Curriculum Vitae
Cellular, Tissue and Gene Therapies Advisory Committee
Kurt C. Gunter, MD
I. PERSONAL DATA
Name: Kurt C. Gunter, M.D. Home Address: ----------------------
----------------------Professional Address: Senior Vice President
Clinical & Regulatory Affairs/Government Relations
ViaCell Inc.
One Innovation Drive
Biotech III
Worcester, MA 01605
-----------------------Date of Birth: --------------------- Place of Birth: --------------------- Citizenship: ---------------------
II. EDUCATION
Stanford University, B.S. (Biological Sciences, with Distinction), -----, Stanford, California.
University of Kansas School of Medicine, M.D., ----, Kansas City, Kansas.
University of Kansas School of Medicine, Residency (Anatomic Pathology), 1980-1982, Kansas City, Kansas.
National Institutes of Health, National Institute of Allergy and Infectious Diseases, Laboratory of Immunology, Medical Staff Fellow (Cellular Immunology), 1982-1986, Bethesda, Maryland.
University of Maryland School of Medicine, Residency (Anatomic Pathology), 1986-1987, Baltimore, Maryland.
National Cancer Institute, National Institutes of Health, Experimental Immunology Branch, Biotechnology Fellow (Molecular Immunology), 1987-1988, Bethesda, Maryland.
Johns Hopkins University Hospital, Department of Laboratory Medicine, Clinical Pathology Fellow (part time), 1989-1992, Baltimore, Maryland.
III. PROFESSIONAL REGISTRATIONS, LICENSES, CERTIFICATIONS
Specialty Boards Anatomic Pathology, 1987
Clinical Pathology, 1992
Transfusion Medicine, 1996Medical Licensure Massachusetts ------------ (active)
Kentucky --------- (active)
District of Columbia ----------- (voluntarily not renewed)
Kansas -------- (voluntarily not renewed)
Maryland --------- (voluntarily not renewed)
Virginia ---------- (voluntarily not renewed)
IV. EXPERIENCE
July 2001-Present Senior Vice President, Clinical and Regulatory Affairs/Government Relations, ViaCell Inc., Boston, MA August 2002-Present Instructor, Transfusion Medicine, Hospital Laboratories, UMass Memorial Hospital, Worcester, MA 1998-Present Assistant in Pathology (Blood Bank and Therapeutic Apheresis), Children's Hospital, Boston, MA 1996-2001 Vice President, Clinical and Regulatory Affairs, Transkaryotic Therapies Inc., Cambridge MA 1995-1996 Director, Stem Cell Processing/Donor Center/Hematology, Children's National Medical Center, Washington, D.C. 1993-1994 Assistant Director, Transfusion Medicine/Hematology, Children's National Medical Center, Washington, D.C. 1993-1996 Assistant Professor, Departments of Pathology and Pediatrics, George Washington University Medical School, Washington D.C. 1993 Acting Deputy Director, Division of Cellular and Gene Therapies, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. 1989-1993 Chief, Cytokine and Cell Biology Branch, Division of Biological Investigational New Drugs, Office of Biological Product Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. 1988-1989 Medical Officer, Division of Biological Investigational New Drugs, Office of biological Product Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration.
V. MILITARY EXPERIENCE
None
VI. SOCIETIES AND HONORS
Societies: American Association of Immunologists
American Society of Clinical Pathology
American Association of Blood Banks
American Society for Apheresis
International Society for Cell Therapy
International Association of Pediatric Laboratory Medicine (inactive)Honors: Graduation with Distinction, Stanford University, ----
Clinical Fellowship, American Cancer Society, 1986
FDA Group Recognition Award, 1992
VII. COMMITTEES
Children's Hospital Blood Utilization Review Committee, 1993-1996
Children's Hospital Laboratory Medicine Quality Assurance Committee, 1993-1996
Children's Hospital Tumor Board, 1995-1996
Children's Hospital Patient Care Committee, 1995-1996
Children's Hospital Laboratory Medicine Safety Committee, 1995-1996
VIII. ADMINISTRATIVE, TEACHING AND OTHER DUTIES
FDA Regulatory Scientist Peer Review Promotion Committee
FDA Working Group on Growth Factors
Alternate FDA Liaison to the NIH Recombinant DNA Advisory Committee (RAC)
FDA Somatic Cell and Gene Therapy Policy Committee
Ad hoc reviewer, Journal of Immunology
NIAID, Strategic Program for Innovative Research for AIDS Study Section
Small group tutorial leader: Laboratory Medicine Medical Student Rotation
IX. CONSULTANT APPOINTMENTS
Consultant to Transkaryotic Therapies, Inc., Cambridge MA, 1993-96
Baltimore Rh Typing Laboratory, Therapeutic Apheresis Physician, 1995-96
X. GRANTS AWARDED
American Cancer Society, 1986
Biotechnology Fellowship, National Cancer Institute, 1987
Cooperative Clinical Trial in Adult Renal Transplantation, Investigator, submitted 1995
Children's National Medical Center (CNMC) RAC Award, 1996
XI. PUBLICATIONS AND LECTURES
Invited Regulatory Speeches
"Update on Gene Therapy", FDA Biological Response Modifiers Advisory Committee, 1990.
"Human Gene Therapy", FDA Consumer Affairs Officers' Conference, 1990.
"Clinical Studies: How to successfully resolve clinical problems to achieve FDA approval.", Regulatory Affairs Professionals Society, 1990.
"Preclinical Studies", Drug Information Association, 1990.
"How to Prepare INDs", BioEast, 1991.
"Points to consider in preparation for and conduct of clinical trials", Associates of Clinical Pharmacology, 1991.
"Early Access to Therapy", Biologics '91, 1991.
"Clinical Hold Issues", Biologics '91, 1991.
"Update on Gene Therapy", FDA Biological Response Modifiers Advisory Committee, 1991.
"Gene Therapy and Somatic Cell Therapy", American Society of Hematology, 1991.
"Clinical Issues in Cytokine Drug Development", BioEast 1992.
"The Safety of Retrovirus Gene Therapy Vectors", BioEast 1993.
"The Safety of Retrovirus Gene Therapy Vectors", ABC Meeting, 1993.
"Somatic Cell and Gene Therapy Policy Developments", Food and Drug Law Institute, 1993.
"Safety Issues in the Development of Gene Therapy Products", Bio-International 193,1993.
"FDA Industry and Academia Perspectives", BioInternational Conference and Exhibition, 1993.
"Preclinical and Phase I Biologic Development", BioEast 1994.
"Biologic Drug Development", BioConferences International 1994.
“Toxicity Versus Disease? The Role of the Clinical Laboratory”, Drug Information Association 1996.
Academic Lectures
Hematological features of HIV Infection, CNMC Department of Laboratory Medicine, 1994.
Microcytic Anemias, CNMC Department of Adolescent and Young Adult Medicine, 1994.
Therapeutic Apheresis, CNMC Department of Critical Care Medicine, 1994.
Hypercoagulopathies, National Cancer Institute, 1995.
Therapeutic Apheresis, CNMC Department of Laboratory Medicine, 1995.
Therapeutic Apheresis, National Cancer Institute, 1995.
Hypochromic Anemias, National Cancer Institute, 1995
Neonatal Hemostasis, George Washington University Medical School, 1995
Gene Therapy, George Washington University Medical School, 1995
Blood Component Therapy, CNMC Department of Critical Care Medicine, 1995
Pediatric Hematology, CNMC Board Review Course, 1995
Diagnosis of Hemoglobinopathies, National Cancer Institute, 1995
Blood Component Therapy, CNMC Department of Hematology/Oncology, 1995
Neonatal Hemostasis, National Cancer Institute, 1995
Neonatal Hemostasis, CNMC Department of Neonatology, 1995
Von Willebrand's Disease, National Cancer Institute, 1996
Blood Component Therapy, CNMC Department of Critical Care Medicine 1996
Hematopoietic Stem Cell Processing, CNMC Department of Hematology/Oncology 1996
Von Willebrand's Disease, CNMC Department of Hematology/Oncology 1996
Peer Reviewed Publications
Rengachary SS, McMahorn M, Bigongiari R, Ketchside J, and Gunter KC: Neurofibroma of the infratemporal fossa. Case report and technical note. Neurosurgery 11:43,1982.
Cox GG, Lee KR, Price HI, Gunter KC, Noble MJ, and Mebust WK: Colonic infarction following ethanol embolization of renal cell carcinoma. Radiology 145:343-346,1982.
Gunter KC, Malek TR, and Shevach EM: T cell-activating properties of an anti-Thy-1 monoclonal antibody: Possible analogy to OKT3/LEU-4. J. Exp. Med. 159:716-730,1984.
Logdberg L, Gunter KC, and Shevach EM: Rapid production of monoclonal antibodies to T lymphocyte functional antigens. J. Immunol. Meth. 79:239-250,1985.
Gunter KC, Kroczek RA, Shevach EM, and Germain RN: Functional expression of the murine Thy-1.2 gene in transfected human T cells. J. Exp. Med. 163:285-300,1986.
Kroczek RA, Gunter KC, Seligmann B, and Shevach EM: Induction of T cell activation by monoclonal anti-Thy-1 antibodies. J. Immunol. 136:4379-4384,1986.
Kroczek RA, Gunter KC, Germain RN, and Shevach EM: Thy-1 functions as a signal transduction molecule in T lymphocytes and Thy-1 transfected B lymphocytes. Nature 322:181-184,1986.
Stingl G, Gunter KC, Tschachler E, Yamada H, Lechler RI, Yokoyama WM, Steiner G, Germain RN, and Shevach EM: Thy-1 + dendritic epidermal cells belong to the T cell lineage. Proc. Natl. Acad. Sci. USA 84:2430-2434,1987.
Sneller MC, and Gunter KC: DNA methylation alters chromatin structure and regulates Thy-1 expression in EL-4 cells. J. Immunol. 138:3505-3512,1987.
Gunter KC, Germain RN, Kroczek RA, Saito T, Yokoyama WM, Chan C, Weiss A, and Shevach EM: Thy-1 mediated T cell activation requires co-expression of the CD3/Ti complex. Nature 326:505-507,1987.
Saito T, Weiss A, Gunter KC, Shevach EM, and Germain RN: Cell surface T3 expression requires the presence of both a- and b-chains of the T cell receptor. J. Immunol. 139:625-628,1987.
Gunter KC, Germain RN, Leo O, Chan C, and Shevach EM: Mitogenic activation of EL-4 cells does not require surface Thy-1 expression. Cellular Immunology 112:135-146,1988.
Gunter KC, Irving SG, Zipfel PF, Siebenlist U, and Kelly K: Cyclosporine A-mediated inhibition of mitogen-induced gene transcription is specific for the mitogenic agent and cell type. J. Immunol. 142:3286-3291,1989.
Wright JJ, Gunter KC, Mitsuya H, Irving SG, Kelly K and Siebenlist U. Expression of a zinc finger gene in HTLV-I and HTLV-II transformed cells. Science 248:588-591,1990.
Gunter KC, Khan AS, and Noguchi PD. The safety of retroviral vectors. Human Gene Therapy 4:643-645,1993.
Gunter KC, and Rock RC. The clinical laboratory in pharmaceutical development. Therapeutic Drug Monitoring 17:189-194, 1995.
Gunter KC. Transfusion transmitted cytomegalovirus: The part time pathogen. Pediatric Pathology and Laboratory Medicine 15:515-534, 1995.
Poniatowski B, Cohen G, Tillett M, Carr E, Gunter KC, Erickson S, Hailey R, and Melick C. Evaluation of the Gemini Infusion Pump for the safe delivery of peripheral blood progenitor cells (stem cells). J. Clin. Apheresis 13:23-27, 1998.
Schiffmann R, Murray GJ, Treco D, Daniel P, Sellos-Moura M, Myers M, Quirk JM, Zirzow GC, Borowski M, Loveday K, Anderson T, Gillespie F, Oliver KL, Jeffries NO, Doo E, Liang TJ, Kreps C, Gunter K, Frei K, Crutchfield K, Selden RF, and Brady RO. Infusion of a -Galactosidase A Reduces Tissue Globotriaosylceramide Storage in Patients with Fabry Disease. Proc Natl Acad Sci U S A. 97(1):365-70, 2000.
--------------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------------
-----------------------------------------Abstracts
Gunter KC, Gorenz DL, Fixley MS, Youll D, Kerby GR, and Stechschulte DJ: Effects of salicylate in salicylate responsive asthmatics. Clin. Res. 28(2);426A,1980.
Gunter KC and Stechschulte DJ: Generation of slow reacting substance termed leukotriene C-1 from human peripheral blood monocytes. Clin. Res. 28(4);707A,1980.
Gunter KC, Stechschulte DJ , and Ruth WE: Generation of slow reacting substance from human blood monocytes and selected alveolar lavage cells. Am. Rev. Respir. Dis. 125 (4 Part 2) 55,1982.
Gunter KC, Malek TR and Shevach EM: T-cell activating properties of an Anti Thy-1 monoclonal antibody. J. Cell. Biochem. (8 Part A) 178, 1984.
Gunter KC, Germain RN and Shevach EM: The role of Thy-1 in T cell activation. Fed. Proc. 44 (4) 327, 1985.
Romani N, Stingl G, Tschachler E, Gunter KC, Shevach EM, and Schuler G: Induction of Birbeck granule-like structures in murine T lymphocytes and dendritic Thy-1-positive epidermal cells by a T cell-activating anti-Thy-1 monoclonal antibody. Clin. Res. 33 (2 Part 2) 679A, 1985.
Gunter KC, Kroczek RA, Germain RN and Shevach EM: Thy-1 is a signal transducing molecule in lymphoid cells. Fed. Proc. 45 (3) 241, 1986.
Stingl G, Gunter KC, Tschachler E, Yamada H, Lechler RI, Steiner G, Germain RN and Shevach EM: Thy-1-positive dendritic epidermal cells are thymus-dependent lymphocytes. Clin. Res. 34 (2) 783A, 1986.
Sneller M and Gunter KC: Methylation of 5' Sequences influences chromatin structure and expression of the Thy-1 gene. J. Cell. Biochem. Suppl. (11 part C) 505-507, 1987.
Wright JJ, Gunter KC, Mitsuya H, Irving SG, Kelly K, and Siebenlist U: Expression of a Zinc Finger Gene in HTLV-I and HTLV-II Transformed Cells. FASEB Oncogene Meeting, Copper Mountain, Colorado, August 1989.
Schiffmann R, Treco D, Myers M, Borowski M, Gillespie F, Daniel P, Gunter KC, Murray G, Quirk J, Oliver K, Brady R, and Selden R: A Phase I Trial of Enzyme Replacement Therapy for Fabry Disease. 5th Joint Clinical Genetics Meeting, Los Angeles, CA, March 1, 1998.
Schiffmann R, Murray G, Treco D, Daniel P, Myers M, Quirk J, Zirzow G, Oliver K, Kreps C, Gunter KC, Borowski M, Frei K, Crutchfield K, Selden R, and Brady R: A Phase I Trial of Enzyme Replacement Therapy for Fabry Disease. Prospects in the Treatment of Rare Diseases, Trieste, Italy, July 2-4, 1998.
Dix RK, Davidow C, Howard D, Stewart W, Gunter K, and Sinnassamy P. A Phase 1 Study of Gene-activated Erythropoietin (HMR4396; GA-EPO) in Healthy Volunteers. International Society of Nephrology, Buenos Aires, Argentina, May 1999.
Dix RK, Davidow C, Howard D, Gunter K, Sinnassamy P, Stewart B, and Smith W. A Phase II Study of Gene-activated Erythropoietin (HMR4396;GA-EPO) in Subjects with Chronic Renal Failure Requiring Hemodialysis. J. of the Am. Soc. of Nephrol. 10: Abs. A082, 1999.
Roth D, Tawa NE, O'Brien J, Levine JD, Furie B, Furie BC, Proper J, Roman VA, Sabine ZM, Lamsa JC, Gunter KC, Phillips CW, Savioli NA, Treco DA, and Selden RF. Non-viral Gene Transfer of Blood Coagulation Factor VIII in Patients with Severe Hemophilia A. American Society of Hematology Meeting, December 2001.
Kaufman RL, Altamore N, Gunter KC, Harvey D, Mroczkowski G, and Dracker R. Outcome Data from Eleven Consecutive Hematopoietic Stem Cell Transplants, Nine Allogeneic and Two Autologous, using Units from a Family Cord Blood Banking Service. American Society of Hematology Meeting, December 2002.
Books
Soldin SJ, Brugnara C, Gunter KC, and Hicks JM: Pediatric reference ranges, 2nd Ed. American Association for Clinical Chemistry Press, 1997.
Book Chapters
Chapekar MS, and Gunter KC: FDA Regulations for Growth Factors and Related Products. In Angiogenesis, R. Steiner, P.B. Seisz and R. Langer Eds., Birkhauser Verlag Basel, 1992.
Gunter KC, and Luban NLC: Transfusion-transmitted Cytomegalovirus and Epstein-Barr diseases. In Principles of Transfusion Medicine, 2nd Ed. EC Rossi, TL Simon, and GS Moss Eds., Williams & Wilkins, 1995.
-------------------------------------------------------------------------------------------------------------------------------------------------
Other Publications
Choosing an Automated Hematology Analyzer for a Pediatric Laboratory. Newsletter: International Association of Pediatric Laboratory Medicine. 1:36, 1995.
Tips for Pediatric Laboratory Medicine, Newsletter: International Association of Pediatric Laboratory Medicine. 2:4, 1996.
The Frontier of Cellular Medicine: Expanding Umbilical Cord Blood Stem Cells for Clinical Use. Cancer Journal. 7, Suppl. 2:S95-S105, 2001