Leonard Sacks

CURE ID : A Platform to Collect Real‐World Treatment Data for Drug Repurposing in Rare Genetic Disorders

Tahsin Farid, Maura R. Z. Ruzhnikov, Mili Duggal, Keyla C. Tumas et autres

Rare diseases collectively affect millions of Americans, but less than 5% have approved treatments, and new drug development remains limited. For such diseases, drug repurposing may be an effective strategy to find new treatment options. In the rare genetic disorder community, drugs …

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Evidence Generation for Drugs and Biological Products isn't Magic or Myth

John Concato, Leonard Sacks, Peter Stein, Jacqueline Corrigan‐Curay

The authors declared no competing interests for this work.

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Decentralized Clinical Trials in the Development of Drugs and Biological Products

Ryan Robinson, Leonard Sacks

Decentralized clinical trials (DCTs) are trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. FDA supports decentralization to improve participation in clinical trials. While there are benefits of DCTs, including convenience for participants, …

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A metagenomic analysis for combination therapy of multiple classes of antibiotics on the prevention of the spread of antibiotic-resistant genes

Matthew J. Igo, Lei Xu, Ashok Krishna, Sharron Stewart et autres

Antibiotics used systemically to treat infections may have off-target effects on the gut microbiome, potentially resulting in the emergence of drug-resistant bacteria or selection of pathogenic species. These organisms may present a risk to the host and spread to the environment with …

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Evaluation of a Sequential Antibiotic Treatment Regimen of Ampicillin, Ciprofloxacin and Fosfomycin against Escherichia coli CFT073 in the Hollow Fiber Infection Model Compared with Simultaneous Combination Treatment

Ashok Krishna, Tesfalem Zere, Sabyasachy Mistry, Omnia A. Ismaiel et autres

OBJECTIVE: Employ the hollow fiber infection model (HFIM) to study sequential antibiotic administration (ampicillin, ciprofloxacin and fosfomycin) using human pharmacokinetic profiles to measure changes in the rate of antibiotic resistance development and compare this to simultaneous combination therapy with the same antibiotic …

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Digital Health Technologies in Pediatric Trials

Leonard Sacks, Elizabeth Kunkoski, Marianne Noone

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Eligibility criteria and clinical trials: An FDA perspective

Mili Duggal, Leonard Sacks, Kaveeta P. Vasisht

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Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective

Leonard Sacks, Elizabeth Kunkoski

Digital health technology (DHT), including wearable and environmental sensors, video cameras and other electronic tools, has provided new opportunities for the measurement of movement and functionality in Parkinson's disease. Compared to current standards for evaluation of the disease (MDS-UPDRS), DHT may offer …

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546. Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies During COVID-19

Mili Duggal, Heather Stone, Parvesh Paul, Reema Charles et autres

Abstract Background CURE ID is an internet-based repository developed collaboratively by FDA and NCATS/NIH, with the support of WHO and IDSA. It encourages clinicians globally to share novel uses of existing drugs for patients with difficult-to-treat infections. It is designed to serve …

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The effect of antibiotics on the gut microbiome: a metagenomics analysis of microbial shift and gut antibiotic resistance in antibiotic treated mice

Lei Xu, Anil Surathu, Isaac Raplee, Ashok Chockalingam et autres

BACKGROUND: Emergence of antibiotic resistance is a global public health concern. The relationships between antibiotic use, the gut community composition, normal physiology and metabolism, and individual and public health are still being defined. Shifts in composition of bacteria, antibiotic resistance genes (ARGs) …

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Mycobacterium tuberculosis bloodstream infection prevalence, diagnosis, and mortality risk in seriously ill adults with HIV: a systematic review and meta-analysis of individual patient data

David Barr, Joseph M. Lewis, Nicholas Feasey, Charlotte Schutz et autres

BACKGROUND: The clinical and epidemiological significance of HIV-associated Mycobacterium tuberculosis bloodstream infection (BSI) is incompletely understood. We hypothesised that M tuberculosis BSI prevalence has been underestimated, that it independently predicts death, and that sputum Xpert MTB/RIF has suboptimal diagnostic yield for M …

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Additional file 4 of The effect of antibiotics on the gut microbiome: a metagenomics analysis of microbial shift and gut antibiotic resistance in antibiotic treated mice

Lei Xu, Anil Surathu, Isaac Raplee, Ashok Chockalingam et autres

Additional file 4: Supplementary Table 4. Ampicillin species relative abundance.