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Big Pharma and university scientists are hopeful that a wave of new research collaborations between the two will speed up the drug discovery process and help put new drugs on a relatively stagnant market.
Over the next two years, the patents will expire on some of the pharmaceutical industry’s most lucrative drugs, including the industry’s two top sellers for 2010 — Lipitor, a drug that treats high cholesterol, and Plavix, a blood thinner.
From the university end, government grant money could run dry as a result of the growing economic crisis. And the pressure on researchers to convert their findings into medical products is ever-increasing.
As a result, research collaborations between drug companies and universities over the past few years have become more common.
Most recently, Pfizer announced a new drug discovery collaboration with the University of California at San Diego in August worth more than $50 million over five years. The partnership offers researchers at UC San Diego access to Pfizer’s antibody libraries and technology, which the company hopes will speed up the drug discovery process. In turn, Pfizer will receive intellectual property rights.
A number of similar drug discovery research collaborations established over the past two years include partnerships between Gilead Sciences and Yale School of Medicine, Sanofi-Aventis and Columbia University Medical Center, and the University of Pennsylvania and AstraZeneca.
Although the relationship between Big Pharma and academia has existed for decades, this new wave of partnerships is different, according Dr. Glen Gaulton, executive vice dean and chief scientific officer at the University of Pennsylvania’s Pearlman School of Medicine, which is currently collaborating with AstraZeneca.
“Historically it was industry largely identifying what they needed exactly, be it research or trials, and then reaching out to established, distinguished labs or clinicians to collaborate,” said Gaulton. “Now they [pharmaceutical companies] are meeting with academic institutions and saying ‘We’re looking for a new approach in cardiovascular cures or Alzheimer’s disease.’ They are saying, ‘Work with us and work with our scientists in industry to help plan, at a more intimate level, where opportunities lie.'”
Dr. Joseph Schlessinger, Chairman of Pharmacology Department at Yale University, agrees. “Usually collaborations were much smaller; they funded a particular target,” he said. “There was nothing in the dimension of 10 million a year” — the amount Yale stands to profit from their collaborative partnership with Gilead Sciences, brokered in March of 2011.
According to Gaulton, these partnerships have become commonplace over the past three years. And although there is optimism about promising outcomes, there are also some potential risks.
Below, Dr. Kevin Schulman, Director of the Health Sector Management Program at Duke’s Fuqua School of Business and a professor of medicine answers our top questions about the nature, implications and possible ethical conflicts posed by the new collaborations.
NewsHour: Is this kind of arrangement a good thing for the public?
Shulman: One of the things that the public is complaining about is the dearth of new drugs on the market. To some extent this is an attempt to fill that pipeline. We have to get to the early science, see if it will be useful as a therapeutic and accelerate its development if we are going to bring new drugs to market. I think society is putting a lot more pressure on researchers to say, ‘Is this a discovery that has clinical importance and clinical significance?’ I think the pharmaceutical in this relationship is just another step in that evolution.
NewsHour: What effect does this have on university research?
Schulman: Big pharma has a lot of tools that would help research scientists. So if I, as a researcher, find I am very excited about something in discovery, but I don’t have a library of compounds to create a potential drug target, there are tools that pharma has developed over time that can help accelerate the research at the university. The other thing that’s different today are the financial pressures on the research community given the federal government budget issues. The National Institute of Health (NIH), where most medical schools get their research funding from, at best is going to have flat budgets if not potentially shrinking budgets. The universities are trying to understand if the government isn’t going to be there, how do they move these things forward from basic science to discoveries to cures?
NewsHour: How many of these university collaborations will lead to a big breakthrough?
Schulman: Pharmaceutical drug development remains a very risky business, which means that most of the projects that they do fail. These are all early stage discovery projects and they need thousands of these things to have a chance to have one drug on the market for a period of a decade or two. Like oil companies, like mines, they are prospecting. They want to make a lot of bets to try to find technologies out there that are potential candidates, because most of them will fail.
NewsHour: What are the potential risks to this set-up, for both sides?
Schulman: I think the best of the universities have been very burned over time by their relationships with industry. Hopefully they are better able to protect their rights. I have no qualms that pharmaceutical companies are very good at protecting their rights. If you don’t know how to craft an agreement so that you protect the rights, and the process, the independence, the publication and the scientific process then there is a risk to all of this. If I have a new discovery, I need to publish so that other people can find out about it. Historically, pharmaceutical companies would publish at much later stages. If I am developing a commercial product, I don’t want to tell anyone about that product until it’s ready to go to market. That is very different than what academia does.
NewsHour: Do you have specific examples of researchers being “burned”?
Schulman: I was at Georgetown University Medical Center when they had a relationship around neuroscience with an Italian pharmaceutical company that ended up going bankrupt after Georgetown had invested a lot in a whole series of infrastructure. Another really famous case was where an investigator did a clinical study that was sponsored by a manufacturer of a thyroid hormone, a drug called Synthroid, and the university didn’t have publication rights. When the investigator submitted to a medical journal, the sponsor made him pull it. I think that was a case where the university really learned the importance of protecting the academic freedom of investigators.
NewsHour: More broadly, does mixing cash from pharmaceutical companies with academic research pose an ethical dilemma?
Schulman: It depends on the contract. Some of them are not an ethical dilemma at all. The opportunity to take research and translate it into product is what we should be doing. The Bayh-Dole Medical Act tells us to do that; the public wants new therapies. The issue is whether commercial pressure on scientists limits the kinds of research they could do. So if I am in the lab and I make a discovery, one might move the science forward but one might move it to a commercial pathway. Which pathway do I choose? It could be an ethical dilemma. On the flip side, I think while that is theoretically possible, I am not sure in reality that happens that often. The idea is that people are driven by academic interest. The pursuit of science in real-world research is driven by the pursuit of grants, and a lot of criteria for successful grant investigation then is not that dissimilar to what pharma is interested in. Research these days is very expensive and hard to do. That is much more the paradigm than the idea that I am just pursuing knowledge for knowledge’s sake. It’s hard to get that grant funded.
NewsHour: So all and all, would you qualify this as a step in the right direction?
Schulman: At the end of the day, what the public wants from basic research is new products, and I don’t think there is anything wrong with being responsive to that. At some level it’s unfair for scientists paid by public and private money to get to set the agenda at their own time and own pace. Research is very expensive and it’s part of everyone’s responsibility to understand what products we are getting out of that research.