Evidence and Access Archives

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CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of

December 13, 2024 The Centers for Medicare & Medicaid Services (CMS) is piloting a program…

CertaraDecember 13, 2024

Case Study

Joint Clinical Assessment (JCA) And Potential Consequences For The Evaluation Of Gene Therapies

In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…

CertaraJune 17, 2024

Case Study

Accelerating a drug launch with value communication technology and an integrated workflow

With early approvals for a targeted cancer drug in Brazil and Argentina, this global pharmaceutical…

CertaraOctober 2, 2023

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…

CertaraJuly 25, 2023

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…

CertaraApril 17, 2023

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…

CertaraApril 5, 2023

Case Study

Agent-Based Model Predicts Impact of Monoclonal Antibody Treatment, Prophylaxis & Vaccines on Viral Transmission during Pandemic

Agent-based models focus on the heterogeneous behavior of individual agents and their interactions with one…

CertaraMarch 2, 2023

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…

CertaraOctober 28, 2021

White Paper

Using Real-world Evidence to Advance Market Access for New Therapeutics

CertaraSeptember 29, 2021

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…

CertaraSeptember 23, 2021

Evidence and Access

CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of

Joint Clinical Assessment (JCA) And Potential Consequences For The Evaluation Of Gene Therapies

Accelerating a drug launch with value communication technology and an integrated workflow

ICER’s Unsupported Price Increase Report: Unfit for Policymaking

Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial

Using Real Word Evidence to Enhance Drug Development

Agent-Based Model Predicts Impact of Monoclonal Antibody Treatment, Prophylaxis & Vaccines on Viral Transmission during Pandemic

Defining path-to-market strategy through a data-driven and scientific approach

Using Real-world Evidence to Advance Market Access for New Therapeutics

The Scary Future of Rare Disease Management

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