GUEST COLUMNISTS

• How To Navigate Drug Repurposing And Bridging Studies

  Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials. 

• How To Build A Strong CRO Partnership And Find Drug Development Success

  Building a collaborative and highly engaged partnership with a CRO to optimize study enrollment is critical for a company’s success, particularly with so much reliance on virtual interactions. Here are some tips on how to do just that.

• Clinical Trial Duration Trends & The Study Closeout Gap

  Clinical study durations are increasing. Contributing significantly is what we will refer to as a study closeout gap. Is your company positioned to reverse this trend and reduce time to market for your new drugs and therapies? This article explores study duration data as well as related labor challenges and macroeconomic trends. 

• How To Leverage RWE To Facilitate Access To Cell & Gene Therapies

  As more and more cell and gene therapies hit the market, the already intense pressure to figure out how to pay for them will only increase. This article shares how real-world evidence (RWE) can be leveraged to help offset economic uncertainties, facilitate access, and create a sustainable foundation for long-term data generation.

• Improving Diversity In Clinical Trials With A Community-Based Approach

  Executives of clinical trial sponsors and CROs must acknowledge that the current system fosters inequities such as decreased access and poorer healthcare outcomes for historically underserved patient populations. By committing to a community-based approach to enhance clinical trial diversity, we can further enable improved healthcare outcomes for all.

• Latin America: A Compelling Region To Conduct Your Clinical Trials

  This article examines the need to conduct clinical trials outside the U.S., addresses the recruitment crisis in the U.S., reviews the incentives for clinical trials overseas, and explores the growth of clinical trials in Latin America. Colombia is highlighted as a country that stands out as ripe with opportunity.

• IVDR Compliance: You May Need To Rethink Your Clinical Evidence Strategy

  European notified body feedback reveals that the biggest gaps in In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) submissions are being found in clinical evidence, particularly around clinical performance data. Also covered in this article is discussion of overlap between EU and FDA requirements.

• How Can We Investigate Biomarkers For Lung Cancer Patients More Effectively?

  With a 5-year mortality rate of nearly 90%, lung cancer is in dire need of targeted control interventions. There is a serious lack of sufficient predictive biomarkers, turning the lung cancer journey into one in which the patient and physician alike may as well be wearing blindfolds. This article discusses how we can start to swing the needle in the patient's favor.