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  • Africa Trainee Research Spotlight Session: New Insights in Pharmacokinetics drug-drug interactions (DDI) among HIV and TB Patients in Africa
    Contains 3 Component(s) Includes a Live Web Event on 06/17/2025 at 10:00 AM (EDT)

    Join us for an exciting webinar spotlighting emerging research led by African trainees tackling some of the continent’s most pressing health challenges. This session, with attendees drawn from the recently concluded ISSX Africa workshop, will feature four dynamic presentations exploring complex pharmacokinetics drug-drug interactions (DDI) and modelling in African patients.

    Join us for an exciting webinar spotlighting emerging research led by African trainees tackling some of the continent’s most pressing health challenges. This session, with attendees drawn from the recently concluded ISSX Africa workshop, will feature four dynamic presentations exploring complex pharmacokinetics drug-drug interactions (DDI) and modelling in African patients. 

    Featured Topics Include:

    • The Effect of Pregnancy and Breastfeeding on the Population Pharmacokinetics of Levofloxacin in South Africans with Rifampicin-Resistant Tuberculosis
    • Population pharmacokinetic analysis of pyrazinamide and isoniazid in plasma and cerebrospinal fluid in adults with HIV-associated tuberculosis meningitis
    • Personalised Tacrolimus Dosing in African Kidney Transplantation: Insights from a Single Centre in Kenya
    • Darunavir and Rilpivirine Plasma Concentrations with and Without Progestin Implants, and Their Impact on HIV Viral Load in Ugandan Women

    Jose M. Calderin

    Jose M. Calderin is an early-career scientist in Pharmacometrics, currently pursuing his PhD at the University of Cape Town. Originally from Havana, Cuba, he holds a Bachelor's degree in Pharmaceutical Sciences from the University of Havana. His doctoral research focuses on population PK/PD modelling to optimize treatment strategies for pulmonary and meningeal tuberculosis, integrating preclinical and clinical data.

    Shadia Nakalema

    Shadia Nakalema is an Internal Medicine Physician and Research Scientist at the Infectious Diseases Institute, Mulago, committed to expanding her expertise in healthcare to address emerging challenges. Shadia has extensive experience working with special populations, including pregnant and breastfeeding women. As part of the Contraceptive Implant Research Consortium for Low-Income Countries, she focuses on building evidence for the safe use of contraceptive implants among women living with HIV. Her primary research interests lie in pharmacokinetics and pharmacogenomics, with a particular focus on drug-drug interactions between antiretroviral drugs (such as efavirenz and nevirapine) and contraceptive implants.

    Shadia is also part of the DolPHIN-3 consortium, which focuses on optimizing long-acting injectable antiretroviral therapy for pregnant and postpartum women living with HIV. As part of this, she is pursuing a PhD, examining the drug interactions between standard antiretroviral therapies and hormonal contraceptives. Additionally, she aims to explore implementation science aspects related to the integration of long-acting ART and family planning services for women living with HIV. This research will further contribute to improving treatment strategies and reproductive health options for women living with HIV.

    Davies Otieno

    Davies Otieno is a first-year PhD Candidate in Makerere University, Infectious Diseases Institute, working under the supervision of Prof. Catriona Waitt. Drawing on a background in Medicine from the University of Nairobi, and an MSc in Clinical Pharmacology from the University of Aberdeen, he developed a keen interest in variability in clinical pharmacokinetics and clinical outcomes. Davies' doctoral research currently focuses on antimicrobial pharmacokinetics in maternal sepsis. Prior to his PhD, Davies completed specialty training in Internal Medicine where he investigated CYP3A4 genotypes using a clinical predictive index in patients taking tacrolimus after kidney transplantation. These findings were presented at the ISSX 2025 African Chapter. He is also interested in open-source tools for pharmacometrics and keen on collaborative initiatives.

    Sharon Sawe

    My name is Sharon Sawe, and I am originally from Kenya. I have a background in biostatistics and data science, and I am currently pursuing a PhD in Pharmacometrics at the University of Cape Town, in the Department of Medicine, Division of Clinical Pharmacology. My research mostly focuses on the pharmacokinetics and pharmacodynamics of antitubercular drugs in pregnant and breastfeeding women, as well as drug exposure in their infants. I am enthusiastic about the application of artificial intelligence and machine learning in pharmacometrics, and I am passionate about advancing maternal and child health through pharmacometrics.

    Mathew Njoroge (Moderator)

    Senior Scientist

    Holistic Drug Discovery and Development Centre

    Mathew Njoroge is a senior scientist at the Holistic Drug Discovery and Development Centre (H3D), University of Cape Town (UCT), where he works as part of a multidisciplinary team to advance preclinical drug discovery projects. His interest in drug discovery was sparked during his undergraduate in Pharmacy at the University of Nairobi and forged during postgraduate studies with Prof. Kelly Chibale's group at UCT, where he graduated with his PhD in 2010.

    His postgraduate work, and his career since then have focused on understanding the metabolism and pharmacokinetics of compounds with a view to translating in vitro data to human exposure – efficacy relationships, as part of drug discovery projects in malaria, tuberculosis and antimicrobial resistance. This work, combined with H3Ds mission to build Africa-specific models, has led to research interests in drug metabolism and disposition in the African population – more specifically in considering the impact of pharmacogenetic variability on the pharmacokinetics of drugs in African populations. 

    Julius O. Enoru (Moderator)

    Director (Senior Principal Research Scientist)

    AbbVie

    Julius O Enoru (Ph.D.) is a Director (Senior Principal Research Scientist) at the Department of Qualitative Translational and ADME Sciences (QTAS), AbbVie Pharmaceutical Research & Development, South San Francisco, CA, USA. He holds a Ph.D. in Molecular Biology from Vrije Universiteit Brussels (VUB), Belgium and completed a Postdoctoral Research Fellowship program at the department of Drug Metabolism and Pharmacokinetics, Wyeth Pharmaceuticals, Pennsylvania. Julius is a subject matter expert in Translational ADME sciences, currently responsible for scientific oversight of pre-FIH in Vitro ADME Sciences functions at the AbbVie South San Francisco, CA site. He has contributed to many INDs, NDAs and responses to regulatory agencies’ inquiries. Julius represents AbbVie on the pharmaceutical industry consortium - International Consortium for Innovation and Quality in Pharmaceutical Development – “Guidelines for development of Targeted Covalent Inhibitors Working Group”.

    Julius is passionate about the advancement of xenobiotic research in the African continent and seeks to connect partners to establish collaboration with industry/academic colleagues. He was the co-chair of the 2025 ISSX Africa workshop in Johannesburg, South Africa, and is a member of many international professional organizations. Julius has been a mentor to many students and continues to mentor early career scientists through the ISSX mentorship program.

  • Predicting clearance of metabolically stable compounds using novel human hepatocyte models
    Contains 3 Component(s)

    Quantitative, Translational, & ADME Sciences (QTAS), Abbvie Inc., North Chicago, IL, USA Abstract: Compounds exhibiting low metabolic clearance are often favored to improve pharmacokinetic profiles and decrease dose. To predict clearance, common experimental techniques include incubations with liver microsomes or cryopreserved hepatocytes in suspension. Hepatocytes in suspension are generally favored as they enable testing of a nearly comprehensive set of metabolic enzymes. However, suspension hepatocytes gradually lose viability in culture, limiting ability to test stable compounds that require longer incubations. Plated hepatocytes will survive for days but lose most drug metabolizing enzyme capacity within 48 hours. In this presentation, methods to overcome loss of phenotype (or increase in assay analytical sensitivity) will be presented. Also, the performance of the models with up to 50 compounds of varying physical chemical properties for predicting clearance will be discussed. The models include hepatocyte suspensions, co-cultures with mouse fibroblasts, tri-cultures with human stromal and endothelial cells, high well density spheroids, and finally a “pre-load” model using mono-culture hepatocytes.

    Compounds exhibiting low metabolic clearance are often favored to improve pharmacokinetic profiles and decrease dose. To predict clearance, common experimental techniques include incubations with liver microsomes or cryopreserved hepatocytes in suspension.  Hepatocytes in suspension are generally favored as they enable testing of a nearly comprehensive set of metabolic enzymes. However, suspension hepatocytes gradually lose viability in culture, limiting ability to test stable compounds that require longer incubations. Plated hepatocytes will survive for days but lose most drug metabolizing enzyme capacity within 48 hours. In this presentation, methods to overcome loss of phenotype (or increase in assay analytical sensitivity) will be presented. Also, the performance of the models with up to 50 compounds of varying physical chemical properties for predicting clearance will be discussed.  The models include hepatocyte suspensions, co-cultures with mouse fibroblasts, tri-cultures with human stromal and endothelial cells, high well density spheroids, and finally a “pre-load” model using mono-culture hepatocytes.

    Learning Objectives:

    1. Gain an understanding of novel and emerging methods for evaluating hepatic intrinsic clearance of metabolically stable small molecules
    2. Learn how suspension hepatocytes, pre-loaded plated human hepatocyte monocultures, co-cultures and high-density spheroid cultures compare to each other
    3. Learn how models perform with Lipinski’s Rule-of-Five and beyond Rule-of-Five compounds
    4. Gain understanding of the inter-donor reproducibility for selected models 

    David Kukla, PhD

    David Kukla is a Senior Scientist in the Quantitative, Translational, and ADME Sciences department at AbbVie where he uses and develops hepatocyte systems, including complex in vitro models and microphysiological systems aimed at understanding clearance and metabolism pathways. Additionally, his team supports assays to investigate internalization, accumulation, and distribution of small and large molecules within target cells. He received his doctorate in Bioengineering from the University of Illinois at Chicago in the laboratory of Salman Khetani where he developed multiscale human liver platforms for drug development, disease modeling, and regenerative medicine. He received his bachelor’s in Materials Science and Engineering from the University of Illinois at Urbana-Champaign.

    David Stresser, PhD (Moderator)

    David Stresser is a Research Fellow in the Quantitative, Translation & ADME Sciences department at AbbVie. Prior to joining AbbVie in 2016, he held research, management and business development positions at Gentest Corporation, BD Biosciences and Corning Life Sciences in Woburn, MA.  He received post-doctoral training in the laboratory of David Kupfer at the University of Massachusetts Medical School and completed his graduate work in the laboratories of David E. Williams and George S. Bailey at Oregon State University, obtaining a Ph.D. in toxicology.  He has co-authored > 60 articles or book chapters on drug metabolism and is an active participant in various pharmaceutical company consortia.

  • Zonal Hepatic Transporter Distribution in MASH and THC Interactions with Hepatic and Placental Transporters: Implications for Drug Disposition and Response in Specific Populations
    Contains 3 Component(s)

    This webinar aims to present novel research on hepatic transport zonation in metabolic dysfunction-associated steatohepatitis (MASH) and the interaction of Δ9-tetrahydrocannabinol (THC) with hepatic and placental transporters, thereby enhancing our understanding of THC disposition in pregnant women. This includes elucidating the identity of transporters influencing the disposition of THC and its metabolites, and the application of a novel liver PBPK model that incorporates zonal distribution of hepatic transporters to predict disease-related changes in statin disposition for patients with MASH.

    This webinar aims to present novel research on hepatic transport zonation in metabolic dysfunction-associated steatohepatitis (MASH) and the interaction of Δ9-tetrahydrocannabinol (THC) with hepatic and placental transporters, thereby enhancing our understanding of THC disposition in pregnant women. This includes elucidating the identity of transporters influencing the disposition of THC and its metabolites, and the application of a novel liver PBPK model that incorporates zonal distribution of hepatic transporters to predict disease-related changes in statin disposition for patients with MASH. 

    This webinar will feature two presentations and a panel discussion on the above topics.

    Kim Brouwer

    Professor

    University of North Carolina

    Kim L.R. Brouwer, Pharm.D., Ph.D., is the William R. Kenan Jr. Distinguished Professor in the Division of Pharmacotherapy and Experimental Therapeutics at the UNC Eshelman School of Pharmacy, associate dean for research and graduate education, and a professor in the curriculum in toxicology.

    Brouwer received her B.S. in pharmacy from Oregon State University. She completed her Pharm.D. at the University of Kentucky (UK) College of Pharmacy in conjunction with a pharmacy residency at the UK Medical Center and a PhD in pharmaceutical sciences/pharmacokinetics. After postdoctoral training (pharmacology/drug metabolism) in the UK College of Medicine, she joined the faculty at the University of North Carolina in 1986, where she served as director of graduate studies for the UNC Eshelman School of Pharmacy from 1996 to 2004, and Chair of the Division of Pharmacotherapy and Experimental Therapeutics from 2004-2015.

    Jashvant Unadkat

    Professor

    Jashvant (Jash) Unadkat, Ph.D. is a Professor in the Dept. of Pharmaceutics at the School of Pharmacy, University of Washington, Seattle.   He received his Bachelor’s degree in Pharmacy (B.Pharm.) from the University of London (1977), his Ph.D. from the University of Manchester and his postdoctoral training at the University of California at San Francisco.  He held the Milo Gibaldi Endowed Professorship in the Department from 2016-21. Dr. Unadkat’s research interests are on mechanisms of transport and metabolism of drugs during pregnancy, and transport of drugs across the placental, hepatic, intestinal and blood-brain barrier.  Dr. Unadkat has published more than 250 peer-reviewed research papers.  He is a fellow of AAAS, AAPS, JSSX, and the founding co-chair (1999-2001) of the focus group of AAPS on Drug Transport and Uptake.  Dr. Unadkat received the AAPS Research Achievement Award in 2012 and the ISSX Scientific Achievement Award in 2023.  Dr.  Unadkat created and led the UW Research Affiliates Program on Transporters (UWRAPT), a cooperative effort between the UW School of Pharmacy and pharmaceutical companies, for 10 years. He also leads UWPKDAP, a NIDA funded Program Project grant (P01) on drug disposition during pregnancy and co-leads UW Transporter Elucidation Center (https://depts.washington.edu/uwtec/) funded by NICHD to identify and characterize novel transporters in the placenta and the developing intestine.  Dr. Unadkat has been an Associate Editor for the Journal of Pharmaceutical Sciences, an Editor of AAPS Journal, and a member of the NIH Pharmacology study section (2000-3).  Dr. Unadkat has organized or co-organized numerous national and international conferences on the role of transporters and pregnancy in the disposition of drugs.   

    Billy Murphy

    University of North Carolina

    Xin Chen

    University of Washington

  • Navigating Complexities in Oligonucleotides: DMPK Strategies and CNS-Targeting Solutions
    Contains 3 Component(s)

    This webinar is intended to provide drug developers with a comprehensive understanding of the unique DMPK challenges posed by oligonucleotide therapeutics and practical strategies to overcome them. Attendees will gain insights into advanced delivery platforms, customized pharmacokinetic approaches, and specialized administration methods, particularly for CNS-targeting oligonucleotides. By exploring real-world examples and established methodologies, the webinar aims to empower researchers to accelerate preclinical development and enhance their success in drug development and regulatory submissions.

    Oligonucleotides have emerged as a rapidly growing class of therapeutics, with nearly 20 oligo-based drugs approved by the U.S. FDA to date. However, due to their novelty, complexity, and limited regulatory guidance, oligonucleotides pose unique technical challenges for drug developers compared to traditional small molecules or biologics. Specialized pharmacokinetic evaluation systems are essential to address these complexities.

    Advancements in delivery platforms have heightened the need for customized PK strategies during preclinical development. For in vitro ADME studies, selecting the right metabolic model based on the drug's structure and in vitro-in vivo extrapolation (IVIVE) is critical. In vivo PK studies require tailored administration methods to thoroughly investigate pharmacokinetics. This webinar will discuss strategies for overcoming DMPK challenges and accelerating oligonucleotide drug development, drawing from extensive experience in early-stage screening and IND filings. 

    CNS-targeting oligonucleotides add further complexity, primarily entering the brain through nervous system administration methods such as cerebrospinal fluid injections (ventricular, cisterna magna, and lumbar) and nasal administration. Among these, lumbar injection is preferred for its simplicity and feasibility for repeated dosing. Over years of refinement, a standardized platform for lumbar administration in monkeys has been developed.

    This webinar is sponsored by WuXi AppTec.

    Dr. Jing Jin

    Senior Director, DMPK Services Department

    WuXi AppTec

    Dr. Jing Jin currently serves as the Senior Director heading the DMPK Study Director team at WuXi AppTec. Before joining WuXi AppTec in 2016, he worked as an Investigator of Clinical Pharmacology at Novartis. Over these roles, he has gained extensive experience in DMPK research of multiple drug modalities, including oligonucleotides, protein degraders, and antibody-drug conjugates. Jing received his Ph.D. in Pharmacology from Vanderbilt University in Nashville, TN, and completed his undergraduate training in Biochemistry at Nanjing University, China.

    Shoutao Liu

    Director, DMPK Services Department

    WuXi AppTec

    Shoutao Liu joined WuXi AppTec DMPK Department in 2005. With over 19 years of experience in large animal PK (pharmacokinetics) studies, he currently serves as the head of the large animal PK group in the DMPK Department. Under his leadership, the team provides high-quality large animal PK study services for global clients, successfully assisting hundreds of clients in completing nearly a thousand preclinical drug development projects.

  • Dynamic Free Fraction: Concept, Methodology and Utility in DMPK
    Contains 3 Component(s)

    This webinar will introduce dynamic free fraction (fd) as a new concept characterizing drug protein binding and demonstrate the utility of fd in hepatic clearance mediated by CYP and OATP transporter.

    As dictated by the free drug theory (FDT), fraction of unbound drug in plasma (fu,p) is routinely measured to rationalize pharmacological readouts such as drug potency and hepatic clearance. There is an increasing body of evidence contradicting the FDT when fu,p is applied, and one prominent example is the systematic under-prediction of hepatic clearance for highly bound compounds. We reason that fu,p is a static measure of drug binding extent and it does not capture drug protein binding dynamics. As a result, we have introduced the "dynamic free fraction" (fD) as a new binding parameter describing drug protein binding affinity/dynamics that can be indirectly determined by coupling the drug binding assay with a reporter enzyme in combination with high-resolution mass spectrometry, circumventing a long-standing challenge inherent in determining drug binding kinetics constants such as kon and koff. Using a large group of diverse drugs representing both CYPs and OATP transporter substrates, we demonstrated that the well-stirred model incorporating with fD correctly predicted both hepatic clearance and liver extraction ratio without apparent systematic bias, which is markedly better than those predicted with fu,p. The results suggest that dynamic free fraction (fD) as a measure of protein binding affinity is a key determinant in hepatic clearance, which is contrary to the currently held view.

    Zhengyin Yan

    Zhengyin received his BS/MS degrees in Chemistry from Wuhan University in China and his PhD in Biochemistry from Georgetown University in US. After a brief tenure as a postdoc at the National Cancer Institute, NIH, Zhengyin joined Johnson & Johnson Pharmaceutical Research Institute as a Senior Scientist in 1998 where he used to lead both in vitro ADME and discovery bioanalytical groups. In 2015, Zhengyin moved to Genentech, and currently he is a Distinguished Scientist leading the Discovery in vitro DMPK group. His scientific interest includes drug metabolism and bioactivation, ADME-guided lead optimization utilizing both in vitro assays and in vivo studies to assess and/or predict drug-like DMPK properties such as drug clearance and DDI potential. He has published more than 60 research articles and a number of book chapters, and co-edited three books published by Springer. Additionally, Zhengyin served on the US NSF Grant Review Panel and the editorial board of scientific journals such as Drug Metabolism Letter and Pharmaceutical Analysis.

  • From Kidney and Liver Interaction in Patients with CKD to the Drug-Drug-Severe CKD Disease Interaction Predicted by PBPK
    Contains 3 Component(s)

    This webinar is intended to raise the awareness of complicated scenario where drug-drug-disease interaction occurs and how to evaluate the PK of drugs using PBPK to inform the optimal use of drugs in such patient group.

    Chronic kidney disease (CKD) is more than renal malfunction alone. It may affect drug disposition by multiple pathophysiological changes including the changes in abundancy and activity of hepatic drug transporters. Also, the disease factors may interplay with drug-drug interaction (DDI) in patients with CKD causing a different DDI scenario from the one in healthy volunteers. The translation of DDI magnitude between healthy subjects and patients with CKD may not be straightforward due to the complex drug-drug-disease interaction (DDDI) scenarios, whereas physiologically based pharmacokinetic (PBPK) model-based approach may serve as a valuable quantitative tool to predict the complex DDDI. Herein, we illustrate how to use PBPK modelling to predict the DDI between statins and roxadustat mediated by hepatic transporters in patients with severe CKD, and answer the following questions: how much does severe CKD affect the abundancy and activity of hepatic transporters? Which pathways(s) are the major one(s) responsible for the observed alteration of statins PK in patients with severe CKD? Is the magnitude of statin-roxadustat DDI in severe CKD patients similar to that in HV? What are the optimal dose regimens when statins and roxadustat are co-administered in patients with severe CKD?

  • Bioanalysis of Today and Tomorrow: Current Best Practices and Emerging Technologies Enabling Diverse Therapeutic Conjugate Evaluation | An ISSX 2024 Virtual Workshop
    Contains 2 Product(s)

    This workshop focuses on bioanalytical techniques, including biotransformation (and subsequent bioanalysis) of macromolecules. This workshop provides both content focusing on fundamentals and new and emerging technologies.

    This workshop is organized through the efforts of the ISSX Bioanalysis in ADME Science Focus Group and is organized by Drs. Matthew Albertolle, Bingming Chen, Joe Cannon, Mei Han, Thomas Kraft, John Tran, Jim Shen, Faye Vazvaei, and Brian Booth.

    The scope of this workshop is to provide content for attendees from early career/grad school who want to learn fundamentals (Day 1) to senior career leaders in the field who want to learn about what is the new and emerging technologies (Day 2). Workshop topics can include bioanalytical techniques, including biotransformation (and subsequent bioanalysis) of macromolecules. Each session of the workshop consists of presentations from several expert speakers. In addition, there will be an interactive virtual poster session which will be selected from the pool of abstracts from attendees. 

  • An African Hepatic Modeling Platform: Can We Get There?
    Contains 3 Component(s)

    In this webinar we will discuss efforts for improving the global underrepresentation of African genetics in science. We will further explore the current landscape and challenges in realizing an African hepatic modeling platform - with a specific focus on the development of hiPSC models that can better recapitulate hepatic function.

    The African continent harbors unparalleled genetic diversity yet remains largely underrepresented in  pharmaceutical  research  and  development.  Pharmacogenomics  is  fundamental  to  precision medicine strategies, and although to date largely absent from implementation, representing the genetic diversity of the African population within the laboratory is critical to the democratization of stratified  and  effective  healthcare  in  Africa.  Afrocentric  preclinical  resources  could  support precision  medicine on  the  continent  and  reshape  the  global  underrepresentation  of  African genetics  in  science. Models  which  could  begin  to  address  this  include  primary  human hepatocytes,  immortalized  hepatic  cell  lines,  and human induced  pluripotent  stem  cell  (hiPSC)derived hepatocyte-like cells – derived from individuals of African genetic ancestry. The feasibility of an African hepatic modeling platform is slowly being realized due to the convergence of several technologies and methodologies which have traditionally been siloed on the continent.

  • How To Build Robust Predictive Human Organ Models To Improve the Prediction of Drug ADME Parameters
    Contains 3 Component(s)

    This symposium/webinar is intended to educate ADME scientists on MPS technology and its potential to generate clinically translatable data.

    Despite billions in annual investment, most drugs never reach the market because preclinical experiments fail to predict human effects. In this webinar, we will cover why in vivo models only deliver an approximation of what is likely to happen in the human body and why building more predictive, human-relevant models is key to reducing drug attrition. During the webinar we will introduce ADME scientists to the field of microphysiological systems (MPS), also known as organ-on-a-chip (OOC).

    We will explore how MPS technology can be implemented to create human-specific tissue models such as the gut and liver and interconnect them into systems that generate clinically translatable data. We will demonstrate how a deeper and earlier knowledge of human drug ADME profiles enables issues to be addressed prior to costly preclinical studies.

    The webinar will conclude by highlighting how the complementary use of MPS bridges the human-relevance gap, facilitating the confident selection of safer and more effective drug candidates, whilst also reducing costs.

    This webinar is sponsored by CN Bio Innovations.

    Marco Ortiz

    CN Bio

    Marco Ortiz has experience in developing cell types as commercial products and clinical therapeutics. In his most recent role, he performed preclinical experiments of iPSCs derived hepatocytes for acute liver diseases as a potential indication.  Marco Ortiz completed a bachelors in genomic sciences working at the University of Wisconsin-Madison and completed a UCL Wellcome Trust PhD programme at the Francis Crick Institute. 

  • Pharmacogenomics from a Protein Structure Perspective
    Contains 3 Component(s)

    The human genome comprises approximately 20,000 protein-coding genes and over 900 million variants according to dbSNP. Systematic understanding of the impact of genomic alterations in humans is critical for the development of effective medicines. However, it is simply not feasible to study every single variant in detail. This challenge extends to the analysis of how pharmacogenes are affected by genetic polymorphisms, as it is impossible to study the impact of every individual single nucleotide polymorphisms/variations (SNPs/SNVs) of pharmacogenes in human clinical trials. Yet, understanding drug metabolism and pharmacokinetics is crucial for assessing drug efficacy and safety. To minimize harmful side effects from drugs while maximizing their therapeutic effectiveness in each patient or group of patients, we would need to understand the effects of population specific SNPs in pharmacogenes and drug-enzyme interactions. To date the effect of non-synonymous SNPs, more specifically missense mutations, at the protein level is poorly studied in pharmacogenomics research. We previously proposed a post-hoc analysis approach of molecular dynamics (MD) simulations using dynamic residue network (DRN) analysis to consider the dynamic nature of functional proteins and protein-drug complexes and to probe the impact of mutations and their allosteric effects. This talk will discuss the computational approaches and tools that we have developed over the years with applications to pharmacogenomics.

    The human genome comprises approximately 20,000 protein-coding genes and over 900 million variants according to dbSNP. Systematic understanding of the impact of genomic alterations in humans is critical for the development of effective medicines. However, it is simply not feasible to study every single variant in detail. This challenge extends to the analysis of how pharmacogenes are affected by genetic polymorphisms, as it is impossible to study the impact of every individual single nucleotide polymorphisms/variations (SNPs/SNVs) of pharmacogenes in human clinical trials. Yet, understanding drug metabolism and pharmacokinetics is crucial for assessing drug efficacy and safety. To minimize harmful side effects from drugs while maximizing their therapeutic effectiveness in each patient or group of patients, we would need to understand the effects of population specific SNPs in pharmacogenes and drug-enzyme interactions.   To date the effect of non-synonymous SNPs, more specifically missense mutations, at the protein level is poorly studied in pharmacogenomics research. We previously proposed a post-hoc analysis approach of molecular dynamics (MD) simulations using dynamic residue network (DRN) analysis to consider the dynamic nature of functional proteins and protein-drug complexes and to probe the impact of mutations and their allosteric effects. This talk will discuss the computational approaches and tools that we have developed over the years with applications to pharmacogenomics.

    Özlem Tastan Bishop

    Özlem is full Professor in structural bioinformatics at Rhodes University, South Africa and distinguished adjunct Professor at Saveetha University, Chennai, India.

    She received her BSc degree in Physics from Boğaziçi University, Istanbul, Turkey. Then she moved to the Department of Molecular Biology and Genetics at the same University for her MSc degree. She obtained her PhD from Max-Planck Institute for Molecular Genetics and Free University, Berlin, Germany in 2003. While doing her PhD, Özlem became interested in structural biology, and during her postdoctoral positions (Texas University, USA; University of Western Cape and University of Pretoria, South Africa) she gained experience in structural bioinformatics as well as structural biology.

    In 2009, Özlem took up an academic position at Rhodes University, South Africa. She established the Research Unit in Bioinformatics (RUBi) in 2013. She has graduated 25 PhD and 38 MSc students since she joined Rhodes University. She received Rhodes University Internationalization award for 2018; Rhodes University Vice Chancellor’s Distinguished Senior Research award for 2020 and South African Society for Bioinformatics (SASBi) Silver Award, 2022.

    She serves on the Editorial Board for PLOS Computational Biology, PLOS One and Frontiers in Molecular Biosciences and Frontiers in Applied Mathematics and Statistics, Biological Modeling and Simulation Section, and she is an Advisory Board member of F1000Research Bioinformatics Gateway. Özlem’s broad research interest is structural bioinformatics and its applications to drug design and development. Her recent interest is in the allosteric mechanisms of proteins and understanding the effects of nonsynonymous single nucleotide variations on protein structure and function in the context of drug resistance and drug metabolism. She has published roughly 100 research articles.