James Stevenson - Academia.edu (original) (raw)

Scholarship of Teaching and Learning by James Stevenson

After looking briefly at the history of the introduction of Crew Resource Management into the avi... more After looking briefly at the history of the introduction of Crew Resource Management into the aviation industry, we will go on to outline the central tenets of the approach and discuss how they are transferrable to the HE teaching environment. We will highlight four key areas:

1. Flattening hierarchy
2. The role of facilitation
3. Rethinking error correction
4. Peer support.

We will demonstrate the relevance of aviation-style Crew Resource Management to Higher Education teaching, outline the importance of effecting a culture shift with regard to attitudes towards error and instruction and suggest ways in which CRM might be employed as an alternative to current models of peer observation.

Papers by James Stevenson

Journal of the National Comprehensive Cancer Network, 2016

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) are a statement of consensu... more The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) are a statement of consensus of the authors regarding their views of currently accepted approaches to treatment. The NCCN Guidelines ® Insights highlight important changes to the NCCN Guidelines ® recommendations from previous versions. Colored markings in the algorithm show changes and the discussion aims to further the understanding of these changes by summarizing salient portions of the NCCN Guideline Panel discussion, including the literature reviewed. These NCCN Guidelines Insights do not represent the full NCCN Guidelines; further, the National Comprehensive Cancer Network ® (NCCN ®) makes no representation or warranties of any kind regarding the content, use, or application of the NCCN Guidelines and NCCN Guidelines Insights and disclaims any responsibility for their applications or use in any way. The full and most current version of these NCCN Guidelines are available at NCCN.org.

ChemRxiv, 2021

Transferable high dimensional neural network potentials (HDNNP) have shown great promise as an av... more Transferable high dimensional neural network potentials (HDNNP) have shown great promise as an avenue to increase the accuracy and domain of applicability of existing atomistic force fields for organic systems relevant to life science. We have previously reported such a potential (Schrodinger-ANI) that has broad coverage of druglike molecules. We extend that work here to cover ionic and zwitterionic druglike molecules expected to be relevant to drug discovery research activities. We report a novel HDNNP architechture, which we call QRNN, that predicts atomic charges and uses these charges as descriptors in an energy model which delivers conformational energies within chemical accuracy when measured against the reference theory it is trained to. Further, we find that delta learning based on a semi-empirical level of theory approximately halves the errors. We test the models on torsion energy profiles, relative conformational energies, geometric parameters and relative tautomer errors.

Aquaculture in the Philippines is a long-standing activity but has witnessed relatively recent, r... more Aquaculture in the Philippines is a long-standing activity but has witnessed relatively recent, rapid, technical change with the introduction of hatchery technology and commercial feed-mills changing the production possibilities for a fishpond operator. We are confronted with a diversity of aquaculture practices in the coastal areas of the Philippines, with new technologies being incorporated into more traditional systems. As a first step to understanding the sector, we therefore present a typology of farming systems with the motivation of generating domains (farm “types”) over which we can compare performance on a number of indicators. Our typology, restricted to brackish-water pond systems, is constructed using multivariate methods (principal components analysis, cluster analysis). Eight variables are used relating to the management of the farm across all the major factors of production. A stratified net sample of 136 observations provides the data for the analysis, from a farm-le...

1. Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman S... more 1. Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania (Daniel H Sterman, MD, Adri Recio, RN, Susan Metzger, RN, Edmund Moon MD, Andrew R Haas, MD/PhD, Anil Vachani MD, Paul Kennedy, Steven M Albelda MD) 2. Division of Hematology/Oncology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania (Evan Alley MD/PhD, James Stevenson MD, Corey Langer MD) 3. Division of Thoracic Surgery, University of Maryland School of Medicine (Joseph Friedberg MD, Melissa Culligan, RN, MS) 4. Department of Radiology, Perelman School of Medicine at the University of Pennsylvania (Sharyn Katz MD) 5. Department of Biostatistics & Epidemiology, Perelman School of Medicine at the University of Pennsylvania (Daniel Heitjan PhD, Kay See Tang PhD, Wei-Ting Hwang, PhD) 6. Department of Pathology and Laboratory Medicine, Perelman School of Medicine at the University of Pennsylvania (Leslie...

Dynamically screened scalar field theories form an attractive collection of models that were intr... more Dynamically screened scalar field theories form an attractive collection of models that were introduced to drive the late-time expansion of our universe. A common consequence of these theories is a screening mechanism which leads to the suppression of the fifth-forces mediated by the scalar field in sufficiently dense environments. This enables the models within this class of theories to avoid conflict with the stringent results from local tests of gravity, without the need for any fine tuning. The prototypical example of a dynamically screened scalar field is the chameleon model, for which screening arises due to the mass of the scalar responding to the local density. It has been recently demonstrated that atom interferometry is a powerful technique for constraining such scalars, with near future experiments capable of probing a large portion of the model parameter space. The nature of screening however means that closing in on what remains of the chameleon parameter space is going...

Journal of Clinical Oncology

7092 Background: Currently there are no validated biomarkers for assessment or prediction of dise... more 7092 Background: Currently there are no validated biomarkers for assessment or prediction of disease burden or activity in SCLC. Enumeration of CTCs by CellSearch is FDA approved, highly reproducible and validated in other malignancies. Application as a prognostic and predictive marker in SCLC is limited due to a lack of studies documenting serial monitoring in pts on therapy. Methods: We are conducting a prospective study serially enumerating CTCs in pts with newly diagnosed SCLC. CTC number (per 7.5 ml peripheral blood) and percentage of CTCs demonstrating DNA damage and apoptosis based on γH2AX and M30 staining respectively, are being assessed prior to initiation of chemotherapy, during each cycle and at relapse. We are correlating CTC number with disease stage, number of metastatic sites, response to therapy, and time to progression (TTP). Results: 21 SCLC pts are evaluable. 9 pts with limited disease (LD) had median baseline CTC value of 1 (0-8); only 2 of 9 pts had >5 CTCs....

Journal of Clinical Oncology

11547 Background: The absolute neutrophil count (ANC), absolute monocyte count (AMC) and neutroph... more 11547 Background: The absolute neutrophil count (ANC), absolute monocyte count (AMC) and neutrophil to lymphocyte ratio (NLR) are known markers of inflammation. We evaluated whether ANC, AMC and NLR are prognostic for overall survival (OS) and evaluated change in NLR as a predictive marker of response per RECIST in non -small cell lung cancer (NSCLC) patients treated with nivolumab. Methods: A total of 115 patients with NSCLC treated with nivolumab were included. ANC, AMC and NLR were examined at initiation of nivolumab therapy and after two cycles. The prognostic role of ANC, AMC and NLR on OS and changes in NLR ratio in responders was assessed using Cox regression model. Results: ANC > 6, AMC > 0.5 and NLR > 2.8 at baseline were independently associated with shorter OS (Hazard ratio (HR) 1.17 (1.08-1.27), p = .00001; HR 4.53 (1.99-10.31), p = 0.04 and HR 1.09 (1.04-1.13), p = 0.0002 . Responders had a decrease in NLR by (median (range) -0.93 (-14.7-52.95), p = 0.03) where...

Journal of Clinical Oncology

6565 Background: Per accepted guidelines, pGCSF is not recommended for pts receiving CT regimens ... more 6565 Background: Per accepted guidelines, pGCSF is not recommended for pts receiving CT regimens with low risk ( 20%) or intermediate risk (10-20%) if other risk factors for FN were present. Use with low-risk CT was considered inappropriate. We implemented three QI strategies: education of NSCLC providers, development of TCI Consensus Guidelines for the use of pGCSF in NSCLC, and EMR modification: labeling of CT regimens by FN risk and removal of s...

Journal of Clinical Oncology

11603Background: Drugs targeting the PD1/PD-L1 pathway show significant clinical activity across ... more 11603Background: Drugs targeting the PD1/PD-L1 pathway show significant clinical activity across several tumors. However, a majority of patients (pts) do not respond to these agents. Biomarker assays to predict response is an active area of research however the predictive value of PD-L1 IHC assays is inconsistent across clinical trials. In this meta-analysis of clinical trials with PD1/PD-L1 targeted agents we evaluate the predictive value of PD-L1 IHC. Methods: We searched databases (PubMed, Medline, Cochrane) and major conference proceedings up until 01/2015 for clinical trials using PD1/PD-L1 inhibitors with reported PD-L1 biomarker data. Objective response rates (primary endpoint) from all phase I-III trials investigating Nivolumab, Pembrolizumab, Atezolimumab, Durvalumab and Avelumab for non-small cell lung cancer (NSCLC), melanoma and genitourinary cancers were collected. Odds ratios (OR) for response in PD-L1 (+) pts compared to PD-L1 (-) pts were calculated using the DerSimonian-Laird random effec...

Journal of Cosmology and Astroparticle Physics

Chameleon scalar fields can screen their associated fifth forces from detection by changing their... more Chameleon scalar fields can screen their associated fifth forces from detection by changing their mass with the local density. These models are an archetypal example of a screening mechanism, and have become an important target for both cosmological surveys and terrestrial experiments. In particular there has been much recent interest in searching for chameleon fifth forces in the laboratory. It is known that the chameleon force is less screened around non-spherical sources, but only the field profiles around a few simple shapes are known analytically. In this work we introduce a numerical code that solves for the chameleon field around arbitrary shapes with azimuthal symmetry placed in a spherical vacuum chamber. We find that deviations from spherical symmetry can increase the chameleon acceleration experienced by a test particle, and that the least screened objects are those which minimize some internal dimension. For the shapes considered in this work, keeping the mass, density and background environment fixed, the accelerations due to the source varied by a factor of ∼ 3.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, Jan 20, 2018

Cohort G of KEYNOTE-021 (NCT02039674) evaluated the efficacy and safety of pembrolizumab plus pem... more Cohort G of KEYNOTE-021 (NCT02039674) evaluated the efficacy and safety of pembrolizumab plus pemetrexed-carboplatin (PC) versus PC alone as first-line therapy for advanced nonsquamous NSCLC. At the primary analysis (median follow-up, 10.6 months), pembrolizumab significantly improved objective response rate (ORR) and progression-free survival (PFS); hazard ratio (HR) for overall survival (OS) was 0.90 (95% CI, 0.42‒1.91). Herein, we present an updated analysis. 123 patients with previously untreated stage IIIB/IV nonsquamous NSCLC without EGFR/ALK aberrations were randomized 1:1 to 4 cycles of PC with/without pembrolizumab 200 mg Q3W. Pembrolizumab treatment continued for 2 years; maintenance pemetrexed was permitted in both groups. Eligible patients in the PC alone group with radiologic progression could cross over to pembrolizumab monotherapy. P values are nominal (one-sided P<0.025). As of December 1, 2017, median follow-up was 23.9 mo. ORR was 56.7% with pembrolizumab plus P...

Journal of the National Comprehensive Cancer Network

This selection from the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) focuses on targete... more This selection from the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) focuses on targeted therapies and immunotherapies for metastatic NSCLC, because therapeutic recommendations are rapidly changing for metastatic disease. For example, new recommendations were added for atezolizumab, ceritinib, osimertinib, and pembrolizumab for the 2017 updates.

Policy Research Working Papers, 2016

The Policy Research Working Paper Series disseminates the findings of work in progress to encoura... more The Policy Research Working Paper Series disseminates the findings of work in progress to encourage the exchange of ideas about development issues. An objective of the series is to get the findings out quickly, even if the presentations are less than fully polished. The papers carry the names of the authors and should be cited accordingly. The findings, interpretations, and conclusions expressed in this paper are entirely those of the authors. They do not necessarily represent the views of the International Bank for Reconstruction and Development/World Bank and its affiliated organizations, or those of the Executive Directors of the World Bank or the governments they represent.

Journal of managed care & specialty pharmacy, 2016

The most appropriate naming convention for biologics and biosimilars has been an area of signific... more The most appropriate naming convention for biologics and biosimilars has been an area of significant debate. The ultimate decision will have an impact on patient safety, pharmacovigilance program effectiveness, and, potentially, the overall adoption of biosimilars in the United States. This article reviews some of the advantages and disadvantages of various naming approaches. For clarity in communication, optimal pharmacovigilance, and patient safety, it is recommended that biosimilars be named with a common USAN (United States Adopted Name) with the reference product, along with a suffix that is memorable, such as one associated with the original manufacturer of the product. This approach supports the FDA's mission of protecting patient safety and public health, while minimizing the possibility of inadvertent switching of products and facilitating effective pharmacovigilance. No funding supported the writing of this article. Stevenson reports consulting fees from Amgen, Inc., A...

Assent is an act of the mind, congenial to its nature; and it, as other acts, may be made both wh... more Assent is an act of the mind, congenial to its nature; and it, as other acts, may be made both when it ought to be made and when it ought not. It is a free act, a personal act for which the doer is responsible.1

After looking briefly at the history of the introduction of Crew Resource Management into the avi... more After looking briefly at the history of the introduction of Crew Resource Management into the aviation industry, we will go on to outline the central tenets of the approach and discuss how they are transferrable to the HE teaching environment. We will highlight four key areas:

1. Flattening hierarchy
2. The role of facilitation
3. Rethinking error correction
4. Peer support.

We will demonstrate the relevance of aviation-style Crew Resource Management to Higher Education teaching, outline the importance of effecting a culture shift with regard to attitudes towards error and instruction and suggest ways in which CRM might be employed as an alternative to current models of peer observation.

Journal of the National Comprehensive Cancer Network, 2016

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) are a statement of consensu... more The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) are a statement of consensus of the authors regarding their views of currently accepted approaches to treatment. The NCCN Guidelines ® Insights highlight important changes to the NCCN Guidelines ® recommendations from previous versions. Colored markings in the algorithm show changes and the discussion aims to further the understanding of these changes by summarizing salient portions of the NCCN Guideline Panel discussion, including the literature reviewed. These NCCN Guidelines Insights do not represent the full NCCN Guidelines; further, the National Comprehensive Cancer Network ® (NCCN ®) makes no representation or warranties of any kind regarding the content, use, or application of the NCCN Guidelines and NCCN Guidelines Insights and disclaims any responsibility for their applications or use in any way. The full and most current version of these NCCN Guidelines are available at NCCN.org.

ChemRxiv, 2021

Transferable high dimensional neural network potentials (HDNNP) have shown great promise as an av... more Transferable high dimensional neural network potentials (HDNNP) have shown great promise as an avenue to increase the accuracy and domain of applicability of existing atomistic force fields for organic systems relevant to life science. We have previously reported such a potential (Schrodinger-ANI) that has broad coverage of druglike molecules. We extend that work here to cover ionic and zwitterionic druglike molecules expected to be relevant to drug discovery research activities. We report a novel HDNNP architechture, which we call QRNN, that predicts atomic charges and uses these charges as descriptors in an energy model which delivers conformational energies within chemical accuracy when measured against the reference theory it is trained to. Further, we find that delta learning based on a semi-empirical level of theory approximately halves the errors. We test the models on torsion energy profiles, relative conformational energies, geometric parameters and relative tautomer errors.

Aquaculture in the Philippines is a long-standing activity but has witnessed relatively recent, r... more Aquaculture in the Philippines is a long-standing activity but has witnessed relatively recent, rapid, technical change with the introduction of hatchery technology and commercial feed-mills changing the production possibilities for a fishpond operator. We are confronted with a diversity of aquaculture practices in the coastal areas of the Philippines, with new technologies being incorporated into more traditional systems. As a first step to understanding the sector, we therefore present a typology of farming systems with the motivation of generating domains (farm “types”) over which we can compare performance on a number of indicators. Our typology, restricted to brackish-water pond systems, is constructed using multivariate methods (principal components analysis, cluster analysis). Eight variables are used relating to the management of the farm across all the major factors of production. A stratified net sample of 136 observations provides the data for the analysis, from a farm-le...

1. Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman S... more 1. Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania (Daniel H Sterman, MD, Adri Recio, RN, Susan Metzger, RN, Edmund Moon MD, Andrew R Haas, MD/PhD, Anil Vachani MD, Paul Kennedy, Steven M Albelda MD) 2. Division of Hematology/Oncology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania (Evan Alley MD/PhD, James Stevenson MD, Corey Langer MD) 3. Division of Thoracic Surgery, University of Maryland School of Medicine (Joseph Friedberg MD, Melissa Culligan, RN, MS) 4. Department of Radiology, Perelman School of Medicine at the University of Pennsylvania (Sharyn Katz MD) 5. Department of Biostatistics & Epidemiology, Perelman School of Medicine at the University of Pennsylvania (Daniel Heitjan PhD, Kay See Tang PhD, Wei-Ting Hwang, PhD) 6. Department of Pathology and Laboratory Medicine, Perelman School of Medicine at the University of Pennsylvania (Leslie...

Dynamically screened scalar field theories form an attractive collection of models that were intr... more Dynamically screened scalar field theories form an attractive collection of models that were introduced to drive the late-time expansion of our universe. A common consequence of these theories is a screening mechanism which leads to the suppression of the fifth-forces mediated by the scalar field in sufficiently dense environments. This enables the models within this class of theories to avoid conflict with the stringent results from local tests of gravity, without the need for any fine tuning. The prototypical example of a dynamically screened scalar field is the chameleon model, for which screening arises due to the mass of the scalar responding to the local density. It has been recently demonstrated that atom interferometry is a powerful technique for constraining such scalars, with near future experiments capable of probing a large portion of the model parameter space. The nature of screening however means that closing in on what remains of the chameleon parameter space is going...

Journal of Clinical Oncology

7092 Background: Currently there are no validated biomarkers for assessment or prediction of dise... more 7092 Background: Currently there are no validated biomarkers for assessment or prediction of disease burden or activity in SCLC. Enumeration of CTCs by CellSearch is FDA approved, highly reproducible and validated in other malignancies. Application as a prognostic and predictive marker in SCLC is limited due to a lack of studies documenting serial monitoring in pts on therapy. Methods: We are conducting a prospective study serially enumerating CTCs in pts with newly diagnosed SCLC. CTC number (per 7.5 ml peripheral blood) and percentage of CTCs demonstrating DNA damage and apoptosis based on γH2AX and M30 staining respectively, are being assessed prior to initiation of chemotherapy, during each cycle and at relapse. We are correlating CTC number with disease stage, number of metastatic sites, response to therapy, and time to progression (TTP). Results: 21 SCLC pts are evaluable. 9 pts with limited disease (LD) had median baseline CTC value of 1 (0-8); only 2 of 9 pts had >5 CTCs....

Journal of Clinical Oncology

11547 Background: The absolute neutrophil count (ANC), absolute monocyte count (AMC) and neutroph... more 11547 Background: The absolute neutrophil count (ANC), absolute monocyte count (AMC) and neutrophil to lymphocyte ratio (NLR) are known markers of inflammation. We evaluated whether ANC, AMC and NLR are prognostic for overall survival (OS) and evaluated change in NLR as a predictive marker of response per RECIST in non -small cell lung cancer (NSCLC) patients treated with nivolumab. Methods: A total of 115 patients with NSCLC treated with nivolumab were included. ANC, AMC and NLR were examined at initiation of nivolumab therapy and after two cycles. The prognostic role of ANC, AMC and NLR on OS and changes in NLR ratio in responders was assessed using Cox regression model. Results: ANC > 6, AMC > 0.5 and NLR > 2.8 at baseline were independently associated with shorter OS (Hazard ratio (HR) 1.17 (1.08-1.27), p = .00001; HR 4.53 (1.99-10.31), p = 0.04 and HR 1.09 (1.04-1.13), p = 0.0002 . Responders had a decrease in NLR by (median (range) -0.93 (-14.7-52.95), p = 0.03) where...

Journal of Clinical Oncology

6565 Background: Per accepted guidelines, pGCSF is not recommended for pts receiving CT regimens ... more 6565 Background: Per accepted guidelines, pGCSF is not recommended for pts receiving CT regimens with low risk ( 20%) or intermediate risk (10-20%) if other risk factors for FN were present. Use with low-risk CT was considered inappropriate. We implemented three QI strategies: education of NSCLC providers, development of TCI Consensus Guidelines for the use of pGCSF in NSCLC, and EMR modification: labeling of CT regimens by FN risk and removal of s...

Journal of Clinical Oncology

11603Background: Drugs targeting the PD1/PD-L1 pathway show significant clinical activity across ... more 11603Background: Drugs targeting the PD1/PD-L1 pathway show significant clinical activity across several tumors. However, a majority of patients (pts) do not respond to these agents. Biomarker assays to predict response is an active area of research however the predictive value of PD-L1 IHC assays is inconsistent across clinical trials. In this meta-analysis of clinical trials with PD1/PD-L1 targeted agents we evaluate the predictive value of PD-L1 IHC. Methods: We searched databases (PubMed, Medline, Cochrane) and major conference proceedings up until 01/2015 for clinical trials using PD1/PD-L1 inhibitors with reported PD-L1 biomarker data. Objective response rates (primary endpoint) from all phase I-III trials investigating Nivolumab, Pembrolizumab, Atezolimumab, Durvalumab and Avelumab for non-small cell lung cancer (NSCLC), melanoma and genitourinary cancers were collected. Odds ratios (OR) for response in PD-L1 (+) pts compared to PD-L1 (-) pts were calculated using the DerSimonian-Laird random effec...

Journal of Cosmology and Astroparticle Physics

Chameleon scalar fields can screen their associated fifth forces from detection by changing their... more Chameleon scalar fields can screen their associated fifth forces from detection by changing their mass with the local density. These models are an archetypal example of a screening mechanism, and have become an important target for both cosmological surveys and terrestrial experiments. In particular there has been much recent interest in searching for chameleon fifth forces in the laboratory. It is known that the chameleon force is less screened around non-spherical sources, but only the field profiles around a few simple shapes are known analytically. In this work we introduce a numerical code that solves for the chameleon field around arbitrary shapes with azimuthal symmetry placed in a spherical vacuum chamber. We find that deviations from spherical symmetry can increase the chameleon acceleration experienced by a test particle, and that the least screened objects are those which minimize some internal dimension. For the shapes considered in this work, keeping the mass, density and background environment fixed, the accelerations due to the source varied by a factor of ∼ 3.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, Jan 20, 2018

Cohort G of KEYNOTE-021 (NCT02039674) evaluated the efficacy and safety of pembrolizumab plus pem... more Cohort G of KEYNOTE-021 (NCT02039674) evaluated the efficacy and safety of pembrolizumab plus pemetrexed-carboplatin (PC) versus PC alone as first-line therapy for advanced nonsquamous NSCLC. At the primary analysis (median follow-up, 10.6 months), pembrolizumab significantly improved objective response rate (ORR) and progression-free survival (PFS); hazard ratio (HR) for overall survival (OS) was 0.90 (95% CI, 0.42‒1.91). Herein, we present an updated analysis. 123 patients with previously untreated stage IIIB/IV nonsquamous NSCLC without EGFR/ALK aberrations were randomized 1:1 to 4 cycles of PC with/without pembrolizumab 200 mg Q3W. Pembrolizumab treatment continued for 2 years; maintenance pemetrexed was permitted in both groups. Eligible patients in the PC alone group with radiologic progression could cross over to pembrolizumab monotherapy. P values are nominal (one-sided P<0.025). As of December 1, 2017, median follow-up was 23.9 mo. ORR was 56.7% with pembrolizumab plus P...

Journal of the National Comprehensive Cancer Network

This selection from the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) focuses on targete... more This selection from the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) focuses on targeted therapies and immunotherapies for metastatic NSCLC, because therapeutic recommendations are rapidly changing for metastatic disease. For example, new recommendations were added for atezolizumab, ceritinib, osimertinib, and pembrolizumab for the 2017 updates.

Policy Research Working Papers, 2016

The Policy Research Working Paper Series disseminates the findings of work in progress to encoura... more The Policy Research Working Paper Series disseminates the findings of work in progress to encourage the exchange of ideas about development issues. An objective of the series is to get the findings out quickly, even if the presentations are less than fully polished. The papers carry the names of the authors and should be cited accordingly. The findings, interpretations, and conclusions expressed in this paper are entirely those of the authors. They do not necessarily represent the views of the International Bank for Reconstruction and Development/World Bank and its affiliated organizations, or those of the Executive Directors of the World Bank or the governments they represent.

Journal of managed care & specialty pharmacy, 2016

The most appropriate naming convention for biologics and biosimilars has been an area of signific... more The most appropriate naming convention for biologics and biosimilars has been an area of significant debate. The ultimate decision will have an impact on patient safety, pharmacovigilance program effectiveness, and, potentially, the overall adoption of biosimilars in the United States. This article reviews some of the advantages and disadvantages of various naming approaches. For clarity in communication, optimal pharmacovigilance, and patient safety, it is recommended that biosimilars be named with a common USAN (United States Adopted Name) with the reference product, along with a suffix that is memorable, such as one associated with the original manufacturer of the product. This approach supports the FDA's mission of protecting patient safety and public health, while minimizing the possibility of inadvertent switching of products and facilitating effective pharmacovigilance. No funding supported the writing of this article. Stevenson reports consulting fees from Amgen, Inc., A...

Assent is an act of the mind, congenial to its nature; and it, as other acts, may be made both wh... more Assent is an act of the mind, congenial to its nature; and it, as other acts, may be made both when it ought to be made and when it ought not. It is a free act, a personal act for which the doer is responsible.1