Eli Lilly: Recreating Drug Discovery for the 21st Century

Presented By:
Gayatri GiriShanker Hemanth Hima Harita Indulekha Jaydevan Jyothilakshmi Karthik Keerthi Ashok Keerthi Chandran

Parent Company Founded Category Tagline/ Slogan USP

Eli Lilly & Co 1876 Pharmaceutical & chemical Transforming challenges in advances Lilly makes medicines that help people live longer, healthier, more active lives 24.8 billion

Annual revenue

VISION
It has a more sophisticated and complex business facing

environmental pressures. Drawing scientific, technical and business expertise to serve patients, meet the community's needs and reduce our environmental footprint. Developing collaborative, strategic initiatives that both serve society and enhance business performance Aligning the business with pressing social needs opens up new opportunities to provide greater value to people around the world. A special focus on improving the health of underserved people in low- and middle-income countries around the globe through The Lilly Global Health Innovation Campaign

 To improve global health by helping expand access to

medicines, by working to strengthen policies that foster better health Collaborating with governments and other stakeholders builds trust and reinforces the mutual interest in bringing value to patients and society Launch of Lilly Pad, a blog that focuses on public policy issues, such as health and wellness, innovation, and job creation, as well as our corporate responsibility initiatives and advocacy efforts.

ACCOMPLISHMENT OF VISION

We will lead the industry by

LEAD ON VALUES AND BRAND

Build relationships with all key constituents patients, payers,

physicians, regulators to understand what they value

Deliver quality, innovative medicines that improve individual

patient outcomes. Tailor medicines for the right patient, delivered in the right dose and at the right time.
Build upon our expertise in therapeutic areas which today are

neuroscience, endocrine, oncology, and cardiovascular and seize opportunities in other areas.
Combine our deep therapeutic expertise with both our small-molecule

and biotechnology capabilities.

 Create and integrate external networks to access molecules, capabilities and

capacity. Demonstrate the value of our products in ways that are meaningful to our customers.
Earn the trust and respect of everyone we touch by the way we operate our

business and our commitment to patients and society.

Influence our environment to reward innovation. Hire and develop leaders who are motivated to make a difference in the lives of

patients.
Create an agile organization and a culture of inclusion to access the best

ideas and capabilities and to reflect the diversity of the patients we serve.
Execute better than our competitors.

TARGETED THERAPEUTICS
Focus on high value niche products

Targeting therapies to specific subpopulation of patients

and capturing those niche opportunities with highly effective products Relationship with diagnostic companies Presented idea as a part of executive program-Leading in Lilly and in a series of town hall style talks DVD made available on companys intranet

FIPCO vs TARGETED THERAPEUTIC MODEL

Conventional FIPCO 1. Large patient populations 2. One size fits all products 3. Few large products generate majority of revenue Targeted Therapeutic FIPCO 1. Targeted patient populations 2. Customized treatment 3. Many equally sized products generate most revenue

4. Mid-sized R&D portfolio 5. Dedicated manufacturing focused on few, high volume products 6. Primary care large sales force

4. Large R&D portfolio 5. Highly flexible manufacturing capability 6. Specialty, technical, smaller sales force

TAILORED THERAPEUTICS
Can narrow the target population of patients, tighten up

dosing guidance based on various criteria, address the timing of therapy, or provide better information to patients Insulin

TAILORING SCENARIOS
Tailoring Drug Engineering therapies with a specific patient sub population in mind

Identifying Patient best suited for drug

Tailoring Dose Tailoring Time

Identifying those patients for whom benefits outweigh risks

Optimizing dosing regimen for patient subpopulation to achieve optimal benefit/risk Identify the time to intervene during disease progression, the time to complete therapy, or time to alter treatment Accommodate information for patient diversity, questions specific to prayers or providers, or provide tools to meet needs of customers.

Tailoring Information/Tools

Tailored based patient characterization

Quintile 1 Descriptors, preferences, behaviour, Attitudes Quintile 2 Patient preference, Progression of the disease, Biochemical markers, Quintile 3 Risk prediction tools, outliers identified, Clinical studies, Differentiation can be important

 Quintile 4 Multiple target exists, Phenotypic analysis, Individualized dosing Quintile 5 Predictable health outcomes, existing polymorphism which defines disease or risk of disease, well defined disease phenotype

BUILDING CAPABILITIES
Lillys organizational structure was fundamentally functional,

with research and development structured as a tightly integrated matrix. Lilly also set aside roughly $100 million to develop the new capabilities needed to support the tailored therapeutics strategy. They identified and build capabilities in the given areas: R & D Sales and Marketing Manufacturing

RESEARCH AND DEVELOPMENT

A cross functional Tailored Therapeutics Review Panel for

identifying and overseeing the building of capabilities within LRL . Integrative informatics and diagnostics were identified as the two capabilities that most needed to build.
INTEGRATIVE INFORMATICS Entailed pulling together data generated across various functions and

attempting to use it to generate hypotheses as to where tailoring could be applied. A tailored therapeutics workbench described as a visualization tool, was designed to help people think about how to look at data across medical, pharmakinetics and discovery, to observe trends, and generate hypotheses.

 Having access to this information across the value chain

enabled to generate better hypotheses, and to understand diseases and how patients react to certain drugs. It had limited development and no diagnostic commercial experience. Company had fee-for-service arrangements with a wide range of companies including small biotechs and large diagnostic companies.

 Gaps that had been identified with regard to the companys

diagnostic capabilities included: Diagnostic partnerships that provided a virtual capacity Internal legal diagnostic IP core competency and awareness of how phase-appropriate IP and asset protection strategies impacted options for diagnostic development Stored/banked tissue specimens required to expedite diagnostic registration in late phase drug development Resources required for functional support, esp. legal Lilly continued to build upon its existing biomarker capability

Sales and Marketing

The central sales and marketing is responsible for

planning of new product. Marketing and sales messages would be less about how a tailored therapeutic is better than competing products. Marketing organization tries to find more and better ways to integrate with developed organization.

MANUFACTURING
Flexibility is the key capability that Lilly needs to possess

when it comes to manufacturing. Manufacturing requirements is less predictable than they were under the traditional FIPCO model.

STAKEHOLDER CHALLENGES
Patients Patients Compliance. value proposition offered by targeted medicine, ensuring

that patients took their medications Collaboration among companies, providers, payers, and the government

Providers
Education is needed on how targeted therapies could

work on smaller patient populations Ensure that clinical information systems would be able to accommodate personal medicines increased data and networking demands. Prepared to either provide these services, which would require additional staffing, or to outsource them.

Payers
Significant roadblock for both the development and use of targeted medicines due to the fact that reimbursement procedures were geared toward the one-size-fits-all blockbuster model.
Inadequate reimbursement was a key reason why companies were not developing diagnostic products. Payers pertained to patient data.

Diagnostic Firms
Diagnostic companies put themselves at financial risk by

developing a diagnostic for a drug that was years away from market approval, assuming it won approval. Development cycle times and the costs for drugs and diagnostics were quite different: 10-13 years for a drug at a cost of $1 billion compared to 1 to 2 years for a diagnostic at a cost of $1 million to $2 million.

Regulatory Body
Many players in the industry complained that the agencys

approval procedures had not kept up with the advancement of drug development.

Pharmaceutical Companies
Greater collaboration and sharing of information

throughout the industry. Transparency around clinical trials in pharma was a right step. Disclosing clinical trials helped to learn from each others work and to improve their credibility.

Five Forces Model

Competitive Force 1: Rivalry among existing firms. Eli Lilly (Lilly) is a leader in a somewhat competitive pharmaceutical industry. Major competitors are Pfizer Inc., GlaxoSmithKline PLC, and Novo Nordisk A/S. Competition in this industry is primarily based on product differentiation. The exit barriers in the pharmaceutical industry are very high which makes this industry that much more competitive. Lilly is a very specialized company, focusing solely on pharmaceuticals.
Competitive Force 2: Threat of New Entrants
The threat of new entrants into this highly specialized industry is very low. There is a big first mover advantage for those companies such as Lilly that have

been in the industry a long time and have a big investment in research and development built up. There is a very steep learning curve in the pharmaceutical industry which also prevents competitors from entering the market.

 Competitive Force 3: Threat of Substitute Products.

In the pharmaceutical industry there is a somewhat substantial degree of

product substitution with many drugs being offered to treat the same illness. The threat of substation lies not with the end user, but with the doctor that prescribes the medication. Drug companies such as Lilly spend a great deal of resources to send out drug reps. to inform doctors of new drugs on the market. In order to have an advantage over its competitors a drug company has to spend extensive amounts of money on research and development costs, as well as marketing in order to discover and sell new and innovative drugs. The drugs ability to successfully cure whatever illness it is designed to cure is the basis of the industry. Therefore, the company that comes out with the best drug will have a considerable share of the market for curing that particular illness for as many years as it has a patent on that drug.

 Competitive Force 4: Bargaining Power of Buyers.

The bargaining power of buyers is intermediate in the pharmaceutical markets the

same holds true for Lilly and Co. Two elements of bargaining power of buyers are price sensitivity and relative bargaining power. Buyers are less sensitive to price because Lilly produces some drugs that have no substitutes and are not replicated in the generic drug markets.

Competitive Force 5: Bargaining Power of Suppliers.

The bargaining power of suppliers is low because there are many drug suppliers

that produce generic compounds that are used in a great number of pharmaceutical products. Lilly purchases large quantities chemicals and chemical compounds many of which are used in more than one type of drug.

SWOT ANALYSIS
STRENGTHS Strong capability to create strategic alliances & marketing partnerships with other corporations Strong marketing ability Well developed in house R&D capability Global footprint & ability to sell drugs all over the world They employ more than 7000 people in LRL spanning 50 countries Worldwide product availability OPPORTUNITIES Improvement global living standards Increasing awareness about healthcare needs Global societies growing older WEAKNESS Loss of patents in US & other major market affects performance Drop sales because of new generic products Eli Lilly has captured fragmented market shares which prevents it from becoming market leader

THREATS Over the years there is considerable increase in generic Economic slow down Increased hurdles for drug discovery & development