Digital Commons Network^™

Smart Missions That Enable Innovation In High-Risk Environments., Ed Hoffman

Level 3

This article is a lightly edited version of Ed Hoffman’s talk on to the 01-June-2023 seminar hosted by the PRST entitled ICH Q9(R1): The Next Frontier – An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient. Ed’s remarks are focused on the future of work, and the needs for relationships, storytelling, and understanding the mission to get the best out of our collective intelligence and navigate the future of work.

The Potential Of Stem Cell Therapy In Multiple Sclerosis Treatment: A Review, Sorina Amarculesei, Ava O'Meara Cushen, Cathy Brougham

SURE Journal: Science Undergraduate Research Experience Journal

Multiple Sclerosis is an autoimmune and neurodegenerative disease of the central nervous system. There are currently 2.8 million people living with Multiple Sclerosis worldwide, including 9000 people in Ireland, with a prevalence of 193 per 100,000 people. Symptoms of Multiple Sclerosis include sensory loss, fatigue, cognitive dysfunction, spasticity, depression, optic neuritis, gait ataxia, diplopia, and loss of bladder control. Currently, there is no standardised treatment or cure for Multiple Sclerosis with many strategies focusing on symptoms. Stem cells have emerged as promising approaches for Multiple Sclerosis therapeutics. Clinical trials primarily focus on mesenchymal stem cell-based therapies for Multiple Sclerosis. Furthermore, …

Tiny But Mighty, An Exploration Of Microbes And Plants As Sources Of Small Novel Bioactive Compounds Against Invasive Mycoses., Hannah Mai Peacock, James Anthony O'Connor

SURE Journal: Science Undergraduate Research Experience Journal

Despite the high mortality rate involved with invasive cerebral mycoses, there is a relative lack of research available around antifungals capable of crossing the blood brain barrier.

In this study the metabolites of four plants (Crocus vernus, Miniature Narcissus (daffodil), Osmanthus delavayi and Taraxacum officinale (common dandelion)) and two bacteria (Lacticaseibacillus paracasei and Staphylococcus epidermidis) were extracted and assayed for antifungal activity against Candida albicans and Saccharomyces cerevisiae. Thin layer chromatography and bioautography were then employed to assess the activity of the constituent components of sources showing antifungal activity.

Metabolites of S.epidermidis, and extracts …

Responsiveness Of Higher Education Programs To Policy And Recommendations In The Biopharmaceutical Sector, Maeve Scott

Other resources

This essay will review the business and government policies relevant to the biopharmaceutical sector which influence higher education programs. The mechanisms which enable higher education to adapt to policy will be summarised and the pace of the response estimated.

Higher education (HE) programs need to respond in a timely manner to dynamic industries to maximise opportunities for graduates and support the Irish economy. The author manages internships and teaches on pharmaceutical science programs and aims to ensure the program is current to maximise student success. This review intends to identify the most relevant policy sources that can inform the Pharmaceutical …

Industry Update October 2022, Elaine Harris

Articles

Company news Bend Bioscience invests in expansion of drug-delivery capabilities Bend Bioscience (OR, USA) and NovaQuest Private Equity, have announced plans on 11 October 2022 to invest in a new facility in Bend, Oregon. The group will focus on developing new R&D partnerships, and early phase manufacturing and development activities based on proprietary particle engineering-based drug-delivery technologies. This new facility will consist of approximately 20,000 square feet of laboratory and processing areas and it is anticipated that manufacturing and analytical capabilities will operational by the end of Q2 2023. Announcing the investment decision, Dan Dobry, Bend Bioscience’s co-founder said “We …

Evaluation Of Selenomethionine Entrapped In Nanoparticles For Oral Supplementation Using In Vitro, Ex Vivo And In Vivo Models, Shane Forde, Giuliana Vozza, David J. Brayden, Jesus Maria Frias, Sinead M. Ryan

Articles

Selenium methionine (Se Met) is an essential micronutrient required for normal body function and is associated with additional health benefits. However, oral administration of Se Met can be challenging due to its purported narrow therapeutic index, low oral bioavailability, and high susceptibility to oxidation. To address these issues, Se Met was entrapped in z e i n-coated nanoparticles made from chitosan using an ionic gelation formulation. The high stability of both the Se Met and s e l e n o methionine nanoparticles (Se Met-NPs) was established using cultured human intestinal and liver epithelial cells, rat liver homogenates, and rat …

Peptidases Are Potential Targets Of Copper(Ii)-1,10-Phenanthroline-5,6-Dione Complex, A Promising And Potent New Drug Against Trichomonas Vaginalis, Graziela Vargas Rigo, Fernando Gomes Cardoso, Matheus Menonca Pereira, Michael Devereux, Malachy Mccann, Andre L.S. Santos, Tiana Tasca

Articles

Trichomonas vaginalis is responsible for 156 million new cases per year worldwide. When present asymptomatically, the parasite can lead to serious complications, such as development of cervical and prostate cancer. As infection increases the acquisition and transmission of HIV, the control of trichomoniasis represents an important niche for the discovery and development of new antiparasitic molecules. This urogenital parasite synthesizes several molecules that allow the establishment and pathogenesis of infection. Among them, peptidases occupy key roles as virulence factors, and the inhibition of these enzymes has become an important mechanism for modulating pathogenesis. Based on these premises, our group recently …

Electrochemical Biosensors For The Detection Of Antibiotics In Milk: Recent Trends And Future Perspectives, Baljit Singh Dr., Abhijnan Bhat, Lesa Dutta, Kumari Riya Pati, Yaroslav Korpan, Isha Dahiya

Articles

Antibiotics have emerged as ground-breaking medications for the treatment of infectious diseases, but due to the excessive use of antibiotics, some drugs have developed resistance to microorganisms. Because of their structural complexity, most antibiotics are excreted unchanged, polluting the water, soil, and natural resources. Additionally, food items are being polluted through the widespread use of antibiotics in animal feed. The normal concentrations of antibiotics in environmental samples typically vary from ng to g/L. Antibiotic residues in excess of these values can pose major risks the development of illnesses and infections/diseases. According to estimates, 300 million people will die prematurely in …

Portable Hepa Filtration Successfully Augments Natural-Ventilation-Mediated Airborne Particle Clearance In A Legacy Design Hospital Ward, Mehael Fennelly, S. Hellebust, J. Wenger, D. O'Connor, G.W. Griffith, B.J. Plant, A.P.C. Microbiome Institute

Articles

As the severe acute respiratory syndrome coronavirus-2 pandemic has proceeded, ventilation has been recognized increasingly as an important tool in infection control. Many hospitals in Ireland and the UK do not have mechanical ventilation and depend on natural ventilation. The effectiveness of natural ventilation varies with atmospheric conditions and building design. In a challenge test of a legacy design ward, this study showed that portable air filtration significantly increased the clearance of pollutant aerosols of respirable size compared with natural ventilation, and reduced spatial variation in particle persistence. A combination of natural ventilation and portable air filtration is significantly more …

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 …

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

Level 3

No abstract provided.

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.

Managing Risk And Knowledge: Frameworks To Guide Knowledge-Enabled Technology Transfer, Martin Lipa Dr, Anne Greene

Level 3

Technology transfer is not only about the transfer of technology, but also about the transfer of knowledge, as evidenced by definitions of KM within the biopharma industry and beyond. However, knowledge transfer is often not well structured and its effectiveness – in particular for tacit knowledge (i.e., know how) – is an opportunity for improvement which can lead to many benefits. This article profiles recent research into the topic of improving knowledge transfer during technology transfer and presents several recently developed frameworks for improving such. The article furthermore explains how the frameworks can be co-deployed in support of robust knowledge …

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 …

At War With A Silent Killer: An Ipa Study Of The Lived Experiences Of Community Pharmacists In Ireland During Covid-19, Regina Brady, Niamh Imbusch

Articles

Objectives: The purpose of this research was to give voice to the unique lived experiences of community pharmacists who continued to work in patient-facing roles throughout the COVID-19 pandemic. Research objectives sought to understand how they felt about working during this time including any risks felt, why they choose to continue working, and what the post-COVID future might hold for them and their profession. Method: The study was guided by the principles of traditional interpretative phenomenological analysis (IPA). Primary research was collated using semi-structured interviews of a small, purposively selected homogenous group of pharmacists. The research context was a …

Formulation, Characterisation And Evaluation Of The Antihypertensive Peptides, Isoleucine-Proline-Proline And Leucine-Lysine-Proline In Chitosan Nanoparticles Coated With Zein For Oral Drug Delivery, Minna Khalid Danish, John P. Gleeson, David J. Brayden, Hugh Byrne, Jesus Maria Frias, Sinead Ryan

Articles

Isoleucine-Proline-Proline (IPP) and Leucine-Lysine-Proline (LKP) are food-derived tripeptides whose antihypertensive functions have been demonstrated in hypertensive rat models. However, peptides display low oral bioavailability due to poor intestinal epithelial permeability and instability. IPP and LKP were formulated into nanoparticles (NP) using chitosan (CL113) via ionotropic gelation and then coated with zein. Following addition of zein, a high encapsulation efficiency (EE) (>80%) was obtained for the NP. In simulated gastric fluid (SGF), 20% cumulative release of the peptides was achieved after 2 h, whereas in simulated intestinal fluid (SIF), ~90% cumulative release was observed after 6 h. Higher colloidal stability …

“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)

Level 3

Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.

“Gaining Organisational Acceptance Of A Data Analytics Programme In Eli Lilly”, Anthony Maguire, Marcus O'Mahony

Level 3

This paper describes how Eli Lilly overcame barriers to enable new use of data. This was achieved by adopting a deep understanding of end-user needs and the support of site leaders and end-users to standardise process monitoring. A standard approach of ‘Contexting’, ‘Data-Extraction’, ‘Model build’, ‘On-line Config’, ‘Deploy’, was utilised, using a commercial off-the-shelf software. The paper describes proof of concept demonstrations undertaken and discusses the ingredients to make the journey a success.

A Survey Report On The Current State Of Quality Risk Management (Qrm) And Knowledge Management (Km) Integration, Martin Lipa, Kevin O'Donnell, Anne Greene

Level 3

As part of research to better define and improve the integration between quality risk management (QRM) and knowledge management (KM) as dual enablers of an effective pharmaceutical quality system, a survey was conducted in February 2021 to explore this relationship. The survey explored the current state relationship in theory and in practice, solicited feedback on a proposed framework, the Risk-Knowledge Infinity Cycle, to improve the connection between QRM and KM, associated benefits and potential actions to make progress in this regard. The results suggest QRM and KM are highly interdependent in theory but much less so in practice. Further, …

Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane

Level 3

Knowledge management is positioned as an enabler of ICH Q10, and the visibility and availability of product and process knowledge across the entire pharmaceutical product lifecycle is vital to the sustained success of an organization and to the effectiveness of an organization’s pharmaceutical quality system as defined by ICH Q10. This paper illustrates where knowledge management has a role to play within each product lifecycle phase. This paper goes on to further define phase-appropriate KM methods and tools to help address these needs and create end-to-end product and process knowledge visibility and availability.

Solving The Continual Improvement And Innovation Challenge For The Benefit Of Patients: How An Effective Pharmaceutical Quality System (Pqs) And Risk-Based Approach Could Transform Post-Approval Change (Pac) Management, Emabelle Ramnarine

Dissertations

Patients deserve their medicines on time every time. Regulators safeguard public health by ensuring availability of safe, effective, high-quality medicines. Pharmaceutical companies must continually improve and innovate to deliver such medicines. In spite of these patient-centric objectives, drug shortages have continued to grow as a global public health concern. The drug shortage problem has existed for decades though there has been no shortage of effort, recommendations, papers, and expectations to resolve it. During the ongoing COVID-19 pandemic even exceptional measures were rapidly implemented to prevent shortages, yet no long-term solutions have been found.

This research hypothesis was that due to …

Producing Urban Aerobiological Risk Map For Cupressaceae Family In The Sw Iberian Peninsula From Lidar Technology, Raúl Pecero‐Casimiro, Santiago Fernández‐Rodríguez, Rafael Tormo‐Molina, Inmaculada Silva‐Palacios, Ángela Gonzalo‐Garijo, Alejandro Monroy‐Colín, Juan Francisco Coloma, José María Maya‐Manzano

Articles

Given the rise in the global population and the consequently high levels of pollution, urban green areas, such as those that include plants in the Cupressaceae family, are suitable to reduce the pollution levels, improving the air quality. However, some species with ornamental value are also very allergenic species whose planting should be regulated and their pollen production reduced by suitable pruning. The Aerobiological Index to create Risk maps for
Ornamental Trees (AIROT), in its previous version, already included parameters that other indexes did not consider, such as the width of the streets, the height of buildings and the geographical …

Biopharmaceutical Revolution In Saudi Arabia: Progress And Development, Rihana Alzahran, Elaine Harris

Articles

Purpose This paper aimed to analyze the situation of the biopharmaceutical industry in Saudi Arabia to improve the situation in a way that achieves high levels of development similar to those in Europe, the United States of America (USA), and Japan. Methods To achieve the objective of the study, the authors surveyed 18 out of 21 Saudi pharmaceutical companies that have received licensing for manufacturing from the Saudi Food and Drug Authority (SFDA) to diagnose the situation of manufacturing in relation to biopharmaceuticals. An interview with SFDA officials was carried out as a supplement to the survey. Results Findings revealed …

Bioactive Indanes: Development And Validation Of An Lc-Ms/Ms Bioanalytical Method For The Determination Of Ph46a, A New Potential Anti-Inflammatory Agent, In Dog And Rat Plasma And Its Application To A Pharmacokinetic Study In Dog, Gaia Scalabrino, Tao Zhang, Neil Frankish, Helen Sheridan

Articles

A new chemical entity, which is a chiral indane dimer, PH46A, has been developed by our research group. As a clinical candidate. PH46A has recently completed Phase I clinical studies in man. Previously, during its pre-clinical development, in in vivo pre-clinical studies PH46A showed potent anti-inflammatory properties, which can be targeted at a range of diseases, including inflammatory bowel disease (IBD). To support the pre-clinical development of this drug candidate, we developed a LC MS/MS method for determining PH46 (the acid form of PH46A salt) in both dog and rat plasma using Compound 1 as internal standard (IS). Those species …

Introducing A Model And A Framework To Unify The Pharmaceutical Quality System Enablers Quality Risk Management & Knowledge Management, Martin J. Lipa, Kevin O'Donnell, Anne Greene

Articles

An organization that effectively manages knowledge should be able to recognize and proactively apply new learnings to better anticipate risks. This is particularly important in the manufacture of medicinal products. Since the publication of ICH Q10 in 2010, Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System. The authors of this paper present a Knowledge Management process model to foster greater practical understanding of the practice of knowledge management. This model when joined with the familiar ICH Q9 process model for QRM, should enable a company to better manage their knowledge …

Design, Synthesis, And Biological Evaluation Of Aryl Piperazines With Potential As Antidiabetic Agents Via The Stimulation Of Glucose Uptake And Inhibition Of Nadh:Ubiquinone Oxidoreductase, R. Devine, M. Kelada, S. Leonard, D.S.D. Martin, J.M.D. Walsh, C.J. Breen, R.B. Driver, Gemma K. Kinsella, J.B.C Findlay, J.C. Stephens

Articles

The management of blood glucose levels and the avoidance of diabetic hyperglycemia are common objectives of many therapies in the treatment of diabetes. An aryl piperazine compound 3a (RTC1) has been described as a promoter of glucose uptake, in part through a cellular mechanism that involves inhibition of NADH:ubiquinone oxidoreductase. We report herein the synthesis of 41 derivatives of 3a (RTC1) and a systematic structure-activity-relationship study where a number of compounds were shown to effectively stimulate glucose uptake in vitro and inhibit NADH:ubiquinone oxidoreductase. The hit compound 3a (RTC1) remained the most efficacious with a 2.57 fold increase in glucose …

Synthesis And Novel Applications Of Cerium Dioxide, Rafaela Cristina De Carvalho

Doctoral

Cerium dioxide nanoparticles (NPs) were synthesised using a novel precipitation procedure and their function explored in a range of applications. The impact of different factors on CeO2 NPs synthesis including temperature and reactant concentration were evaluated experimentally and optimised. The resulting nanoparticles (with an average size of 35 nm) was then characterised by a range of physical and spectroscopic techniques including dynamic light scattering, scanning electron microscopy in conjunction with energy dispersive spectrometry, X-ray diffractometry,Brunauer–Emmett–Teller isotherm measurement, Raman spectroscopy, UV-visible spectroscopy and X-ray photoelectron spectroscopy. A new nanoparticle synthetic route, the “frozen NH4(OH) cubes method”, was developed, resulting in a …

Evaluation Of A Drug Delivery System Based On Cyclodextrins For Cancer Therapy, Caroline Mendes

Doctoral

Due to the side-effects caused by regular chemotherapy, the development of drug delivery systems that can specifically target cancer cells and deliver the therapeutic dose is required. In this study, a folate-derivative of β-cyclodextrin has been studied as a vehicle for targeting folate receptors (FR) and delivering the chemotherapeutic drug methotrexate (MTX). FRs can be considered key cell membrane targets since they are commonly over-expressed in cancer cells and play an important role in cancer development and progression. Cyclodextrins (CDs) are cyclic oligosaccharides with a unique structure that allows them to form inclusion complexes with guest molecules, increasing their aqueous …

A Blueprint For Knowledge Management In The Biopharmaceutical Sector, Paige Kane

Doctoral

This research examined current industry Knowledge Management (KM) methodologies and capabilities in order to gain insights into the level of maturity and understanding of KM within the biopharmaceutical sector. In addition, the researcher has developed models, tools and processes that can assist the sector to gain greater clarity of the value and merits that KM can offer to organizations. The researcher proposes that a systematic KM program can be used to “unlock” the knowledge and organizational capabilities necessary to convey real competitive advantage, but more importantly for the patient, to enable organizations to successfully develop and deliver the next generation …

A Mathematical Analysis Of Drug Dissolution In The Usp Flow Through Apparatus, David Mcdonnell, Deirdre M. D'Arcy, Lawrence J. Crane, Brendan Redmond

Articles

This paper applies boundary layer theory to the process of drug dissolution in the USP (United States Pharmacopeia) Flow Through Apparatus. The mass transfer rate from the vertical planar surface of a compact within the device is examined. The theoretical results obtained are then compared with those of experiment. The paper also examines the effect on the dissolution process caused by the interaction between natural and forced convection within the apparatus and the introduction of additional boundaries.