history and for science, Netherlands-born Dr. Jan Vijg earned his Ph.D. in biology at the University of Leiden in 1987 and was previously Scientific Director and Founder of Ingeny B.V., a Dutch biotechnology company. He built a career as a molecular geneticist, witnessing the revolution in genetics, from recombinant DNA technology to the human genome project of the 1990’s. Dr. Jan Vijg moved to the United States in 1993 to become Associate Professor of Medicine at Harvard Medical School in Boston (1993-1999), a Professor of Physiology at the University of Texas Health Science Center in San Antonio, Texas (1999-2005), and a Professor at the Buck Institute for Age Research, Novato, California (2006-2008). With his research team he was the first to develop transgenic mouse models for studying mutagenesis in vivo (in 1989) and have used these models ever since in studying the possible relationship between damage to the genome and aging. He has published more than 200 scientific articles and is inventor or co-inventor on 8 patents. He is currently developing single-cell whole-genome sequencing methods to study somatic mutations and epimutations in cancer and aging. Dr. Vijg is currently Professor and Chairman of the Department of Genetics at the Albert Einstein College of Medicine in New York. He is also very focused on technology development. An important part of his responsibilities is to translate new discoveries, made by the faculty, into clinical applications. He has a great professional interest in the implementation of new technology in society.
Matthew Walls, CEO, Epistem Plc
Matthew has successfully led the growth and development of several UK biotech and healthcare Companies including leading Epistem through admission to the London Stock Exchange: AIM market in April 2007. Epistem has grown significantly over the past 7 years and is recognised as one of the best performing European personalised medicine/biotech stocks. Alongside its stem cell heritage, Epistem is now preparing to launch its first novel handheld molecular diagnostic product (Genedrive®) later this year.
Gene W. Walther, Deputy Director Diagnostics, Integrated Development, Global Health Program, Bill & Melinda Gates Foundation
Gene Walther joined the Bill & Melinda Gates Foundation in November 2010 as Deputy Director – Diagnostics. Mr. Walther is responsible for the Foundation’s diagnostics strategy to organize and harmonize cross-Global Health Diagnostics efforts to achieve maximum impact. Before joining the foundation, Walther worked in the Venture Capital industry with Bay City Capital and as Executive Chairman for one of their investment companies, GenturaDx. Walther has over two decades of experience in the health care field. Walther joined Chiron in 2000 and held several senior leadership positions including President of Chiron’s Blood Testing Division prior to the acquisition by Novartis in 2006. Following the acquisition, he was President, Novartis Diagnostics directing global operations for an $800+ million business focused in blood testing and diagnostics. He has held senior leadership positions at Gen-Probe, Abbott Laboratories and American Hospital Supply in the area of global commercial operations. Mr. Walther holds a Bachelor of Science degree in Microbiology and Immunology from Michigan State University and a Master of Business Administration degree from the University of Washington.
Yong Wang, Ph.D., Research Scientist, Nicholas E. Navin Laboratory, Department of Genetics, Department of Bioinformatics, MD Anderson Cancer Center
Dr. Wong received my Ph.D. of Bioinformatics from UT Southwestern in 2009. During my graduate training, I developed a protein homology detection algorithm. From 2009 to 2011, I worked as a senior computational biologist at the Human Genome Sequencing Center at Baylor College of Medicine. I was actively involved in analyzing next-generation sequencing data from TCGA and the 1000 Genomes Project. In 2011, I joined Dr. Navin’s laboratory at the MD Anderson Cancer Center for my postdoctoral training. During this time I have been developing new methods to perform single-cell genome and exome sequencing. Currently, I am applying these methods to study intratumor heterogeneity in breast cancer and investigate clinical applications in diagnostics and non-invasive monitoring.
Anton Wellstein, M.D., Ph.D., Professor, Oncology, Pharmacology and Medicine, Georgetown University Medical School; Associate Director, Basic Science, Lombardi Comprehensive Cancer Center
Dr. Wellstein is a senior investigator at the Lombardi Cancer Center who trained as an MD/PhD and then joined NIH to study growth factor signaling in breast cancer in the Medicine Branch of the NCI in Marc E Lippman’s lab. Thereafter he was recruited to the faculty of Georgetown University in the Departments of Pharmacology and Oncology, where he is a Tenured Professor. He discovered that the receptor for the growth factor pleiotrophin was anaplastic lymphoma kinase (ALK) and also identified and defined the role of secreted binding proteins for FGF and their function in cancer and development. During the past decade Dr. Wellstein’s work focused on tumor /stromal interaction with a particular emphasis on the function and regulation of the activity of FGFs and the pleiotrophin/ALK signaling pathways. His major interest is in mechanisms of cancer progression to invasive and metastatic disease. His laboratory is focused on cellular, molecular and biochemical signal transduction mechanisms utilized by cancer cells in malignant progression in vitro as well as in xenograft tumors, transgenic and in knockout animal models. He has published >170 papers.
Aaron Wheeler, Ph.D., Director, Wheeler Microfluidics Lab, Department of Chemistry, University of Toronto
Aaron Wheeler completed his PhD in Chemistry at Stanford University in 2003. After a two-year NIH postdoctoral fellowship at UCLA, Wheeler joined the faculty at the University of Toronto, where he is the Canada Research Chair in Bioanalytical Chemistry.
Rina Wolf, Vice President, Commercialization Strategies, Consulting & Industry Affairs, XIFIN, Inc.
Rina Wolf is a nationally recognized expert in the field of laboratory commercialization and reimbursement, with over 20 years of experience in diagnostic laboratory industry, specializing in molecular diagnostics. She lectures extensively and advises investor audiences. Prior to joining XIFIN, Wolf held positions responsible for creating and implementing successful reimbursement and commercialization strategies. She is an active participant with CCLA, ACLA and the PMC.
Ian White, Ph.D., Assistant Professor, Fischell Department of Bioengineering, University of Maryland
Dr. Ian White is an Assistant Professor in the Fischell Department of Bioengineering at the University of Maryland. Dr. White received his PhD in Electrical Engineering from Stanford University in 2002. Dr. White completed a postdoctoral fellowship in Biological Engineering at the University of Missouri's Life Sciences Center in 2008 and joined the faculty at the University of Maryland. He research group is interested in optofluidics, mcirosystems, and paper-based analytical devices.
Sunney Xie, Ph.D., Mallinckrodt Professor of Chemistry, Department of Chemistry and Chemical Biology, Harvard University
Xiaoliang “Sunney” Xie received a B.S. from Peking University in 1984 and his Ph.D. from the University of California at San Diego in 1990, followed by a short postdoctoral experience at the University of Chicago. In 1992, Xie joined Pacific Northwest National Laboratory, where he later became a Chief Scientist. In 1999, he was appointed Professor of Chemistry at Harvard University. He is now the Mallinckrodt Professor of Chemistry and Chemical Biology at Harvard, and the Cheung Kong Visiting Professor at Peking University, Biodynamics Optical Imaging Center (BIOPIC). Xie has made major contributions to the emergence of the field of single-molecule biophysical chemistry and its application to biology. His team also pioneered the development of coherent Raman scattering microscopy and single-cell whole-genome sequencing. His honors include the Harrison Howe Award, Biophysical Society Founders Award, E.O. Lawrence Award in Chemistry, Leibinger Innovation Prize, the NIH Director’s Pioneer Award and the Sackler Prize for Physical Sciences. Xie is a fellow of the American Academy of Arts and Sciences and a member of the National Academy of Sciences.
Benjamin Yellen, Ph.D., Associate Professor, Mechanical Engineering and Materials Science, Duke University
Benjamin Yellen’s research focuses on techniques for controlling the self-organization and transport of colloidal particles and cells with space-time varying magnetic fields. The goal of his recent collaborations with medical school investigators at Duke and UNC are to utilize these magnetic controllers to develop circuits for performing computerized operations on single cells in large arrays similar to a random access memory.
Asad R. Zaidi, President & CEO, Epinex Diagnostics, Inc.
Asad Zaidi, a biochemist and biomedical engineer, has been in the biomedical industry for over 40 years, working with companies such as Shiley (Pfizer), C.R. Bard, Mitral Medical, Bicer Medical, and Medtronic. He has been responsible for licensing and transferring medical device manufacturing technology from Latin America to Canada and to England. His areas of expertise range from product development to patenting and production.
Theresa Zhang, Ph.D., Vice President, Research Services, Personal Genome Diagnostics
Theresa Zhang is an experienced leader of bioinformatics and translational science for oncology. She had more than 10 years of experience in drug discovery and development at Merck, where she led the bioinformatics and molecular profiling group to support oncology pipeline by analysis of large-scale ‘omics data and discovery and clinical translation of biomarkers. She joined PGDx in 2014 and has focused on bringing the cutting-edge molecular tests developed by PGDx to researchers in academia, biotechnology and pharmaceutical development. Dr. Zhang received her Ph.D. in Computational Biology from University of Virginia, after which she completed postdoc training in Bioinformatics at Cold Spring Harbor Lab.
John F. Zhong, Ph.D., Associate Professor, Pathology, University of Southern California School of Medicine
Dr. Zhong is an associate professor with the Department of Pathology, Keck School of Medicine, University of Southern California. He obtained his B.S. degree in molecular biology from California State University, San Jose, his M.S. in computational biology and his Ph.D. in Biochemistry and Molecular Biology from University of Southern California. His research focuses on molecular analysis of single mammalian cells, especially gene regulations within a mammalian cell in normal development or diseases such as cancer.
Justin Zook, Ph.D., Biomedical Engineer, National Institute of Standards and Technology
Justin is currently working on developing reference materials, reference data, and reference methods for human genome sequencing with the Genome in a Bottle Consortium (www.genomeinabottle.org). He is developing methods to compare and integrate whole genome DNA sequencing data from multiple platforms and sequencing runs, and thereby measure performance of sequencing methods.
Hongwei Zhang, Ph.D., Director, R&D and Process Engineering, Luminex Corporation
Dr Hongwei Zhang, with over 14 years of biotechnology industry experience, is the Director of R&D and Process Engineering at LuminexCorporation in Toronto, Canada. Shejoined Luminex Toronto as Director of R&D in January 2008 and is responsible for developing multiplex molecular diagnostics products including the flagship Respiratory Viral Panel assays, Gastrointestinal Pathogen Panel assay, Bloodstream Pathogen Panel assay, Cerebral Spinal Fluid Pathogen Panels and pharmacogenomics assays. In addition to her R&D role, Dr Zhang is also leading the Design Transfer and Process Engineering group to ensure product is effectively and efficiently transferred to theOperation/Manufacturing group and to provide process validation support for on-market products. Prior to Luminex,Dr Zhang was the Director of Biomarker Development at GeneNews, a biotechnology company focused on discovering and developing blood-based biomarkers and assay development for various diseases, including colorectal cancer and arthritis. Before her biotechnology industry career, Dr Zhang spent 3 years as a researcher at Arthritis Centre of Excellence at Toronto Western Hospital. Prior to her just over 20 years in Canada, Dr Zhang was a staff physician in the prestigious Beijing Great Wall Hospital (also known as 301 hospital)for 4 years. Dr Zhang received her MD from Norman Bethune University of Medical Science in China (now as part of JiLin University) and her PhD from University of Toronto, Canada.