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Marks, Peter

0000-0001-5619-4404

Mayo Clinic

Center for Biologics Evaluation and Research

Citations 5

The value of observational registry studies for the next infectious disease emergency
Senefeld, Jonathon W. , Joyner, Michael J. , Casadevall, Arturo , Joyner, Michael J , Senefeld, Jonathon W , Marks, Peter , Casadevall, Arturo

mBio | November 8, 2023 | Volume: 14 | Issue: 6 | Pages: No page available

10.1128/mbio.02565-23 Get It

ABSTRACT During infectious disease emergencies, it may be necessary to deploy new therapies without conclusive evidence for their effectiveness. During the SARS-CoV-2 pandemic, several countries used registries to track the use of COVID-19 convalescent plasma (CCP). Those registries provided evidence that CCP was effective when used early and with high titer.
Proceedings of the AABB blood center executive summit
Jones, Jefferson M. , Sher, Graham D., Bult, J. M., Carden, Bob, Stone, Leah Mendelsohn, Jones, Jefferson M. , France, Christopher R. , Marks, Peter , Winters, Jeffrey L. , Barbeau, James M.

Transfusion | September 6, 2023 | Volume: 60 | Issue: S4 | Pages: No page available

10.1111/trf.16054 Get It

AbstractAABB hosted the Blood Center Executive Summit on 20 October 2019 during the AABB Annual Meeting in San Antonio, Texas. The session was sponsored by the Commonwealth Transfusion Foundation, a nonprofit, private foundation whose mission is to inspire and champion research and education that optimizes clinical outcomes in transfusion medicine and ensures a safe and sustainable blood supply for the United States. The Summit focused on the intersection of blood centers and plasma centers. Presenters and attendees explored existing and needed data, regulatory requirements, risks and benefits of different donor models, and future direction of the plasma community and blood centers. The Summit also identified priority issues that warrant further investigation and provide opportunities to drive progress. Introductory remarks provided context for the Summit presentations. Debra BenAvram, FASAE, CAE, Chief Executive Officer, AABB (Bethesda, Maryland), noted that during the past year, she and other AABB staff have had many discussions with blood center executives on key issues and challenges. In these talks, many executives requested that AABB provide programming specifically for this member segment. The Summit is a direct result of those requests, and the AABB supports a fruitful discussion as well as important and actionable next steps. Kevin Belanger, DHS, MS, MT(ASCP)SBB, President and Chief Executive Officer of the Shepeard Community Blood Center (Evans, Georgia), observed that he and his colleagues have seen a decrease in the donor base and, at the same time, an increase in plasma centers. He also noted that the resulting discussions about competition and donor compensation have been muted. The Summit provides a forum for a broad, open discussion that can be the start of something important. As chair of the Summit planning committee, he thanked both panelists and audience members for participating. Bob Carden, Chief Executive Officer of the Commonwealth Transfusion Foundation (Richmond, Virginia), who moderated the Summit, joined BenAvram and Belanger in welcoming participants to the day's presentations. He emphasized the need for data and noted that one outcome of the day would be a list of potential research projects that could be pursued and considered for funding.
Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research priorities for ultra-rare inherited bleeding disorders
Nugent, Diane J. , Acharya, Suchitra S. , Baumann, Kimberly J., Bedrosian, Camille L. , Bialas, Rebecca, Brown, Kai , Corzo, Deya, Haidar, Amar, Hayward, Catherine P.M. , Miller, Margaret E., Nammacher, Kate, Peltier, Skye , Pruthi, Rajiv K. , Sørensen, Benny, Tarantino, Michael D. , Wolberg, Alisa S. , Menegatti, Marzia , Palla, Roberta , Peltier, Skye , Pruthi, Rajiv K , Recht, Michael , Wolberg, Alisa S , Shapiro, Amy D , Baumann, Kimberly, Corzo, Deyanira , Marks, Peter

Expert Review of Hematology | March 15, 2023 | Volume: 16 | Issue: sup1 | Pages: 55-70

10.1080/17474086.2023.2175661 Get It

Early administration of COVID‐19 convalescent plasma with high titer antibody content by live viral neutralization assay is associated with modest clinical efficacy
Huang, Yin , Villa, Carlos H. , Whitaker, Barbee , Anderson, Steven A. , Verdun, Nicole, Joyner, Michael J. , Wright, Scott, Carter, Rickey E. , Hung, Deborah T. , Homer, Mary J. , Hoffman, Corey M., Lauer, Michael S. , Wright, Scott R, Marks, Peter , Carter, Rickey E , Joyner, Michael J , Belov, Artur , Forshee, Richard A. , Eder, Anne F. , Wright, Scott R.

American Journal of Hematology | March 18, 2022 | Volume: 97 | Issue: 6 | Pages: 770-779

10.1002/ajh.26531 Get It

AbstractThe efficacy of COVID‐19 convalescent plasma (CCP) as a treatment for hospitalized patients with COVID‐19 remains somewhat controversial; however, many studies have not evaluated CCP documented to have high neutralizing antibody titer by a highly accurate assay. To evaluate the correlation of the administration of CCP with titer determined by a live viral neutralization assay with 7‐ and 28‐day death rates during hospitalization, a total of 23 118 patients receiving a single unit of CCP were stratified into two groups: those receiving high titer CCP (>250 50% inhibitory dilution, ID50; n = 13 636) or low titer CCP (≤250 ID50; n = 9482). Multivariable Cox regression was performed to assess risk factors. Non‐intubated patients who were transfused with high titer CCP showed 1.1% and 1.7% absolute reductions in overall 7‐ and 28‐day death rates, respectively, compared to those non‐intubated patients receiving low titer CCP. No benefit of CCP was observed in intubated patients. The relative benefit of high titer CCP was confirmed in multivariable Cox regression. Administration of CCP with high titer antibody content determined by live viral neutralization assay to non‐intubated patients is associated with modest clinical efficacy. Although shown to be only of modest clinical benefit, CCP may play a role in the future should viral variants develop that are not neutralized by other available therapeutics.