Kara Wacker

[Clayton Collier @ClaytonJCollier]

Derek Wacker had himself a day!

The @YutanChieftains product amassed 13 tackles, 2 TFLs and a sack in Nebraska's spring game.

"That's what you go out there to do. To prove you can play in that environment versus good players."

#Huskers #GBR

[Kara Wacker @WackerKara]

@HuskerFootball @CoachMattRhule Happy birthday, Coach!

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

FACT extends sincere thanks to Texas Representative @BrooksLandgraf (District 81) and his staff for hosting a 1:1 meeting in Austin this week.

FACT CEO David Schmahl and Austin-based FACT Inspector Dr. Aravind Ramakrishnan discussed FACT’s founding mission, volunteer peer-driven structure, and the vital role of its Standards and accreditation in promoting safety and quality in cell and gene therapies.

The meeting followed the passage of Texas House Bill 3057, sponsored by Rep. Landgraf. FACT emphasized its commitment to being an open, collaborative resource to all cell and gene therapy stakeholders in Texas as the law takes effect and in future legislative efforts.

#FACTaccreditation #FACTStandards #celltherapy #genetherapy #patientsafety #texashealthcare #healthcarepolicy #quality #txlege #cart #hb3057

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

Very informative and engaging @ASTCT Webinar highlighting how FACT is helping to expand patient access to life saving therapies in their local communities. Academic and community physicians emphasize how quality systems help to onboard new products and get therapies to patients more efficiently.
📹Access the recording at https://t.co/NQSMRhRhjp

#FACTAccreditation #CellTherapy #PatientAccess #Quality

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

"A local Omaha woman became the first in Nebraska to receive CAR-T cell therapy as an outpatient—'staying at home was just amazing' and she’s 'ready to be an advocate' for others.”

Enjoy this patient story from a FACT-accredited program!🏅

#FACTAccredited #PatientAccess #CellTherapy

[Tyler Pedersen @TylerSPedersen]

Derek Wacker walked onto Lincoln in 24 from Yutan, Nebraska! Excelling in football, wrestling (state runner-up) and track (state champ) he joined the blackshirts linebacker room and used a RS in 24 as he continues to develop in 25! We are 42 days away til Husker Kickoff!

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

Before the FACT HQ Team Retreat in Chicago, the Accreditation Coordinators had the opportunity to tour the Blood and Marrow Transplant Program at the University of Illinois Hospital & Health Sciences System, led by FACT Board Member Dr. Nadim Mahmud. Experiencing a program firsthand was an invaluable experience, and we are sincerely grateful to @Nadim_M_Chicago for making it possible!

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

Last week, FACT’s HQ Team joined the FACT Board of Directors in Chicago, IL, for a meaningful in-person retreat. As our organization continues to expand globally, these moments to connect face-to-face are invaluable for building relationships and aligning on our shared mission.🌎🙌

Following Thursday’s Board of Directors meeting, we gathered at the Columbia Yacht Club for a special reception—celebrating both a successful year and three outstanding team members who have reached a remarkable milestone: 30 years of service!👏

🎉 Please join us in congratulating:
• Phyllis I. Warkentin, MD, Chief Medical Officer
• Linda Miller, MPA, Chief Operating Officer
• Jay Ann Witt, Business Manager
Each has played an integral role in building FACT from the ground up.🏅

FACT President Cath Bollard and CEO David Schmahl shared thoughtful reflections on FACT’s growth, achievements, and exciting future.

The second day of the retreat focused on strengthening leadership and communication—core components of any high-performing organization. The HQ Team explored strategies to foster trust, deepen collaboration, and enhance meaningful conversations that drive results. These insights will be key as we continue to deliver on our mission and maintain the highest standards in cellular therapy.🧬

We’re grateful for the opportunity to gather, reflect, and grow—together.🖇️

#FACTAccreditation #LeadershipDevelopment #TeamRetreat #CellularTherapy #QualityMatters

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

📢Press Release - June 13, 2025

FACT Represented at Distinguished Cell and Gene Therapy Roundtable Attended By HHS Secretary, FDA Commissioner, CMS Administrator

Read the full press release here📲: https://t.co/K1LI8aga9u

[Kara Wacker @WackerKara]

Looking forward to working with community providers on this important initiative.

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

📢Press Release - April 10, 2025

FACT CONVENES ‘COMMUNITY CAR T WORKING GROUP’ TO REVIEW AND PROPOSE CLINICAL ACCREDITATION STANDARDS #FACTAccreditation #CellTherapy

Read the full press release here📲: https://t.co/r1PuWnLXPR

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

📢Press Release - April 10, 2025

FACT CONVENES ‘COMMUNITY CAR T WORKING GROUP’ TO REVIEW AND PROPOSE CLINICAL ACCREDITATION STANDARDS #FACTAccreditation #CellTherapy

Read the full press release here📲: https://t.co/r1PuWnLXPR

[Kara Wacker @WackerKara]

@HuskerFootball @CoachMattRhule Happy birthday, Coach!

[Kara Wacker @WackerKara]

Dr. Phyllis Warkentin presents during the Advanced Therapies Week session titled, “New Market Models for Supply - Risk Mitigation, GPOs, and Stability of Supply” and explains FACT’s modular accreditation and readiness assessments. @FACTcelltherapy

[Kara Wacker @WackerKara]

@Carter83854638 Praying for a smooth recovery, Carter! You got this!

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

Risk-based assessments, including the use of FACT accreditation, bring efficiencies to cell starting material collection and bring therapies to patients faster. A new article provides tools for incorporating risk-based assessments into your processes: https://t.co/0KhfxJaElv

FREE ACCESS expires December 11, 2024!🗓️⏳

[Kara Wacker @WackerKara]

Risk-Based Qualification of Cellular Starting Material Collection Sites: Tools to Determine Scope of Manufacturer Audits and Reduce Duplicative Efforts - ScienceDirect https://t.co/2G3FozeNms

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

FACT and JACIE Publish the Ninth Edition Hematopoietic Cellular Therapy and Third Edition Immune Effector Cell Standards for Public Comment

Download a copy of the draft HCT and IEC Standards at: https://t.co/mJT1pLRNlp

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) have published a preliminary draft of both the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition (HCT 9 Standards)and the FACT-JACIE International Standards for Immune Effector Cells, Third Edition (IEC). These drafts are now open for public comments which will be accepted through December 15, 2024.

The objective of the FACT-JACIE HCT Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and other cellular therapies. The scope of the Standards includes but is not limited to hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use, immune effector cells (IECs), and genetically modified cells.

The objective of the FACT-JACIE IEC Standards is to promote quality medical and laboratory practice in the field of immune effector cell therapy. Immune effector cells are defined as cells, in vitro modified or not, that have differentiated or been manufactured into a form capable of modulating or effecting a specific immune response, including T cells, tumor infiltrating lymphocytes, natural killer cells, dendritic cells, and mesenchymal stromal cells. Final products include, but are not limited to, genetically modified chimeric antigen receptor T cells (CAR-T cells), CAR-NK cells, and dendritic cell vaccines. The broad designation includes cellular therapy products with widely diverse manufacturing methods, constructs, clinical indications, and safety and toxicity profiles.

The field of cellular therapy is continuously evolving, and our goal for each new edition of the Standards is to accurately capture and reflect those changes to remain a relevant and useful resource for programs. The comments, suggestions, and feedback solicited during the public comment period are not only welcome, but vital to ensuring that we achieve this goal. Participating in our public comment survey is a direct way to make your thoughts known because each comment is reviewed by the Standards Committee. Additionally, responses to the comments received during this period will be published alongside the final version of the Standards.

The review for both the HCT and IEC Standards includes multiple structural and content changes for which we are requesting specific comments. These include:
• A single collection section was created in the HCT Standards which includes apheresis, marrow, and other tissue sources. This change was introduced to reflect advances in the field and incorporate evolving cell collection types and practices.
• Standards and edits introduced to standardize practices related to Risk Evaluation and Mitigation Strategies (REMS).
• New Standards recommending a Chain of Identity Identifier (C7.1.3, C7.3.2, C7.3.5, D7.1.3, and D7.3.2) to be assigned before or at the time of collection to each collection intended for further manufacturing.
• The Standard for Processing Facility Director qualifications (Standard D3.1.1) has not changed. The committee proposed guidance to consider a pathway for people who do not possess a doctoral level degree to serve as the director.
• New audit requirements were added in Clinical, Collection, and Processing Standards 4.8.4 through 4.8.6.

The published draft includes a redlined document intended to highlight the changes made to these Standards. Minor changes to the organization or phrasing (including edits to correct or improve grammar and punctuation) of the document may not be tracked. Some of the highlighted changes are new standards; others are intended to clarify rather than change the intent of existing standards. In addition, many changes were made to harmonize the language and provide greater consistency among all sets of FACT Standards.

There are two surveys. Complete the HCT survey if your comments are related to HCT and/or IEC practice. Complete the IEC survey if your comments are related to IEC only practice. Additional instructions can be found in the surveys at: https://t.co/5E63wW2p42

There is no limit to the number of comments you can submit. This survey allows you to enter up to thirty (30) comments per section. If you wish to provide additional comments, please start a new survey.

For questions regarding the survey, please contact Monique Summers-Currington, FACT Standards Development Manager at [email protected].

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

Happy Apheresis Awareness Day! Thank you to the apheresis community and our volunteers for all that you do to support patients!🙌🧬🧑‍⚕️#AAD2024 #apheresisday2024

Celebrate five years of awareness and get involved by visiting https://t.co/qtAc0hRyOf. We highly recommend checking out the anniversary video put together by @apheresisASFA!

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

In case you missed it...Check out FACT Consulting's newest offering: Audit & Assessment Services! #FACTConsulting

🔍Learn more by attending our FREE webinar on August 23!📅
Register📲: https://t.co/TrcJcChVdZ

Request Audits Today💻 https://t.co/38Wdk57SJN

[Foundation for Accreditation of Cellular Therapy @FACTcelltherapy]

Introducing FACT Consulting Audit & Assessment Services: a win-win-win solution that reduces the audit burden on industry and sites so they can serve more patients.🏆🏥🌐 #FACTConsulting #audit

Request Audits Today💻 https://t.co/g8i4EUfnH4