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Innovation in Medicine

Lilly is a global research-based pharmaceutical company where new and highly innovative pharmaceuticals together with disease prevention and management capabilities and information technologies are forming creative and effective new health care solutions for patients.

The convergence of pharmaceutical science and information technology is providing unprecedented opportunities to better understand and address people’s health care needs and to positively affect the prevention and management of diseases. By improving communication among patients, health care providers, pharmacists and those who pay for care — all those involved in the delivery of health care — Lilly is improving the quality of health care and helping lower the costs.

The Lilly Pipeline

Lilly scientists are concentrating on diseases that take a huge toll in human suffering and that create enormous costs for health care systems throughout the world. Over the past five years, Lilly has devoted nearly $4 billion, or 15 percent of sales, to research and development of medicines that can improve health and save lives.

As part of its strategy, Lilly is targeting specific research priorities in these five disease categories: central-nervous-system and related diseases; endocrine diseases; infectious diseases; cancer; and cardiovascular diseases.

These research priorities include, among others, Alzheimer’s disease, schizophrenia, pain, depression, diabetes, osteoporosis, cancer, stroke, drug-resistant diseases and heart disease. The company’s research pipeline includes promising compounds for a number of these afflictions.

Lilly has proven internal capabilities in many areas of pharmaceutical discovery research, including medicinal chemistry, computational chemistry, biochemistry, and molecular biology. As a result of Lilly development of human insulin and human growth hormone, for example, the company has accumulated enormous experience in synthesis, development, clinical evaluation, and registration of biosynthetic products. No company has had more experience than Lilly in the large-scale production of biosynthetic compounds.

Drug development involves a great amount of risk. It is important to note that, historically in this industry, only 12 percent of compounds that make it to the research phase just prior to clinical trials are ever marketed. Bringing a product to patients — from preclinical evaluation to market launch — traditionally has taken 15 years. Furthermore, only 1 in 10,000 compounds investigated becomes a marketed medicine. Lilly has implemented plans to cut that time nearly in half, aiming for seven years from pre-clinical to the formal product launch to patients.

The Drug Development Process — From Discovery to Launch

Pharmaceutical product development begins with discovery research, which is responsible for identifying new chemical entities that may be useful for treating a disease or disorder. In selecting compounds to study, researchers consider whether a new compound satisfies unmet medical needs or how a compound might compare with pharmaceutical products already available. Once a compound is approved for further development, a comprehensive plan is prepared that will guide the compound through the development process to product launch.

Compounds identified as candidates for further development undergo extensive testing to ensure they can be safety administered in humans. Appropriate regulatory submissions also must be made to gain approval to administer the first human dose. Quality checks are built into the development process to evaluate the scientific information gathered and the implications for administering the compound to humans.

Once approval to administer the first human dose is obtained, the clinical trials begin. In Phase I trials, compounds typically are given to healthy human volunteers first in single doses well below anticipated therapeutic levels, then in gradually increased amounts to determine tolerance to the compound. The main purpose of these studies is to establish the safety of the compound across a dose range. When these pharmacology studies are completed, a thorough review is conducted to evaluate the clinical results to determine if the compound has met objectives and is safe for further evaluation. Once the safety of a drug substance has been reviewed and it is approved for further studies, investigators enter Phase II of clinical trials to study the effect of the drug candidate in a few patients with the targeted illness to determine if a therapeutic response is produced.

As a result of these studies, a decision is made whether to proceed with a project — based on efficacy and safety data. A positive product decision triggers the implementation of a global registration and commercialization phase.

Approximately 90 percent of all patients and volunteers who will have been studied prior to market launch of a new drug are enrolled in this third phase of clinical trials. These Phase III studies may also demonstrate the potential advantages of the new compound compared with other similar compounds already marketed.

With a successful conclusion of clinical research, the company prepares for review and approval by regulatory agencies worldwide and prepares to market and supply the product to patients as soon as it is approved. When new pharmaceuticals are introduced to the marketplace, the company initiates information and education programs for physician specialists, other health care providers and patients about the uses of the new drug, the primary mechanism of action, the dosage form and regimen of treatment, side effects, and advantages compared with other available therapies.