By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
The process of creating a public-private partnership (P3) can be very challenging. First, consider the size of the organizations involved. The NIH, the largest source of funding for medical research in the world, consists of 27 institutes and centers alone. The University of Texas M.D. Anderson Cancer Center has over 1,100 clinical resident fellows. Even for a company the size of Eli Lilly and Company (NYSE: LLY), the navigation of academic and government-institution policies and procedures for brokering a partnership can be a labyrinth.
Additionally, outcomes are often not in alignment. For example, folks at Lilly are charged with developing innovative medicines that are both safe and effective for patients while providing a return to its shareholders. The typical academic researcher is striving to create cutting-edge scientific discoveries that can be published in a high-profile peer-reviewed journal.
If you are a pharmaceutical company wanting to leverage the full potential of P3s, where is the best place to start? Lilly has embraced a multipronged approach toward developing and implementing its P3 strategy. First, Lilly created an executive-level position responsible for the global strategy and governance of P3s. Second, the company placed an individual in the position with experience in traversing the P3 maze. Third, Lilly launched a postdoctoral fellowship award program. Finally, the company developed its P3 objectives and identified opportunities to advance its work in this area.
In August 2012, as part of the company’s larger external innovation strategy, Dale Edgar, Ph.D., took on the responsibility for consortia and P3s across Lilly’s research enterprise in the newly created position of global head of science and technology partnerships. A former associate professor at the Stanford University School of Medicine, he has had his share of NIH and DoD grants and industry-sponsored projects that delivered a strong list of publications. He ultimately spun out his laboratory at Stanford to found a start-up biotech company called Hypnion Inc., which Lilly acquired in 2007. The translation of Edgar’s basic research, from the bench to the bedside, resulted in numerous patents. Here, Edgar shares his insights on Lilly’s strategy and governance approach to P3s, starting with the creation of the company’s global postdoctoral scientist training program.
Peer-To-Peer Scientific Approach to Partnerships
“When we create a partnership,” Edgar explains, “we don’t pitch money over the walls and then wait for results.” This is what Edgar defines as a traditional sponsored project. “A real partnership is where you’re working together in real time, hand in hand.” For example, at Lilly, this involves a peer-to-peer relationship between Lilly scientists and academic and government researchers. To do this, Edgar believes you first need to create a trust-based peer-topeer culture within your organization. So in addition to placing Edgar, a former academic peer, in charge of brokering academic relationships, Lilly seeks ways for its scientists to engage with external researchers in a peer-to-peer capacity. “To help build relationships, trust, and the common sense of purpose that is vital to innovation, we created the Lilly Innovation Fellowship Award (LIFA),” Edgar explains. This competitive postdoctoral fellowship provides up to four years of funding for exceptional postdocs, so they don’t have to constantly be looking over their shoulder for money and, instead, can spend all of their time innovating. This includes a full salary and benefits paid by Lilly, as well as a $5,000 annual stipend for travel expenses. Here is how it works.
The LIFA program is both an award and a partnership-based training program, with a Lilly mentor, an academic mentor, and a postdoc, all creating what Edgar refers to as an innovation triad. What Edgar likes about this approach is that both the academic and industry mentor are working together in the interest of the postdoc’s success (the common sense of purpose). This not only creates a high-trust peer-to-peer relationship between the parties, but also establishes connectivity and a mutually beneficial flow of innovation through the postdoc. “Lilly receives nominations from our scientists as to which universities and institutions they believe can help us address five grand challenges that are broadly relevant to the pharmaceutical industry.” Those challenges are:
to establish clinical efficacy and safety earlier in the drug development process
to develop the right medicine for the right patient
to deliver exceptional patient outcomes
to simplify large-scale chemistry and protein production and minimize its environmental impact
to target and deliver biologics and small molecule drugs precisely and safely.
“P3s are an especially powerful strategy for answering a wide variety of critical unanswered questions embodied by the grand challenges,” he states. A small sample of potential critical unanswered questions include:
What is the best way to objectively segment patients with disease to understand why some are responders to medication and some are not?
Controlling for diet and environment, why are some individuals at greater risk for Type 2 diabetes?
Can in silico informatics technologies predict behavioral pharmacology?
Can large-molecule medicines be made orally available and brain-penetrant?
Who are the caregivers of the 21st century, and what are the disease/health risks of their occupation?
Lilly solicits LIFA applications by invitation only through the deans of nominated schools and institutions. Lilly senior scientists then review the applications for innovative merit with emphasis on innovative concept and the qualities of the postdoc and academic mentor. Finalists were selected in April of this year and invited to Lilly for interviews. From June to October, Lilly performs the onboarding process for LIFA recipients. The postdoc will spend a certain amount of time working at both the academic institution and Lilly, depending on the nature of the project. Postdocs and their academic mentors will typically be located in the same continent as the relevant Lilly research laboratory, which can include sites in the U.S., U.K., Spain, Singapore, and China. Edgar believes working at Lilly is part of the incentive to participate in the program since it provides the postdoc with access to Lilly resources and technologies not typically available in academia. The company also provides funds to the academic institution in support of the training partnership. “Maybe they decide they need to buy a new tool, supplies, or send the postdoc to a meeting. It’s completely up to them what they do, as long as the money is used to support the postdoc,” says Edgar. The annual payment to an institution in the United States is $45,000. The program also benefits the academic mentoring investigator, because they will be a principal author on the resulting publications, as the research is largely precompetitive in nature.
“There are far more critical unanswered questions than there is manpower at Lilly to pursue. Indeed, we certainly do not have all the answers we need to deliver innovative medicines to patients who are waiting.” Edgar believes that incorporating P3 as part of the long-term research strategy and engaging postdoctoral scientists and other relationship-based frameworks are vital to the transformation of the pharmaceutical industry. “This is how we bring great minds together to help solve the biomedical challenges of our time,” he asserts.
Collaborating with Academia
Academia and industry are aligned in their desire to deliver innovative medicines to patients and see this as more than useful symbiosis. P3s enable academia and industry to join forces in a noble cause. But differences between academic and industry cultures present challenges. Publication is the currency by which academic scientists are judged for future NIH funding, promotions, tenure, and the most precious of all currency in academic institutions — the size of an academic investigator’s laboratory space. Yet protecting IP is critical to industry, and publishing research too soon can threaten a company’s IP.
For this reason, the vast majority of P3s are precompetitive in nature — fundamental science, tools, and techniques that can be readily published. There is an unrelenting appetite for precompetitive P3s, especially with limited NIH and other federal research funding. More universities throughout the United States are building drug discovery centers with the goal of producing valuable new medicines for patients in partnership with industry.
Seek Engagement For Public-Private Partnership Success
When Lilly seeks to engage with the global medical innovation ecosystem, Edgar says it is driven by first thinking of the critical unanswered questions he previously described. “We present those critical unanswered questions into different mechanisms or forums,” he states. There are a number of ways in which Lilly does this. “In Europe, we work with the Innovative Medicines Initiative (IMI),” he explains. IMI is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Members of the IMI governing board include representatives from industry (e.g. Lundbeck, Genzyme, Novartis, UCB), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Commission. Lilly presently has 19 projects with IMI, all seeking to address at least one critical unanswered question. “All the projects are precompetitive,” he states. “However, all are driving to solve something that we know will help us in our programs to speed up the breakthroughs.”
The company has similar initiatives in the United States. For example, Lilly is actively engaged with the NIH’s National Center for Advancing Translational Science (NCATS). Edgar explains, “NCATS has created the Clinical and Translational Science Awards, CTSA program.” The CTSAs provide support, infrastructure, and resources for clinical research around the country, providing academic homes for translational sciences, which is similar to Lilly’s LIFA initiative. The NCATS program is also creating Centers for Clinical and Translational Science (CCTS) throughout the United States, in partnership with academic institutions (e.g. Spectrum: The Stanford Center for Clinical and Translational Education and Research). “The CCTSs have also self-assembled into regional consortia that we have been engaging via the critical unanswered question approach,” he states.
Under the NCATS program, there is a mandate for academic industry partnerships to help facilitate the translation of research for the benefit of patients. For example, according to Edgar, 20 years ago, the vast majority of molecules in development would fail for toxicology. Through a number of concerted efforts within industry, different technologies were created that helped reduce the risk of compounds failing for technical reasons. For example, early discovery efforts now include in situ salt screening, preclinical toxicology, in vitro genetic toxicology and metabolism studies, quantitative pharmacology, and other steps to increase development success of candidate molecules. “Nowadays, less than 10 percent of molecules die for toxicology reasons in Phase 2 clinical trials, while considerably more fail for efficacy reasons,” he says. “The NCATS program was created to help reduce clinical trial failures due to insufficient efficacy by developing predictive biomarkers and fostering studies to better understand how medicines can be targeted to those patients most likely to benefit. If you help reduce Phase 2 and Phase 3 failures, you can potentially shave years off the drug development process.”
Participating In The TransCelerate BioPharma Program
Another program Lilly is actively involved with is TransCelerate BioPharma, which is also designed to develop and share industry research and solutions to simplify and accelerate drug discovery and development. The initiative was started by 10 biopharmaceutical companies, including Lilly, just one year ago, and has already managed to develop common clinical-trial site qualifications and create a standardized methodology for risk-based monitoring of clinical trials. It also recently established the Clinical Trials Comparator Network to establish reliable and rapid sourcing of quality drug products for use in clinical trials via a master service agreement between TransCelerate members. “It’s a very actionoriented consortium,” Edgar states. “Everything in TransCelerate is about improving the quality and speed of the drug development process.” According to Edgar, the TransCelerate initiative will also help the FDA. For example, by companies collaborating and developing standardized modules within a regulatory submission package, the agency will become familiar with the format. “When industry understands what the FDA needs, it is easier to deliver the information required in a standardized way, making it easier to be processed,” he states.
Edgar describes P3 engagement as an active process of seeking out the academic pillars of excellence. For example, in 2008, Lilly created a public-private partnership called the Center for Cognitive Neurosciences (CCN). This was a partnership between Lilly and six academic centers in England. “Before this program, not only did these six academic centers not interact with each other, they overtly competed with one another,” he states. “We brought them together by focusing on trying to solve tough questions in the area of cognition, which would ultimately help patients with Alzheimer’s disease, neuropsychiatric disorders, and Parkinson’s disease.”
By placing a former academic researcher in a position to head up the brokering of peer-to-peer relationships, along with the creation of a postdoctoral science training program, Lilly is well positioned to capitalize on the open-innovation industry trend. “That framework has done a lot to help align academia and industry toward the common goal of really trying to find ways to build science and create a sense of urgency around that science — to take us through the right steps to deliver innovation to patients,” Edgar says.
As a result of this work, today Lilly is engaged in more than 50 consortia and P3s. “My advice to anyone looking to become involved with public-private partnerships is to determine your objectives, develop and foster relationships with academia in your local area, and reach out to the NIH,” says Edgar. “Today’s health challenges are vast and complex. There is opportunity for us to all collaborate as a way to help accelerate the delivery of innovative medicines to patients.”