'Valley of death' bridged? Biopharma, academia look to 'real-world' solutions

PHILADELPHIA – For decades, young biotechs have circled the so-called "Valley of Death," trying not to fall into the funding chasm that can occur during the period between discovery and clinical proof of concept – the critical milestone when most venture capital (VC) firms are willing to get on board. But Ofra Weinberger, director of Columbia Technology Ventures at New York's Columbia University, made an intriguing observation at the conclusion of a panel she facilitated Tuesday at the BIO International Convention in Philadelphia.

Ten years ago, Weinberger recalled, academic start-ups were fixated on how to cross the Valley of Death before they could partner or attract VC dollars. Today, the term has almost dropped from the vernacular. The question is whether that's due to wide-eyed optimism or to win-win partnerships between academic researchers and biopharma. Evidence suggests the latter is more the case, she said, and data from a BIO-commissioned study by the Battelle Technology Partnership Practice (BTPP) suggested that translational research is, indeed, gaining traction.

Mitch Horowitz, vice president and managing director at BTPP, introduced the data – the first comprehensive measurement of current industry-academic collaborations, according to BIO – by observing that the report, Advancing Translational Research for Biomedical Innovation, offers an opportunity to "step back" and consider the framework for translational medicine in the context of current drug development efforts. Before the launch of the National Institutes of Health Roadmap in 2004, "I don't think many of us even thought about translational research," he acknowledged. That initiative forced academic researchers and biopharma to realize that "we cannot move biomedical innovation forward on the scale that's needed to solve challenges facing patients without actually recognizing that industry and academic partnership is possible."

It's taken a decade, but early efforts are beginning to bear fruit. Among the key findings in the report:

• In 2013, direct funding of university biomedical-related research by biopharmas represented 49 percent of industry-funded university research, topping $1.73 billion or just over 5 percent of university biomedical-related research.

• Joint industry-academic publications – those involving a university, hospital or research institute – in biomedical-related fields grew by nearly 23 percent between 2004 and 2014.

• Industry patents that cite academic research articles increased from 27,549 during the period from 2000 to 2004 to 49,997 during the period from 2010 to 2014, or a growth of 81.5 percent. In contrast, the overall growth rate of biomedical industry patents was just 59.7 percent between the two periods.

• One in eight industry-sponsored trials now has an academic institution as a co-sponsor or collaborator.

• Between 2010 and 2014, 93 percent of drug-related new chemical entities (NCE) and biologics that were associated with patent-protected intellectual property cited academic research, compared with just 64 percent of NCEs and 79 percent of biologics launched between 2000 and 2004 that cited academic research.

"We tried to come up with measures that crossed over sectors" to define the "real-world" context of developments that are occurring in industry-academic collaborations, Horowitz explained.

In terms of indications, neurology had the greatest increase in joint industry-academic publications over the past decade, at 118.9 percent. That finding did not surprise Melinda Richter, head of Johnson & Johnson Innovation JLABS, who observed during the panel that industry and academia must work together "in some of these very large areas, like schizophrenia or Alzheimer's, or it's going to be a very long time before we solve the problem."

Other disease indications with large increases in joint publications over the past 10 years included rheumatology (100.8 percent), metabolism and nutrition (94.6 percent), hematology (71 percent), gastroenterology (68.7 percent) and ophthalmology (62 percent).

Biopharma still recognizes a raft of "very real challenges," Richter added, citing issues such as privacy, competition, ethics and informed consent, but "but our job is to scout out the science, no matter where it exists, and help give it the tools to accelerate," she said.

SEEKING TO BE 'THE SILICON VALLEY OF HEALTH CARE'

The report suggests that multi-institutional and multi-company collaborations as well as open innovation models predominate among academic-industry partnerships. Among the former, the Tuberculosis Drug Accelerator Consortium, which consists of seven pharmas and four research institutes, is seeking to develop five preclinical drug candidates. The Asian Cohort Consortium, based in Seoul, is bringing partners from the U.S. and Asia together to identify markers of early disease based on genetics, environmental exposure and disease etiology. And through the Strategic Pharma-Academic Research Consortium for Translational Medicine, the University of Indiana, Washington University, Ohio State University and Northwestern University are working with Eli Lilly and Co., of Indianapolis, and Takeda Pharmaceuticals USA, of Deerfield, Ill., to advance research on autoimmune diseases.

Open innovation models, typically sponsored by individual companies to reduce barriers to academic collaborations by reducing red tape and up-front negotiations, also are growing in popularity, according to the report. Although these processes involve a higher level of confidentiality, biopharmas are using them to provide academic researchers with a range of assistance that might include direct grants, access to research tools and equipment and actual collaboration with company scientists. Lilly, Astrazeneca plc and Glaxosmithkline plc, both of London, and Merck and Co. Inc., of Kenilworth, N.J., are among the companies with formal open innovation programs.

Craig Wegner, executive director of the translational science emerging innovations unit in Astrazeneca's Scientific Partnering and Alliances, observed that "many more products that are coming to market are inventions that are happening outside the walls of pharmaceutical companies," and, he added, "that's the future."

Industry-academic collaborations are helping in another way, Wegner pointed out, as greater sharing of data across consortia are helping to reduce duplication of effort instead of having "four, five or six pharmaceutical companies failing with the same mechanism in the same disease."

In addition, Astrazeneca is among the pharmas that are providing academic collaborators with approved compounds as well as candidates that failed late-stage trials "to test new hypotheses and see if they might potentially yield new treatments," Wegner said. The company has 19 ongoing studies, mostly funded by public agencies, to test molecules in its pipeline in new indications.

Despite the increased willingness of biopharma and academia to work together, it's still not a perfect world.

"We've done some of the easy stuff," said Stephen Klasko, president and CEO of Thomas Jefferson University and Jefferson Health System. "Everybody says they want to look at things differently, but we haven't necessarily been willing to change the way we do business."

Some of the biggest disconnects remain on the academic side, he admitted, starting with the failure by most institutions to develop and promote faculty members who want to engage in entrepreneurial activities.

"If you're a faculty member at a traditional academic medical center and you work on inventions, you're not going to advance," Klasko told BioWorld Today.

Under the current system, even researchers who discover a technology that results in an approved drug and then seek promotion at their institution "get reviewed by 17 67-year-old biochemists who say, 'I don't see you in Science and Nature,'" he pointed out. No matter that those academics may be writing for Harvard Business Review or Wired, "they'll be rejected," he said.

To combat that mentality, Jefferson recently created a tenure track around entrepreneurship as part of an "innovation" pillar that carries equal weight with the traditional "academic" and "clinical" tracks as well as a newer "philanthropic" pillar designed to facilitate collaborations with nonprofit research and patient advocacy organizations.

Klasko also lamented the fragmentation of health care, which he said prevents the coalescence of competing organizations within given regions.

"Everybody wants to be the Silicon Valley of health care, but nobody wants to do the hard things to be the Silicon Valley of health care," he said.

"Philadelphia is the perfect example. The DNA here is incredible. That's the good news. The bad news, as one of my colleagues said, is that 'All you guys do is beat each other up.'"

The fledgling CEO Council for Growth, which encompasses major corporations and institutions across northern Delaware, southern New Jersey and southeastern Pennsylvania, last month launched the Healthcare Innovation Collaborative to begin turning that tide. In addition to Jefferson, the founding members include Ben Franklin Technology Partners of Southeastern Pennsylvania, Children's Hospital of Philadelphia, Comcast, Drexel University, Independence Blue Cross, Safeguard Scientifics Inc. and the University of Pennsylvania Health System.

Long term, the sustainability of collaboration between and within academic and industry partners depends on their willingness "actually to exchange some fluids and not just be proud of the fact that you've done a joint venture or two," Klasko insisted. "As equal partners, we're sharing fluids now. What we haven't done yet is attract something like a Johnson & Johnson Innovation lab. At the end of the day, what J&J needs to see is not just that the individual DNA is here but that the DNA is coming together to create a new life force."

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