Engineering Manager

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.

Peptide Design & Discovery: D360 enhancements make it faster to move from a sequence idea to a prioritized design candidate. The latest release of Certara's scientific informatics platform, D360 26.5, continues to help discovery teams access, analyze, and visualize molecule and bioactivity data across therapeutic modalities. Building on the peptide sequence design capabilities introduced earlier, the 26.5 release gives scientists an even stronger toolkit for generating and evaluating peptide ideas within a sequence alignment. This includes: * A new find and replace capability lets scientists swap monomers or sequence motifs across sandbox sequences in a single action * A new monomer enumeration tool automates classic design strategies such as alanine scanning * Newly added calculated properties, including monomer count, natural monomer count, specific monomer counts, and BILN-based sequence differencing - update automatically as sequences are edited, giving scientists immediate insight into each new design * Improved error detection for branched peptides This update also improves usability with expanded dashboard search, a redesigned Web All Entity details report, direct Excel import, and new equation functions for in-app analysis. On the administration side, D360 26.5 adds configurable Preferred Results for assay queries, a new Client Plugins panel for independently updating sketchers and renderers, and enhancements to authentication and automated testing tools. Want to bring faster peptide design and streamlined workflows to your team?

Get the presentation: Building investor-ready biotech strategies. See the full presentation from Certara's Biotech Forum, a strategic workshop built to help biotech executives, founders, and R&D leaders develop investor-ready strategies ahead of RESI and JPM Healthcare 2027. What's in the presentation. This deck covers the full day of content from Certara's Biotech Forum, held in partnership with Life Science Nation (LSN), organizers of RESI, including: * Building a clear value proposition: what investors actually look for in a pitch: a well-defined medical need, genuine differentiation, and the regulatory and commercial foresight to back it up * Designing a development plan that supports financing and regulatory success: how to build a realistic path from IND to first-in-human that satisfies both regulators and investors * Selecting the right clinical candidate: what "investor-ready" evidence looks like, from translational relevance to study design and manufacturability * Corporate factors that shape investor decisions: LSN's perspective on the factors investors weigh beyond the science * Future trends in regulatory science: how recent regulatory shifts are changing the way companies need to plan earlier in development * Preparing for RESI and JPM week: how to prepare before these events, run productive meetings during them, and convert conversations into real momentum after it ends * [Discussion only] Cross-functional perspectives on early development: perspectives from biotech leaders, investors, pharma, and Certara experts on how early strategic decisions shape risk, speed, and fundability. This presentation is built for: * Biotech CEOs, founders, and executive teams preparing for RESI and JPM * R&D leaders refining development strategy * Venture and investment professionals evaluating early-stage programs * Business development teams preparing for partnering meetings Featuring insights from: Sougato Das (Life Science Nation), Tony Arulanandam, DVM, PhD (SynaptImmune Therapeutics), Wojciech Dworakowski (Pioneering Medicines), Katya Tsaioun, PhD (Akttyva Therapeutics), Dustin Armstrong, PhD (Parasail LLC), and Certara's Fran Brown, Maximilian Vargas, Kevin Hershberger, Geoff Fatzinger, Tong Zhu, Diana Marcantonio, John Pennet (Mid Atlantic Bio Angels) and Koji Yasuda (Fast Track Initiative) Ready to see the full presentation? Get instant access to the complete deck, covering value proposition development, regulatory-ready planning, clinical candidate selection, and RESI/JPM meeting prep. Download the presentation Access this resource