Epilepsy is the fourth most common neurological disorder in the world1, affecting over 68 million people globally, and approximately 2.2 million people in the US2. In pediatric populations, it is estimated that about 470,000 US children under the age of 14 have epilepsy1. However, developing anti-seizure medications for pediatric patients has long been a challenge due…
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Clinical Development
RAPS San Francisco Bay Area Chapter In-person 2025 Kick-Off Meeting
In today’s fast-paced world of scientific discovery, cutting-edge technology is revolutionizing the way we approach complex biological problems. One such innovation is in silico modeling, a method that harnesses the power of computer simulations to model biological systems. But what exactly is in silico modeling? How does it work, and why is it becoming a…
In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. Regulatory Pathway 505(b)(2) versus 505(b)(1) In the US, novel new small molecule drug products, including some peptides, are…
In May 2024, the International Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a final draft of the newly developed scientific guidance on drug-drug interaction (DDI) studies, ICH M12, that will be adopted by ICH-abiding regulatory agencies (FDA, EMA, Japan). Read on to discover what is new about this DDI guidance…
Asking the appropriate questions during a pre-IND meeting with the FDA is a critical step in planning a development program. A Pre-Investigational New Drug Application (pre-IND) meeting can be a valuable component in planning a development program. For companies that have not previously interacted with the FDA in the early stages of a product’s development,…
Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. The Cell and Gene Therapy (CGT) field has unprecedented potential to effectively treat and/or cure genetic-based rare and orphan diseases and expand the reach of personalized medicine. This blog will…