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AABB CellSource - October 2016

 
AN UPDATE ON CELL THERAPY NEWS FROM AABB
October 2016

IN THE NEWS

2016 AABB Annual Meeting CT Schedule at a Glance Posted

AABB is looking forward to welcoming attendees to the 2016 AABB Annual Meeting, to be held Oct. 22-25 in Orlando, Florida. For the CT professional, there are many opportunities to make the experience ”magical.” Networking and educational activities have been assembled in their own CT Schedule at a Glance. Networking events include the Friday evening Networking Reception, Sizzling Topics Luncheon on “New Frontiers in Cellular Therapy,” and the CT RAP session on “New Horizons for GvHD.” The ever-popular “Solve It! Scenarios in Cellular Therapy,” returns this year - attendees rotate to different roundtable discussions and solve real issues and challenges on a variety of topics. Educational sessions showcase not only the state of CT today but also its future. A session presented by Duane Mitchell, MD, PhD, and Joanne Kurtzberg, MD, reviews research advances that may lead to new treatments for neurological disorders; this session gives participants the opportunity to earn SAM credit. A joint AABB/TERMIS Americas program presented by James Yoo, MD, PhD describes technologies under development to treat wounded soldiers on the battlefield. Another session presented by David McKenna, MD, and Bruce Levine, PhD, addresses “blood banks’ role in T-cell immunotherapeutics.”

CT Booth Set to Greet Annual Meeting Attendees

The AABB Center for Cellular Therapies (CCT) serves as the single service portal for cellular therapy professionals. Attendees should plan to visit the CCT booth in AABB Central at the 2016 Annual Meeting where they can preview the AABB Cellular Therapies Certificate Program, produced in partnership with The George Washington University. The online program consists of 12 professionally narrated modules including videos, animations and a variety of other resources. Students who successfully complete the full program and comprehension assessments will earn a certificate. Interested individuals can sign up to receive an email notification once the program becomes available.

Tools Available for AABB Annual Meeting Planning

Tools to get the most out of the 2016 Annual Meeting come in a variety of forms. The AABB mobile app can help attendees navigate the meeting and personalize the experience. The app can be downloaded via a search for “AABB Annual Meetings” through the Apple App Store and Google Play. The app can be loaded on a single device and synced with multiple devices. Visit the AABB website to learn more about the features.

September Issue of ‘Transfusion’ Features Research to Be Presented at 2016 AABB Annual Meeting

The supplement to the September issue of “Transfusion” contains the abstracts of administrative and scientific research that will be presented at the 2016 AABB Annual Meeting. Attendees will be able to view presentations and meet presenters at the Abstract Poster Luncheon on Saturday Oct. 22, the Plenary Session on Monday Oct. 24 and the oral and poster presentations during each day of the meeting. Abstracts will also be available through the ePosters/Online Abstract System, which will remain open during and after the Annual Meeting.

AABB Seeks a Few Good Bloggers

The AABB Annual Meeting Blog is now live and providing information readers can use to navigate education sessions, networking events and other activities. Throughout the Annual Meeting, AABB staff and guests will post daily updates about sessions and activities. If you are interested in sharing your experiences as a guest blogger, contact jschweitzer@aabb.org.

CT Research Receives Majority of NBF Awards in 2016; Applications for 2017 Now Being Accepted

Three of five projects awarded funding this year by AABB’s National Blood Foundation went to recipients conducting CT research. Details of the research proposals for the CT awardees (pictured left to right: Mobin Karimi, MD, PhD; Troy Lund, MD, PhD; and Sandhya Panch, MBBS, MPH) can be found on the NBF grant recipient website. Each awardee will receive up to $75,000 to further one- or two-year research projects. The NBF has begun accepting applications for the 2017 Scientific Research Grants program. For more information, contact the NBF at +1.301.215.6552 or nbf@aabb.org. Applications are due Dec. 1, 2016. The NBF will announce 2017 grant awards in June and provide funding in early July.

New Draft Proposal for ISBT 128 Coding for MPHO Released for Comment

The ICCBBA released a “public document” for comment with the proposed ISBT 128 coding for medical products of human origin (MPHO) that use nonproprietary names. This document provides background information and details for how ISBT 128 can be used to identify MPHO with an approved international non-propietary name and/or United States adopted name. The document can be found in the Documents for Review section of the ICCBBA website. Comments can be be submitted through Nov. 20, 2016.

REGULATORY AND GOVERNMENT UPDATE

HHS Posts Final Ruling to Increase Trial Transparency on ClinicalTrials.Gov

The Department of Health and Human Services published its final rule outlining requirements for submitting clinical trials to ClinicalTrial.Gov. The new rule, effective January 18, 2017, applies to clinical trials involving drug, biological and device products regulated by the Food and Drug Administration (FDA) and expands the legal requirements for submitting registration and results information to the registry/database. A few key components of the final rule include expanding the scope of trials required to submit summary results, adding a checklist to identify the regulations in which a clinical trial is subject, and adding additional data elements for registration and summary results to be submitted to ClinicalTrials.Gov. This rule will not impact study design or metrics collected during a clinical trial. Information on the impact of the final rule can be found in this archived Final Rule Webinar Series.

Impact of Zika Virus Donor Screening Requirements on U.S. Cord Blood Supply Assessed in Survey

In July 2016, AABB, the National Marrow Donor Program/Be The Match and the Cord Blood Association launched a survey of NMDP affiliated public cord blood banks to assess the impact of FDA’s Zika virus (ZIKV) donor screening requirements on the U.S. cord blood supply. The results from 17 respondents of the survey were presented by AABB President Donna Regan, MT(ASCP)SBB at the NMDP Cord Blood Advisory Group meeting in September. These results revealed that though banks employ a variety of ways to comply with the guidance, all agree that ZIKV is and will continue to exert a negative impact on the national inventory. Based on the feedback from the Advisory Group it was determined that another survey would be sent out when FDA updates the HCT/P ZIKV guidance.

FDA Workshop and Hearings Address Regulation of HCT/Ps

FDA held a workshop on Sept. 8 to address scientific evidence regarding development of HCT/Ps subject to premarket approval. The workshop’s purpose was to provide the scientific and ethical rationale behind the cautionary approach toward regulation of these products. Experts generally agreed that some regulatory oversight of stem cell clinics is needed to protect patients from potentially dangerous and unproven stem cell therapies. However, they also recognized the extraordinary therapeutic potential of this area of research. Regulation of HCT/Ps has proven to be a controversial issue, with patients demanding access to unproven stem cell therapies and researchers raising concerns about the potential impact of regulations on innovation. Speakers presented perspectives from government agencies, academia, industry and professional societies. Speakers also addressed specific cases of severe adverse events related to unapproved therapies.

On Sept. 12-13, a 2-day public hearing gave industry and public stakeholders the opportunity to provide testimony on their views of four guidance documents. Naynesh Kamani, MD, AABB vice president for cellular therapies and research, presented comments.

RESEARCH FOCUS

New Research Findings on Cord-Blood Transplant From an Unrelated Donor

Patients with acute leukemia or myelodysplastic syndrome may need hematopoietic cell transplants. HLA-identical siblings are often unavailable as donors. Can umbilical cord blood from an unrelated donor be used successfully? New research findings are summarized in a short video appearing in the “New England Journal of Medicine.” The video is based on published research by Milano et al.

Print On-Demand Bone Could Quickly Mend Major Injuries

Researchers are creating custom bone implants that can trigger their own replacement with real bone. Jakus et al have created what they call “hyperelastic bone” that can be manufactured on demand. Research on animal models indicates that the product is almost as effective as real bone. The researchers used a promising biomaterial that can be manufactured using a 3-D printer. This video demonstrates the process and shows how in the future, a 3-D printer and special ink could be used to overcome current challenges in replacing shattered or missing bones.

A New Type of Microscope That Can Change the World

Microscopes play an important role in developing therapies and diagnosing disease. Many scientists are accustomed to traditional light microsopes that are constructed using metal and complex lenses. What if a microscope could be designed with basic functional principles yet use inexpensive material ─ and folded to fit almost anywhere? What if it could even withstand an accidental trip through the washing machine or fall from far above? In this video, Manu Prakash, MD, a recent recipient of a 2016 MacArthur Foundation Genius Award, granted for exceptional insight and potential, demonstrates his foldscope: a microscope created from paper folded like origami.

Surgeon General’s Prescription for Happiness

The United States’ Surgeon General, Vivek Murthy, MD, MBA, discusses the importance of happiness to our health. What creates happiness? Long-term happiness is driven by how we process life events. In addition to exercise, nutrition and social interaction — an untapped, unrecognized resource — gratitude is critical. Murthy suggests a 10-second gratitude exercise in which individuals reflect on those who play an important role in their lives. As the 2016 Annual Meeting approaches, CCT and the staff of CELLSOURCE would like to take this opportunity to express our gratitude to our readers, volunteers, meeting participants, and others who contribute infinitely to the CT field.

EVENTS, OPPORTUNITIES, RESOURCES

AABB CT Audioconferences and Webinars

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

Upcoming Audioconferences:
11/02 How to Develop Competency Tests for Training Programs (#164953)

The AABB HUB ─ a Place for Members to Chat

AABB’s online collaborative space, the AABB HUB, serves as a platform for members to help each other. Members of the Cellular Therapies discussion group have exchanged advice on topics including whether cord blood bags can be wrapped with plastic wrap. The start of a new Spanish Language Subsection was recently announced. The AABB HUB enables participants to ask and answer questions, share ideas and network with colleagues from around the world. If you have not yet tried it, take a peek and start connecting with your peers today.

FOR MEMBERS ONLY

 

Asia Pacific Group, or APG: This subsection discusses a variety of topics related to cord blood for members in the Asia Pacific region. APG holds teleconferences the second Wednesday of each month at 0400 UTC (universal coordinated time). Interested individuals are encouraged to enroll and participate. Recent presentations have included “Effect of Volume Reduction of CB Units Before Storage on Transplantation Outcomes: A Retrospective Analysis of Eurocord-EBMT and Netcord,” by Riccardo Saccardi, MD, and “Ethics of Hybrid Cord Blood Banking,” presented by Sudipto Bari, a PhD student in Singapore.

Regulatory Affairs: Subsection leaders Ljiljana Vasovic, MD, and Olive Sturtevant, MHP MT(ASCP)SBB/SLS, initiated discussions on an assortment of regulatory issues, including the most recent draft guidances 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 the deadlines on announcements to ensure a timely review by AABB. Past comments related to CT submitted by AABB can be found on its website.

CT Management: Subsection leaders Suzanne Dworsky, MBA, MT(ASCP), and Brian Jones, SBB(ASCP), presented a variety of topics related to efficient management of the laboratory. The most recent discussion involved “Clinical Trial Management from a Laboratory Perspective.”

Novel Therapies and CT Product Development: Subsection leaders Pampee Young, MD, PhD, and Magali Fontaine, MD, PhD, facilitated several “novel” discussions including “Meeting Regulatory Requirements When Processing Novel Cellular Therapies,” presented by Day Bangon Longomboon, PhD. The MSC Workgroup led by Richard Schaefer, MD, welcomed the FDA’s Steven R. Bauer, PhD, who presented “Stem-Cell Based Product Characterization and Regulatory Science.”

CT Quality Operations: Subsection leaders Kathy Fortune, BS, MT(ASCP), Ed Brindle, MSc, MLT(CMLTO), and Deb Sesok-Pizzini, MD, MBA, welcomed several speakers including Lizette Caballero, MLS(ASCP)CM, who presented “Improving Quality Through Effective and Timely CAPA” and Alexey Bersenev, MD, PhD who presented “Failures in CAR T-cell Product Manufacturing.”

CT Product Collection and Clinical Practices: Subsection leaders Tom Spitzer, MD, Jay Raval, MD, and Joseph ‘Yossi’ Schwartz, MD, MPH, held several journal club sessions and discussed upcoming Annual Meeting activities.

CT Product Manufacturing and Testing: Subsection leaders, Vasiliki Kalodimou, PhD, and Ronit Slotky, PhD, MSc, presented a variety of talks including “Things to Consider When Deciding How to Prepare Umbilical Cord Blood for Transplant.”

Cord Blood Subsection: Subsection leaders Salem Akel, PhD, and Gwen Epstein, BSC, RT, welcomed several speakers. Mike Halpenny, MLT(CMLTO), spoke on “CB Post Thaw Process and Testing - Challenges and Initiatives,” and Akel spoke on “The Generation of MSCs from Umbilical Cord Tissue Using Enzyme-Free Homogenization.”

Spanish Language Subsection (SLS): Members of the newly formed Spanish-speaking subsection, under the leadership of Lizette Caballero, MT(ASCP), and Angel Guerra, MD, met for the first time in September. The group welcomed guest speaker Mónica Freire, who presented information on ISBT 128. Spanish-speaking members are encouraged to join the SLS.

 

Editor: Christina Celluzzi
Contributors: Kathy Loper and Brandon Sandine

AABB Center for Cellular Therapies
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