Merck and Lab Pharmaceuticals Case Study

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.

A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

* we did not take time of the different dental procedures into consideration. This is because I thought that the clinic would never get full, so there would never be a bottleneck situation where patients would have to wait that long that they would leave for the competitor.

The company is so large that no one drug can lift it from its current sales doldrums. In addition, the company was once highly attractive to investors, but its recent stock price fell to 1997 lows. This may put pressure on the company to attempt acquisitions at a time when the company is ill-equipped to integrate a new company into its organization, and it is engaged in a cost-cutting program at a time when it may need to invest even more in research and development (McTigue Pierce, 2005).

2. For projects that seemed to have medical effectiveness in Phase I and II clinical trails, GMP would forecast market potential to see whether these products should be terminated or moved forward.

The reason for this is that are typically several hundred patients. The point of Phase III is to determine if the new drug is better than the standard of what is already out there. Participants are chosen randomly and are chosen to get the new drug or the standard treatment. It is very important that neither the doctor nor the patient know which type of drug they are getting. If this happens then the trial is no longer effective as the results would not be a true comparison.

This paper will research the Product recall involving the Drug Company known as Merck, who produced the drug Vioxx use to treat osteoarthritis, and acute pain in adults. Looking at the relationships Merck had with government and lobbyist one can see what actions the drug company may have taken to lead them to this recall. In Addition, This paper will look at the actions Merck took in the approval process and recall of their drug. Using all information provided on this case this paper will decide whether Merck was ethically correct in bringing the drug to market and if they took the right steps in recalling it. Finally I will discuss the other stakeholder responsibilities and provide solutions to prevent this from happening in the future.

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.

Research and Development: Merck is a research-driven company that has a new research and development model incorporating its business strategy. Merck hopes to improve the success of is R&D and to reduce costs by focusing on therapeutic areas that have unmet medical needs, and scientific and commercial opportunity. It plans to develop products within these therapeutic areas that are highly valued by patients and doctors.

Since its humble beginning as a small drugstore, Merck has placed a large amount of importance on improving the health and well-being of its customers. As drug patents expire and genetic forms of their top products become available, Merck’s strategy is to do the unexpected; instead of raising the price of their older products in favor of patent protected new drugs, Merck focuses on reducing their cost in order to better compete with their generic counterparts. Additionally, Merck’s plan for growth now encompasses a much more aggressive pursuit of new drugs in their pipeline through extensive research. Merck became the second largest health care company in the world after the merger with Schering-Plough in 2009 and has

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;

* Competitive Pricing – Merck is sometimes forced to lower prices of products, either ones that have gone off patent to maintain market share in the product, as well as for products that are still on patent in order to compete with rival products for the same treatment that are marketed by competitors

Drug portfolio management is one of the most important determinants of long-term prosperity of research-oriented pharmaceutical companies.

Overall, because Expected value of NPV > 0 and IRR > WACC, both results are consisted and strongly recommend the purchase of the Pathrite System. After the calculation, the result of NPV which by using nominal cash flow and nominal WACC is the same as which using real cash flow and real WACC.

Merck and Co., Inc. was, in 1978, one of the biggest makers of physician endorsed sedates on the planet. Headquartered in Rahway, New Jersey, Merck followed its starting points to Germany in 1668 when Friedrich Jacob Merck obtained a pharmacist in the city of Darmstadt. More than three hundred years after the fact, Merck, having turned into an American firm, utilized more than 28,000 individuals and had operations everywhere throughout the world.