Last Call! Submit Comments on Draft Standards by August 30

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

Feedback on draft Standards is a critical step of updating requirements to remain relevant and useful to the current state of cellular therapy. Comments will be accepted on two sets of draft Standards through August 30, 2020. This is a direct way to make your thoughts known on any requirement because each comment is reviewed by the Standards Committee. Do you support the new requirements? Is there a standard that you find to be unclear? Let us know!

The following are descriptions and pertinent links for the two drafts available for review. As a peer-driven organization, we look forward to your feedback!

For questions or assistance, please contact Andra Moehring, MHA, Standards Development Manager.

FACT – JACIE International Cellular Therapy Standards

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) published the draft Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment. These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood.

Description and Instructions for Review and Comment

Summary of Changes

Draft Eighth Edition FACT-JACIE International Standards

Comments regarding the draft Eighth Edition FACT-JACIE International Standards can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

FACT Standards for Immune Effector Cells

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Second Edition FACT Standards for Immune Effector Cells for inspection and public comment. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Description and Instructions for Review and Comment

Summary of Changes

Draft Second Edition FACT Standards for Immune Effector Cells

Comments regarding the draft Second Edition FACT Standards for Immune Effector Cells can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.


SITC Requests Feedback on Immune Effector Cell-Related Adverse Events Guideline

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

Comments due by September 11, 2020

The Society for Immunotherapy of Cancer (SITC) announced a public comment period on its upcoming clinical practice guideline, The Society for Immunotherapy of Cancer consensus statement on immune effector cell-related adverse events. Comments are due by the end of September 11, 2020.

This manuscript is part of the SITC Cancer Immunotherapy Guidelines program, which is a collection of clinical practice guidelines available in the open-access, peer-reviewed online journal, Journal for ImmunoTherapy of Cancer (JITC). It was written by an expert panel that included representatives from the American Society of Hematology (ASH), the American Society for Transplantation and Cellular Therapy (ASTCT), and the Foundation for the Accreditation of Cellular Therapy (FACT).

Instructions for accessing the draft manuscript


FACT Resources to Assist Your Program Throughout the Accreditation Process

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

FACT aims to provide organizations with valuable resources to aid in achieving and maintaining their accreditation. Our website has useful documents for organizations in all phases of the accreditation process. However, we understand that finding the right information can become overwhelming at times especially for organizations completing their initial application or for personnel new to the accreditation process.

The following overview provides categories, definitions, and the location of important resources. We encourage you to share this information with all personnel involved in your organization’s FACT accreditation process:

FACT Standards

The FACT Standards webpage contains links to the most recent versions of the four sets of Standards published by FACT:

  • HCT StandardsFACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
  • Common StandardsCommon Standards for Cellular Therapies
  • Immune Effector StandardsStandards for Immune Effector Cells
  • Cord Blood Bank StandardsNetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration

The pages for each set of Standards contain useful documents relevant to the current editions of FACT Standards, including, but not limited to:

  • FACT Standards and Accreditation Manuals
  • Summary of Changes, Compare, and Crosswalk documents to identify changes between the previous and current versions of FACT Standards, if applicable.
  • Forms used during the compliance application submission, including but not limited to Document Submission Requirements, Educational Activities, Critical Electronic Record Systems, and Facility Site Grids.

 The above resources can also be found in the Cellular Therapy Library and Cord Blood Bank Library.

Accreditation Process Requirements

The Cellular Therapy Accreditation Process Requirements and Cord Blood Bank Accreditation Process Requirements provide a structured overview of the accreditation process, from completing the Compliance Application to requirements after the on-site inspection.

Self-Assessment Tools

The Self-Assessment Tools can be used to assess readiness for FACT accreditation. They are located in the Cellular Therapy (CT) and Cord Blood Bank (CB) Libraries, and you will find individual self-assessment tools for each current set of FACT Standards:

Educational Resources

FACT’s comprehensive, robust training and development program is responsive to the current needs of inspectors and organizations, providing extensive opportunities for all skill levels in all corners of the world. With a focus on real-life examples and practical application, FACT educational sessions provide tools not only for achieving accreditation, but for ensuring quality patient care in accordance with the Standards. The Education and Resources page contains links to upcoming and previously recorded events:

FACT Accreditation Coordinator

FACT’s Accreditation Coordinators provide these and additional FACT resource links in an email sent to organizations at the beginning of the compliance application process. Your accreditation coordinator is available throughout the accreditation process to answer questions via email or phone. The coordinator’s contact information is available in the accreditation portal.

Clinical Outcomes Resource Center

FACT supports blood and marrow transplant (BMT) programs’ efforts to evaluate one-year survival data to improve patient outcomes, advance the field, and maintain payer and public confidence. The Clinical Outcomes Resource Center includes comparative data sources, educational resources, guidelines for corrective action plans (CAP), as well as CAP examples.

Data Management Resource Center

The FACT-CIBMTR Data Audit Committee reviews implementation, adequacy, and effectiveness of corrective action plans with the goal of providing education and assistance to programs throughout the accreditation cycle to achieve quality improvement in data management. The Data Management Resource Center provides CIBMTR and educational resources, guidelines for data management submissions and examples, and audit report examples and templates.

Immune Effector Cells (IEC) Resource Center

FACT is committed to supporting efforts to make quality immune effector cellular therapy accessible to patients much like it did for blood and marrow transplantation and cord blood banking. Several resources are available to assist with understanding immune effector cells and implementing FACT Standards. The Immune Effector Cells (IEC) Resource Center includes resources to assist with understanding immune effector cells and implementing applicable FACT Standards.

Portal Resource Center

The Portal Resource Center provides access to all available resources and training materials for navigating and assisting organizations in completing applications in the portal.

FACT News

Use the links below to access recent news releases, as well as current and previous volumes of our newsletter:

We hope that you find this information useful as you prepare for your next accreditation cycle. If you have additional suggestions regarding how FACT can better inform organizations of the resources available, please email fact@unmc.edu.


REMINDER: Public Comment Period Open for FACT Cellular Therapy Standards and Immune Effector Cell Standards

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

FACT – JACIE International Cellular Therapy Standards

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) published the draft Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment. These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood.

Description and Instructions for Review and Comment
Summary of Changes
Draft Eighth Edition FACT-JACIE International Standards

Comments regarding the draft Eighth Edition FACT-JACIE International Standards can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

FACT Standards for Immune Effector Cells

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Second Edition FACT Standards for Immune Effector Cells for inspection and public comment. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Description and Instructions for Review and Comment
Summary of Changes
Draft Second Edition FACT Standards for Immune Effector Cells

Comments regarding the draft Second Edition FACT Standards for Immune Effector Cells can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

For questions or assistance, please contact Andra Moehring, MHA, Standards Development Manager.


Immune Effector Cellular Therapy Webinar: Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

Register now:

Bringing a Stand-Alone Immune Effector Cell therapy Program into FACT Compliance


New Immune Effector Cellular Therapy Webinar: Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

Register now:
Bringing a Stand-Alone Immune Effector Cell therapy Program into Compliance


Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020


Just the FACTs, 2020 Volume 2

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

It was great to see many of you at the TCT meetings in Orlando (I didn’t pack a warm enough jacket!) where the solid emergence of cell therapies was in constant evidence. The Quality Boot Camp was another smashing success, as were the applicant and inspector training courses at the FACT Inspection & Accreditation Workshop, and the cellular therapy leadership courses. I had an opportunity to make a presentation on FACT Immune Effector Cell Accreditation to the administrative track, which evoked many questions, some showing the importance of educating our administrative colleagues in the importance of coordinated, comprehensive, quality-driven care to optimize outcomes for our patients and the role community-driven accreditation plays. We had a chance to express our thanks to Mark Litzow for his many years of service on the FACT Board of Directors and as the first FACT Technology Committee chair. You are already missed, Mark! Travel restrictions and meeting cancellations are coming at a rapid pace and paper goods are flying off the shelves as COVID19 cases increase. Our patients would be among the greatest affected—if you are ill take care of yourself and stay home for their sake.

Hand wave from greater than 6 feet—see you soon.

Dennis Gastineau, MD

 

 

 

FACT President

 


FACT Announces Immune Effector Cellular Therapy Webinar Series

Posted in :: 2020 Volume 1 :: Monday, January 27th, 2020

The FACT Education Committee and Immune Effector Cell Task Force have developed a series of webinars on Immune Effector Cellular Therapy.  Six webinars are planned throughout 2020 and include the following topics:

The State of FACT Immune Effector Cell Therapy Accreditation Today presented by Dr. Patrick Hanley
Wednesday, March 4, 2020
11:00 am ET, 16:00 GMT

Dr. Patrick Hanley, Director of GMP for Immunotherapy at Children’s National Health System Blood and Marrow Transplant Program, will present the State of FACT Immune Effector Cell Therapy Accreditation Today. Dr. Hanley will discuss the growth and expected direction of IEC Accreditation and describe the major concepts addressed the FACT IEC Standards. He will also explain various methods of compliance, as well as compare requirements between FACT and commercial manufacturers.

Register now

Labeling and Chain of Custody for IEC Products presented by Dr. Sarah Nikiforow
Wednesday, April 22, 2020
11:00 am ET, 15:00 GMT

Dr. Sarah Nikiforow from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, will present  Labeling and Chain of Identity and Custody for IEC Products.  Dr. Nikiforow will review the IEC Standards related to labeling and chain of identity and custody and explain FACT expectations for clinical trial research product labeling and chain of custody from bench to bedside.  In addition, she will describe how ISBT 128 coding and labeling can be used with commercial cellular therapy products.

Register now

Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier
June 17, 2020
11:00 am ET, 15:00 GMT

Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program in Nashville, will present Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program.  Dr. Bachier will begin by discussing the requirements for transplantation and immune effector cellular therapy.  He will highlight opportunities and challenges when incorporating immune effector cellular therapy into an existing Quality Management Plan, and provide steps that can be taken to incorporate immune effector cellular therapy into a transplant program.

Register now

Other sessions within this series include:

  • Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance (Date/time TBD)
  • IEC Inspector Training (Date/time TBD)
  • Data Reporting and REMS Compliance (Date/time TBD)

Webinar Series on Implementing Commercial CAR T-cell Products

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

The American Society of Gene & Cell Therapy (ASGCT) has partnered with FACT and the American Society for Transplantation and Cellular Therapy (ASTCT) to bring you the two-part webinar series, “Centers’ Experience with Implementing Commercial CAR T-cell Products.”

The first webinar will be on Thursday, July 25, 2019 at 11:00 am ET.  Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in this process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.

Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement
  • FACT accreditation

View meeting details and register


New CARTOX App Assists Grading and Management of IEC Toxicities

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

By Sherry Adkins, RN, MSN, ANP-C and Kara Wacker, MBA, RAC

The CARTOX Mobile App for iPhone and Android, created by MD Anderson Cancer Center, is now available to assist clinicians with accurate and timely grading and treatment of toxicities associated with immune effector cellular therapy (IEC). The app is intended for physicians, nurse practitioners, physician assistants, nurses, and pharmacists who treat patients receiving IECs.

Sherry Adkins, RN, MSN, ANP-C, Advanced Practice Provider Supervisor, Lymphoma Research at the MD Anderson Cancer Center developed the idea of an app to allow for safer and more efficient care of the rapidly expanding population of patients receiving IECs. “We recognize that the app has helped our group improve the safety and efficiency of care for this group of patients,” explains Adkins. “We hope it will help other clinicians, particularly those who are just beginning to administer this therapy.”

Ms. Adkins led the implementation strategy with coding assistance from Darren Skeete and his team from the center’s Informational Technology (IT) department. Members of the MD Anderson CARTOX Committee, including Drs. Sattva Neelapu and Elizabeth Shpall, reviewed and tested the app. The process started in the Fall of 2017, and MD Anderson clinicians had access by August of 2018.

The app is based on published guidelines, and will continue to be updated as science evolves to reflect the most current practice guidelines. The initial version of toxicity grading was based on the MD Anderson’s CARTOX program guidelines, but has since been updated to reflect the ASTCT (formerly known as ASBMT) consensus grading. (Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25. Review.)

Toxicity management is based on the CARTOX program’s guidelines, which were developed by a multidisciplinary, multi-institutional group of clinicians (Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19. Review). Toxicity management guidelines are currently being updated and the mobile APP will be updated to reflect those changes in the near future.

To download the app, search for CARTOX in the Apple Store or Google Play.


June is Cancer Immunotherapy Awareness Month

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

This month we recognize and celebrate June as the 7th Annual Cancer Immunotherapy Month™ hosted by the Cancer Research Institute. Patients, caregivers, advocacy organizations, health care professionals and industry partners, unite to raise awareness of the lifesaving potential of cancer immunotherapies. Every day, so many work to transform T-cell therapy including researchers who have helped pioneer this research and continue to make seminal advances in this growing field.  This month is not only termed to promote general awareness, but also to provide educational growth and professional development opportunities for clinicians, researchers, and patients.

Below are some of the benefits of cancer immunotherapy: (Benefits of Immunotherapy (n.d.). Retrieved from: http://www.cancerresearch.org/immunotherapy/why-immunotherapy).

Cancer immunotherapy can work on many different types of cancer

  • Immunotherapy enables the immune system to recognize and target cancer cells, making it a universal answer to cancer.
  • The list of cancers that are currently treated using immunotherapy is extensive. See the full list of Immunotherapies by cancer type.
  • Immunotherapy has been an effective treatment for patients with certain types of cancer that have been resistant to chemotherapy and radiation treatment

Cancer immunotherapy offers the possibility for long-term cancer remission

  • Immunotherapy can “train” the immune system to remember cancer cells. This “immunomemory” may result in longer-lasting remissions.
  • Clinical studies on long-term overall survival have shown that the beneficial responses to cancer immunotherapy treatment are durable—that is, they can be maintained even after treatment is completed.

Cancer immunotherapy may not cause the same side effects as chemotherapy and radiation

  • Cancer immunotherapy is focused on the immune system and is often more targeted than conventional cancer treatments such as chemotherapy or radiation.
  • Both chemotherapy and radiation damage healthy cells, leading to common side effects such as hair loss and nausea/vomiting. These side effects may be less likely with immunotherapy.
  • Side effects of cancer immunotherapy will vary depending on which type of immunotherapy is used. They are usually related to stimulation of the immune system and can range from minor symptoms of inflammation (e.g., fever) to major conditions similar to autoimmune disorders.

To learn more about Immunotherapy visit: http://www.cancerresearch.org/immunotherapy/what-is-immunotherapy

View Cancer Immunotherapy Month Events in June 2019


FACT Submits Comments to CMS Regarding Proposed National Coverage Determination for CAR T-Cell Therapies for Cancer

Posted in :: 2019 Volume 4 :: Wednesday, April 17th, 2019

By: Kara Wacker, MBA,  FACT Strategic Planning Administrator

The United States Centers for Medicare & Medicaid Services (CMS) released a proposed decision memo that outlines coverage for CAR T-cell therapies for cancer using a National Coverage Determination (NCD) with Coverage with Evidence Development (CED). FACT responded to this proposal on March 15, 2019. Comments were a result of input from a variety of stakeholders, including the FACT Board of Directors and Immune Effector Cell Task Force, FACT-accredited programs, FACT inspectors, professional societies, data registries, manufacturers, and payers. We commend the cellular therapy field for its collaborative efforts to provide feedback that would be helpful to CMS as it seeks to provide beneficiaries access to CAR T-cells, and we appreciated this opportunity to provide feedback.

Highlights of FACT’s comments include:

  • Suggestion that coverage is provided based on Food and Drug Administration (FDA)-approved product labels to allow coverage as therapies advance.
  • Support for the use of the Center for International Blood and Marrow Transplant Research (CIBMTR) as the data registry, and suggestion to certify the registry prior to finalization of the proposed decision memo.
  • Request for clarification on the utility of quality of life data for the stated purposes.
  • Clarification regarding the scope of various sets of FACT Standards.
  • Agreement that hospitals should meet FACT requirements to promote safety and efficacy of CAR T-cell therapies; increase harmonization across requirements of regulators, payers, and manufacturers; and reduce burden on hospitals.

Additional FACT Volunteer Opportunities

Posted in :: 2019 Volume 4 :: Wednesday, April 17th, 2019

By: Andra Moehring, MHA, FACT Standards Development Manager

The Foundation for the Accreditation of Cellular Therapy (FACT) has several committees to help FACT achieve its vision of being the premier organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.

In addition to other standing committees, FACT has a special committee for which we are seeking volunteers. We invite you to review the charge for the FACT Standards Committee and either nominate yourself or a colleague to serve as a committee member.

­­­­­­­­­­­­­­­Purpose

The FACT Standards Committee drafts standards and guidance for cellular therapy product collection, processing, and administration; and cord blood collection, banking, and release for administration, using evidence-based science and considering evolving uses of cellular therapy.

The committee’s goal is to provide clear and user-friendly FACT standards and effective transition between editions of Standards.

Commitment

  • 3 year term
  • Minimum of 2 three-month periods with weekly or bi-weekly teleconferences
  • Complete initial edits prior to the public comment period
  • Review of public comments submitted
  • Ongoing participation until the development of the next edition of Standards

The majority of the hard work is completed during subcommittee discussions that take place several months before the actual publication of the Standards. The experience and expertise of our volunteer subcommittee members is invaluable to the development of each edition of Standards.

Standard Development Schedule

FACT currently has four sets of Standards, with multiple subcommittees (e.g., Clinical, Collection, Processing, Quality Management, Immune Effector Cell) under each set. The Standards Development process for each upcoming edition of Standards is below:

  • FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (July 2019)
  • FACT Standards for Immune Effector Cells (July 2019)
  • FACT Common Standards for Cellular Therapies (May 2020)
  • NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. (January 2021)

Volunteers are an essential resource for FACT. Our success and accomplishments are directly attributable to the selfless commitment of our knowledgeable volunteers. FACT’s volunteers bring new ideas and energy to the Foundation. Your volunteering makes a difference in the organization and the cell therapy community.

Please submit your interest in serving as a committee member along with a description of your qualifications to Andra Moehring, FACT Standards Development Manager, at andra.moehring@unmc.edu by May 1, 2019.


Clinical Research and Commercial Products are Both within Scope of FACT Standards

Posted in :: 2019 Volume 1 :: Wednesday, January 16th, 2019

Although clinical research has been a major part of the blood and marrow transplant (BMT) field since its inception, recent developments have prompted questions regarding the scope of FACT Standards. The number of programs participating in research of new cellular therapy products beyond minimally manipulated hematopoietic progenitor cells (HPCs) is increasing. Furthermore, two immune effector cell (IEC) products are now commercial and treated as “standard of care.”

FACT Standards apply to both clinical research and standard of care cellular therapy products. If an accredited program provides both types of products, then it must comply with FACT Standards for both. There is not an option to be accredited for only one or the other.

Both cellular therapy products administered within the context of clinical research, and products administered within regulatory licensure (such as Kymriah® and Yescarta®), must comply with FACT Standards as they are applicable to the requirements. Products must be collected and processed using controlled and documented procedures; personnel must be trained and competent; recipient and donor health must be evaluated and managed; facilities, equipment, supplies, and reagents must meet specifications; and records must be created and maintained.

Both clinical research and licensed cellular therapy products must be incorporated into the program’s quality management (QM) program. As more products are administered, this is challenging due to the involvement of additional providers and companies, increasing data collection and reporting requirements, varying protocols, and more. These challenges, though, are the very reasons why a QM program can help the program! Evaluating, creating, and documenting procedures and protocols, training staff on those procedures, and maintaining a centralized mechanism to access documents and records will assist the program with maintaining control of its services.

The FACT Immune Effector Cell Task Force acknowledges these challenges and seeks to provide resources and education to assist programs experiencing the growing types of products administered. For example, see the article from a past Just the FACTs newsletter regarding reporting adverse events for commercial products and the IEC resources webpage. The task force is also hosting a webinar on January 30, 2019 to describe programs’ approaches to using nonconforming commercial products. These resources are based on real-world program experiences, and we appreciate the questions and feedback programs have provided FACT as we all learn more about these exciting new developments in cellular therapy.

David Porter, MD, Director of Cell Therapy and Transplantation at Penn Medicine (second from left), Member of FACT’s IEC Task Force, presents “CAR-T Cells: On the road to a cure” at the University of Nebraska Medical Center Hematologic Malignancies Research Meeting. With him are Julie Vose, MD, MBA, James Armitage, MD, and Phyllis Warkentin, MD.


FACT Submits Comments to Governmental Agencies

Posted in :: 2018 Volume 3 :: Wednesday, August 22nd, 2018

FACT-accredited organizations are regulated by several governmental agencies around the world in relation to quality and safety of cellular therapy products and reimbursement. When draft regulations or guidance documents are released, FACT committees review the information and submit comments as applicable to the scope of FACT accreditation. In the past decade, comments have been submitted to agencies in the United States, Australia, and Europe. The FACT Global Affairs Committee also supports cellular therapy leaders in developing countries to encourage use of FACT Standards.

So far this year, FACT has submitted comments on three topics to two agencies in the United States:

FACT also plans to review the recently published FDA draft guidance documents for gene therapies. These comments are due by October 10, 2018. If you have input you would like FACT to consider for inclusion, submit those to Kara Wacker at kwacker@unmc.edu by August 31, 2018.


The University of Texas MD Anderson CARTOX Program is First to Achieve Accreditation Under the FACT Standards for Immune Effector Cells

Posted in :: 2018 Volume 2 :: Tuesday, May 22nd, 2018

By Mikaela VanMoorleghem, FACT Education and Training Coordinator

The University of Texas MD Anderson CARTOX Program received accreditation for immune effector cellular therapy by the Foundation for the Accreditation of Cellular Therapy (FACT) at the University of Nebraska Medical Center. The University of Texas MD Anderson CARTOX Program, directed by Elizabeth Shpall, MD, and Sattva S. Neelapu, MD, is the first program to be recognized by FACT for compliance with the new FACT Standards for Immune Effector Cells independent of a bone marrow transplant program. The program received accreditation on April 19, 2018.

Dr. Elizabeth Shpall states, “We are very excited to receive the accreditation for the first stand-alone immune effector cell program. It was a major effort of so many people at MD Anderson to coordinate the many different departments and clinical care teams with such broad expertise. We are very grateful for the FACT IEC Standards which we used extensively as a guide for the development and continued operation of our CARTOX program.”

Dr. Phyllis Warkentin, FACT Chief Medical Officer states, “I welcome the University of Texas MD Anderson CARTOX Program to a network of cellular therapy programs and experts that promote the highest quality in the delivery of cellular therapy and care to the patients they serve. Accredited cellular therapy programs such as the CARTOX program have met rigorous standards and I commend them on this tremendous success.”

The FACT website lists all FACT-accredited immune effector cellular therapy programs, which includes bone marrow transplant programs also providing these services.