CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of Blog CMS による細胞・遺伝子治療(CGT)アクセスモデルの解説:意外と知られていない、薬価に関する最重要法案 2024年12月13日 The Centers for Medicare & Medicaid Services (CMS) is piloting a program…Certara2024年12月13日
Joint Clinical Assessment (JCA) And Potential Consequences For The Evaluation Of Gene Therapies Case Study 遺伝子治療の評価における臨床評価(JCA)と潜在的な影響 In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…Danielle Pillsbury2024年6月17日
Accelerating a drug launch with value communication technology and an integrated workflow Case Study バリューコミュニケーション技術および統合されたワークフローを用いて医薬品の上市を加速 With early approvals for a targeted cancer drug in Brazil and Argentina, this global pharmaceutical…Jim Gallagher2023年10月2日
ICER’s Unsupported Price Increase Report: Unfit for Policymaking White Paper ICER’s Unsupported Price Increase Report: Unfit for Policymaking Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported…Danielle Pillsbury2023年7月25日
Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial Case Study Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial Our client was developing a new anti-viral drug for a rare, life-threatening viral infection that…Danielle Pillsbury2023年4月17日
Using Real Word Evidence to Enhance Drug Development Case Study Using Real Word Evidence to Enhance Drug Development Real-world evidence (RWE) has emerged as an increasingly important tool in the drug development process,1…Danielle Pillsbury2023年4月5日
Agent-Based Model Predicts Impact of Monoclonal Antibody Treatment, Prophylaxis & Vaccines on Viral Transmission during Pandemic Case Study パンデミック時のウイルス感染に対するモノクローナル抗体治療、予防、ワクチンの影響を予測するエージェントベースのモデル Agent-based models focus on the heterogeneous behavior of individual agents and their interactions with one…Danielle Pillsbury2023年3月2日
Defining path-to-market strategy through a data-driven and scientific approach Case Study Defining path-to-market strategy through a data-driven and scientific approach How Certara supported a gene therapy manufacturer by using a selection of gateway and value…Jim Gallagher2021年10月28日
Using Real-world Evidence to Advance Market Access for New Therapeutics White Paper 新薬のマーケットアクセスを成功に導くためのリアルワールドエビデンスの利用 Jim Gallagher2021年9月29日
The Scary Future of Rare Disease Management On-Demand Webinar The Scary Future of Rare Disease Management In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…Jim Gallagher2021年9月23日