Evidence map›Paper›PMID 36410389›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

The LEAP Process: Streamlining the Development of Long-Acting Products and Formulations for Infectious Diseases.

Charles Flexner, Marco Siccardi, Fazila Bunglawala, Andrew Owen

Abstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. A Holistic Review of the Preclinical Landscape for Long-Acting Anti-infective Drugs Using HIV as a Paradigm.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Charles FlexnerDivisions of Clinical Pharmacology and Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Marco SiccardiDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
Fazila BunglawalaDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
Andrew OwenDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.

Funding

The Long-Acting/Extended Release Antiretroviral Resource Program (LEAP)R24AI118397 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Charles W. Flexner · 2015 to 2026
$9.4M
Long acting NRTI therapies for HIVR01AI134091 · NIAID · JOHNS HOPKINS UNIVERSITY · PI FREEL MEYERS, CAREN L., RANNARD, STEVE · 2017 to 2021
$3.1M
NIAID NIH HHS R01AI134091NIAID NIH HHS R24 AI118397NIH HHS NIAID R24 AI118397Wellcome Trust
6 · The paper itself

Abstract

Developing long-acting products and formulations for infectious diseases is a nontrivial undertaking that is frequently classified as high risk and low reward by the pharmaceutical industry. The Long-Acting/Extended Release Antiretroviral Research Resource Program (LEAP) was founded in 2015 with the support of the National Institutes of Health to encourage, promote, and accelerate the development of such products. Assessment methodology for any new proposal brought to this group is part of a framework-the LEAP Process-that includes a landscape analysis of what is currently available in the public domain. This is followed by in silico modeling and simulation offered as a service to the relevant scientific community. A variety of preclinical and clinical outcome metrics are applied to each new agent as part of a continuous feedback loop to improve product characteristics. This allows us to catalog knowledge gaps and barriers that can be addressed by engaged stakeholders. Results are communicated in scientific articles, reviews, and position papers. This undertaking serves to de-risk discovery, development, and implementation by bridging the gaps between academic, regulatory, and industrial investigators, and by engaging those in the community who will be the eventual users of these medicines. The LEAP Process has supported formulations now approved for human immunodeficiency virus, as well as products in clinical and preclinical development for tuberculosis and hepatitis viruses B and C.

Indexed as

HIV InfectionsTuberculosisAnti-Retroviral AgentsDrug IndustryHumansNational Institutes of Health (U.S.)United StatesAnti-Retroviral AgentsHIV therapylong-acting formulationspharmacokinetic modelingphysiologically based pharmacokinetic modelingtuberculosis therapy

Identifiers

PMID36410389
PMCPMC10200316

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.