Janet MacPherson, PhD
Senior Editor, ISCT Telegraft
NSW Health Pathology
SLHD Cell Therapy Program
Australia
Last month I had the privilege to connect and chat with one of the early leaders of ISCT (or ISHAGE as it was back then). Our third President, Scott Rowley, MD, FACP, is now retired and enjoying the ability to travel and explore the world. He was humble in describing his role in shaping ISCT and regulation of the field of Cell Therapy from it’s infancy. Dr. Scott Rowley was in clinical practice for over 40 years. He specialized in hematologic oncology with experience in transplant medicine, and cellular immunotherapy. Immediately prior to his recent retirement, Scott was a member of the transplant and cellular immunotherapy program at Hackensack University Medical Center and Chief, Stem Cell Transplantation and Cellular Immunotherapy at MedStar Georgetown University Hospital. His involvement in cell therapy and in shaping ISCT started many years earlier. He is rightly proud of his contributions to the field of cell therapy, and the role that he and others played in shaping regulation of the emerging field to ensure safe and effective treatment options for patients.
Scott received his medical degree from University of Massachusetts Medical School in 1978 and completed his Fellowship at Johns Hopkins (Baltimore) in 1984 after a residency at Rhode Island Hospital/Brown University Health. His tenure at Johns Hopkins was before we understood the role of erythropoietin and growth factors like Granulocyte Colony Stimulating factor. His early research focused on how to expand bone marrow in vitro, and how to ‘purge’ malignant cells from stem cell products. CD34+ stem cells were known to be able to support engraftment, and resistant to cyclophosphamide . This purging strategy was explored to support autologous marrow replacement for patients with AML and other hematologic malignancies. Dr Scott Rowley, MD had created an impression. Straight out of his fellowship he was invited to become lab director at Johns Hopkins and later, across the Country to the Fred Hutchinson Cancer Center.
My chat with Scott revealed his close relationship with several others involved in the establishment of ISHAGE including Nancy Collins and Adrian Gee. He spoke of how they got together with a shared passion to shape the development of ISHAGE. He talked about the critical role the lab folk played in driving standards for cell -based therapies. In the early days there was no regulation in the field, and the FDA was ‘hands off’. The FDA became interested in regulation of tissues as a consequence of the developing potential for commercialization of cord blood collection and storage. At that time FDA proposed placing these cell products under the regulations for blood products including the need for product licensure if either the product or the donor travelled across state borders. Such a regulatory approach would have greatly harmed the ability to conduct clinical research using hematopoietic cell products. The challenge was to develop a new framework for clinical cell therapy without imposing an explicit way of operating, that may have restricted research and clinical outcomes. Scott proposed using quality standards instead of product standards for both FDA regulatory and professional accreditation activities, leading to what became 21 CRF 1271 Good Tissue Practice for the regulation of all human tissue.
In the early days of ISCT the President rotated through promoting education and research publications, building respect and engaging directly with the close-knit membership of a few hundred members with common goals.
Scott reflected on the challenges of an emerging society managing its own journal as a conduit to communicate advances in the field to the broader community. ISHAGE partnered with a well-known publisher to provide the Journal of Hematotherapy. There were challenges for the voluntary leadership to retain ownership and control of the publication in the face of legal battles. But Scott and the other visionary leaders did not allow this unpleasantness to change their drive! Cytotherapy is a great place to publish your cell therapy research findings.
Scott was recruited from Seattle WA to Hackensack NJ, to be the director of the transplant service at Hackensack University Medical Center (HUMC), leaving laboratory practice for clinical medicine. A consequence of the developing relationship between HUMC and the Lombardi Cancer Research Center at Georgetown University, Scott became the director of the stem cell transplant and cellular immunotherapy program at MedStar Georgetown University Hospital, responsible for re-opening a FACT-accredited transplant service after a hiatus of many years. Importantly, he was instrumental in developing a cell processing laboratory at HUMC replacing the commercial operation that previously provided these services. I’m sure this move was managed through a Change Control process and involved significant quality operations oversight based on the standards that Scott helped to bring into practice.
As an early champion of embracing regulatory systems Scott expressed some frustration with the FACT model, citing the positive encounters he had with FDA inspectors while in Seattle, where inspections went beyond a checklist. His opinion is that a site should be ready to withstand an unannounced inspection by any regulator including the FDA, knowing that the site has in place robust equipment qualifications, QC validations and manufacturing processes. However, not all inspection programs or inspectors provide the same level of oversight and confidence of safe and quality products and sites should be self-aware. A good audit response from one body does not mean that you can sit back. There is always room for improvement. It all comes back to knowledge of your product, manufacturing controls and a quality improvement mindset.
If you are an ESP, Scott advised that you should be ready for the next ‘black swan” event that may dramatically change the field of cellular immunotherapy. For example, PBSC came changing the field from bone marrow. CAR T-cells opened new treatments for a variety of cancers. Science evolves, and changes quickly. To stay at the forefront the cell therapy practitioner needs to keep up with new advances, critically reading the literature, and scanning the landscape to be ready for where the field is going next.
Clinical innovation is an essential element of the cell therapy manufacturing pathway. However there needs to be a clear delineation between research activity and product manufacturing, where traditional cGMP product quality and safety requirements come first. While deviations should not be the norm, there is scope to modify processes in a controlled manner. The field is making amazing advances and patients can be the winners! But only if developers and cell therapy practioners follow quality guidelines and actively participate in shaping the regulatory structure to support implementation and appropriate regulation of new modalities.
ISCT has always welcomed technicians, clinicians and regulators and worked with stakeholders and visionary leaders to find ways for them to work together to develop innovative treatments for patients in need.
Be a leader not a follower.
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