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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 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

演讲嘉宾:

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 通过基于模型的荟萃分析(MBMA),推动已发表的临床结果数据融入开发决策及商业与监管策略。Matt 与临床开发团队密切合作,确保在做出最关键决策的时候,能利用 MBMA 发挥最佳影响力。

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, MEng

SVP, Evidence & Access

作为一名应用卫生经济学家和市场准入战略专家,Roman 亲自领导了数百项与产品价值展示相关的全球市场准入、HEOR 和真实世界证据方面的工作,并在与支付方和 HTA 机构的正式和非正式交流中积累了丰富的经验。

 

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