This paper introduces external control studies and provides an overview of the key methodological issues to be considered in the design of these studies. A series of case studies are presented in which evidence derived from one or more external controls was submitted to regulatory and HTA agencies to provide support for the consistency of … Continued
Innovation and investment in advancing lifesaving therapies for pediatric patients to the commercial stage remains a daunting task, but rapid advances today in modeling and simulation are reducing the hurdles for drugmakers.
By easing regulatory requirements for animal testing, the Act allows scientists to use innovative, leading-edge technologies more fully in future drug development strategies.
More than a simple report, clinical evaluation now needs to be part of the medical device design process to ensure sufficient clinical evidence, avoid nonconformance and questions from the notified bodies (NB). In this article, we explain the stages of clinical evaluation and required documentation, the literature protocol and review, key components of the CER, … Continued
Model informed drug development (in silico modelling) continues to be a game changer in accelerating drug development. Quantitative Systems Pharmacology (QSP) is one such technology, which employs virtual patients in virtual clinical trials, allowing more approaches to be investigated than would be possible in the real world. Examples described here demonstrate the impact on some … Continued
Modelling and simulation (M&S) plays a crucial role in drug development. It allows information from diverse sources – pre-clinical and in-vitro data, early and late-stage clinical trial data, biomarkers, and efficacy outcomes – to be included with a dataset. Modelling enables researchers to visualize complex scenarios and determine what will happen if a parameter is … Continued
One word you don’t hear too often in current political discourse relating to Brexit is ‘streamlining’; but that’s exactly what the UK’s regulator hoped its Innovation Passport, which forms part of the Innovation Licensing and Access Pathway, would do for getting new drugs on the market more effectively when it was launched in early 2021.
Vyasa has developed deep-learning artificial intelligence solutions for organizations looking to solve the complex data challenges associated with healthcare and …
By: Claire Dyer, Director Global Submissions; Justin Hay, Senior Director; Daniel Smith, Director Regulatory Strategy Brexit reached a significant milestone at the end of January 2023 – three years since the United Kingdom left the European Union. Whilst we’ll be debating its relative merits and pitfalls for decades to come, here in the pharmaceutical industry … Continued
By: Rajesh Krishna, PhD, FAAPS and Steve Sibley According to the National Institutes of Health, more than 30 million people in the United States are affected by a rare disease. Defined in the Orphan Drug Act as any disease that affects less than 200,000 people in the United States, rare diseases total more than 7,000 … Continued
