Kyle T. Baron, Pharm.D., Ph.D.

Group Leader PKPD, Senior Principal Scientist I, Fellow I

Kyle joined MetrumRG in 2010 after receiving his Pharm.D. and Ph.D. in Experimental and Clinical Pharmacology from the University of Minnesota. As a member of our translational and systems pharmacology group, Kyle has worked to support sponsor development programs in a variety of therapeutic areas, including chronic hepatitis C infection, HIV, calcium homeostasis and bone health, type-2 diabetes, and cystic fibrosis.

Kyle is the developer and maintainer of mrgsolve (https://mrgsolve.github.io) and also leads workshops at all levels to guide other M&S scientists in the effective use of this simulation tool in PKPD, PBPK, and QSP modeling. Kyle also serves as adjunct faculty in Experimental and Clinical Pharmacology at the University of Minnesota.

Recent publications by this scientist

Simulated efficacy of nerandomilast on forced vital capacity decline in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis across background antifibrotic therapies

March 18, 2026

Presented at the ASCPT 2026 Annual Meeting. An exposure-response model was developed to evaluate the effect of nerandomilast on forced vital capacity (FVC) in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) , capturing both an initial “offset effect” and a long-term “disease-modifying effect” on the rate of FVC decline. The analysis confirmed a positive exposure-response relationship that is maintained regardless of the underlying diagnosis. Furthermore, simulations support using an 18 mg twice-daily dose to mitigate the reduced drug exposure associated with background pirfenidone use, ensuring a robust treatment response for patients on multi-drug regimens.

Simulated efficacy of nerandomilast on forced vital capacity decline in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis across background antifibrotic therapies Samuel P. Callisto1, Kyle Baron1, Elias Clark1, Curtis Johnston1∗, Nikolas Onufrak2∗, Sonja Hartmann2∗, Steve Choy2 1Metrum Research Group, Boston, MA, U.S.A., 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, U.S.A. ∗Affiliation during time of analysis Introduction.

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OptiDose with mrgsolve for eﬃcacy and safety-driven dose optimization

September 16, 2025

Presented at ACCP Annual Meeting 2025. This work showcases the OptiDose method in mrgsolve, enabling efficient and systematic optimization of dosing regimens with respect to both efficacy and safety considerations. By optimizing across multiple clinical endpoints and patient preferences, these model-informed strategies can guide patient-centered dosing decisions in oncology.

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Exposure–Response Relationships in Patients with Non-Small-Cell Lung Cancer and Other Solid Tumors Treated with Patritumab Deruxtecan (HER3-DXd)

April 14, 2025

This paper contributes to the oncology MIDD field by using robust exposure-response modeling to identify the optimal dosing regimen for HER3-DXd in EGFR-mutated NSCLC. Analyzing data from over 700 patients across four studies, it demonstrates that 5.6 mg/kg Q3W offers a favorable balance of efficacy and safety. The analysis incorporates patient covariates and compares fixed and up-titration regimens, supporting data-driven selection. These methods align closely with the goals of Project Optimus, emphasizing the importance of modeling and simulation in selecting doses that are both effective and tolerable, rather than defaulting to the maximum tolerated dose.

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