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Author Details

Peter W Marks
Center for Biologics Evaluation and Research
1988
81
28
PMIDPaper TitleJournal TitlePublished Year
36484995Urgent Need for Next-Generation COVID-19 Vaccines.JAMA2023
37642154HIV risk behavior profiles among men who have sex with men interested in donating blood: Findings from the Assessing Donor Variability and New Concepts in Eligibility study.Transfusion2023
37325963Synergistic Strategies to Accelerate the Development of Function-Promoting Therapies: Lessons From Operation Warp Speed and Oncology Drug Development.J Gerontol A Biol Sci Med Sci2023
37324525Benefit-risk assessment of Covid-19 vaccine, MRNA (MRNA-1273) for males age 18-64 years.Vaccine X2023
36971288End of a Declared Public Health Emergency - Implications for U.S. Emergency Use Authorizations.N Engl J Med2023
37435958Lessons From COVID-19 for Pandemic Preparedness: Proceedings From a Multistakeholder Think Tank.Clin Infect Dis2023
36696486Biological therapies need definitive randomized controlled clinical trials.Sci Transl Med2023
36920862Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research priorities for ultra-rare inherited bleeding disorders.Expert Rev Hematol2023
36786604High-Throughput Neutralization and Serology Assays Reveal Correlated but Highly Variable Humoral Immune Responses in a Large Population of Individuals Infected with SARS-CoV-2 in the US between March and August 2020.mBio2023
36803214COVID-19 vaccines: the start of a new era in regulation?Expert Rev Vaccines2023
36730407The NIH-led research response to COVID-19.Science2023
35303377Early administration of COVID-19 convalescent plasma with high titer antibody content by live viral neutralization assay is associated with modest clinical efficacy.Am J Hematol2022
35499853COVID-19 Vaccination-Becoming Part of the New Normal.JAMA2022
35370016Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16-29 years.Vaccine2022
32495492The critical need for postmarketing surveillance in gene therapy for haemophilia.Haemophilia2021
33851175Program and patient characteristics for the United States Expanded Access Program to COVID-19 convalescent plasma.medRxiv2021
33523609Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19.N Engl J Med2021
34928960Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study.PLoS Med2021
34377737Evidence generation and reproducibility in cell and gene therapy research: A call to action.Mol Ther Methods Clin Dev2021
34568831Scalable Manufacturing of CAR T cells for Cancer Immunotherapy.Blood Cancer Discov2021
34711974What regulators must learn from COVID-19.Nat Med2021
33427035Safe and Effective <i>In Vivo</i> Targeting and Gene Editing in Hematopoietic Stem Cells: Strategies for Accelerating Development.Hum Gene Ther2021
32242078Toward a new framework for the development of individualized therapies.Gene Ther2021
32727913Scientific considerations for global drug development.Sci Transl Med2020
32861333Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients.Mayo Clin Proc2020
32629463Identifying the Risks of Unproven Regenerative Medicine Therapies.JAMA2020
32766736Unwavering Regulatory Safeguards for COVID-19 Vaccines.JAMA2020
31218709Toward universal pathogen reduction of the blood supply (Conference Report, p. 3002).Transfusion2019
31328862The FDA's Regulatory Framework for Chimeric Antigen Receptor-T Cell Therapies.Clin Transl Sci2019
31608932A novel lethal recognizable polymicrogyric syndrome caused by ATP1A2 homozygous truncating variants.Brain2019
31597016Drug Regulation in the Era of Individualized Therapies.N Engl J Med2019
29514023Balancing Safety and Innovation for Cell-Based Regenerative Medicine.N Engl J Med2018
27959704Clarifying Stem-Cell Therapy's Benefits and Risks.N Engl J Med2017
28406277The Blood Supply and Men Who Have Sex with Men.N Engl J Med2017
28345226Decision making in the face of uncertainty: the challenge of emerging infectious diseases.Transfusion2017
29267913Clinical Development Strategies and Considerations for Zika Vaccine Licensure.J Infect Dis2017
26765975Modeling complete removal of risk assessment questions in the USA predicts the risk of HIV exposure in blood recipients could increase despite the use of nucleic acid testing.Vox Sang2016
27974039Transforming Evidence Generation to Support Health and Health Care Decisions.N Engl J Med2016
27959688Real-World Evidence - What Is It and What Can It Tell Us?N Engl J Med2016
27337368Screening of Blood Donations for Zika Virus Infection - Puerto Rico, April 3-June 11, 2016.MMWR Morb Mortal Wkly Rep2016
26962237Maintaining a Safe Blood Supply in an Era of Emerging Pathogens.J Infect Dis2016
24722624Update in hematology and oncology: evidence published in 2013.Ann Intern Med2014
23953338Hematologic manifestations of liver disease.Semin Hematol2013
22369322Decitabine for acute myeloid leukemia.Expert Rev Anticancer Ther2012
23074233Relapsing and remitting severe hypoglycemia due to a monoclonal anti-insulin antibody heralding a case of multiple myeloma.J Clin Endocrinol Metab2012
22859709Iron out for nontransfused thalassemia.Blood2012
22459128Treatment-related myelodysplasia in patients with primary brain tumors.Neuro Oncol2012
20626616WAG-F8(m1Ycb) rats harboring a factor VIII gene mutation provide a new animal model for hemophilia A.J Thromb Haemost2010
20930085Gemtuzumab ozogamicin: is there room for salvage?Blood2010
19186284Coagulation disorders in the ICU.Clin Chest Med2009
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Collaborators

Nicole Verdun
Center for Biologics Evaluation and Research
Co-authored papers 6
Rickey E Carter
Mayo Clinic
Co-authored papers 5
Michael J Joyner
Mayo Clinic
Co-authored papers 5
R. Scott Wright
Mayo Clinic
Co-authored papers 5
Robert M Califf
From the National Institutes of Health
Co-authored papers 5
Philippe R Bauer
Mayo Clinic
Co-authored papers 4
Noud van Helmond
The Spine & Pain Institute of New York
Co-authored papers 4
Matthew A Sexton
Mayo Clinic
Co-authored papers 4
Matthew N P Vogt
Mayo Clinic
Co-authored papers 4
Katie L Kunze
Mayo Clinic
Co-authored papers 4
Matthew R Buras
Mayo Clinic
Co-authored papers 4
Jeffrey L Winters
Mayo Clinic
Co-authored papers 4
Chad C Wiggins
Mayo Clinic
Co-authored papers 4
Allan M Klompas
Mayo Clinic
Co-authored papers 4
Camille M van Buskirk
Mayo Clinic
Co-authored papers 4
DeLisa Fairweather
Mayo Clinic
Co-authored papers 4
Janis E Blair
Mayo Clinic Hospital
Co-authored papers 4
Jonathon W Senefeld
University of Illinois at Urbana-Champaign
Co-authored papers 4
Vitaly Herasevich
Belarusian Medical Academy of Postgraduate Education, Belarusian State Medical University, Brest Medical College, Mayo Clinic, Mayo Graduate School
Co-authored papers 4
James R Stubbs
Mayo Clinic
Co-authored papers 4
Sarah E Baker
Mayo Clinic
Co-authored papers 4
Katelyn A Bruno
Mayo Clinic
Co-authored papers 4
Kathryn F Larson
Mayo Clinic
Co-authored papers 4
Nigel Paneth
College of Human Medicine, Michigan State University
Co-authored papers 4
Stephen A Klassen
Brock University
Co-authored papers 4
Arturo Casadevall
Johns Hopkins Bloomberg School of Public Health
Co-authored papers 4
Juan G Ripoll
Mayo Clinic
Co-authored papers 4
Patrick W Johnson
Division of Clinical Trials and Biostatistics, Mayo Clinic
Co-authored papers 4
Robert F Rea
Mayo Clinic
Co-authored papers 3
Jennifer Soto
Mayo Clinic
Co-authored papers 3
Release 1.2