With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading cause of death worldwide [1]. Antibody Drug Conjugates (ADCs) when first approved in 2000, seemed ideal in that they could deliver the cytotoxic drug (also referred to as the warhead) directly to the tumor site, resulting in reduced off-target damage … Continued
There is a lot of misinformation about whether or not the COVID-19 vaccines have “full” FDA approval or Emergency Use Authorization (EUA). The words approval and authorization are often used incorrectly; they are not interchangeable. On March 27, 2020, the Secretary of health and Human Services (HHS) issued a declaration that there is a public … Continued
Strategic consulting within drug discovery and development is an exciting career choice for many. Unlike a biotechnology or pharmaceutical enterprise, where the assets one typically works on are within that ecosystem, consulting offers the possibility of working on many different innovation pipelines. At any given time, you might be working on solving a problem for … Continued
FDA has more than 300 forms to collect and receive information across a wide range of drug development subjects. In the case of electronic Common Technical Document (eCTD) submissions, there is a specific form (based upon submission type) to be completed and included with every eCTD sequence you submit. These fillable PDF forms provide FDA … Continued
Streamline developing a summary of changes for an Investigator’s Brochure, a document that summarizes the clinical and nonclinical data on an investigational drug.
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
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 hiruing 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
What you need to know about the FDA’s proposed new PMR/PMC forms The FDA has released guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments). The guidance … Continued
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
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
