Translational Bytes

Nov24 How Do You Develop a Bispecific Antibody for the Treatment of B-cell Non-Hodgkin Lymphoma? A Review of Key Lessons From Approved CD20×CD3 Products

Therapeutics for B-cell non-Hodgkin lymphoma (B-NHL) have advanced over recent decades, with immunotherapies taking a central role in the evolving treatment paradigm. Bispecific antibodies (bsAbs) that engage T cells (via CD3) and malignant B cells (via CD20), including four CD20×CD3 bsAbs (mosunet...

Are you involved in drug development for therapeutic peptides—whether in DMPK, clinical pharmacology, or other related disciplines? Are you unsure of how the development program differs from your standard small molecule projects? In 2023, we published an industry position paper , which was the fir...

Voriconazole (VRCZ) is a potent antifungal agent used to treat invasive fungal infections. However, its clinical utility is limited by the large inter-individual variability in blood concentrations and narrow therapeutic window, which contributes to toxicity and treatment failure. A key factor is g...

With school, college, and university Fall semesters underway, we reflect on the 2025 Clinical and Translational Science ( CTS ) journal award. Every year, the CTS Editorial Team has the opportunity to present a CTS award, typically at the annual meeting of the American Society for Clinical Ph...

Clear and standardized terminology is essential for the effective communication and adoption of emerging technologies. To address this need in the field of liquid biopsy, The Blood Profiling Atlas in Cancer (BLOODPAC) Consortium has developed a comprehensive lexicon for circulating tumor DNA (ctDN...

Identifying cardiovascular (CV) risks early in drug development is essential, especially for detecting arrhythmias and hemodynamic changes. Despite this, many nonclinical toxicology studies still rely on brief, restraint-based ECG and blood pressure measurements that often miss the timing of peak d...

Large language models (LLMs), like ChatGPT, are no longer just tech-world curiosities; they’re increasingly making their way into drug discovery and clinical development. In this new Clinical and Translational Science primer article , the authors walk through how LLM models work, what makes them...

Aug28 Pursuit of Standardized Data!

Liquid biopsies are tests for detecting a cancer-associated signal in a body fluid sample to improve outcomes for patients with cancer. BLOODPAC is a not for profit consortium that works to accelerate the development, validation and accessibility of liquid biopsies. More than 40 BLOODPAC members ha...

Data integrity remains a major challenge in decentralized clinical trials. Especially during eligibility assessment, ensuring comprehensive participant characterization is paramount in remote settings. To address this, our team conducted a randomized, open-label, single-center, fully remote trial i...

Chronic pain is a widespread issue that presents significant treatment challenges. There are a variety of pharmacotherapy options, with opioids among them. The two most widely prescribed opioids are hydrocodone and tramadol; however, their effectiveness is associated with CYP2D6 function, given the...

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