Drug development This entire section on drug development highlights concerns which are very particular to the industry. They therefore lead to the implementation of CSR activities which are also very industry specific, although aspects such as animal testing and ethics in research can be shared by other industries such as the cosmetics industry, or the medical device sector for instance. Need for R&D and innovation Today, the need for R&D and innovation is great, maybe greater than ever. In the developed world, access to medicines is becoming a society’s demand and an ever increasing expectation from patients. Yet, in spite of the significant amount of medicines that have been developed over the decades, there are still many diseases which have not been addressed or for which appropriate treatments have yet to be developed. Many patients suffering of orphan diseases (or rarely occurring diseases) are waiting for appropriate treatments, and parents with sick children desperately watch for medicines adapted to pediatric needs. Additionally, in the developing world, thanks to globalization and global communication, people are more aware of what treatments are potentially available and, in return, have increased expectations. Moreover, populations are rising, and on the whole, aging. People are living longer and rightly expect appropriate care all along their life. Finally, and as seen recently in the case of the porcine flu, the event of a pandemic, and its potentially devastating effects on a global scale, is something that humanity has to face on recurrent occasions, calling for fast and efficient drug development and easy access to most populations. All these factors contribute to the fact that research and development (R&D) re... ... middle of paper ... ...otential new drugs, only a dozen will make it to preclinical trials. Eventually, after clinical trials on animals then humans, only one or two of the original 10,000 molecules will make it to the ultimate marketing authorization stage and commercialization to patients (Les Entreprises du Médicament, 2008). Overall, the process will take 7 to 12 years to complete, with a cost of development reported to be US$800 million for each drug (Dickson & Gagnon, 2004). Understandably, with such lengthy processes and need for extensive investment, and given the fact that developments of drugs are the endeavors of private entities, only companies with substantial profits can re-inject their benefits into research and development. This not only limits the number of companies that can perform R&D but also potentially affects the span of diseases that can be studied and addressed.
Case 1: In this case. As a certified public accountant, Erickson oversaw and initiated an arbitrary adjustment to increase cash and decrease accounts receivable. Also, Erickson signed Form 10-K with full knowledge that the financial statements include therein incorporated entries misstating revenues. As we can see from this case, Erickson’s behavior not only violate the Business and Professions Code, Division 3, Chapter 1, § 5100(g) and (i), but also against the ethical theories.
The pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals compounds for medical purpose. Pharmaceutical companies produce generic, brand medications and medical devices. The industry is subject to a complex regulatory environment regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs.
When people think of pharmaceutical companies, they instantly associate the word pharmaceutical with medicine. There are scientists solely dedicated to find the remedy to cancer and incurable diseases. These professionals have devoted their educated lives to help the ailing human population recover.
Blockbuster drugs are usually a significant therapeutic breakthrough compared to previously available therapies. However greater therapeutic value alone is not enough for cr...
Medical science has undergone a great revolution, it is getting better and more advanced than it was some decades back. In spite of such breakthrough advancement there are several diseases that don’t have a cure yet. A very hefty amount is being spent every day
The time and cost it takes to put a drug through the trials as well as the FDA’s regulations make the rarely successful process a huge commitment for these drug companies. Next, the author compares the cost of drugs to the amount of lawsuits the companies receive. There are many risks to mass-producing drugs and with the FDA siding with Public Safety, the author states that drug companies can lose a lot of money. This is because the FDA is not willing to take any risks in approving drugs due to the repercussions being so severe, The final idea the author discusses is the process of research itself. The drug companies revenue is put towards developing new drugs that will help the public. This can be a very costly process which is why a lot of money is needed to support the research. Epstein’s purpose in writing this article is to defend the rising costs of pharmaceutical drugs in order to get people to understand the drug companies point of view and contributions to society. This article can be considered credible because it comes from Opposing Viewpoints in Context. This is a very reliable database for gathering
History: Humans have been trying to cure disease and illness for thousands of years, only truly succeeding in 1796. Edward Jenner created the firs...
The FDA offers programs called clinical trials where a new drug is tested in patients, but the patients are only considered when every other treatment option has been exhausted (Falloon 4). Clinical trials are also selective, as only people of certain ages, sexes, and types or stages of disease with previous treatment are even considered to participate (Inside Clinical Trials 2). This causes almost ninety seven percent of terminally ill patients to be ineligible for a trial (Corieri 3). Also, clinical trials only allow a small amount of people, with only between 20 and 80 people chosen to participate in phase 1 (Inside Clinical Trials 2). With this margin, even ...
trials of investigation medical products. The FDA also has to review and approve in a
With today’s technology, we are capable of doing countless features such as coming up with new medical innovations to treat diseases and other medical related issues. Since we now
The Indian pharmaceutical industry enjoys certain advantages, which include low cost of innovation and capital expenditure, and strong domestic support in production, from raw material requirements to finished goods. The competitive structure of the pharmaceutical industry was being redefined due to the threat of new entrants, intense price competition, entry of large players, and new regulations and rules as well as a shift in focus. In addition, the partnerships between pharmaceutical and biotechnology companies were growing rapidly. The global pharmaceutical market is undergoing rapid transformation. There has been a dramatic shift towards emerging markets as western markets slow down.
Other companies cannot replicate the drug and therefore they are forced to either wait until the patent expires or they must find an alternative drug that carries out the same purpose.... ... middle of paper ... ... It is clear to see that there are many pros and cons to patents in the pharmaceutical industry.
My interest with Regulatory affairs started with the basics of subjects in my bachelor degree like Pharmacy Administration, Forensic Pharmacy, etc., and also some regulations included in subjects like Biopharmaceutics , Pharmacokinetics, and Dosage Form Design. A subject called Dosage Form Design & Novel Drug Delivery Systems helped me understand GMP, Quality Assurance and Evaluation of various types of Drugs and other health care products.
Throughout the history of biotechnology there have been so many wonderful achievements. There are currently more than three hundred biotech drug products and vaccines that are being clinically tested that target more than two hundred different diseases including Alzheimer’s disease, diabetes, and AIDS (Smith, 2005). Biotechnology is solely responsible for h...
The future of biotechnology can be seen as one that is relatively safe and guaranteed. Because the industry is constantly focused on the future, as long as there are always new innovations and goals to work towards (like cures for diseases and renewable energy sources), the industry will remain to be a key part of the United States and global economies. When looking at future forecasts for this industry, it is no wonder that venture capitalists, private investors and universities are looking to grant or invest large sums of capital to these firms; biotechnology products accounted for 21% of the total 714 billion dollars in the global market for prescription drugs in 2012, and is expected to grow to 25% by 2018. This substantial growth forecasted in a risky stock is what helps keep our economy healthy.