SYMPOSIUM 4: Simplifying drug assays for low-resource environments
Tracks
Track 4
| Monday, September 22, 2025 |
| 11:00 AM - 12:30 PM |
| Grand Copthorne Waterfront Hotel - Waterfront Ballroom III |
Details
This symposium addresses the critical need for accessible and reliable drug monitoring methods in resource-limited settings. Experts from four continents will share practical approaches and innovative solutions for implementing drug assays in challenging environments. The session will begin with fundamental considerations for establishing new assays, followed by specific applications in paediatric care where sample volumes and analytical resources are often limited. The discussion will then focus on real-world implementation of rapid testing strategies for HIV treatment monitoring in rural South Africa, demonstrating how analytical challenges can be overcome in remote settings. Finally, the symposium will explore practical approaches to DPD phenotyping for safer chemotherapy administration in resource-constrained environments. Throughout the session, speakers will emphasize cost-effective methodologies, simplified sample preparation, and practical solutions that can be implemented with limited infrastructure, aiming to improve patient care in low- and middle-income countries.
Speaker
Dr Danijela Kocic
St. Vincent's Hospital
Setting up a LC-MS/MS assay for a new therapeutic drug - Lessons learnt
Abstract
The implementation of mass spectrometry (MS) assays for new therapeutic drugs necessitates careful consideration of several key factors that vary with the laboratory's pre-existing capabilities. This presentation will discuss the essential lessons learned from different laboratory scenarios .
As laboratories integrate new analytical instruments, particularly LC-MS/MS, it is crucial to prioritize effective training and adaptations in methodology to ensure accurate data interpretation. This presentation will explore the challenges and strategies involved in transitioning from conventional techniques, such as HPLC, to advanced methods like liquid chromatography-tandem mass spectrometry (LC-MS/MS). We will discuss the significance of method adaptation for optimizing analytical performance and the necessity for existing facilities to refine protocols for new applications to facilitate efficient integration. Additionally, we will strongly emphasize the critical importance of maintaining regulatory compliance and validating methods across diverse laboratory settings, underscoring the need for robust methodological development tailored to specific research and clinical objectives. This presentation aims to provide insights applicable to a variety of laboratory scenarios, enhancing overall analytical capabilities and ensuring the highest quality of work.
Additionally, cost considerations will be addressed to encompass both initial equipment investment and ongoing operational expenditures. A thorough engagement with these aspects is crucial for the successful establishment and operation of MS assays, ultimately facilitating the advancement of therapeutic drug development.
As laboratories integrate new analytical instruments, particularly LC-MS/MS, it is crucial to prioritize effective training and adaptations in methodology to ensure accurate data interpretation. This presentation will explore the challenges and strategies involved in transitioning from conventional techniques, such as HPLC, to advanced methods like liquid chromatography-tandem mass spectrometry (LC-MS/MS). We will discuss the significance of method adaptation for optimizing analytical performance and the necessity for existing facilities to refine protocols for new applications to facilitate efficient integration. Additionally, we will strongly emphasize the critical importance of maintaining regulatory compliance and validating methods across diverse laboratory settings, underscoring the need for robust methodological development tailored to specific research and clinical objectives. This presentation aims to provide insights applicable to a variety of laboratory scenarios, enhancing overall analytical capabilities and ensuring the highest quality of work.
Additionally, cost considerations will be addressed to encompass both initial equipment investment and ongoing operational expenditures. A thorough engagement with these aspects is crucial for the successful establishment and operation of MS assays, ultimately facilitating the advancement of therapeutic drug development.
Biography
Dr. Kocic is the Scientific Head of Clinical Pharmacology and Toxicology at SydPath, affiliated with St. Vincent’s Hospital in Sydney, Australia. In her pivotal role, she oversees the rigorous analysis of Therapeutic Drug Monitoring (TDM) results, providing critical insights to clinicians, patients, and various stakeholders. Her work is instrumental in optimizing patient outcomes across complex clinical scenarios and diverse clinical trials. An active member of the TDM Matters Multi-Disciplinary Team Service at St. Vincent’s Hospital, Dr. Kocic was appointed as a Conjoint Senior Lecturer at St Vincent’s Clinical School, University of New South Wales, in 2020. In this capacity, she contributes to the academic advancement of clinical pharmacology and toxicology, enhancing the educational landscape for future practitioners. Dr. Kocic is a distinguished committee member of the NSW Health Pathology Clinical Mass Spectrometry Forum, which convenes 3-4 times annually. This forum addresses a variety of pertinent topics for clinical scientists, healthcare professionals, and researchers by featuring esteemed speakers from both national and international arenas. Through this role, she fosters collaborative networks with peers and enhances her engagement with laboratories across Australia and globally. Recently, Dr. Kocic was appointed chair of the Special Drugs Advisory Committee with The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP). In this position, she provides expert consultation regarding the program designed to uphold and advance laboratory standards both nationally and internationally. Dr. Kocic began her scientific journey at Novartis Pharmaceuticals as a Research Scientist, laying the groundwork for her expertise in the field. Following the completion of her PhD, she advanced her career at the Drug Toxicology Unit of the NSW Forensic and Analytical Scientific Service, where she served as Senior Scientist in Charge of Research & Development and Innovation. In this capacity, she was pivotal in developing high-throughput, robust methodologies for drug detection and confirmation. Her research interests are focused on enhancing the sample throughput of standard LC-MS/MS equipment through Active Flow Technology, exploring avenues within Therapeutic Drug Monitoring, and advancing the principles of personalized medicine. Dr. Kocic's commitment to scientific advancement and patient care exemplifies her leadership in the field of clinical pharmacology and toxicology.
Dr Paula Schaiquevich
Hospital De Pediatria Jp Garrahan
Pushing the limits: Biomarkers and bioanalytical assays for paediatric patient care in low- and middle-resource settings
Biography
Dr Azucena Aldaz
Consultora
Clinica Universidad De Navarra
Using Pharmacokinetics as a Surrogate Marker for Pharmacogenetics to Optimize Resource Allocation
Abstract
The integration of pharmacokinetics (PK) and pharmacogenetics (PGx) represents the most comprehensive approach to optimizing the dosing of drugs with a narrow therapeutic index. PGx is particularly valuable for guiding initial dosing, offering a personalized starting point that reduces the risk of adverse effects or subtherapeutic exposure. In contrast, PK plays a critical role in ongoing dose adjustment, ensuring that drug levels remain within the therapeutic range as patient-specific variables evolve.
In theory, the combined use of PGx and PK maximizes both safety and efficacy. However, the routine implementation of PGx in clinical practice remains limited, primarily due to concerns about cost-effectiveness and the strength of supporting evidence. These challenges are particularly relevant in resource-constrained healthcare settings, where PK may serve as a pragmatic surrogate for PGx to support individualized therapy while minimizing resource utilization.
Pharmacokinetics does not directly determine the genotype of a specific enzyme isoform, as it reflects only the phenotype. This phenotype represents the net outcome of multiple contributing factors, including but not limited to genetic variability. Other influencing variables include age, body weight, co-medications, organ function, and environmental factors.
Therefore, relying exclusively on genetic data to guide dosage regimens can, at times, be imprudent, as co-medications may significantly influence genotype-phenotype relationships, potentially leading to dosing decisions that pose a risk to patient safety.
Using PK as a surrogate for PGx may represent a cost-effective strategy in specific contexts—particularly for drugs with well-characterized PK-PGx relationships—but it cannot serve as a universal substitute for genetic testing.
In theory, the combined use of PGx and PK maximizes both safety and efficacy. However, the routine implementation of PGx in clinical practice remains limited, primarily due to concerns about cost-effectiveness and the strength of supporting evidence. These challenges are particularly relevant in resource-constrained healthcare settings, where PK may serve as a pragmatic surrogate for PGx to support individualized therapy while minimizing resource utilization.
Pharmacokinetics does not directly determine the genotype of a specific enzyme isoform, as it reflects only the phenotype. This phenotype represents the net outcome of multiple contributing factors, including but not limited to genetic variability. Other influencing variables include age, body weight, co-medications, organ function, and environmental factors.
Therefore, relying exclusively on genetic data to guide dosage regimens can, at times, be imprudent, as co-medications may significantly influence genotype-phenotype relationships, potentially leading to dosing decisions that pose a risk to patient safety.
Using PK as a surrogate for PGx may represent a cost-effective strategy in specific contexts—particularly for drugs with well-characterized PK-PGx relationships—but it cannot serve as a universal substitute for genetic testing.
Biography
Dr Azucena is a Specialist Pharmacist in Hospital Pharmacy with a PhD in Pharmacy, working at Clínica Universidad de Navarra (CUN) since 1984. She established and leads the Clinical Pharmacokinetics Unit at CUN and has played a key role in multiple institutional and national initiatives, including the Cardiorespiratory Care Group and the PROA antimicrobial stewardship program.
She is actively involved with several scientific societies, including SEFH, SIO, and IATDMCT, and has coordinated the PKgen group of SEFH since 2007. An Associate Professor since 2013, she teaches Clinical Pharmacy and Pharmacotherapy and has supervised 15 doctoral theses.
Her academic contributions include 50 published articles, 14 book chapters, 4 books, and 187 conference presentations. She has led 15 R&D projects and serves as a peer reviewer for several scientific journals.
Dr Binu Susan Mathew
Clinical Pharmacology Unit, Christian Medical College, Vellore, Tamil Nadu, India
Phenotyping of DPD enzyme: A practical approach to make 5-FU chemotherapy safer in resource-limited settings
Abstract
Partial or complete deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme activity is responsible for most serious adverse events, including mortality associated with 5-FU. While genotyping of the DPYD gene is the most popular approach to identify DPD deficiency, the ideal approach would be to use both phenotypic and genotypic information. Although this multiparametric approach for the dosing of 5-FU is practised in some centres, most rely solely on DPYD genotyping. However, genotyping of DPD, whilst widely acceptable, is impractical in low-resource settings.
In view of the cost constraints associated with performing pharmacogenomic testing for every patient requiring 5-FU at our hospital, a phenotypic approach to indirectly estimate DPD activity by measuring plasma uracil concentration and the ratio of dihydrouracil/uracil (DHU/U) concentrations is being employed.
This talk will focus on the phenotypic approaches available for pretherapeutic screening of DPD, prior to initiating 5-FU. A proposed algorithm for dose optimisation based on phenotyping results before 5-FU administration will also be discussed. In addition, issues related to the stability of plasma uracil and the feasibility of offering the phenotype test to distant hospitals will be addressed.
In view of the cost constraints associated with performing pharmacogenomic testing for every patient requiring 5-FU at our hospital, a phenotypic approach to indirectly estimate DPD activity by measuring plasma uracil concentration and the ratio of dihydrouracil/uracil (DHU/U) concentrations is being employed.
This talk will focus on the phenotypic approaches available for pretherapeutic screening of DPD, prior to initiating 5-FU. A proposed algorithm for dose optimisation based on phenotyping results before 5-FU administration will also be discussed. In addition, issues related to the stability of plasma uracil and the feasibility of offering the phenotype test to distant hospitals will be addressed.
Biography
Dr Binu Susan Mathew is Professor in the Department of Pharmacology and Clinical Pharmacology at the Christian Medical College, Vellore in South India. Her work initiated with Therapeutic Drug Monitoring of immunosuppressants, which progressed to include anti TB drugs, antibiotics and antifungals. Past few years she is working on the phenotyping of 5-FU and TDM of anticancer drugs. She was involved in the progression of TDM services in this premier tertiary care hospital and has organized regional national conferences and annual workshops in TDM. She was instrumental in setting up multiple assays on the LC MS/MS. She is currently involved in alternate sampling strategies which would enable TDM services to be offered to remote hospitals and from a distance.
Session chair
Ofelia Noceti
National Center for Liver Transplantation and Liver Diseases, Uruguay
Marieke Sturkenboom
University Medical Center Utrecht
