Peter W Marks (Peter Marks)

ORCID

Publication Activity (10 Years)

Years Active: 2018-2023
Publications (10 Years): 21

Top Venues

The New England journal of medicine

Science translational medicine

Gene therapy

Nature biotechnology

US Food and Drug Administration

This page only lists publications with an associated author ORCID identifier.

Affiliation History

US Food and Drug Administration Jan 11o 2016

United States

Director :: Center for Biologics Evaluation and Research

Publications

Rosaly Correa-de Araujo, William J Evans, Roger A Fielding, Venkatesh Krishnan, Robert H Carter, James Appleby, Jack Guralnik, Lloyd B Klickstein, Peter W Marks, Alison A Moore, Sue Peschin, Shalender Bhasin
Synergistic Strategies to Accelerate the Development of Function-Promoting Therapies: Lessons From Operation Warp Speed and Oncology Drug Development. The journals of gerontology. Series A, Biological sciences and medical sciences 78 (Supplement_1) (2023)
Peter W Marks, Hilary D Marston, Lindsey R Baden
End of a Declared Public Health Emergency - Implications for U.S. Emergency Use Authorizations. The New England journal of medicine 388 (13) (2023)
Peter W Marks, Hilary D Marston, Lindsey R Baden
End of a Declared Public Health Emergency - Implications for U.S. Emergency Use Authorizations. The New England journal of medicine 388 (13) (2023)
Robert M Califf, Peter W Marks
Biological therapies need definitive randomized controlled clinical trials. Science translational medicine 15 (680) (2023)
Robert M Califf, Peter W Marks
Biological therapies need definitive randomized controlled clinical trials. Science translational medicine 15 (680) (2023)
Robert M Califf, Peter W Marks
Biological therapies need definitive randomized controlled clinical trials. Science translational medicine 15 (680) (2023)
Peter W Marks, Hilary D Marston, Lindsey R Baden
End of a Declared Public Health Emergency - Implications for U.S. Emergency Use Authorizations. The New England journal of medicine (2023)
Robert M Califf, Peter W Marks
Biological therapies need definitive randomized controlled clinical trials. Science translational medicine 15 (680) (2023)
Peter W Marks, Hilary D Marston, Lindsey R Baden
End of a Declared Public Health Emergency - Implications for U.S. Emergency Use Authorizations. The New England journal of medicine 388 (13) (2023)
John T Brooks, Peter W Marks, Robert H Goldstein, Rochelle P Walensky
Intradermal Vaccination for Monkeypox - Benefits for Individual and Public Health. The New England journal of medicine 387 (13) (2022)
Artur Belov, Yin Huang, Carlos H Villa, Barbee I Whitaker, Richard Forshee, Steven A Anderson, Anne Eder, Nicole Verdun, Michael J Joyner, Scott R Wright, Rickey E Carter, Deborah T Hung, null null, Mary Homer, Corey Hoffman, Michael Lauer, Peter W Marks
Early administration of COVID-19 convalescent plasma with high titer antibody content by live viral neutralization assay is associated with modest clinical efficacy. American journal of hematology 97 (6) (2022)
Jennifer L Wilson, Kit Wun Kathy Cheung, Lawrence Lin, Elizabeth A E Green, Analia I Porrás, Ling Zou, David Mukanga, Paul A Akpa, Delese Mimi Darko, Rae Yuan, Sheng Ding, Wiltshire C N Johnson, Howard A Lee, Emer Cooke, Carl C Peck, Steven E Kern, Dan Hartman, Yoshikazu Hayashi, Peter W Marks, Russ B Altman, Murray M Lumpkin, Kathleen M Giacomini, Terrence F Blaschke
Scientific considerations for global drug development. Science translational medicine 12 (554) (2021)
Peter W Marks
What regulators must learn from COVID-19. Nature medicine 27 (11) (2021)
Jonathon W Senefeld, Patrick W Johnson, Katie L Kunze, Evan M Bloch, Noud van Helmond, Michael A Golafshar, Stephen A Klassen, Allan M Klompas, Matthew A Sexton, Juan C Diaz Soto, Brenda J Grossman, Aaron A R Tobian, Ruchika Goel, Chad C Wiggins, Katelyn A Bruno, Camille M van Buskirk, James R Stubbs, Jeffrey Lawrence Winters, Arturo Casadevall, Nigel S Paneth, Beth H Shaz, Molly M Petersen, Bruce S Sachais, Matthew R Buras, Mikolaj A Wieczorek, Benjamin Russoniello, Larry J Dumont, Sarah E Baker, Ralph R Vassallo, John R A Shepherd, Pampee P Young, Nicole C Verdun, Peter W Marks, N Rebecca Haley, Robert F Rea, Louis Katz, Vitaly Herasevich, Dan A Waxman, Emily R Whelan, Aviv Bergman, Andrew J Clayburn, Mary Kathryn Grabowski, Kathryn F Larson, Juan G Ripoll, Kylie J Andersen, Matthew N P Vogt, Joshua J Dennis, Riley J Regimbal, Philippe R Bauer, Janis E Blair, Zachary A Buchholtz, Michaela C Pletsch, Katherine Wright, Joel T Greenshields, Michael J Joyner, R Scott Wright, Rickey E Carter, DeLisa Fairweather
Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study. PLoS medicine 18 (12) (2021)
Jonathon W Senefeld, Patrick W Johnson, Katie L Kunze, Noud van Helmond, Stephen A Klassen, Chad C Wiggins, Katelyn A Bruno, Michael A Golafshar, Molly M Petersen, Matthew R Buras, Allan M Klompas, Matthew A Sexton, Juan C Diaz Soto, Sarah E Baker, John R A Shepherd, Nicole C Verdun, Peter W Marks, Camille M van Buskirk, Jeffrey Lawrence Winters, James R Stubbs, Robert F Rea, Vitaly Herasevich, Emily R Whelan, Andrew J Clayburn, Kathryn F Larson, Juan G Ripoll, Kylie J Andersen, Matthew N P Vogt, Joshua J Dennis, Riley J Regimbal, Philippe R Bauer, Janis E Blair, Katherine Wright, Joel T Greenshields, Nigel S Paneth, DeLisa Fairweather, R Scott Wright, Arturo Casadevall, Rickey E Carter, Michael J Joyner
Program and patient characteristics for the United States Expanded Access Program to COVID-19 convalescent plasma. medRxiv : the preprint server for health sciences (2021)
Michael J Joyner, Rickey E Carter, Jonathon W Senefeld, Stephen A Klassen, John R Mills, Patrick W Johnson, Elitza S Theel, Chad C Wiggins, Katelyn A Bruno, Allan M Klompas, Elizabeth R Lesser, Katie L Kunze, Matthew A Sexton, Juan C Diaz Soto, Sarah E Baker, John R A Shepherd, Noud van Helmond, Nicole C Verdun, Peter W Marks, Camille M van Buskirk, Jeffrey L Winters, James R Stubbs, Robert F Rea, David O Hodge, Vitaly Herasevich, Emily R Whelan, Andrew J Clayburn, Kathryn F Larson, Juan G Ripoll, Kylie J Andersen, Matthew R Buras, Matthew N P Vogt, Joshua J Dennis, Riley J Regimbal, Philippe R Bauer, Janis E Blair, Nigel S Paneth, DeLisa Fairweather, R Scott Wright, Arturo Casadevall
Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19. The New England journal of medicine 384 (11) (2021)
Peter W Marks, Steven Solomon
Clarifying US regulations on xenotransplantation. Nature biotechnology (2021)
Katie L Kunze, Patrick W Johnson, Noud van Helmond, Jonathon W Senefeld, Molly M Petersen, Stephen A Klassen, Chad C Wiggins, Allan M Klompas, Katelyn A Bruno, John R Mills, Elitza S Theel, Matthew R Buras, Michael A Golafshar, Matthew A Sexton, Juan C Diaz Soto, Sarah E Baker, John R A Shepherd, Nicole C Verdun, Peter W Marks, Nigel S Paneth, DeLisa Fairweather, R Scott Wright, Camille M van Buskirk, Jeffrey Lawrence Winters, James R Stubbs, Katherine A Senese, Michaela C Pletsch, Zachary A Buchholtz, Robert F Rea, Vitaly Herasevich, Emily R Whelan, Andrew J Clayburn, Kathryn F Larson, Juan G Ripoll, Kylie J Andersen, Elizabeth R Lesser, Matthew N P Vogt, Joshua J Dennis, Riley J Regimbal, Philippe R Bauer, Janis E Blair, Arturo Casadevall, Rickey E Carter, Michael J Joyner
Mortality in individuals treated with COVID-19 convalescent plasma varies with the geographic provenance of donors. Nature communications 12 (1) (2021)
Peter W Marks, Celia Witten
Toward a new framework for the development of individualized therapies. Gene therapy 28 (10-11) (2020)
Janet Woodcock, Peter W Marks
Drug Regulation in the Era of Individualized Therapies. The New England journal of medicine 381 (17) (2019)
Peter W Marks, Scott Gottlieb
Balancing Safety and Innovation for Cell-Based Regenerative Medicine. The New England journal of medicine 378 (10) (2018)

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Publication Activity (10 Years)

Top Topics

Top Venues

Peter W Marks (Peter Marks)