Medicine Development

The research-based pharmaceutical industry is uniquely able to discover, develop, and produce lifesaving medicines for patients To make the best use of our R&D investment and provide the greatest benefit to patients, we largely concentrate in therapeutic areas in which we have deep expertise, including diabetes, neuroscience, cardiovascular diseases, and oncology. We seek to develop pharmaceuticals that are "first-in-class" (i.e., creating a treatment where none existed) and/or "best-in-class" (i.e., improving on existing treatments). Here is how the process unfolds in the United States.[1]

What does it take to produce a successful drug?*

*Figures provided are capitalized, meaning they account for the cost of capital to complete each phase.

Drug Discovery

Lilly discovery scientists search for biological targets within the body that play a role in a given disease. They create or find unique molecules that might someday be medicines, and they screen millions of molecules against the targets to pick promising leads.

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Preclinical Trials

Preclinical trials assess the potential safety, toxicity, and efficacy of compounds, as evaluated through laboratory and animal studies.

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Clinical Trials: Phase I

Phase I clinical trials determine the safety and dosage of a new drug candidate, and are conducted with an average of 20 to 80 healthy human volunteers or patient volunteers with the disease being studied.

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Clinical Trials: Phase III

Phase III clinical trials continue to evaluate the efficacy of a new drug candidate, and monitor adverse reactions from long-term use. Phase III trials involve an average of 1,500 to 2,500 patient volunteers with the disease being studied. In some cases, however, as many as 15,000 to 25,000 patients are needed for Phase III.

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Regulatory View

In this phase of the drug development process, a new drug application (NDA) is filed with the Food and Drug Administration (FDA). The drug is either approved or rejected.

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Lilly has a rich history of creating breakthrough products that enhance and preserve life. Today, our commitment to scientific research and development remains as strong as ever, and we've developed some innovative approaches that are helping us speed the creation of new medicines. Yet we recognize that the responsibilities we have go far beyond the laboratory.

 

Lilly Global Patient Safety Organization

Lilly’s global patient safety organization is a team of more than 300 individuals, including physicians, pharmacists, nurses, and other drug-safety professionals. This group leads the company's efforts to report adverse events* and continuously monitor the safety of Lilly's products through their entire life cycle, including the identification of changes in the benefit/risk balance.

* The FDA defines an "adverse event" as any undesirable experience associated with the use of a medical product in a patient.

 

At all stages of the development and use of our medicines, Lilly strives to maintain the highest standards of ethical behavior. This begins with our bioethics program and guiding principles and is reflected in our commitment to safeguard and protect the rights of people who participate in our research and use our products. It is also reflected in our commitment to use animals in research only when needed and to ensure their humane treatment.

The Drug Development Process

To make the best use of our R&D investment and provide the greatest benefit to patients, we largely concentrate in therapeutic areas in which we have deep expertise, including diabetes, neuroscience, cardiovascular diseases, and oncology. We seek to develop pharmaceuticals that are "first-in-class" (i.e., creating a treatment where none existed) and/or "best-in-class" (i.e., improving on existing treatments).

Today, Lilly is generating potential biotech solutions (using therapeutic proteins or antibodies to treat disease), alongside more traditional chemistry-based work to deliver innovative treatments for a wide range of diseases, including cancer, multiple sclerosis, diabetes, osteoporosis, rheumatoid arthritis, and Alzheimer's disease. Review our current pipeline.

[1]We have adapted the phase chart from PhRMA and supplemented it with cost data from a recently published article on R&D productivity: Paul S, Mytelka D, Dunwiddie C, et al. How to Improve R&D Productivity: The Pharmaceutical Industry's Grand Challenge. Nature Reviews Drug Discovery. 2010; available from: doi:10.1038/nrd3078. Accessed October 25, 2011.