Optimizing Early-Stage Drug Development - Pharmaceutical Technology

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PharmTech Europe

Optimizing Early-Stage Drug Development
Pharmaceutical companies and contract service providers adapt strategies and capabilities to reduce costs and accelerate drug-development timelines.

Pharmaceutical Technology
Volume 36, Issue 11, pp. 32-37

Sanofi. Sanofi also is restructuring its R&D activities, and in September 2012, it provided further detail about its plans for its R&D sites in France during the next three years. The development activities in Vitry/Alfortville, Chilly-Mazarin/Longjumeau, and Lyon will continue in their current configuration. The Montpellier site will evolve toward a strategic center focused on development, and the research activities at Vitry/Alfortville and Chilly-Mazarin/Longjumeau will be increased. The Strasbourg site will maintain its collaborative platform open to academic research and biotechnology companies. Sanofi had 64 NMEs and vaccines in its portfolio in development as of July 2012, which included 29 products (four vaccines and 25 NMEs) in Phase I and 17 products (3 vaccines and 14 NMEs) in Phase II.

Sanofi has emphasized several goals in its R&D model: improve R&D cost structure, execute on late-stage projects, use medical value and translational feasibility to guide early-stage portfolio prioritization, establish new models of external innovation, enhance the value of external partnerships, and create open and creative models of pharma/biotechnology partnerships.

One example of such a partnership is Sanofi's collaboration with Warp Drive Bio, which specializes in microbial genomics for natural products research. Warp Drive Bio was founded by venture capitalists and scientists from Harvard Medical School and the University of California, San Francisco. In a deal announced in January 2012, Sanofi and private funders are providing $125 million in initial funding, including a $75-million equity investment in although Warp Drive Bio retains strategic direction, operational management, and full rights to select assets. This approach enables Warp Drive Bio to advance its programs in collaboration with Sanofi while maintaining the ability to secure future partnerships.

Also, earlier this year, Sanofi formed a two-year agreement with Massachusetts General Hospital aimed at furthering translational medicine research to develop new treatments for hematological malignancies and solid tumors. The academic and industry cross-organizational expertise will include preclinical and clinical translational research to elucidate questions on proof-of-concept, tolerability, efficacy, and effectiveness.

Novartis. Novartis, while essentially using the same model as the traditional drug-development process, has tailored it to consist of two parts: exploratory and confirmatory development. Exploratory development consists of clinical proof of concept and involves small clinical trials (typically 5–15 patients) that combine elements of traditional Phase I/II testing. These customized trials are designed to give early insight into safety, efficacy, and toxicity. Once a positive proof of concept has been established, the drug moves to the confirmatory development stage, which has elements of traditional Phase II/III testing aimed at confirming the safety and efficacy of the drug in the given indication.

Novartis is investing $600 million for new laboratory and office space in Cambridge, Massachusetts, close to its research facilities and announced restructuring of some of its R&D sites and staffing. With regard to partnerships, in August 2012, Novartis and the University of Pennsylvania (Penn) formed an exclusive global collaboration to research, develop, and commercialize targeted chimeric antigen-receptor immunotherapies for treating cancers. In addition, the parties will jointly establish a new R&D facility on the Penn campus.

Other companies. Other companies are pursuing a path of R&D restructuring and external partnerships. In June 2012, Roche announced a streamlining of its R&D activities within the pharmaceuticals division, which involves closing its site in Nutley, New Jersey, by the end of 2013, with a reduction in the workforce of approximately 1000 people. The R&D activities at Nutley will be consolidated at existing sites in Switzerland and Germany and at the planned Translational Clinical Research Center in the US. Merck& Co. increased the level of its partnerships with several recent pacts with Ablynx, AiCuris, Chimerix, and Yamasa. Bristol-Myers Squibb formed several academic partnerships this year in drug development with separate pacts with Vanderbilt University and Emory University and formed the Immuno-Oncology Network, a global collaboration between industry and academia with 10 leading cancer-research institutions participating.

AstraZeneca announced further restructuring in its R&D operations earlier this year, including the creation of a new "virtual" neuroscience innovative medicines unit (iMed). The neuroscience iMed is one example of an iMed. iMeds focus on particular disease areas and work across discovery and early development. Eli Lilly established the Center for Cognitive Neuroscience, an industry–academic consortium and post-doctoral fellowship program focused on increasing the probability of clinical success for drugs to treat cognitive impairment. It is also participating in the Innovative Medicines Initiative, a public–private collaboration to speed drug development. Finally, Johnson & Johnson plans to open four innovation centers in California, Boston, London, and China, with the aim of accelerating early innovation.


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