Our patients have the potential to enhance the quality and efficiency of clinical trials by providing their input, ideas and feedback during this journey.
Here is an overview of our drug development process and how your input matters.
Discovering, testing, and refining the compound.
First, we determined the drug target, or the biological molecule that we're going after to modulate its function with a drug. In our case, we're targeting a synaptic protein called PSD-95 to boost BDNF activity.
Once we've collected the evidence to show efficacy and safety, our next step is to ask the FDA for permission to test our drug in humans. This is done through an IND, or Investigative New Drug application.
Clinical trials: the first time our drug is given to humans.
In Phase 1, we address the question of: what dose can we safely and effectively give our drug to people?
In Phase 2, we answer: at the dose we picked in Phase 1, does it work? Is it safe for sure?
In Phase 3, the question is: does it really work? Is it better than what we already have?
Filing for and receiving final approval.
After successful clinical trials Phase 1-3, we apply for FDA approval through an NDA, or New Drug Application. The Center for Drug Evaluation and Research within the FDA will then decide if we can make the drug available to the people.
After approval of our compound.
This stage, also known as post- approval pharmacovigilance, determines: how'd our drug do? Looking at various populations, how well did it work? Are there any rare or long term side effects?
It's critically important to study the actual impact of our drug- did we help our patients? Our mission is to fix your brain- this is where we'll find out if we accomplished it.
Our patients have the potential to enhance the quality and efficiency of clinical trials by providing their input, ideas and feedback during this journey.
Here is an overview of our drug development process and how your input matters.
Discoverying the initial drug compound.
First, we determined the drug target, or the biological molecule that we're going after to modulate its function with a drug. In our case, we're targeting a synaptic protein called PSD-95 to boost BDNF activity.
Once we've collected the evidence to show efficacy and safety, our next step is to ask the FDA for permission to test our drug in humans. This is done through an IND, or Investigative New Drug application.
Testing and refining the compound.
In Phase 1, we address the question of: what dose can we safely and effectively give our drug to people?
In Phase 2, we answer: at the dose we picked in Phase 1, does it work? Is it safe for sure?
In Phase 3, the question is: does it really work? Is it better than what we already have?
Filing for and receiving final approval.
After successful clinical trials Phase 1-3, we apply for FDA approval through an NDA, or New Drug Application. The Center for Drug Evaluation and Research within the FDA will then decide if we can make the drug available to the people.
After approval of our compound.
This stage, also known as post- approval pharmacovigilance, determines: how'd our drug do? Looking at various populations, how well did it work? Are there any rare or long term side effects?
It's critically important to study the actual impact of our drug- did we help our patients? Our mission is to fix your brain- this is where we'll find out if we accomplished it.
