Beyond Approval: Model-Informed Label Optimization, Commercial Strategy, and Market Access for Antibody

Model-Based Meta-Analysis (MBMA), Quantitative Systems Pharmacology (QSP), and Advanced Modeling in Early Reimbursement Strategy

Tuesday, March 3rd, 2026

11am EST | 4pm GMT | 8am PST

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Why the most important Phase 3 decisions should be made before Phase 3

Decisive early decisions compound value, while delayed decisions compound risk. Rather than waiting for Phase 3 results to determine access viability, advanced modeling approaches such as MBMA and QSP, enable HEOR teams to inform go/no-go decisions and Phase 3 study design earlier, when development and access strategies remain adaptable.

This webinar focuses on how advanced modeling can support high-impact, Phase 3–critical decisions, helping teams reduce uncertainty, align evidence generation with payer expectations, and improve the likelihood of reimbursement success.

Key decisions explored include:

Realistic target product profile (TPP) development
Trial design to support future clinical and RWE needs
Pipeline prioritization and launch sequencing
Regulatory and submission strategy
Commercial viability, including price potential and target population size

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Meet the Speakers

Ananth Kadambi, PhD

VP, Real World Evidence & Modeling Solutions
Certara

Matt Zierhut, PhD MBA

VP, MBMA Capability Lead
Certara

Doug Chung

Sr Director, QSP
Certara

Roman Casciano, PhD MEng

SVP, Evidence & Access
Certara

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