He has five lifetime achievement awards and countless honors and distinctions. He launched 17 companies, sold nine for almost $8 billion and took two public. He has funded research at the University of Southern California, Purdue University and Israel’s Technion to the tune of several hundred million dollars. His innovations are saving lives every day. He is wealthy beyond imagination. But at 86, Alfred E. Mann is nowhere near ready to call it quits. The serial entrepreneur and philanthropist is still working 70 hours a week and only now is he ready to admit that running eight companies may be a bit much. He would like to scale back, he says, to say 50 hours a week and relax a bit more — maybe even take a vacation. But even as he contemplates cutting back on his commitments, the man who helped power spacecraft in the 1960s, who created the pacemaker and insulin pump, and whose innovations are helping, in his words “the deaf to hear, the blind to see and the lame to walk,” has one more pressing thing to do: to finalize and bring to market an inhaled form of insulin. Working on that is Valencia-based MannKind Corp., which Mann calls his biggest priority — as well as his biggest headache — right now. The inhaled insulin, Afrezza, promises to eliminate some of the dangers that accompany today’s insulin therapies, namely that they don’t respond fast enough to glucose and take too long to dissipate after a meal, causing blood sugar to drop dangerously low. Trying to get FDA approval for Afrezza has cost more than $2 billion and taken 14 years so far — longer than Mann ever imagined. To fund it, MannKind has had to jettison other promising projects, including some cancer therapies. But if there is one more thing Mann still wants to do, it is to see Afrezza through to final approval. “Diabetes is the greatest challenge to health care in the world today,” he said. “If we don’t find a solution, it will be disastrous.” Mann is confident Afrezza will get the green light sometime within two years. But he is also baffled by how long it’s taking and the cost. He says “innovation is in trouble” because companies and regulators alike are too risk-averse. The cost in terms of life-saving products that are not getting to market is very high. “We have to understand,” he says, “that progress requires innovation and innovation involves risk.” Question: You have founded 17 companies in your lifetime and you are wealthy beyond imagination. What motivates you to keep going? Answer: In my early career, one of my first companies provided solar power systems for most of the free world’s spacecraft. One of my customers was the Johns Hopkins University Applied Physics Laboratory, which came to me in 1969 and asked if I’d be willing to develop a cardiac pacemaker that would last more than 18 to 20 months. Pacemakers were quite large back then and did not last very long. The goal was to create one that would last at least five years and maybe 10. So this is just to give you an idea of what excites me — early last year I learned that our second patient, who was implanted in July of 1973 as a child, was still alive and after 37 years is still using the same pacemaker. So we beat the five years. Q: So what does excite you? A: Since the 1970s, I’ve been driven to try to find solutions for unmet or poorly met medical needs and for me, that’s what it’s all about — making a difference in people’s lives. That’s a reward you cannot measure. Of all the things I have done — and if you think about it, it’s almost biblical — we created cochlear implants, which allow the deaf to hear; we have created retinal prosthesis that allows a blind person to see — not well yet, but maybe in the future; and my foundation developed devices that enable the lame to walk. So, the deaf to hear, the blind to see and the lame to walk. That’s sort of biblical. Q: What is your most important goal right now? A: My most challenging project now is the MannKind Corp. Our lead project — one that consumes most of our attention, effort and money — is Afrezza, the first ultra fact-acting insulin that closely mimics the insulin delivered by a healthy pancreas. Q: You have sunk a great deal of money into Afrezza. Why is it so important to you? A: Diabetes is the greatest challenge to health care in the world today. According to the International Diabetes Federation, there are 366 million diabetics globally and that number will increase by half in the next 12 years. If we don’t find a solution, it will be disastrous. As an example, in 2009 our country spent $217 billion in the treatment of diabetes, and many say that’s enormously understated. But we only spent $20 billion on the therapy. We’re spending 10 times on treatment what we spend on control of the disease. If we could only control the disease, we would save enormous amounts of money. Q: What is unique about Afrezza? A: Key opinion leaders are saying that because of the way we deliver our insulin and the kind of insulin we deliver, we remove the stress from the pancreas and the liver, and the consequence to that is that it will slow the progression of Type 2 diabetes and maybe even stop the progression of Type 2 with this product. It has a tremendous potential to make a huge difference. Q: I understand you have put about $1 billion of your personal fortune into this? A: $900 million. Q: How many years ago did you start work on this? A: 14 years ago. Q: You are in final trials with the FDA, but I understand it’s been a difficult process. Can you tell us what happened? A: I’m not saying it’s the fault of the agency. Some of it is the fault of our people in the way they interpreted what the agency would require. What happened is that we did some 53 trials with a different delivery device, which was bigger — about the size of a cell phone. But we figured we would need to make millions of these so we redesigned the device so we could automate its production. So we went to the agency to see if they would accept a simple re-filing. We expected their evaluation in six months and all through the development and review period, they seemed very positive. At one point we even said we were cautiously optimistic about approval. In fact there was information on the message board that it would be approved. But then finally they came back with a request for a complete response letter. Q: Does that mean more testing? A: Yes. The FDA came back and suggested this might be a very desirable product for early stage Type 2… and guided us to do trials in early stage Type 2. Title: Chairman and CEO AGE: 86 EDUCATION: B.A., M.S. Physics University of California, Los Angeles. Personal: Grew up poor in Portland, Ore. selling magazines and lemonade; Married with seven children,10 grandchildren. INTERESTING FACT: Donates 90 percent of estate to charity. NET WORTH: $1 Billion Q: So you are hoping for approval soon? A: I am as optimistic as I can be based on our interactions with the agency. We don’t see much risk in the trials. We were essentially told this is what we need to get approved. Q: Is this potentially a blockbuster? A: A blockbuster is a billion dollar device. I don’t think we will get there until the second or third year. (Chuckles) In the U.S. there are 26 million diabetics. How many do you think we can capture with a therapy that is likely to be more effective and convenient? Q: What’s your best guess? A: I’d be shocked if we can’t get 25 percent of them. Say you are doing only six million people in the U.S. Today, insulin therapy is close to $2,000 a year. That’s $12 billion in the U.S. Q: I’d like to focus a bit on your work with universities. You have given more than $160 million to the University of Southern California and about $100 million to Purdue University with the goal of bridging the gap between research and product development. What are some things you are really proud of that has emerged from the funding you have given to these institutions? A: I have to say I’m not as optimistic as I would have liked to have been. I tailor these things to repeat some of the things we do at the Alfred Mann Foundation here in Valencia. The Foundation has created a long term glucose sensor that was very effective. They did the early work on the cochlear implant, which I frankly did not intend to turn into a business. The Foundation did the early work. The only reason it became a company is that one company came to us and wanted to take it over. I said, ‘What are you offering?’ They said, ‘We’ll take the patients in the trial.’ I said, ‘What else?’ They said, ‘That’s it.’ So I said to my people, ‘I think we are now in the cochlear implant business.’ Q: So are you suggesting that you are more pleased with the work that’s come out of the Foundation than the work that’s come from the universities? A: It’s still early. We’ll see. But I won’t create any more of these institutions, and in fact, we are terminating Purdue. Q: Are you unhappy with the way they have used your money? A: I’m not objecting to it. The question is… if I give them $100 million, or in the case of USC, $163 million, is the income from that sufficient to create much value? So far I have not seen spinoffs of the technology into ventures that make enough to make a difference. Q: What do you think about how companies are innovating these days? A: I think innovation is in trouble right now. President Obama has said innovation is his goal in medicine now. But the regulatory path is very difficult. For devices, it’s very difficult. And for drugs, it’s almost impossible. We have now taken 14 years and spent almost $2 billion to develop a product that’s really the same insulin your body makes. The whole regulatory approval process is very difficult. Q: Is there a solution? A: We have to understand that progress requires innovation and innovation involves risk. We need to find a way to shorten the registration process, which involves taking some risk — maybe expanding the Phase II trials. My proposal is that at that point you have provisional approval and you market it for three to five years and at that point it’s reviewed. If it takes you 15 years and $1.5 billion to get it to market, the patent is only good for 20 years. So you have five years to build up the revenue and earn a return on the investment and get some profit on it. It’s a very short time. The result is that today you find pills that cost five cents to make, but companies have to charge $10 to make the return back. It doesn’t work. Q: Was this easier with your other start-ups? A: Most of my career has been in medical devices. That’s not easy, but it’s not as significant an issue in devices. The system still works. But with drugs, it takes much too long. This is why you see the major pharmaceutical companies cutting back on research. Q: Going back to Spectrolab, your first business, how did you make the decision as a young man to start a business rather than going to work for a company? A: The world would not let this happen today. I was in graduate school at UCLA when I was offered a job at Technicolor Corp. They wanted me to do something in electro-optical physics, which I love. The U.S. Army was developing an anti-tank missile system and they needed the technology I was pioneering in guidance systems. They wanted my help but I was not permitted (by Technicolor) to work on it. But I gave them some advice. The Army eventually came to me and said, ‘Would you start the company if we give you a contract?’ That was in 1956. I started the company with a few tens of thousands of dollars and the rest came from the Army. Q: And later? A: I was so excited by the pacemaker, I wanted to devote my life to medical things. I had such satisfaction from making a difference in people’s lives. I said that’s what I want to do with the rest of my life. Q: Today, you are involved with eight companies. How is that going? A: I got overly successful and I started too many. The truth is I don’t have time to run them all so I have run into problems with some of them. I have Quallion, Stellar Microelectronics. I started those to support the medical work because I could not get good sub-assemblies of electrical devices or the right batteries. I’ve had to cut back so I’ve put some of them up for sale. Q: What’s sold so far? A: Just Stellar. Q: And the others? A: Under the right circumstances I would sell Quallion, as well. But I ran into an issue I have to resolve first. It’s a personnel issue and I can’t discuss it. Q: What do these companies share in common? A: Medical need. They use some kind of electrical stimulation for pain relief, or treating retinal blindness or deafness or trying to restore the function of arms and legs. MiniMed and MannKind are devoted to the diabetes and drug delivery system. Q: Have you had any failures? A: If I have, I have not admitted to any failure. But it depends how you define failure. If failure is a failure to create a product or get a return on investment, so far I have not had that, though one or maybe two of my current ventures — if I sell them before they get to be larger, I may lose money on those. But it won’t change the way I live. Q: Let’s talk about that. You said before you work 70 hours a week still? A: Yes, I’m semi-retired. I work seven days a week. A typical day for me starts between 6 and 7 a.m. I live where my main office is. I will sit at my desk and work until dinner. They bring me breakfast or lunch at my desk, and I don’t leave until at least 7 p.m. So I put in close to 12 hours. Sometimes I go back to work after dinner. Saturday and Sunday, maybe instead of a dozen hours, I only work 10 hours. Q: What do you do during those hours? A: Oh God, I have so much work thrown at me. Q: Don’t you have people handle things for you at this stage? A: Of course, I do but I have too many ventures. It’s too much now. I’m too old for this. Q: You are clearly very wealthy. What does that allow you to do that you enjoy? A: I just came back from a trip around the world. We took my plane and by doing that we were able to stop in 13 cities in 20 days. But it was a killer. Q: How do you mean? A: It just really exhausted me. Q: Did you have a favorite city? A: I’m not much of a tourist. My wife enjoys the cities. I dropped her off in Nice. She loved Beijing. We were very impressed with Dubai. Q: So your wife loves the cities. What do you love to do? Do you have any hobbies besides work? A: I used to play tennis but I don’t have time for it now. If I had to say what I love to do now, it’s being with my wife. I have an extraordinary wife. Q: How long have you been together? A: 22 years. Q: What would you change about your life now? A: I’d like to reduce my work week to 50 hours and relax a little more. Take a vacation once in a while. Q: You have accomplished so much in a long life. What are you looking forward to now? A: My greatest priority today is to see Afrezza to market. We will be addressing the single most important problem in health care. And if I had to pick a second one, I want to see an even better solution for people who are blind. I’d like to see some of the things we are working on for the lame to function better. Q: And you are in your 80s? A: 86 Q: How do you do it? What’s your secret? A: I don’t know. I take after my parents, I think.