Xomix Associates

The Xomix Team

Ann LeFever, Ph.D.

Senior Consultant, Clinical and Regulatory Affairs

LeFever has over 30 years experience in the development of biological products for the treatment of cancer and other diseases. Recently, she has provided her expertise to biotechnology companies as a member of a Scientific Advisory Board tasked with strategic planning of clinical trials and product development, serving as a consultant in regulatory affairs pertaining to clinical biological product evaluation in the United States and Canada.

In addition, Dr. LeFever has evaluated biotechnology products for venture capital concerns and audited company processes, facilities and staff in preparation for external FDA inspections.

For the past 14 years she directed the activities of the Autologous Stem Cell Transplant and Immunotherapy Programs at Aurora St. Luke’s Medical Center in Milwaukee, WI. Six cancer therapeutics were developed in her translational laboratory. She administered over 20 clinical trials (Phase I through Phase III) based upon these therapeutics, as well as co-operative group and pharmaceutical company trials.

The clinical product manufacturing facility under her direction was a Federal Registered HCT/P establishment and maintained accreditation from the American Association of Blood Banks (AABB) and conformed to JCAHO and FDA requirements.

Dr. LeFever is an experienced communicator having presented over 100 invited seminars and research presentations at both national and international venues. She is a widely published author of research reports in Cancer Research, Journal of Immunotherapy and Journal of Urology as well as serving on the peer review boards of additional prestigious publications.

Dr. LeFever was an Associate Professor in the Departments of Pediatrics and Microbiology of the Medical College of Wisconsin for 10 years. The basic and translational research and product development was funded by research grants totaling more than $1 M.

She received a B.A. in Cell Biology from Northwestern University in 1973 and M.S. in Radiobiology and Immunology from the University of Oklahoma Health Sciences Center in 1975. Dr. LeFever earned her Ph.D. in Immunology in 1981 from Marquette University. She completed an additional 3 years of post-doctoral studies in experimental stem cell transplantation and preclinical evaluation of biological products.