StemCell Therapy

By William A. Haseltine, PhD

When I became an assistant professor at Harvard in the mid-1970s, creating a company was never part of my plan. I had only a dim understanding of how corporations were organized and no understanding of finance. But I was slowly becoming aware of how biotech businesses could be a positive force for health.

I had been keeping tabs as close friends from various universities gave up their tenured positions to join nascent companies gaining an early foothold in the new field of biotechnology. All were racing to apply the new techniques of recombinant DNA (gene splicing) to make new drugs and vaccines. I was beginning to realize that the work I was doing as a research scientist might create a conceptual breakthrough, but the businesses were the ones taking that breakthrough and delivering it in the form of drugs to patients in need.

I was working at the time on retroviruses and their potential role as a cancer-causing agent in animals. Id planned a trip to the West Coast to build up my collection of mouse leukemia viruses, which is where I learned from my friend Richard Lerner, a research chemist at Scripps who had been studying protein structures, that you could accelerate an antibody response by using peptide fragments, as opposed to using whole viruses or virus proteins. I understood the impact of the discovery immediately: using peptide fragments would be a faster, cheaper way to make vaccines.

That was the tipping point. I knew that this knowledge could shorten the time it took to develop new drugs, which at that time required at least ten years and many tens of millions of dollars. I also knew that pets and livestock suffered serious viral infections. If we could test the idea in animals, we wouldnt need to go through the FDA. I could create a company that would be a shortcut to demonstrate that a vaccine can prevent retrovirus infections that cause cancer.

I worked with Deborah Ferris, who had helped get Biogen off the ground, to develop the business plan for a company that would develop animal vaccines with this new technology. I went to every Wall Street banker and venture capitalist I knew, and I eventually landed myself a $5 million commitment. These financiers understood the power of knowledge and the economic benefits it could bring.

I thought, after securing financing, that I had jumped over the hardest and highest hurdle in the process, but I was wrong. I didnt yet realize the political hurdles I still had to jump at Harvard. There was no precedent for a Harvard assistant professor starting a company. Even for full professors, the idea was highly controversial. Harvards president had voiced skepticism, and faculty across the university grumbled, some with outrage, at the notion that biologists or biochemists might turn discoveries developed at Harvard into a personal fortune. This, despite the fact that many of the universitys history and economics professors were making tens of thousands from the sale of their books.

I was faced with many setbacks but managed to overcome them after a bit of luck followed me onto a plane flying from New York to Boston early the next year. I ended up seated beside Larry Fouraker, dean of the Harvard Business School at the time. I pitched him my idea for a company and explained the challenges I was running into at the university. He told me something I had not realized: thanks to the Bayh-Dole Act, which had been passed during a lame-duck session of Congress just months before, universities were now required to create a technology transfer office to turn new ideas into companies.

The laws intent was to promote commercialization of research funded by the federal government. Birch Bayh, Democrat of Indiana, and Bob Dole, Republican of Kansas, were the legislations sponsors in the Senate. Jimmy Carter signed the bill into law. The law states that all universities and research institutes that receive federal funding must file patent applications on all discoveries with practical application and must make best efforts to transfer the technology to businesses for commercial development.

That was my green light. Larry became a close friend and mentor to me. The only requests he ever made of me were to speak to his students at the business school from time to time about entrepreneurship and to pledge some shares of the company I would found, Cambridge BioScience, to the universitys endowment fund. I ended up offering Harvard 5% equity, but they turned it down. They hadnt worked out what they thought the ethics might be of such a transaction. I can assure you that by now they have.

Far from harming my career, creating Cambridge BioScience turned out to be a huge plus. I developed powerful relationships with some of the department chairs and became a role model and adviser to other faculty members in starting their companies. Eventually, Harvards governing board and administration embraced the benefits of professors starting companies, and I was asked to chair a university-wide committee that would clarify the rules governing relationships between professors and the companies they seek to start.

Ironically, the university now requires faculty to pledge a percentage of the founding shares as well as royalties received for startups based on a professors patents. As I noted earlier, Harvard never accepted my 5% offer. But after Cambridge BioScience went public, I sold the 5% and donated the cash. They were happy to accept it.

I learned through the process that our scientific reputation is our capital. I also learned that no person or company ever becomes a success without people like Larry to support and mentor them. This is why I am so pleased to have been invited to contribute to this commemorative, 40th Anniversary edition of GEN. The magazines founder, Mary Ann Leibert, has been a great support to me over many years, but especially at two inflection points in my life.

The first was in the early years of the HIV/AIDS crisis, when I suggested that we create a journal to help cover some of the most exciting, but often neglected, developments in the field. Mary Ann jumped at the idea and took no more than two seconds to agree, and we founded the Journal of AIDS Research and Human Retroviruses.

Fifteen years later, I conceived of the idea of regenerative medicine and began to work with Tony Atala and others to create awareness of the new field and its motto: Regenerative medicine is any medicine designed to restore a person to normal health, including cell and stem cell therapies, gene therapy, tissue engineering, genomic medicine, personalized medicine, biomechanical prosthetics, recombinant proteins, and antibody treatments.

Mary Ann responded immediately and positively once again, offering to create the Society of Regenerative Medicine and another new journal, initiatives that were soon launched. Mary Ann, through her journals, publishing company, and GEN, has always been the wind in the sails of the biotechnology industry.

William A. Haseltine, PhD, is known for his groundbreaking work on HIV/AIDS and the human genome. Haseltine was a professor at Harvard Medical School, where he founded two research departments on cancer and HIV/AIDS. Haseltine is a founder of several biotechnology companies, including Cambridge BioSciences, the Virus Research Institute, ProScript, LeukoSite, Dendreon, Diversa, X-VAX, and Demetrix. He was a founder, chairman, and CEO of Human Genome Sciences, a company that pioneered the application of genomics to drug discovery.

Haseltine is the president of the Haseltine hivFoundation for Science and the Arts and is the founder, chairman, and president of ACCESS Health International, a not-for-profit organization dedicated to improving access to high-quality health worldwide. He was listed by Time Magazine as one of the worlds 25 most influential business people in 2001 and one of the 100 most influential leaders in biotechnology by Scientific American in 2015.

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Making the Transition from an Academic to a Biobusiness Entrepreneur - Genetic Engineering & Biotechnology News

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