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Eli Lilly and Company – Tailored Therapeutics and Diagnostics © Eli Lilly and Company 2012 The views and opinions expressed herein and/or during the accompanying.

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Presentation on theme: "Eli Lilly and Company – Tailored Therapeutics and Diagnostics © Eli Lilly and Company 2012 The views and opinions expressed herein and/or during the accompanying."— Presentation transcript:

1 Eli Lilly and Company – Tailored Therapeutics and Diagnostics © Eli Lilly and Company 2012 The views and opinions expressed herein and/or during the accompanying discussion are those of the author and do not necessarily represent the policies, viewpoints, or business of Eli Lilly and Company or its management. Robert L. Sharp Patent Counsel Eli Lilly and Company

2 Eli Lilly and Company- Fast Facts © Eli Lilly and Company th largest pharmaceutical company in the world   38,000 employees;  7,400 employees engaged in R & D  products marketed in  125 countries Mission: Make medicines that help people live longer, healthier, more active lives Strategy: Create value for all our stakeholders by accelerating the flow of innovative medicines that provide improved outcomes for individual patients.

3 A heritage more than 135 years strong Founded in May 1876 by U.S. Civil War veteran Colonel Eli Lilly Three generations of Lilly family leadership defined today’s core values: Respect for people Integrity Thirst for excellence Colonel Lilly’s priorities Manufacture high-quality products Recruit the best employees Satisfy the customer Develop new products Eli Lilly and Company- Heritage © Eli Lilly and Company First research policy established in 1898 “To contribute to the progress of medicine by developing new and superior agents through research.”

4 Lilly’s Strategy - Innovation Driven Lilly’s fundamental strategy is predicated on innovation The science has never been more promising and the need for new medicines never greater Lilly currently has the richest mid-to-late stage pipeline in its history, with  13 molecules currently in Phase III clinical development ―  13 molecules are in Phase II testing ―  22 molecules are in Phase I testing R&D expenditures total  $5 BILLION in 2011 R&D as a percentage of workforce and sales: both  20 percent Cost of a new pharmaceutical – average cost to discover/develop a new drug = $800 to  $1.2 BILLION – average length of time from discover to patient = 10 to 15 years – only one new chemical entity (NCE) out of 10,000 candidates will make it to launch © Eli Lilly and Company 20124

5 5 Eli Lilly and Company – Tailored Therapies and Diagnostics The rise of personalized medicine is one of the most important developments in health care today. Personalized medicine will change health care almost across the board... But nowhere, I would argue, are the cross-currents of change more powerful or the stakes higher than in the development, manufacture, and sale of prescription medicines. In my industry, we would be powerless to resist personalized medicine, not to say foolish. [W]e are not only on board [with personalized medicine], we’re also trying in recent years to... put others on board and our business model will accommodate personalized medicine – in fact, it may depend on it. John Lechleiter – President and COO, Eli Lilly and Co. (now CEO and Chairman) Conference on Personalized Medicine: A Call to Action, Boston, November 29, 2007  Biomarker strategies in place for nearly all molecules at the earliest clinical development stage.  Diagnostics to help demonstrate that a medicine is having the intended effect and will identify: The right patient, the right dose, the right time

6 Evolution of Lilly - FIPNet Copyright © 2012 Eli Lilly and Company6  No single company, industry, agency, or even nation will add very much to improving human health by working on its own. Rather, accelerating the development of new medicines will depend on collaboration, flexibility, and trust. Sidney Taurel– Chairman and CEO, Eli Lilly and Co. Wharton Health Care Business Conference – Speaking on Tailored Therapeutics, March 2008 Fully Integrated Pharmaceutical Network (FIPNet) Access to ideas/capabilities we don't possess; "many sources, share risk, share work” -Lillypedia Being a FIPNET = leveraging external competencies and collaboration will be a primary driver

7 Evolving Complexity Diagnostic Cos. Clinical Laboratories Health Care Providers Patients Pharma Cos. Research Institutions Payers Patent Holders FDA Waived (Class I novel device) 510(k) or “de novo” (Class 2 device, market clearance) PMA (Class 3 device, Pre-Market Approval) Complex, evolving science Complex, evolving, competitive industry Complex, evolving regulatory environment Complex, evolving economics Complex, evolving IP 7 Copyright © 2012 Eli Lilly and Company

8 Patient with diabetes before and two months after taking insulin Lilly researchers collaborated with scientists at the University of Toronto to develop a process to mass-produce insulin. The work resulted in the introduction of the world’s first commercial insulin product in 1923 by Eli Lilly and Company. Why we do what we do - patients © Eli Lilly and Company 20128


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