
Conference: BioTechX US 2025 – register here
Date: September 16 - 17, 2025
Location: Philadelphia, PA
Booth: #604
Certara at the 2025 BioTechX US
We’re excited to sponsor BioTechX US and highlight our collaboration with Bristol Myers Squibb (BMS). At the conference, Anna Kondic, Vice President of Pharmacometrics, Translational Medicine, and Clinical Pharmacology at BMS, will present alongside Matteo Marano, Director and Global Portfolio Leader at Certara, on the broad impact of mechanistic modeling in improving patient care.
Visit our booth to meet Certara experts and explore how solutions like BaseCase, D360, Simcyp, QSP, and Model-Based Meta-Analysis (MBMA) empower pharma and biotech teams to communicate value, unify and analyze data, simulate drug behavior and disease biology, and integrate evidence across studies to optimize development, dosing, and regulatory decisions.
Where You Can Find Us
Date: Tuesday, September 16
Time: 2:50pm
Poster Title: Derisking Decision Making by Incorporating Early Economic Evaluation for Pharmaceutical Assets
This presentation will highlight how integrating quantitative approaches—such as pharmacometrics and model-based meta-analysis—with health economics early in drug development can optimize both clinical and economic outcomes, illustrated through three case studies that underscore the importance of cross-functional collaboration, clearly defined model assumptions, and conducting evaluations prior to Phase 3.
Anna Georgieva Kondic, Vice President of Pharmacometrics, Translational Medicine, and Clinical Pharmacology, BMS
Dr. Anna Kondic currently heads the Pharmacometrics group at BMS; this group includes mechanistic modeling and clinical pharmacometrics, data science and noncompartmental analysis and has dedicated efforts to create workflow in ML/AI. Anna has worked as a quantitative scientist in various therapeutic areas and companies over the last 25 years and has extensive experience in both mechanistic and empirical model development across the whole spectrum of R&D, as well as reimbursement. She holds a PhD in mathematics from Duke University and MBA from Stern School of Business at New York University. Anna is particularly passionate about the use of quantitative methods to make personalized medicine a reality, especially for cancer patients.
Anna is a competitive master artistic swimmer, participating in both national and international meets. She is particularly proud of having been the captain for the Merck Rhode Island team for Swim Across America in 2018. The charity swim that year raised more than 700 000 for cancer research at the Women and Infants Hospital in Providence, RI.
Craig Comisar, Senior Director of Pharmacometrics
With over 16 years in the field, Craig brings a deep expertise in modeling & simulation, helping streamline drug development across diverse therapeutic areas—including oncology, immunology, and cardiovascular diseases. His journey began with a PhD in chemical engineering, where he specialized in reaction kinetics, later transitioning to pharmacometrics to tackle the complexities of drug behavior in patients.
He joined Certara (formerly Quantitative Solutions) in the spring of 2013. He spent a majority of his career as a pharmacometrician at Janssen [formerly Centocor] and worked in the area of modeling biologic entities for regulatory submissions including exploratory and confirmatory analyses along with dosing guidance simulations. His work covers areas including pediatric indications, immunology, neuroscience, oncology and anti-infectives. Dr. Craig Comisar received his chemical engineering PhD from University of Michigan under Dr. Phillip Savage in reaction kinetics in 2007, after which he obtained a pharmacometrics postdoctoral fellowship at Children’s Hospital of Philadelphia under Dr. Jeffery Barrett. Aside from his modeling/simulation activities, Craig enjoys painting, contrabass clarinet, and German board games with his family. He also enjoys a good game of soccer, basketball, Ultimate Frisbee or any other pickup game that he can find.
Poster
Closing the Evidence Gap: Model-Informed Drug Development (MIDD) Strategies to Align Regulatory Approval and Payer Reimbursement
Authors: Craig Comisar, Matthew L. Zierhut, Roman Casciano, Ananth Kadambi
Our poster outlines how early use of MIDD can bridge the “regulatory–payer evidence gap” that delays patient access to novel therapies. Regulators focus on safety and efficacy from clinical trials, while payers require additional proof of long-term effectiveness, cost-effectiveness, quality-of-life benefits, and real-world outcomes. Addressing these needs late in development can result in years-long reimbursement delays. By integrating payer-focused evidence strategies early—using tools such as Quantitative Systems Pharmacology (QSP) and Model-Based Meta-Analysis (MBMA)—sponsors can align requirements, shorten approval-to-reimbursement timelines, and deliver treatments to patients faster and more affordably.
Product Demo Schedule Booth 604
Representatives from CoAuthor™, Certara AI, GlobalSubmit™, and Phoenix® will also be on hand to answer questions
Explore Certara Resources
Explore our solution ecosystem through the resources below.
Drug Discovery
- D360 Scientific Informatics Platform
- Chemaxon – search, design, property prediction, registration and more
- D360-Design Hub integration
Mechanistic Modeling – PBPK
Mechanistic Modeling – QSP
- QSP Software | Advanced Mechanistic Modeling | Certara
- Quantitative Systems Pharmacology Consulting
- Certara IQ – Coming Soon
PK/PD Analysis and popPK Modeling
- The Phoenix Platform for PK/PD Analysis and popPK Modeling
- Phoenix NLME
- Pirana – PMX Modeling Workbench with ML-Driven Model Search and Selection
Non-Clinical Data Analysis and Toxicology
- SEND Explorer for visualizing and analyzing SEND datasets
- Quantitative Systems Toxicology and Safety Consulting to predict adverse reactions earlier
Clinical Data Management and Biometrics
- Pinnacle 21 for study builds, data standardization, validation, and submission preparation
- Pinnacle 21’s Data Exchange for centralized vendor data specification, validation, and transfer
- SDTM mapping specification
- Biometrics and Data Sciences Services
Model-based Meta Analysis (MBMA)
Regulatory Sciences and Document Creation
- CoAuthor: The Generative AI-Enabled Regulatory Writing Platform
- AI-enabled regulatory writing services
- Transparency and disclosure solutions
Package Submission
Evidence, Value and Access
- Real World Evidence and Market Access Services
- Health Economics and Outcomes Research
- Basecase for product value communication
Certara.AI – GPTs specialized for the life sciences
Request a meeting with our experts