Helping companies in the cell therapy field

Was the 3rd employee and led the manufacturing and process development. Designed and implemented the Gen2 commercial process in the registration trial.

Led manufacturing and clinical programs for dendritic cell cancer vaccines for glioblastoma and ovarian cancer

R&D consultant at Celula, Inc. supporting the development of technology to isolate fetal cells from the maternal circulation

R&D consultant for Allergan Medical on adipocyte stem cell therapies.

Project leader for a therapeutic lung cancer vaccine, IDM-2101 and managed a phase II trial of this product in advanced NSCLC patients, Managed two teams (~12 people), in Paris and California, to design and qualify processes for making cell products, and develop the associated batch records and assays, including potency assays. These teams also developed immune monitoring assay to evaluate patient responses to the vaccines. Supported the regulatory submissions for multiple trials in the US and Europe treating patients with melanoma, colorectal, ovarian and bladder cancer.Supported development of a liposomal formulated immune activator, L-MTP-PE (mifamurtide) that completed a phase III trial for the treatment of osteosarcoma.

Nexell was formed in 1998 as a new cell therapy company from the Baxter Immunotherapy Division. During this time the Isolex®, a stem cell enrichment system, was launched in the U.S., as well as an automated cell washer called Cytomate™ was developed.I was the leader of several programs to develop new therapeutic cell products. One program used dendritic cells to prepare a cellular vaccine against colon cancer that was later developed at IDM. The second program used dendritic cells and immunomagnetic selection to deplete alloreactive T-cells and prepare a graft that retains anti-viral activity but is reduced in its ability to stimulate graft vs host disease. PI on a phase I SBIR grant to support this program. In addition, I supported a number of FDA submissions for clinical trials including phase I INDs, phase III PMA applications and phase IV post marketing studies.

Established a flow cytometry facility and developed a research program in bone marrow transplantation. This facility supported projects from other divisions (Renal Therapy, Gene Therapy etc) and worked with investigators to develop flow cytometry methods appropriate for their application. I also managed an associated cell biology laboratory doing hematopoiesis research and maintained ongoing collaborations with bone marrow transplanters. Developed methods to characterize and quantitate CD34+ stem cells and technology to purify stem cells that became the core technology of Nexell. This was a magnetic bead based system to purify CD34+ cells. This was subsequently developed as an automated system, the Isolex 300i.Developed technology to expand stem cells for therapy. Project leader of a team to develop a system for ex vivo expansion of cells for therapeutic use.

Graduate research in the area of neutrophil metabolism and inflammation. Awarded a postdoctoral fellowship from the Cystic Fibrosis Foundation to study the mechanisms of lung inflammation in children with cystic fibrosis. Collaborated with the National Flow Cytometry Resource in Los Alamos and focused on hematopoiesis and the characterization of cells from in vitro cultures of mouse bone marrow using multiparameter flow cytometry. Awarded an NIH New Investigator Award and later an NIH FIRST award that was transferred to Baxter.

Microbiologist covering bacteriology, virology, parasitology/mycology, and immunology. Developed and implemented new technology and methods, including establishing methods to identify anaerobic bacteria using gas chromatography. Supervised department of 10-12 medical technologists and managed scheduling, supervised medical technology students and expanded the capabilities of the immunology laboratory

Developed and implemented new assays and assisted in ongoing public health surveys. Assays included improved methods for parasitology screening and analytical methods for protein determination in feeds.