Accelerating ADCs’ development pipeline using Simcyp PBPK

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

A Day in the Life of a Clinical Pharmacology Consultant

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

Best Practices for Completing FDA Forms

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

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 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

FDA Provides Draft Guidance Prior to Implementing New Forms 3988 & 3989

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

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

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