IN THE NEWS
Comment Period Opens for Proposed 7th Edition of ‘Standards for Cellular Therapy Services’
The proposed draft for the seventh edition of “Standards for Cellular Therapy Services” is now available for public comment. The comment period concludes on Sept. 11. This draft edition contains many changes, including an expanded clinical activities section. Requirements for hematopoietic progenitor cells, or HPCs, cadaveric tissue and clinical activities are presented in greater detail. In addition, the Cellular Therapy Standards Program Unit, or CT SPU, has made an effort to ensure that the products covered by each standard are clearly delineated. The CT SPU encourages all interested individuals to
submit comments during the comment period. Comments and feedback may also be provided via a dedicated thread in the AABB
AABB Offers Pre-Annual Meeting Workshop Focusing on CAR T Cell Therapies
AABB and the University of Pennsylvania will be conducting a
workshop, “CAR T Cell Adoptive Therapies: Product Engineering to Clinical Outcomes,” on Oct. 24 at the Pennsylvania Convention Center, prior to the start of the 2014 AABB Annual Meeting. This all-day event will cover an introduction to T cell receptors, CAR T cell applications, CAR T cell manufacture for clinical use, CAR T technologies, needs of future therapeutic modalities, and regulatory hurdles.
Registration discounts apply to those attending the AABB Annual Meeting.
AABB Annual Meeting Registration Opens for Members and Exhibitors
Registration for the 2014 AABB Annual Meeting, to be held Oct. 25-28 in Philadelphia, is open for association members and exhibitors. This four-day event offers participants access to educational sessions on the latest research; continuing education credits; networking opportunities; social events; and exhibits featuring innovative products and services. AABB offers four
educational tracks including cellular therapies. Discounted registration rates apply for AABB members. Individuals seeking to become AABB members can do so by checking the appropriate box on the Annual Meeting registration form or by
joining online. Registration will open to the general public on July 23.
Association Unveils New Mentoring Program
AABB is developing activities for members to give back to the community through its Professional Engagement Program, or PEP. This
mentoring program is a six-month informal program that matches experienced professionals with those who are new to blood banking, transfusion medicine, patient blood management and cellular therapies. This exciting program provides opportunities to exchange information and ideas while building lasting professional networks. Mentors and mentees will be matched based on job requirements, career goals and interests. This program is for AABB members only.
To qualify for participation in this program, mentees must have less than five years of experience or have recently taken on a new assignment or responsibility. Other requirements include a desire to learn and a positive attitude toward the profession. Mentors should have at least five years of professional experience plus the willingness to help and encourage others. To apply, fill out an
application and return it to
PEP@aabb.org. For more information, email the AABB volunteer coordinator at
CTSCC Elections: Leadership Openings for Current AABB CT Section Members
Positions are available to current members of the AABB Cellular Therapy, or CT, Section who would like to seek election to the
CT Section Coordinating Committee, or CTSCC. Members who serve on the CTSCC gain the opportunity to meet other professionals in the field, provide expertise and enhance their industry knowledge by engaging members, developing professional education programs and learning tools, and facilitating the application of quality management principles. Interested CT Section members — from any CT subsection — should submit an email message by Aug. 31 to
email@example.com, stating their intention to seek election and listing
subsection areas of interest. Additionally, the email should include a photo and brief summary — no more than 250 words — that describes the member's relevant experience and potential contribution to the CTSCC. To ensure fairness, submissions exceeding the word limit will not be accepted. Those who submit information will receive an email from AABB acknowledging receipt. Names, summaries and photos of qualified candidates will be posted on the AABB Center for Cellular Therapies Web page. 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 Philadelphia this October. Individuals seeking election are not required to attend the business meeting and international participation is highly encouraged.
Survey Aims to Gauge Practices for Day-to-Day Management of Cellular Processing Laboratories
The AABB Center for Cellular Therapies
CT Management Subsection is conducting a
survey to gauge the range of practices used in the day-to-day operational management of cellular processing laboratories in the United States. Results of the survey should provide a better understanding of where participants fall along the spectrum of practice compared to their peer group based on the number of cellular therapy products manufactured. Information from the study may be useful in justifying approvals for additional personnel.
Click here to participate in the survey.
Updated Crosswalks Are Available on AHCTA Website
Alliance for Harmonisation of Cellular Therapy Accreditation, or AHCTA — composed of representatives from the different standards-setting organizations — created a series of crosswalks, which are posted on its
website. Alliance members periodically revise the crosswalks, which are categorized by specific topic areas. Updated documents addressing quality management and cell collection standards are now available. Additional documents on other topic areas will be posted as they are revised.
Clinical Case Forums Accessible to ASBMT Members
A clinical case forum, or CCF, is available to members of the American Society for Blood and Marrow Transplantation, or ASBMT. The CCF, designed for participants to share medical knowledge and improve care, has included postings of nearly 50 cases since its launch in February 2014. The site provides a listing and a review of cases by disease state category. ASBMT members have the opportunity to post cases for peer feedback. The CCF is a closed forum, accessible only to health care providers specializing in hematopoietic stem cell transplantation, or HCT. The goal is to provide access to expert opinions and foster discussion among professionals of potentially complex cases. In order to encourage open discussion, membership is restricted to HCT professionals. To view the post or submit a case, log in to
NIH Launches 3D Print Exchange
The National Institutes of Health, or NIH, has launched a new website that allows visitors to share, edit, and download 3-D print files related to health and science. The
NIH 3D Print Exchange, the result of a collaborative effort led by the NIH National Institute of Allergy and Infectious Diseases, features files that can be used to print customized lab equipment and models of bacteria and human anatomy, among many other things.
3-D printing is the creation of a physical object from a digital model, and the NIH uses the technique to study viruses, plan medical procedures, and repair and enhance lab equipment. The 3D Print Exchange also has video tutorials, a discussion forum, and tools to convert scientific and clinical data into ready-to-print 3-D files.
DSMB Approves Calimmune to Treat Second Group in HIV Stem Cell Gene Modification Study
Calimmune, a clinical-stage HIV gene medicine company focused on developing cell-based therapies for HIV,
announced encouraging safety data from its Cal-1 gene-based stem cell therapy. According to a press release dated June 25, 2014, the company “was given the green light to move ahead following a review of safety data by the Data Safety Monitoring Board (DSMB). The DSMB found none of the participants experienced any serious adverse events or dangerous side effects from the therapy. The phase I/II clinical trial focuses on a protein called CCR5 that plays a key role in enabling HIV to infect cells. Blocking CCR5 may provide the cells a protective shield against HIV, which in turn would help retain immune system functionality. In the first phase of this study, four HIV-positive participants were infused with their own blood stem cells as well as mature T cells that had been modified to carry a gene that blocks production of CCR5. The hope is that those stem cells will then create a new blood system that is resistant to HIV. The second group of three to four participants will not only get Cal-1 but will also receive a preconditioning regimen, aimed to make the therapy more effective. The goal of the trial is to assess the safety of the therapy, to determine the ease of use and feasibility of the approach for HIV/AIDS patients and to evaluate what, if any, side effects there may be.
Herpes-loaded Stem Cells Target Brain Tumors
Harvard Stem Cell Institute scientists at
Massachusetts General Hospital have a potential solution for how to more effectively destroy tumor cells using cancer-killing viruses. The investigators report that trapping virus-loaded stem cells in a gel and applying the cells to tumors significantly improved survival in mice with
glioblastoma multiforme, the most common brain tumor in human adults and also the most difficult to treat. Details of the research are published in the “Journal of the National Cancer Institute.”
Fasting Induces Immune System Regeneration
study reports the first evidence of a natural intervention triggering stem cell-based regeneration of an organ or system. Cycles of prolonged fasting not only protect against immune system damage — a major side effect of chemotherapy — but also induce immune system regeneration, shifting stem cells from a dormant state to a state of self-renewal. The study has major implications for healthier aging, in which immune system decline contributes to increased susceptibility to disease as people age. The research, published in the June 5, 2014, issue of “Cell Stem Cell” outlines how prolonged fasting cycles — periods of no food for two to four days at a time over the course of six months — eradicated older and damaged immune cells and generated new ones. The findings also have potential implications for chemotherapy tolerance and for those with a wide range of immune system deficiencies, including autoimmunity disorders.
Human Neural Stem Cells Become Neurons in Monkey Brains
A team of
scientists based in Korea and Canada who transplanted human neural stem cells, or hNSCs, into the brains of nonhuman primates report that the hNSCs had differentiated into neurons at 24 months and did not cause tumors. The hNSCs were labeled with magnetic nanoparticles to enable them to be followed by magnetic resonance imaging. The researchers, who did not use immunosuppressants, claim their study is the first to evaluate and show the long-term survival and differentiation of hNSCs without the need for immunosuppression.This research shows that hNSCs could be a key a source for cell replacement and gene transfer for the treatment of Parkinson's disease, Huntington's disease, Alzheimer's disease, amyotrophic lateral sclerosis, spinal cord injury and stroke. The
study is scheduled to be published in “Cell Transplantation.”
Guiding Cell Therapy Development: Emphasis on Ability to Characterize Products
A robust manufacturing and development plan helps guide product commercialization; however, a panel presentation at the
2014 BIO International Convention, “Targeting the End Game: Keys to Reaching Commercial Viability by Establishing the Right GMP Processes for Cell Therapy Clinical Trials from Processing to Delivery to the Patient,” concluded that there are still significant roadblocks and technical challenges that are preventing a large number of cell therapies from being commercialized. Discussed in “GEN,” Robert Preti, PhD, co-founder, president, and chief scientific officer of PCT, and one of the panelists, explained “the notion that the process is the product is one of the issues that is preventing us from getting products from the bench to the bed. The emphasis needs to be on our ability to characterize a product and to think about where that analytic development and characterization falls in a proper development scheme. There is no doubt that processes will change over time. All processes in Phase I will change by the time they go to commercial production; they will not survive.”
Generating Human Platelets from Pluripotent Stem Cells
More than 1.5 million allogeneic platelet products in the United States and about twice as many in Europe are administered each year . About 3 percent of platelet infusions are complicated by allergic reactions ranging from mild to severe . Alloimmunization to platelets as well as nonimmune reactions can result in refractoriness to further platelet transfusions . In practice, human leukocyte antigen, or HLA, matching is not routinely performed before platelet transfusions, and HLA matching for platelet refractory patients may not be the complete answer to refractoriness . With AB (universal platelet) donors representing only about 4 percent of the population, a source of platelets that do not elicit an immune response is certainly an unmet medical need.
An obvious source of manufactured platelets is the hematopoietic stem cell, or HSC, but HSCs are difficult to expand in vitro, limiting the necessary first step in generating large numbers of platelets for transfusion. As an early proof of concept model, successful generation of megakaryocyte progenitors, or MPs, from human cord blood cultures was recently reported
REGULATORY AND GOVERNMENT UPDATE
AABB Posts Summaries of Regulations in South Africa and Taiwan
New summaries describing cellular therapy-related regulations in
South Africa and
Taiwan have been added to the
AABB International Competent Authorities Web page. These summaries also include links to applicable guidelines, resources and regulations.
FDA Publishes Final Rule on Electronic Postmarketing Safety Reporting; Issues Draft Guidance to Assist With Compliance
In a “Federal Register” notice dated June 10, 2014, the Food and Drug Administration issued a final rule amending the postmarketing safety reporting regulations for human drug and biological products. The amended regulation, which is codified in Title 21 of the Code of Federal Regulations, Sections 310.305, 314.80, 314.98 and 600.80, does not apply to whole blood, whole blood components or human cellular and tissue-based products regulated solely under Section 361 of the Public Health Service Act. The rule will require mandatory reporting requirements to be submitted electronically to improve the collection and analysis of postmarketing safety reports. The amended regulation becomes effective on June 10, 2015.
To assist sponsors in complying with the amended postmarketing safety reporting regulations, the FDA — also in a June 10, 2014, “Federal Register” notice — announced a draft guidance, “Providing Submissions in Electronic Format — Postmarketing Safety Reports.” The draft guidance provides information on the content, specifications, labeling and notification of electronic submission of postmarketing safety reports. In addition, the guidance addresses how to develop individual case safety reports — or ICSRs — attachments to ICSRs, and other postmarketing safety reports. The scope of the draft guidance is limited to the same product types as the above final rule. Comments to the draft guidance should be submitted by Aug. 11, 2014.
FDA Updates and Announcements
FDA Develops a Consolidated Guidance on Expedited Programs for Serious Conditions
In a Federal Register
notice dated May 30, 2014, the FDA announced a final guidance for industry titled ‘‘Expedited Programs for Serious Conditions - Drugs and Biologics.’’ The purpose of this guidance is to provide a single resource for information on FDA’s policies and procedures related to expedited drug development and review programs. The guidance addresses the qualifying criteria and features of the following programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. These programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.
A Decade of Cellular Therapy: An Update from the U.S. National Heart, Lung, and Blood Institute-Funded Production Assistance for Cellular Therapies Program
From a National Heart, Lung and Blood Institute, or NHLBI, workshop attended by experts in cellular product manufacturing and clinical design more than a decade ago, emerged the idea that improved access to current Good Manufacturing Practice facilities, regulatory assistance and training would help to foster the transition of cellular therapies into the clinic. This idea led to the formation and eventual expansion of the NHLBI-funded Production Assistance for Cellular Therapies, or PACT, program. The goal of the PACT program was to facilitate the translation of promising therapies from the bench to the bedside; provide leadership in the field of cellular therapy; and provide education to researchers, clinicians and health care professionals in the expanding therapeutic area. D. Wood et al.
reviewed the first 10 years of PACT, which has served as a unique model and valuable resource in forging relationships among academia, industry and other institutions to advance the cellular therapy field and deliver more than 650 clinical products. The clinical roadmap, shown here, is located on the
PACT website and is accompanied with useful details.
Impact of the Affordable Care Act on Stem Cell Transplantation
The U.S. Patient Protection and Affordable Care Act, or ACA, has been discussed in a variety of forums. The law is intended to increase access to health care while reducing the overall cost of health care in the U.S. As the ACA becomes more fully implemented, it will be helpful to learn about its impact in the stem cell arena. In the January issue of
Current Hematologic Malignancy Reports, S. Farnia, et al.
reviewed the main provisions of the ACA with specific attention to their impact on the field of stem cell transplantation. The authors report that generally patients who have had or who will need a stem cell transplant should benefit from expanded access to affordable insurance options and the removal of long-standing benefit and coverage restrictions as provided under the ACA. However, there remains significant room within the law that raises other concerns regarding access that will need to be monitored for potential impact to patients and providers. In this article, S. Farnia, et al. explore specific sections of the ACA and their potential impact on patients and providers, suggesting ways in which the provider community may want to respond to the new challenges and opportunities presented by the law in order to best serve themselves and their patients.
Current Thawing and Infusion Practice of Cryopreserved Cord Blood: The Impact on Graft Quality, Recipient Safety, and Transplantation Outcomes
Methods of handling, thawing, and infusion of cord blood, or CB, products vary substantially among thaw/transplant centers, or TCs. In their
review, S. Akel, et al. 1) compare currently available CB product types and thaw methods recommended by CB banks, or CBBs, 2) discuss causes of inconsistency in thaw method application at TCs, 3) advise elements to consider in thaw method approval or selection at the TC, 4) provide a procedural template for the traditional thaw methods, and 5) suggest acceptable time from product thaw to infusion and other considerations for safe infusion. The review also compares post infusion adverse reaction and engraftment data as functions of thaw methods. Remarks and suggestions made throughout are 1) not intended to supersede manufacturer's instructions but meant to support the standardization of preparative procedures recommended by CBBs and 2) intended to help TCs to investigate relevant quality issues and handle challenges, especially when the TC is unable to follow recommendations due to foreseeable technical, quality, and/or clinical factors.
Training Practices of Hematopoietic Progenitor Cell, Apheresis and Cord Blood Collection Staff
As hematopoietic stem cell transplantation expands globally, identification of the key elements that make up high-quality training programs will become more important to optimizing collection practices and quality of the products collected. In their survey, members of the Alliance for Harmonisation of Cellular Therapy Accreditation, or
AHCTA, collected data from respondents worldwide on facility demographics, job descriptions, and the content of training programs including general practices, staff assessment, retraining, and unique program features, which may assist facilities in further developing and strengthening their own training programs. The results are reported online in “Transfusion.”
Biologic Scaffold for CNS Repair
Injury to the central nervous system, or CNS, typically results in significant morbidity. Endogenous repair mechanisms are limited in their ability to restore fully functional CNS tissue. Biologic scaffolds composed of individual purified components have been shown to facilitate functional tissue reconstruction following CNS injury. Extracellular matrix scaffolds derived from mammalian tissues retain a number of bioactive molecules, and their ability for CNS repair recently has been recognized. In addition, repairs of the dural mater, the tough outermost membrane enveloping the brain and spinal cord, are of clinical interest as the dura provides a barrier function and maintains homeostasis to CNS. In a review appearing in “Regenerative Medicine,” F. Meng, et al.
describe the application of regenerative medicine principles to the CNS tissues and dural mater repair.
Un- and Differentiated Adipose-derived Stem Cells Improve Nerve Regeneration in a Rat Model of Facial Nerve Defect
Autologous nerve grafting is the current procedure used for repairing facial nerve gaps. Tissue engineering cell-based therapy using induced pluripotent stem cells, or iPS, Schwann cells and bone marrow-derived mesenchymal stem cells has been proposed. However, these cells have problems, including tumorigenesis in iPS and invasiveness and limited tissue associated with harvesting for the other cells. Y.
Watanabe et al investigated the therapeutic potential of adipose-derived stem cells, or ASCs, which can be harvested easily and repeatedly by a minimally invasive liposuction procedure. The ASCs had characteristics of mesenchymal tissue lineages and could differentiate into Schwann-like cells that were relatively simple to isolate and expand in culture. In an in vivo study, a silicone conduit containing undifferentiated ASCs, differentiated ASCs or Schwann cells were transplanted, embedded in a collagen gel and the efficacy of repair of a 7 mm-gap in the rat facial nerve examined. Morphometric quantification analysis of regenerated facial nerves after a regeneration period of 13 weeks showed that undifferentiated ASCs, differentiated ASCs, and Schwann cells had similar potential for nerve regeneration. Furthermore, the functional recovery of facial nerve regeneration using a rat facial palsy scoring system in the three groups was close to that in autologous nerve graft positive controls. Their findings, reported in the June 1, 2014, issue of the “Journal of Tissue Engineering and Regenerative Medicine,” suggest that undifferentiated and differentiated ASCs may both have therapeutic potential in facial nerve regeneration as a source of Schwann cells in cell-based therapy performed as an alternative to autologous nerve grafts.
A 3-D Sphere Culture System Containing Functional Polymers for Large-Scale Human Pluripotent Stem Cell Production
Utilizing human pluripotent stem cells, or hPSCs, in cell-based therapy and drug discovery requires large-scale cell production. Scaling up conventional adherent cultures presents challenges of maintaining uniform high quality at low cost. Suspension cultures are a viable alternative because they are scalable and do not require adhesion surfaces. 3-D culture systems such as bioreactors can be exploited for large-scale production. However, limitations of current suspension culture methods include spontaneous fusion between cell aggregates and suboptimal passaging methods by dissociation and reaggregation. Shearing forces may damage hPSCs. T.
Otsuji et al. discuss in “Stem Cell Reports” a simple 3-D sphere culture system which may be optimal for applications involving large-scale hPSC production that incorporates mechanical passaging and functional polymers, potentially resolving issues associated with suspension culture methods and dynamic stirring systems.
Cell Nuclear Transfer and the Starbucks Effect
Scientists have taken skin cells from a woman suffering from type 1 diabetes, reprogrammed them into embryonic stem cells, and then converted those cells into insulin-producing cells in mice, according to a new study. They found that they had more luck cloning embryos when they delayed cell division after introducing the donor nucleus. Other researchers have used caffeine to delay cell division, a trick dubbed "the Starbucks effect." The authors have
reported success using histone deacetylase inhibitors, which essentially block the activity of certain enzymes. Though caffeine may have beneficial effect, it may not be the factor that alters
EVENTS, OPPORTUNITIES, RESOURCES
Stay Current with AABB Audioconferences and Webinars
Only three CT
audioconference programs remain for 2014; Upcoming CT programs include:
Surviving an FDA Inspection: GMP and GTP Considerations (#144812)NEW!
Deviation Reporting: Hematopoietic Progenitor Cells (#144825)
Top 10 Cellular Therapy Non-Conformances (#144830)
The AABB Center for Cellular Therapies offers a varied menu of topics in its
webinar series, in which experts share their knowledge and experience, answer questions from participants and provide helpful references. Economically priced for individuals, the hour-long interactive webinars consist of 45-50 minutes of presentation, followed by a 10-15 minute period for questions and answers.
CME credits are available for the live sessions. Upcoming webinars include:
3-D Printed Cellular Therapy Products: Regulatory Considerations (#1415)
Intellectual Property- Patents 101 (#1421)
Efficient Generation of Cytotoxic T Cells (#1422)
The Future Direction of the Blood Banking Industry in Regenerative Medicine (#1412)
Key Elements of Cord Blood Processing (#1423)
Computer, Software and Spreadsheet Validation Cellular Therapy Lab (#1424)
Do I Know What I Should About Patents? Webinar Spotlight
What do Thomas Edison, Abraham Lincoln, Steve McQueen, Jamie Lee Curtis, Francis Ford Coppola, George Lucas, Michael Jackson, Marlon Brando and Paula Abdul all have in common? Besides being well known public figures, each holds patents for various innovations. Some of these innovations are related to the work that made them famous, while others are offshoots of hobbies or just the result of a great idea. Do you have a great idea or believe you have developed an innovation pertaining to cells, blood, medical devices or any other technology resulting from research in your lab? If so, participate in AABB’s webinar,
Intellectual Property- Patents 101 (#1421), on Sept. 11, and
learn how you might be able to protect your idea or innovation.
Look Ahead to 2015 Call for Annual Meeting Education Program Proposals
While at the 2014 Annual Meeting, please take notes on what inspires you or what you would like to see ‘covered’ in next year’s program. It is never too early to plan for your educational sessions. The AABB Annual Meeting Education Program Unit already is
soliciting proposals for educational programs to be presented at the 2015 AABB Annual Meeting to be held in Anaheim, Calif. Consideration will be given to
proposals for both 90-minute and three-hour programs.
FOR MEMBERS ONLY
Did You Hear the Latest?
Members of the AABB Center for Cellular Therapies subsections meet regularly via teleconferences and participate in an assortment of interactive activities such as journal clubs and presentations on timely topics and challenges. They work in teams to develop tools and reference materials. The materials or “projects” produced by the subsections are located on the
AABB Center for Cellular Therapies Web page. The following is a list of recent subsection information and activities.
Asia Pacific Group, or APG: This subsection, set up to specifically accommodate members in the Asia Pacific time zones, has been expanding its discussions to bring awareness to a variety of topics including unique challenges to the region. Recent presentations on its monthly teleconferences have included “A Clean Room in the Desert” delivered by Mark Fuller, facility manager, and “Regulation vs State Laws” by Chris Goodman, MS, CEO, both at Virgin HealthCare in Doha, Qatar. The APG meets via telephone on the second Wednesday of each month at 0400 UTC (universal coordinated time). Interested individuals are encouraged to
Quality Operations Subsection: This subsection held several
presentations this quarter: Ed Brindle, manager of Quality and Regulatory Affairs (Insception Lifebank), discussed “Implementing an Electronic Document Management System-Points to Consider;” Karen Snow (ASCP)BB, CQA(ASQ), quality assurance officer (Massachusetts General Hospital) presented “Vendor Qualifications: Internal and External” and Diane Kadidlo, BS, MT(ASCP), facility director and Fran Rabe, MS,CQM(ASQ), quality assurance director (University of Minnesota) led a joint discussion on “Rapid Microbial Validation.”
CT Product Collection and Clinical Practices: Tom Spitzer, MD (Massachusetts General Hospital) presented a talk on “Bone Marrow vs Peripheral Cell Transplantation: A Changing Landscape?”
Product Manufacturing and Testing, or PMAT:
Presentations were given by subsection leader David Stroncek, MD, (National Institutes of Health) on “Isolation of CD34+ Cells With The CliniMACS Prodigy” and Vasiliki Kalodimou, PhD, (IASO Maternity Hospital, Greece) on “The Importance of Flow Cytometry in Measuring Viablity and How it Affects Thawed Cord Blood Products.” The
PMAT subsection meets the third Thursday of every month at 11:00 am ET.
Cord Blood Subsection: Merry Duffy, MT(AMT), director, Cord Blood Operations, NMDP, presented a talk on “NMDP Cord Blood Advisory Group Organization and Highlights.” Merry also attended and was joined by several of her subsection colleagues who had the opportunity to lunch and network face to face at the International Cord Blood Symposium in San Francisco, Calif., held June 6-9. Two subsections whose members attended the symposium gave mini reviews or highlights of the sessions to their members during their June teleconferences. Arun Prasath, MS, (Singapore Blood Bank) gave a review to members of the APG and Rebecca Haley, MD, (Puget Sound Blood Center) offered her summary for the members of the
Regulatory Affairs subsection. A poster on the regulatory analysis of HPC, Cord Blood Biologics License Application, or BLA, approvals was presented at the Symposium by Rafael Cassata of the AABB Center for Cellular Therapies.
CT Management: In addition to launching its
survey on Cellular Therapies Management Practices, this subsection is starting a new project on what to say on a subsection call where people do not know what to say — how to fill the silence. If you are already an AABB member, please consider contributing your input to the project and survey.
Enroll here if you are interested.