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The future of drug innovationSupplement to Nature Publishing Group Journals October 2011reprint collectionS P ONS OR E D CONT E NTwww.nature.com/reprintcollections/lilly/drug-innovation Sponsored byFor the past 135 years, science has been at the foundation of all we do here at Eli Lilly and Company. We adapt and evolve in order to research and develop breakthrough medicines that deliver improved outcomes for individual patients. From collaborating to produce the worlds frst insulin, to the discovery and development of medicines that have helped revolutionize the treatment of depression and schizophrenia, Lilly has spent decades delivering innovative medicines that address unmet medical needs in neuroscience, diabetes, cancer, osteoporosis and more. We are currently standing at the threshold of potential new breakthroughs in science and we plan to deliver to the patients who are waiting.INSIDE Lef Coverwww.nature.com/reprintcollections/lilly/drug-innovation NATURE REPRINT COLLECTION | THE FUTURE OF DRUG INNOVATION | OCTOBER 2011 | 1Nature Reprint CollectionThe future of drug innovationpublisher: MELANIE BRAZILsponsorship: DAVID BAGSHAW, YVETTE SMITH, GERARD PRESTONweb production: ANITHA SONIA, MANPREET MANKOOmanufacturing production: SUSAN GRAY, STEPHENRUSSELLcover artist: SUSIE LANNIsponsor: ELI LILLY AND COMPANYCITING THE COLLECTIONAll papers have been previously published in Nature Publishing Group journals. Please use the original citation, which can be found on the table of contents below.For the past 135 years, science has been at the foundation of all we do here at Eli Lilly and Company. We adapt and evolve in order to research and develop breakthrough medicines that deliver improved outcomes for individual patients. From collaborating to produce the worlds frst insulin, to the discovery and development of medicines that have helped revolutionize the treatment of depression and schizophrenia, Lilly has spent decades delivering innovative medicines that address unmet medical needs in neuroscience, diabetes, cancer, osteoporosis and more. We are currently standing at the threshold of potential new breakthroughs in science and we plan to deliver to the patients who are waiting.INSIDE Lef CoverThe future of drug innovationSupplement to Nature Publishing Group Journals October 2011reprint collectionS P ONS OR E D CONT E NTwww.nature.com/reprintcollections/lilly/drug-innovation Sponsored bySponsors ForewordThe biopharmaceutical industry faces intense pressures including scientifc, regulatory and payer-related concerns that afect R&D productivity. Just as signifcant are the opportunities to serve unmet patient needs. The worlds population is also aging and, as a result, the number of patients with Alzheimers disease, diabetes and cancer, and other chronic diseases associated with aging is increasing. There is an urgent need for medicines that cure, prevent, or slow the progression of disease.To provide innovative treatments that address diseases caused by interplay between genetics, lifestyle, and environmental factors, Lilly, and the rest of the biopharmaceutical industry, will need to continue to discover and develop new medicines often collaborating with academia, biotechnology companies, and regulatory agencies to do so. In fact, the current diabetes mellitus type 2 global epidemic is one key example of a complex disease involving factors such as lack of exercise and inappropriate nutrition, coupled with genetic susceptibility.The articles included in this supplement demonstrate some of the problems facing the biopharmaceutical industry today, but solutions are also included which focus on answers to critical questions like: How can we intervene to treat diseases earlier or prevent disease progression? How can genome mining be done more efectively in order to fnd more human validated disease targets and increase our understanding of multiple cell signaling pathways?Other aspects of the solution the industry is pursuing include the development of multi-specifc therapeutics to boost efcacy by combining more than one unique mechanism of action into one molecule. Industry is increasingly tailoring medicines to suit specifc patient populations, including the use of companion diagnostics. Therefore, at Lilly, we are developing a deeper understanding of genetic diferences between ethnic patient groups, a prerequisite for global registrations. We are also increasingly better at understanding the real life patient experience with our medicines, including the importance of patient convenience for delivery and administration.Through these eforts to improve success rates and other strategies, Lilly will improve R&D productivity and shift away from the current inefcient paradigm of multiple shots on goal to try to get medicines to market. Rather, we like the idea of timely shots in goal, which means delivering a timely fow of innovative medicines with a greater likelihood of reaching patients with a diferentiated value proposition for clinically meaningful outcomes including data with relevant comparators. This evolution in our R&D strategy will beneft patients, prescribers, payers, and other stakeholders and fuel our industry in the years ahead.The future advances of treatments for human disease will continue to be determined, to a large extent, by the innovation generated by the biopharmaceutical industry and in close collaboration with others. Vast knowledge and experience with disease mechanisms and therapeutic molecule research and development are held within biopharma companies. Successful treatment advances will also depend on a healthcare innovation ecosystem that encourages continuous enhancements of scientifc, technical and medical capabilities. This is supported by advanced analytic information technology, as well as productive external partnerships to access unique capabilities and to create fexible capacity, reduce costs and share risks to solve complex R&D problems together. Intellectual property protection and data package exclusivity are necessary to support investments in pharmaceutical R&D. Its also important that we provide our cutting-edge drug hunters and developers with the right scientifc capabilities, supported by organizational empowerment to encourage transparent risk-taking and the willingness to play to win even in a difcult and uncertain environment rather than playing safe not to lose. Science has been, and will continue to be, a foundation upon which innovation driven pharmaceutical companies succeed or fail. We believe that pharma mega mergers risk sequestering innovation, create distraction and may destroy unique capabilities that have been built up for years. Instead, we believe that optimal critical mass capability, continuous adoption of new science and technology with a long-term approach is the way forward to truly supporting innovation.In this reprint collection, we provide a compilation of some of the papers which describe issues and solutions for innovation and create a dialogue around which efective strategies can be built. Unmet medical need has an eternal horizon and the ultimate reward for our scientists is to invent meaningful medicines that help humans live longer, active and healthier lives. That is the ultimate reward for all of us who do this important work and contribute positively to solving societys healthcare and economic challenges.Jan M. Lundberg, Ph.D.Executive Vice President, Science and TechnologyPresident, Lilly Research LaboratoriesThis supplement is published by Nature Publishing Group on behalf of Eli Lilly and Company. All content has been chosen by Eli Lilly and Company.2 How to improve R&D productivity: the pharmaceutical industrys grand challenge. Paul, S.M. et al. Nature Reviews Drug Discovery 9, 203-214 (2010); doi: 10.1038/nrd307814 Network pharmacology: the next paradigm in drug discovery. Hopkins, A.L. Nature Chemical Biology 4, 682-690 (2008); doi: 10.1038/nchembio.11823 How were new medicines discovered? Swinney, D.C. et al. Nature Reviews Drug Discovery 10, 507-519 (2010); doi: 10.1038/nrd348037 Development trends for human monoclonal antibody therapeutics. Nelson, A.L. et al. Nature Reviews Drug Discovery 9, 767-774 (2010); doi: 10.1038/nrd322945 Bridging the efcacyefectiveness gap: a regulators perspective on addressing variability of drug response. Eichler, HG. et al. Nature Reviews Drug Discovery 10, 495-506 (2011); doi: 10.1038/nrd350157 Innovative drug R&D in China. Qi, J. et al. Nature Reviews Drug Discovery 10, 333-334 (2011); doi: 10.1038/nrd343559 The impact of mergers on pharmaceutical R&D. LaMattina, J.L. Nature Reviews Drug Discovery 10, 559-560 (2011); doi: 10.1038/nrd351461 Crowd sourcing in drug discovery. Lessl, M. et al. Nature Reviews Drug Discovery 10, 241-242 (2011); doi: 10.1038/nrd341263 The future of drug development: advancing clinical trial design. Orlof, J. et al. Nature Reviews Drug Discovery 8, 949-957 (2009); doi: 10.1038/nrd302573 The case for entrepreneurship in R&D in the pharmaceutical industry. Douglas, F.L. Nature Reviews Drug Discovery 9, 683-689 (2010); doi: 10.1038/nrd32302 | OCTOBER 2011 | THE FUTURE OF DRUG INNOVATION | NATURE REPRINT COLLECTION www.nature.com/reprintcollections/lilly/drug-innovationinnovative and first-in-class NMEs have remained stable at about 56 per year. however, the number of potential revenue-generating drugs (innovative or other wise) as a percentage of R&D expenditures has undeniably fallen sharply.with an estimated $50 billion in collective annual R&D spending by the large pharmaceutical companies, and appropriate allocation over time to the successful discovery and development of NME

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