Expert Details

Expert in Stem cells, ischemia, stroke, cryopreservation, bioengineering, wound healing, inflammation, blood, vascular biology, cancer immunology

Expert ID: 727711 Massachusetts, USA

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Expert is currently a consultant specializing in scientific and biotechnological writing and review.

Previously Expert had a leading role in the 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 a 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 the 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.

Expert led 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 an 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 the 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 an extensive analysis of MSC markers using microarrays, real-time PCR and flow cytometry. She identified several new markers that distinguish MSC from fibroblasts (published).

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.

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.

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).

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 the 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 the induction of tolerance to ischemia. These in vitro findings were further supported by animal studies showing the neuroprotective effect of ceramide in the permanent middle cerebral artery occlusion model of stroke and in the 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.

2008-2010 Consultant, Expert's firm: R&D program development; Expansion of IP; FDA correspondence; Government grant application

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 - Providence, Rhode Island

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Education

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

Work History

Years Employer Title Department Responsibilities
Years: 2012 to Present Employer: Undisclosed Title: Founder Department: Consulting Responsibilities: Consulting services in pre-clinical and clinical product development, IND preparation, patent drafts, grant writing, mobile health applications.
Years: 2011 to Present Employer: Undisclosed Title: Panel Expert and Rapporteur Department: Responsibilities: Review and assessment of applications for funding from scientific consortia (universities, medical institutions, businesses) in the framework of European Commission Programs (the latest Horizon 2020) in the field of biomaterials, bioengineering, and regenerative medicine.
Years: 2017 to 2019 Employer: Cactus Global Title: Freelance writer Department: Responsibilities: Medical and scientific writing based on client research data

Years: 2010 to 2012 Employer: Macrocure Title: Head, New Biotechnology Research Department: startup Responsibilities: Cryopreservation of the current product
Product pipeline, new indications
Assay development
IND application
Patent writing
Years: 2004 to 2010 Employer: Teva Pharmaceutical Industries, Israel Title: Head; Associate Director Department: Cell Therapy Lab Responsibilities: Established an adult stem cell laboratory.
Developed and standardized assays for differentiation of mesenchymal stem cells (MSC); QC assays; transportation conditions.
GMP-grade cryopreservation program for suspended and scaffold-seeded MSC.
Developed and patented a new method for isolation of bone progenitors from unprocessed bone marrow.
Novel MSC markers and markers of osteogenic differentiation: real time PCR, microarrays; FACSAria.
Preclinical studies: critical size calvarial and long bone defect models of bone repair in rodents

Years: 2002 to 2004 Employer: National Institute of Ageing, NIH, Title: Scientist, Stem Cells Department: Laboratory of Neurosciences Responsibilities: Established human embryonic stem cell laboratory
Standardization of human embryonic cell culture.
Human embryonic stem cell gene and protein markers
Adviser for Postdoctoral and Visiting Fellows
Years: 2001 to 2002 Employer: National Institute of Neurological Disorders and Stroke (NINDS) Title: Senior Research Fellow Department: Laboratory of Molecular Biology Responsibilities: Experimental work: effect of hypoxia on mouse embryonic stem cell differentiation
Years: 1996 to 2001 Employer: National Institute of Neurological Disorders and Stroke (NINDS) Title: Senior Research Fellow Department: Stroke Branch Responsibilities: Established cell culture facilities
Cellular models (neurons, astrocytes) of of ischemia and ischemic tolerance.
Adviser for Postdoctoral and Visiting Fellows
Years: 1994 to 1996 Employer: Boston University School of Medicine Title: Instructor Department: Pathology Department Responsibilities: Experimental work: leukocyte-endothelial interactions, inflammation, hypoxic injury
Assay development
Years: 1991 to 1994 Employer: Boston University School of Medicine Title: Postdoctoral Fellow Department: Cancer Research Center Responsibilities: Experimental work: leukocyte-endothelial interactions, inflammation, hypoxic injury
Assay development
Years: 1990 to 1991 Employer: Dana Farber Cancer Institute, Harvard Medical School Title: Postdoctoral Fellow Department: Pediatric Oncology Responsibilities: Experimental work: leukocyte-endothelial interactions, inflammation, hypoxic injury
Assay development

Government Experience

Years Agency Role Description
Years: 2011 to Present Agency: European Commission; Seventh Framework Programme (FP7), Horizon 2020 Role: Expert Evaluator and Rapporteur Description: 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.
Years: 2004 to 2010 Agency: Chief Scientist’s Office of the Israeli Ministry of Industry & Trade Role: Coordinator of the Adult Stem Cell Cluster; Israeli Consortium for Cell Therapy Description: 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
Years: 2002 to 2004 Agency: National Institute of Ageing, NIH Role: Staff Scientist Description: Established human embryonic stem cell facilities and program
Years: 1996 to 2002 Agency: National Institute of Neurological Disorders and Stroke, NIH Role: Senior Research Fellow Description: Conducted research in the area of stroke injury

International Experience

Years Country / Region Summary
Years: 2004 to 2012 Country / Region: Israel Summary: Teva Pharmaceutical Industries, Head Stem Cell Therapy; Macrocure LTD; Coordinator of the Adult Stem Cell Cluster; Israeli Consortium for Cell Therapy

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.
Medical / Professional
1980; MD; the 2nd Moscow State Medical Institute named after N.I. Pirogov.
1980-1984; Clinician-Biochemist; Kidney Transplantation Center; Moscow City Clinical Hospital No. 1; Publication: Lopatkin NA, Chudnovskaia MV, Nenasheva NP, Rodoman VE, Expert IV. Urol Nefrol (Mosk). [Biochemical characteristics and treatment of chronic pyelonephritis in the clinical remissions phase]. 1978 Mar-Apr;(2):3-7. [Article in Russian]
2013-current; Adviser, mobile health applications: obesity, metabolic syndrome, CVD, healthy lifestyle


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Publications and Patents Summary
Expert has more than 30 peer-reviewed publications and book chapters, first author of 5 patents, co-author of other 2 patent families

Additional Experience

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

Language Skills

Language Proficiency
Russian Mother tongue. Excellent oral and written skills; Review of the scientific literature, scientific collaborations
English The highest level of oral and written skills; multiple scientific writings, peer reviews, patent applications, presentations at international conferences
Hebrew Average level

Fields of Expertise

blood cell, blood product, growth factor, inflammation, macrophage, monocyte, neutrophil, phagocyte, chronic inflammation, lymphocyte, wound, cell (biology), leukocyte, acute wound, chronic wound, wound healing, inflammatory response, cytokine, granulocyte, cancer immunology, blood platelet, cellular immunology, bone morphogenetic protein, fibronectin, flow cytometry, pluripotent cell, stem cell transplantation, mesenchymal stem cell transplantation, stem cell, bone healing, biological cell differentiation, fibroblast, cryopreservation, freezing, cryoprotection, apoptosis, cell damage, cell disruption, antibody, assay development, bioassay, biological testing, cell culture, enzyme activity assay, experiment, flow cytometer, flow cytometer quality control, flow cytometry procedure, immunoassay, protein assay development, protocol, staining, literature search, new product development, patent application, pharmaceutical patent, research, peer review, brain hypoxia, brain ischemia, cell death, central nervous system cell culture, brain hypoxia ischemia, brain infarction, brain injury, poly-L-lactide, bone transplantation, tumor marker testing, biological therapy, chronic ulcer, blood fractionation, isotype, polylactic acid, in vivo biodegradable polymer, cytotoxicity testing, vascular endothelial cell growth factor, polycaprolactone, fibrin glue, Current Good Manufacturing Practice, mast cell, chemotaxis, lymphoblast, animal model development, cell lysis, alkaline phosphatase, nitric oxide, immunosuppression, phagocytosis, blood separation, platelet aggregation, enterotoxin, decubitus ulcer, bone marrow, endothelial cell biology, endothelium, endothelial cell, biological cell development, glial cell, enzyme immunoassay, immunity, epithelization, bone structure, bone mechanics, blood plasma, bone, cell membrane, blood-brain transport, biodegradable plastic, cytotoxicity, T lymphocyte, collagen, tumor necrosis factor, neuron, new drug application, monoclonal antibody, investigational drug, immunology, Good Laboratory Practice, epidermal growth factor, eosinophil, cytotoxic T lymphocyte, connective tissue, bone formation, blood, antigen, angiogenesis

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