Market Access Archives - Insights From Our Labs to Yours

Navigating COVID-19: the importance of a nimble reimbursement call center operation

by Richard Cesarskiupdated on Monday, June 7, 2021Tuesday, March 24, 2020

COVID-19 has the potential to significantly impact call center operations. However, a proactive crisis management plan and a dispersed, redundant operating model can go a long way towards safeguarding your patient support programs. As governments and citizens address challenges posed by this global pandemic, many companies are limiting in-office operations …

Closing the knowledge gap with Real-World Evidence (RWE) studies: the importance of starting early

by Labcorp Drug Developmentupdated on Monday, June 7, 2021Monday, February 17, 2020

Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what …

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Real-world evidence applied in real-life case studies

by Labcorp Drug Developmentupdated on Monday, June 7, 2021Friday, August 16, 2019

Real-world evidence (RWE) can be used to meet different objectives, and RWE studies can be designed using different study types and methodologies, as well as multiple sources of real-world data (RWD). Teams often work separately and could benefit from a shared learning experience in the planning and execution process. A …

Real world evidence (RWE) and market access in the US

by Labcorp Drug Developmentupdated on Wednesday, June 17, 2020Tuesday, February 13, 2018

Randomized control trials demonstrate drug safety and efficacy and hence are fundamental for regulatory approval. However, real world data (RWD) becomes a progressively more important source of evidence as we move across the development continuum of a drug. RWD can be potentially useful for obtaining regulatory approval as well. Communicating …

Medical writing for patients: An important niche

by Labcorp Drug Developmentupdated on Monday, June 7, 2021Wednesday, January 3, 2018

With evolving medical knowledge, there is an ever-increasing need to effectively facilitate knowledge transfer to key target audiences, especially patients and caregivers. Medical writing for patients must not only meet stringent good clinical practice standards and good publication practices but it must also communicate specific information in a clear, relevant and compelling …

The Biosimilars Landscape: What All Developers Need to Know

by Labcorp Drug Developmentupdated on Wednesday, May 19, 2021Thursday, March 16, 2017

As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, …

Drug Development Market Access Covance Shanghai at night, China

Maximizing the Value of a Product: A Perspective from China

by Labcorp Drug Developmentupdated on Wednesday, May 19, 2021Tuesday, May 17, 2016

Drug development in China is progressing quickly, due in part to shifting regulations, increased innovation and growing opportunities for global partnerships. However, making the most of market opportunities requires not only a focus on the intended end results but also careful, early phase planning. At a recent clinical seminar in …

Advancing Rare Disease Drug Development: Four Key Considerations for Market Access

by John D. McDermott, Jr, MBAupdated on Wednesday, May 19, 2021Monday, April 18, 2016

Our industry is witnessing increasing growth in the rare disease market, thanks to financial and regulatory incentives to develop orphan drugs. This has been good news for both sponsors and patients, but the fact remains that rare disease trials are inherently challenging to run. In addition, completing a complex study …