Full Text Journal Articles by
Author Joseph P Menetski


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Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines-Selecting Compounds for Clinical Evaluation in Coronavirus Disease 2019 Clinical Trials.

Timothy G Buchman, Ruxandra Draghia-Akli, Stacey J Adam, Neil R Aggarwal, Joshua P Fessel, Elizabeth S Higgs, Joseph P Menetski, Sarah W Read, Eric A Hughes, ,

Given the urgent need for coronavirus disease 2019 therapeutics, early in the pandemic the Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership rapidly designed a unique therapeutic agent intake and assessment process for candidate treatments of coronavirus disease 2019. These treatments included antivirals, immune modulators, severe acute ... Read more >>

Crit Care Med (Critical care medicine)
[2021, 49(11):1963-1973]

Cited: 0 times

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Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis.

Elena S Izmailova, William A Wood, Qi Liu, Vadim Zipunnikov, Daniel Bloomfield, Jason Homsy, Steven C Hoffmann, John A Wagner, Joseph P Menetski,

Clinical safety findings remain one of the reasons for attrition of drug candidates during clinical development. Cardiovascular liabilities are not consistently detected in early-stage clinical trials and often become apparent when drugs are administered chronically for extended periods of time. Vital sign data collection outside of the clinic offers an ... Read more >>

Digit Biomark (Digital biomarkers)
[2021, 5(1):103-113]

Cited: 0 times

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A Biomarker-Centric Approach to Drug Discovery and Development: Lessons Learned from the Coronavirus Disease 2019 Pandemic.

Kelly A Fader, Jiangwei Zhang, Joseph P Menetski, Ravi I Thadhani, Elliott M Antman, Gary S Friedman, Shashi K Ramaiah, Vishal S Vaidya,

Faced with the health and economic consequences of the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the biomedical community came together to identify, diagnose, prevent, and treat the novel disease at breathtaking speeds. The field advanced from a publicly available viral genome to a commercialized globally scalable ... Read more >>

J Pharmacol Exp Ther (The Journal of pharmacology and experimental therapeutics)
[2021, 376(1):12-20]

Cited: 0 times

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Accelerated Preclinical Paths to Support Rapid Development of COVID-19 Therapeutics.

Jay A Grobler, Annaliesa S Anderson, Prabhavathi Fernandes, Michael S Diamond, Christine M Colvis, Joseph P Menetski, Rosa M Alvarez, John A T Young, Kara L Carter,

When SARS-CoV-2 emerged at the end of 2019, no approved therapeutics or vaccines were available. An urgent need for countermeasures during this crisis challenges the current paradigm of traditional drug discovery and development, which usually takes years from start to finish. Approaches that accelerate this process need to be considered. ... Read more >>

Cell Host Microbe (Cell host & microbe)
[2020, 28(5):638-645]

Cited: 11 times

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Establishing the Link Between Lean Mass and Grip Strength Cut Points With Mobility Disability and Other Health Outcomes: Proceedings of the Sarcopenia Definition and Outcomes Consortium Conference.

Peggy M Cawthon, Thomas G Travison, Todd M Manini, Sheena Patel, Karol M Pencina, Roger A Fielding, Jay M Magaziner, Anne B Newman, Todd Brown, Douglas P Kiel, Steve R Cummings, Michelle Shardell, Jack M Guralnik, Linda J Woodhouse, Marco Pahor, Ellen Binder, Ralph B D'Agostino, Xue Quian-Li, Eric Orwoll, Francesco Landi, Denise Orwig, Laura Schaap, Nancy K Latham, Vasant Hirani, Timothy Kwok, Suzette L Pereira, Daniel Rooks, Makoto Kashiwa, Moises Torres-Gonzalez, Joseph P Menetski, Rosaly Correa-De-Araujo, Shalender Bhasin,

<h4>Background</h4>Lack of consensus on how to diagnose sarcopenia has limited the ability to diagnose this condition and hindered drug development. The Sarcopenia Definitions and Outcomes Consortium (SDOC) was formed to develop evidence-based diagnostic cut points for lean mass and/or muscle strength that identify people at increased risk of mobility disability. ... Read more >>

J Gerontol A Biol Sci Med Sci (The journals of gerontology. Series A, Biological sciences and medical sciences)
[2020, 75(7):1317-1323]

Cited: 26 times

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Remote digital monitoring in clinical trials in the time of COVID-19.

Jennifer C Goldsack, Elena S Izmailova, Joseph P Menetski, Steven C Hoffmann, Peter M A Groenen, John A Wagner,

Nat Rev Drug Discov (Nature reviews. Drug discovery)
[2020, 19(6):378-379]

Cited: 6 times

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The FNIH Biomarkers Consortium embraces the BEST.

Joseph P Menetski, Christopher P Austin, Linda S Brady, Guy Eakin, Chris Leptak, Abbey Meltzer, John A Wagner,

Nat Rev Drug Discov (Nature reviews. Drug discovery)
[2019, 18(8):567-568]

Cited: 1 time

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The Foundation for the National Institutes of Health Biomarkers Consortium: Past Accomplishments and New Strategic Direction.

Joseph P Menetski, Steven C Hoffmann, Stephanie S Cush, Tania Nayak Kamphaus, Christopher P Austin, Paul L Herrling, John A Wagner,

The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) is a public-private partnership that aims to facilitate drug development with biomarkers across a range of therapeutic areas. The BC is organized to address specific precompetitive biomarker projects, giving participating stakeholders a role in the design and conduct ... Read more >>

Clin Pharmacol Ther (Clinical pharmacology and therapeutics)
[2019, 105(4):829-843]

Cited: 7 times

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What evidence do we need for biomarker qualification?

Chris Leptak, Joseph P Menetski, John A Wagner, Jiri Aubrecht, Linda Brady, Martha Brumfield, William W Chin, Steve Hoffmann, Gary Kelloff, Gabriela Lavezzari, Rajesh Ranganathan, John-Michael Sauer, Frank D Sistare, Tanja Zabka, David Wholley,

Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of ... Read more >>

Sci Transl Med (Science translational medicine)
[2017, 9(417):]

Cited: 17 times

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Evaluation of glyceraldehyde-3-phosphate, prolylpeptidyl isomerase A, and a set of stably expressed genes as reference mRNAs in urate crystal inflammation.

Cristina Della Beffa, Frank Klawonn, Joseph P Menetski, H Ralph Schumacher, Frank Pessler,

<h4>Background</h4>The murine air pouch membrane represents an easily accessible tissue for studies on gene regulation in acute inflammation. Considering that acute inflammation may affect expression of molecular reference genes, we evaluated the expression of glyceraldehyde-3-phosphate dehydrogenase (GAPDH) and prolylpeptidyl isomerase A (PPIA) in the air pouch membrane during a complete ... Read more >>

BMC Res Notes (BMC research notes)
[2011, 4:443]

Cited: 6 times

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Identification of novel monosodium urate crystal regulated mRNAs by transcript profiling of dissected murine air pouch membranes.

Frank Pessler, Christian T Mayer, Sung Mun Jung, Ed M Behrens, Lie Dai, Joseph P Menetski, H Ralph Schumacher,

<h4>Introduction</h4>The murine air pouch is a bursa-like space that resembles the human synovial membrane. Injection of monosodium urate (MSU) crystals into the pouch elicits an acute inflammatory response similar to human gout. We conducted the present study to identify mRNAs that were highly regulated by MSU crystals in the pouch ... Read more >>

Arthritis Res Ther (Arthritis research & therapy)
[2008, 10(3):R64]

Cited: 23 times

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