Real-World Evidence
Introduction Real-world evidence (RWE) is accelerating drug development by using routinely collected patient health data, known as real-world data (RWD), to deliver insights beyond…
Advancing Early-Stage Oncology Drugs: Overcoming Trial Challenges
Introduction Researchers are developing novel, safer treatments for cancer, but bringing new oncology therapies to market is challenging. This white paper will examine the…
The Frontiers of Obesity Treatment
Introduction As global obesity rates continue to rise, the search for effective treatments is more critical than ever. Obesity is associated with an increased…
Understanding and Navigating Changes to Clinical Trial Management in the European Union
Introduction Changes in how clinical trials are managed in the European Union (EU), mandated by the European Union Clinical Trial Regulation 536/2014 (EU CTR),…
Therapeutic RNAs: Past, Present, and Future
Introduction RNA based drugs are a promising new class of therapeutics with tremendous potential for treating a wide range of diseases. There are various…
Bioanalysis of mRNA
About Messenger Ribonucleic Acid (mRNA) Current mRNA (messenger ribonucleic acid) research has rapidly driven the discovery and production of this new therapeutic. Modified mRNAs…
Therapeutic Oligonucleotide Metabolite Identification, Profiling and Quantitation
Introduction Development of DNA or RNA analogs that can block the activity of selected genetic sequences makes the design of highly specific therapeutic treatments…
Regulatory Considerations in Gene and Cellular Therapy Development
The Gene And Cellular Therapy Landscape Gene and cellular therapy holds the extraordinary potential to transform global health care. As a result, the gene…
Plasma Protein Binding
Introduction Drugs bind to plasma proteins including albumin, α1-acid glycoprotein, and lipoproteins with different affinities and selectivities depending on the physical/chemical properties of the…
Five Criteria to Use When Selecting a CRO for a Gene Therapy Study
Choosing A CRO For Gene Therapy Trials Contract research organizations (CROs) have been an integral part of drug development since the 1920s, first as…