AM21-52: Financial Challenges in the Age of Cell and Gene Therapies

Oct 19, 2021 6:15pm ‐ Oct 19, 2021 7:15pm
Expiration Date: Dec 31, 2023

Credits: None available.

Cell and gene therapies offer unprecedented hope to a growing number of patients. In the treatment of refractory/relapsed malignancy, a single dose may be lifesaving. Payment models may threaten the commercial viability of these therapies. Incremental cost effectiveness analyses have supported manufacturers’ high retail prices for these agents. Payers, on the other hand, are hesitant to pay for such an expensive agent when the benefit may be enjoyed by a competitor to insurance churn. Patients are unlikely to be able to cover such high-cost therapies out of pocket. Operational challenges are also a threat to successful implementation of these therapies. Commercialization of these agents has exposed uncompensated effort throughout the procurement cycle. This session aims to highlight different perspectives on financial challenges of cell and gene therapies and prompt the investigation of innovative solutions.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Describe common financial challenges faced by academic medical centers with respect to cell and gene therapies
  • Describe common financial challenges faced by payers with respect to cell and gene therapies
  • Discuss possible solutions or future directions for cell and gene therapy payment

Moderator(s):

Speaker(s):

Disclosures

  • Robert Moravec, MD:
    Nothing to Disclose
  • Suzanne Dworsky, MBA, MT(ASCP):
    Nothing to Disclose
  • Andrew Fesnak, MD:
    Nothing to Disclose

AM21-53: Future Trends in Cell & Gene Therapy: Developments in the Field of Personalized Medicine

Oct 19, 2021 8:00pm ‐ Oct 19, 2021 9:00pm
Expiration Date: Dec 31, 2023

Credits: None available.

This session will focus on future trends in the field of Cell and Gene Therapy and Personalized Medicine. Some of the topics to be discussed include cell therapies, genetically engineered cells, and gene editing technology. Where do we see an increase in Cell & Gene Therapy and what clinical indications? What is developing in the field of personalized medicine that will bring on improvements in Healthcare and how will these improvements affect Healthcare economics? Even with the high cost of these therapies we may see a benefit financially. This session will consist of innovators in the field of Cell and Gene Therapy. Besides short presentations it will include a lively debate as to where the field is headed.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Describe new technology seen in Cell and Gene Therapy and Personalized Medicine
  • Discuss Product Development challenges in the field of Cell and Gene Therapy
  • Evaluate of Healthcare Economics of Cell and Gene Therapy

Moderator(s):

Speaker(s):

Disclosures

  • Bruce Levine, PhD:
    Consultant: Terumo; Scientific Advisory Board: Akron, Avectas, Immuneel, Immusoft, In8bio, Ori Biotech, Vycellix; Co-Founder and equity holder: Tmunity Therapeutics; Royalties: University of Pennsylvania/Novartis; Field of cell and gene therapy: Declaration of financial interest due to intellectual property and patents
  • Julie Allickson, PhD:
    Nothing to Disclose
  • Anthony Windebank, MD:
    Scientific Advisory Board: AxoMax

AM21-54: World Health Organization Programs to Develop Improved Global Transfusion Practices and Patient Safety

Oct 19, 2021 8:00pm ‐ Oct 19, 2021 9:00pm
Expiration Date: Dec 31, 2023

Credits: None available.

Patient safety is a universal challenge. World Health Organization (WHO) endorsed resolutions and launched programs to eliminate avoidable harm in healthcare and blood transfusion: 

  • Universal Health Coverage – access to affordable healthcare for all
  • Model Lists: Essential Medicines; in vitro Diagnostics including blood products and test kits – access to affordable medicines and diagnostics
  • Resolution 72.6 Global action on patient safety – Global Patient Safety Action Plan 2021-2030 includes blood transfusion.

Annually millions of patients suffer injuries or die because of unsafe and poor-quality healthcare including unsafe blood transfusion and poor practices; ±134 million adverse events occur each year due to unsafe care in hospitals in poor economics countries, causing 2.6 million deaths/year to which poor and unsafe transfusion practices contribute. The session will discuss these programs and the role of safe and evidence-based transfusion in eliminating avoidable patient harm.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Recognize the importance of the WHO resolutions and programs to develop safe and evidence-based transfusion practices to eliminate avoidable patient harm.
  • Discuss the key governance and stewardship elements needed to develop availability of a safe, and efficacious blood transfusion system.
  • Explain the role of safe blood transfusion in eliminating avoidable patient harm

Moderator(s):

Speaker(s):

Disclosures

  • Linda Barnes, DrPH, MHA, RAC:
    Full-time/Part-time Employee: X-CellSystem, Inc.
  • Cees Smit Sibinga, MD, PhD, FRCP Edin, FRCPath:
    Nothing to Disclose
  • Yetmgeta Abdella, MD, MPH:
    Nothing to Disclose

AM21-55: The Impact of Using a Smart Storage Radio Frequency Identification (RFID) System on New Platelet Guidance Implementation and Compliance

Oct 19, 2021 8:00pm ‐ Oct 19, 2021 9:00pm
Expiration Date: Dec 31, 2023

Credits: None available.

Utilizing Smart Storage RFID for manufacturing and inventory control of 48-hour Large Volume Delayed Sampling (LVDS) and Pathogen Reduced (PR) platelets as part of the new Food and Drug Administration Guidance to Industry. The session details planning, validating, and implementing a Smart Storage RFID system in the donor center and hospital. RFID allows for electronic tracking of component manufacturing time frames related LVDS and PR platelets in the donor center, as well as supports the hospital blood bank in managing multiple platelet inventories and selection of platelets for use in transfusion. The risk/cost benefit of implementing RFID includes monetary and intellectual allocation to innovation that is used in the non-pharmaceutical industry and applying this concept to manufacturing, distribution, and inventory control of blood components. Implementation requires a detailed evaluation of current processes to allow for a tailored implementation specific to each unique facility.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Evaluate the potential impact of Smart Storage RFID on platelet manufacturing strategies and hospital inventory control.
  • Discuss the regulatory aspect of manufacturing timeframes in relation to FDA Guidance to Industry with and without a Smart Storage RFID system.
  • Compare and contrast dual platelet inventory control with and without a Smart Storage RFID system.

Speaker(s):

Speaker(s):

Disclosures

  • Stephanie Kinney:
    Nothing to Disclose
  • Judith Gonzalez, BS, MLS(ASCP):
    Nothing to Disclose

AM21-56: COVID-19 Convalescent Plasma: Impact on Donation Safety and Eligibility

Oct 19, 2021 8:00pm ‐ Oct 19, 2021 9:00pm
Expiration Date: Dec 31, 2023

Credits: None available.

COVID-19 convalescent plasma (CCP) from individuals recently recovered from SARS-CoV-2 infection is an important therapeutic option for individuals at risk for severe complications from COVID-19. Ensuring donor safety is of paramount importance for collection of CCP. Common donor adverse events (DAEs) generally involve complications such as vasovagal reactions, local arm pain or hematomas, as well as reactions related to apheresis collections. Other unique aspects related to donor health in individuals recovered from COVID-19 must also be considered, including donors who have received COVID-19 Convalescent Plasma (CCP) or monoclonal antibody therapy, as well as SARS-CoV-2 vaccination post-recovery. The AABB Donor Hemovigilance Working Group will share the results from their multi-institutional study analyzing key safety metrics related to the collection of CCP. Join this session to learn about new insights on donor hemovigilance gleaned from recent efforts collecting CCP.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Identify challenges encountered by blood centers with the collection of CCP donors related to the impact of unique eligibility requirements
  • List examples of common blood center protocols to improve donation safety during the COVID-19 pandemic
  • Recognize differences in risks factors for donor adverse events (DAEs) in CCP donors compared to conventional plasma donors identified in a large multicenter study
  • Define acceptance criteria for collection of COVID-19 Convalescent Plasma (CCP) and variations between organizations screening for suitable donors

Moderator(s):

Speaker(s):

Disclosures

  • Nancy Van Buren, MD:
    Nothing to Disclose
  • Jed Gorlin, MD, MBA:
    Nothing to Disclose
  • Mary Townsend, MD:
    Consultant: Cerus: Medical Advisory Board, non-paid: Terumo

AM21-57: Stop Data Entry Errors Now!

Oct 19, 2021 8:00pm ‐ Oct 19, 2021 9:00pm
Expiration Date: Dec 31, 2023

Credits: None available.

Currently manual processes with multiple steps create opportunities for human error. As more information about units of blood components and cell therapies is needed, labels become cluttered and more difficult to read. Manual entry of information such as antigen testing is error prone and inefficient. Extensible Markup Language (XML) data transfer and 2-D labels reduce the need for manual entry. Data transfer using XML offers an opportunity for a safe and efficient long term solution to the problem. This session will review the need for improved data transfer for blood components and cell therapies. It will include a discussion of the current status of XML data transfer and 2-D barcoding as well as describe a process for implementation.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Describe how more information about donor units can be securely transferred from the donor center to the transfusion service.
  • Describe how information transfer using standardized XML messaging and 2-D labels can be implemented.
  • Define the role of XML and 2-D barcoding in preventing data entry errors

Moderator(s):

Speaker(s):

Disclosures

  • Paul Ashford, MSc CSci:
    Nothing to Disclose
  • Suzanne Butch, MLS(ASCP)SBB:
    Nothing to Disclose
  • Patricia Dahl:
    Nothing to Disclose

AM21-58: COVID-19 Convalescent Plasma Donor Recruitment, Collection, and Use

Oct 19, 2021 8:00pm ‐ Oct 19, 2021 9:00pm
Expiration Date: Dec 31, 2023

Credits: None available.

This session will explore the collection and use of COVID-19 convalescent plasma (CCP). Dr. Sachais will describe his center’s experience as a blood collection center during COVID-19 and address and describe issues with implementing a CCP program. Dr. Simon will describe the experience of plasma collection centers in the plasma consortium during COVID-19 and the implementation of a CCP collection program. Speakers will address donor recruitment and collection issues including trends across the country in CCP collection. The selection criteria for CCP donors will be discussed. Speakers will describe methods used to test donor antibody levels and describe trends in antibody decline over time. Effect of ethnicity, gender and other donor characteristics on COVID-19 antibody levels and decline will be presented. Differences in total and neutralizing antibodies will be discussed. The use and efficacy of CCP to treat COVID-19 in different patient populations will be summarized.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Discuss the advantages and disadvantages of different methodologies used in measuring COVID-19 convalescent plasma (CCP) antibody levels
  • Summarize the difference between COVID-19 overall antibody level and COVID-19 neutralizing antibody levels and which donors have better overall and/or neutralizing antibodies
  • Describe the differences in COVID-19 antibody levels in donors based upon gender, ethnicity, region, and time since infection
  • Describe the correlation between the donor's CCP antibody level and the clinical impact/outcome for the recipient.
  • Describe issues and difficulties around recruiting and retaining COVID-19 convalescent plasma donors

Moderator(s):

Speaker(s):

Disclosures

  • Amy Schmidt, MD, PhD:
    Consultant: CSL Plasma
  • Toby Simon:
    Stock Shareholder (self-managed), Full-time/Part-time Employee: CSL Plasma
  • Bruce Sachias, MD, PhD:
    Nothing to Disclose

AM21-59: Does Your Massive Transfusion Protocol Require Massive Revision?

Oct 19, 2021 8:00pm ‐ Oct 19, 2021 9:00pm
Expiration Date: Dec 31, 2023

Credits: None available.

Massive transfusion protocols (MTPs) are activated in the setting of uncontrolled hemorrhage. This session will help the audience identify potential unintended adverse medical and operational consequences of MTPs. It will begin with an engaging clinical case presentation and debrief. The 1st speaker will examine potential medical risk including: 1) misappropriate activation 2) immunohematologic complications 3) risk of transfusion-associated circulatory overload and 4) product appropriateness. The 2nd speaker will address ways to monitor and audit MTPs to find opportunities for institution-wide, patient-focused process improvement. Discussion will include: 1) what quality metrics should be captured and reviewed and 2) what is an effective quality management program that addresses communication and engages stakeholders outside of the laboratory. Last, we explore whether triggering one protocol for all patients is appropriate given the various clinical settings that require MTPs.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Describe processes that create a rigorous quality management system to support safety and sustainability of effective massive transfusion protocols and debrief massive transfusion events
  • Explain the importance of intradepartmental and interdepartmental coordination and communication in safe and effective massive resuscitation
  • Debate the extent to which massive transfusion protocols could better reflect the ideals of “personalized medicine”
  • Recognize potential medical risks associated with massive transfusion protocols

Moderator(s):

Speaker(s):

Disclosures

  • Wen Lu, MD:
    Nothing to Disclose
  • Patricia Brunker, MD, DPhil(Oxon):
    Nothing to Disclose
  • J. Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ):
    Nothing to Disclose

AM21-60: Apheresing Heartbreak: Etiology and Treatment of Antibody-Mediated Cardiac Allograft Rejection

Oct 19, 2021 8:00pm ‐ Oct 19, 2021 9:00pm
Expiration Date: Dec 31, 2023

Credits: None available.

Anti-Human Leukocyte Antigen (HLA) donor specific antibodies (DSA) and anti-Angiotensin II Receptor Type 1 (AT1R) antibodies threaten short and long-term cardiac allograft survival. In this symposium we review the role of anti-HLA DSA and anti-AT1R antibodies in acute and chronic cardiac transplant antibody-mediated (AMR) rejection. We outline antibody-mediated allograft injury mechanisms, both complement dependent and independent, and describe HLA, other DSA and AT1R antibody detection, attributes and clinical correlates. We discuss the role of apheresis in AMR informed by one of the largest cardiac rejection cohorts in the United States. We hope to harness data from this evolving field to better manage antibody-mediated allograft rejection and to ultimately improve long-term allograft outcomes.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Summarize HLA- and AT1R-antibody detection and antibody-mediated allograft injury diagnosis
  • Examine the role for apheresis in antibody-mediated allograft rejection by examining a large cohort of cardiac allograft patients
  • Describe the mechanisms of antibody-mediated cardiac allograft injury

Moderator(s):

Speaker(s):

Disclosures

  • Raymond Comenzo, MD:
    Nothing to Disclose
  • Jensyn Cone Sullivan, MD:
    Nothing to Disclose
  • Elaine Reed, PhD:
    Nothing to Disclose

AM21-61: A Blood Center Physician's Group Run Outpatient Clinic - Getting Paid for Services Rendered

Oct 19, 2021 8:00pm ‐ Oct 19, 2021 9:00pm
Expiration Date: Dec 31, 2023

Credits: None available.

Healthcare landscape challenges such as increasing medical legal concerns, sicker patients and higher patient expectations have required blood centers to redefine their current business models. An increasing number are looking to adjacent lines of business for possible synergies and new revenue streams. A physician-run clinic specializing in transfusion medicine services may be the right model for some centers. This session will explore the business and medical cases for developing an outpatient physician run transfusion medicine clinic within the confines of a blood center. The requirements for analyzing, developing, implementing and sustaining such a model will be discussed. The scope of services currently offered (e.g. therapeutic phlebotomy and outpatient therapeutic apheresis) and potential future services (e.g., preop anemia evaluation and treatment, iron deficiency evaluation and treatment and outpatient transfusion) will be evaluated on how to best meet changing needs.


To view Spanish or English subtitles, click the "CC" box in the video player.
Para ver subtítulos en español o inglés, haga clic en el cuadro "CC" en el reproductor de video.


Learning Objectives:
  • Cite the business and medical cases needed to analyze, develop, implement and sustain the clinic
  • Appraise current and projected future demands for appropriate scope of services on how they can best meet the changing needs of patients
  • Analyze whether a physician-run outpatient clinic offering transfusion medicine services is the right model for their blood center

Moderator(s):

Speaker(s):

Disclosures

  • Marisa Saint Martin, MD, ACC:
    Nothing to Disclose
  • Rita Reik, MD:
    Nothing to Disclose
  • Richard Gammon, MD:
    Nothing to Disclose