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EDUCATION:
Ph.D.   Doctor of Philosophy, The Johns Hopkins School of Hygiene and Public Health, Department of Immunology and Infectious Disease. (1988-1994)
B.S. Bachelor of Science in Biological Sciences and Creative Writing. Carnegie-Mellon University.(1982-1986)
 
EXPERIENCE:
CURRENT POSITION:
Nov 2002:		   Senior Consultant, Biologics Consulting Group Inc.
   
2000 to Oct. 2002  

Regulatory Reviewer, Division of Cellular and Gene Therapy,
Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, The Food and Drug Administration.

  • Reviewed cellular therapy INDs, IDEs, and MFs.
  • Developed Policy and Guidance for stem cell therapies including development of standards for hematopoietic cord blood and peripheral blood stem cells.
  • Developed policy for the use of embryonic stem cells.
  • Developed policy for cellular product comparability.
  • Developed policy for the use of clinical flow cytometry
  • Had experience with combination products
    (biologic/device)
  • Reviewed products where cellular products are combined
    with therapeutic proteins and/or monoclonal antibodies)
   
1999 to 2000  

Research Associate, Department of Environmental Health
Sciences, Division of Physiology, The Johns Hopkins School of Hygiene and Public Health.

  • Researched the role of complement proteins on T helper cell switching and development of airway hyperresponsiveness in a murine model for human asthma in the laboratory of Dr. Marsha Wills-Karp.
   
1997 to 1999  

Research Scientist, Immunology, Osiris Therapeutics, Inc.

  • Project co-leader for DARPA-funded research into the use of adult human mesenchymal stem cells as antigen presenting cells.
  • Developed retroviral expression systems to transform mesenchymal stem cells to express erythropoietin, transplanted transformed cells using encapsulation technology, and performed histological and biological studies in rats.
  • Conducted independent research on the development of osteogenic factors through immune stimulation in a rat mesenchymal stem cell model.
   
1994 to 1997  

Postdoctoral Fellowship, The Johns Hopkins School of Medicine Department of Medicine, Division of Rheumatology.
   
1990 to 1991  

Teaching Assistant, The Johns Hopkins School of Hygiene and Public Health, Biological Basis of Infectious Disease.
   
1986 to 1988  

Research Assistant, The Rockefeller University. Dr. Angela Granelli-Piperno. Department of Cellular Physiology and Immunology.
   
Summer 1985 and 1986   Laboratory technician/undergraduate research, Carnegie-Mellon University, Dr. R.F. Murphy, Center for Fluorescence Research, Department Biological Sciences.
   
Summer 1984   Intern. Department of Regulatory Affairs, Personal Products Co. Johnson & Johnson Corp. Milltown, NJ.
   
Summer 1983   Intern. Department of Experimental Chemistry. Personal Products Co. Johnson & Johnson Corp. Milltown, NJ.

CONTINUING EDUCATION:
Oct. 2001 to Dec. 2001 Ethical and Regulatory Aspects of Human Subjects Research
National Institutes of Health, Department of Clinical Bioethics.
Dec. 2001 The CBER Education Forum: Assay Validation Case Study
March 2001 CBER Inspection Training for Product Specialists and Reviewers
ORGANIZATIONAL & COMMITTEE EXPERIENCE:
2002   Cellular Product Comparability Working Group, CBER/FDA
2000-2002   Hematopoietic Stem Cell Standards Committee CBER/FDA
2000-2002   Clinical Flow Cytometry Safety Issues, Co-Chair, FDA & ISAC
2000-2002   Xenotransplantation Working Group, FDA
2000-2002   Stem Cell Working Group, CBER/FDA & NINDS
2000-2002   Transmissible Spongiform Encephalopathy Working Group, OTRR/CBER/FDA
1998-1999   Institutional Animal Care and Use Committee (IACUC). Osiris Therapeutics, Inc.
1994-1996   1994-1996 Department of Medicine's Academic Women's Task Force Executive Council, Fellows' Committee Co-chair, The Johns Hopkins School of Medicine.
1990-1992   1990-1992 Executive Immunology Council, The Johns Hopkins University
PUBLICATIONS & PRESENTATIONS:
1.   Keane-Moore, M. "A Regulatory Framework for Manipulated Cellular Products." Workshop on Immune Reconstitution After Stem Cell Transplantation sponsored by the National Heart, Lung, and Blood Institute and the Department of Transfusion Medicine, NIH. 4-26-02.
   
2.   Keane-Moore, M., Marti, G., and Coder D. "Summary of the Public Meeting and Workshop on "Safety Issues Pertaining to the Clinical Application of Flow Cytometry to Human-Derived Cells." Cytotherapy (2002) Vol. 4, No. 1, 89 - 90.
   
3.   Keane-Moore, M. Safety Issues Pertaining to the Clinical Application of Flow Cytometry to Human-Derived Cells (ISHAGE abstract, oral presentation. June 2001).
   
4.   Karp, CL, Grupe A, Schadt E, Ewart SL, Keane-Moore M, Cuomo PJ, Kohl J, Wahl L, Kuperman D, Germer S, Aud D, Peltz G, Wills-Karp M. Identification of complement factor 5 as a susceptibility locus for experimental allergic asthma. Nature Immunology, 2000 Sep;1(3):221-6
   
5.   MA Keane-Moore, P. Vanguri, J. Mosca, and KR McIntosh. Genetically engineered mesenchymal stem cells can act as antigen presenting cells (ASH abstract, poster presentation, 1998).
   
6.   MA Keane-Moore and M. Soloski. Immunization with a novel plasmid construct: Characterization of the humoral immune response to mycobacterial Heat Shock Protein 65.
(FASEB/AAI abstract, oral presentation 1998).
   
7.   Michele A. Keane, 1994. Cellular Mechanisms of Protection in Experimental T. cruzi Infections. Dissertation.
   
8.   Steven P. Nickell, Michele Keane, and Magdalene So. 1993. Further characterization of protective Trypanosoma cruzi-specific CD4+ T cell clones: T helper 1-like phenotype and reactivity with shed trypomastigote antigens. Journal of Infection and Immunity, 61(8) 3250-3258.
   
9.   Granelli-Piperno, A., Keane, M. and Steinman, R. 1989. Growth factor production and requirements during the proliferative response of human T-lymphocytes to anti-CD3 monoclonal antibody. Journal of Immunology 142: 4138-43.
   
10.   Granelli-Piperno. A. and Keane, M. 1988. Effects of Cyclosporin A on T lymphocytes and accessory cells from human blood. Transplantation Proceedings vol. XX (2) 136-142.
   
11.   Granelli-Piperno, A.; Keane, M. and Steinman RM. 1988. Evidence that cyclosporin inhibits cell-mediated immunity primarily at the level of the T lymphocyte rather than the accessory cell. Transplantation Proceedings 46(2): 53S-60S.

Page Updated July 25, 2007