Indiana CTSI Pharmacometrics Modeling and Simulation Symposium

Recordings from our March 2025 symposium are available now! 

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Souvik Bhattacharya, PhD
Associate Director, Pharmacometrics
Clinical Pharmacology and Exploratory Development
Astellas Pharma, Cambridge, MA

Currently working as a pharmacometrician at Astellas Pharma since 2021, Dr. Souvik Bhattacharya is involved in Oncology compounds, both early-stage and late-stage, providing development support through modeling and simulation. Previously, Souvik was appointed at Novartis, where they supported development in hematology and dermatology therapeutic areas.

Dr. Bhattacharya graduated from the University of Florida with a degree in Mathematics, specializing in modeling immunological and epidemiological models. After graduation, Souvik served as an instructor at North Dakota State University, the University of Florida, and Santa Fe Community College, and completed postdoctoral work at the University of Trento, Italy, and the College of Pharmacy, University of Florida. Currently, Dr. Bhattacharya co-leads the AI/ML subSiG of the International Society of Pharmacometrics, promoting the use of AI/ML within Clinical Pharmacology.

 

Supriya Bidanta, MS
PhD Student in Bioengineering
Luddy School of Informatics, Computing and Engineering
Indiana University

Supriya Bidanta is a Ph.D. student majoring in Bioengineering, with a minor in Bioinformatics, under the guidance of Dr. Katy Borner at the Luddy School of Informatics, Computing, and Engineering at Indiana University, Bloomington. Her research interests include systems biology, spatial biology, mathematical modeling, and cancer studies. Before pursuing her Ph.D., she earned a Master’s degree in Bioinformatics from the same university, which further enhanced her expertise in computational biology and data analysis. A lifelong biology enthusiast, her passion for the field was sparked during her undergraduate studies in Biotechnology at the Odisha University of Technology and Research. During this time, she actively volunteered to collaborate with faculty members and research associates, gaining valuable experience in academic research. She also has over six years of professional experience as a Data Engineer, having worked with a multinational company based in India. Throughout her tenure, she mastered the handling of complex datasets and the presentation of insights through intuitive and informative visualizations, effectively bridging the gap between technical complexity and user-friendly representation.

 

Robert R. Bies, PharmD, PhD
Professor and Associate Dean of Graduate Education, Department of Pharmaceutical Sciences
School of Pharmacy and Pharmaceutical Sciences
Member, Institute for Artificial Intelligence and Data Science
University at Buffalo 

Dr. Bies is currently Professor of Pharmaceutical Sciences and Associate Dean for Graduate Education at the School of Pharmacy and Pharmaceutical Sciences as well as a member of the Institute for Artificial Intelligence and Data Science at the State University of New York at Buffalo. Prior to this, Dr. Bies was Associate Professor of Medicine and Medical and Molecular Genetics at the Indiana University School of Medicine and Director of the Disease and Therapeutic Response Modeling program for the Indiana Clinical Translational Sciences Institute. He serves as: project scientist at CAMH, University of Toronto; on the editorial boards of the Journal of Pharmacokinetics and Pharmacodynamics, Clinical Pharmacology and Therapeutics: Pharmacometrics and Systems Pharmacology, Journal of Clinical Pharmacology, Biopharmaceutics and Drug Disposition; and the British Journal of Clinical Pharmacology. Dr. Bies is a member of ISoP, ACCP and ASCPT. He is also a Fellow of the International Society for Pharmacometrics.

Dr. Bies received a BSc degree in Pharmacy from the University of Toronto (1991), a Pharm.D. from the UTHSCSA and the University of Texas at Austin (1994) and a Ph.D. Pharmacology from Georgetown University in 1998. This was followed by postdoctoral training at the Center for Drug Development Sciences until 2000.

His research focuses on the application of pharmacometric approaches in HIV, opiate addiction, pediatrics, psychiatry, oncology and neurology as well as on novel methods development including machine learning approaches to model selection and optimization methods for parameter optimization in dynamic systems.

 

Ahmed Elmokadem, PhD
Senior Scientist II
Metrum Research Group 

Dr. Ahmed Elmokadem is a pharmacometrician specializing in mathematical and computational modeling for drug development. With over seven years at Metrum Research Group, he has contributed to modeling various diseases, including cancer, HIV, and rare conditions, leveraging tools such as R, Julia, and NONMEM. His expertise spans population PK/PD modeling, QSP, PBPK, and machine learning applications in pharmacometrics.

Dr. Elmokadem is also an adjunct professor at Indiana University and the University of Connecticut, where he teaches pharmacometrics and PBPK modeling. He has authored multiple peer-reviewed publications and has delivered workshops on modeling and simulation. He holds a PhD in Biomedical Sciences from the University of Connecticut.

 

Debora Gisch, PhD
Assistant Research Professor of Medicine
Division of Clinical Pharmacology
Indiana University School of Medicine 

Dr. Debora Gisch is an Assistant Research Professor in the Division of Clinical Pharmacology at the Indiana University School of Medicine. She is a mathematician with expertise in single-cell technologies, including scRNA-seq and scATAC-seq assays, and their integration with pharmacokinetics (PK) and pharmacodynamics (PD) modeling. Dr. Gisch earned her Ph.D. in mechanical engineering modeling, focusing on three-dimensional applications of the Advection-Diffusion equation.

Her research is exploring drug-drug interactions involving cannabidiol (CBD) and tacrolimus using clinical trial data to bridge biomolecular data with clinical pharmacology.  She is passionate about advancing personalized therapeutics through data-driven approaches and mentoring the next generation of scientists.

 

Derrick Johnson, Ph.D.
Senior Director Bioanalytical Scientific Strategy
B2S Life Sciences

Dr. Derrick Johnson is a bioanalytical scientist with nearly a decade of experience in large molecule bioanalysis, specializing in immunoassays, protein characterization, and biochemical assay development. As Senior Director of Bioanalytical Scientific Strategy at B2S Life Sciences, he leads scientific initiatives and provides strategic oversight for bioanalytical method development supporting pharmacokinetics (PK), anti-drug antibodies (ADA), and biomarker analysis. His expertise helps clients navigate complex bioanalytical challenges, ensuring regulatory compliance and advancing innovative strategies to support the evolving landscape of new therapeutic modalities.

Dr. Johnson earned his PhD in Biochemistry and Molecular Biology from Indiana University School of Medicine and a BS in Biology from Indiana University–Purdue University Indianapolis. His academic research focused on protein kinases, intrinsically disordered proteins, and biochemical signaling pathways.

Before joining B2S Life Sciences, Dr. Johnson served as Director of Assay Development and previously worked as a Principal Investigator and Senior Scientist at AIT Bioscience.

A dedicated leader in bioanalytical science, Dr. Johnson continues to drive innovation in large molecule bioanalysis. He provides technical leadership and scientific expertise to biopharmaceutical clients, developing tailored bioanalytical strategies that streamline and accelerate drug development.

 

Jennifer Lang, PhD
Advisor PK/PD - Global PK/PD & Pharmacometrics
Eli Lilly & Company 

Jennifer Lang received her Pharmacy degree from the University of Paris Descartes in France. In 2021, she completed her PhD in Physiologically-based Pharmacokinetic Modelling, at the University of Manchester, UK, focusing on CYP3A4 metabolism in special populations and P-gp transport. During her postdoctoral research at Servier Laboratories in France, she evaluated an immune-oncology QSP model to support the oncology portfolio. She joined Eli Lilly & Company in 2022 as a PK/PD advisor in the Global PK/PD & Pharmacometrics group. At Lilly, she has gained substantial modelling experience in the siRNA field supporting several projects in both preclinical and clinical spaces and has worked on various modalities in the cardiometabolic health area.

 

Xinnong Li, MS, BS

PhD Candidate
Department of Pharmaceutical Sciences
University at Buffalo

Xinnong Li is a PhD candidate in the Pharmaceutical Sciences Program at University at Buffalo in Dr. Robert Bies Lab. Xinnong's research interest is applying pharmacometric tools in solving the real-world problems. Current research projects include application of machine learning methods in nonlinear mixed effect model selection and optimization, PBPK model of female reproductive tract, as well as population PK model building in HIV.

 

James Lu, PhD
Distinguished AI Scientist 
Clinical Pharmacology, Genentech Inc.

James Lu is a Distinguished Scientist in AI at Genentech. He received his degrees from MIT, including a S.B. in Mathematics and a Ph.D. in Computational Fluid Dynamics. He has been an active researcher in the areas of computational systems biology, in-silico disease modeling, and machine learning in the context of drug discovery & development. Prior to Genentech, he held modeling roles in AstraZeneca and Roche. He has co-authored more than 50 journal and conference publications and is the co-inventor on more than 6 AI/ML patent applications. He is an editorial board member of the journal CPT: Pharmacometrics and Systems Pharmacology and currently serving as a co-chair of the Innovation & Quality (IQ) Consortium Machine Learning Advisory Group and the Scientific Programming Chair for the 2025 American Conference on Pharmacometrics.

 

Paul Macklin, PhD
Associate Professor, Intelligent Systems Engineering
Associate Dean for Undergraduate Education
Luddy School of Informatics, Computing and Engineering
Indiana University 

Paul Macklin is a mathematician, Associate Professor of Intelligent Systems Engineering, and Associate Dean for Undergraduate Education at the Luddy School of Informatics, Computing and Engineering at Indiana University. He works with biologists, modelers, and clinicians to develop and validate sophisticated 3D computer models of cancer and other multicellular systems, using the open source PhysiCell platform developed by his lab. He also works to integrate simulation models, tissue cultures, and artificial intelligence to create digital twins for the future of personalized predictive cancer medicine. 

 

Tarunendu Mapder, PhD
Senior Research Investigator
QSP Immuno-Oncology
Bristol Myers Squibb 

Dr. Tarunendu Mapder is an experienced Researcher with ~10 years interdisciplinary exposures in mechanistic modeling. With skills of Mathematical Physics, Mapder works in broad area of Stochastic Modeling, Optimization & Control, Variability Modeling, Computational Virology, Emerging Infectious Diseases, Cancer Signaling & Chemotherapy, Quantitative Systems Pharmacology. His major interest is in Mathematical Medicine to design intervention strategies by calibrating pre-clinical and clinical data for virtual patient population.

 

Nieves Velez de Mendizabal, PhD  

Nieves Velez de Mendizabal re-joined Eli Lilly & Co. in 2024 as head of pharmacometrics, bringing more than 15 years of experience in academia, consulting, and the pharmaceutical industry. She holds a BS and MS in Computer Engineering and Science, and a Ph.D. in Computer Science from the University of the Basque Country (Spain). During her Ph.D., she interned at Harvard Medical School. 

Nieves has worked in quantitative analysis fields such as systems biology, pharmacometrics, bioinformatics, graph theory, and data mining. Her post-doctoral research was conducted at the University of Navarra and Indiana University, where she was later promoted to Assistant Professor.

In 2014, she joined Eli Lilly's PK/PD & Pharmacometrics Department, and in 2020, she transitioned to Metrum Research Group. In 2022, she joined Gilead Sciences Inc to develop the Pharmacometrics group.

Nieves has maintained an adjunct position at Indiana University since 2014 and is involved with La Casa de España en Indiana. She is dedicated to promoting and advancing the Pharmacometrics discipline and has consistently attended and contributed to external conferences. Nieves excels at creating unity, developing bonds, and mentoring early-career scientists. She believes in the importance of innovative approaches in scientific research.

 

Mark Sale, MD
Vice President
Integrated Drug Development
Certara 

Dr. Mark Sale has more than thirty years in population pharmacokinetic/pharmacodynamics modeling in both academics and industry. In his current role as Vice President at Certara, he is responsible for conducting and overseeing population pharmacokinetic/pharmacodynamic analyses and strategic consulting on drug development. 

Dr. Sale also contributes to the software development group at Certara, supporting development of artificial intelligence and machine learning systems in pharmacometrics.

Prior to this role, Dr. Sale was global director of Modeling and Simulation at GlaxoSmithKline and Assistant Professor of Medicine and Pharmacology at Georgetown, respectively.  He also has faculty appointments at Indiana University School of Medicine and Mercer University School of Pharmacy and State University of New York at Buffalo. 

Dr. Mark Sale completed his medical training at the Ohio State University, residency training in internal medicine at Indiana University and a fellowship in Clinical Pharmacology at Stanford. 

 

Stacey Tannenbaum, PhD, FISoP

Stacey Tannenbaum, PhD, FISoP is currently on sabbatical, but was most recently Vice President of Scientific Engagement at Metrum Research Group. She had more than 20 years of Modeling and Simulation experience in Pharma, first at Novartis and then Astellas; during her last 5 years at Astellas she was the lead of the US Pharmacometrics group. Stacey completed her BSE in Biomedical Engineering at Duke University, and her PhD in Pharmaceutical Sciences and Applied Mathematics at the University of Arizona, followed by a post-doctoral fellowship at the Center for Drug Development Science at Georgetown University. She holds faculty positions at the University of Arizona, University of the Pacific, and the University of Tennessee Health Science Center. Stacey has had significant impact on the global Pharmacometrics community by co-founding the International Society of Pharmacometrics (ISoP), serving as its first President, and sits on a number of ISoP committees and interest groups including leadership on the Statistics and Pharmacometrics Special Interest Group. She received the ISoP Fellowship in 2014 and Leadership Award in 2018.  Stacey co-founded the American Conference on Pharmacometrics (ACoP) and was conference chair for the first three events. She was a co-founder of the local networking group Modeling and Simulation Applications in Clinical Pharmacotherapy (MoSAiC) and is the Executive Committee chair for the World Conference on Pharmacometrics (WCoP). She served as a board member of the American Association of Pharmaceutical Scientists (AAPS), chaired the AAPS M&S Focus Group, and was the co-chair for the AAPS Forum for Connecting Predictive Modelers.  She is also the chair elect of the Quantitative Pharmacology Network at the American Society of Clinical Pharmacology and Therapeutics (ASCPT).

 

Katherine M.C. Totten, PhD
TDA Rotational Development Program
Pharmacokinetics and Pharmacodynamics (PKPD)
Eli Lilly & Company 

Katherine Totten is an advisor at Eli Lilly & Company whose contributions have spanned PKPD and genetic medicines. She earned her bachelor’s degree in biology from Bethany Lutheran College and her PhD in biomedical sciences with an emphasis in molecular pharmacology and experimental therapeutics from the Mayo Clinic, where she studied the potential of bacteriophage viruses to treat antibiotic-resistant periprosthetic joint infection. In her free time, Katherine enjoys downhill skiing and reading a good book.

 

Tim Waterhouse, PhD
Group Leader Statistics, Principal Scientist II
Metrum Research Group 

Tim Waterhouse has worked at Metrum Research Group since 2019, in both PK/PD and statistics. He attained his Ph.D. in Statistics from the University of Queensland, where he applied optimal design methods to PK/PD models. He then worked at Eli Lilly and Company in pharmacometrics before joining Metrum. His work involves using modeling and simulation to inform decision making in all phases of drug development across a range of therapeutic areas.

 

Yoon Yeo, PhD
Associate Department Head, Industrial and Molecular Pharmaceutics
Lillian Barboul Thomas Professor of Industrial and Molecular Pharmaceutics and Biomedical Engineering
Purdue University 

Prof. Yoon Yeo is the Lillian Barboul Thomas Professor and Associate Department Head of Industrial and Molecular Pharmaceutics at Purdue University. She has built expertise in pharmaceutical sciences and drug delivery through Ph.D. training in protein microencapsulation and post-doc training in hydrogel-based biomaterials. At Purdue, Prof. Yeo leads a research program specializing in immunomodulatory formulations for anti-inflammatory applications and cancer immunotherapy, intracellular delivery of gene therapeutics and peptide antibiotics, new methods of delivering anticancer drugs, and long-acting drug delivery systems, with the support of the NIH, NSF, and industry. She has authored 132 peer-reviewed papers with an h-index of 63 and >13500 citations. Prof. Yeo is a Fellow of the American Association of Pharmaceutical Scientists (AAPS, 2019) and the Controlled Release Society (CRS, 2022) and currently serves as a Deputy Editor-in-Chief of the Journal of Controlled Release and for the CRS Board of Directors (2023-2026). She received the NSF CAREER award (2011), New Investigator Awards from the AAPS (2009), and American Association of Colleges of Pharmacy (2008).

 

Youngjae You, PhD
Professor of Empire Innovation
Department of Pharmaceutical Sciences
School of Pharmacy
University at Buffalo 

Dr. Youngjae You is a pharmaceutical scientist specializing in medicinal chemistry and drug delivery systems. He serves as a Professor of Empire Innovation in the Department of Pharmaceutical Sciences at the University at Buffalo, where he leads cutting-edge research in site-specific drug delivery, photodynamic therapy, and targeted prodrug activation strategies. His work focuses on developing novel therapeutic approaches for treating non-muscle invasive bladder cancer, metastatic cancers, and drug-resistant tumors. His recent research utilizes PKPD and QSP modeling approach to understand underlying mechanisms and optimize therapeutic efficacy.

With a strong background in pharmaceutical chemistry, Dr. You earned his Ph.D. from Chungnam National University, Korea, followed by postdoctoral training in medicinal chemistry at SUNY Buffalo. Over the years, he has held several academic positions, including Professor and PHF Presidential Professor at the University of Oklahoma Health Sciences Center (OUHSC). His extensive experience spans synthetic chemistry, molecular targeting, and light-responsive drug conjugates, bridging the fields of chemistry and biomedical sciences.

Dr. You has secured multiple NIH R01 grants, Department of Defense (DoD) research awards, American Cancer Society (ACS) with funding exceeding $10 million for his pioneering work in singlet oxygen-cleavable prodrugs and light-activatable chemotherapy strategies.

A prolific scholar, Dr. You has authored over 100 peer-reviewed publications and delivered numerous invited presentations at international scientific conferences. His research has been instrumental in translating light-mediated drug activation into potential clinical applications.

At the University at Buffalo, Dr. You actively mentors graduate students and postdoctoral researchers, fostering the next generation of pharmaceutical scientists. He is a Director of Graduate Studies at his department. He also holds an Adjunct Research Professorship at the Roswell Park Comprehensive Cancer Center, further strengthening his contributions to translational cancer research.

 

Yifan Yu, MS, BS
PhD Candidate
Department of Pharmaceutical Sciences
University at Buffalo 

Yifan Yu is a PhD candidate in the Pharmaceutical Sciences Program in University at Buffalo. He is a graduate student researcher working under the supervision of Dr. Robert Bies. Yifan completed his undergraduate degree in Pharmaceutical Sciences at Capital Medical University and his master’s degree in Pharmacometrics at the University at Buffalo. He previously interned at AstraZeneca Clinical Pharmacology Quantitative Pharmacology Oncology group. His current research focused on application of pharmacometrics in HIV treatment and pre-exposure prophylaxis. He is also interested in using mathematical modeling approaches to support drug development in pregnancy and pediatric populations. 

 

Haiying Zhou, PhD
Executive Director, PBPK R&D
Simulations Plus

Haiying Zhou is the Executive Director of PBPK R&D at Simulations Plus. She joined Simulations Plus in 2009 and focused on the development of modeling and simulation software for quantitative understanding of the pharmacokinetics and pharmacodynamics of drug candidates (GastroPlus). She also spent two years in the development of DDDPlus for the simulation of in vitro dissolution of active pharmaceutical ingredients and formulation excipients.

She received her Ph.D in Biomedical Engineering from Case Western Reserve University (CWRU) in 2009. Her research interests in CWRU include multi-scale mathematical modeling of gas transport and cellular metabolism with emphasis on the metabolic regulation of physiological systems