By Richard J. Jones, MD
Director, Bone Marrow Transplantation Program
The Johns Hopkins Sidney Kimmel Cancer Center
On May 29, 2023, the stem cell biology and transplantation communities lost one of our colleagues, Dr. Ian K. McNiece. Ian, a long-standing member of the FACT Board of Directors and Chair of its Regenerative Medicine Task Force, endured a prolonged illness over several years, but passed away peacefully in his home in Coral Gables, FL. Ian had a long and productive career in both industry and academics. Growing up in Australia, he received his Ph.D. in Physiology from the University of Melbourne with his thesis work at the Peter MacCallum Cancer Institute. Ian subsequently came to the United States as a postdoctoral fellow with Dr. Peter Quesenberry at the University of Virginia, Charlottesville.
In 1988, Ian joined Amgen in Thousand Oaks, CA, as a Research Scientist, playing a key role in the emerging field of growth factor therapeutics. In 1994, he became Laboratory Head in the Department of Developmental Hematology at Amgen, and in 1995, he was appointed to head the Amgen Central Laboratory at Saint Luc University Hospital in Belgium. In 1997, Ian returned to academia as Director of Research for the Bone Marrow Transplant Program and Director of the Stem Cell Biology Program at the University of Colorado Health Science Center. In 2003, he moved to Baltimore as Professor of Oncology at Johns Hopkins University, where he served as Director of the Cell Therapy Laboratory, as well as Director and CEO of the Division of Biomedical Sciences Johns Hopkins Singapore. In 2007, he was recruited to the University of Miami as Professor of Medicine in the Interdisciplinary Stem Cell Institute, and Director of the Experimental and Clinical Cell Based Therapies Program which supported translational clinical research in cellular therapy. In 2012, he was recruited to MD Anderson in Houston to be the Director of the Stem Cell Transplantation and Cellular Therapy Clinical Laboratories. Then in 2017, Ian returned to industry as Chief Scientific Officer of BioCardia, directing the development of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease.
Ian’s research focused on stem cell biology, as well as translational medicine using stem cells and the generation of cellular products for clinical use. In addition to his work in the development of growth factor therapeutics, his later efforts focused on stem cell expansion for cord blood, as well as regenerative medicine strategies particularly for cardiovascular diseases.
On a personal note, Ian and his wife Peggy (an expert transplant nurse and case manager at University of Colorado, Hopkins, and currently at the University of Miami) were dear friends of my wife and me. I first met Ian when he was a post-doc in Peter Quesenberry’s lab almost 40 years ago, got to know him better when my lab was doing studies with various growth factors while he was at Amgen, and recruited him to direct the Hopkins clinical Cell Therapy Laboratory. I was not happy when my colleague at Hopkins, Josh Hare, convinced Ian to move with him down to Miami to develop a cellular therapeutics program and lab, although I must admit that a big part of my sadness was also losing Peggy, one of the best transplant case managers on the planet. However, we remained close, traveled together, and visited each other often (his son David still lives in Baltimore). He loved Australian rules football. (I hear he was quite a player in his day.) He also loved Denver Broncos football, beer, French wine, bicycling, golf, laughing, and of course Peggy and the grandkids. One of my favorite memories was when we were visiting Peggy and him on what just happened to be the weekend when Super Bowl favorite Denver was playing Baltimore in the 2012 NFL playoffs. He and Peggy were wearing Peyton Manning jerseys and my wife and I Joe Flacco jerseys, while watching the game at a Denver Broncos bar in Miami. The bar was going crazy after Denver scored the apparently game-winning touchdown late in the 4th quarter, and then the Mile High Miracle unfolded. For the first and only time since I met him, Ian actually remained quiet for the rest of the evening.
Ian was always a force of nature, and his scientific impact to the fields of stem cell biology and transplantation will endure. We will certainly miss him but will treasure the memories forever.
Richard J. Jones, M.D.
Director, Bone Marrow Transplantation Program
The Johns Hopkins Sidney Kimmel Cancer Center
Dr. McNiece’s Many Contributions to FACT and ISCT
- FACT Board of Directors: 2010-2018
- Chair, FACT Regenerative Medicine Task Force: 2010-2023
- Member, FACT Common Standards Steering Committee: 2017-2023
- FACT Inspector since 1998 and performed 17 cellular therapy inspections
- Member of ISCT since 1995
- Chair of the ISCT Hematopoietic Stem Cell Committee from 2004 to 2011
- Co-Chair ISCT 2008 Annual Meeting and Organizing Committee member from 2005-2009
- Cytotherapy Editorial Board Member from 2009 to 2022
- ISCT representative on FACT Board of Directors from 2010 to 2018
FACT and JACIE Remained Committed to Publishing the Eighth Edition Hematopoietic Cellular Therapy Standards Despite Worldwide Pandemic
As an international Standards Committee, the FACT-JACIE Hematopoietic Cellular Therapy (HCT) Standards Committee is accustomed to remote collaboration. Its ability to work primarily online was brought to the test during the COVID-19 pandemic in 2020, and the committee rose to the challenge! The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying Accreditation Manual were published on May 17, 2021.
“Even with the challenges of a pandemic combined with very rapid advances in the field, amiable dedicated colleagues allowed successful completion of the task,” says Dr. Paul Eldridge, Chair of the Standards Committee. “I want to express my thanks and gratitude to everyone.”
Dr. Kim Orchard, Co-Chair of the Clinical Standards Subcommittee, adds, “The preparations for the eighth edition of the Standards proceeded with only minimal delays due to the COVID-19 pandemic. Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”
“It was a challenge to continue with everything during the pandemic,” according to Dr. Nina Worel, Co-Chair of the Collection Standards Subcommittee. “Not so much with the FACT-JACIE team working on the eighth edition as the time schedule is perfect. We are used to working remotely and the meetings always close on time, but this time there were a lot of other additional meetings that were remote.”
“We managed to have the second face-to-face meeting of the combined FACT and JACIE teams just before the full impact of the first wave occurred, and all subsequent meetings were held by remote means which were already planned,” says Dr. Orchard. “Credit is due to all those involved who continued to review and prepare the Standards despite the impact on their work and personal lives.”
The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
The HCT Standards Committee consists of 64 expert members among a Steering Committee and five subcommittees that reviewed clinical, collection, processing, quality, and immune effector cell (IEC) requirements. These members reside in 14 countries, contributing a truly international perspective to the Standards.
Following months of initial reviews and revisions, the HCT Standards Committee considered approximately 770 comments, submitted by 78 participants from 20 countries, during the public comment period. Additionally, other experts from FACT and JACIE participated in discussions related to new developments in the field, including Dr. John Snowden, member of the JACIE Committee and secretary of the European Society for Blood and Marrow Transplantation (EBMT), the FACT Immune Effector Cell Task Force, and others. These experts provided the HCT Standards Committee advice to consider when finalizing the Standards, with revisions ultimately drafted by the Standards Committee and approval granted by the FACT and EBMT Boards of Directors.
“It was really exhausting [with the other remote meetings]. However, we managed to finalize a great new edition of Standards for best quality in cellular therapy for our patients,” says Dr. Worel.
“It was a pleasure to work with committee members on the new edition of standards,” says Dr. Eldridge. “The opportunity to learn from such a diverse group of international experts is amazing.”
The eighth edition Standards become effective on August 16, 2021. All organizations accredited under these Standards are expected to be in compliance with the requirements by that date. Although there may be a few inspections remaining to be completed under the previous edition due to COVID 19-related delays, all other inspections scheduled after this date will be under the eighth edition.
By Suzanne Birnley, MS, MBA, FACT Accreditation Services Manager
It has been a very busy few months at FACT between the implementation of virtual inspections and publishing the eighth edition of the FACT-JACE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. These developments have led to some changes and improvements to the FACT Accreditation Process.
- Although initially developed for virtual inspections, some changes to submission requirements will continue to be part of the accreditation process moving forward. All applicant programs and banks are now required to submit additional documentation in preparation for their FACT inspection. For applicants currently waiting for their inspection to be scheduled, these documents can be uploaded in the FACT Accreditation Portal Document Library under the Virtual Inspection Documents tab. These documents are expected to be submitted a minimum of 4 weeks prior to the inspection. These additional submissions have been included with the Eighth Edition Hematopoietic Cellular Therapy (HCT) Compliance Application, and will be included in other Standards as new editions are published. These include:
- A copy of all policies and Standard Operating Procedures referenced in the Quality Management Plan.
- The most recently completed Annual Report on the Effectiveness of the Quality Management Program.
- Whether for a virtual inspection or on-site, beginning July 1, 2021, all programs are required to use OneNote or the equivalent to organize documents for their inspection. This can be accomplished in several ways:
- Use the OneNote template provided by FACT.
- Use a software developed within the organization or a commercially available software.
- Use the FACT Self-Assessment Tool or checklist from your completed application in the FACT Accreditation Portal, and add additional columns for links to documents and information regarding where to find documentation of compliance for each standard.
- For on-site inspections, use the binder method. Match each standard to the documentation of compliance in paper form, all organized by standard in three-ring binders.
- For virtual inspections, beginning July 1, 2021, all programs are required to use a document camera to display documentation that exists in paper format. This is particularly important in collection or processing facilities that use paper records.
Finally, it is very important that inspectors have access to any updated documents, especially if the Compliance Application was completed a year ago. FACT Accreditation Coordinators will send Requests for Information (RFIs) to update documentation known to be out of date, such as medical licenses and continuing education. It is your responsibility to let your coordinator know if there are any other policies or SOPs that were submitted that have since been revised. If inspectors do not have access to these documents, it is a risk that they may not see evidence of compliance, resulting in deficiencies cited on the Accreditation Report.
FACT greatly appreciates the hard work of the inspectors and applicants as we transition through this challenging time. We do intend to return to on-site inspections as soon as it is safe to do so. We are actively seeking and welcoming feedback on both the virtual inspection process and these process changes. If you have any questions or concerns, please contact your Accreditation Coordinator or the Manager of Accreditation Services, Suzanne Birnley.