12:00 AM
Apr 29, 2013
 |  BioCentury  |  Strategy

Zerhouni's progress report

Two years in: What Zerhouni expects from Sanofi's transformed R&D by 2016

When Elias Zerhouni joined Sanofi as the head of R&D in January 2011, the former NIH director decided the pharma's pipeline needed to be pruned and refocused around disease pathways. Two years into the job, Zerhouni's late-stage housecleaning is evident, but the bigger changes to the pharma's drug discovery strategy will take three to five more years to bear fruit.

Sanofi is the product of dozens of small and large mergers, including a merger encouraged by the French government between Aventis S.A. and Sanofi-Synthelabo S.A. in 2004. These resulted in an amalgam of redundant and sometimes antiquated R&D capabilities spread across 25 facilities.

Job one thus was to reduce the redundancies and eliminate R&D programs and technologies that weren't going to generate value.

Zerhouni has centralized Sanofi's R&D to four hubs and lopped off programs he didn't think would create value, while placing more emphasis on novel targets that address different pathways than existing marketed drugs.

His main focus has been to modernize Sanofi's R&D and look for new targets and therapeutics in a way that reflects current thinking about disease pathways.

"We've made great progress in basic research in disease biology, human genomics and proteomics, yet this seemed not to translate into new therapies at Sanofi," he told BioCentury.

Zerhouni hopes his appointment of seven new therapeutic area heads, along with a slew of discovery partnerships focused on translational research, will help solve this problem.

Additionally, according to Zerhouni, Sanofi's 2011 acquisition of Genzyme Corp. helped to balance out the pharma's small molecule-heavy pipeline with biologics. And going forward, Genzyme will be responsible for Sanofi's Orphan and multiple sclerosis pipeline.

Zerhouni expects the real fruits of his labor will not be obvious for a few more years. "By 2016, we will start to see tremendous change in R&D at Sanofi," he told BioCentury.

Shifting Sanofi

Zerhouni is drawing on his experience at NIH and in academia to rebuild Sanofi's R&D business.

During 1996-2002, Zerhouni served as chair of the department of radiology and radiological services, vice dean for research and executive vice dean of the Johns Hopkins University School of Medicine.

During this time, he said, "I realized that translational research was broken. I worked in research labs but they were not really connected to the clinical side."

As director of NIH over 2002-08, he oversaw the organization's shift to translational research from basic discoveries with NIH's Roadmap for Medical Research project, as well as the development of multiple public-private partnerships, including the Biomarkers Consortium.

In February 2009, Zerhouni became scientific advisor to Christopher Viehbacher, who had joined Sanofi as CEO in September 2008. Zerhouni was named president of global R&D in January 2011.

In his first two years as an advisor, Zerhouni said he realized Sanofi's R&D strategy hadn't changed to reflect realities in both the scientific and consumer worlds.

"The R&D operations were so internally oriented that it had missed many of the turns outside, from not just me-toos but to more efficacious drugs and linking up the science to drug discovery and the ability to understand disease biology," he said. "They also had a lack of biologics expertise. There was significant presence in terms of insulin and the vaccine business, but the first impression told me that there needed to be a reinvention of R&D."

First, Zerhouni went after the low-hanging fruit on both sides of the pipeline ledger.

"We looked at the portfolio to see where we had programs with marginal improvements. If they were in between phases, we stopped them," he said.

Zerhouni trimmed 19 Phase II and Phase III programs from the pharma's R&D pipeline over 2009-12. Some of the programs missed Phase II endpoints. Others were discontinued because the value proposition wasn't there from either the patient or payer perspective (see "Sanofi's Discontinued Programs," A6).

For example, in 2011, Sanofi discontinued development of two antiarrhythmics, including cilivarone, which was in Phase II. The...

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