For the first time, the European Medicines Agency (EMA) has passed new regulations to help patients understand the results of clinical trials of investigational drugs that they volunteer for. Known as EU-CTR (European Union Clinical Trial Regulation 536/2014), these regulations require a Plain Language Summary (PLS) or “Lay” Summary for every clinical trial conducted in … Continued
Under European Union Clinical Trial Regulation 536/2014 (EU-CTR), replacing the EU Clinical Trial Directive (Directive 2001/20/EC), drug developers must now anonymize or redact clinical trial documents at the same time they are preparing them for regulatory submission (read more about the redaction process in this blog). This makes complying with transparency and disclosure requirements necessary … Continued
Properly understanding the probability of successful drug development requires utilization of all available information. Critical drug development decisions cannot be made with internal data alone. Model-based meta-analysis (MBMA) extracts important insights contained within both proprietary data and publicly available clinical trial results, thus enabling critical R&D, financial (e.g., in/out-licensing), and commercial decision-making with the highest … Continued
In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance [1]. This is a welcome addition and clarifies the position of the agency on some key aspects regarding development of oligonucleotide therapies. Whilst the guidance still leaves a few open questions, it provides drug developers with a starting point and acknowledges that … Continued
While innovation alone has the power to draw clinical interest, it takes more to show—to prove—that a medical device is truly a solution after being studied in the clinic. Real-world effectiveness has become paramount to achieve optimal market access in the current environment for 2022 and beyond. Clinicians and payers are now placing similar demands … Continued
What is a “cell therapy”? It is a phrase that has been used in nearly every recent oncology clinical conference. Cell therapies, such as CAR-Ts (chimeric antigen receptor T-cells), are not small molecules or a simple, straightforward biologic. They’re a whole new class of therapeutics! How does CAR-T technology work? In simplistic terms, it’s a … Continued
One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of … Continued
Join us on November 15th for this webcast being held in partnership with TOPRA. In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting … Continued
