BioSpace recently spoke with Mir Imran, CEO and Chief Innovator at Rani Therapeutics, a company developing and testing a “robotic” pill that delivers biologics orally.
Mir Imran, CEO and Chief Innovator at Rani Therapeutics, pictured above. (Rani)
BioSpace recently spoke with Mir Imran, CEO and Chief Innovator at Rani Therapeutics, a company developing and testing a “robotic” pill that delivers biologics orally.
Q: What is your role at Rani?
A: In the early days, as an entrepreneur building a company from scratch, I did everything, including cleaning the conference room table after a meeting. Today, as the company grows, I am working to develop and build a team. As we grow, I spend a lot of time with the scientists and engineers, mentoring them and helping them understand the problem we are solving. I really enjoy that part, working with brilliant scientists and engineers. We have an amazing team. Ultimately, I’m deeply involved with all aspects of our business from engineering and manufacturing to business development, finance and clinical and regulatory matters. It’s a dynamic environment.
Q: What is your background and why Rani?
A: My training is in engineering - electrical and mechanical engineering and materials science. I went to medical school but never practiced; skipped all the residency and all the difficult parts, and decided to start up a company. And this was ’79, I think. We developed the first implantable defibrillator using my engineering background and medical knowledge. INTEC SYSTEMS was the first medical company I did. That company was acquired by Eli Lilly five years later. They came in as an investor in 1985. And several years later, they spun out a company called Guidant, which was acquired by Boston Scientific in 2006 for $27.5 billion. So the implantable cardioverter defibrillator came out of my work, and it has been implanted in millions of patients, saving millions of lives.
What I learned from that is that what shapes you is really the kind of things you do in life, the kinds of problems you work on. If you work on big and difficult problems, it helps you grow. And even if you fail at those, it really shapes you and deepens your understanding of the problem. In 1995, I set up an applied research lab called InCube Labs. It is in this laboratory that we identified big problems, unmet needs and tried to figure the problem out and see if we can create a solution. And some of those things become companies. So periodically, a company comes out of this research lab, and Rani was one of those companies.
Q: What is the RaniPill™ capsule?
A The oral delivery of biologics is considered the holy grail of drug delivery. I was in a meeting where I heard of a small company that was trying to convert a peptide into an oral formulation. They just couldn’t get the bioavailability that was needed. So, I left the meeting thinking about that, and why not create a capsule that the patient takes and which passes through the stomach into the intestine? The intestines don’t have pain receptors like your skin does. You can poke needles all day long, and you won’t feel a thing. So, we could actually create a capsule that would transform itself once it’s in the intestine and deliver a pain-free injection of the drug that’s contained in it.
Q: How big is this pill?
A: You are familiar with fish oil capsules? And calcium pills or Centrum? So, it’s closer to the size of the fish oil pill. And it has a lubricious coating, very slick. As soon as it comes in contact with fluid in your mouth, it becomes slippery and just goes down; it’s very easy to swallow.
Q: And there is powdered medication in there with a dissolvable needle?
A: Yes. When I was examining the problem of delivering biologics into the gut, I asked myself, why can’t we use a dissolvable needle? The minute you talk about a dissolvable needle, you really cannot push a liquid drug through it because as it’s going through, it’s dissolving the needle. So I said, okay, the drug can’t be liquid, so it has to be solid. That sort of converged to a solution, where we have a dissolvable needle made out of injectable-grade materials. And it’s hollow, and inside that hollow lumen, we stuff it with the drug that we want to deliver. The intestinal wall is a muscle, and it’s highly vascularized because the intestines are designed to absorb the nutrients. The blood supply is incredible, the microvascular supply. Much better than a subcutaneous injection. We get a much faster uptake because of the rich blood supply.
Q: Do you think this will work?
A: It does. We have done hundreds of preclinical studies. We have conducted two human studies. A phase one study - one of those was a phase one study with a biologic. And we’ve talked to the FDA several times. They’ve given us a pathway going forward. We have a pipeline of drugs that we plan to develop. And in order to support that, we have invested heavily in manufacturing automation. So we’re scaling up sufficiently to support the clinical trials that are going to happen this year and next year.
Q: Why did you tackle this?
A: My passion is going after unsolved problems, unsolved mysteries and leveraging my engineering skills and other skills to create solutions. To, first of all, understand the problem, and then create solutions. We did a survey of hundreds of patients and hundreds of physicians, and 85 to 90 percent said, “we’ll switch to oral.” We decided to have Frost and Sullivan survey patients who are currently taking insulin, for instance, or Humira and talk to physicians who prescribe these drugs. They both said 85 to 90 percent will switch. For the patient, it’s a huge improvement in quality of life; you don’t have to poke yourself periodically.
Q: That’s amazing. You are the Chief Innovator at Rani. What does that mean for you?
A: I was fascinated by the innovation process at a very young age. I was intrigued by why I innovate. Why am I able to do it? Why can I do it well? And why are some people better and others are not at innovation or invention? And I couldn’t find any explanation. I read a number of books. This was in my early 20s. So I decided to become a conscious observer of my work, the thought process that was going on as I was inventing things or solving problems. And so observing that for about 10, 15 years, over a dozen companies I had started. It really came together with the clarity on how to innovate - how to innovate, not what to innovate. And then I asked the question, can I make it teachable? We all have the capacity to be inventors and innovators, and I happened to stumble on it early in life. But I’ve turned it into a teachable subject. So I think that, to me, the second-- the parallel journey that I have is the journey to figure out innovation and figure out a way to teach innovation. As a result, I’ve gone around the country to a number of universities giving talks and lectures on innovation.
