Insights: A Cerus Leadership Blog

Highlights from the Annual AABB 2020 Virtual Meeting

Even during a global pandemic, one of the most rewarding experiences within the global transfusion community is the opportunity to gather and share findings with colleagues, peers, and friends.  This fall, representatives from Cerus were excited to present data from 17 abstracts at the Annual AABB 2020 Virtual Meeting.

One of the largest scientific symposiums focused on transfusion medicine, this year’s AABB meeting theme included the “hot” topics of COVID-19 and the FDA’s Guidance for Industry on Bacterial Risk Control Strategies for Platelets, which takes effect on April 1, 2021.

The upcoming Guidance has the ability to shift the discussion across the transfusion medicine community to a more proactive and preventative approach to platelet safety, which is very much in line with the Cerus mission as well. Cerus presented several abstracts on pathogen reduction that ranged from platelet stewardship and availability to economics.

Our team captured highlights from several of Cerus’ abstracts below. To see the full list of all 17 abstracts presented, click here.

Platelet Stewardship and Availability (a sample summary)

Central to this year’s theme, Cerus sought to engage the community on several topics relevant to the FDA Guidance, including platelet availability and supply chain management:

• Optimizing US Platelet Supply by Shifting Minimum Platelet Dose, Travis Berry, Meredith Lummer
  The inclusion of lower minimum dose platelet products enables blood centers to increase platelet component availability while more effectively implementing FDA Bacterial Guidance strategies.
• Optimizing Platelet Availability and Access to a ~100% Pathogen Reduced Inventory, Tracy Collier, Vera Chrebtow, Patricia Schmidt
  A blood center’s experience with decreased platelet expiry resulting in $120,000 in savings per year when converting to a 100% pathogen reduced platelet inventory.
• Replacement of Vector-Borne Disease Deferrals by Robust Pathogen Reduction Technology: A Study Based on Pathogen Loads in Blood Donors and Inactivation Efficacy, Susan L. Stramer, Marion C. Lanteri, Bryan Spencer et al
  Significant donor retention and increased platelet availability may be attained when using pathogen reduction as an alternative to certain deferrals and donor screening strategies.

Platelets Stored for 7 Days

Abstracts highlighting in vitro studies to assess pathogen reduced platelets stored for 7 days were also presented.  Cerus continues to progress on its two-stage recovery and survival study to support its planned FDA submission for 7-day storage of INTERCEPT^®treated platelets. An FDA submission for a 7-day shelf life for platelets in both 100% plasma and 35% plasma/65% PAS is targeted for early 2021. (ClinicalTrials.gov Identifier: NCT04022889.)

• In Vitro Evaluation of Platelets Stored for 7 Days Prepared with INTERCEPT Blood System, Jamie R. Genthe, Waseem Anani, Jose A. Cancelas, et al.
  In vitro study demonstrates retained metabolic and functional properties of INTERCEPT-treated platelet components stored for 7 days.
  (The INTERCEPT Blood System for 7-day storage of platelets is not approved in the US. Clinical trials are in progress: ClinicalTrials.gov Identifier: NCT04022889.)

Economics

The economics associated with the implementation of the FDA Guidance is challenging to normalize across the various mitigation options and is under intense scrutiny in the months leading up to the compliance deadline. To address this, the Cerus team partnered with Rutgers University to provide insights on the economic impact of FDA Guidance strategies via a budget impact model for hospitals:

• Costs and Reimbursements for Bacterial Risk Control Strategies for Platelets: Results from a Hospital Budget Impact Model, Katherine M. Prioli, Jay H. Herman,
  Laura T. Pizzi
  Comparable net budget impact is shown between pathogen reduced, and large volume delayed sample tested platelet products with a hospital budget impact model.

As an extension of the Virtual Meeting, Cerus and AABB recently co-hosted an Innovation Theater webinar entitled, “Pathogen Reduction of Platelets: Hospital Perspectives on Economic Efficiencies, Pediatric Patient Safety, and Implementation.” With over 200 attendees, the webinar included the following speakers and topics:

• Laura T. Pizzi, PharmD, MPH, Director, Health Outcomes, Policy, and Economics (HOPE) Program at Rutgers University) who presented on the hospital perspective of economic and operational considerations compared to other Guidance strategies via a model developed by Rutgers University.
• Jennifer Andrews, MD, MSc, Medical Director, Blood Bank and Associate Professor of Pathology, Microbiology, and Immunology (Division of Transfusion Medicine) and Pediatrics (Division of Hematology/Oncology) who presented on the role that pathogen reduction plays in meeting the needs of hospitals to deliver timely, safe and efficacious products to pediatric patients from the perspective of a pediatric hematologist/oncologist.

Cerus’ Commitment to Blood Safety

It is well recognized worldwide that safe and available blood is critical for a functional healthcare system. We are passionate about the potential that pathogen reduction has to provide a proactive, robust, and cost-effective approach to blood safety.

As we continue to see a rise in transfusion-transmitted infections due to emerging known and unknown pathogens, coupled with the corresponding severe impact on blood availability, it is crucial that Cerus and our industry partners press forward with the innovation required to ensure that pathogen reduction can deliver a new foundational strategy for safe blood components. As always, it was a privilege to participate in this year’s AABB 2020 Virtual Meeting and to share our optimism for the future with the transfusion medicine community.

About Vera Chrebtow
Vera Chrebtow has been involved in the blood transfusion space for over 20 years and serves as the senior director of Global Marketing at Cerus, where she oversees global marketing activities in support of the geographic and portfolio expansion of the INTERCEPT Blood System. Vera brings a wealth of blood safety and healthcare experience with her, including previous work at Novartis Vaccines and Diagnostics, where she oversaw product management of the fully automated Procleix Tigris System and assays for nucleic acid technology-based (NAT) blood screening. She holds a BS in Clinical Science from San Francisco State University and an MBA in Marketing and Finance from Saint Mary’s College of California.