Originally aired: Tuesday, March 3, 2026
Duration: 60 minutes
In partnership with Citeline
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 model-based meta-analysis (MBMA) and quantitative systems pharmacology (QSP) enable teams to inform go/no-go decisions and Phase 3 study design earlier, when development and access strategies remain adaptable.
In this on-demand webinar, our experts discuss how advanced modeling approaches 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
- Developing a realistic target product profile (TPP)
- Designing trials to support future clinical and real-world evidence needs
- Pipeline prioritization and launch sequencing
- Regulatory and submission strategy
- Assessing commercial viability, including price potential and target population size
Who should watch
This webinar is ideal for professionals involved in development strategy, evidence generation, and market access planning, including:
- HEOR and market access professionals shaping value and reimbursement strategy
- Evidence generation and real-world evidence teams planning lifecycle studies
- Clinical development leaders aligning trials and endpoints with evidence needs
- Portfolio and strategy decision makers guiding investment and development priorities
- Quantitative sciences and analytics experts supporting modeling and simulation
Speakers
Ananth Kadambi, PhD
VP, Real World Evidence & Modeling Solutions, Certara
Ananth has more than 20 years of experience in pharmaceutical consulting across disciplines including quantitative systems pharmacology modeling, health economic modeling, systematic literature reviews, indirect treatment comparisons, and statistical analyses of clinical and real-world data supporting regulatory, payer, and HTA submissions worldwide.
Matt Zierhut, PhD, MBA
Vice President, MBMA Capability Lead, Certara Drug Development Solutions
Matt leads efforts to integrate published clinical outcomes data into development decisions and commercial and regulatory strategy through model-based meta-analysis (MBMA). He works closely with clinical development teams to ensure MBMA informs the most critical strategic decisions.
Douglas W. Chung, BS, MS
Senior Director, QSP, Certara
Douglas Chung specializes in mechanistic modeling to support drug discovery and development. With over 12 years of consulting experience in biotech and pharmaceuticals, he focuses on advancing the field of quantitative systems pharmacology and expanding diversity across scientific disciplines and clinical trial populations.
Roman Casciano, MEng
SVP, Evidence & Access, Certara
Roman is an applied health economist and market access strategist who has led hundreds of engagements in global market access, HEOR, and real-world evidence strategy. He has extensive experience supporting product value demonstration and payer and HTA interactions worldwide.
Watch the Webinar
Access the on-demand recording to learn how MBMA, QSP, and advanced modeling approaches can help inform development strategy, strengthen evidence generation, and improve reimbursement readiness.
Watch the Recording
