International differences in cellular starting material quality and regulatory requirements

Bethanie Kuker, MS, is the Regulatory Affairs Manager with the National Marrow Donor Program/Be The Match. She is responsible for assessing the organization’s compliance with applicable laws and regulations, monitoring and interpreting changes to regulations and leading initiatives to develop and improve regulatory processes.Beth brings over 6 years of experience in regulatory affairs in the field of cell and gene-based immunotherapies. Previously, she served as a regulatory consultant in the medical device and pharmaceutical industries. In those roles she worked with clients to successfully manage regulatory submissions. Beth is a member of the Regulatory Affairs Professionals Society (RAPS) and the University of Minnesota Alumni Association. She graduated from the University of Minnesota with a B.S. and M.S. in Biological Sciences.

Petr Machalik is the international collection network manager for Be The Match BioTherapies. He manages operations of the international BioTherapies Collection Network with an emphasis on developing and managing complex international relationships, and maintaining an effective and stable network of international collection centers for clients of Be The Match BioTherapies. He provides guidance to centers in the collection and processing of cells that are compliant with country-specific laws and regulations, in addition to international standards and regulatory requirements.Petr has more than 10 years of experience managing international projects in the health care industry, including positions in pharmaceuticals, medical devices and clinical research. In his previous role, he was the lead apheresis network manager for Sotio, a European company developing cellular immunotherapies. Along with managing the collection network covering more than 20 European countries, Petr was involved in quality surveillance of China-based operations, including case analyses and inquiry and communication of quality issues.Petr earned his M.S. in Hydrobiology from Mendel University in Brno, Czech Republic, as well as a B.S. in Political Science from Charles University in Prague, Czech Republic.

Salmah Ahmed has been with Anthony Nolan for over 10 years in a variety of roles in Quality & Transplantation Services, today as Director of Quality and Regulation.Salmah is the lead for quality and regulatory compliance for the organisation. She ensures that Anthony Nolan’s strategic objectives are aligned with our quality and regulatory requirements and works with the other leaders to achieve compliance in all areas of the organisation.

She is currently chair of the World Marrow Donor Association Cellular Therapy Task Force, previous to this she was Chair of the Quality and Regulation working group

Serves as the Human Tissue Authority ‘Designated Individual’ for the stem cell registry.

Chairs the Anthony Nolan Independent Review Board.

Received my PhD in Biochemistry and Cell Biology from the University of Saskatchewan with a specific interest in the spread of colon cancer cells. After that moved to the USA working first in Houston, TX and then Philadelphia, PA. My research in the US involved the early stages of utilizing gene repair/editing for blood stem cell gene therapy of diseases including sickle cell disease and hemophilia. Returned to Canada to take up the position as Director of the Cellular Therapy Lab here at APL in Calgary in 2007. I also hold appointments as a clinical assistant professor in the Departments of Hematology and Pathology/Laboratory Medicine. I am the chair of Standards for the Foundation of Accreditation of Cellular Therapy (FACT) and the Director at Large for Regulatory & Quality for the CTTC. In CTL, we focus on providing innovative, novel cellular therapy products for clinical application in our transplant patients. Including, using liver cells for treatment of neonatal patients with urea cycle disorders, participation in the first blood stem cell gene therapy clinical trial in Canada which treated patients with Fabry’s disease, generating the first alphabeta depleted T cell transplant product for clinical use in Canada, and generation of Alberta made CAR-T cells to treat lymphoma and leukemia.