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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

講演者

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

マットは、公開された臨床結果データをMBMAを用いて開発、商業、規制戦略に統合しています。臨床開発チームと緊密に連携し、クライアントが最も重要な意思決定を行う際にMBMAから十分な情報を引き出せるよう日々支援しています。

Douglas Chung

Douglas W. Chung, BS, MS

Sr Director, QSP

Douglas W. Chung は、創薬・医薬品開発における意思決定を支援する機序モデルを専門とする、経験豊富なサイエンティスト兼コンサルタントです。彼は生体医工学をバックグラウンドとし、バイオテクノロジーおよび製薬分野において12年以上のコンサルティング経験を有する、定量的システム薬理学の専門家です。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

Romanは応用医療経済学者およびマーケットアクセス戦略家として、製品価値実証に関連するグローバルマーケットアクセス、HEOR(医療経済学・アウトカム研究)、リアルワールドエビデンスの分野で数百件のプロジェクトを自ら主導し、ぺイヤーやHTA機関との公式・非公式な交渉において豊富な経験を有しています。

 

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