IN THE NEWS
CMS Grants AABB Deemed Status for Cellular Therapy Activities in Lieu of Agency Survey Requirements
The Centers for Medicare and Medicaid Services, or CMS, granted deemed status to AABB as an accrediting organization for two new activities, Cellular Therapy Services and Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens. AABB will have deemed status for these programs for six years. CMS may grant deeming authority to an accrediting organization if the organization’s requirements are equivalent to or more stringent than the applicable regulations of the Clinical Laboratory Improvement Amendments of 1988. Facilities accredited by a deemed accrediting organization are exempt from agency surveys to determine compliance. For AABB accredited facilities, AABB may serve as the CLIA provider for the testing performed in the accredited laboratory. Additional information about deemed status is available on the CMS website.
Call for AABB 2014 Annual Meeting Abstracts
The Call for Abstracts for the 2014 AABB Annual Meeting in Philadelphia is open. Submit abstracts online to AABB by May 7, noon ET, for consideration. Individuals will be notified by June 30 if their submitted abstracts are accepted. All accepted abstracts will be published in the September supplement to "Transfusion." Individuals with questions about the abstract submission process should contact AABB's Professional Development department.
Alliance for Regenerative Medicine Announces Introduction of Regenerative Medicine Promotion Act of 2014 in the U.S. Senate
The Alliance for Regenerative Medicine, or ARM, the national voice for regenerative medicine, announced on March 13 the introduction of the Regenerative Medicine Promotion Act of 2014 in the United States Senate and expressed appreciation for the efforts of its lead sponsors, Sens. Barbara Boxer (D-Calif.) and Mark Kirk (R-Ill.). The field of regenerative medicine is of national significance because of its acknowledged potential to cure or dramatically diminish the effects of many serious and economically burdensome conditions — including diabetes, cardiovascular and neurodegenerative disease, cancer and traumatic injury — by harnessing the restorative properties of living cells and bioactive materials. Major provisions of the bill include creation of a multi-agency Regenerative Medicine Coordinating Council within the U.S. Department of Health and Human Services, or HHS; and a call for a detailed assessment of federal activities in regenerative medicine as well as progress compared to national programs in other countries.
India is Moving to Tighten Regulations for Stem Cell Therapies
The Economic Times reports on the proposal for a license regime for stem cells in India. A committee on stem cells set up by India’s Ministry of Health and Family Welfare recently submitted a report to the Central Drugs Standard Control Organization, or CDSCO, that included a road map for regulating the use of stem cells and other cell-based therapies. The panel was formed in June last year after authorities noticed the increasing use of stem cells and related therapies by clinicians for treatment of diseases. The proposed licensing would cover stem cell banks, medical institutions conducting stem cell-related clinical trials and companies importing stem cell-based products or those who manufacture them in India. The CDSCO is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the Pharmaceuticals and Medical Devices Agency of Japan and the U.S. Food and Drug Administration, or FDA.
Harvard Researchers Define ‘Good’ Stem Cells
According to the journal “Stem Cell Reports,” Harvard Stem Cell Institute's Kevin Kit Parker, PhD, has identified 64 crucial parameters for judging stem cell derived cardiac myocytes, making it possible for scientists and pharmaceutical companies to quantitatively judge and compare the value of the countless commercially available lines of stem cells. The researchers maintain that the standards will offer the entire stem cell industry a reliable method to assess their cells, which in turn will help to establish unifying research standards— improving the industry's cell lines as well as the research quality across the board.
One Minute Stem Cell Videos Receive National Science Foundation Award
Explaining complex biological processes to the general public is an important yet tricky challenge. With all the specialized language and acronyms that scientists use, it is difficult for the non-scientist to visualize the microscopic life of cells. This is where video animation can be helpful. “Science” and the National Science Foundation presented the winners of the 2013 International Science and Engineering Visualization Challenge in a variety of categories and range of topics. Honorable mention went to a series of “StemCellShorts” that introduced basic concepts in stem cell research. Each of the three videos in the series answers a simple question about stem cells and is narrated by a prominent Canadian stem cell researcher.
U.S. FDA Approves Pluristem’s Commercial Scale Cell Manufacturing Process
Pluristem Therapeutics Inc., a developer of placenta-based cell therapies, announced that the U.S. FDA has reviewed Pluristem’s comparability studies of its PLacental eXpanded or PLX, cell products and granted approval for the company to manufacture these products in its new commercial-scale cell manufacturing facility. Scott Rodeo, MD— at the recent American Academy of Orthopedic Surgeons’ Annual Meeting — presented his preliminary research on the “Use of Human Placental-Derived Adherent Stromal Cells Improves Tendon Healing in a Preclinical Model of Tendon Injury.” He reported that: a) placental-expanded cell therapy appeared to have an early beneficial effect on tendon healing following collagenase injury in this preclinical model; b) since these cells are immunoprivileged and are expanded ex vivo, the potential for “off-the-shelf” use of this therapy is attractive relative to existing cell-based therapies; and c) additional preclinical studies are necessary to understand how these cells may affect tendon repair.
Genea Biocells Becomes the World’s Largest Provider of Human Embryonic Stem Cells
The Australian stem cell company, Genea Biocells has now become the world’s largest provider of human embryonic stem cell lines to the National Institute of Health, or NIH, Stem Cell Registry, with 52 approved lines providing material to academic and commercial researchers across the globe. The company has an inventory of lines that includes the expression of genes coding for genetic cancers, metabolic conditions, vascular diseases and eye conditions. The company's stem cell lines approved for use by the NIH were all derived in full compliance with the international ethical and regulatory standards.
Researchers Report Generating Living Brain Cells from Biobanked Alzheimer’s Tissue
Researchers at the New York Stem Cell Foundation Research Institute and the Columbia University Medical Center report in “Acta Neuropathologica Communications” that they have generated induced pluripotent stem, or iPS, cell lines from non-cryoprotected brain tissue of patients with Alzheimer's disease. The new stem cell lines will allow researchers to observe how Alzheimer's develops in the brain, potentially revealing the onset of the disease at a cellular level long before any symptoms associated with Alzheimer's are displayed. These iPS cells also could provide a platform for drug testing on cells from patients that were definitively diagnosed with the disease as well as permit scientists — for the first time — to compare “live” brain cells from Alzheimer's patients to the brain cells of other non-Alzheimer's patients.
Alzheimer’s in a Dish: Scientists Convert Skin Cells From Patients to Study This Disease
Harvard stem cell scientists have successfully converted skins cells from patients with early onset Alzheimer’s into the types of neurons that are most affected by the disease, making it possible for the first time to study this leading form of dementia in living human cells. This research also may make it possible to develop therapies more quickly and accurately than in previous models by enhancing the ability to predict which treatments will best help diagnosed patients.
Large Study Evaluates Potential for Repairing Damaged Heart Tissue With Stem Cell Treatments
A London stem cell study involving 3,000 patients in 11 European countries has commenced, and the findings may reveal whether or not stem cell treatments can cut the death rates and repair damaged tissues in individuals who have experienced a heart attack. Patients who suffer heart attacks will undergo the normal procedure of adding a stent to widen their arteries, as well as be injected with stem cells taken from their own bone marrow. This study aims to be the definitive clinical trial on stem cell efficacy in heart attack patients. Due to the broad collaboration and large data set to be gained, this trial should give a much clearer answer as to whether or not stem cells effectively heal cardiac tissue.
Researchers Study Artificial Bone Marrow for Possible Leukemia Treatment
For decades, doctors have been treating leukemia patients by transplanting stem cells from people with healthy bone marrow. Transplants can be a fairly effective treatment; however, there are not enough donors to treat every leukemia patient. Researchers are taking the first steps toward making bone marrow in a lab by culturing stem cells in a setting that mimics the natural environment of bone marrow. The researchers' goal is to create artificial bone marrow that is capable of differentiating into stem cells to treat leukemia patients.
Stem Cells as Potential Therapy for Chronic Pain
Marie Csete MD, PhD
An estimated 30.7% of Americans report chronic pain (chronic, recurrent, or long-lasting pain lasting at least 6 months) , making it an incredibly common and poorly treated disease state. Pain can be generally divided into two types: nociceptive and neuropathic. Nociceptive pain is the result of an injury (or surgery) or a lesion putting pressure on a nerve. Pain is usually proportional to the degree of injury, often responsive to opioids, and is usually time-limited—when the injury resolves so does the pain. Neuropathic pain, however, can start with an injury, but has many other causes, the pain is persistent beyond the injury resolution, is often not responsive to opioids, and may be very difficult to treat. Common neuropathic pain syndromes include diabetic neuropathy and post-herpetic neuralgia. Most pre-clinical studies using stem cells to ‘treat’ chronic pain have focused on neuropathic pain models. Read more
REGULATORY AND GOVERNMENT UPDATE
AABB Posts New Summaries About International Regulations
New summaries describing cellular therapy-related regulations in Australia and Argentina have been added to the AABB International Competent Authorities Web page. These summaries also include links to applicable guidelines, resources and regulations.
FDA Finalizes Guidance Documents on BLAs and INDs for HPC Cord Blood; AABB Summarizes Significant Changes
In a March 5 "Federal Register" notice, the U.S. FDA announced the availability of the guidance document, "Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System." FDA also announced the availability of a related guidance document, "Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System," in a separate March 5 "Federal Register" notice. The guidance documents provide recommendations to assist establishments in obtaining biologics license applications and submitting investigational new drug applications for hematopoietic progenitor cells from cord blood. The documents also finalize 2013 draft guidances of the same name. AABB has posted a comparative analysis of the significant change of these 2014 final guidance documents with the respective final guidance documents from 2009 and 2011, respectively.
AABB Submits Comments to Draft Guidances on West Nile Virus and Syphilis Testing
AABB submitted comments to the U.S. FDA on the draft guidances titled, "Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products." The draft guidance on West Nile virus testing includes the recommendation that donors of human cells, tissues and cellular- and tissue-based products, or HCT/P, be tested for West Nile virus, or WNV, by individual donor nucleic acid testing using an FDA-licensed assay. In the comments, AABB expresses support for the general requirement for testing HCT/P donors for WNV. The association also acknowledges that the recommendation is consistent with the package inserts of the two FDA-licensed donor screening assays for WNV, which are currently approved for testing individual — but not pooled — samples from HCT/P donors. However, AABB believes that the recommendation should not be restricted to testing only individual donor samples. The association suggests a revised, more flexible recommendation that leaves room for future advances in donor screening assays such as the ability to test for WNV using pooled donor samples.
Similarly, AABB submitted comments on the draft guidance on “Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis).” This draft guidance provides updated recommendations regarding testing for T. pallidum — the causative agent of syphilis. All donors of human cells, tissues and cellular- and tissue-based products, or HCT/Ps, must be tested for this infection. One recommendation states that an appropriate, FDA-licensed, approved or cleared donor screening test should be used in accordance with the manufacturer's instructions, unless an exception under 21 CFR 1271.90 applies. FDA also clarifies that the use of diagnostic tests or pre-amendment devices are no longer adequate for T. pallidum testing of HCT/P donors. In the comments, AABB expresses support for these recommendations and commends FDA for continually evaluating the status of the infectious disease testing environment and updating recommendations based on scientific developments. AABB also encourages FDA's efforts to enhance patient safety and safeguard public health by reducing the risk of transmission of relevant communicable disease agents and diseases.
Updates, Approvals, and Announcements from FDA
CBER Updates Listing of Human Cell and Tissue Product Inspection Information for 2013
Humanitarian Device Exemption Granted to Miltenyi Biotech for the CliniMACS CD34 Reagent System Read More
FDA Announces CBER Will Move to the Agency's White Oak Campus Read More
CBER Releases List of Guidance Documents Planned for CY 2014 Read More
CBER Hosts Public Workshop on "Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products" Read More
AABB CCT Regulatory Toolkit Templates Now Available to Aid With FDA Regulatory Submissions
The AABB Center for Cellular Therapies has added the final templates to its four-part regulatory resource toolkit series. The Informed Consent template is designed to assist sponsors in developing a comprehensive informed consent document for clinical trials using an investigational cellular therapy product. User instructions and samples in the Electronic Common Technical Document templates can aid in the preparation of investigational new drug and biologics license application submissions. These templates — as well as the Pre-IND Meeting Request and Briefing Package and Phase 1 Clinical Trial Protocol templates — are available for purchase in the AABB Marketplace. Each toolkit item includes templates and user instructions designed in accordance with FDA regulations and technical specifications from the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Summary and Analysis of the Impact of FDA's Unique Identification System for Medical Devices Posted
AABB posted an analysis of the U.S. FDA final rule for the unique device identification, or UDI, system, which is expected to provide better tracking, inventory management and reporting of adverse events that may occur with a medical device. The analysis describes the regulations as they apply to cellular therapies, software and other medical devices involved in blood collection. FDA is phasing in the implementation of the UDI requirements depending on the classification of the medical device.
The UDI system consists of two parts. The first component is the device identifier, or DI, the fixed portion of the overall UDI code that identifies the labeler and the specific version number or model of the medical device. The DI must be issued under a system operated by an FDA-accredited issuing agency and will be searchable in a global public database. The second component is the variable portion of the UDI known as the product identifier. The product identifier contains variable, product-specific information on the medical device such as the lot or batch number, serial number, expiration date, manufacture date and/or the cell therapy product distinct identification code. AABB's analysis of the UDI system also includes links to government and FDA resources.
HRSA Requests Nominees to Serve on the Advisory Council on Blood Stem Cell Transplantation
In a "Federal Register" notice dated March 10, the Health Resources and Services Administration, or HRSA — an agency within the United States Department of Health and Human Services, or U.S. HHS — issued a request for nominees to fill expected vacancies on the Advisory Council on Blood Stem Cell Transplantation. The council advises the secretary of HHS and the administrator of HRSA on activities and policies related to the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory Program. HRSA will consider nominations of scientific experts — in the areas of adult stem cell biology, hematology, transfusion medicine and bone marrow or cord blood transplantation — and members of the general public. The notice lists specific categories for nominees and provides additional information about the nomination package. The agency will accept nominations on a continuous basis.
AABB Submits Comments to FDA on Proposed Rule Regarding Drug and Biologic Shortages
AABB submitted comments to the U.S. FDA on the proposed rule "Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products," which aims to reduce the consequences of drug or biologic product shortages on affected patient populations. AABB's principal recommendation is that whole blood, blood components, and cellular and gene therapy products be exempt from the proposed regulations. Despite being listed as products that would be subject to the new rule, whole blood, blood components, and cellular and gene therapy products do not have a history of shortages as described for other drugs and biologicals affected by the requirements of the proposed rule. If whole blood products are included in the final regulation, AABB suggests that the FDA identify a number of whole blood units manufactured annually that will be used as the threshold for reporting. This approach is more straightforward than asking a biologics license application holder to estimate what percentage of the U.S. blood supply it is collecting. Currently, it is not possible for the application holder to know this percentage because a total U.S. collection number is not available. Since very little information is provided in the proposed rule preamble concerning cellular and gene therapy products, AABB recommends the creation of a specific guidance document if these products are included in the final regulations.
FDA Releases Draft Guidance on Analytical Procedures and Methods Validation for Drugs and Biologics
In a "Federal Register" notice dated Feb. 19, the U.S. FDA announced the availability of the draft guidance for industry, "Analytical Procedures and Methods Validation for Drugs and Biologics." The draft guidance describes how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity and potency of drug substances and drug products. The guidance, when finalized, will help biologics license application sponsors by providing strategies for validating tests for sterility, cell markers and stability as well as presenting data to support their analytical methodologies. The notice includes directions for submitting comments, which are due by May 20.
This draft guidance supersedes the 2000 draft guidance of the same name and, when finalized, will replace the 1987 guidance, "Submitting Samples and Analytical Data for Methods Validation."
FDA Issues Draft Guidance on IND Requirements for the Use of Fecal Microbiota
In a Feb. 26 "Federal Register" notice, the U.S. FDA announced the availability of the draft guidance for industry, "Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies." The document relates to investigational new drug, or IND, requirements for the use of fecal microbiota for transplantation, or FMT, to treat Clostridium difficile. The draft guidance modifies the enforcement policy originally described in a July 2013 guidance document of the same name. The 2013 guidance explains that FDA will exercise enforcement discretion of the IND requirements when physicians seeking to use FMT obtain an adequate letter of informed consent from the patient or his legally authorized representative. The enforcement discretion is limited to treatment of C. difficile that is unresponsive to standard therapies. The 2014 draft guidance includes the additional requirements that the stool is obtained from a donor known to either the patient or his licensed health care provider and the donor and stool are qualified by appropriate screening and testing. The 2014 draft guidance document, when finalized, will supersede the 2013 guidance document.
Identifying Limbal Stem Cells: Classical Concepts and New Challenges
The presence of a clear cornea is required for vision, and corneal epithelial cells play a key role. There is a long held view that corneal epithelial stem cells reside at the limbus to regulate homeostatic cell turnover and wound healing. The identification of specific markers that allow the isolation and characterization of limbal stem cells remains elusive. In their review, AW Joe and SN Yeung describe the classical concepts of limbal stem cell identity and highlight the current state of the field.
Stem Cell-Based Approaches to Red Blood Cell Production for Transfusion
Blood transfusion is a common procedure practiced throughout the world; however, many countries report a less than sufficient blood supply. Projected demographics predict an insufficient supply as early as 2050. Occasional widespread disasters and crises strain the blood supply. Transfusion of blood components such as red blood cells, or RBCs, platelets, and neutrophils are increasingly used from the same blood unit for multiple purposes and to reduce alloimmune responses. Alloimmunity, especially in patients with chronic transfusion requirements, could occur for RBCs and platelets lacking nuclei and many antigenic cell-surface molecules. Once alloimmunization occurs, such patients require RBCs from donors with a different blood group antigen combination, making it a challenge to find donors after every successive episode. Alternative blood substitutes such as synthetic oxygen carriers have so far proven unsuccessful. In their review, S Shah et al focus on current research and technologies that permit RBC production ex vivo from hematopoietic stem cells, pluripotent stem cells and immortalized erythroid precursors.
Generating Replacement Cartilage with Gene Delivery Methods
Duke University researchers claim to have moved a step closer to being able to generate replacement cartilage where it is needed in the body by combining a synthetic scaffolding material with gene delivery methods. Initiating tissue repair with stem cells usually requires the use of large amounts of growth factors. This is expensive and can be challenging once the developing material is implanted within a body. In a new study published in PNAS titled, “Scaffold-mediated Lentiviral Transduction for Functional Tissue Engineering of Cartilage,” the Duke team found a way around this limitation by genetically altering the stem cells to make the necessary growth factors all on their own.
Cord Blood a Major Topic in ‘Transfusion’
The March printed edition of “Transfusion” has several articles devoted to different topics focusing on cord blood. National Marrow Donor Program’s M. Boo, JD, presents an editorial on the “Current Challenges for Public Cord Blood Banks.” Research submissions include the minimum number of cord blood units for transplantation in Korea; remobilization of hematopoietic stem cells in patients with non-Hodgkin’s lymphoma and multiple myeloma after failure to mobilize with chemotherapy and cytokines; successful cord blood transplantation after repeated transfusion of unmobilized neutrophils; a new system for quality control in hematopoietic progenitor units before reinfusion in autologous transplant; effects of cryopreservation on microbial-contaminated cord blood; discordant CD34+ cell results: implications for clinical decisions; factors affecting cord blood stem cell suitability for transplantation in an in utero collection program; and optimization of microbial screening for cord blood.
EVENTS, OPPORTUNITIES, RESOURCES
Stay Current with AABB Audioconferences and Webinars
The complete 2014 audioconference schedule is posted on the AABB website. Upcoming CT programs include:
04/23 Impact of the Affordable Care Act on Stem Cell Transplants* (#144800)
06/04 Confronting Cellular Therapy LEAN Management Issues* (#144816)
08/20 Surviving an FDA Inspection: GMP and GTP Considerations* (#144812)
09/17 Deviation Reporting: Hematopoietic Progenitor Cells* (#144825)
11/19 Top 10 Cellular Therapy Non-Conformances* (#144830)
The AABB Center for Cellular Therapies offers a variety of topics in its webinar series where experts share their knowledge and experience, answer questions from participants and provide valuable resources. 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:
05/08 3D Printed Cellular Therapy Products: Regulatory Considerations (#1415)
05/15 Basic Statistics for Cellular Therapy Products (#1410)
05/22 Extracorporeal Photophoresis in Children (#1416)
06/19 The Importance of Internal Audits (Asia Pacific Time Zone Webinar) (#1417)
07/17 Engaging PowerPoint Presentations: Design to Presentation (#1418)
08/07 Hematopoietic Stem Cells: Understanding Clonal Expansion (#1419)
09/11 Intellectual Property - Patents 101 (#1421)
10/02 Efficient Generation of Cytotoxic T Cells (#1422)
10/07 The Future Direction of the Blood Banking Industry in Regenerative Medicine (#1412)
11/20 Key Elements of Cord Blood Processing (#1423)
12/16 Computer, Software and Spreadsheet Validation Cellular Therapy Lab (#1424)
Spotlight on September Webinar: Intellectual Property - Patents 101
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, please join us on the webinar Intellectual Property- Patents 101 (#1421) September 11 to learn how you might be able to protect your idea or innovation.
Education on Demand
Recorded versions of the webinars are available through the AABB Marketplace.
Recordings of past audioconferences on topics in cellular therapies are available through the Live Learning Center.
The AABB Center for Cellular Therapies offers a directory of training opportunities as a member benefit. This resource is designed for members interested in various training opportunities in Cellular Therapies offered by member institutions. Listings include patient care, clinical programs and practical laboratory and quality activities. Structured classroom courses are not included. If your facility has a training program that you would like to see included in the directory, you are invited to complete the submission form. The information will be evaluated for posting to the directory. AABB reserves the right to verify, decline or remove postings. Preference will be given to AABB accredited facilities.
ISBT 128 Validation and Implementation Guides Available
New versions of CT validation and implementation guides on cellular therapy terminology are available on the ICCBBA website. The AABB Center for Cellular Therapies website also includes information on ISBT 128 for cell therapy.
AABB Center for Cellular Therapies Leads Regenerative Medicine Foundation Panel
The Regenerative Medicine Foundation will hold its Annual Conference, REGMEDCON, in San Francisco May 5-7. The AABB Center for Cellular Therapies, or CCT, and the Regenerative Medicine Foundation will be presenting a joint session on “Leveraging Standards to Expedite Clinical Product Delivery and Biobanking Services.” The moderator of the session, AABB CCT Division Director, Naynesh R. Kamani, MD, will be joined by other participants including Morey Kraus, chief scientific officer, PerkinElmer; Robert Preti, PhD, president and chief scientific officer, PCT; Uplaksh Kumar, PhD, MBA, chief operations officer, RoosterBio; and Julie Allickson, PhD, director, Translational Research, Wake Forest Institute for Regenerative Medicine.
International Cord Blood Symposium June 5-7
At its annual symposium to be held in San Francisco, June 5-7, the Cord Blood Forum and its contributing partners will bring together the leaders and experts in the areas of stem cell transplantation, regenerative medicine, cellular therapies and cord blood banking. This year the AABB Center for Cellular Therapies is proud to participate as a contributing partner and also will be hosting an “Ask the Assessor” opportunity during the conference. Visit the International Cord Blood Forum Symposium website for registration, scientific program and other information, and plan to stop by the AABB booth with your accreditation questions.
PACT-Sponsored Educational Web Seminar May 8
Registration is now open for the PACT web seminar “Scaling up Cell Culture: Application of Closed Cell Culture Systems in Clinical Research.” Information is available through the PACT seminar site.
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 website. The following is a list of recent subsection information and activities.
Asia Pacific Group: Members located in the Asia-Pacific Region now have available a subsection specifically to allow fellow group members to participate on teleconferences at more convenient times for the region. The group meets via telephone on the second Wednesday of each month at 0400 UTC (universal coordinated time). Interested individuals are encouraged to enroll.
Quality Operations Subsection: This subsection held several presentations this quarter: Pat Distler, MS, MT(ASCP)SBB (ICCBBA) discussed “ISBT and European Coding System” and Sharon Tindle, MS (Mount Sinai Hospital) led a discussion on “Audits for Cellular Therapy Collection and Processing Facilities.”
Regulatory Affairs Subsection: Fran Rabe, MS, CQM(ASQ), the subsection leader, led a lively discussion on “FDA Untitled Letters and Warning Letters.” Karen Whilden, MT(ASCP)SBB, CQA(ASQ) (AABB’s Accreditation department) discussed common “Non-Conformances for the AABB Standards for Cellular Therapy Services 6th Edition.”
Product Manufacturing and Testing (PMAT): This subsection assumed different leadership with David Stroncek, MD (National Institutes of Health) and Vasiliki Kalodimou, PhD (IASO Maternity Hospital, Athens, Greece) as its leader and associate leader, respectively. It also changed its meeting time to make the subsection teleconferences accessible to more of its members. The PMAT subsection now meets the third Thursday of every month at 11:00 am ET.