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Trevor Mundel leads the Bill and Melinda Gates Foundation’s efforts to develop high-impact interventions against the leading causes of death and disability in developing countries. He manages the foundation’s disease-specific R&D investments in HIV, tuberculosis, malaria, pneumonia, enteric and diarrheal diseases and neglected tropical diseases. He also manages cross-cutting product development programs, including Discovery & Translational Sciences, Innovative Technology Solutions, Integrated Development, and Vaccine Development & Surveillance. This work relies on close collaboration with an international network of grantees and partners.
Prior to joining the foundation in 2011, Trevor was global head of development with Novartis and previously was involved in clinical research at Pfizer and Parke-Davis.
Born and raised in South Africa, Trevor earned his bachelor’s and medical degrees from the University of the Witwatersrand in Johannesburg. He also studied mathematics, logic and philosophy as a Rhodes Scholar at Oxford University, and he earned a Ph.D. in mathematics at the University of Chicago.
Jeanine U. Condo, MD, MSc , PhD, is an Associate Professor of Public Health at UR and adjunct Ass Prof at Tulane, joined Rwanda Biomedical Center (RBC) from February 2nd -2016 up to July 2019 where she serves as the Director General, an implementing institution of the Ministry of Health with the mandate of implementing preventive, promotion, and curative health interventions covering communicable and non communicable diseases including outbreaks. She holds expertise in institution management and leadership – maternal and child health impact interventions including nutrition and performance based financing (PBF) in limited resource countries.
Previously, she served as the Deputy Dean of Research and Dean of the School of Public Health and Principal of the College of Medicine and Health Sciences under UR.
She served as a member of Technical Evaluation Review Group (TERG) at the Global Fund from 2015-2018 and a member of the International Advisory Group for Primary Health Care at WHO in 2018. She is now serving as a member of Evaluation Advisory Committee (EAC) at GAVI since 2016 and serves a member of African Academy of Sciences (AAS).
Lena Friberg is since 2014 a Professor in Pharmacometrics at the Faculty of Pharmacy, Uppsala University, Sweden. She obtained her PhD degree in 2003 under the supervision of Mats Karlsson and spent nearly 2 years as a postdoc at the University of Queensland, Brisbane, Australia, with Steve Duffull as a mentor. Her research is focused on advancing pharmacometric concepts, supporting dosing strategies for new and available drugs, based on PK and PD modelling. She has published > 110 articles in the area and (co-)mentored 20 students to PhD degree. Much of her research during recent years has focused towards quantitative translation of response-time profiles from preclinical (in vitro and in vivo) to patients for antibacterial treatments. Oncology is a continued research area of interest where pharmacometric approaches are applied to integrate models of concentrations, biomarkers, clinical response variables such as tumor size and survival, as well as adverse effects.
Lena is Deputy Editor-in-chief of CPT: Pharmacometrics & Systems Pharmacology, and on the boards of PAGE, WCoP and ISAP. She has received the Georgio Segré prize for distinction in the field of PKPD, and the Innovation award from ISoP.
Rada Savic is an Associate Professor at the Department of Bioengineering and Therapeutic Sciences and Division of Pulmonary and Critical Care Medicine at the University of California San Francisco, where she leads her Global Health Data and Modeling Team. Her expertise is in data science and advanced pharmacokinetic, biomarker, and pharmacodynamics modeling focused on optimizing drug development process and improving outcomes in all patients, including children and pregnant women.
Dr. Savic is scientific leader on several Global Health large-data initiatives directed by CDC, BMGF, and WHO. She trained in clinical pharmacology, biostatistics, pharmacy, and pharmacometrics at institutions in Sweden, France, Serbia, and the US.
Symposia Chairs and Speakers
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Hesham Al-Sallami is a senior lecturer of clinical pharmacy and co-runs a pharmacometrics research laboratory at the University of Otago in Dunedin, New Zealand. Hesham studied pharmacy at Otago and holds a master’s degree in clinical pharmacy (Otago) and a PhD in clinical pharmacology & pharmacometrics (Otago). He has 18 years clinical experience in community and hospital pharmacy practice and 12 years teaching experience in the area of clinical pharmacy/pharmacology. Hesham has studied and worked in clinical pharmacology and pharmacometrics research for 10 years and his research interests include paediatric pharmacology, dose-individualisation, and the influence of body composition on drug dose-response.
Billy Amzal is Senior VP, Decision and Real-World Data analytics in Certara’s Evidence and Access Group. Billy is an expert in study simulations, optimal design, Bayesian modelling, and real-world data analytics and predictive modelling. He has developed hundreds of models including PK/PD, trial simulations, epidemiological or health economic models. Billy supported >100 health product regulatory or HTA submissions including in developing countries. Prior to joining Certara, Billy founded and led quantitative methodology groups in academia, health authorities and in the pharma industry. Billy graduated in mathematics from Ecole Polytechnique (France) with a PhD in Bayesian Decision Statistics from Paris-Dauphine University.
Karim Azer is the head of the quantitative systems pharmacology (QSP) and DMPK modeling at the Bill & Melinda Gates Medical Research Institute. His focus is on leveraging the spectrum of bioinformatics, systems biology, QSP, PBPK and PK-PD modeling approaches, and data analytics, to address translational medicine needs of the Institute, in the areas of tuberculosis, malaria, diarrheal and enteric diseases, and maternal neonatal health. Karim also develops supportive computational and mathematical approaches and pipelines to enable robust in-silico simulations and visualizations of models and model outputs.
Prof. Nitin Baliga is the Director of the Institute for Systems Biology, where his team deciphers molecular networks within pathogens, cancer cells, and microbial communities to enable solutions for global health, precision medicine, and environmental health. He has published >100 peer-reviewed articles with >20,000 citations, serves as editor for several scientific journals, and is on the board of Climate Solutions. Dr. Baliga and his work has been profiled in The Scientist, Wired Magazine, ArsTechnica, Xconomy, and many popular science magazines, and he has won the Alvin J. Thompson award for education and outreach efforts that have impacted >2.5 million students worldwide.
Paul’s experience is in PK/PD analysis and pharmacology, with emphasis on early and late clinical development and translational biology across several therapeutic areas including oncology respiratory, autoimmune, and cardiovascular diseases. He recently joined Roche as Head of Clinical Pharmacometrics Oncology. Prior to Roche, Paul enjoyed various PK/PD scientist roles at AstraZeneca, MedImmune, Lilly, and Pfizer. He holds a degree from the Pharmaceutical University of Paris (France) and completed his PhD in the field of modelling and simulation at Uppsala University (Sweden). Paul recently graduated from the Cambridge Judge Business School (UK) to complement his scientific curiosity with business acumen in order to broaden his understanding of today’s drug development paradigm.
Jens Markus Borghardt
Dr. Jens Markus Borghardt is the Team Leader for PK/PD Modelling in Drug Discovery Sciences at Boehringer Ingelheim located in Biberach, Germany. He is a trained pharmacist doing his undergraduate studies at the “Westfälische-Wilhelms Universität Münster”. Afterwards, he obtained his PhD from the “Department of Clinical Pharmacy and Biochemistry” at the “Freie Universität Berlin”. The topic of his thesis was about applying pharmacometric approaches to better understand the fate of orally inhaled drugs, which was done in a collaborative setting between academia and the clinical pharmacometrics group at Boehringer Ingelheim. After graduating, he joined the Drug Discovery Sciences department at Boehringer as a Laboratory Head for Modelling and Simulation. Currently, he leads a PK/PD modelling & simulation team of several modelling & simulation scientists covering the therapeutic areas ranging from Immunology and Respiratory, Cardiometabolics, CNS, to Research Beyond Borders. Besides his role as a team lead, he is teaching in the PharMetrX program, supervising one collaborative PhD project, as well as being the industry mentor of two PhD students in the PharMetrX Program.
René Bruno is a Staff Scientist in Clinical Pharmacology at Genentech Research and Early Development. He provides scientific leadership in M&S in drug development, with a focus in oncology and immuno-oncology. René has more than 30 years of experience in academia, industry, and consulting. René’s research interest is oncology tumor growth inhibition modeling, including linking tumor response to outcomes data, and application of these models to trial design and development decisions. He has 65+ peer-reviewed research articles, 16+ invited book chapters, reviews, and commentaries, and 50+ invited lectures at global scientific conferences and universities. René is a founding member for PAGE, and is Fellow and past President of ISoP.
Simon Buatois is a Clinical Pharmacometrician at F. Hoffmann-La Roche ltd. Pharmacist by training Simon hold a Master’s degree in Pharmacometrics and a Ph.D. in Biostatistics. During his PhD, he enjoyed the opportunity to work on innovative pharmacometrics approaches such as item response theory and model averaging, to leverage the information provided by clinical trials, and thereby, empower drug development in progressive diseases. He has received the Lewis Sheiner award from PAGE for his work on a pharmacometric extension of MCP-MOD in dose finding studies.
Samuel Callisto is a Research Scientist at Metrum Research Group. His current work focuses on PK-PD modeling for various clinical research programs. He completed his PhD in Experimental and Clinical Pharmacology at the University of Minnesota where his research focused on pharmacometric approaches to studying adverse cognitive effects of the anti-seizure drug topiramate and pharmacogenomic predictors of drug efficacy.
Teresa Dalla Costa
Teresa Dalla Costa is a Full Professor at the Federal University of Rio Grande do Sul (UFRGS/Brazil) and leader of the Pharmacokinetics and PK/PD Modeling Laboratory. Her research interests are the disease effect on antimicrobials tissue distribution, investigated in animal models of infection using microdialysis; PK/PD modeling of antimicrobials and antifungals; PK/PD alterations due to drug’s nanoencapsulation. She published more than 140 scientific papers and advised more than 40 Master and Doctorate students. She is a member of the Brazilian Pharmacopeia Technical Thematic Committee on Pharmaceutical Equivalence and Bioequivalence (CTT EqBio) and Brazilian Coordinator of the Ibero-American Pharmacometrics Network – RedIF.
Oscar Della Pasqua
Prof Oscar Della Pasqua is Senior Director Clinical Pharmacology Modelling & Simulation at GSK, United Kingdom and Chair Clinical Pharmacology & Therapeutics at the University College London. In addition to his extensive experience in early and late clinical development, he leads a research group focused on paediatric pharmacology, disease modelling and clinical trial design methodology. Prof. Della Pasqua also chairs the Medicines for Children Advisory Network, an internal expert advisory panel for paediatric development programs at GSK, where he coordinates the efforts on the implementation of quantitative clinical pharmacology principles for extrapolation and evidence generation in children. He has more than 130 publications in clinical and scientific journals.
Paolo Denti is an associate professor of pharmacometrics at the University of Cape Town (UCT), South Africa. He holds an MSc in computer engineering and a PhD in biomedical engineering from the University of Padua, Italy. He joined UCT in 2009, where he and his team of pharmacometricians apply mathematical modelling to better characterize the PK/PD of the treatment of HIV, tuberculosis, and malaria, and thus inform how to optimize dosing regimens. He teaches PK/PD to post-graduate students at UCT and participates in training initiatives to develop pharmacometrics skills in Africa, combining the use of online courses and hands-on workshops hosted in different African countries.
Kelly Dooley is Associate Professor of Medicine & Pharmacology at Johns Hopkins University with appointments in Clinical Pharmacology and Infectious Diseases. Her research focuses on tuberculosis therapeutics with an emphasis on clinical trials of TB drugs and HIV/TB co-treatment. She is lead investigator for trials of therapeutics for drug-sensitive and drug-resistant TB, TB meningitis, and TB prophylaxis. She is on the scientific committees of the Tuberculosis Trials Consortium, AIDS Clinical Trials Group, and IMPAACT. She is a consultant to WHO and has been a member of Guidelines Development Committees. She has a particular interest in optimizing drugs for special populations.
Thomas Dorlo is leading a research group focused on clinical pharmacology and pharmacometric modelling and simulation in poverty-related diseases at the Netherlands Cancer Institute and is a consultant in clinical pharmacology, bioanalysis and pharmacometrics to the non-profit organization Drugs for Neglected Diseases initiative (DNDi). His work is aimed at the application of pharmacometric methodologies to optimize drug regimens in a variety of diseases, such as leishmaniasis, malaria and cancer, with a particular focus on vulnerable populations like children and pregnant women. Thomas is currently chair-elect of the Scientific Organizing Committee of PAGE.
Geoff Garnett is deputy director for data and metrics on the TB and HIV team. In this role, he works on improving the efficiency and effectiveness of healthcare delivery. Geoff has served as chair of the UNAIDS Reference Group on Estimates Models and Projections and on many Institute of Medicine and Wellcome Trust panels. Geoff holds an undergraduate degree in zoology, a Ph.D. in pure science from Sheffield University, and an M.Sc. in biological computation from York University. His professional training included a Wellcome Trust Training Fellowship in Mathematical Biology and a Royal Society University Research Fellowship at Oxford University.
Antonio Gonçalves is 3rd year PhD student in the INSERM research team ‘Biostatistical Modelling and Pharmacometrics in treatment of Infectious Diseases’ headed by France Mentré. Pharmacist by training, Antonio has also Master’s degrees in both Pharmacometrics and Biostatistics and prospects a position of pharmacometrician in the pharmaceutical industry. As a PhD student, he works on the development of novel viral dynamic models in Hepatitis B to gain knowledge on the disease and improve drug development. He also had the opportunity to present his methodological work on model averaging in dynamic models at the PAGE meeting.
Dr. Stefanie Hennig, MSc, PhD is a PK/PD consultant at Certara since July 2019. Before joining Certara, she held a tenured academic position at the University of Queensland (2011-2019) and was a senior fellow of the Humboldt Foundation with the Freie Universitaet in Germany. She supervised and mentored > 20 higher research students and taught thousands of undergraduate students on PK/PD.
Stefanie is very active within the Pharmacometrics community worldwide, as the secretary of PAGANZ, a member of the executive committee of WCoP and the Chair of the local organising committee for WCoP2016. Her main research interests are around optimising dosing in children and dose individualization using Bayesian forecasting.
Anneke C. Hesseling
Anneke Hesseling is a South African clinician-scientist dedicated to research in tuberculosis and HIV in children and other special populations, with a special interest in therapeutics. She is Distinguished Professor in Paediatrics and Child Health, Department of Pediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, where she is Director of the Desmond Tutu TB Centre. She also holds a South African National Research Foundation SARChi chair in Pediatric Tuberculosis. She has published more than 240 peer-reviewed papers. She chairs the NIH IMPAACT TB Scientific Committee and is joint PI for the Stellenbosch NIH-funded Clinical Trials Unit
Dr Holford is Professor of Clinical Pharmacology at the University of Auckland. His research interests include population PKPD analyses of clinical trials of drugs, PKPD in neonates and children and rational approaches to dose individualization. He has developed the use of disease progress models for understanding clinical pharmacology with an emphasis on the effects of drugs in Parkinson’s Disease and predicting clinical outcome events through the use of biomarker driven hazard functions. A web based dosing tool (www.nextdose.org) has been created to implement dose individualization using the target concentration strategy.
Andrew C. Hooker
Andrew Hooker is an Associate Professor of Pharmacometrics at Uppsala University, Sweden. His research ranges between methodological and applied pharmacometrics, including: optimal experimental design, methodological problems associated with building, evaluating and using pharmacometric models and the development and use of PKPD models in a range of therapeutic areas and drug classes including cancer, addiction, PET, bioequivalence and biologics. Andrew is also a co-developer of a number of pharmacometric software programs including Xpose, PsN and the optimal design program PopED.
Dr. Tobias Kanacher is a senior consultant in pharmacometrics at Pharmetheus. He is a licensed pharmacist
and received his PhD from the University of Tübingen in 2003, for biochemical analysis and characterization of enzymatic regulatory domains as potential drug targets.
Before joining Pharmetheus (2019-present), he gathered extensive experience in drug discovery and translational clinical development at Altana Pharma AG (2003-2006), Nycomed (2006-2011), Takeda (2011-2012), Bayer (2012-2017) and for SGS-Exprimo (2017-2019). He has broad experience to advice clinical development teams when and how to apply PBPK modelling for influencing internal and regulatory decisions across different stages of clinical drug development.
Dr Kasai is an Instructor at the Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine. He has more than 20 years of experience in Japanese pharmaceutical companies, Keio University and a Japanese CRO. He has experience in pre-clinical pharmacokinetics, population PK/PD analysis, and modeling and simulation strategies in various therapeutic areas including infection, oncology, osteoporosis and CNS. He has contributed to more than a hundred projects with Japanese pharmaceutical companies, universities and hospitals. He also conducted research on mathematical statistics at Tokyo University for two years.
Professor Carl Kirkpatrick is the Director of the Centre for Medicines Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University. Since receiving his Doctor of Philosophy (Medicine) from the University of Otago (NZ) in 2002, Carl has worked at the University of Queensland and more recently Monash University. Carl has extensive knowledge in the area of PK/PD modelling and the factors that alter these processes, pre-clinical and clinical drug development, and clinical applications to optimization of therapy. He has worked on projects and produced publications across a number of therapeutic areas including diabetes, cardiovascular disease, cancer, aged/frailty, and infectious diseases (bacteria, viruses, and fungi).
Dr. Holly Kimko works at AstraZeneca in Clinical Pharmacology & Safety Science since 2019. Previously she was at Johnson & Johnson and Georgetown University Medical School. She has championed the use of modeling and simulations using population analysis & quantitative systems pharmacology approaches and edited three books. She implements modeling & simulation tools in drug development by designing cost-effective clinical studies and solving compound-specific regulatory challenges in all aspects of drug development and post-approval life cycle management. She has a PhD in Pharmaceutical Sciences from the University at Buffalo with a thesis on Physiological Indirect Response Modeling.
Prof. Dr. Charlotte Kloft, is full professor, Head of Department of Clinical Pharmacy & Biochemistry and director of the Institute of Pharmacy at Freie Universität Berlin since 2011. Before this, she was full professor and Head of Department at the Martin-Luther-Universitaet Halle-Wittenberg. Charlotte has been principal investigator of many international research consortia and is Chair of the Graduate Research Training program PharMetrX. During her career so far, she has successfully supervised over 50 PhD and MSc theses and published over 100 peer-reviewed articles in high impact journals. She holds a prominent position in both pharmacometric research and education, is head of the Berlin/Brandenburg section of the German Pharmaceutical Society and is active in the board of among others ISoP, ASCPT, AAPS, PAGE SOC, Noordwijkerhout/QSPC member and CESAR.
Thorsten Lehr graduated in pharmaceutical sciences at Frankfurt University in 2003. He defended his doctoral thesis in 2006 at the Martin-Luther University Halle-Wittenberg focusing on PK/PD modelling in Alzheimer’s disease. Between 2006 and 2012, he was a member of the pharmacometrics team of Boehringer Ingelheim, Germany. In 2012, he was appointed as Professor of Clinical Pharmacy at Saarland University, Germany. His research focuses on the individualization of pharmacotherapy using biomathematical modeling and simulation techniques, with a focus on population approaches and PBPK / QSP modelling.
Michael Looby is the Global head of Pharmacometrics at Novartis. Over the last 25 years, he has worked at the application of quantitative sciences to clinical drug development at Pfizer, Roche and Novartis. He obtained a PhD in Pharmacology from University College Dublin and Free University Berlin.
Guangda holds a BPharm and MHSc (Hons) from the University of Auckland, and practices as a pharmacist in New Zealand and Australia. Guangda is currently a PhD student with the Auckland Pharmacometrics Group, under the supervision of Professor Nick Holford, and Dr Jacqui Hannam. His research focuses on optimizing anticoagulant and antibiotic individualization and translation of pharmacometrics to the clinic to improve the quality, safety and costs of medicines use.
Bernd Meibohm, PhD, FCP, FAAPS, is a Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the College of Pharmacy, The University of Tennessee Health Science Center, Memphis, Tennessee. Dr. Meibohm’s scientific interests include infectious and inflammatory diseases, pediatric pharmacotherapy and the application of pharmacometric techniques in preclinical and clinical drug development, with specific focus on therapeutic proteins. He was the President for the American College of Clinical Pharmacology (ACCP) 2014-2016, and has most recently served as Member-at-Large on the Board of Directors of the American Association of Pharmaceutical Scientists (AAPS) from 2016-19.
France Mentré is Professor of Biostatistics in the School of Medicine of the University of Paris. She heads an INSERM research team on Biostatistical Modelling and Pharmacometrics in treatment of Infectious Diseases. She has worked on the development and application of methods for nonlinear mixed-effects models and pharmacometrics for more than 30 years. She applies these models to understand the variability in the response to anti-infective agents. She is leading the development of the software PFIM for optimal design in pharmacometrics. She has published more than 250 articles in biostatistics, pharmacometrics, clinical pharmacology or medical research. She received in 2013 the USCF/ISoP Lewis B. Sheiner Lecturer Award and in 2018 the ASCPT Sheiner-Beal Pharmacometrics award. She is the co-chair and one of the founders of the Special Interest Group on Statistics and Pharmacometrics of ASA and ISOP. She is editor in chief, since October 2018, of CPT: Pharmacometrics and System Pharmacology.
Dr David Metz is a Paediatric Nephrologist & Clinical Pharmacologist at the Royal Children’s Hospital Melbourne and clinician-researcher at the University of Melbourne. His PhD work involved strategies to optimize mycophenolate dosing in kidney transplantation, including proof-of-concept for pre-transplant dose individualization, understanding the changing pharmacokinetics of total and unbound mycophenolic acid in the early post-transplant period and development of a population pharmacokinetic model for Bayesian dosing to an unbound MPA target.
Dr. ir. Robin Michelet, MSc, PhD is a senior scientist at the Department of Clinical Pharmacy and Biochemistry at Freie Universitaet Berlin. He obtained his PhD in Pharmaceutical sciences in 2018 on the topic of bottom-up, top-down and middle-out modeling and simulation in pediatric drug research under supervision of Prof. Dr. An Vermeulen and Prof. Dr. Jan Van Bocxlaer at Ghent University, Belgium. Currently he mentors a dozen graduate students at FUB and teaches in the module curriculum of the graduate program ‘PharmetrX’. His main research interest is the application and combination of modelling tools in different therapeutic areas.
Elisabet Nielsen is an Associate Professor and Senior Lecturer in Clinical pharmacy at the Department of Pharmaceutical Biosciences, Uppsala University. Her main research focus is within the infectious disease area, where she has over 15 years of experience working with pharmacometric models for antibacterials. The research aims to advance the understanding of PKPD for antibiotics and to develop and evaluate methods for preclinical to clinical translation and for dose individualization. Elisabet is a member of the executive committees of the ESCMID PK/PD of Anti-Infectives Study Group (EPASG) and the International Society of Anti-Infective Pharmacology (ISAP).
Shan Pan completed her PhD in Pharmacometrics in University of Otago, New Zealand. Following this she worked as a pharmacometrician in GSK UK supporting dose selection of a mAb and a small molecule intended for the treatment of rheumatoid arthritis and/or inflammatory liver disease. Since the beginning of 2018, Shan has worked as a pharmacometric researcher, on full-time or part-time terms, in UCL Great Ormond Street Institute of Child Health on biomarker, efficacy and toxicity of retrospective and prospective studies in paediatric patients, and in Guy’s and St Thomas’ NHS Foundation Trust on real-world clinical effectiveness and utility of ustekinumab and adalimumab monotherapy in adults with moderate to severe plaque psoriasis.
Professor Parikh’s research interests focus on translational studies of malaria in sub-Saharan Africa. Dr. Parikh received his M.D. degree from Johns Hopkins University School of Medicine and completed his medical residency training at the Beth Israel Deaconess Medical Center. After completing his fellowship in Infectious Diseases at the University of California, San Francisco and Masters in Public Health at UC Berkeley he joined the faculty at UCSF. He has been a member of the Department of Epidemiology of Microbial Diseases in the Yale School of Public Health and Section of Infectious Diseases in the Yale School of Medicine since 2012.
Colin Pillai runs two social ventures that develop scientific capability in drug discovery and development in low- and middle-income countries. He has previously worked as a pharmacometrician and a senior leader at Novartis and Roche in Switzerland. He acquired his clinical and research experience in hospital and community pharmacy, academia and at the South African Medical Research Council’s Tuberculosis Research programme running Phase 1 clinical trials. Colin is an Honorary Professor at UCT, an Honorary Fellow of the Royal College of Physicians and a Senior Advisor on capacity development for global health to the Bill and Melinda Gates Foundation.
Maria M. Posada
Maria Posada is a Principal Research Scientist in the Mechanistic Pharmacokinetic Group at Lilly and works on developing PBPK models that have supported multiple programs from discovery to registration. She completed her B.S. in Pharmaceutical Chemistry at the National University of Colombia and her Ph.D. in Pharmaceutical Sciences at the University of Michigan. She has been at Lilly since 2012.
Matthew Riggs, Ph.D., FISoP, is Chief Science Officer at Metrum Research Group. His research efforts focus on pharmacometrics and systems pharmacology for model-driven decision support within drug development. Matthew is past-chair and a founder of the AAPS System Pharmacology (SP) Focus Group, founding chair of the ASCPT SP Community, serves on the ISoP Quantitative SP (QSP) Special Interest Group (SIG) Steering Committee and 2 SIG Working Groups, and was an AAPS Connecting Predictive Modelers Forum co-chair. In 2019, he was co-recipient of the ISoP Innovation Award and was recognized as an ISoP Fellow.
Stephen J. Ruberg
Dr. Ruberg received a bachelor’s degree in mathematics from Thomas More College, an MS in Statistics from Miami University and a PhD in Biostatistics from the University of Cincinnati. Throughout his 38 years in pharma, he has published widely and lectured internationally on a variety of topics relevant to pharmaceutical research, including being a co-author of ICH-E9. Recently, he has been deeply involved in the topic of estimands. He has held many leadership positions in his companies and the statistics profession. He is a Fellow of the American Statistical Association and an elected Fellow of the International Statistics Institute.
Stephan Schmidt, PhD, FCP, is an endowed Associate Professor in the Department of Pharmaceutics at the University of Florida, where he also serves as the Associate Director for the Center for Pharmacometrics and Systems Pharmacology. Dr. Schmidt’s research focuses on chronic progressive diseases, special patient populations, and drug-drug interactions. He published more than 80 peer-reviewed scientific manuscripts, 7 book chapters, and 2 textbooks. Dr. Schmidt serves as the Chair of the Special Interest Group on Precision Medicine of the International Pharmaceutical Federation (FIP) and Section Editor for the European Journal of Pharmaceutical Sciences.
Dr. Christine Sekaggya-Wiltshire holds a Master’s degree in Internal Medicine and a PhD in medicine. She is a physician at Mulago National Referral hospital and a research scientist at the Infectious Diseases Institute, Makerere University. She leads pharmacokinetic studies, clinical trials, research related to drug-drug interaction and optimization of tuberculosis treatments and other research projects related to HIV and tuberculosis. She is also the Vice President of the Association of Physicians of Uganda.
Phumla Sinxadi is a Senior Lecturer at the Division of Clinical Pharmacology at the University of Cape Town. She hold bachelors degree in medicine and surgery, Master and Doctoral Degrees in Clinical Pharmacology. She was a WHO/TDR fellow. Her research focusses on infectious diseases that most affect Africans, such as HIV and tuberculosis. including mitochondrial genomics and antiretroviral therapy-associated metabolic complications in HIV-positive South Africans to the effects of rifampicin-based anti-tuberculosis therapy on plasma ARV concentrations in children.
Assoc. Prof. Sjögren graduated in pharmaceutical sciences at Uppsala University in 2004. He defended his doctoral thesis in 2010 at the department of Pharmacy, Uppsala University, with a focus on mechanistic analysis in hepatic drug disposition and pharmacokinetic assessments. He was appointed Associate Professor in Biopharmaceutics in 2016 and has published over 50 scientific papers. Assoc. Prof. Sjögren joined Pharmetheus in 2017 as a senior consultant with responsibilities in mechanistic and physiologically based modelling & simulation, i.e., PBPK, PBBM and QSP, for prediction, translation and analysis across all phases of drug development.
Shruti D. Shah
Currently pursuing her PhD at Roswell Park Comprehensive Cancer Center and University at Buffalo, NY. Her project is focused on understanding the tumor immune dynamics in bladder cancer by integrating computational and in vivo models. The objective of her project is to apply the models to predict the dynamic changes in the tumor microenvironment with treatment and use this information to design treatment regimens.
Babajide Oluwasegun Shenkoya
Shenkoya Babajide trained as a Pharmacist at Obafemi Awolowo University in Nigeria. After graduation, he worked for about 3 years in community and hospital pharmacies where he counselled HIV and Hepatitis patients.
Owing to his experiences with patients, Babajide became more interested in undertaking research whose outcome will have positive impact on the health of patients living with communicable viral infections.
Because he had prior computing knowledge, he set out to actualise his interest through Pharmacometrics and biostatistical analysis. He recently used PBPK modeling to describe prenentration of antiretroviral drugs into lymphoid tissues of humans in his postgraduate research.
Elin holds a Master degree in Chemical Engineering (2011) and a PhD in Pharmaceutical Sciences (2016), both from Uppsala University, Sweden. The focus of her research is pharmacokinetic and pharmacodynamic population modeling aiming to improve treatment of infectious diseases. Currently Elin holds researcher positions at Radboud University Medical Center, Nijmegen, Netherlands, and at Uppsala University. Elin is active within the PanACEA consortium and the pediatric clinical trials networks IMPAACT. She is also part of the WHO Task Force on PK/PD of tuberculosis medicines.
Stacey Tannenbaum, Ph.D., FISoP, Senior Director, leads the Pharmacometrics group at Astellas Pharma, and Chairs the WCoP Executive Committee. She co-founded the International Society of Pharmacometrics, serving as its first President, and sits on a number of ISoP committees and interest groups. She also co-founded the American Conference on Pharmacometrics (ACoP) and was conference chair for the first three events. She received the ISoP Fellowship in 2014 and Leadership Award in 2018. Stacey served as a board member of the American Association of Pharmaceutical Scientists, chaired the M&S Focus Group, and was the co-chair for the AAPS Forum for Connecting Predictive Modelers.
Professor Tarning received his PhD from Goteborg University in 2007 and started his scientific research career the same year at the Mahidol-Oxford Tropical Medicine Research Unit (MORU) in Bangkok, Thailand. In 2013, he took on the responsibility as Head of Clinical Pharmacology at MORU, and has been leading the department since. He was conferred the title Professor of Clinical Pharmacology, University of Oxford, in 2016. He has published over 140 peer-reviewed articles, and act frequently as an external expert for the World Health Organisation. He received the Giorgio Segré Prize in 2014 and the Bailey K. Ashford Medal in 2019.
Dr. Watt’s overarching career goals are to advance public health by optimizing drug therapy in children and to train the future generation of healthcare scientists. Dr. Watt is an associate professor in the division of critical care and the division chief of clinical pharmacology in the department of pediatrics at the University of Utah. He received his medical degree and PhD from the University of North Carolina. He completed his pediatric residency, critical care fellowship, and a research fellowship at Duke University. He was faculty at Duke for 7 years before accepting a position at the University of Utah.
Thanaporn Wattanakul holds a Master Degree in Pharmacy from Chulalongkorn University, Thailand. She is currently a PhD student at University of Oxford. She conducts her research at Mahidol-Oxford Tropical Medicine Research Unit, Thailand. She is working with pharmacometric research in the field of tropical medicine, focusing on population pharmacokinetics and pharmacodynamics of antimalarial drugs used in P. falciparum malaria.
Johan has worked within PKPD for 20 years in industry, academia as well as clinical care, focusing on oncology and immunosuppression. Since 2009 he is part of the Eli Lilly PKPD/PMx group, working with oncology drug discovery and development, both with direct project support as well as strategic methodology development. He has a MSc and PhD degree from Uppsala University.
Mélanie Wilbaux works as a pharmacometrician in Novartis, based in Basel, where she contributes to early development of oncology compounds using population PKPD modeling. Mélanie has a background in biostatistics. She obtained her PhD in Pharmacometrics from the University of Lyon, in France. Her research interest was the clinical applications of PKPD modeling of tumor growth and serum tumor markers in ovarian and prostate cancers. Then, she did a post-doctoral fellow in the Pediatric Pharmacology & Pharmacometrics team from the Children’s Hospital of Basel (UKBB), focusing on pharmacometrics approaches in neonates. She joined Novartis nearly 3 years ago.