Hope all is going well. I wanted to continue on from the theme of last week’s #FactualFriday related to delivery of a therapeutic to the brain. It is a topic that has been in the headlines in the news recently with two drugs that are being evaluated for Alzheimer’s and ALS (Lou Gehrig’s Disease). These are absolutely brutal diseases, with minimal options available. Most of us know someone who has succumbed to one or both of these diseases. This is personal to me as my mom was afflicted with Alzheimer’s disease and passed away earlier this year from this disease. Those of you who know someone who has this disease, the ticks that can occur (she developed severe OCD with loss of her verbal skills) can be so hard to watch. Many people were kind to offer condolences and I would let them know that she was dying every day for many years and toward the end, I just wanted her to be at peace. As she laid in the hospital bed right before she passed away, it was the first time in many years that I saw her still and resting. While it was a sad time, that moment filled my heart with joy to see her finally have a moment of peace that she deserved.
The title of this week’s blog comes from an old African proverb about needing many people to raise a family. This same concept is needed when developing a potential therapy. I am always really excited about all of the programs we are working on. Each one of them has a special place in my heart (and I know our team members have their own personal favorites), almost like having a child. We put so much blood, sweat and tears into developing a device or a particular program that it leaves a mark on you. I know you must be thinking that I’m a drama king mentioning “blood”, but even though we work in a clean lab, I can’t tell you how many times we’ve cut ourselves on razor blades, needles and broken test tubes (we keep band-aids on hand for a reason 😊).
As you know from our previous blogs, we are developing a cell chamber (Bio-Spun™ Cell Chamber) that is used to enclose cells that have been modified to deliver a target therapeutic over a long period of time. This approach uses the body’s natural functions to keep the cells nourished and by doing that, these cells churn out the therapeutic. It is like getting a constant infusion of the drug, keeping the dosage in the patient at constant levels. This would keep the patient compliant and could possibly deliver a drug to a special part of the body. Developing a device is not always straight-forward. Sometimes you have to overcome obstacles that are out of your control. For example, when we first started this development program, we were charged by our partner to develop three potential devices, with this chamber being one of them. Before we started, our primary contact was told by his company not to waste his or our time trying to develop a cell chamber. It was likely not going to work and there was really no need for it. I knew that it was a passion of our contact and I basically said to him that we are going to ignore that view and we were going to keep developing this chamber in our plan. As I mentioned to you before, I am pretty stubborn (yes you can feel bad for Tina now) and I love a good challenge. When you’ve been told that you’ll never make it as a scientist by your college advisor, everything else is just cake.
Over the past several years, we have focused on developing this cell chamber along with the other two devices (a perianal fistula plug and a drug-delivery sheath) both at the benchtop and in preclinical studies. Our team, which involved our internal folks as well as several outside people that we consider as honorary BioSurfaces members, has been fully committed to making this device a reality. We faced many challenges to get this to be a working device. Many companies have tried and failed to get a cell delivery device even to this stage. We have always believed in the mission and through it all, we have thought about what this could do for patients someday. Over the past year, we conducted preclinical studies to see how this device could be used to deliver a drug in the subdural (space below skull bone) in the brain. For these studies, we had to make the device very small (1.5mm width X 5mm length) to get them to fit into this space in the brain of a rat. It was amazing for us to see that the cells in the chamber were producing this target drug for 50 days (length of study) in the brain, getting into the brain tissue and getting into the blood stream through the fluid from the brain into the spinal cord (cerebral spinal fluid). We have a long way to go but these studies are extremely encouraging and could one day provide a way to deliver a drug that may not cross over the blood-brain barrier.
One thing we did “backwards” in our approach was to speak with the end-user, the surgeon, last. Normally, the clinical surgeon is approach during the development process to get his or her opinion about the device need for the patient, the way that it would be delivered and issues that we could encounter. We had many things to overcome during the development process and wasn’t sure if we could get this to work. We contacted a neurosurgeon who I had met in the past and was willing to speak with us. Some of the time, surgeons will charge you for this time. He was generous to provide us with his thoughts on all of the areas I mentioned. His kind words about the technology and the belief it could help patients was really motivating. He provided additional insights for several other applications that we had not thought about. It is so refreshing to have a surgeon that is willing to think about the patient first.
After all, it takes a village.
Please check out our next #FactualFriday on October 7th. We’ll see you back here on October 14th.