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Lessons learned from a small university seeking to commercialize a big discovery

A Laurentian University lab has made a chance discovery that may lead to better breast cancer therapy.

BY STEPHEN STRAUSS | FEB 12 2014
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Baoqing Guo and Amadeo Parissenti in their lab at Laurentian. Photos by Joanne Ratajczak.

It was November 2009, and Gisele Roberts and Amadeo Parissenti were running out of time. Ms. Roberts, a technology transfer agent at Laurentian University, and Dr. Parissenti, a biochemistry professor at the university, had the blueprint for a potentially game-changing medical test that could reveal which breast-cancer patients, relatively early in their treatment, faced no hope of being helped by chemotherapy.

The test was based on a chance discovery by Dr. Parissenti. However, the temporary patent for Dr. Parissenti’s discovery was set to expire by the end of February 2010, and the two needed to raise more money to file a new patent application. If the patent expired, the diagnostic test based on Dr. Parissenti’s discovery would no longer be patentable in most parts of the world and would therefore lose any commercial value.

Laurentian University had never licensed a discovery before, and the neophyte Ms. Roberts was the university’s sole technology transfer agent; she didn’t have the connections to drum up the funds they needed. Complicating matters was the venture-capital drought brought on by the world financial crisis in 2008. What came next was a series of events that exemplify the often disjointed world of technology transfer and which may serve as a primer for other smaller-sized universities in the same situation.

As it happened, Marc Castel, director of commercialization with the Ontario Centres of Excellence, was arriving in Sudbury that week for a routine visit to the area to talk about tech transfer. Ms. Roberts and Dr. Parissenti “crashed” – in Dr. Parissenti’s words – Mr. Castel’s get-together to make their pitch. Their presentation was so intriguing to him that talks continued over dinner at a restaurant.

When Mr. Castel learned about the medical discovery and the urgency involved, things jumped into high gear. From the restaurant he called John Connolly at York Medtech Partners, a firm of angel investors in Toronto, telling him the Ontario agency would provide half the money if his company and Laurentian could come up with the rest – in total, about $50,000.

A week later, Ms. Roberts was at a meeting with Mr. Castel in Toronto when his phone rang. “He picked it up,” she remembers, “and said, ‘It’s John Connolly’ and handed me the phone.” Mr. Connolly told her he was interested. That conversation led to others, and by January they had come to an agreement in principle. “I was over the moon,” recounts Ms. Roberts. “This is a technology that I really believed in and wanted it commercialized for the benefit of society.”

The group applied for a patent in the United States and other countries, and in March 2010 they had incorporated a new Toronto-based company, Rna Diagnostics Inc., to market the technology. But their journey down the road of commercialization had only just begun and would take some unexpected swerves along the way.

Three years earlier, in 2006, Dr. Parissenti is in his laboratory at Laurentian, examining some malignant breast-tumour samples that had been gathered from across the country for a chemotherapy research project. His goal is to see whether he can identify any genetic differences that might help explain why 75 percent of breast-cancer patients receive no life-extending benefit from chemotherapy treatment.

The samples have been stored for up to four years, so his first task is to make sure the samples haven’t started to deteriorate while they were in storage. The standard way to do this in tissue is to look at the integrity of ribonucleic acid, or RNA; it, along with DNA, helps to regulate the gene-based operations of cells.

But, when Dr. Parissenti’s lab partners start to examine the RNA, an unexpected result keeps turning up: in some tissue samples, the RNA collected in the middle of the cycle of chemotherapy treatments is increasingly degraded, presumably due to the chemotherapy; in other samples collected at the same mid-point in the cycle, the RNA is highly preserved. After checking and rechecking their results, Dr. Parissenti and his research associate Baoqing Guo rule out contamination or any problem related to sample collection and storage. Theoretically, all the RNA samples should have begun to degrade from chemotherapy by mid-stage of the treatment, so why had some samples stayed intact?

Then a glimmer of a possible explanation dawns on Dr. Parissenti and Dr. Guo. Perhaps the differences in RNA integrity are indicating something essential about the ultimate future effectiveness of chemotherapy in these patients.

Dr. Parissenti selects the 10 best-conserved RNA samples, which he knows only by patient number. He phones Maureen Trudeau, a physician at Sunnybrook Hospital in Toronto who is heading the chemotherapy genomics trial for the National Cancer Institute of Canada. “I said to her, ‘I am just curious, but is there anything in common amongst the following patients?’” recalls Dr. Parissenti. “And then I gave her the patient ID numbers. She grabbed the charts and then said, ‘Oh, my god, how did you do that? You have identified the patients that are all faring quite poorly.’”

In hindsight, looking for RNA integrity during chemotherapy seems an obvious first step in determining who eventually will respond to the therapy – a “no brainer,” says Dr. Parissenti. Indeed, his first instinct was that surely somebody had already noted this connection, and thus his team’s discovery was probably no big deal. But, when he searched both the scientific and patent literature, he found everyone had overlooked the obvious.

Since then, there has been a rapid expansion in research to find out what it is in RNA that might explain its connection to chemotherapy’s success or failure in breast-cancer patients, and to verify the results. Rna Diagnostics Inc. – the company formed to commercialize the discovery – now has 10 employees and is working towards marketing an RNA-based assay that can tell doctors midway or earlier in the chemotherapy cycle which of their breast-cancer patients will benefit from the treatment and which ones will not. In addition to saving a patient from needless suffering related to chemotherapy treatment, this knowledge should also save money. Dr. Trudeau estimates each chemotherapy cycle in Canada costs roughly $10,000, and there can be up to eight cycles depending on the drug being given.

Dr. Parissenti, meanwhile, has added a few more titles to his CV, starting with chief scientific officer of Rna Diagnostics. He also has new affiliations with the University of Ottawa and several hospitals. The change of circumstances still surprises him: “I didn’t ever think of the idea of being associated with a company,” he says. “What I always knew is that I wanted to do research as a professor and do that for the joy of discovery.”

That joy, however, is now tempered by the fact he’s a major shareholder and officer in a company, with all the responsibilities that entails. Similarly, his enthusiasm for this new adventure is tempered by the many, sometimes difficult, lessons that he and the university have learned along the way. Here are some of them.

Lesson One: Your research colleagues may distrust you

Dr. Parissenti says his research results are now seen by colleagues as intrinsically suspicious because of his connection with Rna Diagnostics. For example, when his laboratory found a correlation between RNA integrity and chemotherapy success in ovarian cancer, they had an independent statistician check the results. But that wasn’t sufficient for the National Cancer Institute of Canada, which wouldn’t accept the validity of the results until the institute’s own statistician analyzed the data independently, says Dr. Parissenti. He speculates that because he now has shares in the company, “some think I am the last person to trust on anything related to RNA degradation.”

Even when collaborators are less mistrustful, they chafe at the publishing restrictions that arise from the commercial connection. “We don’t have the same level of freedom as before,” Dr. Parissenti acknowledges. He and his students are required to show Rna Diagnostics a draft of any paper they’re submitting for publication. The company has three months to decide whether to apply for a patent on the findings in the paper. If the company doesn’t act, then the academic researchers may get the paper published as is.

The backdrop to their experiences with colleagues is that Laurentian University isn’t known for a culture of commercialization in the way, for instance, that the University of Waterloo is. Ms. Roberts, who carried the spear in Laurentian’s licensing of the RNA finding, says that some professors she encounters “refer to commercialization as ‘the dark side’.”

Lesson Two: You need to keep your findings very, very secret

In 2010, the university’s alumni magazine Laurentian published a 290-word synopsis of Dr. Parissenti’s work, concluding with this sentence: “Now Parissenti is teaming up with Carita Lanner at Laurentian’s Northern Ontario School of Medicine to expand this work to ovarian cancer tumours.”

Those seemingly innocuous words have, three years later, become potentially toxic to Rna Diagnostics’ business plan. The patent applications that the company is filing around the world posit the idea that the tests might prove useful on both breast and ovarian cancers. Someone in the European Union trolled the Internet and found that throw-away sentence in the Laurentian story and, as a result, the EU is saying that the patent application for ovarian cancer tests should be denied because it’s already on the public record.

“I didn’t even provide data about anything – the type of patients being assessed or what type of ovarian cancer we were looking at,” says a rueful Dr. Parissenti. “One of the things that I and Gisele and Patrice (Laurentian’s vice-president, research, Patrice Sawyer) had to learn is that when these things end up on the Net, you are essentially giving away IP.” Dr. Parissenti now reviews any presentation his students plan to make – even a talk for biology research day at Laurentian – to check for statements that could void a potential patent.

In practice, it’s hard to do: censoring yourself all the time requires a huge switch in the mindset of academics and of universities in general. “Academic institutions are traditionally very leaky creatures in terms of confidentiality,” says Adi Treasurywala, a partner in a firm that links Canadian inventors and discoverers with three large international companies looking for concepts to invest in; he is one the individuals who advised Dr. Parissenti and Ms. Roberts on how to proceed in commercializing their discovery.

Lesson Three: Your students are now like contract employees

Once Rna Diagnostics existed, the question of who owned the intellectual property rights the company was trying to exploit became paramount. Laurentian – similar to about a third of Canadian universities – allows the discoverer or inventor to own their discovery or invention. But it didn’t, and still doesn’t, have a policy that defines the students’ and research associates’ ownership stakes.

Dr. Parissenti decided that his research associate, Dr. Guo, was entitled to a share of the benefits and chose to divide royalties from Rna Diagnostics and other financial benefits with him, but that was Dr. Parissenti’s choice. Nowadays, with students who work in his lab, he uses a four-page legal agreement on “confidential information, ownership of intellectual property and invention assignment” that Rna Diagnostics drew up, based on a contract developed at the University of Waterloo. New students joining Dr. Parissenti’s lab have to sign it.

This has turned him into a hybrid of mentor, lawyer and business owner in his relationship with graduate students. “I go through everything and every clause. I give my interpretation of them. They are also told that they should be free to consult their own lawyer or whoever they wish,” says Dr. Parissenti.

Perhaps not surprisingly, none of the three students interviewed for this article had checked with any legal expert and instead relied on Dr. Parissenti’s good faith before signing the agreement. Overall, they seem happy with the commercial angle in their studies. “I look at it as a positive,” says master’s student Aoife Cox, “because you get exposed to academia by being involved both in the university and in the private sector.”

Even so, some intrinsic conflicts may remain, says Carol Miernicki, a patent agent in Kingston, Ontario, and former vice-president of intellectual property at PARTEQ Innovations, the tech-transfer office of Queen’s University.

“The student is counting on using that research to further his or her own career,” she says. “He wants to publish it; he wants to use it in his PhD thesis.” As a result, students may feel pressured to accept an agreement they don’t entirely agree with; some students may not fully understand what they are signing. “Maybe they come from a country where you just don’t say ‘no’ to a professor.”

Lesson Four: Seek help – steep learning curve ahead

Ms. Roberts admits she had to learn about tech transfer on the fly. That meant consulting with and questioning everyone she could find who had more experience then she had. “I just called a lot of people,” she says, laughing at her wondrous “technique.” Those people regularly included Dr. Miernicki and Dr. Treasurywala, who was formerly chief operating officer of the University of Toronto’s Innovation Foundation. She also talked to people at other small institutions that may have faced some of the same hurdles – for instance in Sudbury, Ontario, where Laurentian is located, there are no patent agents.

Dr. Parissenti, too, embraced the need to learn from others. “The first thing Amadeo said when I met him was, ‘I don’t know anything about business. Can you help me?’” says Dr. Treasurywala. “His humility and his discipline made him an ideal candidate to promote his ideas.”

Others concur that the personal connection is paramount. “It always boils down to people,” says Scott Inwood, director of commercialization at the seven-person commercialization office at U of Waterloo. “When I work with a faculty member who I sense is not ‘mentorable,’ who wants to drive the business and has no business experience, I am much less motivated to take on that technology.”

A final lesson for universities – and for their business partners – is that if they choose to take the licensing risk, they need to accept that they may fail. But that doesn’t mean they or their scientists are failures. “You know what? For our first licence, it has worked out phenomenally well,” Ms. Roberts reflects. “I have had a lot of people say to me, ‘Wow, that doesn’t usually happen.’”

PUBLISHED BY
Stephen Strauss
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