About Us
Stewart Craig, Ph.D., Co-founder & Principal Consultant
Stewart Craig, Ph.D., Co-founder & Principal Consultant
Stewart Craig, Ph.D., Co-founder & Principal Consultant
An accomplished biotechnology professional with over 30 years of experience in development, technical operations, quality systems and regulatory affairs for complex biologicals. For the past 25 years he has held executive level positions designing, implementing and operating the CMC and GMP manufacturing infrastructure for various pioneer
An accomplished biotechnology professional with over 30 years of experience in development, technical operations, quality systems and regulatory affairs for complex biologicals. For the past 25 years he has held executive level positions designing, implementing and operating the CMC and GMP manufacturing infrastructure for various pioneering cell and gene therapy companies, including Orchard Therapeutics, Sangamo Therapeutics, StemCells Inc., PCT Cell Therapy Services, Xcyte Therapies, Osiris Therapeutics, and SyStemix, Inc.
In his career he has successfully led the development, manufacture and clinical delivery of recombinant proteins, monoclonal antibodies, hematopoietic stem cells (HSCs), mesenchymal stem cells (MSCs), neural stem cells (NSCs), activated T cells, gene-modified T cells & gene-modified HSC products, as well as adeno-associated virus (AAV), gamma-retroviral (gRV) and lentiviral (LV) vector products.
Stewart also has extensive experience in business development and the successful management of regulatory affairs for cell and gene therapy submissions in US, Canada, Switzerland and Europe.
Lisa Fox-Craig, MS, MT(ASCP), Co-founder
Stewart Craig, Ph.D., Co-founder & Principal Consultant
Stewart Craig, Ph.D., Co-founder & Principal Consultant
An accomplished cell and gene therapy professional with more than 25 years of experience in the development, cGMP manufacturing, and quality control for cell and gene therapy products. Successfully led development, manufacture and clinical delivery of ex vivohematopoietic stem cells (HSCs), neural stem cells (NSCs), activated T cells, gen
An accomplished cell and gene therapy professional with more than 25 years of experience in the development, cGMP manufacturing, and quality control for cell and gene therapy products. Successfully led development, manufacture and clinical delivery of ex vivohematopoietic stem cells (HSCs), neural stem cells (NSCs), activated T cells, gene-modified T cell & HSC products as well as in vivoadeno-associated virus (AAV) products. Lisa has held leadership roles at Orchard Therapeutics, Sangamo BioSciences, StemCells Inc, and Xcyte Therapies and has experience preparing CMC regulatory submissions with for cell and gene therapy submissions in the US, Canada, Switzerland and Europe.