Despite decades of progress in the fight against seasonal influenza, a troubling phenomenon has persisted: people 65 and older remain especially vulnerable to the condition, accounting for far too many flu-related hospitalizations and most of the deaths, which reached an estimated 56,000 in the U.S. during the 2012-13 flu season. A big part of the problem has been that vaccines to protect millions of people under 65 simply don’t work as well in older populations. This discrepancy prompted Sanofi, the world’s fifth largest pharmaceutical company and an established global leader in vaccine development, to seek a solution.
“It doesn’t sound like a hard thing to do,” said John Shiver, head of research and development at Sanofi Pasteur, Sanofi’s vaccine division, “but it turns out to be quite hard.” It took years of research and many millions of dollars, but ultimately Sanofi was able to develop an effective vaccine that became the first FDA-approved flu treatment specifically for people 65 and older.
Innovation is essential if your business model involves finding breakthrough treatments for some of the toughest challenges in health care, including multiple sclerosis, diabetes, cancer and infectious disease. Innovative thinking takes many forms at Sanofi, from the way people like Shiver and his group choose their projects and conduct experiments and clinical trials, to how teams of specialists search the globe for companies and academic institutions Sanofi can partner with to develop new products and improve existing ones.
It’s all part of a company-wide commitment to encourage and support new ideas and approaches at every level. That means using every opportunity to leverage the power of advances in medical science and digital technology to remain at the forefront of a fast-changing industry. It also means keeping the people who use Sanofi’s products—the patients themselves—at the center of the equation.
In fact, one of the most revolutionary innovations to come out of Sanofi in the last few years may have been to create the position of chief patient officer, a first for a major pharmaceutical company. “There’s a broad dialogue taking place in health care,” said Dr. Anne Beal, who was chosen to fill the role in 2014. “And it’s incumbent upon all of us to ask how we can be more responsive in meeting patients’ needs. There are different ways to respond, and certainly creating the position of chief patient officer is a good way to start.”
It’s a big job that Beal, a physician and health services researcher by training, has distilled into three core components she calls pillars. The first, input and understanding, is about patient engagement using a variety of channels such as social media, advocacy groups (including MS One to One, the program Sanofi created in 2012 for people with multiple sclerosis) and other tools to get feedback and determine needs. “Patients are no longer passive recipients of our care or our products,” Beal said. “I think in part it’s a function of the areas where we are working: diabetes, multiple sclerosis and even vaccines. All of these are conditions that require patients to play a major role in caring for themselves. And they need to feel empowered to be able to do it well.”
The second pillar, outcomes and solutions, is the most important, said Beal. It’s what her work and that of all 110,000 Sanofi employees ultimately comes down to. “We can do a lot of great activities with patients, but at the end of the day we know we’re succeeding when we can demonstrate that it improves outcomes. It’s outcomes that matter to patients.”
Culture and community, the third pillar, involves Beal’s efforts to spread innovation in patient centricity throughout Sanofi. And she discovered in her first few months on the job that it’s not a hard sell. “What I have found is that even the person who doesn’t work directly with patients, who’s in a back lab or working in the finance or legal department, who you might think doesn’t have any interaction with patients, is here because they want to work in an industry that benefits people’s lives. As a result, they are usually open to trying something new to improve our ability to serve patients.”
The power of partnerships
In another profound shift for the pharmaceutical industry, big companies have become more open to outside ideas as the pace of discovery in the biological sciences has accelerated over the last 20 years. Sanofi, for one, has embraced the new dynamic.
“When you talk about innovation in the pharma-biotech industry it really is a collective effort,” said Adam Keeney, Sanofi’s global head of External Innovation. “The world is a big place and not all the best ideas can be found or managed internally.”
Major components need to come together for a good idea to develop through pre-clinical testing, clinical trials and introduction to the marketplace, Keeney explained. In his blueprint, a strong academic group explores new targets, new breakthroughs and new biology, and does the fundamental research. Then a small biotech company with venture-capital backing takes that new idea and does some critical experiments, to “de-risk it,” in Keeney’s words. Finally, the big pharma partner refines, manufactures and markets the new product on a global scale.
“The key to success in pharma today is to have this flourishing ecosystem to find new science, develop it and ultimately commercialize it,” Keeney said. “And Sanofi is a major player in that ecosystem.”
Keeney and his teams are the interface between the outside world and Sanofi. Their primary job is to seek out “novel external opportunities” that complement the company’s internal portfolio of treatments. Just last month, for example, Sanofi entered into a licensing agreement with Principia Biopharma, a small California-based biotech company, for a potential new MS treatment. Sanofi currently has two approved MS drugs and several others in the pipeline. Under the terms of the deal, Sanofi will continue to develop the Principia drug, which is in a Phase 1 clinical trial. “It’s a system that allows the best ideas to survive,” said Keeney, “and it’s not a question of where they come from.”
Seeding the future
To further advance its never-ending hunt for promising new ideas, Sanofi launched its iAwards program in 2015. The overriding goal is to find innovative approaches to drug development in specific therapeutic areas, among them diabetes and rare diseases. Ten academic medical centers currently participate in the program, including Johns Hopkins Medical Center, Massachusetts General Hospital and the University of Texas.
More than 700 proposals have been considered to date and 70 have been chosen. Selected projects receive seed funding for one year along with support and expertise from Sanofi. Each project is managed by a dedicated project champion and a management team. Successful projects receive additional funding for up to two years and become part of Sanofi’s early-stage research portfolio.
Among the 2017 projects are two at Columbia University that focus on a condition called nonalcoholic steatohepatitis (NASH). NASH has emerged as the leading cause of chronic liver disease worldwide, and currently there are no FDA-approved drugs to treat it. The iAward funding has enabled close collaboration between Sanofi and Columbia researchers to develop and test novel therapeutic molecules in animal models of NASH. If successful, they’ll move on to the next investigative stage.
Clinical trails and the challenges of big data
Whether it’s for a vaccine that might be given to millions of healthy people in different parts of the world or a treatment for a relatively rare disease like multiple sclerosis, every clinical trial comes with an array of challenges that must be met and overcome. Patients have to be recruited, screened and carefully monitored. They have to take the proper dose of the drug being tested at the proper time and report any adverse effects. They may have to undergo blood tests and other diagnostic procedures during the trial and, in some cases, follow up may continue for years after the trial ends. Patients with the disease the experimental drug targets have the added burden of managing their condition during the course of the trial. The list goes on, including managing the oceans of data that clinical trials generate.
Sanofi’s latest initiative to improve clinical trials is a partnership with Science 37, a clinical research services and technology company. By leveraging mobile technology and telemedicine capabilities, the new approach will allow Sanofi to develop “site-less,” decentralized clinical trials and eliminate many of the common obstacles to participation. Using digital technologies that make it easy for patients to join and stay in trials streamlines the recruiting process and improves retention of subjects for the entire length of a study. This has the potential to reduce the time required for a typical trial by at least 30 percent. “With digital clinical trials we can get and analyze the data on how a new medicine works in the real world a lot sooner,” said Lionel Bascles, Sanofi’s global head of Clinical Sciences and Operations.
As for big data—massive amounts of raw information that can be mined for trends and other useful facts—Milind Kamkolkar, Sanofi’s chief data officer, pointed out that it is still in the early stages of being fully leveraged in health care. “As computational capabilities get faster,” he said, “and the cost of doing work becomes cheaper, the use of artificial intelligence in big data will allow us to accelerate and identify novel therapies and apply more targeted interventions.” He also noted that big data is no longer just about large group demographics, but has evolved to include very specific personal details about the individual. “The quantified self has exponentially increased our opportunity to understand patient populations and discrete ethnographies to truly personalize medicine.”
The payoffs is personalized care
At Sanofi, looking ahead defines the company’s work every day. The people who work there don’t dream about the future, they create it. When Karen Chandross, Sanofi’s senior director of strategies, infrastructure and scientific relations, thinks about electronic health records (EHR), for example, she doesn’t dwell on the technology problems that have dogged the management of information, with the result that it’s often been underused.
“We appreciate the limitations of EHR,” she said. “What we’re interested in is linking EHR to other data sources, such as physician notes, that have not typically been looked at in much depth.” She mentioned a Sanofi collaboration with Duke University that links health information about people with diabetes to insurance claims and socio-geographic information. “There’s also a potential to link to wearables and sensors,” said Chandross, “and a potential to link to genetic data. So you will use various data sources to get a much more holistic view of a patient. And that’s the goal.”
Not surprisingly, it’s a goal that matches the one set by Kamkolkar and Chandross’s Sanofi colleague, Dr. Beal. “We’re very used to the concept of personalization from a genetic perspective and our need to tailor our care based upon a person’s genetic profile,” said Beal. “But there’s also a behavioral profile, an emotional profile, a life stage profile, a contextual profile. All these factors have to be taken into account for true personalized care.”