BioTechX US 2025

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.

日期： Tuesday, September 16

时间： 2:50pm

Title:Derisking Decision Making by Incorporating Early Economic Evaluation for Pharmaceutical Assets
Data Integration + FAIR (202B)

Effective drug development today requires addressing both clinical efficacy, safety, robust patient characterization but economic viability to ensure successful patient access amid rising healthcare costs and complex regulations. Integrating quantitative approaches such as pharmacometrics, model-based meta-analysis with health economics allows pharmaceutical developers to anticipate and mitigate risks related to clinical trial design and reimbursement challenges. In this talk, three different examples will be provided for how this integration can happen. In two of them the integrated analysis led to positive changes in the development program. The third one provides a framework that should be readily implementable in every single biopharmaceutical organization. All examples highlight the 1) critical importance of the cross-functional collaboration, 2) the need to have clearly stated assumptions in the models and 3) the need to conduct these evaluations prior to Phase 3 trials.

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.