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AABB CellSource - October 2017

 
AN UPDATE ON CELL THERAPY NEWS FROM AABB
October 2017

IN THE NEWS

Attendees to Gather Soon for AABB Annual Meeting: A Few Highlights

Thousands of professionals in the fields of transfusion medicine, cellular therapies and patient blood management will gather in San Diego Oct. 7-10 for the 2017 AABB Annual Meeting. The event will include many activities that will appeal to veterans and first-time attendees alike, including social gatherings, networking events and education sessions. Those in the field of cellular therapies will find many sessions relevant to their interests, including “How to Make a Cellular Immunotherapy,” “Blood Components Produced in Vitro From Stem Cell Sources,” “Cleaning, Sanitization and Disinfection Best Practices for CT Laboratories,” and “Biorepositories 202.” There are also several relevant joint sessions led by AABB and other organizations, including session co-hosted with ISCT on “Pooled Human Platelet Lysate for Cell Therapies Manufacturing”; with TERMIS on developing approaches to regenerative medicine; and with ASBMT on state-of-the-art therapies involving CAR-T cells, NK cells and expanded cord blood cells. Other not-to-be-missed sessions include the CT RAP session, “Cell Therapy in the Spotlight: Up and Coming CT Technologies,” and “Solve It: Scenarios in Cellular Therapy,” where attendees discuss scenarios in roundtable format. There is a special breakfast for new AABB members and first-time meeting attendees to help them get acquainted with the meeting and the benefits of AABB membership. The full searchable program is available online.

Irving L. Weissman, Recipient of 2017 AABB Karl Landsteiner Award, to Speak at AABB Annual Meeting

The Karl Landsteiner Memorial Award and Lectureship was established to recognize a scientist whose original work resulted in an important contribution to the body of scientific knowledge. This year’s recipient is Irving L. Weissman, MD, director, Institute of Stem Cell Biology and Regenerative Medicine, Stanford University School of Medicine. Weismann developed methods to identify stem cells. Throughout his career, he has extensively researched stem cells with a focus on "the phylogeny and developmental biology of the cells that make up the blood-forming and immune system. Widely recognized as the "father of hematopoiesis," Weissman was the first to purify blood-forming stem cells in both mice and humans. His work has contributed greatly to the understanding of how a single hematopoietic stem cell can give rise to different specialized blood cells. Weissman is also a leading expert in the field of cancer stem cell biology, shedding light on the understanding of the pathogenesis of multiple human malignancies. He is known for his transgenic research growing human brain cells in mouse brains, as well. The Karl Landsteiner lecture will be held on Tuesday, Oct. 10, during the 2017 AABB Annual Meeting in San Diego. Weissman will present “Stem Cell biology, Regenerative Medicine and Cancer.” Click on his image to enjoy a brief video on stem cell therapies – “treat once for life.”

CT Booth Will Greet AABB Annual Meeting Attendees

The AABB Center for Cellular Therapies (CCT) serves as the single-service portal for cellular therapy professionals. Attendees may visit the CCT booth in AABB Central at the 2017 Annual Meeting to learn more about CT at AABB, including the AABB Cellular Therapies Certificate Program and a variety of other offerings.

"Ask the FDA & CMS/CLIA" Session Will Provide Access to FDA Representatives at AABB Annual Meeting

This popular session provides an opportunity for meeting attendees to question FDA representatives and hear about the agency's current thinking on policies, regulations, guidance documents and inspection programs relevant to the oversight of blood and cellular therapies.

AABB Annual Meeting App Available

The AABB mobile app is designed to help attendees navigate the 2017 AABB Annual Meeting. Attendees can get real-time event alerts, location updates and information on sessions, shuttle service and hotel accommodations. The app also has interactive maps to help locate exhibitors and a platform to share experiences using the hashtag #AABB17 on Facebook, Twitter and Instagram. To download the app, search for “AABB Annual Meeting 2017” in the App Store or Google Play. Visit the AABB website to learn more about the features.

September Issue of Transfusion Features Research to Be Presented at 2017 AABB Annual Meeting

Transfusion readers can find abstracts of administrative and scientific sessions to be presented at the annual meeting in the supplement to the September issue. Attendees will be able to view presentations and “Meet the Authors” at the Abstract Poster Luncheon on Saturday Oct. 7, the Plenary Session on Monday, Oct. 9 and the oral and poster presentations during each day of the meeting.

AABB Annual Meeting Attendees Eligible for Discount Registration at 16th International Cord Blood Symposium

The International Cord Blood Symposium (ICBS) is the premier event for the cord blood, cord tissue and regenerative medicine industry. The meeting brings together top experts from around the world. Individuals who attend the 2017 AABB Annual Meeting in San Diego can receive special discount pricing for the 2018 symposium by visiting the ICBS kiosk in the AABB Bookstore.

Special Rate to Meeting on the Mesa Scientific Symposium Available for AABB Annual Meeting Attendees

The AABB Center for Cellular Therapies has partnered with the Alliance for Regenerative Medicine to offer the opportunity to attend the 12th Annual Cell & Gene Meeting on the Mesa Scientific Symposium for the discounted rate of $95. Attendees must provide their own transportation to and from the event, which will be held at the Salk Institute for Biological Studies in La Jolla, Calif., on October 6. The symposium draws leading scientists, clinicians, life science business executives, patient advocates and government officials to examine and discuss the imminent scientific and ethical challenges facing cell and gene therapy research. Registration information is available online. To receive the discounted rate, AABB Annual Meeting attendees can select Industry & General Admission when registering for the Scientific Symposium and enter the code “AABB” when prompted.

AABB Annual Meeting Will Be Available on Demand

On-Demand presentations of the educational sessions at the 2017 AABB Annual Meeting are available for purchase after the meeting’s conclusion. These presentations are accessible online in slide format synchronized to the speakers’ voice. Attendees receive access to the online sessions of the presentations they attend (when available) by swiping their badges at the session. Attendees can continue learning and earning continuing education credits all year and access the sessions they missed by purchasing the full Meetings on-Demand package when they register. Those who are unable to attend the meeting can purchase the Annual Meeting on-Demand; see the website for more information.

World Cord Blood Day is Approaching; Join the Celebration on November 15

Nov. 15 is World Cord Blood Day, an initiative of Save the Cord Foundation. As an “inspiring partner,” AABB invites members to participate in the celebration by joining the discussion on social media and posting the events scheduled at their cord blood banks. Members can follow AABB on Facebook, Instagram and Twitter to discuss cord blood, share highlights of their experiences working in the field, and describe their role or interest in cord blood practice and education, not only on World Cord Blood Day, but every day. World Cord Blood Day will be marked with a free, live virtual conference on the website www.worldcordbloodday.org.

Production Assistance for Cellular Therapies (PACT) Updates

PACT is designed to assist researchers in pre-clinical studies through validation of current Good Manufacturing Practices (cGMP) methods. PACT is pleased to have issued Task Order awards to the PACT Cell Processing Facilities for several approved request-for-services applications from the time when the PACT program began accepting applications on Feb. 1. PACT will present a session, “NIH Production Assistance for Cellular Therapies (PACT): Support for Pre-clinical, IND-enabling Cell Therapy Protocols,” at the upcoming Tissue Engineering and Regenerative Medicine International Society (TERMIS) Annual Meeting on Dec. 3-6 in Charlottesville, N.C., where experts will discuss the pathway from the laboratory bench to the patient bedside. PACT also offers educational web seminars for the cell therapy community. To view and register for upcoming web seminars, visit www.pactgroup.net for details.

REGULATORY AND GOVERNMENT UPDATE

FDA Approves First CAR-T Cell Product; Releases Gene Therapy Definition

Kymriah (tisagenlecleucel) recently became the first FDA-approved CAR-T cell product. It is a genetically-modified autologous T-cell immunotherapy approved to treat pediatric and young adult patients with refractory or second or later relapsed B-cell precursor acute lymphoblastic leukemia. Since Kymriah is genetically modified, it is also the first gene therapy approved by FDA. FDA also recently defined gene therapy. Patient-derived cellular gene therapy products are “cells removed from the patient, genetically modified (often using a viral vector) and then returned to the patient.”

FDA’s Statement on Unproven Cellular Therapy Treatments

FDA Commissioner Scott Gottlieb, MD, recently released a statement on the “proper oversight of stem cell therapies and regenerative medicine.” Gottlieb commended the field of cellular therapies and discussed the potential danger of unproven therapies. The FDA will ensure that proper regulation and enforcement measures are in place to advance a framework to “establish clearer lines around when regenerative medicine products have sufficient complexity to fall under the agency’s current authority, and define an efficient process for how these products should be evaluated for safety and effectiveness. The policies will be set forth in a series of FDA guidance documents, which are the result of a public process held in recent years. The new policy will build upon the agency’s current risk-based, flexible regulatory framework. It will also serve to implement provisions of the 21st Century Cures Act related to regenerative medicine.”

FDA Provides New Tools to Aid in Development and Evaluation of Zika Virus Detection Assays

FDA released a new tool for Zika virus detection using a panel of human plasma samples. These human plasma samples come from anonymous individuals infected with Zika, West Nile or dengue viruses and can be used to aid in the “regulatory evaluation of serological tests to detect recent Zika virus infection.” Developers can contact FDA to request a panel.

FDA Requests Input on Direct-to-Consumer Broadcast Advertisements

Direct-to-Consumer (DTC) broadcast advertisements can help consumers and health care providers understand current FDA-approved treatments. To ensure they are accurate and not misleading, FDA oversees DTC advertisements for prescription drugs and biologics. FDA recently posted a request in the Federal Register requesting information and comments on DTC broadcast advertisements.

FDA Submits Work Plan and Proposed Funding Allocations for 21st Century Cures Act to Congress

FDA submitted its Work Plan and Proposed Funding Allocations of the FDA Innovation Account, required in the 21st Century Cures Act, to the U.S. Congress. The act contains various measures relevant to FDA, such as the Regenerative Medicine Advanced Therapy Designation (RMAT). According to FDA, standards for Regenerative Medicine and Regenerative Advanced Therapies “will help foster the development, evaluation, and review of regenerative medicine therapies, including with respect to the manufacturing processes and controls for such products.”

RESEARCH FOCUS

Manufacturing Cell Therapies: Paradigm Shift in Health Care

Haddock et al, via the National Academy of Medicine, discuss some of the key aspects associated with cell therapy manufacturing. Although the number of products in the clinical pipeline and on the market are currently increasing, the industry has yet to coalesce around an appropriate cell sourcing, manufacturing, and logistics and delivery model, in part due to the rapid speed at which this sector evolves. Common platforms for crosscutting tools, measurement, and functional assays and a robust logistics and supply chain have advanced the translation of various products rapidly. The authors concentrate on three main aspects of regenerative medicine manufacturing: current manufacturing models, facilities, equipment, and analytical capabilities; raw materials such as cells and ancillary materials; and quality processes.

EVENTS, OPPORTUNITIES, RESOURCES

AABB eCasts

AABB offers educational programs via eCasts — live, online interactive programs covering topics in transfusion medicine, cellular therapies and patient blood management. Registration is available for individuals and groups, and institutions can host eCasts for employees at one or more sites. Participants in group eCasts are eligible to earn continuing education credit. On-Demand recordings of eCast sessions are available for those unable to attend a live eCast. Upcoming CT eCasts include:

11/16 Facilities for Cord Blood Processing: Gowning-Cleaning Procedures (#172)

Cellular Therapies Certificate Program

The AABB Cellular Therapies Certificate Program, produced in partnership with the George Washington University, is a self-paced, online program designed for professionals interested in expanding their knowledge of cellular therapies. The program features 12 narrated modules covering scientific, operational and regulatory topics. Students who work through the modules, complete each assessment with a score of 80% or higher and fill out a program evaluation form will receive a certificate of completion. The program also provides 37 continuing education credits (CMEs).

NEW - Three-Year AABB Memberships Available

Individuals (physicians (MD), PhD, healthcare professionals, physicians in residency) who are interested in joining AABB now have the option to purchase a three-year (best value) membership. Current members will have that option at their next membership renewal.

Easy Access to Resources for AABB Members

The AABB Member Resources web page provides links to relevant news sources, educational programs, advocacy updates, networking and volunteering opportunities, and more. Visit the web page to discover new ways to build a network of colleagues, investigate opportunities for professional development and keep up with the latest advances in transfusion medicine, cellular therapies and patient blood management.

FDA Learning Portal Provides Relevant Resources

FDA’s learning portal provides information and resources related to FDA’s regulatory, product quality and safety requirements. Each section contains educational materials, such as lectures and courses, as well as web pages related to the particular topic. Topics include an FDA overview, medical products, in vitro diagnostics, biologics and other information listed by FDA organizations.

ICCBBA Booklets Give Overview of ISBT 128 Standard

ICCBBA has a variety of booklets that provide a basic overview of the ISBT 128 Standard and other related topics. Topics include an introduction on ISBT 128 for Cellular Therapy.

PEP Offers Mentoring Programs for Experienced- Early Career Professionals

AABB’s Professional Engagement Program (PEP) offers experienced professionals the opportunity to make a difference to an early career professional through its mentoring program. This informal six-month program matches experienced mentors with mentees with less than five years of experience in the fields of transfusion medicine, patient blood management and cellular therapies. Participants expand their professional network, exchange information and ideas, and build lasting friendships. PEP is looking for mentors in CT. Members interested in participating in the program may apply by completing the application. For more information, visit the PEP website.

FOR MEMBERS ONLY

The Latest on CT Subsection Activities

** The subsections will meet face-to-face at the AABB Annual Meeting.
Members may visit the AABB program for meeting details.

Asia Pacific Group (APG): This subsection accommodates members in the Asia Pacific region on the second Wednesday of each month at 0400 UTC (universal coordinated time) to discuss a variety of topics related to cellular therapies. David Jin, MD, PhD, presented “Regulatory and Industrial Landscape of Vascular Stem Cell Therapy in China.”

Regulatory Affairs: This subsection, led by Ljiljana Vasovic, MD, and Olive Sturtevant, MHP, MT(ASCP)SBB/SLS, welcomed Graham Simmons, PhD, who presented “Zika Virus Persistence and Infectivity.” This group also prepared several AABB annual meeting sessions.

CT Management: This group, led by subsection leaders Suzanne Dworsky, MBA, MT(ASCP), and Brian Jones, SBB(ASCP), discussed personnel management, focusing on issues such as position determinations, descriptions and compensation rates. The next meeting will continue the discussion on new topics, including hiring, orientation, training, and performance review, and documentation. They also worked on 2017 AABB annual meeting preparations.

Novel Therapies and CT Product Development: This subsection, led by Magali Fontaine, MD, PhD, and Richard Schaefer, MD, welcomed guest speaker, Heather Pidcoke, MD, PhD, who spoke on “Refrigerated (4oC) Platelets: New Opportunities for Improving the Care of Bleeding Patients.” Pidcoke recommended presentations by Geir Strandenes, MD, “Cold versus warm Stored Platelets in Bleeding CT Surgery Patients,” and LTC Andrew P. Cap, MD, PhD, “RDCR Blood Products Research Current-Future Directions,” presented at Traumatic Hemostasis and Oxygenation Research (THOR) for further information on this topic.

CT Quality Operations: Ed Brindle, MSc, MLT(CMLTO), and Deb Sesok-Pizzini, MD, MBA, led the group in discussion in preparation for AABB annual meeting sessions.

CT Product Collection and Clinical Practices: Subsection leaders Tom Spitzer, MD, Jay Raval, MD, and Joseph ‘Yossi’ Schwartz, MD, MPH, presented information on quality initiatives and prepared for AABB annual meeting presentations.

CT Product Manufacturing and Testing: Ronit Slotky, PhD, MSc, and Yen-Michael S. Hsu, MD, PhD, worked with the group to prepare AABB annual meeting sessions. Slotky presented “How to prepare for FDA approval of CAR-T treatment.”

Cord Blood Subsection: Subsection leaders Salem Akel, PhD, and Gwen Epstein, BSC, RT, discussed updates in AABB’s Standards For Cellular Therapies, 8th Edition. They also worked on AABB annual meeting preparations.

Spanish Language Subsection (SLS): Spanish-speaking members are encouraged to join the SLS. Celina Montemayor, MD, PhD, and Angel Guerra, MD, moderate this subsection, which is conducted entirely in Spanish. The SLS projects page showcases content that has been presented to the subsection.

 

Editor: Christina Celluzzi
Contributors: Kathy Loper

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