By David Sell The Philadelphia Inquirer.
Elizabeth Grice, a University of Pennsylvania assistant professor, embodies the new way academia and drug companies collaborate on research to generate cash for schools and profitable medicines for manufacturers.
Grice, like many researchers, gets most of her funding from government agencies such as the National Institutes of Health, and also foundations. Like some, she also is doing work for a for-profit pharmaceutical company, in her case, Janssen Pharmaceuticals.
What's changed in recent years is the nature of that academic-industry relationship.
Newer academia-industry agreements involve more frequent communication and milestones for completing tasks.
"They are very focused on deliverables and less on the process of how you got there," Grice said, referring to Janssen's goal-oriented emphasis. "Whereas, in academia, it's like, 'Oh, you discovered this cool thing along the way and there is a whole separate story,' they are very focused on what is in the contract."
With urging from Penn President Amy Gutmann, Penn changed focus in 2014. The Center for Technology Transfer became the Penn Center for Innovation. Laurie Actman was hired to be chief operating officer and spur more corporate engagement.
"Traditionally, these were very transactional," Actman said of partnerships. "Universities owned a patent. They were sort of looking to throw the technology over the wall. The future of the business relationship is taking down the wall and being jointly engaged."
Data from the Association of University Technology Managers show that Penn's overall research funded by the federal government fell by 11 percent the last four years, going from $786 million to $697 million, while industry funding rose in the last two years from $55.4 million in 2013 to $77.3 million in 2014.
Drugmakers' in-house research is producing fewer drugs with blockbuster revenue, so they are more inclined to look outside the company. Universities and their researchers, faced with cuts in government money through the National Institutes of Health, have been quicker to conduct research beyond the pure pursuit of knowledge.
"You've seen a big shift at universities, the best example in town being Penn, which historically have been taking NIH money and doing a lot of research but without commercializing those technologies," said Chris Molineaux, the leader of Pennsylvania Bio, the biotech advocacy group. "But now, NIH funding has been down and big pharmaceutical companies need the technology, so the universities are changing their approach and doing more commercialization."
Recent history is replete with cases in which academic researchers have gotten close to industry and reaped large sums for questionable work, to the dismay of some patient advocates. So is getting closer a good idea?
"Intuitively, you might think that a frequent and more intimate relationship might be more a concern," said Josephine Johnston, research director at the Hastings Center, an independent bioethics research institute. Disclosure of the relationship is key in any partnership, along with not giving a veto to releasing the results, she said.
GlaxoSmithKline vaccines chief Moncef Slaoui said that at the height of employment, GSK had 16,000 scientists in a world with 1 million life scientists. GSK's scientists were as good as any, Slaoui said, but the simple math said a lot of good ideas were generated elsewhere. Partnerships are a way to gain access to those ideas.
Bayer AG signed a partnership deal in June with Johns Hopkins to study eye diseases. Chris Haskell, head of Bayer's science hub in San Francisco, said new deals are "more structured," with specific goals, milestones, and communication, than in the past, when "there wasn't a high level of engagement and I don't think it paid off very well."
Haskell said, figuratively, that a drugmaker's experiment must be done four times, not one, so that if the idea doesn't work, such outcomes are clear earlier. But professors need to publish to get tenure.
"Academics often have an approach where they are trying to get to 'yes,' " Haskell said. "They will follow a path of research so they can build a story around it to publish. In pharma, we say 'no' and the default is 'it's not going to work' or 'show me why it will.' "
Drug companies and prominent academic centers say partnerships are increasing, but that might be only with key institutions. BioCentury Innovations reported in February that public-private partnerships dropped overall in the past two years, though the numbers varied.
Meanwhile, the nonprofit Children's Hospital of Philadelphia used its gene therapy research to spin off a for-profit company, Spark Therapeutics, in 2013. In May, GSK created a joint venture with the University of North Carolina to develop new HIV medicine.
Janssen, a subsidiary of Johnson & Johnson, created a "Germinator Project" by funding the nonprofit BioStrategy Partners, which pays for early-stage research at Temple University, Thomas Jefferson University, Penn State Hershey Medical Center, Lankenau Medical Center, and the Wistar Institute.
Dan Baker, a Janssen vice president and the rheumatoid arthritis disease area leader, said part of the change is driven by advances in science in the last five years. "It's hard to keep up with all of it and have all that capability in house," Baker said. "The other change is the willingness of universities to collaborate."
Plaque psoriasis, the most common form of the disease, affects 125 million people worldwide. It shows up as red, scaly patches on the skin. J&J had $8.9 billion in sales in 2014 from two drugs, Remicade and Stelara, approved for treating plaque psoriasis.
That interest, and an adjunct Penn professor working at Janssen, led them to Grice. She and her crew study the microbiome, composed of trillions of cells, living and nonliving, and how they affect skin.
Her nine-member lab is comparing the bacteria that live on normal, healthy skin with those that exist where psoriasis has begun to appear.
Months of negotiations between Penn and Janssen led to a contract that paid about $100,000 for the work, plus a 60 percent overhead charge for Penn, a fee that some companies seeking Grice's expertise won't pay.
"It's set up in a way that I had certain milestones to meet," Grice said. "If I complete it, I send them a report. They give me another chunk of money."
Janssen's study is the only corporate project among the 10 underway in Grice's lab. Most of her money still comes from NIH, which gave her $1.59 million for three projects in the last four years, the NIH database shows.
With Grice's guidance, Janssen must collect skin samples from six to eight body parts from about 100 patients, five or six times during a 112-week period. Janssen isolates the DNA in its labs, and then ships samples to Grice's lab.
In April 2014, the first 3,000 samples arrived and are kept in a freezer.
"Usually, it's them wondering what's taking so long, but I guess that's true of people when they are not familiar with the set of procedures or the delays you can experience, like the reagent enzyme that is on back order," Grice said.
She has several years to go and acknowledges that Janssen has final say on any publication. She says she hopes Penn's new emphasis on partners means her Janssen project will count with the tenure committee. Janssen sent its money to Penn because Grice works in "a little niche," occupied by few other researchers and "I do a good job in that niche," she said. "The university should be happy about this kind of partnership. It is a chance for their scientists to engage in great work that might not be possible otherwise."