Sanofi To 'Innovate On Innovation'
By Rob Wright, Chief Editor, Life Science Leader magazine
Two years ago, Sanofi announced its vision of becoming a diversified global healthcare leader. In order to achieve this goal, the company identified three objectives — increase R&D innovation, adapt for future challenges, and pursue external growth opportunities. The first of those objectives may, in fact, be the most challenging, considering every big and small pharma company is also striving to boost R&D innovation.
Dr. Paul Chew is acutely aware of this problem, since he is the chief science officer (CSO) and chief medical officer (CMO) for Sanofi U.S. Along with Dr. Marc Bonnefoi, head of the Sanofi North America R&D Hub, Chew was responsible for the overall scientific direction and research functions of Sanofi in the United States during last year's transformation. As part of the global R&D leadership team, Chew and Bonnefoi are responsible for implementing the company's product portfolio strategy in North America, as well as bringing products to market in compliance with regulatory, legislative, and medical/health requirements. Chew says the company has successfully completed the first phase of the R&D transformation process, and the next phase starts with a fundamental change of mindset.
From Closed To Open Innovation
Innovation can be categorized as being either open or closed. According to Chew, "Closed innovation is when you have the ideas originating within the four walls of a drug company. No matter how bright you are, there is no way in today's modern age of communication and information that you can have all the best and brightest ideas come from within your own company."
The New York Times, reported in 2009 on the popular appeal of what was then described as the emerging discipline of open innovation. Various permutations of open innovation include crowdsourcing, collective intelligence, and peer production. Sanofi's strategy for dealing with the patent cliff and generic incursion of such key drugs as Lovenox, Plavix, Ambien, and Allegra, was to implement an open innovation drug development model. In order to do this successfully, the company had to streamline decision making and create a new ecosystem of partnerships which allowed for access to the best basic and translational research.
Streamline Decision Making
In order to streamline the decision making process, Sanofi began a process of "stress testing" its product development portfolio. "Drug development can take a decade. A lot can happen in a decade in terms of the relevance of approach, competitive landscape, and alternative therapies," explains Bonnefoi. He advocates a periodic review of the product development portfolio to see if there is still a need for the product in development. Perhaps the benefit-to-risk ratio is not as good as something else that has been approved in the recent past. Bonnefoi describes the process as culling the portfolio, which allows Sanofi to focus on what is still relevant. This includes evaluating the medical value of projects (e.g. , do they address the current market drivers for health and medicine? Do they focus on unmet medical needs with potential to reduce healthcare costs?) and focusing on scientific quality rooted in translational medicine and prioritizing the quality of projects rather than quantity. This more targeted R&D approach allows the company to focus on building projects with the highest medical value and the strongest potential for translational medicine validation. Chew finds the process of thinning out projects less likely to be developed to be very energizing as it frees up resources to explore outside innovation opportunities. In the meantime, Sanofi is delivering on the current late-stage portfolio, which as of November 2011 comprises 66 NME (new molecular entitie) projects and vaccines in clinical development, of which 16 are in Phase 3 or have been submitted to the health authorities for approval. Between July and November 2011 , five new products were submitted: Lyxumia (lixisenatide) in the EU, Aubagio (teriflunomide), and Zaltrap (aflibercept) in the United States.; Visamerin/Mulsevo (semuloparin) in the United States and EU; and Kynamro (mipomersen) in the EU. No single company has ever had so many major submissions in one year.
Two of Sanofi's outside innovation opportunities are Zaltrap, a novel anti-angiogenic agent for the treatment of cancer it is developing in partnership with Regeneron; and Lyxumia, a glucagon-like-peptide (GLP-1) treatment for diabetes tailored for primary care physicians, in licensed from Zealand Pharma. Sanofi's other outside innovation opportunities take the form of what Bonnefoi refers to as academic alliances.
A New Ecosystem For Partnering
Creating academic alliances is not a new phenomenon for pharma. But Sanofi's approach is different in that the company targets institutions in order to capitalize on the convergence of life-sciences and engineering, which includes innovations in areas such as nanotechnology and drug delivery devices. To explain this concept, Chew says, "When I was growing up, MIT and Caltech were engineering schools. A large part of what they're doing now is life sciences, and they're working a lot with biologists, nanotechnology, carbon nanotechnology, and microfluidics — all examples of combining life sciences and engineering." Sanofi has also partnered with academic institutions throughout the world with a novel approach to collaboration that brought together academia and industry to share ideas and focus on translating early research ideas into potential healthcare solutions. For example, in the case of its alliance with The Salk Research Institute in La Jolla, CA, Sanofi placed scientists within the facility to work side-by-side with some of the most distinguished scientists in the world. Through these academic collaborations, Sanofi gains access to innovative ideas and can provide guidance and support to shape promising projects, and many of the partnerships grant Sanofi the first opportunity for establishing future agreements in bringing the resulting products to market. Bonnefoi describes this process as transformational. "We want to be global not only in terms of our marketing and sales, but how we think globally, in terms of where the best ideas come from and bringing new inventions and discoveries to the bedside," he says.
A recent article, in Forbes magazine, highlighted Sanofi as being one of the big pharma companies successful at re-inventing its R&D strategy, focusing on developing breakthroughs — not blockbusters.
In November 2011, Sanofi announced its new North America Research & Development structure, which is part of the company's strategy to create a more open-innovation based model that allows access to the best science and people in research. This new structure includes the creation of the Sanofi Boston R&D Hub, which will consolidate North America discovery and early clinical development in the Boston area, and a North America Development Center, which will be based in Bridgewater, NJ, and include clinical development, regulatory affairs and other development platforms. According to Bonnefoi, this new structure is designed to enhance communication between teams, expedite decision-making, maximize cross-fertilization inside and outside the organization (i.e. open innovation), and build upon the company's ability to accelerate the translation of research from the bench to the patient. Similar hubs are proposed for Germany, France, and Asia. Through increasing R&D productivity through prioritizing the portfolio and implementing a new hub structure, Sanofi hopes to design a new model for successful R&D, reduce the average drug development time, and increase the probability of late-stage successes.