Program Speakers and Poster Presenters

 

Andrew Aijian

Senior Project Leader

DeciBio Consulting

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Andrew Aijian

Senior Project Leader

TBA

Jeff Allard

President

Lakeside Life Science

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Jeff Allard

President

TBA

Ron Ammar

Research Investigator

Bristol-Myers Squibb

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Ron Ammar

Research Investigator

Ron Ammar completed his PhD at the University of Toronto studying chemical genomics and chromatin structure in the labs of Corey Nislow and Gary Bader. He completed a postdoctoral fellowship in the labs of Gary Bader and Michael Brudno developing software to implement clinical genomic workflows in collaboration with several hospitals in Toronto, primarily the Hospital for Sick Children. Along with the Sick Kids team, he directed efforts to integrate pharmacogenomic diagnostics in the clinic. At BMS, Ron focuses on bioinformatic analysis and helping to develop Nextgen sequencing strategies and projects in support of the fibrosis and immuno‐oncology areas.

Steve Anderson

Chief Scientific Officer and Senior Vice President

Covance

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Steve Anderson

Chief Scientific Officer and Senior Vice President

Steven Anderson, PhD, is a Senior Vice President at Laboratory Corporation of America (LabCorp), and the Chief Scientific Officer for the Covance Drug Development business of LabCorp. He has been with the LabCorp organization for 28 years and has held a variety of positions including Director of Operations for ViroMed Laboratories, Director of Operations for Monogram Biosciences, Director of Operations for the Center for Molecular Biology and Pathology, Director of Operations for Integrated Oncology and Genetics, National Director of Research and Development, and Global Head of LabCorp Clinical Trials. Dr. Anderson is a member of a variety of professional societies including the American Association for Cancer Research, the American Society of Clinical Oncology and the Association for Molecular Pathology.

Dr. Anderson’s research interests are in the development and applications for molecular diagnostics, including several examples of companion diagnostics and pharmacogenomic assays. He has authored more than 175 articles and abstracts published in such journals as Genetics, Proceedings of the National Academy of Sciences, Clinical Chemistry, the Journal of Infectious Disease, Human Pathology, American Journal of Obstetrics and Gynecology, Oncogene, the Journal of the National Cancer Institute, Clinical Cancer Research, Breast Cancer Research, BMC Cancer, the Journal of Molecular Diagnostics, Archives of Pathology and Laboratory Investigation and Expert Reviews in Molecular Diagnostics.

He has a PhD in Genetics from Iowa State University, and was an American Cancer Society postdoctoral fellow at the Waksman Institute of Rutgers University.

Flora Berisha

Director of Companion Diagnostics

Daiichi Sankyo Pharma

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Flora Berisha

Director of Companion Diagnostics

Flora Berisha is a Director of Companion Diagnostics, at Daiichi Sankyo Pharma. Flora received her BS in Biochemistry and Master Degree in Biology from City University of New York. She currently lead CDx development for multiple projects in the oncology portfolio. Prior to Daiichi Sankyo, Flora was at Kyowa Hakko Kirin Pharma as a Senior Manager. At KHK she focused on strategic biomarker selection, development and translation into CDx assays. She was the CDx lead on representing the strategies to external partners and regulatory agencies. Prior to KHK, Flora was at Bristol­Myers Squibb where she progressed through the ranks gaining valuable experience in GLP and clinical Bioanalysis, biomarker and CDx assay development from design control through commercialization. In addition to Flora’s industry experience, she is currently an Adjunct Professor in the Department of Biology at CUNY (City university of New York) where she teaches anatomy­physiology and biology over a decade.

Chris Bunker

Vice President of Business Development

Advanced Cell Diagnostics (ACD)

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Chris Bunker

Vice President of Business Development

Dr. Christopher Bunker is the Vice President of Business Development at Advanced Cell Diagnostics (ACD) in Newark, California. Dr. Bunker did his doctoral research in the laboratory of Dr. Robert E. Kingston at Harvard University. He continued work in cancer biology with a Leukemia Society of America postdoctoral fellowship at the University of California, San Francisco. Following his postdoctoral research, Dr. Bunker joined Genome Therapeutics Corporation (GTC) as a senior scientist in cancer functional genomics. Dr. Bunker also has an M.B.A from Boston University.

Dr. Bunker worked for ten years at Cell Signaling Technology (CST) before joining Advanced Cell Diagnostics, where he has lead its assay services business for the past 6 years.

Michele Cleary

Chief Executive Officer

The Mark Foundation for Cancer Research

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Michele Cleary

Chief Executive Officer

Michele Cleary joined The Mark Foundation as CEO in January 2017. Prior to that, she was Vice President of Clinical Translation Technologies & Operations at Bristol-Myers Squibb (BMS). At BMS, she led research teams using cutting-edge technologies to accelerate drug discovery and development for cancer and other diseases. Before joining BMS, Michele held several senior level positions at Merck & Co., Inc., overseeing the development and application of innovative platforms for understanding molecular mechanisms of cancer, identification of new therapeutic approaches for multiple diseases, and functional validation of novel drug targets identified through human genetics.  At Merck, her teams also conducted pioneering work on microRNAs as therapeutic targets and biomarkers in cancer.

Michele is co-author of more than 50 primary research papers in the fields of drug target biology, RNA interference, microRNAs, cell cycle, biomarkers, genomics and oncology.  She is also co- inventor on multiple patents for new technologies with direct application to cancer drug development. Michele received a PhD in Molecular Microbiology and Genetics from Stony Brook University and completed graduate research at Cold Spring Harbor Laboratory followed by postdoctoral training at Princeton University. In addition to her position at The Mark Foundation, she is a member of the Board of Directors of the Society for Laboratory Automation and Screening (SLAS), a scientific society dedicated to advancing life science research through education, scientific networking and professional development.

Nic Dracopoli

Nic Dracopoli

Vice President and Head of Oncology Diagnostics

Janssen Pharmaceuticals

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Nic Dracopoli

Vice President and Head of Oncology Diagnostics

Dr. Nicholas Dracopoli is Vice President, Head Oncology Diagnostics at Janssen R&D, Johnson & Johnson. Previously, he was Vice President of Clinical Discovery Technologies at Bristol-Myers Squibb, and prior to that spent five years in the biotechnology industry at Sequana Therapeutics. Dr. Dracopoli obtained his B.Sc. and Ph.D. degrees from the University of London, and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center and the Massachusetts Institute of Technology (MIT). Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center, and as a Section Chief at the National Center for Human Genome Research at the NIH before moving to the biotechnology industry. Dr. Dracopoli has authored over 80 scientific publications, and has extensive experience in the fields of genomics, molecular biology and cancer research.

Anka Ehrhardt

Consultant

Former BMS

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Anka Ehrhardt

Consultant

Dr. Anka Ehrhardt is a biophysicist with a doctorate degree in human physiology. She most recently worked for Bristol-Myers Squibb. Already during her academic career, Dr. Ehrhardt successfully developed technology and technology based methods, such as anisotropy detection based imaging. Later, she headed a technology laboratory at Merck, covering comprehensive instrumentation in high tech fields such as fluorescence, imaging, flow cytometry, electrophysiology and luminescence for the entire range from early discovery to late stage clinical trials across all disease areas. While at BMS, Dr. Ehrhardt directed the Clinical Cytometry team, covering a large portfolio of immunology, immuno-oncology, and other disease area clinical studies. Her work focused on the practicalities of biomarkers as tools to drive the development of urgently needed new medicines. This reaches from securing that biomarker assays are optimized to gather clear data in support of fast well founded decision making to systematically maximizing the information gathered from clinical samples to support hypothesis generation.  Dr. Ehrhardt is currently on the board of different industry organizations, fostering innovation and collaboration between industry, academia and government organizations.

Ken Emancipator

Executive Medical Director and Head of Companion Diagnostics

Merck & Co.

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Ken Emancipator

Executive Medical Director and Head of Companion Diagnostics

Kenneth Emancipator, MD, DABP is a renowned pathologist who is the Executive Medical Director and Head of Companion Diagnostics for Merck & Company. He led the Merck team which partnered with Agilent Technologies (Dako) to develop the first FDA-approved companion diagnostic in cancer immunotherapy, the 22C3 PD-L1 immunohistochemistry test, which later enabled Keytruda® (pembrolizumab) to become the first immunotherapy to be approved for first-line treatment of non-small cell lung cancer. Dr. Emancipator was one of six members of the Keytruda Team to receive the 2015 PhRMA Research and Hope Award for Biopharmaceutical Industry Research on behalf of Merck. More recently, he received the 2017 Philip Levine Award for Outstanding Research from the American Society for Clinical Pathology.

Dr. Emancipator’s primary interest has always been the role of diagnostic tests in driving clinical decisions. His current focus is personalized medicine, with a special emphasis on precision immuno-oncology. 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, before joining the pharmaceutical industry.

Dr. Emancipator received his A.B. degree from Harvard University and his MD 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, the US Food and Drug Administration, Cornell University, Beth Israel Medical Center, Bayer Healthcare, Siemens Healthcare, and Abbott Molecular prior to joining Merck. He also has held various leadership positions with the American Society for Clinical Pathology (ASCP), including chairing its Council on Clinical Chemistry, serving on its Board of Certification, serving on its Finance Committee, and eventually being elected Treasurer and to the Board of Directors. He continues to serve as a reviewer for ASCP’s American Journal of Clinical Pathology.

Dr. Emancipator has authored over 100 publications and has presented at more than 100 extramural programs. When not in his office at Merck, he is most likely to be found along the beaches and coastal waterways of Eastern Long Island.

Julie Engel

Director of Precision Medicine and Diagnostics Regulatory Affairs

Celgene

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Julie Engel

Director of Precision Medicine and Diagnostics Regulatory Affairs

Julie Engel is the newly appointed Director of Precision Medicine and Diagnostics Regulatory Affairs at Celgene. Prior to joining Celgene, Julie was the Director of Companion Diagnostics Regulatory Affairs at Ventana Medical Systems (Roche Tissue Diagnostics) Tucson, Arizona where she gained PMA approvals for the ALK IHC assay for NSCLC, and the PDL-1 (SP142) IHC assay for bladder carcinoma and NSCLC. Prior to joining Celgene, Julie held positons in both mid-large Pharma (Regeneron, Lilly) as well as emerging Pharma companies (Pharmacyclics, Endocyte, Cytheris, ImClone) in both clinical research and Regulatory affairs. For the past six years, she has focused on Companion Diagnostics, first at Roche Professional Diagnostics in Indianapolis, Indiana, with a focus in CNS diseases, and more recently at Roche Tissue Diagnostics (Ventana Medical Systems, Inc.), with a focus in oncology.

Julie holds a PhD degree in Basic Medical Sciences from the New York University School of Medicine, and a Regulatory Affairs Certification (RAC).

Gerold Feuer

Founder and Chief Scientific Officer

HuMurine Technologies

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Gerold Feuer

Founder and Chief Scientific Officer

Dr. Gerold Feuer is Founder and Chief Scientific Officer of HuMurine Technologies, Inc. Dr. Feuer obtained his B.A. at U.C. Berkeley and his Ph.D. at U.C. Irvine. After post-doctoral studies at U.C.L.A. Medical Center on human retrovirus infections in humanized mice, Dr. Feuer spent 18 years as a professor in the Department of Microbiology and Immunology at SUNY Upstate Medical University, Syracuse, where he established and served as the Director of SUNY UMU’s Center for Humanized SCID Mouse Models. Humurine was founded in 2008 as a SUNY- academic spinoff company, and HuMurine laboratory operations relocated to adjacent to the U.C. Davis Medical Center and Institute for Regenerative Cures in Sacramento, CA, in 2011. Dr. Feuer retired from SUNY UMU in 2015 to return to California and to run HuMurine full-time. Dr. Feuer has published over 35 publications and has extensive background in the fields of human virology, gene therapies and human stem cells.

Kim Folander

Executive Director, Business Development & Licensing

Merck & Co.

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Kim Folander

Executive Director, Business Development & Licensing

Kimberly Folander joined Merck in 1987 as a staff biochemist in the Department of Pharmacology. Her research focused on the molecular biology, structure, function, and pharmacology of ion channels for cardiac drug development. Kim joined Merck’s Business Development & Licensing group in 2001 where she has had increasing roles of responsibility and management. She has had responsibility for Merck’s search, evaluate and licensing of genetically engineered models, molecular profiling and screening technologies, imaging, molecular biomarkers and companion diagnostics. She was a member of the MRL Basic Research Integration team for the Merck Schering­Plough merger and led Merck’s acquisition, licensing and sale of Sirna Therapeutics.

Kim currently oversees BD&L’s Enabling Technology group that has the responsibility for the search and evaluate of technologies at the forefront of chemistry, pharmacology, drug delivery, biomarkers, bioprocess and vaccine and biologics.

Kim holds a Master’s in biochemistry from The University of Connecticut and is a Certified Licensing Professional. With 29 years in laboratory and licensing strategy experience at Merck, Kim brings a wealth of knowledge and a deep network of relationships to the department. kimberly_folander@merck.com

Barbara Joyce-Shaikh

Associate Principal Scientist

Merck & Co.

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Barbara Joyce-Shaikh

Associate Principal Scientist

Ms. Joyce-Shaikh completed her B.S in molecular biology at San Jose State University. She has more than 20 years of biotech industry experience specializing in translational systems of immune function and immuno-oncology. Her work has contributed to several patents as well as peer-reviewed publications in several high-ranking international scientific journals including Nature, Immunity, Nature Medicine, and the Journal of Experimental Medicine. She is currently a project lead in the Discovery Immunooncology group at Merck Research Laboratories, in Palo Alto, California (formerly the DNAX Research Institute). Her research utilizes syngeneic and humanized mouse tumor systems to model tumor microenvironment with the goal of discovering novel immunomodulatory agents and combinatorial treatments to fight drug-resistant cancers.

Brian Kelly

Global Director, Diagnostic Partnering

ThermoFisher Scientific

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Brian Kelly

Global Director, Diagnostic Partnering

Brian Kelly is Global Director, Diagnostic Partnering at ThermoFisher Scientific and leading the effort to partner with Pharma for Companion Diagnostic co-development.  He started his career studying genetic mechanisms of Cancer at Johns Hopkins and has spent the last decade in commercial and business development roles with numerous organizations prior to ThermoFisher such as Life Technologies, Pacific Biosciences and Affymetrix. Mr. Kelly earned a BS Biology/Chemistry from Towson University, and MS Biology/Bioinformatics from The Johns Hopkins University.

Bahram G. Kermani

Founder, CEO

Crystal Genetics

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Bahram G. Kermani

Founder, CEO

Dr. Bahram G. Kermani is the Founder and CEO of Crystal Genetics, Inc. He is an expert in the field of genomics, computational biology, and pattern recognition. Prior to starting Crystal Genetics, he held various executive and technical positions at Guardant Health, Complete Genomics, Illumina, and Bell Labs (Lucent). Dr. Kermani completed his postdoctoral fellowship at Duke University Medical Center. He received his Ph.D. and M.S. in electrical engineering, and biomedical engineering (minor) from North Carolina State University, and received his B.S. in electronics engineering from Amirkabir University of Technology. Dr. Kermani has several publications in the areas of genomics, biomedical engineering, and electrical engineering, and holds in excess of 46 issued patents in the United States, Canada, France, United Kingdom, Germany, and Japan.

Kamala Maddali

Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics

Cancer Genetics

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Kamala Maddali

Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics

Dr. Kamala K Maddali is currently Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics at Cancer Genetics Inc, Rutherford, NJ. Cancer Genetics, Inc. (CGI) is a leader in the field of personalized medicine, offering diagnostic products and services that enable precision medicine in the field of oncology.

Dr. Maddali holds a DVM Ph.D., in Pharmacology from University of Missouri-Columbia and a DVM Veterinary Medicine from Acharya N.G. Ranga Agricultural University in India.

Dr. Maddali brings over 10 years of extensive experience of global P&L scientific and commercial management of clinical biomarker and companion diagnostics (CDx) services covering personalized medicine strategy. She has promoted the proper utilization of biomarkers, personalized medicine and diagnostics in drug development and patient management to bridge the gap between drug and diagnostic industries. She was Global Director Scientific Development -Biomarkers & Companion Diagnostics for Q2 Solutions (A Quintiles & Quest Diagnostics joint venture). She brings a lot of strategic values from her previous roles at Quest Diagnostics, Quintiles and Merck Schering Plough in the arena of biomarkers and companion diagnostics.

Chris Major

Director of Oncology Diagnostics

Janssen Pharmaceuticals

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Chris Major

Director of Oncology Diagnostics

Christopher Major, Director of Oncology Diagnostics at Janssen Pharmaceuticals R&D, received his PhD in Cell and Molecular Biology from the University of Pennsylvania. He completed post-doctoral fellowships at the National Cancer Institute and Johnson and Johnson Pharmaceutical Research & Development. He joined Janssen Pharmaceutical R&D in 2011 and has directed companion and complementary diagnostic development in support of Janssen therapeutic compounds. In 2017 he joined the Janssen Oncology Diagnostic group as Scientific Director, developing the companion diagnostic strategy for multiple oncology programs, providing oversight of all diagnostic development activities in support of the oncology portfolio at Janssen Pharmaceuticals.

Chris has over 15 years’ experience in the pharmaceutical and medical diagnostic industries, bringing expertise in development of in vitro diagnostic assays and companion diagnostics in accordance with global regulations. He has collaborated on NSRs, IDEs, Pre-Subs, & PMAs with IVD partners as well as participated in regulatory interactions with FDA, CFDA, and PMDA. His mission is to ensure the first Janssen drug-companion diagnostic submission to FDA in 2018.

Bill Pignato

Founder and Principal

W.J. Pignato & Associates

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Bill Pignato

Founder and Principal

Bill Pignato is the Founder and Principal of W.J. Pignato & Associates, LLC a Boston based consulting firm specializing in global regulatory affairs strategy focused on in vitro diagnostics, medical devices, companion diagnostics and precision medicine, drug/diagnostics co-development and the regulatory deployment of new technologies. Previously Bill was the Vice President, Global Head of Regulatory Affairs, Companion Diagnostics where he led the companion diagnostic regulatory program at Novartis, for its novel therapeutics in oncology and general medicine. He worked at Genentech, Inc leading the regulatory effort specific to the company’s companion diagnostic initiatives. Bill brings over 30 years of strategic global regulatory diagnostic experience in support of bringing products to market, including working on more than 50 drug/diagnostic codevelopment programs. Prior positions include Vice President of Regulatory Affairs for EXACT Sciences Corp., an applied genomics company focused on the early detection of colorectal cancer and Vice President of Regulatory Affairs for Valeo Medical. He has also previously held senior regulatory positions at Bayer Diagnostics, Chiron Diagnostics and Ciba-Corning Diagnostics. Bill has been active in numerous FDA/Industry cooperative activities regarding regulatory policy impacting diagnostic devices. He has spoken widely on a number of regulatory issues and challenges associated with commercialization of in vitro diagnostic technologies including personalized medicine, companion diagnostics and co-development.

Oscar Puig

Chief Scientific Officer

Phosphorus

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Oscar Puig

Chief Scientific Officer

Oscar Puig is the Chief Scientific Officer at Phosphorus, a genetic diagnostic company founded in 2016 that develops diagnostics for complex genetic diseases and software for clinical data management and analysis. We currently commercialize three genetic panels (Reproductive Health, Cardiology, and Oncology). Prior to that, he was a Biomarker Leader in Oncology at the Roche Innovation Center in New York. He earned his Ph.D. at the University of Valencia, Spain, and carried out postdoctoral research at the European Molecular Biology Laboratory, in Heidelberg, Germany, and in the lab of Bob Tjian, at UC Berkeley, CA. Before joining Roche in 2012, he worked at Merck and at the University of Helsinki, where he is a docent. Dr Puig has over 40 publications in peer-reviewed journals. 

Debra Rasmussen

Senior Director of Global Regulatory Affairs

Janssen Pharmaceuticals

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Debra Rasmussen

Senior Director of Global Regulatory Affairs

Deb’s regulatory and quality career has spanned both large and small companies and both US and global programs. She has been in medical diagnostics for over 25 years and gained her experience working at Bio-Rad Laboratories, Roche Molecular Systems, Chiron Corporation, Applied Imaging Corporation, and Visible Genetics. She joined Johnson and Johnson in 2003. Deb is the Global Regulatory Affairs Diagnostics (GRA Dx) leader at Janssen Pharmaceuticals. GRA Dx is integral in the companion and complementary diagnostic product development programs. For Janssen, GRA Dx is responsible for development of regulatory strategy, policy, and registration of the in vitro diagnostic devices associated with Johnson and Johnson drug development and commercialization.

Annabelle Rodriguez

Founder

Lipid Genomics

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Annabelle Rodriguez

Founder

Dr. Rodriguez is a board certified endocrinologist with expertise in cholesterol disorders and diabetes mellitus. While a full-time faculty member of the Johns Hopkins University School of Medicine in Baltimore, Maryland USA, Dr. Rodriguez developed molecular diagnostic tests to identify people with SCARB1 genetic variations that might be at risk for heart disease in men and women and infertility in women.

Michael Seiler

Director, Commercial Genetically Engineered Models

Taconic Biosciences

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Michael Seiler

Director, Commercial Genetically Engineered Models

Mike earned a bachelors’ degree from the University of Iowa, and Ph.D. in cell and molecular biology from the Baylor College of Medicine in Houston, Texas. At Baylor, Mike worked with Dr. Brendan Lee, investigating the immune response to systemically administered viral mediated gene therapies to treat inborn errors of metabolism. He followed with a postdoctoral fellowship at the University of Chicago with Dr. Albert Bendelac where he worked to define the earliest molecular and epigenetic signals of Natural Killer T cell lineage commitment. Mike published fifteen peer reviewed manuscripts in the fields of airway biology, immunity to viral gene therapies, and developmental immunology. Since joining Taconic, Mike held positions in scientific marketing and product management, focused on aspects of competitive intelligence, business analytics, market forecasting and new product launch. He is currently the portfolio director for Commercial GEMs, responsible for all commercial genetically engineered mouse models, including NOG, second generation NOG, and Precision humanized immune system research models.

Yoav Smith

Manager Genomic Data Analysis Unit

Genefron, Hebrew University of Jerusalem, Medicine Faculty

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Yoav Smith

Manager Genomic Data Analysis Unit

Yoav Smith has a B.S.E.E from the Electrical Department of the Technion in Haifa Israel, an M.S.E.E. from the University of Pittsburg, USA and a Ph.D. from the Hebrew University Medical School, Jerusalem, Israel. In the last 15 years he directs the activity of the Genomic Data Analysis Unit in the Hadassah Medical School, which deals with all aspects of gene expression studies done by many research groups both academic and clinic. His work is published in more than 40 papers in reputed journals along with 4 registered patents and 7 new pending applications for patents. He also is a cofounder of a startup company in the field of personal medicine. Yoav teaches courses in visualization and analysis of data to Master’s and Ph.D. level students. Yoav is the recipient of the Westinghouse Invention Award-For the development of a computerized calibrating system for temperature measurements in Nuclear Plants,The Tadiran Electronic Warfare acknowledge- for developing a method to locate lost pilots and the Hebrew University Key Invention award-For the development of a computerized system to track changes in skin moles.

Brian Soper

Manager, Technical Information Services & Senior Technical Information Scientist

The Jackson Laboratories

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Brian Soper

Manager, Technical Information Services & Senior Technical Information Scientist

Dr. Brian Soper has worked at The Jackson Laboratory for more than 20 years. He has conducted research on hematopoietic stem cell biology, bone marrow transplantation, immune tolerance and treatment strategies for a mouse model of human enzyme deficiency. He now works as Manager of the Technical Information Scientist group providing educational resources to the scientific community. His areas of expertise include: mouse models of human type 1 and type 2 diabetes and research with immunodeficient mice. Brian has extensive knowledge in the immunobiology of humanized mice reconstituted with human hematopoietic cells and tumor bearing humanized mice used in immuno-oncology.

James Storhoff

Director, Diagnostic Product Development

NanoString Technologies

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James Storhoff

Director, Diagnostic Product Development

James Storhoff is Director of Diagnostic Product Development at NanoString Technologies, a provider of life science tools for translational research and molecular diagnostics. James has spent 15 years developing molecular diagnostic assays for clinical microbiology and oncology applications. He previously lead a team of scientists in developing the FDA-cleared Prosigna® Breast cancer prognostic gene signature assay and is now leading development of companion diagnostic assays on the nCounter analysis platform. James holds a doctorate in chemistry from Northwestern University.

Donald Very

Vice President, Scientific Strategy, Technology and Research

Helomics

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Donald Very

Vice President, Scientific Strategy, Technology and Research

With over twenty-five years of diagnostic assay development and performance qualification experience in such diverse clinical areas as oncology, infectious disease, and metabolic disease, Dr. Very has extensive experience in all phases of diagnostic assay research, development, performance validation, clinical trial design and implementation, and regulatory approval.

Dr. Very is currently Vice President, Scientific Strategy, Technology and Research at Helomics Corporation and President & CEO of Naviter Bioanalytics, LLC, a private consulting firm.  At Helomics, Dr. Very is responsible for the identification, evaluation, and implementation of new technologies, assay platforms, and tests to augment the company’s clinical laboratory, comprehensive tumor profiling platform, and contract research offerings.  Prior to Helomics, he was Vice President of Research and Assay Development for Ancera, Inc., where he successfully led efforts to develop quantitative cell, nucleic acid, and protein assays for the company’s proprietary, magnetic fluid-based, diagnostic platform. He also served as Vice President of Immunology and Assay Development for the Institute for Bioanalytics, LLC (IBA).  Responsible for the overall scientific, operational, and research activities of the Institute, he successfully built a profitable contract research business.  Under his leadership, IBA completed over 200 cell, nucleic acid or antibody-based assay development and performance qualification projects in support of the research programs of clients in the pharmaceutical, diagnostic, and biotechnology industries.  Dr. Very also served as a Senior Research Scientist for the Diagnostics Division of Bayer Corporation, where he was responsible for the design and execution of clinical trials, performance validation studies for the AFP, CA 125 II, and CA 15-3 tumor marker assays for the Bayer Immuno 1™ Immunoanalyzer, and the preparation and submission of 510(k) applications to the FDA for these assays.  These activities culminated in the FDA’s approval of all these assays for use in the U.S.  Dr. Very began his career as a researcher and supervisor of the BL-2 and BL-3 laboratories affiliated with the U.S. Army Medical Research Unit in the Republic of Korea.  Managing a staff of six scientists, his team conducted clinical and diagnostic research on hantaviral and rickettsial diseases endogenous to the Korean peninsula.

Dr. Very is a frequently invited speaker at national and international scientific symposia discussing topics ranging from advances in personalized medicine in oncology, the clinical utility of serum biomarkers in the diagnosis and management of disease, the development and performance qualification of multiplexed immunoassays, and the future of the in vitro diagnostic industry.  He received his Bachelor of Science degree in Biology from the University of Notre Dame, a Master of Science degree in Biology from the University of Texas at San Antonio, and a Doctorate in Microbiology/Immunology from Boston University.

Katarina Wikstrom

Head of US Operations

Almac Diagnostics

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Katarina Wikstrom

Head of US Operations

Dr. Katarina Wikstrom (PhD) has worked for over 14 years in the field of translational molecular oncology and holds the position of Head of US Operations at Almac Diagnostics. Katarina has overall responsibility for all US laboratory technologies and services supporting biomarker discovery, assay development and validation, and product delivery.

Katarina obtained a PhD in experimental pathology from Lund University, and subsequently completed a postdoctoral fellowship on the molecular mechanisms of prostanoid signaling in vascular haemostasis and oncology at University College Dublin. Since joining Almac in 2009 Katarina has built up a breadth of experience in the biomarker field with particular focus on assay development and validation.

Xuemei Zhao

Senior Principal Scientist

Merck & Co.

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Xuemei Zhao

Senior Principal Scientist

Xuemei is currently a Senior Principal Scientist in the Translational Molecular Biomarkers Department at Merck & Co., Inc. in Rahway, NJ. She received her Ph.D. in Chemistry from Columbia University and performed her postdoctoral research at Cold Spring Harbor Laboratory. Afterwards, Xuemei joined the Proteomics Department in Molecular Profiling at Merck in 2004. She led the biochemistry group focusing on sample preparation for LC-MS based proteomics profiling for biomarker discovery and new target identification. In 2012, Xuemei transitioned to clinical biomarker development. Currently, she leads the immunoassay group focusing on clinical biomarker assay development, validation, and implementation to support drug development clinical studies across all disease areas at Merck.