Essay on Eli Lilly

This paper hopes to share insight into the steps that are taken by companies, and the strenuous process behind developing an effective new drug.

Phase 3 clinical studies - Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Eli Lilly’s decision to create a joint venture was not surprising (figure 1). The India government limited foreign direct investment to 51%, importing was subject to manufacturing at high costs outside the country and then paying high importation tariffs, and licensing was not prudent due to an absolute lack of product patents laws that were needed to protect Eli Lilly’s intellectual property.

There are several phases and applications to complete for drug development in the United States. The three basic stages in the testing process are preclinical, clinical, and approval. The first step of preclinical usually lasts anywhere from one to six years. During the preclinical phase, toxicology studies on the ingredients are collected and drug testing

The FDA is and agency that falls into the Department of Health and Human Services under the Executive Branch, probably the most interesting agency in my eyes because of its importance in the nation and how a mistake from them or maybe a wrong move can be lethal. This very important agency can actually be traced back to the 1800's but bills were placed after it earlier agencies to become what it is today after protests and cries of those living in the nation around the early 1900's. (Office of the Commissioner) Its food we are talking about and food is something we insert into our body including the drugs we take. Therefore, it involves with our daily lives and with them being around it can protect us form the threats of health out there.

The objectives and goals of Allstar are to look for new opportunities in emerging market with support from healthy and growing cash flow, to introduce new product, to maintain leadership and to maintain long-term profitability and market share in an increasingly competitive and changing environment.

In the year of 2017, I would think 99% of the population of the Western world would believe in the life saving abilities and precautions vaccines are able to provide. But recently, a new wave of danger has befallen the mommy bloggers and soccer moms. The fear of bearing autistic children ‘brought about by vaccines’ is too much for these moms, they couldn’t watch their child suffer such a fate. So what’s their solution to protect their precious miracle? Ultimately, sacrificing the overall physical health of the child, as well as the children around them by depriving the child of a good, healthy start in infancy in exchange for non-medical protection. One making such an ill-informed, naive, and selfish decision for their child ultimately

1. On balance, do you think Merck is an ethical and socially responsible company? Why or why not? How about Pfizer?

The first step in developing a drug is pre-clinical testing. The experimental drug is tested in a laboratory and in animal studies. The drug has to meet safety standards and show potential for being a new drug. If this criterion is met, the drug moves on to the next phase. Phase 1 is concentrated on making sure the drug is safe to use on humans. This is the first time the experimental drug is used on people. Different measures of dosages of the drug are given to a small number of the volunteers. This allows the researchers to be able to measure the body’s response to the drug. The things they measure include how the drug is absorbed, its duration in the bloodstream, and what dosage levels are safe and well accepted by the body. If the experimental drug is deemed safe, it passes on to Phase 2 (Phases of Development, par. 6-7).

* No foreseeable new product in pipeline. Currently takes up to 11,000 compounds to be screened to find one (1) compound to send through final testing (human trials). And even then it’s not guaranteed to make it past the FDA.

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.

3. Collaboration with similar companies in search and development of new products and thereby decreasing the competition for resources within the company.

Eli Lilly & Company (Lilly) was founding in 1876 by Colonel Eli Lilly in Indianapolis, Indiana. A veteran of the United States Civil War and a pharmaceutical chemist by trade, Lilly set out to start a company with three underlying goals. First manufacture high quality pharmaceutical products, second medications would be dispensed by medical staff rather than through a mobile tradeshows which was popular at the time, and finally, Lilly’s medication would be developed using current science data. In 1886, Lilly went on to hire a pharmaceutical chemist which led to Lilly’s esteemed research and development history that they are known for to this very day (Lilly, 2015).

The Eli Lilly Ranbaxy joint venture allowed both Eli Lilly and Ranbaxy as separate companies to grow and expand as one venture. The support and reliability that both companies had with one another allowed for a strong business relationship to form which led to the same business strategy vision and goals. This joint venture eliminated trade with other companies for the same thing that one another could share to become one of the largest and most successful pharmaceutical companies in the Indian market. The problem that Eli Lilly Ranbaxy was being exposed to was a plateau of success with a joint venture and the thoughts of separating and selling stakes became an option. The companies together touch every target market

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001;