at the workshop are of less importance, Spencer said. “When the surgeon walks in the room and says ‘It’s malignant,’ you don’t give a damn about privacy at that point. [The patient only cares about] how are you going to solve that problem for me?”

Spencer said that a leader from the pharmaceutical industry needs to stand up and say, “We’ve got an issue.” The NIH needs to play a role similar to that played by the Department of Defense with SEMATECH, he continued. The industry needs to convince the federal government that it will get products into the market faster and with less expense through a cooperative effort between government and industry. With universities, the desire to protect IP was solved in the SEMATECH case by sending them money. The important issue is to move from basic discoveries to something that will help patients, said Spencer, and “patents in that process are not very important.”

Neil cited as major problems an inadequate clinical research infrastructure and antiquated regulatory science. Attention needs to be devoted to creating the right infrastructure to move faster on the clinical side. Additionally, there needs to be a refocusing of research efforts in human systems as “animal models are very imperfect examples of human biology, let alone human disease.”

Sharon Terry, president and CEO of Genetic Alliance, expressed the opinion that a crisis is needed to drive the necessary changes, because change is difficult. The current crisis is that “the public understands that we’ve spent a lot of money on research, and although it’s a tiny amount of money when we look at other industries … we don’t see a lot of results. We might have hyped things in earlier years without meaning or wanting to, and this stuff takes a long time.” In order to move forward and develop products, the shared understanding of where and what people can make money on needs to change, she said, which is hard for companies, for academia, and even for not-for-profit foundations such as the one she heads.

A lot of issues facing the field today are transactional in nature, said Geoff Ginsburg. When potential collaborative agreements enter into the legal department, the process slows noticeably. There is a disconnect which needs to be addressed where IP protections can be overvalued while the value of the collaboration itself may be overlooked. Ginsburg supported the idea that studies of disease biology and biospecimens should be IP-free. “There’s nothing in a biospecimen that is worth patenting. It’s what you do with them,” he said. “If we could lay down ground rules and say getting specimens and data out into collaboration or to the public domain is not an IP event, to me that changes the dynamics of the transaction.” Terry also called attention to the cultural dimensions of change, which means putting new incentives in place.



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