Just the FACTs 2024, Volume 5
President’s Letter
I hope you are all having exciting times over the summer or winter depending on where you live! On behalf of FACT, I am thrilled to let you know that FACT will publicly launch FACT Consulting’s Audit and Assessment Services to the cell and gene therapy industry. Since the first CAR-T product was commercialized in 2016, industry audit burden has been a focal point of multistakeholder deliberations and collaboration. Feedback from health care institutions, industry, professional organizations, and more have been woven into our processes to provide a valuable, sustainable, and credible solution that will refocus resources on patient care while promoting patient access to cell and gene therapies.
The adoption of our audit and assessment services will bring greater efficiency to this exciting field of medicine. As we like to say, it is a WIN-WIN-WIN solution because industry, health care institutions, and patients all benefit!!!
To drive adoption, we highlight two resources in this newsletter to help key opinion leaders propose the use of our service to their leadership:
- A brief, informative video that illustrates the highlights of the service in less than four minutes.
- A free webinar that features a discussion regarding our pilot assessment project and explains the value of these services to companies and audited sites alike.
Finally, please join us on September 17 as we celebrate Apheresis Awareness Day with ASFA! And wishing you all a very happy time in the sun or in the snow (or both)!
Sincerely,
Catherine Bollard, MD
FACT President
[Insert photos of Cath and Phyllis at ISCT ANZ]
Informational Video About FACT Consulting’s Audit & Assessment Solution Created for Key Decision Makers
The solution for rapid site qualification and reduced audit burden is here – FACT Audit & Assessment Services. To help quality professionals in the cell and gene industry quickly pitch this solution to their key decision makers, FACT Consulting created an informational video that highlights the benefits and process of this new solution. This 3 minute, 48 second video is available on the FACT Consulting website and can be shared widely.
We hope you find this video as enjoyable as it is informational. Contact factconsulting@factglobal.org for more information.
Request Audits Today! Visit: https://www.factglobal.org/request-for-fact-consulting-services/
Attend a FREE Webinar to Learn All About FACT Consulting’s Audit & Assessment Solution
This FREE webinar is the curtain opening of FACT Audit and Assessment Services, a solution provided by FACT Consulting. Cell and gene therapy sponsors, license holders, manufacturers, registries, collection sites, processing laboratories, and treatment sites are invited to learn how this solution increases the return on investment in site assessments via specific, high-value benefits.
As reported extensively, the current industry qualification and auditing approach for cell and gene therapies is unsustainable and may delay or prevent patient access. FACT Consulting confirmed via a recent pilot project that its services can rapidly assess both accredited and non-accredited sites’ ability to participate in a company’s network, perform assessments on behalf of industry, and reduce the duplicative audit burden on healthcare sites while increasing the quality of their services. It is a win-win-win solution that reduces the audit burden on industry and sites to allow them to serve more patients.
Celebrate Apheresis Awareness Day on September 17!
The American Society for Apheresis (ASFA) is pleased to announce that Tuesday, September 17th, 2024 is the 5th Year Anniversary of Apheresis Awareness Day! The purpose is to raise awareness of apheresis medicine and honor the many donors, patients, and apheresis practitioners that have dedicated their lives to saving others by using evidence-based practice to advance apheresis medicine.
If your work or personal life has been touched by the practice of apheresis, we ask that you join ASFA in honoring this special day. Check out ASFA’s newly released celebration video below:
Register for ASTCT’s 4th International Conference on Toxicities of Transplantation and Cellular Therapies
Correction of undesirable trends in clinical outcomes is an important aspect of FACT Standards and is supported by the FACT Clinical Outcomes Improvement Committee. We are appreciative of a conference that is hosted by ASTCT to educate transplant and cell therapy programs on how to manage the toxicities of these therapies.
Registration is now open for the 4th International Conference on Toxicities of Transplantation and Cellular Therapies, which will take place November 15-16, 2024 in Philadelphia. The program will include a wide range of pre-clinical, translational and clinical topics through five main sessions. Offered in-person and virtually, this conference is ideal for physicians, advanced practice providers and nurses involved in HCT or immune effector cell therapies.
The agenda includes:
- The Expanding Scope of Toxicities after Transplantation and Cellular and Gene Therapies
- Optimizing Host Resilience
- Treating Older Transplantation and Cellular Therapy Recipients
- Promises and Pitfalls of Emerging Technologies
- Toxicities of Cellular Therapies for Solid Organ Malignancies
Join the ISCT Early Stage Professionals Committee! Applications Due August 23
The ISCT Early Stage Professionals (ESP) Committee is looking for dedicated and enthusiastic new members to join the Committee and support current and upcoming programs.
Founded in 2015, the goal of the ESP Committee is to facilitate global networking and engagement opportunities for individuals within 10 years of their terminal degree or entry to the field and to develop the future leaders of ISCT and the cell and gene therapy field at large.
The Committee has three working groups from which members can choose to join:
- Mentoring Program & Career Development
- Community Engagement
- Education
For more information and for application instructions, visit the committee webpage on the ISCT website.
Register for Upcoming FACT Education Events!
View the Full Educational Library at https://learn.factglobal.org/
Visit our Upcoming Events Page at https://learn.factglobal.org/upcoming-events
AUGUST
- August 22, 2024: QM Series 12 Webinar #6 – Evaluation of the Implementation of a New Process
- August 23, 2024: FACT Consulting Audit & Assessment Services Webinar: Maximize Your ROI by Enhancing the Value of Site Assessments – What FACT Learned During its Pilot Assessment Project (FREE REGISTRATION)
SEPTEMBER
- September 12, 2024: VIRTUAL FACT Quality Boot Camp – Process Validations
- September 18, 2024: QM Series 12 Webinar #7 – Preparing for Interruption of Operations
OCTOBER
- October 1, 2024: DAY 1 – VIRTUAL FACT Cord Blood Bank Accreditation Workshop
- Please note that registration is for the entire event and cannot be done separately for each day.
- October 10, 2025: DAY 2 – VIRTUAL FACT Cord Blood Bank Accreditation Workshop
NOVEMBER
- November 6, 2024: QM Series 12 Webinar #8 – The Program’s Perspective: Three Views
STAY TUNED….2025 Event Registrations COMING SOON! Download the 2025 FACT Education Calendar.
