Dr. Carolyn A. Keever-Taylor

Dr. Taylor has over 34 years of experience in the field of hematopoietic progenitor cell (HPC) transplantation, transplant immunology, and cellular therapy. She holds a PhD in Microbiology and Immunology from Wake Forest University and was a Research Fellow and Research Associate under Dr. Richard J. O’Reilly at Memorial Sloan-Kettering Cancer Center. She served as the Cell Processing Laboratory Director at Ohio State University (3 years) and at the Medical College of Wisconsin (MCW) for the subsequent 26 years. She was appointed Director of the Lymphocyte Propagation Laboratory at MCW in 1996.

Dr. Taylor was a founding member of the International Society for Cellular Therapy (ISCT) where she served on the board of directors. Dr. Taylor served on the FACT Board of Directors (2008-2015) including two years as Vice President. As a FACT inspector, Carolyn has performed 38 FACT inspections. She has chaired the FACT Standards Committee and has served on the Cell Processing Standards Committee. Dr. Taylor has participated as faculty in 25 FACT Cellular Therapy Inspection & Accreditation Workshops. She has also served as a member of the FACT Accreditation Committee for the past 12 years. She served on the FACT Regenerative Medicine Taskforce since 2010 and was a primary author of the FACT Common Standards. In addition, Dr. Taylor has served as a member (1993-present) and on the Board of Directors (2011-2014) for the American Society for Blood and Marrow Transplantation (ASBMT). She also served as the FACT Representative to the Worldwide Network for Blood and Marrow Transplantation (WBMT) and member of the WBMT Executive Committee from 2009 to 2016. Dr. Taylor has been a member of the American Society of Hematology (ASH) since 1984 where she has served on Abstract Review Committees as a member or coordinating reviewer.

Areas of Expertise

Hematopoietic progenitor cell (HPC) research, characterization, and processing.
HPC and cellular therapy product cryopreservation, storage and release.
HPC and cellular therapy product graft engineering including cell depletion and enrichment, and gene transduction.
Cellular immunotherapy product development, regulatory approval, and production.
Cellular therapy, cord blood banking, and regenerative medicine standards development, training, and application.
Quality systems creation and application
HPC and cellular therapy laboratory facility requirements.

Scope of Experience

34 years of experience in HPC cellular therapy product processing.
20 years of experience with immunotherapy product development and translation.
20 years of experience with FACT standards development, training workshops, and application through inspection and inspection report reviews.

Market Sector Focus

Processing and graft engineering for HPC transplantation and immunotherapy.
Regulatory approval of cellular therapy and immunotherapy through the IND and IDE process.
Requirements and approaches for achieving compliance to all FACT Cellular Therapy standards, including HPC, Cord Blood, and Immune Effector Cells.

Relevant Assignments

Laboratory and Steering Committee, The Unrelated Donor Marrow Transplantation Trial sponsored by NHLBI (1995-2009)
Performed 38 inspections of Cellular Therapy Processing Facilities, including more than minimally manipulated product inspections (1998-2017)
Member, co-chair, edition chair, or steering committee member of FACT/JACIE Laboratory Standards (2000-2016)
National Institute of Allergy and Infectious Disease (NIAID) “Clinical Trials of Hematopoietic Stem Cell Transplantation (HSCT) For Treatment of Autoimmune Disease” Investigational New Drug (IND) Committee (2002-2004), Oversight Committee, 2004-2017)
BMT Clinical Trials Network (CTN) Multi-Center Trials in transplantation. Includes:
CTN 0303 A Single Arm, Multi-center Phase II Trial of Transplants of HLA-Matched, CD34+ Enriched, T cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients with AML in First or Second Morphologic Complete Remission. Protocol Team (2004-2012)
CTN 1301 A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-Versus-Host Disease. Laboratory representative on protocol team (2013-2016)
CTN 1401 Phase II Multicenter Trial of a Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell (DC)/Myeloma Fusions (MY T VAX). Manufacturing Team (2014-2016)
Immunotherapy INDs. Author or Co-Author for IND or IDE CMC Section. Includes:
BB IND-9825 “Allogeneic EBV-specific cytotoxic T lymphocytes derived from allogeneic peripheral blood mononuclear cells cultured Ex Vivo with irradiated EBV+ lymphoblastoid cell line and IL-2”. (2001-2009)
BB IND-10078 “Autologous EBV-specific cytotoxic T lymphocytes derived from allogeneic peripheral blood mononuclear cells cultured Ex Vivo with irradiated EBV+ lymphoblastoid cell line and IL-2” (2001-2010)
BB-IND 13794 “Haploidentical Therapeutic cells-NK” (2011-2016)
BB-IND 14819 “Multi-Virus Cytotoxic T Cell use following T Cell Depleted Allogeneic Hematopoietic Progenitor Cell Transplantation” (2011-2016)
BB-IND 14389 “Magnetic-Activated Cell Sorter (CliniMAS, Miltenyi) for CD34+ Selection of G-CSF Mobilized for Allogeneic (Partially Matched Family Donors or Matched Unrelated Adult Donor) PBSC or BM; TBI, Thiotepa, Cyclosphoshamide, Bulsulfphan, Fludarabine” (2012-2016)
BB-IND 17518 Autologous T-Cells Engineered to Contain an Anti-CD19 and Anti-CD20 scFv Coupled to CD3 zeta and 4-1BB Signaling Domains (CliniMACS Prodigy), (2017)
Member FACT Accreditation Committee (2004-2016)
FACT Board of Directors (2009-2016)
FACT Vice President (2013-2016)
Faculty member FACT Cellular Therapy Inspection & Accreditation Workshops (25 workshops, 1998-2015)
ISCT representative to AABB Standards Committee (2004-2008)
ISCT Board of Directors (1993-1997, 2006-2013)
ISCT Executive Committee, Secretary (2006-2010)
ISCT Somatic Cell Therapy Symposium Organizing Committee and Faculty (2007-2010)
ASBMT Board of Directors (201-2014)
FACT representative to WBMT. Includes membership on the executive committee, 3 international workshops and participation in AHCTA and the Graft Processing Committee (2009-2016)

Qualifications & Registrations

MT(ASCP) registered by the American Society of Clinical Pathologists, 1970
MT(ASCP) Specialist in Blood Bank Technology (SBB) registered by the American Society of Clinical Pathologists, 1972
Wake Forest University, PhD in Microbiology and Immunology, 1984
Medical College of Wisconsin, Cell Processing and Lymphocyte Propagation Laboratory Director (1992-2017)
MCW Professor of Medicine (2002-2017)