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Expert in stem cells, bone repair preclinical, ischemia, inflammation, wound healing, IND, patent writing
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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Expert is currently leading development of new blood-derived products for wound healing in a startup company. Expert is using her previous experience in leukocyte activation, adhesion and inflammation (her thesis research and postdoctoral training resulting in 10 peer-reviewed publications and two patents) on a new industrial level. Prior to joining the company on full time basis Expert served as the company's freelance consultant. Overall Expert has been working with blood products for wound healing for almost four years. She co-authored 2 patents and contributed significantly to IND application to FDA and FDA correspondence. Expert developed and executed an R&D program for upgrading her company's wound healing product for treatment of solid tumors. The mechanism of action for a new product is based on concepts of tumor immunology. Based on this pipeline research a patent application with multiple experimental examples was submitted.
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Expert lead a pioneering research of human embryonic stem cells (hES cells) at the National Institute on Aging, NIH for more than 3 years. She optimized and standardized hES culture conditions and conducted analysis of hES cell markers on a protein and gene level. She established conditions for neuronal differentiation of hES cells. Her work resulted in 6 publications. Expert has vast experience with mesenchymal stem cells (MSC). For 6 years she headed Cell Therapy Laboratory at Teva Pharmaceutical Industries in Israel. She developed and standardized conditions for differentiation of MSC into bone progenitors, osteoclasts, endothelial progenitors, and cardiac myocytes. Expert developed and patented a method for production of bone progenitors growing on biodegradable scaffolds, such as collagen, polylactic acid (PLA), polyglycolic acid (PGA) polymers, hydrogels and others (published). She also developed assays for assessment of MSC viability, apoptosis, proliferation and osteogenic differentiation in a 2-D culture and on the scaffolds. She conducted several pre-clinical studies using bone marrow derived bone progenitors growing on scaffolds for bone repair in critical size bone defect models.
Expert's lab performed extensive analysis of MSC markers using microarrays, real time PCR and flow cytometry. She identified several new markers that distinguish MSC from fibroblasts (published).
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While working at Teva Pharmaceutical Industries as a Head of Cell Therapy Lab Expert established a GMP-grade cryopreservation method for MSC (published). She has developed multiple assays for testing cell viability,
apoptosis and proliferation in order to evaluate freezing injury. In her current position as a Head of New Biotechnology, the expert is developing a cryopreservation protocol for the company's product
using clinical grade cryoprotectants.
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Expert has extensive experience in flow cytometry analysis of cells stained with specific antibodies against various cell markers, such as markers of undifferentiated embryonic stem cells and of neuronal differentiation
(published
work), markers of undifferentiated mesenchymal stem cells and fibroblasts and of osteogenic differentiation (published work), markers of lymphocytes, monocytes and granulocytes and activation markers of these
leukocyte
subsets (current work with a blood product for wound healing). Expert has a vast knowledge of cell biology. She worked with primary cell cultures of many cell types (neurons, astrocytes, embryonic stem cells, bone marrow-derived stromal cells, fibroblasts) as well as tumor cell lines.
She
developed viability, cytotoxicity, apoptosis, proliferation, differentiation, adhesion and other biological assays to study the effects of activation, hypoxia and cryopreservation on these cell types. While working as a Head of Cell Therapy Laboratory and as a Coordinator of the Israeli Stem Cell Consortium and currently as a Head of New Biotechnology Research in a startup company Expert developed detailed
scientific
programs long and short term and implemented these programs through experimental protocols and assay development. The protocols were adjusted based on extensive analysis of experimental data.
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For 20 years Expert has been conducting research in various areas of cell biology, first in academia and then in industry. This research resulted in more than 30 publications and book chapters as well as in a number of patent families. Extensive literature search is a significant part of these activities. Literature search and analysis was performed for development and support of new hypotheses and ideas and for learning new methodology. Detailed citation lists accompany all Expert's publications, patent applications and R&D proposals. Expert closely worked with patent lawyers on her patent applications. Three of her patents have been already published and three others are at various stages of the application process. In her current work Expert has been in charge of the company's IP working closely with the patent firms on patent drafts and updates. Expert performed multiple peer reviews of scientific publications submitted to various journals such as Stem Cells and Development, Tissue Engineering, Cell Physiology and others.
As a Coordinator of the Adult Stem Cell Cluster of the Israeli Consortium for Cell Therapy, Expert reviewed scientific programs submitted to Consortium for funding.
Recently Expert participated in the review of Large Collaborative Project proposals submitted to European Commission Seventh Framework Programme (FP7) as an Expert Evaluator (wrote individual evaluation reports for allocated proposals) and Rapporteur (wrote consensus reports for a panel of experts).
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From 1995 to 2001 Expert worked as a Senior Research Fellow at the Stroke Branch of NINDS, NIH. Her task was to establish cellular models of ischemia/reperfusion based on primary cultures of neurons and astrocytes. Expert studied molecular mechanisms of ischemic tolerance. Her experimental work led to identification of ceramide as an intracellular signaling messenger for apoptotic neuronal death after ischemic brain injury. Ceramide in a lower dose, however, was implicated in induction of tolerance to ischemia. These in vitro findings were further supported by animal studies showing neuroprotective effect of ceramide in the permanent middle cerebral artery occlusion model of stroke and in the in immature rat brain hypoxia-ischemia model of neonatal asphyxia. During her tenure at the Stroke Branch Expert co-authored nine peer-reviewed papers and five review articles and book chapters. Expert supervised a number of postdoctoral and visiting fellows.
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Show Secondary and Basic Areas of Expertise | Localities: Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts;
Worcester, Massachusetts;
Springfield, Massachusetts;
Lowell, Massachusetts;
Cambridge, Massachusetts;
Brockton, Massachusetts;
New Bedford, Massachusetts;
Hartford, Connecticut;
Manchester, New Hampshire;
and Providence, Rhode Island.
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Degree |
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Subject |
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Institution |
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1991
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PhD
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Cell Biology and Pathology
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Boston University School of Medicine
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1980
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MS/MD
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Biochemistry/Medicine
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Moscow Medical Institute
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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2010 to
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(Undisclosed)
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Head, New Biotechnology Research
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Cryopreservation of the current product
Product pipeline, new indications
Assay development
IND application
Patent writing
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2004 to 2010
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Teva Pharmaceutical Industries, Ltd
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Head, Cell Therapy Laboratory; Associate Director
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Established and run mesenchymal stem cell laboratory: differentiation, markers
Preclinical studies: bone repair
Cryo-preservation program
Assay development
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2002 to 2004
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National Institute of Ageing, NIH,
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Laboratory of Neurosciences
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Scientist, Stem Cells
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Established human embryonic stem cell laboratory
Standartization of human embryonic cell culture
Human embryonic stem cell gene and protein markers
Advisor for Postdoctoral and Visiting Fellows
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2001 to 2002
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National Institute of Neurological Disorders and Stroke (NINDS)
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Laboratory of Molecular Biology
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Senior Research Fellow
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Experimental work: effect of hypoxia on mouse embryonic stem cell differentiation
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1996 to 2001
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National Institute of Neurological Disorders and Stroke (NINDS)
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Stroke Branch
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Senior Research Fellow
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Established cell culture facilities
Cellular models (neurons, astrocytes) of of ischemia and ischemic tolerance.
Adviser for Postdoctoal and Visiting Fellows
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1994 to 1996
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Boston University School of Medicine
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Pathology Department
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Instructor
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Experimental work: leukocyte-endothelial interactions, inflammation, hypoxic injury
Assay development
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1991 to 1994
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Boston University School of Medicine
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Cancer Research Center
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Postdoctoral Fellow
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Experimental work: leukocyte-endothelial interactions, inflammation, hypoxic injury
Assay development
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1990 to 1991
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Dana Farber Cancer Institute, Harvard Medical School
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Pediatric Oncology
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Postdoctoral Fellow
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Experimental work: leukocyte-endothelial interactions, inflammation, hypoxic injury
Assay development
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Associations/Societies
International Society for Stem Cell Research (ISSCR)
Israel Stem Cell Society (ISCS)
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Professional Appointments
Member of Editorial Board, Advances in Wound Care, a bimonthly journal (ISSN: 2162-1918) in the field of tissue injury and repair, with an emphasis on acute and chronic wound care to optimize patient outcomes.
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| Publications: |
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Publications and Patents Summary
Expert has more than 30 peer-reviewed publications and book chapters, first author of 4 patents, co-author of other 2 patent families
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| Government Experience: |
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| Years |
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Agency |
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Role |
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Description |
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2011 to 2011
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European Commission; Seventh Framework Programme (FP7).
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Expert Evaluator and Rapporteur
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Large Collaborative Project proposals in "Nanosciences, Nanotechnologies, Materials and New Production Technologies"
•Writing individual evaluation reports for allocated proposals.
•Writing consensus reports for a panel of experts.
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2004 to 2010
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Chief Scientist's Office of the Israeli Ministry of Industry & Trade
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Coordinator of the Adult Stem Cell Cluster; Israeli Consortium for Cell Therapy
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•Development of a scientific program for adult stem cell cluster of the Consortium;
•Preparation of quarterly reports of the program execution.
•Organization of scientific seminars for the Consortium members; establishment of scientific collaborations between academic and industrial members of the Consortium
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2002 to 2004
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National Institute of Ageing, NIH
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Staff Scientist
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Established human embryonic stem cell facilities and program
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1996 to 2002
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National Institute of Neurological Disorders and Stroke, NIH
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Senior Research Fellow
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Conducted research in the area of stroke injury
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| Selected Consulting Examples: |
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2008-2010 Consultant, Expert's firm: R&D program development; Expansion of IP; FDA correspondence; Government grant application
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Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
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Expert is free.
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Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
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Expert is free.
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| International Experience: |
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| Summary |
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Clinician-Biochemist, Moscow City Hospital No 1
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| Language Skills: |
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| Foreign Language |
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Description |
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Russian
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Mother tongue. Excellent oral and written skills
Review of the scientific literature, scientific collaborations
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Hebrew
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Average level; use every day at work
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| Additional Skills and Services: |
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Training/Seminars
Coordinator, Adult Stem Cell Cluster and Tools Development Cluster
Israeli Consortium for Cell Therapy: program development; organization of scientific seminars Biochemistry Instructor, Biomedical Sciences Program, Metropolitan College, Boston University, Boston, MA
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Other Skills and Services
Technical writing: patent applications, IND application, scientific proposals, grant applications
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