Date: Thursday, October 1, 2026
Time: 10:00 - 11:00am ET / 3:00 - 4:00pm GMT
Services: Simcyp® PBPK Modeling
Products: Simcyp® Biopharmaceutics
Summary
Predicting how a drug product will behave in vivo (e.g., accounting for gastric pH, food effects, population variability, etc.) is a central challenge across drug development, whether for a new molecule or a generic. Generics carry an added constraint: reproducing a reference product’s performance without seeing its formulation and clearing a narrow bioequivalence bar under tighter timelines and thinner margins than innovator programs allow.
Model-informed formulation development (MIFD) offers a mechanistic, data-driven path through these challenges. In this webinar, we’ll present the latest features in Simcyp® Biopharmaceutics V25 and real-world case studies applying MIFD.
Key learning objectives:
- Receive an overview of Simcyp Biopharmaceutics, Certara’s software platform for small molecule drug development, including recent capability updates relevant to formulation strategy and biowaiver support
- Learn how mechanistic PBPK modeling was applied in a recent Molecular Pharmaceutics publication to evaluate pH-modifying excipient effects and inform formulation design decisions aimed at mitigating pH-mediated drug-drug interactions
- Understand the role of self-buffering nature of the drugs (free forms and salts), the mechanisms by which pH-modifying excipients overcome elevated pH effects of ARAs, and the role of buffers
- Learn the factors that need consideration when developing pH-DDI mitigating formulations using either salt forms or pH-modifying excipients
Register now
Siri Kalyan Chirumamilla
Siri Kalyan Chirumamilla is an Associate Principal Scientist at Certara UK Limited (Simcyp Division) with focus on absorption modelling of oral drug products. He was the lead for Expansion of IVIVC, Virtual Bioequivalence (VBE) and Oral absorption Projects for Simcyp Simulator. He is currently leading the development of Simcyp Biopharmaceutics software. Prior to joining Simcyp in 2018, he worked for about 5 years as a Formulation Scientist, responsible for developing Oral drug products for both ANDA and 505b2 applications in Dr. Reddy’s Laboratories. He received his master’s degree from National Institute of Pharmaceutical Education and Research (NIPER S.A.S Nagar), India.
David B. Turner, PhD
Senior Scientific Advisor & Head of Mechanistic Oral Absorption ModellingDavid B. Turner PhD is a Senior Scientific Advisor and Head of Mechanistic Oral Absorption Modelling at Certara UK Ltd (Simcyp Division) having joined Simcyp in 2004. He is author or co-author on 44 peer-reviewed papers. His work at Simcyp has mainly focused upon oral absorption modelling but also on physico-chemical aspects of PBPK modelling including tissue distribution and a variety of QSAR models. David was the PI for a recently completed FDA grant to develop modelling tools for handling supersaturating drug products and is co-PI on another FDA grant to look at locally acting drugs in the GI tract. He has a Biochemistry BSc, a Computer Science MSc and a PhD in Chemoinformatics and QSAR modelling all obtained at Sheffield University, UK. Prior to joining Simcyp he worked in a Computational Chemistry Group (Synt:em SA, Nîmes, France) focused mainly upon high throughput in silico discovery and virtual screening projects.
Register now
