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Investment in business development pays dividends for research, patients

Fred Hutch tech transfer specialists help scientists navigate path to bringing innovations to patients
Dr. Matthias Stephan in his laboratory at Fred Hutch.
Dr. Matthias Stephan in his laboratory at Fred Hutch Photo by Robert Hood / Fred Hutch News Service

The gleaming skyscrapers towering along Park Avenue always seemed opaque and out of reach to Dr. Matthias Stephan during his graduate student days in New York City.

“I remember walking along, looking up, wondering what went on inside,” the Fred Hutchinson Cancer Research Center bioengineer recalled.

Stephan assumed that whatever the busy employees did at the banks of computers stretching behind those acres of glass would remain a mystery to him. But more than a decade after receiving his Ph.D., he found himself in a swiftly ascending elevator, rising over a sweeping view of Central Park.

The academic scientist had developed nanoparticles that he hoped would someday quickly and easily engineer anti-cancer immune cells inside patients, and he needed an industry partner to get his tiny tech out of the lab and into the clinic. Like more and more researchers, he was about to begin a crash course on how science and financial investment connect. 

Industry: a new world for scientists

Scientists are trained in making discoveries, not in writing patents, scoping out business opportunities or making connections with venture capitalists. Though Stephan would ultimately co-found the biotech startup Tidal Therapeutics (later bought by pharma giant Sanofi) to commercialize his nanoparticle immune-cell engineering approach, when he first envisioned bringing his technology to patients, he barely knew where to begin.

Fred Hutch business development staffers guide researchers at every step, said Hilary Hehman, Fred Hutch’s associate vice president of strategic partnerships.

“We keep an eye on the entire Hutch [scientific] system,” she said. Different business development teams support the patent-writing and -filing process, identify market opportunities and potential customers, and help researchers connect to industry partners to license technology or even create a biotech startup.

The Hutch’s desire for a stronger focus on technology transfer was inspired by the 2013 launch of immunotherapy-focused biotech company Juno Therapeutics, now a Bristol Myers Squibb company. A joint effort between Fred Hutch, Memorial Sloan Kettering and Seattle Children’s Research Institute, Juno secured $120 million in funding, making it one of the largest biotech launches in history. In 2018 Celgene Corporation acquired Juno for $9 billion.

“The organization recognized the value of that win,” Hehman said.

A steady pipeline of successful biotech ventures, whether new spinouts or licensing deals to established companies, could provide a reliable research-supporting revenue stream alongside grants from the National Institutes of Health and philanthropic donations. To get there, the Hutch “hit refresh” on its business development strategy, Hehman said.

Following the Juno launch, previous Hutch President and Director Dr. Gary Gilliland brought on Dr. Niki Robinson, who now oversees all strategic planning for the center, with the goal of strengthening the flow of the institution’s business-development deals. Robinson fundamentally rebuilt the Hutch’s strategic approach to technology transfer and pipeline curation, Hehman said.

As part of her restructuring, Robinson aimed to create an externally facing team specifically focused on building recognition of the Hutch’s innovation pipeline in the venture, pharma and biotech communities. She recruited Hehman to build and lead this team five years ago.

Initially, the external business development team’s main focus was overcoming hesitancy from industry insiders who respected the Hutch’s scientific bona fides, but erroneously assumed that its development pipeline would automatically funnel to Juno.

“Once people in the venture community realized we’re definitely open for business with anybody — East Coast, West Coast, global — they literally started showing up at the door. The floodgates opened,” Hehman said.

Graph of Fred Hutch startups, high-value deals and total licenses over two five-year periods (FY12-16 and FY-17-21), showing the jump in metrics during the FY17-21 period.
Fred Hutch's revamped business development approach paid off in the number of startups, high-value deals and licenses garnered during the five-year period starting in 2017. Illustration by Ro Ocampo / Fred Hutch News Service

The Hutch’s revamped approach was guided by two leaders with deep expertise spanning academic, clinical and translational research: Gilliland and current President and Director Dr. Tom Lynch, who took the helm at Fred Hutch after stints at the Yale Cancer Center, Massachusetts General Hospital and Bristol Myers Squibb, where he was chief scientific officer.

“The world benefits from [a culture of commercialization],” said Lynch, who is participating in small-format conversations to build a network between the Hutch and interested industry partners. “Patients benefit, the Hutch benefits, the research benefits. And so I want to incentivize that culture.”

Stephan lauded the business development team for their expertise and protective instincts. Their specialized knowledge was invaluable during the time-consuming patent-writing and filing process, and they helped defend him against investors who would rather pick his brain for their own purposes than partner to advance his ideas, he said.

The process “gave me visibility into the corporate side,” said lymphoma researcher Dr. Brian Till about the Hutch’s revamped business development office. Till developed an immune-cell engineering approach to target a molecule common to certain blood cancers and worked with Hehman’s office to patent his approach and license it to Mustang Bio, which is now testing it in a clinical trial.

Stephan said his experiences presenting to potential financial backers have helped him better understand how they (and the U.S. Food and Drug Administration) assess potential therapeutic innovations. He now considers how to avoid overengineering a product and how to manufacture it at a large scale while keeping it affordable.

“You see the world differently,” he said. “There’s less focus on what to publish, more on what’s feasible to translate to patients.”

Startups bar graph
High-value deals bar graph
Fred Hutch's revamped business development approach paid off in the number of startups, high-value deals and licenses garnered during the five-year period starting in 2017.
Fred Hutch's revamped business development approach paid off in the number of startups, high-value deals and licenses garnered during the five-year period starting in 2017. Illustration by Ro Ocampo / Fred Hutch News Service

The Hutch’s revamped approach was guided by two leaders with deep expertise spanning academic, clinical and translational research: Gilliland and current President and Director Dr. Tom Lynch, who took the helm at Fred Hutch after stints at the Yale Cancer Center, Massachusetts General Hospital and Bristol Myers Squibb, where he was chief scientific officer.

“The world benefits from [a culture of commercialization],” said Lynch, who is participating in small-format conversations to build a network between the Hutch and interested industry partners. “Patients benefit, the Hutch benefits, the research benefits. And so I want to incentivize that culture.”

Stephan lauded the business development team for their expertise and protective instincts. Their specialized knowledge was invaluable during the time-consuming patent-writing and filing process, and they helped defend him against investors who would rather pick his brain for their own purposes than partner to advance his ideas, he said.

The process “gave me visibility into the corporate side,” said lymphoma researcher Dr. Brian Till about the Hutch’s revamped business development office. Till developed an immune-cell engineering approach to target a molecule common to certain blood cancers and worked with Hehman’s office to patent his approach and license it to Mustang Bio, which is now testing it in a clinical trial.

Stephan said his experiences presenting to potential financial backers have helped him better understand how they (and the U.S. Food and Drug Administration) assess potential therapeutic innovations. He now considers how to avoid overengineering a product and how to manufacture it at a large scale while keeping it affordable.

“You see the world differently,” he said. “There’s less focus on what to publish, more on what’s feasible to translate to patients.”

Hilary Hehman
Hilary Hehman leads Fred Hutch's externally facing business development efforts. Photo by Robert Hood / Fred Hutch News Service

Bridging the gap between bench and bedside

Stephan began developing his nanoparticles with cancer patients in mind. He wanted to make engineering anti-cancer T cells — an expensive, time-intensive therapy — cheaper, quicker and more accessible.

Though Fred Hutch is an academic research center, this vision is integral to the Hutch’s mission, Hehman said.

“The whole mission of the organization is to not only research the foundations and mechanisms of cancer in order to understand it, but also to create innovative diagnostics, therapeutics, cell therapies to cure and manage the disease,” she said. “So [our office exists] in pursuit of that kind of translational therapeutic mission.

Though publicly funded institutes like Fred Hutch foster many lifesaving advances, it takes partnership with industry to ensure that patients benefit. Funding from the NIH or private foundations can only carry scientific advances so far, Hehman said. To reach patients, new therapies are generally approved by the FDA after proceeding through three stages of clinical trials.

As an academic research center, “We can't take anything that we've grown in-house much past Phase 2 clinical trials,” she noted. “We don't have large-scale, commercial-scale manufacturing. We don't have marketing teams that can take [new therapies] to market. We have to find partners to get from point A to point B, FDA approval and beyond.”

Phase 1 and 2 clinical trials help determine safe dose ranges for a treatment, identify its side effects and demonstrate some efficacy against the disease it’s been developed to treat. They include tens to a couple hundred participants at most, requiring a smaller investment in participant enrollment, monitoring and manufacturing of the experimental treatment. Phase 3 trials are designed to confirm the efficacy and safety of a therapy by testing it in several thousand patients. They require more resources, including manufacturing an experimental therapeutic at a much larger scale than most research centers can support.

In contrast, pharmaceutical companies have the resources to produce new therapies in large quantities, enroll thousands of patients in far-flung locations, and monitor their progress.

Typical grant funding is also more focused on hypothesis-driven research than on technology- or methods-driven research, said computational biologist Dr. Raphael Gottardo, who directed the Hutch’s Translational Data Science Integrated Research Center and held the J. Orin Edson Foundation Endowed Chair until leaving the Hutch in July 2021 to lead a new center in biomedical data science bridging at the University of Lausanne and Lausanne University Hospital in Switzerland.

“In academia, we build methods or computational tools to answer specific biological questions,” said Gottardo, who founded Ozette Technologies Inc. to create analytical tools for revealing meaningful patterns in large, complex biological datasets. Such patterns could be used to identify new drug targets or better understand why certain therapies work in some, but not all, patients.

“But going beyond having a set of tools that are usable by the research community to a tool that is production-level, that we can commercialize, that is easily usable by someone with no computational skills — that’s much harder to do,” Gottardo said.

The financial and personnel resources offered by industry can take new therapies, methods and technologies further. The Hutch’s business development group bridges this gap. 

‘You see the world differently. There’s less focus on what to publish, more on what’s feasible to translate to patients.’

Dr. Matthias Stephan, Clinical Research Division

Till’s and Stephan’s paths illustrate the two major options facing researchers who hope to translate their work into lifesaving clinical advances. Till was approached by two companies interested in licensing his technology, and Fred Hutch’s business development team helped him determine that Mustang Bio would be the better option.

Scientific advisors at Mustang gave recommendations, including thoughts on how to tweak his approach to improve the manufacturing process of the cell therapy once it needed to be produced in large quantities, but also provided plenty of flexibility to Till and Hutch colleague Dr. Mazyar Shadman, who is leading the clinical trial, Till said.

By spinning out his own company, Stephan had more control. He worked very closely with Business Development through the whole process. With Ulrik Nielsen, the president and CEO of Tidal who was already experienced in building biotech companies, he could decide in which diseases Tidal would initially test his nanoparticles. Hehman’s office helped ensure that the intellectual property that Stephan had developed would be appropriately transferred to his new company.

The new, more proactive approach instigated by the revamped business development office is paying off, Hehman said, pointing to Tidal’s recent acquisition and several other Hutch spinouts that are preparing their initial public offerings. These successes are attracting more venture capital interest in the Hutch and what its scientists have to offer, she said.

It won’t happen overnight

Founding a successful new company can have its drawbacks for a young academic who needs to conduct research and publish insights to advance their work and career. But the Hutch is committed to encourage a culture of commercialization, top leadership said.

While publication of scientific findings will remain important in scientific career advancement, Lynch said that academia will continue to develop a wider view of what makes a scientist successful.

“I think there will probably be more fluidity in the other things we think of as being contributions to academic medicine,” said Lynch, who holds the Raisbeck Endowed Chair.

The amount of work it takes to spin out a company was eye-opening, even for researchers accustomed to long hours writing grants and carrying out difficult science. Rather than greeting enthusiastic scientists with buckets of money, investors ask hard-headed, difficult questions.

The time and effort involved in crafting pitches and answering investor questions initially surprised Stephan, who compared the process to writing an NIH R01 grant, in which researchers lay out a complex research program across over 100 densely written pages.

It helps to pick the right partners to work with, Gottardo said, since they’ll be the ones building the team and building on the groundwork laid in academia. 

Man in lab coat looks at 96-well plate.
A licensing agreement with Mustang Bio made a clinical trial of Dr. Brian Till's cell-based cancer immunotherapy possible. Photo by Robert Hood / Fred Hutch News Service

Researchers need to approach the process with reasonable expectations, Till noted. Mustang, like other biotech companies, “doesn’t have infinite money and needs to be a good steward of its resources,” he said.

At a certain point, scientists hand over their ideas to teams with the resources to see them through to the clinic. While Till, Stephan and Gottardo all continue to provide scientific advice to the companies handling their technologies and tools, much of this is out of their hands now.

While it can be hard to let go of a beloved discovery, for the most part, it’s a deal they’re happy to make. The researcher can leave the scaling up, testing and marketing to the experts, able to focus again on their first love: making scientific innovations.

Looking to the future

Many of Fred Hutch’s business deals to date have centered on cellular immunotherapies for cancer. But the Hutch is fortunate to have a wide range of research that could be commercialized. Hehman and others in business development are working to foster other entrepreneurial areas at Fred Hutch, keeping their eyes on trends in the greater scientific community.

“Fred Hutch is different from other academic organizations,” Hehman said. “We have uniquely situated expertise in cell therapies, and immuno-oncology cell therapy happens to be the most exciting thing. But we have a deep bench and upcoming junior researchers.”

There’s still room for growth, Gottardo noted. Biotech-focused business development has historically been tailored to bringing new treatments to patients, not develop methodologies to parse complex datasets. But Gottardo was able to capitalize on Seattle’s position as the hometown of several major players in the cloud computing and computational analysis to make connections with industry partners interested in launching a company to create analytical tools for biologists.

Hehman agrees that computational biology tools and technologies are a growing trend, as are identifying new treatment targets and resolving their structures (and computational tools facilitate both research areas).

She also expects new discoveries and technologies that accelerated during the COVID-19 pandemic will be repurposed to attack other viruses, attracting venture capital that had previously been reticent to dip its toes into infectious disease research.

Perhaps foremost in her mind is maintaining the momentum she and her office have built in the last few years. Many Hutch spinouts have attracted $70-$100 million in Series A funding — the funding that a startup can attract after it’s shown growth and revenue-generating potential — within a year of their founding, Hehman noted. And the connections Hutch business development staff have made have placed Fred Hutch in a position to broker connections between other investors, enabling deals that draw on the strengths of different venture capital firms.

“We can help them create syndicates and bring multiple VCs to table,” she said. “We can now leverage that to make bigger deals, based on our track record. … We’ve set very high expectations.”

Sabrina Richards, a staff writer at Fred Hutchinson Cancer Research Center, has written about scientific research and the environment for The Scientist and OnEarth Magazine. She has a Ph.D. in immunology from the University of Washington, an M.A. in journalism and an advanced certificate from the Science, Health and Environmental Reporting Program at New York University. Reach her at srichar2@fredhutch.org.

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Last Modified, September 21, 2021