Creativity must be nurtured from the beginning of the R&D process if it is to yield successful products. Johnson & Johnson has formed an internal think tank to identify and nurture product opportunities early in the development cycle. Known as COSAT, it is designed to transcend traditional hierarchical boundaries and even go outside the company altogether to promote development.

COSAT encourages networking between J&J’s own branches and businesses as well as between them and outside partners. Contributions come from multiple experts, institutions, geographies, and resources. Partnering entities take on parts of the project, bear certain responsibilities, and share the data for their respective purposes of advancing knowledge or bringing new products forward.

COSAT focuses on openness in innovation early in the development process. With pharmaceuticals, J&J takes things a step further, applying open innovation throughout the R&D cycle, from discovery to pipeline development to final product. J&J’s decentralized structure lends itself to the process of networking and also fosters an entrepreneurial spirit.

Open innovation has gained traction throughout the drug industry, experts say. Scientific research has traditionally been conducted in closed corporate confines with limited interchange of ideas. Shrinking pipelines and the drought in drug development have led companies to approaches that override their bureaucracies.

LSL: Describe COSAT’s mission.

Neil: COSAT was created more than 30 years ago to look for new and emerging technologies that are beyond the horizon, to find new sources of innovation, and to look for opportunities to work in a convergent way across J&J’s different sectors — consumer healthcare, pharmaceuticals, and medical devices and diagnostics.

LSL: What are the driving forces behind COSAT’s stated mission: to revolutionize the development process and support new business models?

Neil: If you look at 2008, only 21 new molecular entities (NMEs) were approved [and 3 biologics] and only about 6 came out of big pharmaceutical companies. If we are looking at an industry that requires new products to sustain growth and to fill unmet needs, we really have to figure out ways of doing things better. And this is becoming more challenging and more expensive.

LSL: How is the open innovation approach integrated into COSAT’s internal activities?

Neil: We view COSAT as a catalyst, connector, or docking station for the external scientific environment into J&J, and vice versa, for operating companies that are seeking outside expertise or within J&J. COSAT sees its internal job is to stimulate innovation and convergence between groups.

We have created a series of tools, such as our link system, which is based on a series of internal algorithms and allows any company scientist around the world to ask the network a question or seek assistance from other colleagues. Another tool is a universal R&D search engine being rolled out now. It allows scientists to search various internal documents, including research data, in addition to the scientific literature.

LSL: How is open innovation integrated into COSAT’s external activities?

Neil: Our scouting network connects COSAT with people at innovation centers of leading laboratories, universities, and research institutes such as Harvard, Massachusetts Institute of Technology (MIT), University of California at San Diego (UCSD), Stanford, University of Toronto, and Princeton.

We try to link those external networks to our internal scientific network, helping J&J scientists who are looking for specific expertise to connect to the appropriate places. We help our operating companies find opportunities that could be translational and make investments in new technologies at research labs.

COSAT has both internal and external scientific advisory boards. One board has senior scientists from different J&J organizations, and the other has between 8 and 10 senior scientists from academia that represent some of the different technologies and therapeutic areas of interest to J&J.

LSL: What kind of technologies and platforms does COSAT seek from universities and other partners?

Neil: We look for technologies that may have either a direct impact on patient care or an indirect effect by enhancing our ability to discover drugs or develop devices. We see the world going forward with advances in areas like molecular diagnostics, cell therapies, nanotechnology, microelectronics, and new high-resolution imaging techniques, as well as genomics and proteomics to identify potential patients for the right therapy. We feel we are on the threshold of some major revolutions in the biomedical space.

LSL: Are other approaches used to interact with the external scientific environment?

Neil: Sometimes our approaches are more conventional, such as licensing, partnering, and contract research. In other cases, they might be public-private partnerships or collaborations with a single academic institute.

LSL: Are there examples of open innovation with your competitors?

Neil: Not usually, but joint research endeavors exist that allow precompetitive knowledge to be shared across the industry. For example, Enlight Biosciences was formed in July 2008 by PureTech Ventures in Boston, which specializes in translating breakthrough research from top-tier academic institutions into therapies. A number of companies including ours, Merck, Pfizer, and Eli Lilly, are members of this consortium. We are working together to try to identify and bring forward new technologies to facilitate drug discovery.

Another example is the NIH Biomarkers Consortium, which was initiated in 2006 to identify and validate biomarkers for disease. It is a public-private partnership formed by the Foundation for the NIH (FNIH) and includes some 60 members — companies, large and small; patient advocacy groups; the NIH; and the FDA. It should accelerate the development of biomarkers to a degree beyond the capacity of an individual partner. All data will end up in the public domain.

LSL: Do company scientists work with individual academic investigators?

Neil: We like to create collaborations where our scientists are working directly with academic scientists. We might be able to do some experiments for them in our laboratories, for example, provide some reagents or just advice and guidance.

LSL: How extensive are COSAT’s efforts to advance the promise of personalized medicine?

Neil: At COSAT, we use the term “precision medicine,” meaning being able to identify exactly the right therapy at the point of care and to follow patients so they get precisely what they need when they need it. We are interested in different monitoring technologies that are not available today for more precision approaches. For example, in the future, with infectious diseases, molecular diagnostics may tell you at the point of care whether the patient has a viral or bacterial infection, which virus or bacteria, and possibly even the right drug to select.

LSL: With the advent of precision medicines, will companies be selling a smaller volume of a particular medicine?

Neil: We envision a world with more certainty about patient outcomes based on being able to select therapies that reduce the risk of certain side effects. The process may have the consequence of reducing the number of patients that select an individual therapy, but it may improve overall outcomes. We feel confident that if we are able to come up with such innovations, an adequate business model for it will evolve.

LSL: Does COSAT become involved with the drug approval process as related to the FDA’s Critical Path Initiative or the CMS Roadmap document?

Neil: No, COSAT focuses more on the front end. However, regulators should find it easier to adjudicate and approve precision medicines, as they allow you to select the right patient for the right drug, carrying a much higher likelihood of success and lower risk of side effects.

LSL: How important is the use of health information technology, including electronic patient records, for “predictive modeling” in personalized medicine?

Neil: Electronic technology is really revolutionizing medicine. We need more information about the patient and the disease linked to genotypic data and other biomarkers. Health information technology may be a way to help us collect that over time, and as that data accumulates, we can use it for better-targeted therapies and precision medicine. However, in my opinion, it will not replace the need for clinical trials to answer certain questions.

LSL: How are biomarkers related to the development of precision medicine?

Neil: A biomarker is an indicator, often in the blood, of a disease state or a treatment effect in patients. One of the best examples is the biomarkers of viral load and CD4-positive count in patients infected with HIV. As to precision medicine, biomarkers make it possible to do earlier diagnosis and to follow the treatment of patients; they provide a clearer, simpler pathway for drug development, and in some cases, they allow one to manage the dose of a drug or to follow-up side effects.

LSL: What advice do you have for firms or institutes that have an emerging technology or a service that might be of interest to J&J?

Neil: Many in the industry already send us their ideas; we encourage that. LSL readers are invited to access COSAT’s website at: www.jnjcosat.com/cosat. On COSAT’s home page, click on “Partnering with Us” and “Submitting Your Ideas” and “Create Account.” Once people are part of our network, we continue to engage them in dialog.