Please note: AABB reserves the right to make updates to this program.
Wednesday, April 12, 2023
2:00 – 3:00 PM Eastern Time
Program Number: 23EL-822
Director: Indira Guleria, PhD Diplomate (ABHI), Associate Director, HLA Tissue Typing Laboratory, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
Moderator: Andrew Fesnak, MD, Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
A broad variety of cell types are being utilized as therapeutics in the cellular therapy field. The most commonly used cellular therapy products (CTP) are stem cells and T cells. Full characterization of CTP requires that cell analytics such as - cell identity, cell viability, cell purity and cell potency be assessed for the product to be safe and effective. The program faculty will describe the current characterization strategies and analytical tools that cellular therapy laboratories and manufacturers use to measure identity, viability, purity and potency of CTPs along with the benefits and limitations of each of these methodologies.
Discussion on product release criteria as to what CTP characterization should be obtained before a cellular therapy product may leave the control of the collection or processing facility will also be part of this program. This includes assessment of all the cell attributes as mentioned above and in addition includes sterility testing and stability testing. This program will also cover future opportunities and techniques on the horizon for more in-depth and automated monitoring of cell analytics.
After participating in this educational activity, participants should be able to:
Registration includes access to both the live and on-demand version of this eCast.
If you are a facility interested in participating in this eCast, simply complete the Group Viewing registration form and AABB will provide detailed instructions to share with your team approximately one week prior to the live program (each team member to register for the program utilizing a promocode). For single viewers, simply click on the Register button below to register.
Please note: registration for the live eCast will close 1 hour prior to the eCast start time. If you register after this time you will receive access to the on-demand eCast when it is available.
This activity is eligible for one (1) continuing education credit/contact hour for Physicians, Nurses (including California-based nursing professionals through CBRN), California Lab Personnel, Florida Lab Personnel and General Participation credit. AABB reserves the right to reduce or increase the number of credits granted based on the final activity duration. For more information on each credit type please visit our Continuing Education Credits webpage.
There is no financial support for this activity.
In support of improving patient care, this activity has been planned and implemented by the Association for the Advancement of Blood & Biotherapies (AABB) and CME Outfitters, LLC. CME Outfitters LLC. is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physicians (ACCME): CME Outfitters, LLC, designates this live activity for a maximum of one (1) AMA PRA Category 1 CreditTM. CME Outfitters, LLC, designates this enduring activity for a maximum of one (1) AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Live Activity - Upon completion of the live activity, you will receive instructions to complete your evaluation, which is necessary to claim credit and receive your certificate of attendance/completion (credit must be claimed by the date provided in the instructions). The evaluation can be found by logging into the AABB Education Platform.
Enduring Activity - Once the enduring (on-demand) program is available, you will receive instructions to access the AABB Education Platform. Upon completion of viewing the enduring activity, you will need to complete the evaluation, which is necessary to claim credit and receive your certificate of completion (credit must be claimed by the date provided in the AABB Education Platform).
Program & Credit Expiration Dates:
It is the policy of CME Outfitters, LLC, and the Association for the Advancement of Blood & Biotherapies to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. CME Outfitters, LLC, has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that the presence of such relationships will have a negative impact on the presentations.
Disclosures for the planners of this event can be found here. Disclosures for the program faculty, peer reviewers, and CME Outfitters, LLC. personnel are provided at the beginning of the program.
Dr. Asawari (Asa) Bapat is a Medical Doctor with specialization in Clinical pathology, (Transfusion, Transplants, Lab Medicine and Immunology). She has 20 years of Leadership experience as Medical Director, PI and Vice-President in USA, UAE, India and Australia, managing and supervising, complex diagnostic labs, facilities for regenerative medicine, gene and cellular therapy companies, and designing successful clinical trials towards success. She has been piloting and managing international teams during complex technology transfers including evaluations, regulatory guidelines and risk analysis. Through her network, Asa has built strong relationships and has optimized successful collaborations, business developments and associations efficiently.
Dr. Andrew Fesnak serves as the Director of the Hematopoietic Stem Cell Laboratory and as an attending physician, Division of Transfusion Medicine, Department of Pathology and Laboratory Medicine at the Hospital of the University of Pennsylvania. He also serves as the Associate Director, ITMAT Education at the Institute for Translational Medicine and Therapeutics, Perelman School of Medicine, University of Pennsylvania. Dr. Fesnak is also the Deputy Director of Clinical Cell and Vaccine Production Facility at the University of Pennsylvania.
Dr. Indira Guleria is Associate Director of HLA laboratory at Brigham and Women’s Hospital and is Assistant Professor of Medicine at Harvard Medical School. Dr. Guleria obtained her PhD in Immunology from National Institute of Immunology in India followed by postdoctoral fellowship at Albert Einstein College of Medicine. Dr. Guleria’s primary research involves studying the mechanisms of transplant tolerance with a focus on the role of various costimulatory molecules in the rejection of, or tolerance to allograft. She has also made original and significant contributions to the field of immunobiology of solid and stem cell transplantation and has been part of the multi-disciplinary team facilitating stem cell transplants at the Dana Farber Cancer Institute. In addition to her research and administrative responsibilities, Dr. Guleria has been a leader in providing education to fellows, residents, and faculty and has helped develop professional educational programs and learning tools such as regular lectures, simple and complex case presentations, boot camps, and wet workshops to enhance knowledge, skill, abilities, and competency of the participants.