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ture capital group, which invests in early- stage technology, along with Janssen labs, an incubator that assists small start-ups, now numbering about 50 companies. More than just imposing the Janssen name on former units such as Centocor and Ortho Biotech, the company has aimed at making its technologies, profi- ciencies, and special knowledge available throughout the Janssen universe. Under Stoffels' direction, the current Janssen units cooperate on discovery and devel- opment in all five therapeutic areas of focus: cardiovascular and metabolic dis- eases, immunology, infectious diseases, neuroscience, and oncology. In addition to Janssen units, the company fully funds a number of "internal ventures," and other ventures such as the alternative-scaffold enterprise Centyrex. Has all the reorganizing and integrat- ing of R&D; paid off for Janssen? Stoffels believes the reforms have succeeded by many measures, including an increase in the actual productivity of the R&D; orga- nization. "We organized ourselves very much in the biotechnology way, but com- pletely focused on certain therapeutic areas. And, like every biotech company knows, to be successful you must have the top experts leading the disease or thera- peutic area. They need to make all the important decisions about which science or type of development we adopt." On the other hand, he says, an organiza- tion that develops a high number of new drugs must be efficient on a global basis. "Because we have worked on significant unmet medical needs, we have learned how to speed up the process." For example, Stoffels cites the devel- opment of Imbruvica (ibrutinib), with Pharmacyclics. The FDA halted the drug's pivotal Phase 3 trial, in chronic lympho- cytic leukemia and small lymphocytic lymphoma, when its interim analysis showed significant PFS (progression- free survival) and OS (overall survival) improvement. "We brought the drug from early Phase 2a to the market for the first indication for CML [chronic myeloid leu- kemia] in only 23 months," he says. "That is only possible if you have an outstanding global development organization that can develop and file medicines globally, in Europe, the United States, Japan, and all the rest of the world." He caps the point by mentioning the company's first-ever success in launching a new drug initially in Japan: the NS3/4A protease inhibitor Olysio (simeprevir), for the treatment of chronic hepatitis C infection. "The global system really works. In drug development, we say do it high PAUL STOFFELS EXPANDS THE JANSSEN LEGACY By W. Koberstein speed, do it high quality, and do it global. That's one of the most important value creators. Don't be inhibited by where the science comes from, internal or external. Just make sure you win access to the best possible drug, with the best possible sci- ence. That was a big change for this orga- nization — not that easy in the beginning but now everyone is fully embracing it." Recently, J&J; announced Janssen's pipeline produced 13 new-drug launches since 2009, "more than doubling its productivity over the past four years." The company antici- pates submitting more than 10 new prod- uct filings and more than 25 "significant brand-line extensions" by 2017. Five of its new-drug indications now have FDA break- through status. New products launched since 2009 accounted for 17 percent of total pharmaceutical sales in 2012, up from 9 percent in 2011, and the company expects the same products to bring in nearly half of the total sales in the segment by 2017. THREAD FROM THE PAST, PATTERN FOR THE FUTURE Although the most sanguine pharma executives don't like healthcare cost- cutting any more than anyone else, they may be quicker to recognize the chal- lenge, shrug their shoulders, and move on. Stoffels quickly turns a question about pressures on the industry into a view of positive solutions. "The answer to economic pressure is inno- vation. If you bring innovative new drugs into the market, society will be prepared to pay for it. We need to produce more and more significant innovation to be reim- bursed by the payors in the world. It is a sci- entific, technical, and global development challenge to develop the best drugs, pick up the best technology, and make sure that we have the best profit margin possible." Stoffels sees great promise in the direc- tion of pharma science and technology, such as the growing understanding of the human genome, disease pathways, immunology, and personalized medicine. "With new biomarkers coming on line, we probably will be able to diagnose much better who will respond best to therapy. That means we have to develop drugs and diagnostics together — on one hand, a P A U L S T O F F E L S Chief Scientif c Off cer at Johnson & Johnson EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM MARCH 2014 26 0 3 1 4 _ F e a t u r e _ J J _ F . i n d d 5 0314_Feature_JJ_F.indd 5 2 / 1 9 / 2 0 1 4 2 : 2 5 : 0 5 P M 2/19/2014 2:25:05 PM