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Translational Bytes

Translational Bytes


Dec01 Can Machine Learning Be Used to Enrich Clinical Trials?

Placebo responders, defined as subjects experiencing a clinically meaningful reduction in disease symptomology when randomized to receive placebo, is one of the major reasons of trial failure in binge eating disorder (BED) trials. Among investigator-led, randomized, placebo-controlled trials evalua...
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Oct18 Clinical Pharmacology Has Similar Benefit for Orphan and Non-Orphan Drug Development

Clinical pharmacology principles are extensively leveraged during drug development, approval, and utilization to support dose optimization and therapeutic individualization, as well as to support benefit-risk assessments (particularly, in subpopulations). In fact, because of the value-add that clin...
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Oct04 Can Real-World Data Drive Clinical Pharmacology Deliverables?

Pharmaceutical products in the current accelerated drug development landscape can benefit from tools beyond data generated from clinical trials. We have seen an abundance of real-world data (RWD) and real-world evidence, driven by the digitalization of healthcare systems and an increased awareness ...
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Sep23 Cells as Therapy: Rethinking Clinical Pharmacology and Toxicity Assessments for Living Therapeutics

Engineered chimeric antigen receptor (CAR) T cells are the latest tool in the immunooncology arsenal, and there is much excitement around their clinical applications. In the last five years, six CAR-T cell therapies have been approved in the US for treatment of hematological malignancies. While the...
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Aug30 CTS's Impact Factor Over 4 for Two Years in a Row

The most recent impact factor (IF) numbers are in, and  Clinical and Translational Science  ( CTS ) clocked in with an impressive 4.438. As you can see from the graph above, the  CTS  IF has trended up over the time frame the journal has been published under the banner of ASCPT and now has be...
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Aug23 Booming Business in Biologics: Drug Combinations or Bispecifics?

Targeting multiple mechanisms of action is a popular choice for biological drug development as it aspires to improve efficacy and safety, increase duration of response, and minimize resistance. The list of bispecific antibodies (BsAbs) with regulatory approval is growing. Next to building multiple ...
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Jul21 CTS Refreshes Our Aim and Scope

Clinical and Translational Science  ( CTS ), an official journal of the American Society for Clinical Pharmacology and Therapeutics, has refreshed and refined our  aim and scope , aligned with the translational approach of the  National Center for Advancing Translational Sciences  (NCATS)  ...
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Jun16 Asking the Right Questions of Big Data

Pharmacoepidemiological studies often ask big questions of big databases that can inform risk/benefit conversations at the be d side such as "What is the association of X outcome in individuals who were exposed to Y drug?" 
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May20 Age Matters in Precision Medicine

Using genetic test results to guide drug therapy (pharmacogenetics) is a cornerstone for the growing field of precision medicine. This approach has been implemented by some medical centers for an array of medications where the association between genetic variation and drug response has been well-es...
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Apr26 Can We Help Address Anti-Vaccination Campaigns?

As part of a course on vaccine development, students are exposed to the phases of vaccine development focused on R&D activities, timing, and cost considerations as well as key features that are distinctly different from drug development. Additional activities and nuances such as the use of global b...
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