Medicine and Health Sciences Commons^™

People Perspectives In The Deployment Of Data Analytics For New Knowledge Generation In Pharmaceutical Manufacturing, Marcus O'Mahony Dr.

Level 3

Digital medicine manufacturing of the future will almost certainly involve greater use of advanced analytics tools for more data-driven decision-making. In this article, the role of people in the deployment of data analytics tools within the pharmaceutical manufacturing setting is explored. Some perspectives are presented for how people can make sense of working cross-functionally on the analytics journey to deliver new knowledge and insights that enable data-driven decisions to be made. Data analytics is defined and is proposed as a critical common ground between the “on-the-ground” data practitioners and the decision-makers who act on new knowledge. Reference is made to …

Steps Towards Digital Transformation In The Pharmaceutical Manufacturing Landscape Knowledge-Enabled Technology Transfer, Anne Greene Professor, Martin Lipa Dr

Level 3

No abstract provided.

Stereocontrolled Access To Δ-Lactone-Fused-Γ-Lactams Bearing Angular Benzylic Quaternary Stereocenters, Timothy K. Beng, Morgan J. Rodriguez, Claire Borg

All Faculty Scholarship for the College of the Sciences

C-fused γ-lactam-lactones are resident in several bioactive molecules, including anticancer agents such as omuralide. In this embodiment, we report mild conditions for the catalytic halolactonization of lactam-tethered 5-aryl-4(E)-pentenoic acids. The use of dichloromethane as the solvent and Ph₃PS as the catalyst led to predominant 6-endo-trig cyclization and furnished the trans-fused-γ-lactam-δ-lactones. The transformation is modular, regioselective, chemoselective, and diastereoselective. The γ-lactam-δ-lactones bear angular quaternary benzylic stereocenters, which is noteworthy since the presence of a quaternary carbon in bioactive small molecules often promotes an element of conformational restriction that imparts potency, selectivity, and metabolic stability. The …

Emerging Technologies: Empowering People To Capture, Share And Transfer Tacit Knowledge, Donncadh J. Nagle, Melanie J. Adams

Level 3

ICH Q10 was published in 2008, and presented a model for an effective Pharmaceutical Quality System (PQS). However, the industry still has some way to go in embracing and implementing its principles in order to achieve greater product realisation, to establish and maintain a state of control, and to facilitate continual improvement.

ICH Q10 introduced us to two key enablers: Knowledge Management (KM) and Quality Risk Management (QRM).^[1] While the pharmaceutical industry has made progress in implementing the principles of QRM since 2008, there has been significantly slower progress in implementing knowledge management practices. However, there may be solutions …

The Implications Of Tacit & Explicit Knowledge For Technology Transfer: When It Goes Well & When It Goes Wrong & What Can Digital Do To Help!, Paige Kane Dr., David Twohig Dr.

Level 3

No abstract provided.

Ciliogenesis Mechanisms Mediated By Pak2-Arl13b Signaling In Brain Endothelial Cells Is Responsible For Vascular Stability, Karthikeyan Thirugnanam, Shubhangi Prabhudesai, Emma Van Why, Amy Pan, Ankan Gupta, Koji Foreman, Rahima Zennadi, Kevin R. Rarick, Surya M. Nauli, Sean P. Palacek, Ramani Ramchandran

Pharmacy Faculty Articles and Research

In the developing vasculature, cilia, microtubule-based organelles that project from the apical surface of endothelial cells (ECs), have been identified to function cell autonomously to promote vascular integrity and prevent hemorrhage. To date, the underlying mechanisms of endothelial cilia formation (ciliogenesis) are not fully understood. Understanding these mechanisms is likely to open new avenues for targeting EC-cilia to promote vascular stability. Here, we hypothesized that brain ECs ciliogenesis and the underlying mechanisms that control this process are critical for brain vascular stability. To investigate this hypothesis, we utilized multiple approaches including developmental zebrafish model system and primary cell culture systems. …

A Cost-Effectiveness Study Comparing Ready-Toadminister And Traditional Vial-And-Syringe Method For Opioids, Prachi Arora, Maria Muehrcke, John Hertig

Scholarship and Professional Work – COPHS

No abstract provided.

Cis- And Trans-Resveratrol Have Opposite Effects On Histone Serine-Adp-Ribosylation And Tyrosine Induced Neurodegeneration, Megha Jhanji, Chintada Nageswara Rao, Jacob C. Massey, Marion C. Hope Iii, Xueyan Zhou, C. Dirk Keene, Tao Ma, Michael D. Wyatt, Jason A. Stewart, Sajish Mathew

Faculty Publications

Serum tyrosine levels increase during aging, neurocognitive, metabolic, and cardiovascular disorders. However, calorie restriction (CR) and sleep lower serum tyrosine levels. We previously showed that tyrosine inhibits tyrosyl-tRNA synthetase (TyrRS)-mediated activation of poly-ADP-ribose polymerase 1 (PARP1). Here, we show that histone serine-ADP-ribosylation is decreased in Alzheimer’s Disease (AD) brains, and increased tyrosine levels deplete TyrRS and cause neuronal DNA damage. However, dopamine and brain-derived neurotrophic factor (BDNF) increase TyrRS and histone serine-ADP-ribosylation. Furthermore, cis-resveratrol (cis-RSV) that binds to TyrRS mimicking a ‘tyrosine-free’ conformation increases TyrRS, facilitates histone serine-ADP-ribosylation-dependent DNA repair, and provides neuroprotection in a TyrRS-dependent manner. …

Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico

Seton Hall University Dissertations and Theses (ETDs)

Background and purpose of study: Pharmaceutical drugs are commonly used to treat various ailments and the pharmaceutical industry is increasingly leveraging expedited pathways to market, like the FDA’s accelerated approval pathway. Thus, these pathways are becoming more prevalent and thus more scrutinized for reliability. A consequence from this increased utilization is observed variability in time to reach full approval from the point accelerated approval was received. Variables that may impact time and ability to reach full approval should be further investigated. The purpose of this study was to explore, identify and predict variables that may influence time from accelerated approval …

Catchem Before They Fall Through The Cracks: Implementation Of A Comprehensive Atherosclerosis Treatment Collaborative Health System Transition Of Care Multidisciplinary Clinic, Youssef Bessada, Taki Galanis, Brandi Thoma, Luis Eraso, Walter Kraft, Geno Merli, Dina Orapallo, Lynda Thomson, Heather Yenser

Pharmacy Presentations, Posters, and Grand Rounds

Introduction: Peripheral Artery Disease (PAD) is a common atherosclerotic cardiovascular (CV) disease that increases the risk for fatal and non-fatal CV events. Guidelines for the treatment of PAD recommend that in addition to necessary revascularization, general CV prevention with optimal medical therapy is of utmost importance and management is recommended to be multidisciplinary. While the prevalence of PAD in various practices is high, physician awareness of the PAD diagnosis is relatively low and the pharmacological component of preventative CV care is often underutilized resulting in patients receiving less intensive treatment. With new pharmacological agents, including advances in antithrombotic therapy, contributing …

Medication Therapy Management Implementation In Conjunction With A Rural Health Clinic In Minnesota: A Cqi Impact On Diabetes Metrics, Abigail Sirek Pharmd

Theses and Dissertations

The purpose of this continuous quality improvement project was to implement a pharmacist-led Medication Therapy Management (MTM) clinic in rural, central Minnesota and assess the impact on patients’ healthcare over a six-month period. Patients were identified through the clinic’s diabetes registry, which included patients 18 through 75 years old with a diagnosis of diabetes not meeting all five D5 goals, as recommended by the Minnesota Community Measurements, independently referred by the provider, or be identified by their insurance company as a patient that would benefit from an MTM visit. The D5 focuses on blood pressure and blood sugar control, appropriate …

Design Of Topical Moxifloxacin Mucoadhesive Nanoemulsion For The Management Of Ocular Bacterial Infections, Ahmed Adel Ali Youssef, Ruchi Thakkar, Samir Senapati, Poorva H. Joshi

Faculty and Student Publications

Ocular bacterial infections can lead to serious visual disability without proper treatment. Moxifloxacin (MOX) has been approved by the US Food and Drug Administration as a monotherapy for ocular bacterial infections and is available commercially as an ophthalmic solution (0.5% w/v). However, precorneal retention, drainage, and low bioavailability remain the foremost challenges associated with current commercial eyedrops. With this study, we aimed to design a MOX-loaded nanoemulsion (NE; MOX-NE) with mucoadhesive agents (MOX-NEM) to sustain MOX release, as well as to overcome the potential drawbacks of the current commercial ophthalmic formulation. MOX-NE and MOX-NEM formulations were prepared by hot homogenization …

The International Cannabis Toolkit (Icanntoolkit): A Multidisciplinary Expert Consensus On Minimum Standards For Measuring Cannabis Use, Valentina Lorenzetti, Chandni Hindocha, Kat Petrilli, Paul Griffiths

Faculty and Student Publications

Background: The lack of an agreed international minimum approach to measuring cannabis use hinders the integration of multidisciplinary evidence on the psychosocial, neurocognitive, clinical and public health consequences of cannabis use. Methods: A group of 25 international expert cannabis researchers convened to discuss a multidisciplinary framework for minimum standards to measure cannabis use globally in diverse settings. Results: The expert-based consensus agreed upon a three-layered hierarchical framework. Each layer—universal measures, detailed self-report and biological measures—reflected different research priorities and minimum standards, costs and ease of implementation. Additional work is needed to develop valid and precise assessments. Conclusions: Consistent use of …

An Evaluation Of The Effect Of The Oxycontin Reformulation On Unintentional Fatal And Nonfatal Overdose, Daniel C. Beachler, Kelsey Hall, Renu Garg, Geetanjoli Banerjee, Ling Li, Luke Boulanger, Huseyin Yuce, Alexander M. Walker

Applied Sciences, Technology and Education Faculty Publications

Objectives:

OxyContin was reformulated with a polyethylene oxide matrix in August 2010 to reduce the potential for intravenous abuse and for abuse by insufflation. The objective of this study was to evaluate the impact of OxyContin's reformulation on overdose (OD) risk for individuals dispensed OxyContin in comparison to those dispensed other opioids under regular care.

Materials and Methods:

Three national insurance databases with National Death Index linkage identified OD in individuals with any dispensing of OxyContin or a primary comparator opioid (extended release morphine, transdermal fentanyl, or methadone) between July 2008 through September 2015. A difference-in-differences design was used to …

Commencement Program 2022, Loma Linda University

Commencement Programs

CONTENTS

1 | Message from the President

3 | 2022 Events of Commencement

5 | The Academic Procession

6 | Institutional Administration

7 | Board of Trustees

8 | Significance of Academic Regalia

9 | University History Highlights

11 | Criteria for Institutional Awards

13 | Loma Linda University Health and Loma Linda University Honorees

27 | The Programs, The School Honorees, and The Speakers

• School of Medicine, 28
• School of Pharmacy, 52
• School of Dentistry, 67
• School of Public Health, 92
• School of Allied Health Professions - Allied Health Studies, Cardiopulmonary Sciences, Clinical Laboratory Science, Communication Sciences and Disorders, …

Enhanced Antioxidant, Antiviral, And Anticancer Activities Of The Extract Of Fermented Egyptian Rice Bran Complexed With Hydroxypropyl-Β-Cyclodextrin, Khaled Nematallah, Sherif Ashraf Fahmy, Noha Khalil Mahdy, Hesham El-Askry, Meselhy Ragab Meselhy, Hassan El-Said Azzazy

Pharmacy

Egyptian rice bran was fermented with baker’s yeast, and released phenolics were extracted with aqueous methanol to give fermented rice bran extract (FRBE). The analysis of the FRBE with ultra-performance liquid chromatography–electrospray ionization–tandem mass spectrometry revealed 21 compounds, mainly phenolic acids and flavonoids. The FRBE was then complexed with (2-hydroxypropyl)-β-cyclodextrin (HPβCD) via noncovalent host–guest inclusion complexation using the thin-film hydration technique to improve the hydrophilicity and bioactivity of the FRBE. The formation of the inclusion complex was confirmed using HPLC, 1H NMR, FT-IR, and a phase solubility study. In addition, the biological activities of the complex were investigated. The FRBE/HPβCD …

A Call To Action From The Purdue University Center For Health Equity And Innovation, Jasmine D. Gonzalvo, Ashley H. Meredith, Omolola A. Adeoye-Olatunde, Carlyn Kimiecik, Sonak Pastakia, Natalia Rodriguez, Yumary Ruiz, Carol Ott, Ellen Schellhase, Elizabeth Crawford, Susie Crowe, Jeffrey Samuel, Megan Conklin, Jerome Adams, Rakhi Karwa

Department of Pharmacy Practice Faculty Publications

The Purdue University College of Pharmacy established the Center for Health Equity and Innovation (CHEqI) to provide students, faculty, and internal and external partners with a coordinating center whose primary purpose is to address inequities in the social determinants of health. Through this article the development of the center, the interdisciplinary activities the center is currently engaged in, ongoing educational efforts to provide instruction related to equity, and research endeavors designed to better understand the impact of our efforts are described. Pharmacists and colleges/schools of pharmacy must optimize health equity efforts with interdisciplinary partners by: (1) providing student opportunities to …

Host-Pathogen Interactions During Leptospirosis In Male C3h/Hej Mice, Advait Bhaskar Shetty

Theses and Dissertations (ETD)

Leptospirosis is a zoonotic disease transmitted from reservoir hosts like rodents to other animals and humans, who are incidental hosts. This infection is prevalent in the areas of Southeast Asia, Africa and South America. Inactivated Leptospira serovars vaccines are available in endemic areas but they have certain limitations such as serovar specificity and short-term protection. Antibiotics are effective treatment strategies useful at least during early stages of infection. Early diagnosis of Leptospirosis is difficult due to lack of accessible laboratory and point of care tests and due to clinical similarities with other diseases. Thus, it is important to understand host-Leptospira …

Targeting Myeloid Protein Kinase C Signaling To Overcome Immune Suppression And Improve Immunotherapy In Cancer, Mehdi Chaib

Theses and Dissertations (ETD)

Checkpoint immunotherapy unleashes T cell antitumor potential which has revolutionized cancer treatment showing unprecedented long-term responses. However, most patients do not respond to immunotherapy which often correlates with a dysfunctional or immunosuppressive myeloid compartment. Immunosuppressive myeloid cells comprise Myeloid-derived suppressor cells (MDSCs) and tumor-associated macrophages (TAMs) and can suppress T cells via production of immunosuppressive factors. Conversely, efficient cytotoxic T cell priming is dependent on the ability of antigen-presenting cells (APCs), mainly conventional dendritic cells (cDCs) and macrophages, to present or cross-present tumor antigens to T cells. Thus, targeting immunosuppressive myeloid cells while simultaneously enhancing APCs represents a promising strategy …

A Detailed Parameter Study Into The Dermal Absorption Of Chemical Warfare Agents And The Effects Of Pharmacokinetics, Koko Lear

Theses

Chemical warfare agents (CWAs) are substances of varying toxicity profiles. These chemicals exhibit complex dynamics and pose a serious health risk when released into the environment. A mathematical model based on Fick’s second law of diffusion was developed to comprehend how these compounds were absorbed into the skin. The analysis applied to both small and large doses and, successfully, predicted experimental results. This work also includes the effects of CWA physicochemical properties on evaporation and dermal absorption through the stratum corneum. A sensitivity analysis was conducted to assess the impacts of small variations in the initial dose, environmental conditions, and …

Crude Extract Of Desmodium Gangeticum Process Anticancer Activity Via Arresting Cell Cycle In G1 And Modulating Cell Cycle-Related Protein Expression In A549 Human Lung Carcinoma Cells, Yuh-Fung Chen, Yi-Hsien Lu, Huei-Yann Tsai

BioMedicine

Background: Desmodium gangeticum (L.)DC., which belongs to the Leguminosae family, has been used in Taiwan and other subtropical countries as an external medicine to remove blood stasis, activate blood circulation, and reduce inflammation. It has been reported to have antioxidant effects and improve inflammatory responses in rats stimulated by pro-inflammatory agents and induced gastric ulcers in experimental animals over the past few decades. This plant has also been used to treat parasitic infections, but there are no reports regarding its effects on lung cancer. Therefore, this study attempted to investigate its water crude extract (in abbreviation DG) on lung …

Fibroblast Growth Factor Receptor 1-Bound Extracellular Vesicle As Novel Therapy For Osteoarthritis, Bryan Gervais De Liyis, John Nolan, Made Agus Maharjana

BioMedicine

Osteoarthritis (OA) is a joint condition that causes significant impairment of the chondrocyte. The gradual degradation of the cartilage lining of one or more freely moving joints, as well as persistent inflammation, are the causes of osteoarthritis. Current medication focus on alleviating symptoms rather than curing the condition. The aim of this review is to evaluate the potential use of fibroblast growth factor receptor 1 extracellular vesicle as novel therapy for osteoarthritis. This review article was completed by searching for the keywords “Fibroblast Growth Factor Receptor 1”, “Extracellular Vesicle”, and “Osteoarthritis” in various journals in several search engines. Of the …

Comparative Studies Between The Murine Immortalized Brain Endothelial Cell Line (Bend.3) And Induced Pluripotent Stem Cell-Derived Human Brain Endothelial Cells For Paracellular Transport, Jiahong Sun, Weijun Ou, Derick Han, Annlia Paganini-Hill, Mark J. Fisher, Rachita K. Sumbria

Pharmacy Faculty Articles and Research

Brain microvascular endothelial cells, forming the anatomical site of the blood-brain barrier (BBB), are widely used as in vitro complements to in vivo BBB studies. Among the immortalized cells used as in vitro BBB models, the murine-derived bEnd.3 cells offer culturing consistency and low cost and are well characterized for functional and transport assays, but result in low transendothelial electrical resistance (TEER). Human-induced pluripotent stem cells differentiated into brain microvascular endothelial cells (ihBMECs) have superior barrier properties, but the process of differentiation is time-consuming and can result in mixed endothelial-epithelial gene expression. Here we performed a side-by-side comparison of the …

A Single Local Delivery Of Paclitaxel And Nucleic Acids Via An Immunoactive Polymer Eliminates Tumors And Induces Antitumor Immunity, Fanfei Meng, Jianping Wang, Yanying He, Gregory M. Cresswell, Nadia A. Lanman, L. Tiffany Lyle, Timothy L. Ratliff, Yoon Yeo

Purdue University Libraries Open Access Publishing Fund

Despite recent advances in cancer therapy, hard-to-reach, unidentified tumors remain a significant clinical challenge. A promising approach is to treat locatable and accessible tumors locally and stimulate antitumor immunity in situ to exert systemic effects against distant tumors. We hypothesize that a carrier of immunotherapeutics can play a critical role in activating antitumor immunity as an immunoadjuvant and a local retainer of drug combinations. Here, we develop a polyethyleneimine-lithocholic acid conjugate (2E′), which forms a hydrophobic core and cationic surface to codeliver hydrophobic small molecules and anionic nucleic acids and activates antigen-presenting cells via the intrinsic activities of 2E′ components. …

Development Of Anti-Inflammatory Theranostic Nanocolloids Using Quality By Design Approaches, Michele Herneisey

Electronic Theses and Dissertations

Nanocolloids are attractive delivery vehicles for drugs with poor aqueous solubility. Despite this, relatively few nanocolloid products exist on the market. Currently, there is a lack of standardization in the pre-clinical, academic setting regarding nanocolloid development and quality control testing. Adaptation of quality by design (QbD) methods used in the pharmaceutical industry to nanocolloid development is a desirable approach that can improve nanocolloid product and process understanding, resulting in an increased number of marketable products.

The central hypothesis of this work is that QbD approaches can be utilized to optimize theranostic (therapeutic and diagnostic) nanocolloid stability, drug loading, and imaging …

Full- Versus Sub-Regional Quantification Of Amyloid-Beta Load On Mouse Brain Sections, Yuu Ohno, Riley Murphy, Matthew Choi, Weijun Ou, Rachita K. Sumbria

Pharmacy Faculty Articles and Research

Extracellular accumulation of amyloid-beta (Aβ) plaques is one of the major pathological hallmarks of Alzheimer's disease (AD), and is the target of the only FDA-approved disease-modifying treatment for AD. Accordingly, the use of transgenic mouse models that overexpress the amyloid precursor protein and thereby accumulate cerebral Aβ plaques are widely used to model human AD in mice. Therefore, immunoassays, including enzyme-linked immunosorbent assay (ELISA) and immunostaining, commonly measure the Aβ load in brain tissues derived from AD transgenic mice. Though the methods for Aβ detection and quantification have been well established and documented, the impact of the size of the …

American Association Of Colleges Of Pharmacy (Aacp) Co-Curriculum Toolkit, Abir Kanaan, Andrea Mekonnen, April Staton, Cameron C. Lindsey, Dave Weldon, Farid G. Khalafalla, Jaime Maerten-Rivera, Kelly Shields, Lara Gomez, Laressa Bethishou, Maria Thurston, Mike Fulford, Nandita Das, Priti Patel, Rebecca Kavanagh, Stacey Olstad, Zachary Jenkins

Pharmacy Faculty Articles and Research

"The co-curriculum is intended to run parallel to the formal curriculum and support the development of students’ professional knowledge, skills, abilities, behaviors, and attitudes, including scientific foundation, knowledge application, and practice competencies. Additionally, the co-curriculum can also support proficiency in skills and achievement of competencies that are concurrently taught within the formal curriculum. ACPE evaluates the way programs assess students’ acquisition of knowledge and application of knowledge to practice within co-curricular experiences and especially how they advance the professional development of students within affective domain areas of learning."

Will Reducing Drug Prices Slow Innovation?, Gregory Vaughan, Fred Ledley

Mathematical Sciences Faculty Publications

The pharmaceutical industry has long argued that high drug prices reflect the high cost of innovation and that reducing drug prices would necessarily slow the pipeline of new drugs. These arguments have been bolstered by studies of large pharmaceutical companies showing statistical associations between the projected market size or revenue for pharmaceutical products and research & development (R&D) activity. Our analysis recognizes the increasingly important role of small biopharmaceuticals in drug development , companies that typically have little revenue and negative earnings, but are now responsible for more than 40% of new drug approvals. We examine the relationship between changes …

Will Reducing Drug Prices Slow Innovation?, Gregory Vaughan, Fred Ledley

Natural & Applied Sciences Faculty Publications

The pharmaceutical industry has long argued that high drug prices reflect the high cost of innovation and that reducing drug prices would necessarily slow the pipeline of new drugs. These arguments have been bolstered by studies of large pharmaceutical companies showing statistical associations between the projected market size or revenue for pharmaceutical products and research & development (R&D) activity. Our analysis recognizes the increasingly important role of small biopharmaceuticals in drug development , companies that typically have little revenue and negative earnings, but are now responsible for more than 40% of new drug approvals. We examine the relationship between changes …

Cerium Dioxide, A Jekyll And Hyde Nanomaterial, Can Increase Basal And Decrease Elevated Inflammation And Oxidative Stress, Robert Yokel, Marsha L. Ensor, Hemendra J. Vekaria, Patrick G. Sullivan, David J. Feola, Arnold Stromberg, Michael T. Tseng, Douglas A. Harrison

Pharmaceutical Sciences Faculty Publications

It was hypothesized that the catalyst nanoceria can increase oxidative

stress/inflammation from the basal state and reduce it from the elevated state .

Nanoceria are cleared by macrophages. To test the hypothesis, M0 (non-polarized),

M1- (classically activated, pro-inflammatory), and M2-like (alternatively activated,

regulatory phenotype) RAW 264.7 macrophages were nanoceria exposed. Responses

were quantified by arginase activity, IL-1ß level, cell oxygen consumption rate (OCR),

the glycolysis stress test (GST), morphology determined by light microscopy,

macrophage phenotype marker expression and morphology using a novel three

dimensional immunohistochemical method, and RT-qPCR. Nanoceria blocked

arginase and IL-1ß effects, increased M0 cell OCR and GST …