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Anonymization vs. Redaction of Clinical Trial Data

The vernacular for disclosing pharmaceutical clinical trial results to the public may seem just as confusing as the process! Some people use “anonymization” and “redaction” interchangeably regarding transparency and disclosure of clinical trial data. But what are the differences in technique or method behind each?   We can think of “anonymization” as the process of removing, … Continued

Key development considerations for cell therapies

What is a “cell therapy”? Nearly every recent oncology clinical conference has featured this phrase. Cell therapies, such as CAR-Ts (chimeric antigen receptor T-cells), aren’t small molecule drugs or simple biologics. They’re a whole new class of therapeutics! How does CAR-T technology work? In simple terms, it’s a method for enabling our immune system to … Continued

What is a Scientific & Medical Publications Professional?

Would your drug development program benefit from partnering with experts in scientific and medical communications and publications? Maybe, we should first address what exactly scientific and medical communications and publishing entail. As medical writers with decades of experience, we can say that every day holds unique, intellectually rigorous challenges. Our work includes the following: Sometimes, … Continued

EU CTIS: Europe’s New Clinical Trial Information System

EudraCT has been Europe’s clinical trial database for almost twenty years. But, now it’s the time to say goodbye to EudraCT and hello to the new Clinical Trial Information System (CTIS). CTIS will be the single entry point for submitting, assessing, authorizing, supervising, and reporting clinical trials in all EU Member States (Figure 1). It … Continued

Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges

Therapeutic proteins (TP) – and more specifically monoclonal antibodies – are part of the therapeutic arsenal for the treatment of several diseases, providing effective and safe therapeutic solutions for patients. As part of the usual therapeutic practice, patients often receive drug combinations (TP/TP or TP/small molecules) and/or concomitant co-medications. Thus, drug-drug-interactions (DDIs) can be a … Continued

RAPS sponsored webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 months

Join us on November 10th for this webcast being held in partnership with RAPS. The Clinical Trials Regulation (CTR) for the European Union (EU) took effect on 1월 31, 2022. Sites and sponsors must now embrace the new regulations to successfully run clinical trials across the European Union. Beginning on January 31st, 2023, sponsors are … Continued

PBPK Modeling & Simulation of Therapeutic Oligonucleotides from Bench to Bedside

Next generation therapeutics Oligonucleotide drugs are unique among therapeutic modalities in that they don’t engage the disease modulating proteins directly but instead target their encoding mRNA (read more about how “oligos” work in this blog). The benefits of this approach are manifold. First, from the synthetic chemistry point of view, different drugs can be assembled … Continued

The Growing Value of Quantitative Systems Pharmacology (QSP)

Drug developers are continuously searching for new ways to improve and expedite biopharmaceutical R&D, inform decision-making, and gain a greater understanding of disease pathophysiology. One of the most promising new disciplines enabling all the above is quantitative systems pharmacology (QSP), a relatively new approach that can predict clinical outcomes for novel targets, modalities, and combinations. … 계속

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