Tag: Real World Data
Evidence generation in Europe- How valuable is the French National administrative health data (SNDS)
Watch this presentation to learn • Overview of the SNDS and the key working practices to access the database and ongoing SNDS developments • Similarities and differences between SNDS and other claims databases • Strengths and opportunities for HTAs and market access in Europe through case studies • Stakeholder perspectives: current and potential benefits to … Continued
Virtual ISPOR Europe 2021
Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation in the United States
Authors: Joseph McGuirk, Clint Divine, Seung Hyun Moon, Aastha Chandak, Zhiji Zhang, Genovefa A. Papanicolaou Hemorrhagic cystitis (HC) caused by viral infections such as BK virus, cytomegalovirus, and/or adenovirus after allogeneic hematopoietic stem cell transplantation (allo-HCT) causes morbidity and mortality, affects quality of life, and poses a substantial burden to the health care system. At … Continued
Legislators: Bring all stakeholders to the table to lower drug costs
BY ROMAN CASCIANO, OPINION CONTRIBUTOR — 03/29/21 05:30 PM EDT No one is happy with the price of drugs nor how we pay for them: not patients, not the lawmakers who represent them, not physicians, not insurance payers and not drug developers. We are at a point where all stakeholders are fed up, and there’s (…)
Strategic Evidence & Value Communication Symposium
Join us on 2021년 4월 21일 수요일, from12:00 PM – 2:00 PM EDT for Certara’s first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.
EMPLOYING REAL-WORLD EVIDENCE TO IMPROVE CLINICAL TRIAL STRATEGIES
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
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
This blog discusses the challenges that drug developers face in getting patients access to cell and gene therapies as well as some potential solutions.