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
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
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 (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
Drug developers often rush through the discovery process to get into human testing. Most are so curious about their new target or molecule that they may forget that the pharmaceutical formulation process that can easily make or break their program. Once in human testing, revisiting these formulations is often time-consuming. By then, depending on drug … Continued
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 2022年1月31日. 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
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
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. … Continued
Historically, the dosing strategy for oncology drugs focused on the maximum tolerated dose. そのため、薬剤の薬物動態（PK）プロファイル、薬物動態/薬力学（PK/PD）関係、臨床標的の阻害などがほとんど無視された状態になっています。そのため、がん患者は長期間の薬物投与に耐えられないことが多く、減量や休薬などの用量変更を余儀なくされています。Project Optimus was initiated by … Continued
