2nd TCE for Autoimmune Disease Summit. Conference: 2nd TCE for Autoimmune Disease Summit. Date: October 27 - 29, 2026 Location: The Colonnade Hotel, Boston, MA Certara is proud to support the 2nd T-Cell Engager for Autoimmune Disease Summit, where discovery, translational, preclinical, and clinical leaders are tackling the field's biggest challenges: reducing CRS toxicities, improving tissue-selective immune depletion, and expanding T-cell engager (TCE) targets beyond B-cells. As autoimmune TCEs move from oncology-inspired concepts into one of the industry's most closely watched therapeutic modalities, Certara's quantitative systems pharmacology (QSP) expertise offers a mechanistic path through the dosing and translational questions shaping this fast-moving field. Meet Certara at the summit. VP, Head of QSP Software Before co-founding Applied BioMath, Josh was a Principal Scientist in the Systems Biology Group of the Department of Immunology and Inflammation at Boehringer Ingelheim Pharmaceuticals. His work leveraged physics-based models to: translate in vitro and in vivo data, assess target feasibility, understand drug mechanism of action, and predict human doses. The ultimate goal of this work was to reduce late stage attrition in drug development through a deep and quantitative interrogation of drug pharmacology and disease pathophysiology. Josh received his PhD from MIT in Biological Engineering where he worked on experiment design for Systems Biology, focusing on the identification of tractable experiments that could allow for the estimation of unknown parameters and reveal complex mechanisms in signal transduction networks. Before that Josh worked at Avaki to develop a highly scalable software platform to support High Performance Computing, and Enterprise Information Integration in the Life Sciences, and Engineering. Scientific poster. Details coming soon - check back here for Certara's latest T-cell engager research being presented at the summit.

How do you know you have the right dose? Using exposure-response evidence to justify and defend dose decisions. Date: Thursday, November 5, 2026 Time: 10:00 - 11:00am ET Summary. Selecting the right dose is one of the most consequential decisions in drug development. But how do you know your selected dose is truly the right one and that the rationale will stand up to scientific and regulatory scrutiny? Exposure-response (ER) analysis can provide critical evidence for dose selection, optimization, benefit-risk assessment, and regulatory decision-making. But an apparent relationship does not always tell the full story. Exposure metric selection, treatment interruptions, dose modifications, and time-dependent confounding can influence results and potentially lead to the wrong conclusions. Join Certara experts to explore how rigorous ER analysis and modeling and simulation can help teams evaluate dose options, address uncertainty, integrate efficacy and safety, and build scientifically defensible dose recommendations. The discussion will also examine how ER analysis fits within Model-Informed Drug Development (MIDD) and the evolving expectations for dose optimization under FDA Project Optimus and ICH M15. During this webinar, you will learn how to: * Select exposure metrics and ER approaches based on the specific development question * Recognize when treatment interruptions, dose modifications, and time-dependent confounding may distort ER conclusions * Use modeling and simulation to evaluate dose options, assumptions, and uncertainty * Integrate efficacy and safety ER evidence to strengthen benefit-risk assessment * Translate ER findings into scientifically defensible dose recommendations * Use quantitative evidence to support regulatory interactions and labeling decisions * Position ER analysis within a broader MIDD evidence strategy This webinar is designed for professionals in clinical pharmacology, pharmacometrics, modeling and simulation, MIDD, clinical development, regulatory and translational sciences, and development strategy involved in dose selection, optimization, and regulatory decision-making. Speakers: Vice President, Europe/APAC Regional Lead of Quantitative Science Dr. Cheung has more than 20 years of experience in modeling and simulation, as well as clinical pharmacology, with expertise in PBPK/PD mechanistic modelling, special populations (e.g., pediatrics, maternal, and geriatrics), extrapolation, model-based meta-analysis, vaccines, infections, HIV, complex biologics, and different therapeutic areas across early, late-phase and post marketing drug development. She is an honorary professor at the School of Engineering at the University of Warwick, UK. She is leading the EU funding project, ERAMET (grant agreement number 101137141), in work package 5, championing the enhancement and utilization of extrapolation in pediatric populations and for rare diseases. Before joining Certara, Amy was a Senior Pharmacometrician and Scientific and Project Leader at the AstraZeneca Pediatric Working Group, which included 22+ cross-functional pediatric experts. During this time, she also served as the company representative on the IMI DDMoRe initiative and co-led work packages (e.g., PMX-workflow, cardiovascular training) and IQ consortium CPLG Pediatric Working Group. Dr Cheung has been a member of the EFPIA MID3 workgroup since the 2011 EMA M&S workshop, which resulted in several white papers. Currently, she is contributing her expertise to various professional societies, such as the IQ Consortium, EFGCP, ASCPT, and EU Horizon-funded projects. She has published over 50 papers on MIDD methodology/applications, reviews, and white papers in peer-reviewed journals. Senior Director Dr. Eline van Maanen brings over 16 years of experience in pharmacometric consulting. She joined Certara in 2018. Before that, she was a PKPD consultant at LAP&P Consultants. Eline has dedicated her entire career to the field of pharmacometrics. Her expertise includes mechanistic PKPD modeling across a range of therapeutic areas, such as neurology, oncology and infectious diseases. Eline received a PhD in Pharmacology from Leiden University in 2017, where she studied systems pharmacology of the amyloid cascade under the supervision of Prof. Meindert Danhof. Eline has a background in engineering, holding a MSc degree in Life Science and Technology from Delft University of Technology. Outside of work, Eline enjoys pilot-gig rowing. Senior Director Anna Largajolli, PhD is a Senior Director at Certara Drug Development Solutions with over 15 years of experience in pharmacometric modelling and clinical pharmacology. She holds a B.Sc. and M.Sc. in Biomedical Engineering (cum laude) and a PhD in Pharmacometric Modelling, all from the University of Padova (Italy). Her career spans academia and industry, including a visiting PhD studentship at the University of Cape Town, a postdoctoral fellowship at Uppsala University (Sweden), and a postdoctoral fellowship at GSK, before joining Certara in 2016 where she has progressively advanced to her current senior leadership role. Anna has deep expertise across a broad range of modelling and simulation techniques - including population PK, PKPD, model-based meta-analysis (MBMA), and machine learning-based covariate selection - applied across multiple therapeutic areas. She leads project teams, mentors junior associates, and contributes actively to scientific innovation through an extensive publication and conference presentation record.