Peter Marks
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View article: Key SARS-CoV-2 testing strategies implemented in the UK: rationale and impact
Key SARS-CoV-2 testing strategies implemented in the UK: rationale and impact Open
View article: Comparative evaluation of swabbing sites for Omicron variant detection in PCR testing
Comparative evaluation of swabbing sites for Omicron variant detection in PCR testing Open
Combined nose and throat swabbing remains the most effective method for SARS-CoV-2 detection. If a single swab is used, a throat swab has a higher sensitivity than nose swabs, although VC in the throat decreases faster in later infection s…
View article: Achieving Diversity Through Decentralization
Achieving Diversity Through Decentralization Open
View article: P999 First in human treatment of Crohn’s disease with autologous ex-vivo expanded polyclonal, gut-targeted regulatory T cells: Initial results of the TRIBUTE feasibility study
P999 First in human treatment of Crohn’s disease with autologous ex-vivo expanded polyclonal, gut-targeted regulatory T cells: Initial results of the TRIBUTE feasibility study Open
Background Despite the increase in novel medications for Crohn’s disease (CD), many patients either fail to respond adequately to, or are intolerant of current drugs. Cell therapies have yet to have a significant impact in IBD but represen…
View article: US FDA Perspective: preparing for a bright and busy future for cell & gene therapy
US FDA Perspective: preparing for a bright and busy future for cell & gene therapy Open
Q How would you sum up 2023, both for Center for Biologics Evaluation and Research (CBER) and for the cell and gene therapy space as a whole?PM: Although there has been concern in the community about contraction of investment in the rare d…
View article: The value of observational registry studies for the next infectious disease emergency
The value of observational registry studies for the next infectious disease emergency Open
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 convales…
View article: <scp>HIV</scp> 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
<span>HIV</span> 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 Open
Background Individual risk assessment allows donors to be evaluated based on their own behaviors. Study objectives were to assess human immunodeficiency virus (HIV) risk behaviors in men who have sex with men (MSM) and estimate the proport…
View article: Performance of self-collected saliva samples for SARS-CoV-2 mass testing in community settings
Performance of self-collected saliva samples for SARS-CoV-2 mass testing in community settings Open
Background: Saliva has been considered a suitable sample material for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA testing, but uncertainty remained regarding sensitivity and reliability of different saliva collection m…
View article: Lessons From COVID-19 for Pandemic Preparedness: Proceedings From a Multistakeholder Think Tank
Lessons From COVID-19 for Pandemic Preparedness: Proceedings From a Multistakeholder Think Tank Open
While the coronavirus disease 2019 (COVID-19) pandemic continues to present global challenges, sufficient time has passed to reflect on lessons learned and use those insights to inform policy and approaches to prepare for the next pandemic…
View article: Benefit-risk assessment of Covid-19 vaccine, MRNA (MRNA-1273) for males age 18–64 years
Benefit-risk assessment of Covid-19 vaccine, MRNA (MRNA-1273) for males age 18–64 years Open
Since the authorization of the Moderna mRNA COVID-19 vaccine, real-world evidence has indicated its effectiveness in preventing COVID-19 cases. However, increased cases of mRNA vaccine-associated myocarditis/pericarditis have been reported…
View article: HIV Risk Behavior Profiles Among Men Who Have Sex with Men Interested in Donating Blood: The Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) Study
HIV Risk Behavior Profiles Among Men Who Have Sex with Men Interested in Donating Blood: The Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) Study Open
Importance Blood donor selection policies should be evidence-based. Individual risk assessment allows potential donors to be evaluated based on their own behaviors. Objective The Assessing Donor Variability and New Concepts in Eligibility …
View article: Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy
Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy Open
As of April 2021, there are five commercially available chimeric antigen receptor (CAR) T cell therapies for hematologic malignancies. With the current transition of CAR T cell manufacturing from academia to industry, there is a shift towa…
View article: Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy
Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy Open
As of April 2021, there are five commercially available chimeric antigen receptor (CAR) T cell therapies for hematologic malignancies. With the current transition of CAR T cell manufacturing from academia to industry, there is a shift towa…
View article: Supplementary Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy
Supplementary Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy Open
Supplementary Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy
View article: Supplementary Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy
Supplementary Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy Open
Supplementary Data from Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy
View article: Performance of antigen lateral flow devices in the UK during the alpha, delta, and omicron waves of the SARS-CoV-2 pandemic: a diagnostic and observational study
Performance of antigen lateral flow devices in the UK during the alpha, delta, and omicron waves of the SARS-CoV-2 pandemic: a diagnostic and observational study Open
UK Health Security Agency, the UK Government Department of Health and Social Care, National Institute for Health Research (NIHR) Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, and the Univ…
View article: Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research priorities for ultra-rare inherited bleeding disorders
Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research priorities for ultra-rare inherited bleeding disorders Open
Centralization and expansion of expertise and resources, flexible innovative research and regulatory approaches, and inclusion of all people with ultra-rare inherited BDs and their health care professionals will be essential to capitalize …
View article: Bivalent Covid-19 Vaccines
Bivalent Covid-19 Vaccines Open
View article: COVID-19 vaccines: the start of a new era in regulation?
COVID-19 vaccines: the start of a new era in regulation? Open
View article: High-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
High-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 Open
The ability to directly measure neutralizing antibodies on live SARS-CoV-2 virus in individuals can play an important role in understanding the efficacy of therapeutic interventions or vaccines. In contrast to functional neutralization ass…
View article: Biological therapies need definitive randomized controlled clinical trials
Biological therapies need definitive randomized controlled clinical trials Open
Adequate and well-controlled clinical trials remain critical tools for helping to bring benefit to patients in medical need.
View article: Synergistic Strategies to Accelerate the Development of Function-Promoting Therapies: Lessons From Operation Warp Speed and Oncology Drug Development
Synergistic Strategies to Accelerate the Development of Function-Promoting Therapies: Lessons From Operation Warp Speed and Oncology Drug Development Open
Background Functional limitations and physical disabilities associated with aging and chronic disease are major concerns for human societies and expeditious development of function-promoting therapies is a public health priority. Methods E…
View article: Comparison of the performance of SARS-CoV-2 RNA qRT-PCR testing based on expectorated and drooled saliva samples
Comparison of the performance of SARS-CoV-2 RNA qRT-PCR testing based on expectorated and drooled saliva samples Open
Purpose Saliva has been considered a suitable sample material for SARS-CoV-2 testing but uncertainty remained regarding the sensitivity and reliability of different saliva collection methods for community mass testing. This study aimed to …
View article: Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research priorities for ultra-rare inherited bleeding disorders
Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research priorities for ultra-rare inherited bleeding disorders Open
Ultra-rare inherited bleeding disorders (BDs) present important challenges for generating a strong evidence foundation for optimal diagnosis and management. Without disorder-appropriate treatment, affected individuals potentially face life…
View article: Urgent Need for Next-Generation COVID-19 Vaccines
Urgent Need for Next-Generation COVID-19 Vaccines Open
This Viewpoint argues that the development of a distinctly improved generation of SARS-CoV-2 vaccines is paramount to offering a greater breadth and depth of protection for a longer duration against COVID-19 disease.
View article: BENEFIT-RISK ASSESSMENT OF COVID-19 VACCINE, MRNA (MRNA-1273) FOR MALES AGE 18-64 YEARS
BENEFIT-RISK ASSESSMENT OF COVID-19 VACCINE, MRNA (MRNA-1273) FOR MALES AGE 18-64 YEARS Open
Since authorization of the Moderna mRNA COVID-19 Vaccine, real-world evidence has indicated its effectiveness in preventing COVID-19 cases. However, increased cases of mRNA vaccine-associated myocarditis/pericarditis have been reported, pr…
View article: Performance of antigen lateral flow devices in the United Kingdom during the Alpha, Delta, and Omicron waves of the SARS-CoV-2 pandemic
Performance of antigen lateral flow devices in the United Kingdom during the Alpha, Delta, and Omicron waves of the SARS-CoV-2 pandemic Open
Background Antigen lateral flow devices (LFDs) have been widely used to control SARS-CoV-2. Changes in LFD sensitivity and detection of infectious individuals during the pandemic with successive variants, vaccination, and changes in LFD us…
View article: Intradermal Vaccination for Monkeypox — Benefits for Individual and Public Health
Intradermal Vaccination for Monkeypox — Benefits for Individual and Public Health Open
View article: Enhancing gene therapy regulatory interactions
Enhancing gene therapy regulatory interactions Open
View article: Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16–29 years
Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16–29 years Open