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AABB CellSource - July 2016

 
AN UPDATE ON CELL THERAPY NEWS FROM AABB
JULY 2016

IN THE NEWS

Opportunities to Network With CT Colleagues at Annual Meeting

The 2016 AABB Annual Meeting, to be held Oct. 22-25 in Orlando, Fla., offers a range of activities for those interested in cellular therapies. Educational sessions address the use of gene therapy to treat immunodeficiencies, combined cellular and organ transplantation, and treatments for neurological diseases. Another session highlights how clinical trials are handled in the CT lab. A joint AABB/TERMIS-AM session will cover new approaches to repairing cells, tissues and organs for clinical applications. Networking is one of the most popular benefits of attending, so start the meeting off right at the Cellular Therapy Networking Reception on Friday, Oct. 21, before the official “Opening.” Take advantage of a variety of opportunities to interact with colleagues—Solve It! Scenarios in Cellular Therapies, the Sizzling Topics Luncheon presenting “Frontiers in Cellular Therapy,” a CT Research and Progress (RAP) session and the CT Business Meeting — to catch up on everything related to CT at AABB. Register by Aug 24 to get the best discounts.

AABB Releases Proposed Standards for Cellular Therapy Services, 8th Edition for Comment

AABB has published a draft of the proposed 8th edition of Standards for Cellular Therapy Services for public comment. The Cellular Therapies Standards Program Unit encourages interested individuals to submit comments before the Wednesday, Aug. 24 deadline. In addition to full ISBT 128 implementation, the proposed changes include donor eligibility modifications for emerging viruses, and processing test requirements for non-HPC products. Comments may be submitted online.

Leadership Opportunities Available for AABB CT Section Members

The AABB CT Section Coordinating Committee (CTSCC) serves many important functions. Elected by the full CT Section membership, the highly active CTSCC works collaboratively to develop educational programs, sets priorities for the section and leads and supports its members in activities that help to expand participation in the field.

At least five positions will become available as current members complete their elected terms. CT Section members— from any CT subsection— who are interested in leading the field into the future should submit an e-mail message by Aug. 31 to celltherapy@aabb.org stating their intention to seek election and specify any subsection(s) of interest. The e-mail should include a photo and brief summary — no more than 250 words — that describes the member's relevant experience and potential contributions to the CTSCC. To ensure fairness, submissions exceeding the word limit will not be accepted. AABB will acknowledge submissions with an e-mail. Following the Aug. 31 submission deadline, CT Section members will receive voting instructions and ballot details. Election results will be announced during the CT Section Business Meeting and Luncheon at the Annual Meeting in Orlando, Fla. in October. Individuals seeking election are not required to attend the business meeting. AABB strongly encourages international participation.

AABB CCT Announces New Spanish Language Subsection

Do you speak Spanish?
The AABB Center for Cellular Therapies announces a new membership benefit for Spanish-speaking CT professionals. The Spanish Language Subsection will offer members the opportunity to network with their Spanish-speaking colleagues. Like other CT subsections, the group will meet monthly by web and conference call to discuss technical topics, hold journal clubs and develop resources for cell-processing programs in Spanish-speaking regions. The group will also work with members from developing programs in Spanish-speaking areas and help mentor them. Participation is open to all AABB individual members and enrollment is available online. Individuals who reside in a country designated as low or medium on the human development index can take advantage of the Emerging Economy E-Membership, which provides AABB membership benefits at a reduced cost.

Revised ‘Circular of Information for the Use of Cellular Therapy Products’ Posted

Tables 1A and 1B in the Minimal Requirements for Testing for Transmissible Agents in Cellular Therapy Products section of the “Circular of Information for the Use of Cellular Therapy Products, June 2016” contained an error. In the June 2016 version, MNC(A) and NC(M) for U.S. requirements and MNC(A), NC(M) and NC(WB) for EU requirements were listed in the incorrect column. This could potentially lead to confusion over the acceptable testing period for donors of these products. The July 2016 version supersedes the June 2016 version and should be replaced with the new version immediately.


New Stem Cell Guidelines Released by ISSCR

The International Society for Stem Cell Research released newly updated guidelines for stem cell research and the development of new clinical therapies. These guidelines build on widely shared principles in science that call for rigor, oversight and transparency in all areas of practice to help assure that stem cell research is conducted with scientific and ethical integrity and that new therapies are evidence-based.

ICBS Highlights Available Online

The 14th International Cord Blood Symposium covered a broad range of topics related to cord blood. Detailed articles describing some of the talks and other highlights from the meeting are available online. Members can also sign up online to receive notification when registration opens for next year’s 15th International Cord Blood Symposium.

AABB Collaborates with Other Organizations to Assess Impact of Zika Virus on Cord Blood Inventory

To assess the impact of the new Zika virus donor screening requirements on the U.S. public cord blood inventory, AABB is partnering with the National Marrow Donor Program/Be The Match, the Cord Blood Association and the Health Resources and Services Administration (HRSA) to survey public cord blood banks in the U.S. on their screening and deferral activities. Survey distribution is targeted for late July. Results of the brief survey will be shared with the cord blood community. The results may also be used to frame additional comments and feedback to FDA on its recommendations for cord blood donor screening and deferral.

REGULATORY AND GOVERNMENT UPDATE

Annual Report: Biological Product and HCT/P Deviation Reporting

The U.S. Food and Drug Administration has published its fiscal year 2015 annual summary of biological product and HCT/P deviation reports. Manufacturers of nonreproductive human cells, tissues and cellular and tissue-based products (HCT/Ps), regulated solely under section 361 of the Public Health Service (PHS) Act and 21 Code of Federal Regulations (CFR), Part 1271, are required to report any deviations in product manufacturing that impacts the safety, purity or potency of a distributed product. This annual summary presents the HCT/P deviations reported to FDA during FY15.

A total of 256 product deviations were reported in FY15, which represents a 15% reduction in product deviation reports from the previous fiscal year. For cellular HCT/Ps, the most common deviations were categorically reported in processing and processing controls. Tissue HCT/Ps' manufacturers reported the most common deviations in donor eligibility. For more information, see pages 34-36 and attachments 5, 6 and 7.

FDA Publishes Draft Agenda for Public Hearing on HCT/Ps

FDA posted a draft agenda for the public hearing on the impact of four draft guidances relating to HCT/Ps. Scheduled for Sept. 12-13 in Bethesda, Md., the hearing will present a platform for testimony from industry experts, member associations, patient advocacy groups and individuals impacted by these guidances. AABB is currently accepting comments to be considered for this hearing. Prospective comments can be submitted to regulatory@aabb.org.

RESEARCH FOCUS

3-D Bioprinting Reshaping Modern Medicine

Drawn by the promise of saving lives, healing people and commercial potential, many researchers are exploring 3-D printing and its applications in modern medicine. For example, scientists have been building experimental models for surgery and creating organoids of human cells that can be used to screen drugs. New 3-D printers enable expanded research but also lead to new scientific questions, such as how to keep the desired cells alive and associated regulatory uncertainties. Though bioprinting applications depend on solving an array of challenges, they also provide many opportunities. A video, “Printing Body Parts,” produced by the Wake Forest Institute for Regenerative Medicine, illustrates some of these opportunities.

Selling Stem Cells in the U.S.: Assessing the Direct-to-Consumer Industry

Direct-to-consumer marketing of unapproved stem cell interventions is a well-known phenomenon in countries with variable medical regulations. However, an examination by Turner and Knoepfler of internet-based marketing, described in Cell Stem Cell, revealed widespread promotion of such interventions by businesses based in the U.S. Using a variety of search terms and strategies in their examination, the researchers concluded that the pervasiveness of such commercial activity indicates a need for more oversight from regulatory agencies.

A ‘Cool’ Algorithm that Drives Optimization of Cryopreservation Protocols

Differential evolution (DE) is a method that optimizes a problem by iteratively trying to improve a candidate solution with regard to a given measure of quality. An investigation by Pollock et al describes the use of a DE algorithm to optimize cryopreservation solution compositions and cooling rates for specific cell types. The researchers combined a lymphocyte model cell type (Jurkat cells) and mesenchymal stromal cells (MSCs) with non-DMSO solutions at concentrations dictated by a DE algorithm. The investigators froze the cells at DE algorithm-dictated cooling rates and iterated the algorithm until they could identify an optimum solution composition and cooling rate. They concluded that implementing the DE algorithm may permit optimization of multicomponent freezing solutions in a rational, accelerated fashion. These findings suggest that the technique could be applied to optimize freezing conditions — which vary by cell type — with significantly fewer experiments than traditional methods.

Stem Cells May Halt Inflammation for Years in Patients with Multiple Sclerosis

Patients with multiple sclerosis (MS) treated with autologous hematopoietic stem-cell transplantation (HSCT) experienced long-term suppression of all inflammatory activity, according to new results from a multicenter, phase II trial by Atkins et al, published in “The Lancet.” The researchers recruited 24 patients with particularly aggressive forms of MS. Treatment entailed immunosuppressing patients with chemotherapy and antibodies before performing HSCT. Disease progression halted in 70 percent of the participants. One-third of participants demonstrated improvement on the Expanded Disability Status Scale in the three years following treatment. An additional one-third of patients stayed at baseline, a notable result given the aggressive nature of MS. The study followed the participants for up to 13 years. It remains unclear how the patients’ conditions may change in the years ahead, in terms of both their MS and other ailments that could arise as a result of HSCT. The researchers believe that about 5 percent of patients with MS would be eligible for the procedure and that the restrictive inclusion/exclusion criteria were a major factor in its success.

Wash Your Hands. No, Like This ─ The Yuck Factor Can Work with Cell Therapists Too!

Handwashing is critical to patient safety. A comparison of methods for applying hand sanitizer was made between a common technique recommended by the Centers for Disease Control and Prevention (CDC) and an alternative technique − that uses more steps − suggested by the World Health Organization (WHO). This video demonstrates how the commonly used CDC technique is inferior to the method suggested by WHO.

If seeing is believing, this video produced by the Henry Ford Health System will convince you to avoid the potential results of improper handwashing, otherwise known as the ‘yuck factor.’

EVENTS, OPPORTUNITIES, RESOURCES

AABB CT Audioconferences and Webinars

Information on 2016 CT audioconference and webinar programs is posted on the AABB website.

Upcoming Audioconferences:
9/28 Process Development & Challenges in Large-Scale Manufacture of MSC Therapeutics (#164952)
11/02 How to Develop Competency Tests for Training Programs (#164953)

NIH Funding Opportunities

NIH has available a portal that lists opportunities for various grants, National Institute of Allergy and Infectious Disease (NIAID) solicitations for research and development contracts, opportunities for possible future NIAID initiatives and a link to information on finding foundations and other funding sources outside NIH.

PEP Mentoring Programs for Early Career Professionals

The mentoring program from AABB’s Professional Engagement Program (PEP) offers the opportunity to make a difference to an early career professional. This informal six-month program matches experienced professionals with those who are new to the fields of transfusion medicine, patient blood management and cellular therapies. Members interested in participating in the program to expand their professional network, exchange information and ideas, and build lasting friendships may apply by completing and returning the application to PEP@aabb.org. For more information, e-mail the PEP volunteer coordinator at PEP@aabb.org.

For those curious about what mentoring entails, this popular video, “On Being a Scientist,” produced by the National Academy of Sciences, discusses the responsibilities of researchers, the importance of mentors and ethical values in science.

FOR MEMBERS ONLY

The Latest on CT Subsection Activities

“Knowing is not enough; we must apply.
Willing is not enough; we must do.”

—Goethe

Asia Pacific Group (APG): Accommodating members in the Asia Pacific time zones, this subsection discusses a variety of topics related to cord blood during teleconferences, held on the second Wednesday of each month at 0400 UTC (universal coordinated time). Interested individuals are encouraged to enroll and participate. Slides from presentations can be found on the APG subsection projects webpage. John Miller, MD, PhD, recently presented “Transplant Darwinism: Evolution of HCT.”

Regulatory Affairs: Leader Ljiljana Vasovic, MD, and Associate Leader, Olive Sturtevant, MPH MT (ASCP)SBB/SLS, led discussions on various regulatory issues, including the most recent draft guidances on HCT/Ps available for public comment. As a service to members interested in commenting on current guidance documents, AABB will accept, review and submit collective comments to the FDA. Members are encouraged to contact the AABB regulatory affairs department at regulatory@aabb.org with any comments prior to announcement deadlines to ensure a timely review by AABB. Past comments related to CT submitted by AABB can be found on its website.

CT Management: Leader, Suzanne Dworsky, MBA, MT(ASCP), and Associate Leader Brian Jones, SBB(ASCP), led discussions on a variety of topics related to efficient management of the laboratory. Topics included case studies on “LEAN Workflow and Staffing to Workload in a CT Laboratory.” Examples of job descriptions for clinical laboratory and quality specialists are posted on the subsection’s projects page.

Novel Therapies and CT Product Development: Subsection leaders Pampee Young, MD, PhD, and Magali Fontaine, MD, PhD, facilitated several “novel” discussions and journal clubs. Within this subsection, the MSC Workgroup, led by Richard Schaefer, MD, will host a representative from FDA to discuss “MSC Therapies and Potency Assay Development” during the August teleconference.

CT Quality Operations: Leaders Kathy Fortune, BS, MT(ASCP), Ed Brindle, MSc, MLT(CMLTO), and Deb Sesok-Pizzini, MD, MBA, led discussions on quality issues. This quarter included presentations by Diane Kadidlo, MT(ASCP)SBB, on “Improving Quality Through Environmental Assessments,” and Angela Yost, MT(ASCP), on “Evaluating Transient Warming Events and the Impact of Frozen Cord Blood Products.”

CT Product Collection and Clinical Practices: Subsection Leaders Tom Spitzer, MD, and Jay Raval, MD, and Associate Leader Joseph ‘Yossi’ Schwartz, MD, MPH, discussed highlights of relevant abstracts presented at the American Society for Apheresis (ASFA) Meeting. They also discussed submissions for the Solve It! Scenarios in Cellular Therapies session scheduled to take place during the upcoming 2016 AABB Annual Meeting in Orlando.

CT Product Manufacturing and Testing: Lizette Caballero, MLS(ASCP)CM, stepped down as subsection leader. The members wish to acknowledge Caballero’s stellar service to the group and welcome its new leadership. Vasiliki Kalodimou, PhD, transitioned from Associate Leader to Leader, and Ronit Slotky, PhD, was chosen as the new Associate Leader. Several topics were presented: Robert Tressler, PhD, MS, described “Public Cord Blood Banking in a Blood Center: Logistics, Quality and Research Products.” Ronit Slotky covered “How to be Better Prepared for the Next Clinical Trial (or What Should be Included on Your Clinical Trial Checklist),” and Vasiliki Kalodimou discussed “Stop Hyping Stem Cell Science Say Some Stem Cell Scientists.”

Cord Blood Subsection: This subsection, hosted by Leader Salem Akel, PhD, and Associate Leader Gwen Epstein, BSC, RT, welcomed Riccardo Saccardi, MD. Saccardi discussed “Effect of Volume Reduction of Cord Blood Units Before Storage on Transplantation Outcomes: A Retrospective Analysis of Eurocord-EBMT and Netcord.” Subsection members who attended ICBS met face-to-face in San Francisco to discuss various issues related to cord blood.

 

Editor: Christina Celluzzi
Contributors: Kathy Loper and Brandon Sandine

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