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
Creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions can be a time-consuming, error prone and complex task. Certara’s software PK Submit provides a compliant solution that keeps research teams from tedious data handling. With its ability to create a complete electronic PK regulatory submission package in minutes the software saves … 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
When it comes to disclosing data from clinical trials of investigational drugs to the public, the vernacular may seem just as confusing as the process! The terms “anonymization” and “redaction” are used interchangeably regarding transparency and disclosure of clinical trial data. But what are the differences in technique or method behind each? We may think … Continued
Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D) requirements to health authorities is a critical decision. The vendor selection process varies greatly. Some organizations have rigorous prescribed procedures, while others boast a less formal, less structured process. You need to select a vendor who will help to maintain … Continued
Outside of protecting study participants’ personal information (PI) within clinical research publications, pharmaceutical organizations should avoid disclosing company-related secrets and procedures which could aid their competitors in gaining market advantage. This type of information is called Commercially Confidential Information (CCI) by the European Medicines Agency (EMA) or Confidential Business Information (CBI) by Health Canada (HC). … Continued
You are initiating the journey of submitting your Medical Device Application to the FDA and want feedback from the agency on your planned application. How do you communicate your questions related to your planned application to the FDA? The answer to that question resides with the agency’s pre-submission program for medical devices, the Q-Submission (Q-Sub) … Continued
After almost twenty years with EudraCT, it’s time to say goodbye to Europe’s old clinical trial database and embrace the new Clinical Trial Information System (CTIS). CTIS will be the single-entry point for submitting, assessing, authorizing, supervising, and reporting a clinical trial in all Member States of the EU (Figure 1). It will be used … Continued
Recruiting and retaining participants for clinical trials of investigational drugs has become increasingly difficult in recent years. Trial enrollment is dropping. One major reason patients cite for this dwindling participation is their lack of engagement and understanding of the clinical trial process. Why would patients volunteer their time and energy to a trial when scientific … Continued
