Antegren Case Study

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

To better understand the issues associated with the prescription drug industry, it would first be best to understand their development and approval process. For a new drug to enter the market, it must first undergo a lengthy and often expensive research and development. Once a company submits an application for a new drug, it is their responsibility to provide the evidence showing its safety and effectiveness. Until they have undergone these criteria of guidelines and standards set in place, they will not receive FDA approval.

Merck is one of the biggest pharmaceutical companies in the world today. Although encountered with success, it still faces many problems today while trying to be the market leader competing against its competition. While being research and development driven company, Merck now has to go beyond R&D to stay competitive in the pharmaceutical industry. The main issue that seems to come up is that how far it can progress with the dual challenge of hitting peak annual financial performance while keeping the research pipeline full continued to weigh on senior management. Through the late 80s to early 90s, Merck was able to boast

The company “23andMe is a personalized DNA service providing information and tools for individuals to learn about and explore their DNA” (23andMe Canada - How Does it Work?). I do think the company should get FDA approval since science should be taken seriously, no matter what the context.

In December 2005, name of the company submitted an NDA to the FDA for approval for

But researchers are notoriously difficult to manage. A strategic plan cannot force a research breakthrough. Within Amgen therefore 20% of the researchers’ time is free to use as they themselves see fit.

Medtech is a pharmaceutical company that has been working on developing cancer drugs for the three years. They have worked on getting them through clinical trials and getting FDA approval for three years. Unfortunately, after working so much on getting the drug approved, they did not have a sales team ready for when the FDA approval came through. They would need to work quickly to get their sales force in place because they only have seven years to maximize on their return.

The strategic implications for Vertex attempting to fund and develop four drugs are as following:

Early in 1997, Genzyme Corporation began negotiations with Geltex Pharmaceuticals in an attempt to launch a joint venture to market Geltex's first product, RenaGel. Geltex was a young biotech research company with only two products in its pipeline, and they didn't have the resources necessary to launch RenaGel on their own. Genzyme, on the other hand, was a quickly growing company that experienced revenues of $518 million in 1996. They were attracted to the joint venture with Geltex because of the likelihood of increased earnings, as well as the joint venture being an excellent fit for Genzyme's specialty therapeutics. Genzyme also felt that the joint venture would lead to a similar deal in launching Geltex's second product, CholestaGel.

So why did the FDA approve this if it needed more time? Apparently a former executive of Monsanto now works in FDA as

Achieve a median composite eight-year product development cycle by 2010. Deliver two new molecular entity (NME) launches on average per year from 2010. In order to achieve the above objective, ensure that we have 10 or more NMEs in Phase III development by 2010. Development cycle times and quality for small molecules and biologics. Number of NME launches per year. Attrition rates. Number of development projects by phase. Number of in-licensing deals, alliances and acquisitions. R&D investment levels. Improving R&D quality and speed through leading-edge science, effective risk management and decision-making and overall business efficiency. Maximising the value of our biologics business and continuing to build a major presence in this fast-growing sector. Investing in external opportunities to enhance our internal innovation through in-licensing, alliances and acquisitions. 2008 target exceeded for small molecule development cycle times. NME and life-cycle management progressions

Trends in regulatory publishing can actually be understood easily by first understanding the trends in regulatory submissions. In a review publication, the authors discussed the data obtained by CDC in December 2002 in a global survey designed to provide insight into emerging and future trends in regulatory submissions. The authors mentioned that 105 responses from the regulatory departments at pharmaceutical, biotechnology, medical device and contract research organizations were received and analysed. The majority (56%) of participants in the survey were from the United States, while the remainder represented various European countries (11% Germany, 8% United Kingdom and 7% Ireland).