Dr. Akshanth Polepally is a Research Fellow and Director at AbbVie with over 15 years of experience in drug discovery, clinical pharmacology, and model-informed drug development (MIDD). At AbbVie, he leads efforts in optimal dose selection and the design and execution of clinical pharmacokinetic and pharmacology studies. He has contributed to multiple successful drug approvals and plays a key role in advancing dose optimization strategies across clinical development programs.

Dr. Benjamin Engelhardt is an Associate Director in Pharmacometrics at AbbVie. Over his nine years at AbbVie, he has led the oncology pharmacometrics team and contributed to multiple successful regulatory submissions, applying methods ranging from exposure-response analyses to advanced model-informed drug development. Beyond industry, he is a lecturer at multiple universities, a reviewer for journals including CPT and Nature, and a regular contributor to major scientific conferences and consortia.

Mark Chaplain is the Gregory Chair of Applied Mathematics at the University of St. Andrews. He received his Ph.D. in mathematics from the University of Dundee in 1990 and has been actively working mathematical biology with an emphasis on oncology since then. During this time he has published over 300 research articles and books. 

Additional details can be found at:
https://research-portal.st-and...

Moustafa M. A. Ibrahim obtained his Ph.D. in Pharmacometrics from Uppsala University, Sweden. Following his Ph.D., Moustafa joined Pharmetheus AB as MIDD Consultant, where he provided pharmacometrics expertise across the spectrum of drug development, from non-clinical studies through late-stage clinical development and regulatory submissions. In 2024, Moustafa joined the Clinical Pharmacology and Safety Sciences Department at AstraZeneca, within the Rare Disease Unit, as a Global Clinical Pharmacology Lead. In this role, he provides scientific and strategic leadership for multiple global development programs to inform dose selection, optimize study design, support regulatory interactions, and enable data-driven decision-making throughout clinical development.

Martin obtained his PhD in Pharmacometrics from Uppsala University. He has 20+ years of drug development experience in areas such as metabolic disorders, autoimmune disease, infectious disease, hematological disorders etc. In 2012 Martin co-founded the consulting company Pharmetheus AB. In the consultant role he has been engaged as strategic advisor on behalf of multiple clients and acted as the main responsible consultant for 50+ pharmacometric data analysis projects on behalf of more than 20 different clients. The projects have ranged from pre-clinical translational projects to submission ready large-scale phase III PKPD analysis. These analyses have among other things contributed to 5+ successful NDA filings. 

Dr. Paridhi Gupta is a Research Investigator in the Clinical Pharmacology–Early Oncology group at Bristol Myers Squibb. She earned her Ph.D. in Pharmaceutical Sciences with a specialization in Pharmacometrics from the University of Tennessee Health Science Center under the mentorship of Prof. Bernd Meibohm. Paridhi has completed internships at Merck, Bristol Myers Squibb, and Johnson & Johnson, gaining broad experience in leveraging modeling and simulation to support preclinical and clinical drug development.

Dr. Vivaswath Ayyar is the R&D Innovation Director for Translational Medicine at GSK and Adjunct Assistant Professor of Pharmaceutical Sciences at the University at Buffalo. His work focuses on advancing innovative therapeutics through translational science and model-informed approaches, leveraging causal data analytics and mechanistic platform modeling to inform decision-making across the R&D stages for emerging modalities, including advanced biologics and nucleic acid medicines. Prior to GSK, he spent six years at Johnson & Johnson, where him and his team built and leveraged mechanistic and/or systems pharmacology models to inform the biologics and oligonucleotide portfolios across disease areas.

Tu Mai is a Senior Principal Scientist in Clinical Pharmacology, Modeling & Simulation at Genentech, where she leads clinical pharmacology and modeling and simulation strategies across multiple early and late-stage development programs. She has extensive experience in model-informed drug development (MIDD), including population PK/PD modeling, Bayesian forecasting, exposure-response analysis, and MIDD strategies to support regulatory submissions and dose optimization. Her work spans ophthalmology, oncology, immunology in small molecules and biologics. Tu received her Ph.D. in Pharmacology from Vanderbilt University.

Gina Song is a Director in the Oncology Global Clinical Development organization, Quantitative Pharmacology and Pharmacometrics (QP2) function at Merck. She has over 10 years of experiences in the Pharmaceutical industry across therapeutic areas including preclinical and clinical oncology, infectious disease and pediatric development for different modalities with time spent at Hamner Institute, Labcorp and currently Merck.  She is currently leading SC pembrolizumab program for clinical pharmacology and modeling &simulation efforts across indications as well as supporting regulatory submissions in global markets.

Mallika Lala is Senior Director, Group Leader at Merck in the Oncology Global Clinical Development organization, Quantitative Pharmacology and Pharmacometrics function. She has 15 years of drug development experience across therapeutic modalities, including early and late clinical oncology, infectious diseases and CV-met. She has been involved with the clinical development of pembrolizumab across indications and regulatory submissions in several global markets, most recently MIDD for dosing regimen and SC formulation additions, as well as multiple oncology assets including ADCs and targeted therapies. Before joining Merck, in industry in India to advancing pharmacometrics and was an ORISE fellow at FDA with focus on application of innovative quantitative approaches to enhance pediatric drug development.

• PhD biostatistics leader with over 18 years of research and development experience in biopharmaceutical industry, in various roles with increasing responsibilities.

• Passionate for complex problem solving and integration of different fields and functions across the biopharmaceutical development continuum.

• Strategic and managerial experience of teams of statisticians and programmers to support multiple programs/indications of various complexity.

• Out-of-the-box thinker and reliable team player with excellent stakeholder management, communication, analytical, computational and technical writing skills.

• Lifelong learner and entrepreneur with original research and publications on adaptive designs for clinical research. 

• Hands on statistical modeling, complex data analysis and simulations; proficiency in SAS and R; very good knowledge of the regulatory landscape.

Federico Reali, PhD, is Group Leader of the Quantitative Systems Pharmacology (QSP) group at Fondazione The Microsoft Research – University of Trento Centre for Computational and Systems Biology (COSBI). His expertise is in systems biology and QSP modeling applied to drug development across multiple therapeutic areas, including neurodegenerative disorders and lysosomal storage diseases. He leads and coordinates multidisciplinary research teams and collaborates with pharmaceutical companies and non-profit organizations on translational QSP projects. He is also a Teaching Fellow at the University of Trento, where he teaches probability and statistics and supervises undergraduate and graduate students. Federico Reali serves as Vice President of the Scientific Committee of the Italian National Life Sciences Cluster ALISEI. His current interests focus on using quantitative models, digital twins, and data-driven approaches to support clinical decision-making, therapeutic stratification, and the translation of complex biological data into clinically meaningful insights.

Alexander is a Chemist with a PhD focusing on theoretical and computational methods for structural and optical property predictions. He then spent several years in academia (U. of Lyon) working on molecular dynamics simulation and free energy methods dedicated to protein structure and aggregation. Alex moved to systems pharmacology applying large-scale disease and quantitative systems pharmacology models integrated into clinical trial simulations, across a number of disease areas. Alex is now leading the QSP team within ESQlabs with the aim to promote widespread application of integrated PBPK and QSP modeling. He is also currently affiliated at the pharmacy Department of University of Namur, working towards better qualifying PBPK/QSP for regulatory decision making. 

Conner Sandefur, PhD, is a Senior Scientist in QSP Solutions at Simulations Plus, where he develops mechanistic, systems-based models to support client decision-making and model‑informed drug development. His work focuses on injury and repair dynamics and nonlinear disease processes, with an emphasis on transparent, mechanism‑first model design that strengthens credibility across QSP applications.