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 Expert  727711

Expert in stem cells, bone repair preclinical, ischemia, inflammation, wound healing, IND, patent writing


Available for your Consulting and Expert Witness Needs

Massachusetts (MA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

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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blood cell

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blood product

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growth factor

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inflammation

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macrophage

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monocyte

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neutrophil

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phagocyte

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chronic inflammation

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lymphocyte

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wound

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cell (biology)

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leukocyte

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acute wound

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chronic wound

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wound healing

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inflammatory response

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cytokine

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granulocyte

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cancer immunology

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blood platelet

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cellular immunology

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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bone morphogenetic protein

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fibronectin

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flow cytometry

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pluripotent cell

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stem cell transplantation

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mesenchymal stem cell transplantation

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stem cell

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bone healing

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biological cell differentiation

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fibroblast

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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cryopreservation

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freezing

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cryoprotection

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apoptosis

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cell damage

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cell disruption

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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antibody

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assay development

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bioassay

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biological testing

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cell biology

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cell culture

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enzyme activity assay

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experiment

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flow cytometer

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flow cytometer quality control

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flow cytometry procedure

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immunoassay

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protein assay development

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protocol

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staining

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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literature search

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new product development

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patent application

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pharmaceutical patent

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research

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peer review

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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brain hypoxia

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brain ischemia

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cell death

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central nervous system cell culture

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brain hypoxia ischemia

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brain infarction

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brain injury


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.

Education:
Year   Degree   Subject   Institution  
1991   PhD   Cell Biology and Pathology   Boston University School of Medicine  
1980   MS/MD   Biochemistry/Medicine   Moscow Medical Institute  

Work History:
Years   Employer   Department   Title   Responsibilities

2010 to

 

(Undisclosed)

 


 

Head, New Biotechnology Research

 

Cryopreservation of the current product Product pipeline, new indications Assay development IND application Patent writing

2004 to 2010

 

Teva Pharmaceutical Industries, Ltd

 


 

Head, Cell Therapy Laboratory; Associate Director

 

Established and run mesenchymal stem cell laboratory: differentiation, markers Preclinical studies: bone repair Cryo-preservation program Assay development

2002 to 2004

 

National Institute of Ageing, NIH,

 

Laboratory of Neurosciences

 

Scientist, Stem Cells

 

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

2001 to 2002

 

National Institute of Neurological Disorders and Stroke (NINDS)

 

Laboratory of Molecular Biology

 

Senior Research Fellow

 

Experimental work: effect of hypoxia on mouse embryonic stem cell differentiation

1996 to 2001

 

National Institute of Neurological Disorders and Stroke (NINDS)

 

Stroke Branch

 

Senior Research Fellow

 

Established cell culture facilities Cellular models (neurons, astrocytes) of of ischemia and ischemic tolerance. Adviser for Postdoctoal and Visiting Fellows

1994 to 1996

 

Boston University School of Medicine

 

Pathology Department

 

Instructor

 

Experimental work: leukocyte-endothelial interactions, inflammation, hypoxic injury Assay development

1991 to 1994

 

Boston University School of Medicine

 

Cancer Research Center

 

Postdoctoral Fellow

 

Experimental work: leukocyte-endothelial interactions, inflammation, hypoxic injury Assay development

1990 to 1991

 

Dana Farber Cancer Institute, Harvard Medical School

 

Pediatric Oncology

 

Postdoctoral Fellow

 

Experimental work: leukocyte-endothelial interactions, inflammation, hypoxic injury Assay development


Career Accomplishments:
Associations/Societies

International Society for Stem Cell Research (ISSCR) Israel Stem Cell Society (ISCS)

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.


Publications:
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


Government Experience:
Years   Agency   Role   Description
2011 to 2011   European Commission; Seventh Framework Programme (FP7).   Expert Evaluator and Rapporteur   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.
2004 to 2010   Chief Scientist's Office of the Israeli Ministry of Industry & Trade   Coordinator of the Adult Stem Cell Cluster; Israeli Consortium for Cell Therapy   •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
2002 to 2004   National Institute of Ageing, NIH   Staff Scientist   Established human embryonic stem cell facilities and program
1996 to 2002   National Institute of Neurological Disorders and Stroke, NIH   Senior Research Fellow   Conducted research in the area of stroke injury

Consulting Services:
Selected Consulting Examples:
  • 2008-2010 Consultant, Expert's firm: R&D program development; Expansion of IP; FDA correspondence; Government grant application
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact 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 (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Summary
Clinician-Biochemist, Moscow City Hospital No 1

Language Skills:
Foreign Language   Description
Russian   Mother tongue. Excellent oral and written skills Review of the scientific literature, scientific collaborations
Hebrew   Average level; use every day at work

Additional Skills and Services:
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

Other Skills and Services

Technical writing: patent applications, IND application, scientific proposals, grant applications


 

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