Pharmaceutics and Drug Design Commons^™

From Advisory To Action: The Case For Preserving Paccarb In The Fight Against Antimicrobial Resistance, Leila S. Hojat, Muhammad Dhanani, Amy Y. Kang, Salome O. Chitavi, Robert A. Weinstein, Edward Stenehjem

Pharmacy Faculty Articles and Research

The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) was established to advise the government on strategies to mitigate antimicrobial resistance (AMR) and its increasing threat to public health and national security. Its members included experts from diverse disciplines such as healthcare, veterinary medicine, industry, public health, and agriculture who were positioned to interface with key stakeholders and the public in an aspirational multidisciplinary approach to combating AMR. The council was successful in elevating AMR as a national priority and played a crucial role in watershed events for antimicrobial stewardship (AS) such as the development of the second National Action …

Quality Improvement (Qi) Project Aimed At Reducing Unnecessary Antibiotic Usage Among Older Adult Patients By Addressing Inappropriate Antibiotic Prescribing In Primary And Long-Term Care Settings, Pamela M. Thomas

Seton Hall University Dissertations and Theses (ETDs)

Antibiotic overuse among older adults remains a significant patient safety and public health concern. Recent national data indicate that approximately 30%–50% of outpatient antibiotic prescriptions may be unnecessary, particularly for viral or self-limiting conditions (Chua et al., 2021). Antimicrobial resistance has been associated with more than 1.27 million deaths globally (Murray et al., 2022). This quality improvement project evaluated a multifaceted antimicrobial stewardship intervention in primary and long-term care settings. Baseline review of 167 antibiotic cases revealed 37.1% were inappropriate or questionable, and 28.7% lacked adequate diagnostic documentation. The intervention incorporated provider education, electronic health record decision-support tools, audit and …

Evidentiary Standards For Newly Approved Antibiotics For Uncomplicated Urinary Tract Infections, Rosa Rodriguez-Monguio, Enrique Seoane-Vazquez, John H. Powers Iii

Pharmacy Faculty Articles and Research

Importance: Uncomplicated urinary tract infections (uUTIs) are among the most common bacterial infections and are typically treated with existing oral antibiotics. In 2024–2025, the FDA approved two new oral agents, sulopenem etzadroxil/probenecid and gepotidacin, via expedited review pathways, for the treatment of uUTIs. Objective: To assess the clinical significance and regulatory evidence supporting FDA approval of sulopenem/probenecid and gepotidacin for uUTI, and to analyze the adherence of pivotal phase III trials to regulatory standards for approval and FDA guidelines. Design, Setting, and Participants: Comparative descriptive analysis of publicly available data from phase 3 randomized, double-blind, active-controlled clinical …

Children With Cystic Fibrosis Can Lead Normal Lives; It All Started With The Nih, The Center For Integration Of Science And Industry

CISI Publication

Cystic fibrosis is a model of what can be accomplished with sustained support from the government, public, and biotechnology industry.

Our research shows that the NIH funded research underlying >99% of all drugs approved 2010-2024 with an average spending of $1.4 billion/drug approval.1-4 This research creates the foundational knowledge required for successful drug development by industry.

Advancing A Patient- And Carer-Centered Approach For The Clinical Development Of New Therapeutics For Aneurysmal Subarachnoid Hemorrhage: Insights From A Qualitative Study, Sonya Abraham, Silvia Amaro, Ellyn Getz, Sylvia Herget, Gregory J. Kato

Journal of Patient-Centered Research and Reviews

Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by a high rate of fatality and high risk of secondary brain injury. More treatment options are needed to improve outcomes. There are very few reports in the medical literature involving patient experience of aSAH, which is known for its unexpected onset and profound medical impact. Improved understanding of this patient experience would help make future clinical research more patient centered. To this end, we convened an advisory board consisting of aSAH patients and care partners in the United States. Participants emphasized the critical role that care partners play during hospitalization and in accessing …

Rwanda's Natural Remedies: A Fresh Look At The Fight Against Malaria, Leandre Nsabimana Ndisanze

Pomona Senior Theses

Malaria remains one of the most devastating parasitic diseases globally, disproportionately affecting sub-Saharan Africa, where Rwanda continues to face high transmission rates and rising resistance to conventional interventions. Despite decades of control efforts, the emergence of drug-resistant Plasmodium falciparum and insecticide-resistant Anopheles mosquitoes threatens to reverse recent gains. This research responds to the urgent need for sustainable and culturally relevant alternatives by exploring the therapeutic potential of Rwandan traditional medicinal plants. These indigenous remedies, long used by local healers, offer an underexplored reservoir of bioactive compounds that may provide the basis for novel antimalarial drugs.

The central hypothesis of this …

Changes In Cardiovascular Risk Factors And Health Care Expenditures Among Patients Prescribed Semaglutide, Yuan Lu, Yuntian Lu, Tedi Totojani, Chungsoo Kim, Rohan Khera, Hua Xu, John E. Brush Jr., Harlan M. Krumholtz, Jason Abaluck

Department of Medicine Faculty Publications

Importance Semaglutide, a glucagon-like peptide-1 receptor agonist, has demonstrated substantial weight reduction and cardiovascular benefits in clinical trials. However, its association with clinical outcomes and health care expenditures remains underexplored.

Objective To evaluate changes in cardiovascular risk factors and health care expenditures among patients prescribed semaglutide across multicenter cohorts.

Design, Setting, and Participants This retrospective cohort study included 23 522 adults (≥18 years) who received an initial semaglutide prescription between January 1, 2018, and January 1, 2025, at Sentara Healthcare and between January 1, 2018, and May 1, 2025, at Yale New Haven Health System.

Exposure The first prescription of …

Fda Approves Neffy®- First Nasal Spray For Anaphylaxis, Abigail Carter, Penlope Mazivanhanga, Haylee Whyde, Rileigh Rahrig, Ashley Jacob, Anna Spalvieri, Joshua Honaker, Samantha Mccord, Andrew Roecker

Pharmacy and Wellness Review

Between 1.6 and 5.1% of the United States population have experienced anaphylaxis, a severe allergic reaction.1 Anaphylaxis occurs when someone is exposed to an allergen, most commonly foods, medications, and insect venom. Epinephrine is the first-line agent for anaphylaxis treatment, and it is critical to administer this medication immediately after the onset of anaphylactic symptoms to prevent worsening that could lead to death. Epinephrine, more commonly known as EpiPen® or Auvi-Q®, has historically only been available as an intramuscular (IM) injection. Many people are afraid, anxious, or uneducated on how to properly give someone an IM injection, causing anaphylaxis treatment …

Molecular Targets For Breast Cancer Therapy, Hamidreza Montazeri Aliabadi

Pharmacy Faculty Articles and Research

"Breast cancer is by far the most common cancer in women, and for a while, it surpassed lung cancer as the most diagnosed cancer, regardless of gender, in 2020 [1]. Chemotherapy and hormone therapy are still the first line of treatment, despite extensive research in molecularly targeted drugs. Therefore, triple negative breast cancer (TNBC) is still known as the most challenging type for treatment due to the limited identified targets. Inherent and acquired resistance are still major hurdles in breast cancer therapy, which further highlights the importance of identifying new molecular targets in this battle. The inherent resistance of unresponsive …

Aspects Of Pharmaceutical Networks, Hannah Rita Joseph, Afia L. Rahaman, Kaya Wilson

ENGL 1102 Showcase

The theme of our anthology is different drugs and processes of drug usage in the result how the various aspects of the pharmaceutical companies. We analyze the quality of health that Americans receive from certain parts of the health care industry. We have focused on informing and analyzing the increase of insulin prices, and how that affects Americans everyday lives. The delivery methods of medical cannabis, how each method is effective, and how they are administered. As well as pharmaceutical scams and how it affects elderly people, who rely on medication.

Towards A Mode Of Action For The Anti-Schistosomal Aryl Hydantoins, Thomas Schulze

Theses & Dissertations

Schistosomiasis is a significant human disease caused by the helminth parasite Schistosoma mansoni. Praziquantel remains the only clinically used treatment, yet it is rapidly metabolized and only effective against the adult stage worm infection. Ro 13-3978 (AR02) is a potent antischistosomal compound with activity against multiple S. mansoni life stages; however, it manifests anti-androgenic activity. Additionally, the mechanism of action for worm clearance remains unknown. The structure of Ro 13-3979 was used to generate optimized derivatives, including AR102, that show increased potency towards worms, reduced off-target anti-androgen effects, and extended half-life thereby increasing the feasibility for a single-dose curative treatment. …

The Implications Of Ferroptosis In Antibiotic Resistance, Marysol Hohl

Senior Honors Theses

Bacterial infections in the United States are becoming increasingly resistant to existing antibiotic treatments. Due to projected increases in resistance and the recent decrease in novel antibacterials, experts have determined that the United States is in the “post-antibiotic era.” The scientific community has failed to resolve resistance despite the continual discovery of new antibiotic compounds. In the past decade, a novel form of cell death called ferroptosis has been implicated in antibiotic treatment by employing the use of nanotechnology. This literature review will describe the problem of bacterial resistance and demonstrate how current research is pioneering a new age of …

Targeting Breast Cancer: The Familiar, The Emerging, And The Uncharted Territories, Hamidreza Montazeri Aliabadi, Arthur Manda, Riya Sidgal, Co Chung

Pharmacy Faculty Articles and Research

Breast cancer became the most diagnosed cancer in the world in 2020. Chemotherapy is still the leading clinical strategy in breast cancer treatment, followed by hormone therapy (mostly used in hormone receptor-positive types). However, with our ever-expanding knowledge of signaling pathways in cancer biology, new molecular targets are identified for potential novel molecularly targeted drugs in breast cancer treatment. While this has resulted in the approval of a few molecularly targeted drugs by the FDA (including drugs targeting immune checkpoints), a wide array of signaling pathways seem to be still underexplored. Also, while combinatorial treatments have become common practice in …

Virtual And In Vitro Screening Of Natural Products Identifies Indole And Benzene Derivatives As Inhibitors Of Sars-Cov-2 Main Protease (MPro), Dony Ang, Riley Kendall, Hagop S. Atamian

Biology, Chemistry, and Environmental Sciences Faculty Articles and Research

The rapid spread of the coronavirus disease 2019 (COVID-19) resulted in serious health, social, and economic consequences. While the development of effective vaccines substantially reduced the severity of symptoms and the associated deaths, we still urgently need effective drugs to further reduce the number of casualties associated with SARS-CoV-2 infections. Machine learning methods both improved and sped up all the different stages of the drug discovery processes by performing complex analyses with enormous datasets. Natural products (NPs) have been used for treating diseases and infections for thousands of years and represent a valuable resource for drug discovery when combined with …

Public Health Product Hops, Michael S. Sinha

All Faculty Scholarship

Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered …

Evaluation Of Pharmaceutically Compounded Oral Caffeine On The Impact Of Medication Adherence And Risk Of Readmission Among Preterm Neonates: A Single-Center Quasi-Experimental Study, Gul Ambreen, Manoj Kumar, Amin Ali, Syed Akbar Ali Shah, Syed Muzaffar Saleem, Ayesha Tahir, Muhammad Sohail Salat, Muhammad Shahzad Aslam, Kashif Hussain

Department of Biological & Biomedical Sciences

Background: Caffeine is available in an ampoule, used via parenteral and enteral routes in preterm neonates to treat apnea of prematurity (AOP) in neonates of gestational age ≥ 35-40 weeks. A longer duration of therapy has a higher risk of medication non-adherence due to higher costs and inappropriate dosage forms. Pharmaceutically compounded oral caffeine (PCC) could be an appropriate alternate dosage form. The researchers aimed to determine the impact of PCC on medication-related factors influencing medication adherence (MA) and the frequency of hospital readmission with apnea (HRA) in preterm neonates.
Methods: We conducted a single-center quasi-experimental study for this quality …

Impact Of A Multifaceted Intervention On Physicians' Knowledge, Attitudes And Practices In Relation To Pharmaceutical Incentivisation: Protocol For A Randomised Control Trial, Muhammad Naveed Noor, Mishal Khan, Afifah Rahman-Shepherd, Amna Rehana Siddiqui, Sabeen Sharif Khan, Iqbal Azam, Sadia Shakoor, Rumina Hasan

Department of Pathology and Laboratory Medicine

Introduction: In settings where the private sector constitutes a larger part of the health system, profit-gathering can take primacy over patients' well-being. In their interactions with pharmaceutical companies, private general practitioners (GPs) can experience the conflict of interest (COI), a situation whereby the impartiality of GPs' professional decision making may be influenced by secondary interests such as financial gains from prescribing specific pharmaceutical brands.
Methods and analysis: This study is a randomised controlled trial to assess the impact of a multifaceted intervention on GPs' medical practice. The study sample consists of 419 registered GPs who own/work in private clinics and …

Variants Associated With Bedaquiline (Bdq) Resistance Identified In Rv0678 And Efflux Pump Genes In Mycobacterium Tuberculosis Isolates From Bdq Naïve Tb Patients In Pakistan, Dania Khalid Saeed, Sadia Shakoor, Safina Abdul Razzak, Zahra Hasan, Saba Faraz Sabzwari, Zahida Azizullah, Akber Kanji, Asghar Nasir, Samreen Shafiq, Najia Karim Ghanchi, Rumina Hasan

Department of Pathology and Laboratory Medicine

Background: Mutations in the Rv0678, pepQ and atpE genes of Mycobacterium tuberculosis (MTB) have been reported to be associated with reduced antimycobacterial susceptibility to bedaquiline (BDQ). Resistance conferring mutations in treatment naïve MTB strains is likely to have implications for BDQ based new drug regimen that aim to shorten treatment duration. We therefore investigated the genetic basis of resistance to BDQ in MTB clinical isolates from BDQ naïve TB patients from Pakistan. In addition, mutations in genes associated with efflux pumps were investigated as an alternate mechanism of resistance.
Methods: Based on convenience sampling, we studied 48 MTB clinical isolates …

The Use Of Advanced Spectral Imaging To Reveal Nanoparticle Identity In Biological Samples, Qamar A. Alshammari, Rajasekharreddy Pala, Ayan K. Barui, Saud O. Alshammari, Andromeda M. Nauli, Nir Katzir, Ashraf M. Mohieldin, Surya M. Nauli

Pharmacy Faculty Articles and Research

Nanoparticles (NPs) have been used in drug delivery therapies, medical diagnostic strategies, and as current Covid-19 vaccine carriers. Many microscope-based imaging systems have been introduced to facilitate detection and visualization of NPs. Unfortunately, none can differentiate the core and the shell of NPs. Spectral imaging has been used to distinguish a drug molecule and its metabolite. We have recently integrated this technology to a resolution of 9 nm by using artificial intelligence-driven analyses. Such a resolution allowed us to collect many robust datapoints for each pixel of an image. Our analyses could recognize 45 spectral points within a pixel to …

Three Waves: The United States Opioid Crisis, Ryan B. Santoro

Senior Scholars Papers in Science, Technology, and Society

The past two and a half decades have witnessed widespread suffering, addiction, and death at the hands of the opioid crisis. This paper analyzes the crisis through a series of time periods, broken down into “waves.” Drawing upon primary material in relation to OxyContin advertisements in the 1990’s, this research takes aim at the origin of widespread opioid abuse disorder. By building upon analysis done on the Sackler Family, Purdue Pharma, heroin abuse, fentanyl overdoses, the COVID-19 pandemic and opioids and addiction in modern pop culture, this thesis shows how despite constant change in public policy, the opioid crisis continues …

Development Of A Bamlanivimab Infusion Process In The Emergency Department For Outpatient Covid-19 Patients, Danny Pham, Sandy Wong, Christina T. Nguyen, Stephen C. Lee, Kimberly J. Won

Pharmacy Faculty Articles and Research

The coronavirus disease 2019 (COVID-19) pandemic has prompted the creation of new therapies to help fight against the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Bamlanivimab is a SARS-CoV-2 monoclonal antibody that is administered as an intravenous infusion to ambulatory patients with mild or moderate COVID-19, but a concern that arose was deciding the optimal location for patients to receive the medication. This report describes the development and implementation of a bamlanivimab infusion center in the emergency department of three hospitals in Orange County, California, shortly after bamlanivimab received emergency use authorization. As a result, a total of 601 …

Listening To Current Practice: Patient Involvement In The Pharmaceutical Packaging Design Process, Giana Carli Lorenzini, Annika Olsson, Andreas Larsson

Journal of Applied Packaging Research

Multiple functional challenges in the use of pharmaceutical packaging reveal a great need of packaging to be designed inclusively. This study investigates patient involvement in the pharmaceutical packaging design process by analysing interview data from representatives of the pharmaceutical and packaging industry. Four main themes related to patient involvement were uncovered: patient expertise levels, patient involvement modes, factors encouraging patient involvement, and factors discouraging patient involvement. Passive patient involvement modes were found to be dominant due to regulations and a traditional perspective regarding physical testing. However, active patient involvement modes were identified, motivated by empathy and understanding of the lives …

Development Of Vaccines And Antivirals Against Zika Virus, Aryamav Pattnaik

School of Veterinary and Biomedical Sciences: Dissertations, Theses, and Student Research

The re-emergence of Zika virus (ZIKV), an arbovirus, poses a major global human health concern because of its ability to cause congenital abnormalities and neurological diseases. While many candidate vaccines and antiviral drugs are in the developmental pipeline, none have been approved for use against ZIKV infection. This dissertation describes the characterization of one vaccine and two antiviral drug candidates against ZIKV infection. A bacterial ferritin-based nanoparticle vaccine, termed zDIII-F, is designed to display multiple copies of ZIKV E protein domain III on its surface. These stable nanoparticles are shown to induce robust antibody-mediated protection against lethal ZIKV infection in …

A Case Study Of Health Information System Workflow On Mitigating Opioid Drug Abuse In Saudi Arabia's Healthcare System, Alogaili Fahad Abdulrahman

Student Works (2020-2029)

The hospitals in Saudi Arabia, which have been studied in this research, are almost entirely automated. Healthcare information systems (HIS) are quite efficient; however, the health information exchange (HIE) is absent in the existing systems for different hospitals. Opioid drugs are an addictive substance, Saudi Arabia has the highest mean of drug abuse disorders in the region (680.5, group mean was 401.8). The lack of HIE had contributed significantly to the increase of opioid drug abuse in Saudi Arabia. If a patient has taken opioid as a painkiller, an interoperable system must have the information available for the healthcare department …

Covid-19: The Vaccine Race Continues, L. Hayley Burgess, Carley Castelein, Andrew Rubio, Mandelin K. Cooper

HCA Healthcare Journal of Medicine

Over a year has passed since the discovery of SARS-CoV-2 and the subsequent COVID-19 pandemic. As mitigation efforts continue, COVID-19 has claimed over half a million lives in the United States and 3.1 million lives globally. The development and availability of vaccines delivering immunity to prevent COVID-19 offers hope to end the pandemic.

Emergency use authorizations from the Food and Drug Administration have been issued in the United States for three vaccines, one each from Pfizer-BioNTech, Moderna and Janssen/J&J. Pfizer-BioNTech and Moderna are both mRNA vaccines with efficacy of 95% and 94.1% respectively, while the vector-based vaccine from Janssen/J&J has …

Suppression Of Human Coronavirus 229e Infection In Lung Fibroblast Cells Via Rna Interference, Hamidreza Montazeri Aliabadi, Jennifer Totonchy, Parvin Mahdipoor, Keykavous Parang, Hasan Uludağ

Pharmacy Faculty Articles and Research

Despite extensive efforts to repurpose approved drugs, discover new small molecules, and develop vaccines, COVID-19 pandemic is still claiming victims around the world. The current arsenal of antiviral compounds did not perform well in the past viral infections (e.g., SARS), which casts a shadow of doubt for use against the new SARS-CoV-2. Vaccines should offer the ultimate protection; however, there is limited information about the longevity of the generated immunity and the protection against possible mutations. This study uses Human Coronavirus 229E as a model coronavirus to test the hypothesis that effective delivery of virus-specific siRNAs to infected cells will …

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

All Faculty Scholarship

This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

Contraceptive Methods In The United States: The Question Of Abortive Mechanisms, Tara Ferenczy

Senior Honors Theses

This thesis reviews the many methods of contraception available in the United States. Although society’s understanding of women’s health has become a major topic, there is still a significant deficit of information regarding how the accessible methods affect women’s bodies, specifically reproductive tissue. The thesis analyzes numerous contraceptive options focusing specifically on the mechanisms of action to determine whether options have abortifacient properties so that readers may develop educated opinions regarding medical and ethical uses. Information involving strengths and limitations of each technique and the effects on both the female body and the reproductive material assist in understanding the process …

Prospects For Rnai Therapy Of Covid-19, Hasan Uludağ, Kylie Parent, Hamidreza Montazeri Aliabadi, Azita Haddadi

Pharmacy Faculty Articles and Research

COVID-19 caused by the SARS-CoV-2 virus is a fast emerging disease with deadly consequences. The pulmonary system and lungs in particular are most prone to damage caused by the SARS-CoV-2 infection, which leaves a destructive footprint in the lung tissue, making it incapable of conducting its respiratory functions and resulting in severe acute respiratory disease and loss of life. There were no drug treatments or vaccines approved for SARS-CoV-2 at the onset of pandemic, necessitating an urgent need to develop effective therapeutics. To this end, the innate RNA interference (RNAi) mechanism can be employed to develop front line therapies against …

Foundational Research And Nih Funding Enabling Emergency Use Authorization Of Remdesivir For Covid-19, Ekaterina Galkina Cleary, Matthew J. Jackson, Zoë Folchman-Wagner, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

Emergency Use Authorization for remdesivir months after discovery of COVID-19 is unprecedented. Typically, decades of research and public-sector funding are required to establish the mature body of foundational research requisite for efficient, targeted drug discovery and development. This work quantifies the body of research related to remdesivir’s biological target, RNA-dependent RNA polymerase (RdRp), or parent chemical structure, nucleoside analogs (NcAn), through 2019, as well as NIH funding for this research 2000–2019. There were 6,567 RdRp-related publications in PubMed, including 1,263 with NIH support, and 11,073 NcAn-related publications, including 2,319 with NIH support. NIH support for RdRp research comprised 2,203 Project …