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The University of Maryland School of Pharmacy, founded in 1841, is a thriving center for life sciences research and community service. Through its education, research, and service programs, the School of Pharmacy strives to improve the health and well-being of society by aiding in the discovery, development, and use of medicines.
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Novel Methods to Assess the In Vivo and In Vitro Performance and Selection of Amorphous Solid Dispersions of Poorly-Water Soluble DrugsThe number of poorly water-soluble drugs in the pipeline has increased, and they are often not well absorbed by the gastrointestinal tract. Amorphous solid dispersion (ASD) is an emerging strategy to improve drug solubility and absorption. The overall aim is to expand methods used to evaluate the performance of ASD as a strategy to improve water solubility. Firstly, we aimed to develop an in vitro-in vivo correlation (IVIVC) model to predict human pharmacokinetics (PK) of itraconazole tablets with different release rates from dissolution experiments and determine formulation and process parameters that affect in vivo performance. Human PK was successfully predicted from in vitro dissolution experiments, and the IVIVC model created here met internal predictability criteria. Secondly, liquid state proton nuclear magnetic resonance (1HNMR) techniques were used to streamline polymer selection for ASDs in a non-destructive and resource-sparing fashion. For three drug-polymer pairs (i.e. etravirine with each HPMC, HPMCAS-M, and PVP-VA), 1HNMR findings were compared to supersaturation studies. Our hypothesis was that strong molecular interactions between polymer and drug observed in 1HNMR predicted precipitation kinetics in the supersaturation studies. Supersaturation studies agreed with 1HNMR predictions, as HPMC and HPMCAS-M maintained etravirine in solution for a longer time than PVP-VA. Thirdly, a robust, viable, and resource-sparing method to measure partition coefficient P (logP) was developed using reverse-phase high-performance liquid chromatography (RP-HPLC). Highly lipophilic drugs lack reliable, experimentally determined logP values in the literature. The RP-HPLC method reported here can be used for high throughput estimation of logP of commonly used drugs. A larger pool of reliable logP values of commonly used drugs shows promise to improve quality of medicinal chemistry and PK models. Lastly, our goal was to assess, for lipophilic drugs, the impact of logP on human volume distribution at steady state (VDss) predictions using the Oie-Tozer, Rodgers-Rowland, GastroPlus, Korzekwa-Nagar, and TCM-New methods. Sensitivity and prediction error analyses were conducted with a range of logP values and specific logP. TCM-New was shown to be the best method for VDss prediction of highly lipophilic drugs, suggesting blood plasma ratio (BPR) as a favorable surrogate for drug partitioning in the tissues.
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Purification of paFur and Exploration of the Heme Regulation Mechanism over the phuS GenePseudomonas aeruginosa is a common bacteria that can cause various infections in the human body and survives in the body during chronic infections via iron from heme. The Wilks Lab is interested in finding ways to disrupt the transportation of heme to P. aeruginosa in order to cure infections. The PhuS protein is part of the heme uptake systems that affect heme delivery into P. aeruginosa and is known to be regulated by heme and iron. This project specifically focuses on finding the heme dependent transciptional regulator of the phuS gene promoter.
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Novel Next-generation Non-catalytic p38alpha/MK2 Immunomodulators with Endothelial-barrier-stabilizing and Anti-inflammatory ActivityWe have previously identified a small three-ring molecule, UM101, targeted to the ED substrate-docking domain of p38alpha MAPK. UM101 modified p38alpha/MK2 signaling, stabilized endothelial barrier and reduced expression of proinflammatory genes. A next-generation analog with modifications on the first and third ring, Gen-1124, has improved anti-inflammatory and endothelial barrier-stabilizing activity, is lung protective in mouse models of influenza and ARDS, and is currently in a Phase II clinical trial in ARDS. To develop additional therapeutic candidates, we designed and synthesized UM101 analogs with modifications on the middle ring and tested the novel compounds for endothelial barrier- stabilizing and anti-inflammatory activity.
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Mitigating Evidence Gaps: A Survey Template to Inform Patient-Centered Value AssessmentBackground: Necessary and informative patient-experience data (PED) needed for value/health technology assessments (V/HTA) are rarely available as they are not routinely collected in clinical trials, the traditional data source for V/HTA. Patient organizations frequently collect PED; however, inconsistent approaches in the methods and type of data collected limit their usefulness for V/HTA. A universal framework, such as a standard, disease-agnostic survey template, could coalesce efforts for collecting patient-centric data for application to V/HTA for more efficiency, alignment, and better patient centricity. Objective: Using a mixed-methods approach and by identifying PED concepts common across conditions (i.e., cross-cutting PED concepts), co-develop a disease-agnostic survey template that can be used to inform a standardized approach to fill patient-centered evidence gaps in V/HTA. Methods: This mixed-methods study used a triangulation of data sources: (1) Voice-of-the-Patient reports, (2) peer-reviewed literature, (3) V/HTA reports, (4) publicly available surveys used by patient organizations to collect and submit data for V/HTA, (5) elicitation from patient experiences with conditions and associated treatments, and (6) patient-advisor and other expert input to identify cross-cutting PED concepts and draft a disease-agnostic survey template. Cognitive interviews with patients were conducted to test and refine survey items and response choices. Following, the draft survey was pilot tested to evaluate and finalize the disease-agnostic survey template by assessing usability from the patient perspective. Results: The resulting survey template is comprised of thirty-one items asking patients about the impact of disease and treatment on health and daily life such as but not limited to symptoms, treatment and treatment-related experiences, ability to work, wellness, finances, healthcare utilization, condition stability, treatment preferences, healthcare and provider experiences, access to healthcare services and treatment, experiences living with the condition, impact on daily life, support from others, impact on others, and additional patient insights. Conclusions: The resulting survey template supports standardized PED collection while offering flexibility to tailor to a condition or population. Continuous patient engagement throughout the development and testing process increases the survey template’s utility as it reflects what patients, who actually live with a condition, experience and think.
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Progression, Prognostic Factors, and Economic Costs of Loss of Independence in Parkinson DiseaseIntroduction: Parkinson disease (PD) is a neurodegenerative disorder causing disability and loss of independence (LOI), impacting patients and families. The longitudinal patterns of LOI in PD, prognostic factors predicting LOI in different types of activities of daily living (ADLs), and costs associated with functional dependency (FD) in PD remain unclear. Methods: We used 2003-2020 data from a prospective PD cohort at a tertiary neurologic center. Disability with LOI was assessed using the modified Older Americans Resource and Services Daily Function Questionnaire at baseline and follow-up. Patterns of LOI were summarized using EventFlow data visualization software. Cox proportional hazards models identified prognostic factors for LOI on different types of ADLs. Costs borne by patients with PD (PWP) and their families were analyzed using 2018-2019 Financial and Social Impact of Parkinson’s Disease Survey data. We estimated the incremental costs comparing families of PWP with and without FD using generalized linear models. Results: Among 270 early-stage PD patients, 133 (45%) developed LOI on one or more ADL, where 57 regained independence at least once. Housework was the most frequent first ADL requiring help (mean time 4.6 years post-first visit). Longitudinal patterns of loss included transient and persistent loss. Strongest associations were dyskinesia (adjusted hazard ratios [aHR], 1.82; 95% CI, 1.12-2.96) for LOI on any ADL; falls (aHR, 1.72; 95% CI, 1.16-2.55) for basic ADLs (BADLs); gait impairment (aHR, 2.04; 95% CI, 1.43-2.91) and dyskinesia (aHR, 2.09; 95% CI, 1.29-3.37) for instrumental ADLs (IADLs); and dyskinesia (aHR, 1.68; 95% CI, 1.05-2.68) for walking. Compared to families of PWP without FD (n=882), families of PWP with FD (n=476) faced higher direct non-medical costs (adjusted average marginal effect [aAME], $3,438; 95% CI, $1,719-$5,157) and indirect costs (aAME, $11,479; 95% CI, $1,545-$21,413). Conclusion: This study provides novel information about LOI patterns in PD and the fluctuations in patients' functioning in daily tasks. We identified factors (e.g., dyskinesia and gait impairment) with varying impacts on BADLs and IADLs. The study quantifies the financial strain on families of PWP with FD, underscoring the need for interventions to delay or prevent LOI in PD.
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Scholarship Reconsidered: Integrating EDI into Appointment, Promotion and Tenure GuidelinesThe objective was to develop inclusive promotion and tenure (P&T) criteria at the University of Maryland School of Pharmacy (UMSOP) that reflect the UMSOP’s mission and values, recognize the rich potential of diverse faculty and reward a breadth of scholarly excellence.
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Base Hydrolysis (or not) for Targeted Sphingolipid QuantitationSphingolipids are a diverse class of lipids that exhibit various structures and functions. Their analysis presents several challenges due to dynamic range, structural diversity, and complex sample matrices. Addressing these challenges requires meticulous sample preparation and dedicated analysis methods. Liquid chromatography (LC) coupled with mass spectrometry (MS) is a commonly used technique for detecting and quantifying sphingolipids. An alkaline hydrolysis step is routinely used during sample preparation to enrich for sphingolipids. The added chemical step during sample preparation can impact lipid extraction efficiency and removes the opportunity to analyze other lipid classes simultaneously. We will present our findings comparing sphingolipid enrichment using mild base hydrolysis pre-treatment versus no hydrolysis in C18 and HILIC LC-MS/MS methods.
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PATIENTS Day 2023: Your Health... Your Voice2023-10-13
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PATIENTS Day 2022: Feature video2022-08-26
