5 Tips for Authoring an Investigator’s Brochure Summary of Changes
Streamline developing a summary of changes for an Investigator’s Brochure, a document that summarizes the clinical and nonclinical data on an investigational drug.
Category: Blog
Building a Robust Clinical Pharmacology & Model-Informed Drug Development Strategy for New Alzheimer’s Disease Drugs
Alzheimer’s disease (AD) is one of the most common forms of neurodegenerative dementia in the United States. In fact, the Alzheimer’s Association predicts that by the year 2050, the number of people age 65 and older with Alzheimer’s dementia is expected to double to comprise 12.4 million patients. AD is caused by a complex dysregulation … Continued
How to Build a Firm Foundation for Your Drug Development Program
Developing an investigational drug and attaining regulatory approval is much like the process of building a house. First, both require coordinating many stakeholders. Building a home requires hiring various tradespeople like carpenters, plumbers, electricians, and more. And you’ll have to oversee and coordinate all their work, which must be done in a certain order. You … Continued
Essentials of Model-informed Drug Development (MIDD) – Top-down vs. Bottom-up Approaches
How can the latest modeling and simulation technologies accelerate drug discovery and development? We frequently receive questions about why model-informed drug development (MIDD) is so critical to informing the development of safer and more effective new drugs? Indeed, all drug discovery and development today involves some level of MIDD, a term that encompasses a large … Continued
How Project Management & Technology Streamline the Patient Narrative Process
Utilizing Synchrogenix™ Writer streamlines the patient narrative process from start to finish. Production is made faster and easier with the use of technology and skilled narrative leads, writers, and Quality Control (QC) reviewers. We partner with Sponsors at kickoff and guarantee we have all components of the process covered through to submission. We share our full process with our partners, so that you’ll … Continued
Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations
The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc. received FDA approval of voretigene neparvovec-rzyl (Luxturna™), a recombinant adeno-associated virus serotype 2 (AAV2) vector expressing the gene for human retinal pigment epithelium 65 kDa … Continued
The Past and Future of Drug Safety Narratives
The process of safety narrative writing has changed drastically over the years. But despite all these changes, the goal remains to deliver a high volume of narratives describing key events, the details of which are important for drug safety reporting. As technology is evolving, the process of developing patient safety narratives is also evolving. The … Continued
Succeeding in Value Communication: Start with the Key Message
This is Part 1 of the ‘Succeeding in Value Communication’ series, a set of articles that examine the key success factors in creating customer engagement tools that successfully communicate the clinical and economic benefits of pharmaceuticals, devices and diagnostics. These recommendations have been drawn from the experiences of the BaseCase Consulting Team. Create a key … Continued
Succeeding in Value Communication: Introduction
Drawn from the experiences of the BaseCase Consulting Team, this is the introduction to ‘Succeeding in Value Communication’. This series of blog articles examines the key success factors in creating customer engagement tools that effectively communicate the clinical value and economic benefits of pharmaceuticals, medical devices, and diagnostic tests. How do you communicate the value … Continued
Succeeding in Value Communication: The Value Story
This is Part 2 of the ‘Succeeding in Value Communication’ series, a set of articles that examine the key success factors in creating customer engagement tools that successfully communicate the clinical and economic benefits of pharmaceuticals, devices and diagnostics. These recommendations have been drawn from the experiences of the BaseCase Consulting Team. Make your value … Continued