MEET OUR PRINCIPAL, WILLIAM E. JANSSEN, PH.D.

For the past 30+ years I have worked at translating lab bench models into cell and gene therapy products for administration to patients. In the course of these efforts I have developed and refined methodologies for all aspects of cellular therapy from collection, through manufacturing, and to administration. I have also been engaged in the regulatory process, and have prepared numerous applications for INDs, IDEs and for RAC approval of recombinant DNA use in clinical trial. I have shepherded these applications through the approval process and have actively participated in their lifecycle management. I have also been responsible for facility design, drug master file creation, development of staff training programs, process engineering, SOP development, process validation, and integration of processes, equipment and raw materials. In addition to my own experience, I have held leadership positions in the International Society for Cell and Gene Therapy and the Foundation for Accreditation of Cellular Therapy, thus the experiential basis that I bring to my consulting is amplified by my interactions with other experienced members of this field and the facilities that they operate. Click here to view my full curriculum vitae.

EDUCATION

  • BA, Biophysics, University of California, Berkeley, California
  • MS, Microbiology & Immunology, University of Colorado Health Science Center, Denver, Colorado
  • PhD, Biophysical Sciences, SUNY at Buffalo, Buffalo, New York

EXPERIENCES

  • Director, Cell Therapies Facility, Moffitt Cancer Center, Tampa, Florida
  • Director, Human Applications Lab, St. Jude Children’s Research Hospital, Memphis, Tennessee

AREAS OF ACCOMPLISHMENT AND EXPERTISE

  • Pre-clinical testing strategies and GLP
  • Scale-up and adaptation of methods from pre-clinical  to GMP environment, SOP generation and process validation
  • Regulatory (IND, IDE, DMF) submission and management (have prepared 20 IND/IDE applications and shepherded through the approval process)
  • Manufacturing for early through mid-phase clinical trials, technology transfer
  • Working with multiple cell types, including antigen presenting cells, lymphocytes, NK cells, tumor cells, and cell lines
  • Working with multiple types of cell processing including cell selection by antibody directed or physical methods
  • Quality management, integrating tools of statistical production monitoring, audits and deviation driven CAPA
  • Effective data recording and analysis, including application of relational databases and reporting tools
  • Application of laboratory methodology for quality and safety testing in the manufacturing environment, development of potency assays
  • Facility design and operation
  • Team building and communication strategies, particularly to align cell collection, processing and clinical components

LEADERSHIP IN THE FIELD OF CELL AND GENE THERAPIES

  • Founding member of the International Society for Cellular Therapy, served as chair of the North American Legal and Regulatory Affairs Committee, Member of the Board of Advisors, and society Vice President for North America
  • Coordinated and chaired stakeholder liaison meetings with 20 organizations and Food and Drug Administration representatives
  • Member of the first class of inspectors for the Foundation for Accreditation of Cellular Therapy, served as member of the Standards Writing Commmittee three terms, once as chair of the Processing Standards Subcommittee, served on the Accreditation Committee and on the Board of Directors
  • Served on standards committee for cell therapies for AABB

COMMUNICATION AND MENTORING

  • Mentor to several individuals who have moved up to positions of leadership and responsibility
  • Resource for Moffitt Cancer Center foundation, meeting with potential donors and provide non-scientist explanations of research activities
  • Coordinated Cell Therapy Industry Stakeholders annual liaison meeting with FDA 2009-2011