Leading drug development companies
Abstract: Drug discovery and development is a complex, high octane, high risk and potentially highly rewarding endeavor. Companies literally burn cash to push through the arduous process, to the tune of $802 million per drug. Why is it so high? Who's paying for it? Can this be sustained?
The development of a new drug requires a major investment of capital, human resources, and technological expertise. It also requires strict adherence to regulations on testing and manufacturing standards before a new drug can be used in the general population. All these requirements contribute to the cost increases for a new chemical entities (NCE, i.e., new drug candidate) research and development (R&D). The central question raised by this trend is who will pay for new pharmaceutical R&D?
With this question in mind, this article has three objectives: 1) to describe how the environment for pharmaceutical R&D has changed over time and the effect of these changes on the R&D process, 2) to summarize available information on the cost of drug discovery and development for NCEs, and 3) to consider the societal value of new drugs. The focus is on the United States, as the largest pharmaceutical market, and for which the relevant literature is most comprehensive, but many of the issues discussed are similarly important in the other major markets.
The Changing Environment for Pharmaceutical R&D
Trends in the type of new drug development. Drug therapy has developed in response to population health care needs to the extent that resources and technology permit. The most recent trend has been to pursue drugs for the treatment of chronic diseases, especially those that most commonly afflict the aged. Of the three leading causes of death — cardiovascular disease (CVD), cancer and stroke — CVD is the biggest killer. In the United States alone, the cost of treating CVD will exceed US $368 billion in 2004, and CVD claims more lives each year than the next seven causes of death combined. As with all health-care technologies, drugs are improved through continued research, without which there would be no advances in treatment.
Although there have been some new uses for older drugs (i.e., thalidomide) and some very old drugs continue to be used today (i.e., digoxin), the drug therapy used today is much improved from even 20 years ago. There have been marked improvements in long-established drug classes (i.e., atypical antipsychotics) and entirely new classes of drugs (i.e., statins) that offer major improvements over previous treatments have emerged. There are now drugs for conditions that were previously without treatment (i.e., Alzheimer’s disease), and the emergence of HIV/AIDS in the early 1980s points to the need to expect the unexpected.
The new drug approval process. In the United States, as in most countries, there is a formal process by which new drugs are approved for marketing. The standards of evidence for new drug approval are similar across countries, although the process may differ. An overview of the drug approval process, shown in Figure 1, demonstrates both its complexity and why it is time-consuming.
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American drug companies - guilty ofby UnpatrioticBehavior
During the Vietnam War the Department of Defense learned that the second leading cause of hospitalization for the troops was malaria. Fed up by the refusal of the profit glutted drug companies to research for new medicines, the Department established its own in-house, first class drug research division at Walter Reed Institute of Health. Many new medicines to treat malaria and other tropical diseases were discovered and made available to the world with staggering efficiency compared to the private drug companies. These drug companies continue to avoid investing their money in vaccines or other related medicines needed for Americans and natives in tropical regions
And yes i agreeby sub_peachies
That having conversations and doing the research and development for treating these type of diseases is a wonderful thing. I am hopeing that they come through with greater coverage and better accuracy. It is a great thing to see that drug companies are at least listening and starting to make the effort to protect women from the leading causes of death and disease. It is about time for them to be doing that too :)
I do hold an opposition to making things government mandated though, maybe a little of my defiance showing through there...
have a great class!
Considered the founder of the biotechnology industry, Genentech has been delivering on the promise of biotechnology for almost 30 years, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs. Today, Genentech is among the world's leading biotech companies, with multiple products on the market for serious or life-threatening medical conditions and over 30 projects in the pipeline. The company is the leading provider of anti-tumor therapeutics in the United States. With its strength in all areas of the drug development process from research and development to manufacturing and commercialization Genentech continues to transform innovative science into breakthrough therapies for patients.
A patient dies, and Elan stock takes diveby 33rdAve
The share price of one of Ireland's biggest companies collapsed on Monday, in a move that sent tremors through financial markets on both sides of the Atlantic. Elan saw $7 billion knocked off its value in a single day's trading after the company and its partner, Biogen, suspended sales of their new drug, Tysabri, following the death of a patient
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Tysabri is used to treat multiple sclerosis. It was launched with considerable fanfare in November, and had been expected to reinvigorate Elan's fortunes
Inform Genomics and Translational Drug Development (TD2) Announce .. — MarketWatch
.. LLC (TD2) based in Scottsdale, Arizona, today announced a strategic collaboration leveraging Inform Genomics' proprietary technology platform and analytic capabilities to biopharmaceutical companies through TD2's oncology drug development services.