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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

This webinar is ideal for:

  • HEOR and market access professionals shaping evidence, value, and reimbursement strategy
  • Evidence generation and real world evidence teams planning studies across the product lifecycle
  • 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 at Certara

Ananth Kadambi, PhD

VP, Real World Evidence & Modeling Solutions

Ananth has more than 20 years’ experience in pharmaceutical consulting across a variety of disciplines, including quantitative systems pharmacology modeling, health economic modeling, systemic literature reviews, indirect treatment comparisons, and complex statistical analyses of clinical and real-world databases required to support regulatory, payer and HTA submissions worldwide.

Matthew Zierhut

Matt Zierhut, PhD MBA

Vice President, MBMA Capability Lead, Certara Drug Development Solutions

Matt advances the integration of published clinical outcomes data into development decisions and commercial and regulatory strategy via model-based meta-analysis (MBMA). Matt works closely with clinical development teams to ensure MBMA is leveraged for optimal impact when making the most critical decisions.

Douglas Chung

Douglas W. Chung, BS, MS

Sr Director, QSP

Douglas W. Chung is a highly experienced scientist and consultant specializing in mechanistic modeling to support drug discovery and development. His background is in biomedical engineering and his focus is in quantitative systems pharmacology with over 12 years of experience consulting in biotech and pharmaceuticals. His passion is to grow the field of quantitative pharmacology by expanding diversity in people, fields of expertise, and clinical trial populations.

Roman Casciano

Roman Casciano, PhD, MEng

SVP, Evidence & Access

As an applied health economist and market access strategist, Roman has personally led hundreds of engagements in the global market access, HEOR and real-world evidence context related to product value demonstration and has deep experience in both formal and informal exchanges with payers and HTA bodies.