At any given time, there are 300,000 names on the waiting list for organ transplantation. That number is so large that a lot of people waiting today will not be around tomorrow unless something becomes available.
The problem is not so much lack of donors. Joe Fischer, CEO of Lifeblood Medical Inc. in Adelphia, New Jersey, knows the biggest problem facing harvested organs is that they simply cannot be preserved long enough to use them. Realizing this was his moment of inspiration for founding Lifeblood in 2001 — and it made him wonder why no significant improvements in organ preservation had occurred in the preceding 30 years.
“I went into this thinking it would be a good niche market,” Fischer says. But seeing the size of the need, he reasoned that his chosen market was anything but.
Fischer will be part of “Entrepreneurial Opportunities in Life Sciences,” a panel sponsored by the New Jersey Technology Council on Wednesday, July 8, at 6 p.m. at the Holiday Inn in Edison. Fischer will join Raman Kapur, chairman of Global Pharmaceutical Services at 791 Alexander Road; Geeta Vemuri, a partner at Quaker Bio Ventures in Philadelphia; and Samir Patel president, CEO and co-founder of Opthotech Corporation at 5 Vaughn Drive. Cost: $60. Visit www.njtc.org.
Lifeblood Medical was founded in 2001 with Fischer’s own seed money (the amount of which he would not say) because he says he saw the need to save organs from going to waste. Many times, he says, an organ — say a kidney — comes into a hospital and “doesn’t look too good.” An organ’s poor shelf life after being removed from a donor is apparent early, and all too often it is past the point of being fully functional by the time it gets to the recipient. Twelve hours to get an organ from a donor to a recipient is about all the luxury you are likely to get, and that counts for samples that have been frozen.
Lifeblood developed a solution that preserves organs for as many as 72 hours, and at room temperature, Fischer says. The solution also is regenerative.
Recently, at Allegheny General Hospital in Pittsburgh, doctors used Lifeblood’s solution to fully regenerate kidneys by sluicing the solution through the organ for about 16 hours. At the end of the procedure, Fischer says, the kidneys not only regenerated, but produced a liter and a half of urine. “We’re the only ones who can do that,” he says.
Returning samples from abroad. A little-known course of action surrounds what happens to organs and tissue from American service personnel overseas. Should a soldier be killed in Afghanistan, says Fischer, any donated organs or tissue will stay overseas because there is no way they will survive intact if they were sent to the States. Those samples often end up in Europe or Asia.
Lifeblood has been working with the U.S. Navy on limb preservation and oxygen therapeutics in an effort to change that outcome. The company’s therapeutic solution is not a mere blood replacement, Fischer says, but a solution that carries oxygen through the body, its organs, and its tissue. The results, so far, have been promising, he says. Lifeblood’s solution can keep samples from deteriorating during long and punishing rides to the U.S.
The niche markets. While Fischer balks at calling his operation a niche, he is not bothered by calling it a specialty. He says that life science companies are finally starting to see niches and sub-specialties in their field and he anticipates that for entrepreneurs, this will be the next trend.
The field of life science, though, is tight on all fronts, Fischer warns. But he suspects startups will follow Lifeblood’s lead in eliminating animal components from their products. A big niche, he says, will likely arise through stem cell research.
With government restraints removed, the amount of research in stem cells is growing, creating a large field. But much of the stem cell research and practice happening now involves using animal components to complete the samples. Lifeblood, which also works with stem cells, does not use any animal matter.
This is no animal rights issue, says Fischer. It is simply good medicine. Animal viruses and genetic differences are eliminated. “In laymen’s terms, it’s just a cleaner, more efficient process,” he says.
He also sees the animal component-free vaccine market as a viable niche market.
Only $50 million? The rewards for successful biotech and life science companies are sufficient enough to make a potential $50 million market sound like small potatoes to venture capitalists and big pharma, Fischer says. His own perspective is that $50 million is one hell of a lot of money, and he would be glad to have it in his bank account any time.
For startups, this kind of revenue might seem huge, but investors see it as the bush league because they are looking at the big players with values in the millions or even billions, says Fischer. The blood market itself, he says, is worth $30 billion.
The perception that a $50 million niche (or $150 million, even, which is the worth of the organ preservation market) is small-time can help and hurt the life science startup, Fischer says. Smaller markets get ignored, leaving more room for development and less competition. But it also makes it tougher to find funding.
Fischer’s approach, and his advice to the life science entrepreneur, is to “stay as virtual as possible.” When he founded Lifeblood, Fischer outsourced everything he could, from research to manufacturing, and kept everybody connected through the computer. In the absence of funding beyond his own money, staying virtual helped keep costs low enough to get through the first few years of research and development, before he landed his first federal contract for $2.2 million and another from the Department of Defense for $1 million to advance limb preservation and stem cell research.
Growing. Had he to do things over again, Fischer says he would have hired a small research staff to be onsite, but in trying to stay within a relatively tight budget he decided to farm out the work. Now that Lifeblood is getting a name and finding that its solutions work on more than just one body part, though, the company is looking to develop licensing partnerships.
Fischer admits it is an enviable position to be in — his company’s business is too diverse to handle everything in-house. Lifeblood is a little different from most life sciences companies in that way, but it still presents a situation that almost sounds like growing pains.
Fischer recommends that companies looking to license some of their technologies look into business development groups to help them facilitate the process. Having just started this himself, Fischer cannot say with whom he is in talks, nor what the talks are about. But he admits his company is at the stage when it needs to let other people take its technologies and run with them.
The process has started to some degree in academic research. The University of Calgary and the University of North Carolina have conducted successful studies with Lifeblood’s technologies.
Fischer himself owes his life to life science technologies. After more than 20 years in senior management in the field Fischer had planned to start a contract company in San Diego in 2000 but was sidelined by lymphoma. After chemotherapy treatment at the Sloane Kettering Institute he decided to start Lifeblood and stay on the East Coast. “Someone helped me survive, I figured I should do the same,” he says.
Born in New York, Fischer moved to Jackson at age 13, dreaming of being in the medical profession. When he went to Rutgers in the late 1960s he couldn’t stay long because his parents — an electrician and a stay-at-home mom — could not afford to keep him working toward his research studies. So he joined the Air Force and spent a year as a radar technician in Vietnam.
Fischer came home, got married, and started taking night classes toward his degree. Along the way, he says, an astute professor and mentor noticed that he had a knack for operations that he did not have for research. Fischer listened and finally received his degree in management in 1978.
He immediately went to work as a manufacturing manager at Worthington Diagnostics in Freehold; he then became director of manufacturing at Elkins Sinn in 1980. In 1990 he moved to Enzon in Piscataway, then to Osteotech, then back to Enzon as vice president of operations.
Around 2000 Fischer started thinking that there had to be a new way forward in life science and eventually ventured into organ preservation. He considers his wife to be a valuable resource. She does not work with him and has never been in business, he says, but she offers the benefits of an outsider’s insight. “She’ll say things and I’ll think, ‘Why didn’t I think of that,’” he says.