The Next Trip with Altasciences and DevelRX
In this podcast episode, experts from Altasciences and DevelRX examine the preclinical, clinical, and regulatory requirements and strategies that second generation psychedelics may utilize to differentiate their pharmacological profile, and strategically demonstrate efficacy and safety data that may differentiate from first generation candidates. The discussion is moderated by Altasciences' Chief Scientific Officer, Dr. Beatrice Setnik.
The potential use of psychedelics for the treatment of various CNS indications is currently under active investigation.
ISSUE NO. 18 — Planning Your First-in-Human Trial
A first-in-human (FIH) clinical trial is a significant milestone in the development of a potential new drug in that it will be the first opportunity for a drug development sponsor to evaluate the impact of their new chemical entity (NCE) or biologic in humans. Typically, FIH trials with compounds intended for treatment of diseases other than cancers or certain rare non-malignant diseases are conducted using normal healthy volunteers (NHVs), unless there is an ethical concern (such as known toxicity) in administering the investigational drug to an otherwise healthy population.
In Issue 18 of The Altascientist, we provide a stepwise guide for how to plan first-in-human trials to mitigate risk, including:
- submitting an Investigational New Drug (IND) Application
- selecting the starting dose
- designing the trial
- participant safety
- identifying and mitigating potential risks
- recruiting, educating, and retaining study participants
- resources need for study conduct
The Many Faces of Recreational Drug Use - Episode 1
Drug addiction is a devastating condition that affects the quality of the user and their families. In this podcast series, we explore the behaviors of individuals who abuse opioids and stimulants, and learn about their patterns of use and motivations to compel them to continue using these drugs through a series of candid interviews with opioid and stimulant recreational drug users.
Contract Pharma: Altasciences Appoints Dr. Bruce Frank as VP, CDMO Operations
Alzamend Neuro Announces It Has Contracted with Altasciences to Conduct a Phase I Relative Bioavailability Study for AL001 for Dementia Related to Alzheimer's Disease in September 2021
Proactive: Emyria Signs Pure CBD Agreement with U.S.-based Altasciences to Help Fast Track Registration
Proactive: Emyria to Accelerate FDA and TGA CBD Registration Programs with Altasciences Deal
Up Close and Personal with Dr. David Nguyen, MD, MBA
Dr.