Evidence and Access Archives

EMPLOYING REAL-WORLD EVIDENCE TO IMPROVE CLINICAL TRIAL STRATEGIES

3월 23, 2021

By: Sumeet Bakshi, Vice President, Real World Data Solutions, Certara’s Evidence, Value & Access groupRichard Tao, Associate Principal Regulatory Writer and Submission Leads Member, Synchrogenix, Certara’s regulatory science company Employing real-world evidence allows for the study of many aspects of diseases, such as natural history, patient populations, and outcomes, under everyday conditions. Therefore, real-world evidence has many … Continued

Commercial and Regulatory Success in Accelerated Gene Therapy Development

2월 22, 2021

By Jim Gallagher

Thanks to regulatory frameworks and driven by high unmet patient needs, the pace for clinical development of gene therapies (GT) is often greatly accelerated. This presents GT innovators with the opportunity to reach their patients faster, but it also raises the bar for critical decision points such as around trial design, endpoint selection and population … Continued

Getting Gene Therapies to Patients

2월 16, 2021

By Ulrich Neumann

This blog discusses the challenges that drug developers face in getting patients access to cell and gene therapies as well as some potential solutions.

Early Value Assessment in Gene Therapy Clinical Trial Design

2월 12, 2021

By Jim Gallagher

Getting Real with RWE

11월 20, 2020

By Jim Gallagher

By Taren Grom Real-world evidence, important for regulatory decision-making, is beginning to touch all areas of the healthcare value chain.

SNDS: Strengths, Limitations and Perspectives for the Largest and Richest Real-World Database in EU

10월 20, 2020

By Jim Gallagher

In this webinar, our experts provided an overview of the SNDS and the key working practices to access the database and ongoing SNDS developments, explained the similarities and differences between SNDS and other claims databases, used case studies to illustrate its strengths and opportunities, and provided stakeholder perspectives on current and potential benefits to patients, … Continued

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Tag: Evidence and Access

EMPLOYING REAL-WORLD EVIDENCE TO IMPROVE CLINICAL TRIAL STRATEGIES

Commercial and Regulatory Success in Accelerated Gene Therapy Development

Getting Gene Therapies to Patients

Early Value Assessment in Gene Therapy Clinical Trial Design

Getting Real with RWE

SNDS: Strengths, Limitations and Perspectives for the Largest and Richest Real-World Database in EU

Key Trends in U.S. Specialty Pharmacy

The Escalating U.S. Policy Environment

Innovative Financing for Novel Therapies

The Rise of Cost Effectiveness Considerations in the US