By Catherine Varmazis
July 28, 2008 | BOSTON | Partnerships between academia and industry are needed more than ever, but they are under attack as never before, said Dennis Ausiello, chief of medicine at Massachusetts General Hospital (MGH) and professor at Harvard Medical School, in his keynote address at the DIA annual meeting.*
Many academic researchers fail to appreciate that understanding a disease is an academic pursuit, but curing it is a business, said Ausiello. This prevents the creation of good relationships with the pharmaceutical industry, which are necessary for drug development: “I can’t tell you how many times a day I have people knocking on my door believing they have the cure for cancer, but not knowing what to do next,” he said.
Public concern about prescription drug marketing practices has cast all academy/industry partnerships in a negative light, he said, citing a bill pending in the Massachusetts legislature that would have criminalized the acceptance by doctors and academics of “pens, peaches, and parties” from pharma. Ausiello noted, however, that he had banned the practice in his institution years ago because it “gives ammunition to those who want to end all such relationships.” [The bill has subsequently been amended to allow industry-funded conferences. See Panel Rejects Ban on Drug Firm Gifts, in the Boston Globe.—Ed.]
There is also a lack of appreciation of the important role academic discovery has played in drug development, he said. “Many of most spectacular drugs in the last 20 years have been brought forward largely through the insight and creativity of academicians.” However, there is a general lack of understanding of how this is done and how long it takes.
The pharma industry is beset by its own problems, he said, and one of the biggest is the biological complexity of disease pathways. Citing the “astounding” changes of the last 25 years, Ausiello said, “For someone like me, who trained in medicine in the 1970s, there were only a few hundred targets. Today, there are tens of thousands in multiple pathways” and prioritization of targets has become huge problem.
Pharmas cannot solve this problem alone because they have historically been chemistry companies. “We are now required to use novel technologies in biological arenas such as peptides, RNAi, and gene therapy. In effect, you’re testing two events simultaneously: the potential target and the potential utility of the technology to get to that target. This is a burden that requires more than one single pharma company and more than one academic institution,” Ausiello said.
He challenged the belief that there is a shortage of innovation in drug discovery. Rather, he said, there is a productivity deficit: “In 1980, R&D was $2 billion per year. Today it is posited to be over $40 billion for about one and a half times the drug launches.”
At the same time, other factors complicate the picture: “Not only is the science tougher, and it is more difficult to prioritize targets, but you now must consider at a very early stage of R&D the marketing, safety, regulatory, and commercial aspects. This has been a huge burden for scientists.”
Both industry and academia need new models with which to tackle these challenges, he said. One innovative example is Boston Biocom, a consortium that brings together academia, big pharma, biotechnology companies, and venture capitalists to run the scientific enterprise as a business. Partners in the venture share the risks and rewards.
Patients as Partners in Discovery
Finally, Ausiello said, patients need to be united with the science, to become partners in drug discovery. Researchers need “early, thoughtful access to the human organism as an experimental model.” While the human genome is often cited as the “surrogate” for such access, technologies such as nanotechnology, information technology, and diagnostic imaging can also provide valuable insights.
The role of information technology in medical research represents an enormous advance, he said. MGH developed electronic medical records and a research patient registry with more than 750 million bits of information on two million patients. After developing the registry, researchers conducted retrospective studies in which they culled out all the patients who were on non-steroidal medicines who had cardiovascular disease. “Had we been smart enough to ask the question five years earlier, we would have been able to pluck out those who were suffering severe cardiovascular effects of such agents as COX-2 inhibitors well before it became public knowledge,” Ausiello said.
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*44th Annual Meeting of DIA, June 22-26, 2008, in Boston.
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