Altasciences

Early phase drug development pathways may seem rigid, but there can be some flexibility when it comes to the steps you take in certain phases. Some studies often associated with Phase 1 do not necessarily have to be done before starting Phase 2. The reverse is also true, in that some elements of Phase 2 can actually be performed by you or your contract research organization during Phase 1. This can help you access vital bioanalysis data earlier in the drug development process. As Phase 1 studies have become increasingly complex, early access to trial results and comprehensive data related to safety and drug pharmacology can help better inform decisions. This information can also help support funding opportunities and solidify your overall program. Here are four things you need to know about the flexibility you have during Phase 1 clinical trials. Early and Clinical Pharmacology Study Timing During a drug development program, exploratory therapeutic studies are required milestones, a...

There has been a recent resurgence in the interest of using psychedelic therapeutic drugs as a potential treatment for mental health issues. The regulatory environment is constantly evolving and has eased some barriers to clinical research. If your organization is considering moving into early clinical development for therapeutic psychedelics, it helps to know a few facts about researching psychedelics to help your organization move smoothly to first in human clinical trials and beyond. How Psychedelics Are Made Generally, psychedelics are either naturally derived or synthetic. Psilocybin, mescaline, and DMT are all naturally occurring, while LSD is fully synthetic. Recent research includes the development of second-generation molecules that will hopefully confer the mental health benefits without potentially unwanted side effects. Types of Mental Health Issues Psychedelics Can Treat A growing body of research shows promise for psychedelics’ potential to treat depression, anxiety,...