Industry/academic partnerships are changing from the traditional hands-off approach to true collaborative efforts that better utilize the expertise and resources of each group. By teaming best-in-class academic researchers with scientists skilled in drug development, life sciences companies expect to make advances that enhance their understanding of a drug candidate, streamline drug development, and quickly translate into the clinic.
“A decade ago, the term collaboration was a misnomer in discussions of industry/academic partnerships,” recalls Erik Halvorsen, director of the technology and innovation office at Children’s Hospital Boston. “Industry/academic research agreements were very hands-off for pharmaceutical companies, and the results weren’t as good as they could have been because neither side leveraged the expertise of the other. Neither party got enough out of the relationship.”
As funding for biotech dried up, “Genentech and others decided to build richer relationships with universities to create ideas around targets that can be developed,” notes James Sabry, M.D., Ph.D., VP of Genentech Partnering. “Universities themselves aren’t interested in drug development, but as their supplementary funding from grants decreases, they are becoming increasingly interested in work that allows them to apply their knowledge in a practical setting. Often, professors have identified novel targets involved in particular processes or have implicated a process in disease. Academics are good at identifying patterns we rely on, and we are good at identifying therapies to treat disease,” Dr. Sabry says.
To remedy this situation, several of the most forward-thinking life sciences companies are changing the traditional collaboration model. Here’s a look at how Bayer, Pfizer, and Genentech are creating a new era in industry/academic partnerships.
“We’re taking a much more collaborative approach to working with scientists at research institutions,” says Christopher Haskell, Ph.D., head, U.S. Science Hub, Bayer Healthcare U.S. Innovation Center. Last January, Bayer opened its U.S. Innovation Center adjacent to the Mission Bay campus of University of California – San Francisco (UCSF) to expand its collaborative relationships. “Our goal is for each organization to bring its bench strengths to a project that advances scientific knowledge and that leads us toward therapeutic breakthroughs. Both organizations share the risks and benefits, creating a balanced partnership as opposed to the more ‘purchased’ research format popular in the past few decades,” Dr. Haskell says.
The key to Bayer’s new Science Hub collaborative structure is a master research agreement between it and UCSF. As Dr. Haskell explains, the master agreement streamlines the legal process of establishing these types of working collaborations, allowing the industry and academic scientists with great ideas to begin their work more quickly.
“These collaborations are day-to-day research partnerships that bring scientists at both organizations together to work on a clearly defined project,” Haskell explains. Partners share the risks, costs, and benefits, leveraging the expertise and resources of each. Therefore, they must be committed to working together. And, he adds, “The collaborations work best when project objectives align with the missions of the organizations.”
To help ensure the projects are productive, the partners establish clear objectives as well as the roles and responsibilities of each organization. Additionally, lead scientists from each organization establish the project plan and meet regularly to ensure it stays on track. Haskell says, “Quick attention to any challenges also is vital to the project’s success.”
“About one year ago, we established the Centers for Therapeutic Innovation (CTI) to provide a different source of innovation,” notes Anthony Coyle, Ph.D., VP and chief science officer of Pfizer’s CTI. Pfizer sees the CTI as an opportunity to work not only with researchers who have pondered a specific scientific question in depth for many years, but also to work in translational medicine with university faculty who have strong ties to the clinic. “The CTI model doesn’t work for everybody,” Coyle notes. “It attracts individuals who want to ask questions in a clinical study, not just in a mouse model. Therefore, we build unique teams composed of basic researchers, clinicians, and Pfizer scientists.”
According to Coyle, the CTI is unique because of the breadth of expertise accessed. With CTI facilities in San Francisco, New York, and Boston, Pfizer is positioned to tap the expertise of some of the world’s foremost scientists. “This network brings together 19 institutions and thousands of investigators throughout the United States — all working off the same basic partnership agreement — to identify candidate drugs and move them into the clinic,” he notes.
CTI’s focus is on translational medicine, rather than upon animal models or upon evaluating therapies in clinical populations. “There’s no predetermined disease focus. Research projects are based upon the opportunity to translate an idea into the clinic,” he says. The CTI does focus, however, on biologics. “That allows us to build more intimate relationships without the need to also involve large teams of medicinal chemists,” he explains.
The scope of collaboration ranges from discovery to Phase 1, helping Pfizer streamline development. For example, by populating a research team with individuals who have spent decades unlocking the scientific mysteries of a particular niche as well as with Pfizer’s own experts in toxicology and pharmaceutical science, the company may benefit by addressing issues as early as possible in the candidate selection and drug development cycles.
About 250 proposals for research have been submitted to the CTI this year, and about 10% of those will be funded by year’s end. “Some are very early stage — some have one paper in Cell — and the individuals have an idea that could become a therapeutic,” Coyle says. Thanks to this collaborative research model, “In less than a year and a half, we’ve been able to achieve what would have taken five to six years to build.”
Proximity to the researchers is so important that Pfizer has leased space across the street from UCSF’s Mission Bay campus, at New York’s Alexandria Center for Life Science near New York City University, and in the same building that houses many of the researchers from Children’s Hospital Boston, Deaconess Beth Israel Hospital, and Dana Farber Cancer Center. The principal investigators (PIs) and post-docs have a Pfizer badge for easy access to the Pfizer facilities, and Pfizer researchers have access to theirs.
All relationships with the institution are for five years, although funding commitments for individual projects will be shorter. The funding mechanism is very venture capital-like. Funding depends on scientific advances, and according to Coyle, a significant number will terminate in two years’ time.
“At the end of a project, if we don’t exercise our option (to advance it), whatever we’ve generated returns to the academic institution to do with as they desire,” he explains. That includes developing the project with another partner. “If it’s a therapy that’s potentially viable, we don’t want it held up,” Coyle emphasizes.
Genentech has an omnibus agreement with the University of California at San Francisco and at Davis to allow materials to be exchanged without tech transfer agreements for each project. Genentech has signed deals for several partnerships all based upon this master agreement. For instance, its agreement with USCF’s Small Molecule Discovery Center is designed to develop a drug candidate against neurodegenerative disease. Under that agreement, the university has the potential to receive more than $13 million — plus royalties — when certain development and commercial milestones are met.
Genentech and other companies engaged in these more collaborative agreements tend to manage the projects through joint project teams — at least for the larger projects — to drive the work toward a common goal. Aside from good science, “An appreciation of the other person’s point of view is one of the key elements in determining the success of the collaboration,” Sabry says. “It’s easy to forget the other partner has different goals. Ours, for example, is to develop great medicines to help patients, while universities’ goals are to educate, advance knowledge, and conduct clinical work. Where they overlap, we can work together.”
The emergence of more collaborative industry/academic partnerships isn’t expected to adversely affect the small biotechs that have traditionally engaged in many of these collaborations. “This will have no real effect on small biotechs,” Sabry says, simply because “there are fewer small biotechs than there were.” In today’s economic climate, researchers considering spinning off research to form their own companies may be daunted by lack of start-up funding.
Pfizer and Bayer both stress the possibilities for similar collaborations with small biotechs. As Coyle says, “We’re looking for opportunities to participate with small biotechs and even venture capital groups to find more creative ways to partner.” Bayer’s Haskell notes, “This collaborative model also is used for other types of partners, in addition to traditional licensing and codevelopment/comarketing partnerships.”
SOURCE: Pfizer & Genentech