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Article ; Online: A Clinical Pharmacist-Led Transitions of Care Program for Veterans With Two Planned Care Transitions (Hospital to Skilled Care and Skilled Care to Home) Amid the COVID-19 Pandemic.

Scannell, Gabrielle A / Bevan, Darion / Cowan, Amy / Weiss, Roxanne J / Brenner, Rachel / Farrell, Timothy W / Yarbrough, Peter M / Rupper, Randall / Eleazer, G Paul

Journal of the American Medical Directors Association

2024

Abstract: Transitional care teams have been shown to improve patient safety. We describe a novel transitional care team with a clinical pharmacist as team leader initiated amid the COVID-19 pandemic. The program focused on Veterans with 2 planned transitions of ... ...

Abstract	Transitional care teams have been shown to improve patient safety. We describe a novel transitional care team with a clinical pharmacist as team leader initiated amid the COVID-19 pandemic. The program focused on Veterans with 2 planned transitions of care: hospital to skilled nursing facility (SNF) and from SNF to home. Ninety older Veterans were enrolled, and 79 medication errors and 80 appointment errors were identified. We conclude that a pharmacist-led program can improve safety in patients with 2 planned transitions of care.
Language	English
Publishing date	2024-04-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	2171030-2
ISSN	1538-9375 ; 1525-8610
ISSN (online)	1538-9375
ISSN	1525-8610
DOI	10.1016/j.jamda.2024.03.117
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Article ; Online: Revisit PEG-Induced Precipitation Assay for Protein Solubility Assessment of Monoclonal Antibody Formulations.

Scannell, Martha J / Hyatt, Matthew W / Budyak, Ivan L / Woldeyes, Mahlet A / Wang, Ying

Pharmaceutical research

2021 Volume 38, Issue 11, Page(s) 1947–1960

Abstract: Purpose: Protein solubility is an important attribute of pharmaceutical monoclonal antibody (MAb) formulations, particularly at high MAb concentrations. PEG-induced protein precipitation has been routinely used to assess protein solubility. To provide ... ...

Abstract	Purpose: Protein solubility is an important attribute of pharmaceutical monoclonal antibody (MAb) formulations, particularly at high MAb concentrations. PEG-induced protein precipitation has been routinely used to assess protein solubility. To provide insights for better understanding and implementation of PEG-induced protein precipitation assay, this work compares different solubility measures and examines their relevance to loss of protein solubility in concentrated formulations. Methods: Solubility of a MAb in 15 formulations was evaluated using PEG-induced precipitation assay. Three apparent protein solubility measures, the middle-point and onset PEG concentrations (c Results: PEG-induced precipitation assay predicted overall protein solubility ranking similar to that by DLS k Conclusions: This study demonstrated good correlations between the protein solubility measures obtained from PEG-induced precipitation experiments and DLS k
MeSH term(s)	Antibodies, Monoclonal/chemistry ; Antibodies, Monoclonal/therapeutic use ; Chemistry, Pharmaceutical/methods ; Polyethylene Glycols/chemistry ; Solubility
Chemical Substances	Antibodies, Monoclonal ; Polyethylene Glycols (3WJQ0SDW1A)
Language	English
Publishing date	2021-10-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	843063-9
ISSN	1573-904X ; 0724-8741 ; 0739-0742
ISSN (online)	1573-904X
ISSN	0724-8741 ; 0739-0742
DOI	10.1007/s11095-021-03119-4
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Zs.A 1937: Show issues

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Article ; Online: Predictive validity in drug discovery: what it is, why it matters and how to improve it.

Scannell, Jack W / Bosley, James / Hickman, John A / Dawson, Gerard R / Truebel, Hubert / Ferreira, Guilherme S / Richards, Duncan / Treherne, J Mark

Nature reviews. Drug discovery

2022 Volume 21, Issue 12, Page(s) 915–931

Abstract: Successful drug discovery is like finding oases of safety and efficacy in chemical and biological deserts. Screens in disease models, and other decision tools used in drug research and development (R&D), point towards oases when they score therapeutic ... ...

Abstract	Successful drug discovery is like finding oases of safety and efficacy in chemical and biological deserts. Screens in disease models, and other decision tools used in drug research and development (R&D), point towards oases when they score therapeutic candidates in a way that correlates with clinical utility in humans. Otherwise, they probably lead in the wrong direction. This line of thought can be quantified by using decision theory, in which 'predictive validity' is the correlation coefficient between the output of a decision tool and clinical utility across therapeutic candidates. Analyses based on this approach reveal that the detectability of good candidates is extremely sensitive to predictive validity, because the deserts are big and oases small. Both history and decision theory suggest that predictive validity is under-managed in drug R&D, not least because it is so hard to measure before projects succeed or fail later in the process. This article explains the influence of predictive validity on R&D productivity and discusses methods to evaluate and improve it, with the aim of supporting the application of more effective decision tools and catalysing investment in their creation.
MeSH term(s)	Humans ; Drug Discovery/methods ; Efficiency
Language	English
Publishing date	2022-10-04
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2062954-0
ISSN	1474-1784 ; 1474-1776
ISSN (online)	1474-1784
ISSN	1474-1776
DOI	10.1038/s41573-022-00552-x
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Zs.A 5564: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Antibiotics: expect to use less, more responsibly.

Scannell, J W / Bruce, A

The Veterinary record

2015 Volume 177, Issue 7, Page(s) 168–170

MeSH term(s)	Animals ; Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/therapeutic use ; Drug Resistance, Bacterial ; Health Policy ; Humans ; Legislation, Veterinary ; United Kingdom ; Veterinary Medicine
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2015-08-15
Publishing country	England
Document type	Editorial
ZDB-ID	390015-0
ISSN	2042-7670 ; 0042-4900
ISSN (online)	2042-7670
ISSN	0042-4900
DOI	10.1136/vr.h4275
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Zs.B 645: Show issues

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Article ; Online: When Quality Beats Quantity: Decision Theory, Drug Discovery, and the Reproducibility Crisis.

Scannell, Jack W / Bosley, Jim

PloS one

2016 Volume 11, Issue 2, Page(s) e0147215

Abstract: A striking contrast runs through the last 60 years of biopharmaceutical discovery, research, and development. Huge scientific and technological gains should have increased the quality of academic science and raised industrial R&D efficiency. However, ... ...

Abstract	A striking contrast runs through the last 60 years of biopharmaceutical discovery, research, and development. Huge scientific and technological gains should have increased the quality of academic science and raised industrial R&D efficiency. However, academia faces a "reproducibility crisis"; inflation-adjusted industrial R&D costs per novel drug increased nearly 100 fold between 1950 and 2010; and drugs are more likely to fail in clinical development today than in the 1970s. The contrast is explicable only if powerful headwinds reversed the gains and/or if many "gains" have proved illusory. However, discussions of reproducibility and R&D productivity rarely address this point explicitly. The main objectives of the primary research in this paper are: (a) to provide quantitatively and historically plausible explanations of the contrast; and (b) identify factors to which R&D efficiency is sensitive. We present a quantitative decision-theoretic model of the R&D process. The model represents therapeutic candidates (e.g., putative drug targets, molecules in a screening library, etc.) within a "measurement space", with candidates' positions determined by their performance on a variety of assays (e.g., binding affinity, toxicity, in vivo efficacy, etc.) whose results correlate to a greater or lesser degree. We apply decision rules to segment the space, and assess the probability of correct R&D decisions. We find that when searching for rare positives (e.g., candidates that will successfully complete clinical development), changes in the predictive validity of screening and disease models that many people working in drug discovery would regard as small and/or unknowable (i.e., an 0.1 absolute change in correlation coefficient between model output and clinical outcomes in man) can offset large (e.g., 10 fold, even 100 fold) changes in models' brute-force efficiency. We also show how validity and reproducibility correlate across a population of simulated screening and disease models. We hypothesize that screening and disease models with high predictive validity are more likely to yield good answers and good treatments, so tend to render themselves and their diseases academically and commercially redundant. Perhaps there has also been too much enthusiasm for reductionist molecular models which have insufficient predictive validity. Thus we hypothesize that the average predictive validity of the stock of academically and industrially "interesting" screening and disease models has declined over time, with even small falls able to offset large gains in scientific knowledge and brute-force efficiency. The rate of creation of valid screening and disease models may be the major constraint on R&D productivity.
MeSH term(s)	Biopharmaceutics/methods ; Biopharmaceutics/trends ; Cost-Benefit Analysis ; Decision Theory ; Drug Discovery/economics ; Efficiency ; False Positive Reactions ; High-Throughput Screening Assays ; Humans ; Models, Theoretical ; Quality Control ; Reproducibility of Results ; Research
Language	English
Publishing date	2016-02-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0147215
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Article ; Online: Financial returns on R&D: looking back at history, looking forward to adaptive licensing.

Scannell, J W / Hinds, S / Evans, R

Reviews on recent clinical trials

2015 Volume 10, Issue 1, Page(s) 28–43

Abstract: Investment in R&D for drugs launched in the late 1970s to early 1990s generated good returns for investors. R&D was inexpensive. Clinical trial success rates were high. Consumption was increasing. Drug prices were outstripping inflation, which raised ... ...

Abstract	Investment in R&D for drugs launched in the late 1970s to early 1990s generated good returns for investors. R&D was inexpensive. Clinical trial success rates were high. Consumption was increasing. Drug prices were outstripping inflation, which raised profit margins. Tax rates were falling. However, returns on R&D have been falling since the early 1990s given rising clinical trial costs, rising trial failure rates, and lower consumption growth in developed markets. Many investors believe that average financial returns on today's R&D will be below the cost of capital, particularly if US drug price inflation moderates. Thus R&D investment by major drug companies is flat or perhaps falling in real terms. Various regulatory initiatives have tried to streamline clinical development and approval. The latest is Adaptive Licensing (AL). The near-term effect of AL on industry-level financial returns will be modest. AL will, however, be salient for decisions to invest in specific trials and may make it easier for smaller companies to fund development. AL could become more important in the long run if it helps shift industry, regulators, and payers from what has been an increasingly linear model of innovation; predicated on the ideas that basic science predicts, trials test predictions, and trial results form a complete description of a drug's attributes. History shows that many drugs become important because doctors and patients discover utility that was not initially apparent to regulators, payers, or investors. One hope for AL, therefore, is that it will bring more acceptably safe chemical diversity into real world use at lower R&D cost.
MeSH term(s)	Drug Discovery/economics ; Drug Discovery/history ; Drug Discovery/trends ; Drug and Narcotic Control ; History, 20th Century ; History, 21st Century ; Humans ; Models, Theoretical ; Research/economics ; Research/history ; Research/trends ; United Kingdom
Language	English
Publishing date	2015-04-29
Publishing country	United Arab Emirates
Document type	Historical Article ; Journal Article
ZDB-ID	2251879-4
ISSN	1876-1038 ; 1574-8871
ISSN (online)	1876-1038
ISSN	1574-8871
DOI	10.2174/1574887110666150430151751
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Article ; Online: Author Correction: Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology.

Ewart, Lorna / Apostolou, Athanasia / Briggs, Skyler A / Carman, Christopher V / Chaff, Jake T / Heng, Anthony R / Jadalannagari, Sushma / Janardhanan, Jeshina / Jang, Kyung-Jin / Joshipura, Sannidhi R / Kadam, Mahika M / Kanellias, Marianne / Kujala, Ville J / Kulkarni, Gauri / Le, Christopher Y / Lucchesi, Carolina / Manatakis, Dimitris V / Maniar, Kairav K / Quinn, Meaghan E /

Ravan, Joseph S / Rizos, Ann Catherine / Sauld, John F K / Sliz, Josiah D / Tien-Street, William / Trinidad, Dennis Ramos / Velez, James / Wendell, Max / Irrechukwu, Onyi / Mahalingaiah, Prathap Kumar / Ingber, Donald E / Scannell, Jack W / Levner, Daniel

Communications medicine

2023 Volume 3, Issue 1, Page(s) 16

Language	English
Publishing date	2023-02-02
Publishing country	England
Document type	Published Erratum
ISSN	2730-664X
ISSN (online)	2730-664X
DOI	10.1038/s43856-023-00249-1
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Article: Determining cortical landscapes.

Scannell, J W

Nature

1997 Volume 386, Issue 6624, Page(s) 452

MeSH term(s)	Animals ; Cats ; Cerebral Cortex/anatomy & histology ; Macaca ; Nerve Fibers ; Species Specificity
Language	English
Publishing date	1997-04-03
Publishing country	England
Document type	Letter
ZDB-ID	120714-3
ISSN	1476-4687 ; 0028-0836
ISSN (online)	1476-4687
ISSN	0028-0836
DOI	10.1038/386452a0
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Article: The Annual Cycle of Energy Input, Modal Excitation and Physical Plus Biogenic Turbulent Dissipation in a Temperate Lake

Simpson, John H. / Woolway, R. Iestyn / Scannell, Brian / Austin, Martin J. / Powell, Ben / Maberly, Stephen C.

Water resources research. 2021 June, v. 57, no. 6

2021

Abstract: ... dissipation rate of 2.5 × 10⁻⁵ W m⁻² corresponding to ∼3%–4% of RWy. Over the same period, the dissipation ... dissipation contributed an average of ∼36% of the total BBL dissipation rate of ∼5.7 × 10⁻⁵ W m⁻². ...

Abstract	A year of measurements by Doppler Current Profilers, a chain of temperature sensors and a suite of meteorological instruments has been analyzed to elucidate the seasonal cycle of the dynamical response of a temperate lake (Windermere) to surface forcing. The efficiency of energy input to the lake (Eff) was determined by comparing the rate of working by the surface wind‐stress RWy with the downward flux of momentum in the atmosphere. Eff was found to increase from values of ∼0.3% in winter mixed conditions, up to ∼1.2% during summer stratification, when internal seiches were present. Water column kinetic energy was similarly enhanced during stratification. Spectral analysis of the axial velocity showed that the first vertical mode was dominant during most of the stratified period with a less prominent second mode appearing in the early part of the summer. The observed periods and vertical structure of these modes generally accorded with estimates from internal wave theory based on density profiles. During stratification, pycnocline dissipation exhibited high variability linked to the surface forcing with an average, depth‐integrated, pycnocline dissipation rate of 2.5 × 10⁻⁵ W m⁻² corresponding to ∼3%–4% of RWy. Over the same period, the dissipation rate in the bottom boundary layer (BBL) exhibited a marked diurnal variation unrelated to physical forcing. Acoustic backscatter indicated the presence of vertically migrating organisms with peak aggregation in the BBL around midday coinciding with maximum dissipation. During stratification, biogenic dissipation contributed an average of ∼36% of the total BBL dissipation rate of ∼5.7 × 10⁻⁵ W m⁻².
Keywords	acoustics ; diurnal variation ; kinetic energy ; lakes ; momentum ; research ; seasonal variation ; spectral analysis ; summer ; temperature ; water ; wind stress
Language	English
Dates of publication	2021-06
Publishing place	John Wiley & Sons, Ltd
Document type	Article
Note	JOURNAL ARTICLE
ZDB-ID	5564-5
ISSN	1944-7973 ; 0043-1397
ISSN (online)	1944-7973
ISSN	0043-1397
DOI	10.1029/2020WR029441
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology.

Communications medicine

2022 Volume 2, Issue 1, Page(s) 154

Abstract: Background: Conventional preclinical models often miss drug toxicities, meaning the harm these drugs pose to humans is only realized in clinical trials or when they make it to market. This has caused the pharmaceutical industry to waste considerable ... ...

Abstract	Background: Conventional preclinical models often miss drug toxicities, meaning the harm these drugs pose to humans is only realized in clinical trials or when they make it to market. This has caused the pharmaceutical industry to waste considerable time and resources developing drugs destined to fail. Organ-on-a-Chip technology has the potential improve success in drug development pipelines, as it can recapitulate organ-level pathophysiology and clinical responses; however, systematic and quantitative evaluations of Organ-Chips' predictive value have not yet been reported. Methods: 870 Liver-Chips were analyzed to determine their ability to predict drug-induced liver injury caused by small molecules identified as benchmarks by the Innovation and Quality consortium, who has published guidelines defining criteria for qualifying preclinical models. An economic analysis was also performed to measure the value Liver-Chips could offer if they were broadly adopted in supporting toxicity-related decisions as part of preclinical development workflows. Results: Here, we show that the Liver-Chip met the qualification guidelines across a blinded set of 27 known hepatotoxic and non-toxic drugs with a sensitivity of 87% and a specificity of 100%. We also show that this level of performance could generate over $3 billion annually for the pharmaceutical industry through increased small-molecule R&D productivity. Conclusions: The results of this study show how incorporating predictive Organ-Chips into drug development workflows could substantially improve drug discovery and development, allowing manufacturers to bring safer, more effective medicines to market in less time and at lower costs.
Language	English
Publishing date	2022-12-06
Publishing country	England
Document type	Journal Article
ISSN	2730-664X
ISSN (online)	2730-664X
DOI	10.1038/s43856-022-00209-1
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