In multiple sclerosis (MS), the immune system attacks the nervous system. Over time, the immune system wears down the protective cover on the nerves, called myelin. My lab at Biogen is focused on developing potential new treatments for diseases such as MS.
There are 3 main steps to bringing a drug from creation to putting it in the hands of patients. These are discovery, development, and manufacturing.
The drug discovery phase involves many disciplines. First, we learn about how the disease affects the body and identify potential targets. We then try and find a promising molecule that may influence the target. This molecule could eventually become a medicine. Finding the molecule can be done in a number of ways. For example, we can create a molecule from living material, or from scratch using chemicals. We may choose a few promising molecules from thousands of potential candidates. Or we may identify compounds found in nature, and use biotechnology to genetically engineer living systems to produce disease-fighting molecules.
It can be a very complex, lengthy, and costly process. This first step may take around 3 to 6 years.
After Biogen identifies a drug candidate, it must go through extensive studies to demonstrate that it is safe and effective before receiving approval from the FDA. The information we collect helps determine dose and treatment regimens for larger clinical trials. This phase may take about 6 to 7 years.
After demonstrating patient benefit and safety, Biogen submits the new drug to the FDA for registration and approval. Once we get approval, we manufacture the new treatment in large quantities. Our quality team manages compliance and supervises consistent and dependable production. At the same time, our supply chain group makes sure that we are able to get our therapies to patients. This allows us to supply medicines to appropriate patients in over 90 countries.
Here is an example of what the overall process looks like:
Thanks to advancements in tools and technology, we are looking at the human body in a whole new way. Throughout the discovery and development process, we may uncover things that lead to new information about MS and treatments. However, it’s not always smooth sailing. There are times when we find a dead end or run into setbacks. This isn’t always a bad thing. It may lead us down a new route. It may force us to take a step back and look again at the way we’re doing things. These challenges can be disappointing, but they're an important part of a complex research and development process. Both the setbacks and successes provide invaluable data. They help guide us to find our next potential treatment.