Eli Lilly and Company –
Tailored Therapeutics and Diagnostics
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
© Eli Lilly and Company 2012
Eli Lilly and Company- Fast Facts
• 10th 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.
© Eli Lilly and Company 2012
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Eli Lilly and Company- Heritage
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
First research policy established in 1898
“To contribute to the progress of medicine by developing
new and superior agents through research.”
© Eli Lilly and Company 2012
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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 2012
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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
© Eli Lilly and Company 2012
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Evolution of Lilly - FIPNet
 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
Copyright © 2012 Eli Lilly and Company
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Evolving Complexity
Payers
Patent Holders
Diagnostic
Cos.
Clinical
Laboratories
Complex, evolving science
Complex, evolving, competitive industry
Complex, evolving regulatory environment
Complex, evolving economics
Complex, evolving IP
FDA
Pharma
Cos.
Research
Institutions
Patients
Copyright © 2012 Eli Lilly and Company
Health
Care
Providers
Waived (Class I novel device)
510(k) or “de novo” (Class 2 device, market
clearance)
PMA (Class 3 device, Pre-Market Approval)
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Why we do what we do - patients
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.
Patient with diabetes before and two months after taking insulin
© Eli Lilly and Company 2012
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