Meet Our Consultants

Tracy Dodd  |  Federico Rodriguez  | Sue Armitage  | Nancy Collins  | Deborah Griffin  | Linda KelleyRobert Rifkin  | Jean Sanders  | Carolyn Taylor

Linda Kelley, PhD

Dr. Kelley has provided leadership for cellular therapy facilities for over twenty years at three academic institutions: University of Utah, Dana Farber Cancer Institute at Harvard and H. Lee Moffitt Cancer Center and Research Institute. Her scientific career evolved from a fundamental interest in immunological mechanisms of T lymphocyte function, growth mechanisms of hematopoietic stem and progenitor cells and molecular changes associated with malignant transformation. Knowledge of the hematopoietic system led to an interest in stem cell biology and therapies. As director of the Cell Therapy Facility at the University of Utah from 1994-2011, she devoted approximately equivalent effort to basic and translational research, patient care, teaching and administration. In that capacity she was responsible for developing and expanding a Cell Therapy and Regenerative Medicine Program which included Cord Blood Banking. As director of the Cell Manipulation Core Facility at the Dana Farber Cancer Institute at Harvard from 2011-2012, she devoted efforts to an extensive reorganization of the laboratory including personnel, procedures and infrastructure to effect change consistent with state-of-the-art cell manufacturing and processing. As director of the Cell Therapy Facility at Moffitt Cancer Center, she is responsible for manufacture and compliance of approved cell therapies for stem cell transplantation of malignant and benign disease, as well as, experimental therapies for immune modulation of cancer treatment. In this capacity, she oversees 22 Investigational New Drug applications for on-going clinical trials. In her current and previous positions, Dr. Kelley has served as director of apheresis for stem and mononuclear cell collections. In addition to academics, Dr. Kelley spent two years in industry as Chief Scientific Officer at CryoCell International, a private cord blood bank. Current and past projects involve collaboration with a variety of industry partners to leverage resources and know-how to propel cell therapies to the market place. Dr. Kelley excels at bridging the gap between laboratory-based discoveries and new therapies for patients. Her career has been closely aligned with the implementation of FDA regulations and guidance, as well as the evolution of FACT standards for the industry.

Areas of Expertise

Cell therapies manufacturing, immunotherapy, stem cell transplantation, regenerative medicine, apheresis, clinical trials cell manufacturing, FDA regulatory compliance, clean room design and operation, laboratory information management systems (LIMS), quality assurance, quality control, flow cytometry, immune monitoring

Scope of Experience

Cell Therapy Laboratory
Apheresis Collection Facility
Quality Assurance

Market Sector Focus

Cell-Based BioSciences
Cord Blood Banking

Relevant Assignments

  • Performed 17 FACT cell therapy collection and cell processing inspections and 16 FACT-NetCord cord blood bank inspections
  • Member of FACT Board of Directors and Chair of Standards, 2001-2004
  • Member of FACT Cord Blood Accreditation Committee 2002-2015
  • Member of FACT Cord Blood Bank Standards Committee 2014-Present

Qualifications & Registrations

  • 2014-present H. Lee Moffitt Cancer Center and Research Institute; Senior Member
  • 2014-present Department of Oncological Sciences, University of South Florida; Professor


As a Matter of FACT

FACT is approved as an accrediting organization by the United States Health Resources Services and Administration (HRSA) for the C.W. Bill Young Cord Blood Transplantation Program.

Accreditation Success Story

Hoxworth Blood Center Apheresis Collection Facility and its Cellular Therapies Division have been accredited by FACT since 2003. The program values their FACT accreditation and the impact it has had on their program’s continuous quality improvement objectives. Read more

Knowledge makes all the difference.

  • FACT Consulting Services
  • 6901 Dodge Street, Suite 207
  • Omaha, NE 68132
  • 402-559-1185